20 1 IJMEJan Mar2012 Libre

ISSN 0974 - 8466 (print)
ISSN 0975 - 5691 (online)
INDIAN JOURNAL OF
MEDIC AL ETHICS
Vol IX No 1 January-March 2012
(incorporating Issues in Medical Ethics, cumulative Vol XX No 1)
www.ijme.in
ENTERING OUR 20TH YEAR
Hunger, ethics and the right to food

Impact of disability certiicates on privacy and welfare
Ambiguities in the Declaration of Helsinki
Mainstreaming AYUSH: ethical and governance issues
Challenges in the regulation of medical education
Film review: 404-Error not found
INDIAN JOURNAL OF MEDICAL ETHICS
VOL IX NO 1 JANUARY-MARCH 2012
Editor Emeritus
Sunil K Pandya Looking back to move forward
Editor
Amar Jesani
Consulting Editor This apparently contradictory step may be inadvisable while crossing the street
Sandhya Srinivasan
or driving, but is essential for IJME when entering its 20th year of publication.
Editorial Coordinator
Meenakshi DCruz The same applies to any social organisation or movement, unless it wants to
Editorial Board replicate past blunders. India in the 21st century is becoming a battleield of
Divya Bhagianadh, Mumbai contradictions: the total population surges ahead while girls are going missing
Mala Ramanathan, Thiruvananthapuram in large numbers; massive stocks of foodgrains rot in the open while people
Nobhojit Roy, Mumbai
starve without the basic right to food being implemented; and a comprehensive
Prabha Chandra, Bangalore
Prathap Tharyan, Vellore scheme exists for integration of traditional medicine into healthcare, with little
Sanjay Nagral, Mumbai practical implementation on the ground. All these gaps have been analysed in
Sanjay A Pai, Bangalore this irst issue of 2012.
Editorial Advisory Board
Amit Sengupta, Delhi Can a research study which aims to reduce suffering caused by a serious health
Chhanda Chakraborti, IIT Kharagpur problem be said to be successful if it has exposed participants to unnecessary
Deepa Venkatachalam, Delhi
harm? A study from the 1970s has been revisited and discussed from varied
Dhanwanti Nayak, Manipal
G D Ravindran, Bangalore standpoints in this issue, re-examining the ethical standards of healthcare
Neha Madhiwalla, Mumbai research. Only public probing into the ethical responsibilities of researchers and
Parthasarathi Mondal, Mumbai clinicians, as also researcher-clinicians, can prevent current and future tragedies
Sridevi Seetharam, Mysore in the name of public welfare. We also need a medical education system which
Sujith Chandy, Vellore
selects and equips doctors to heal the sick in the best possible way. An editorial
Suneeta Krishnan, Bangalore
Vasantha Muthuswamy, Delhi and a comment both look into attempts to reform this system.
Vikram Patel, Goa
Vinay Chandran, Bangalore
Promising legislations await the attention of parliament in several areas. The
International Advisory Board draft National Food Security Bill has inally been tabled in the Lok Sabha, the
Aamir Jafarey, Pakistan culmination of a long struggle by several organisations. This is the right time
Aasim Ahmad, Pakistan to analyse them and press for improvements. We carry an analysis of the new
Abha Saxena, Switzerland
Mental Health Care Bill by a group of practitioners. We have also a strong plea
Aliya Naheed, Bangladesh
Angus Dawson, UK for removal of ambiguity in the Declaration of Helsinki on the existence of
Antony Zwi, Australia placebo-controlled trials so as to make universal standards in healthcare a real
Anurag Bhargava, Canada possibility.
Bashir Mamdani, USA
Bebe Loff, Australia With an issue bursting with energy and ideas, IJME wishes it readers a fruitful
Fatima Castillo, Phillipines and active new year, with the hope that the movement for ethical healthcare
Fiona Miller, Canada and research will stride ahead with increasing conidence.
Helen Sheehan, USA
Jacob Leveridge, UK
Julian Sheather, UK
Richard Cash, USA
Ruth Macklin, USA The Indian Journal of Medical Ethics (formerly Issues in Medical Ethics) is a
Sisira Siribaddana, Sri Lanka platform for discussion on healthcare ethics, with special reference to the
Solomon Benatar, South Africa problems of developing countries such as India. It hopes to involve all
Administration and Subscription cadres of, and beneiciaries from, this system, and strengthen the hands of
Santosh Tirlotkar ijmemumbaiATgmail.com
those with ethical values and concern for the underprivileged.
Editorial Correspondence
Meenakshi DCruz ijme.editorialATgmail.com The Journal is owned and published by the Forum for Medical Ethics Society,
a not-for-proit, voluntary organisation. The FMES was born out of an effort
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Prabhadevi, Mumbai 400 025 Editor: Amar Jesani
Indian Journal of Medical Ethics Vol IX No 1 January - March 2012
CONTENTS
Indian Journal of Medical Ethics
Vol IX No 1, January-March 2012
EDITORIALS
IJMEs 20th year: some new directions......................................................................................................................................................... 2
AMAR JESANI
The legacy of scandals and non-scandals in research and its lessons for bioethics in India ................................................................. 4
MALA RAMANATHAN, AMAR JESANI
MCIs VISION 2015 and PG medical selection: continuing to produce square pegs for round holes? ................................................. 7
PRABHA S CHANDRA, SOWMYASHREE
ARTICLES
International collaborative trials, placebo controls and The Declaration of Helsinki: need for clarification in Paragraph 32 ........ 13
AY MALIK, F GHAFOOR
Less equal than others? Experiences of AYUSH medical officers in primary health centres in Andhra Pradesh.............................. 18
JK LAKSHMI
Continuing oversight through site monitoring: experiences of an institutional ethics committee .................................................. 22
in an Indian tertiary-care hospital
YASHASHRI C SHETTY, PADMAJA MARATHE, SANDHYA KAMAT, URMILA THATTE
COMMENTS
Finding and using evidence that you can trust ....................................................................................................................................... 27
PRATHAP THARYAN
Hunger, ethics and the right to food ........................................................................................................................................................ 32
SRIJIT MISHRA
Attempts at regulation of medical education by the MCI: issues of unethical and dubious practices .............................................. 37
for compliance by medical colleges and some possible solutions
ANANTHAKRISHNAN N, SHANTHI AK
Disability certificates in India: a challenge to health privacy ................................................................................................................ 43
NN MISHRA, LS PARKER, VL NIMGAONKAR, SN DESHPANDE
Ethical aspects of public health legislation: The Mental Health Care Bill, 2011.................................................................................... 46
HARISH THIPPESWAMY, KAUSIK GOSWAMI, SANTOSH CHATURVEDI
CASE STUDY
Observational study of cervical cancer .................................................................................................................................................... 50
FROM CASEBOOK ON ETHICAL ISSUES IN INTERNATIONAL HEALTH RESEARCH
CASE STUDY RESPONSES
Knowledge vs ethics in clinical research in resource-poor settings: a clinicians perspective............................................................. 51
B SUBHA SRI
Lost opportunities ..................................................................................................................................................................................... 53
PRIYA SATALKAR
Observational research where it is most needed .................................................................................................................................... 57
SUJIT D RATHOD
Some ethical issues here: demands of informed consent and ethical justification for research ........................................................ 59
PRAVESH JUNG G
SELECTED SUMMARY
William Oslers medical ethics in the 21st-century ................................................................................................................................. 62
RICHARD L GOLDEN
REVIEWS
Back to the future: Towards a critical medical practice............................................................................................................................. 64
DHRUV MANKAD
Medical students as guinea pigs: 404 Error not found............................................................................................................................. 65
VIVEK JAIN, RASHMI NAUDIYAL
FROM THE PRESS ...................................................................................................................................................................................................................................10

FROM OTHER JOURNALS ....................................................................................................................................................................................................................66
LETTERS.................................................................................................................................................................................................................................................... 69
CLINICAL TRIALS WATCH .....................................................................................................................................................................................................................73
[1]
Indian Journal of Medical Ethics Vol IX No 1 January-March 2012
EDITORIALS
IJMEs 20th year: some new directions

AMAR JESANI
Trustee, Anusandhan Trust, Sai Ashray, Aaram Society Road, Vakola, Santacruz East, Mumbai 400 055 INDIA e-mail: amar.jesani@gmail.com
With this issue of January 2012, the Indian Journal of Medical Ethics (IJME) is entering its 20th year of uninterrupted publication. In
the last 19 years, the journal has never had to combine two issues, and has been published regularly in the irst month of each
quarter. This has been a remarkable feat for a journal on medical ethics and bioethics on a shoestring budget, with voluntary
contributions of time and material resources from individuals. IJME has been able to afford some part-time staff support only for
the last six years. More heartening than its survival has been the support, goodwill and enduring contribution of its readers and
well wishers from India and abroad. Their number is so large that to mention every one of them is impossible. Many may not even
like to be named as they have merely done what they considered right and relevant. Their support in the process of growth in
quality and content allowed the journal to contribute meaningfully to the debate on improving the health system, medical care
and the conduct of health professionals, and in the taking forward and strengthening of bioethics discourse in the country.
While the irst issue of the journal was published in August 1993, the processes that led to its publication began in 1989, with the
coming together of doctors and health activists to intervene in the healthcare system to improve ethical standards, and to bring
the concerns of patients, particularly of the most vulnerable segments, to the centre of healthcare. None of these individuals had
any formal training or qualiications in bioethics, but they were studying it in their practice, in research and in the discussion of
bioethics and the literature. The journal, therefore, became, not just a medium to share views, conclusions and research, but also
a platform to learn. Over the years, the sharing and learning aspects of the journal have only been strengthened, and that is what
we intend to consolidate.
In the beginning, most of us did not harbour any illusion that the journal would be able to carry on for long. In fact, we suffered
from insecurity and the fear that it would die in its infancy or in childhood. Its survival and growth was made possible through
sustained collective effort. With such support, over the last 19 years, IJME was carefully nurtured by four editors. Its executive
editor, who worked with exceptional dedication for 14 years (1998-2011) helped the journal to make the transition from an
amateur activity to a professional publication. However, all this was in the spirit of voluntarism, without having any of the
administrative and inancial support that professionally produced journals normally enjoy.
The dedicated efforts of these individuals, with the support of members of the editorial and advisory boards, both national
and international, and, indeed, of its writers and readers, have taken IJME from an 8-page newsletter in 1993 to a 64-page, peer-
reviewed, indexed journal. Increasing numbers of submissions, theme issues and special issues for activities like the National
Bioethics Conferences (three so far, in 2005, 2007 and 2010) on the platform of the journal, have often pushed the number
of pages to 80 and more than 100. In the year 2000, through voluntary contributions of time and resources by members,
the website of the journal was established, scanned copies of past issues were made available, and IJME became an online
open-access free journal. At present, the online edition is used substantially by interested readers. In 2010, the journal website
received 4.9 million hits, had 330,090 unique visitors with 434,180 visits with over one million pages being viewed and 192 GB
volume of material was downloaded.
The transition
The strength of IJME is its organic, gradual growth. It was not something that a commercial publisher with professional, highly
paid staff brought forth one ine day for everybody to read and appreciate. It has grown along with the consciousness and
commitment to ethics of health professionals and health activists. It has also grown alongside the development of bioethics as
a discipline in the country and in the developing world. Perhaps by being both a platform for expressing critical views on ethical
issues and a fully peer-reviewed indexed academic journal, it has been a part of bioethics activism as well as of the academic
development of bioethics. In that sense, its feet are irmly planted on the reality of the developing world and in movements
struggling to improve peoples health and uphold their rights.
[2]
In the future, as the journal builds on this strength, there are some changes in the ofing. These changes have been necessitated
for various reasons. Given the complexities and demands in terms of time and resources for ensuring effective and eficient
peer review of an increasing volume of submissions for publication, copy editing and many other complex components of the
production process, it is very dificult for only one or two individuals, despite their dedication, to do everything. We have to
gradually put in place a more complex division of labour and adopt the appropriate technology, including an online submission
management and production system. While this process started two years ago, we are now required to consolidate it by
establishing an independent ofice of the journal with some full-time support staff, and pay more attention to fund raising. This
will mean that some editors and members of the Forum for Medical Ethics (FMES) will have to commit more time to establishing
physical structures and work systems for the journal, and also make efforts to raise funds. At the same time, those who have
voluntarily shouldered the responsibility of work for the last several years needed a temporary break or respite from the heavy
workload they have attended to.
This 20th year is, therefore, devoted to such consolidation and transition. We are in the process of establishing an independent
ofice for the journal in Mumbai. In the coming year, we will strive to establish an on-line system for submission, review and
production. George Thomas, who has borne the responsibility of editing the journal for the last six years, has stepped down as
editor. Sandhya Srinivasan, who has done the back-breaking work of being executive editor for the last 14 years, will continue to
provide her expertise and guidance in editing the journal as consulting editor. We are in the process of enlarging the IJME editorial
and administrative teams to tackle the new challenges. Two new members have joined the editorial advisory board. We welcome
Dhanwanti Nayak, who is an anthropologist with a deep interest in the medical humanities. She teaches at the Manipal Institute
of Communication at Manipal University, Karnataka. We also welcome to the board Deepa Venkatachalam. Her key interests are
womens health, technologies and bioethics, and she works with the womens group Sama in Delhi. Another new member has
joined the international advisory board. We welcome Jacob Leveridge, who is school research facilitator at the University College
London, London, UK. We are very happy that these three members have joined us in IJME, and that their support and individual
contributions will enrich the journal. During the coming year, we also intend to invite other individuals to be guest editors of our
theme-based and special issues, to garner national and international bioethics expertise for the development of the journal.
Changes are also occurring in the FMES, the owner and publisher of IJME. This is essential as the FMES, as a non-proit society
and public trust, is actually a product of the medical ethics and bioethics movement, and is to some extent shaped by it. In 2011,
it invited many individuals from the bioethics movement to be its members, and is thus, involved in a process of transformation
from a small, primarily Mumbai-based group to a national level society. In addition, Vasantha Muthuswamy, the distinguished
bioethicist, will be taking over as chairperson of the FMES in the latter part of 2012.
The broadening of horizons around bioethics

The primary focus of the journal continues to be medical ethics and bioethics. From within the healthcare system, the ethical
concerns and issues of many healthcare professionals, such as nurses and AYUSH professionals, demand attention. In the pluralist
healthcare system of India, the quest for healthcare ethics must be enriched and strengthened by including their speciic issues
and concerns.
At the heart of the medical ethics and bioethics movement are the patients, the people, and the more vulnerable they are, the
greater the need to be ethical. Normative ethical guidelines, rules and regulations, therefore, ind their rationale only in so far
as they protect and empower the vulnerable in healthcare relationships. However, as our experiences in India and in many
developing countries testify, the mere existence of guidelines and rules and, for that matter, even laws and the power of regulators
are not, in themselves, suficient to improve ethical standards and professional conduct. The high pressure of work in the closed
environment of health institutions, the pursuit of excellence in technology instead of humane caring, the high status enjoyed
by medical professionals in society, their increasing wealth in the unregulated market of healthcare, etc, have insulated many of
them from the living reality of patients and the widening inequities in society. In such a context, those making efforts to achieve
an equity-based, humane healthcare system with universal access, are contributing to the strengthening of healthcare ethics. To
achieve this, systemic reforms, changes in the conduct of professionals, and greater involvement of patients, and the people in
general, in healthcare decision making is necessary. This process could be greatly enriched by interaction with the perspectives
of the social sciences, law, philosophy, art, literature, and the media. For the development of holistic and humanistic medicine, it
is crucial to open it to public scrutiny and the gaze of other professions. Those perspectives may vary but their interaction with
medicine will be mutually beneicial, leading to a better understanding and appreciation of each others contribution. More so
for bioethics, as it is multi-disciplinary, with medicine being only one component. Such interactions could contribute positively
in the acceptance and observance of ethics by healthcare professionals. They could also act to deepen and widen the processes
of building ethical guidelines and rules, which are often dominated by medical professionals. Therefore, IJME will endeavour to
expand its scope by including the ield of humanities in addressing issues in medical ethics and bioethics. We hope that such an
inclusive approach, will, without diluting our focus, enrich the journal as well as the concerns and disciplines it represents.
[3]
The legacy of scandals and non-scandals in research and its lessons for
bioethics in India
MALA RAMANATHAN1, AMAR JESANI 2
1
Additional Professor, Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Thiruvananthapuram,
Kerala 695 011 INDIA e-mail: mala@sctimst.ac.in 2 Trustee, Anusandhan Trust, Sai Ashray, Aaram Society Road, Vakola, Santacruz East, Mumbai 400 055 INDIA
e-mail: amar.jesani@gmail.com
A case study entitled Observational study of cervical cancer, on research undertaken in a south Asian country, published in a
compilation of case studies by Cash and others (1), is the subject of a collection of commentaries in this issue of IJME. The range
of responses relects the commentators individual disciplinary orientations and views on the state of medical practice in those
times, and the ethical standards that applied.
While reviewing this compilation of case studies, Macklin critiqued the use of historical case studies as they may not resonate
with knowledgeable physicians and researchers who would want material that is relevant to their current or future experience (2).
Another possible criticism is that case studies based on developed world scenarios may not seem as relevant to researchers from
developing countries working within developing world settings. They may respond with What if this happens in our setting?
rather than the more evocative There but for the grace of God, go I! which facilitates changes in perceptions and practices.
Bioethics training and international case studies

Indeed, the case studies employed in bioethics training within India, as well as in other parts of the world, are often international
research cases from developed countries on issues relevant in their contexts. They may also describe the experiences of
researchers from developed countries in the developing countries. As there are very few case studies identifying an Indian
location and research sponsored by Indian agencies, trainees from the Indian subcontinent may feel that violations in ethics
primarily occur elsewhere, and are perpetrated by others on our people.
This belief results in the reiteration of faith in our own morality and ethics, without the realisation that we can learn from
such scandals only after in-depth inquiries, research and debate. The history of the Belmont Report is rooted in the inquiry into
the Tuskegee study. This report initiated reforms in the way clinical research was conducted in the United States of America. It
is also part of the bioethics literature. However, inquiries and scandals that occurred in India are not the subject of bioethics
teaching in India. This is not because they do not occur, but because they are not written about, debated or discussed. This
shortcoming needs to be corrected and the truth needs to be told as part of the development of the bioethics movement in India.
We need to retell history, not as part of a witch hunt to blame or punish those involved, but to teach ourselves and set the record
straight, based on the adage: Those who cannot remember the past are condemned to repeat it.
The case study presented in this issue had women in different stages of dysplasia who were followed up for an extended period,
without treatment; even after evidence for offering such treatment became available. The research was based on the rational
assumption that it was important for a country with limited resources for health to determine which of the dysplasias would
develop into carcinoma in situ (CIS), thereby identifying the high risk cases who could be given preference in provision of
treatment. The study lasted 12 years. This again is reminiscent of the observational study of syphilis in African-American males in
Tuskegee, Alabama, USA. In the Tuskegee study syphilis patients had been observed for 40 years, without providing treatment.
Research similar to that described in the case study

We know of two research studies conducted in the 1970s and 1980s on carcinoma cervix that are similar to the case study
discussed in this issue. One well documented study that was acted upon and followed up was done in New Zealand. The other
was carried out in India.
The research project that was a matter of public debate in New Zealand was on carcinoma cervix but with slightly different
objectives and possible outcomes than the case study published in this issue. This was an observational study on the invasive
potentiality of cervical CIS initiated in the mid 1960s at the National Womens Hospital in Auckland; the patients were not offered
standard treatment. This study was brought to light in 1987, by two womens health activists and journalists, Sandra Coney and
Phillida Bunkle, through an article in New Zealands Auckland-based magazine Metro (3). Following a public outcry, this study
became the subject of a judicial enquiry by Judge Silvia Cartwright (4). The public hearings took place between August 1987 and
January 1988 and the report was released on August 5, 1988.
The indings of this inquiry set the pace for reform in medical research in New Zealand, and the understanding of ethics in health
research within the country (5). A system of research ethics committees in which 50% of members came from the lay public was
[4]
established; their functions included the supervision of clinical observational studies. A successful population-based cervical
screening programme based on cytological smears began. New Zealand enacted the Code of Patients Rights as a part of the
Health and Disability Commissioner Act, 1994. This provided an independent external enforcement system in the Ofice of the
Health and Disability Commissioner (6). Thus, the controversy, the inquiry, and subsequent follow-up created a lasting legacy that
enhanced patients rights and reformed medical practice.
The research carried out in India, like that in the case study published in this issue, observed women with cervical dysplasia,
without offering treatment. It was supported by public funds and carried out by Indian researchers, and it lasted over a decade.
The Indian medical and scientiic community was aware of the research when it was being carried out. After its completion in
1987, its indings were reported in international journals. At the time it was on in the 1970s and 80s, researchers would have
been aware of the international furore generated by the revelations about the Tuskegee trial. When the indings of the Indian
study were being published, the controversy regarding the New Zealand study was being reported in the medical literature. Yet,
there was no critical relection within the community of Indian researchers on what was not done; nor were measures taken to
provide recompense to the participants in the study. Instead, the country waited long for a public controversy. Ten years after the
completion of the study, when some participants started reporting to hospital with cervical cancer, a newspaper report revealed
that those participants were the ones who had not been provided treatment during or after the study, nor followed up in the long
term (7). The report described it as the use of women as guinea pigs. The researchers defended the study by saying that no one
died (8) due to any medical intervention as there was none. However, like any other big scandal on health and research, this one
too died down, was soon forgotten, and hardly anything has been written on it since then.
The perils of ignoring history

Among the cancers in India, carcinoma of the cervix is a major killer of women. There is absolutely no doubt that more research for
its prevention and treatment is needed in the country. Ours is also a resource-poor setting, and so the argument in justiication as
given in the case study can be applicable to the research that was done in India. Indeed, the identiication of dysplasia that would
most likely turn into CIS makes the intervention selective and thus resource saving. In the absence of evidence to the contrary, we
may assume that such good intentions motivated the researchers to undertake the study in India.
However, a research design based on observing the progression of disease in patients over a period without offering standard
treatment during or after the research exposes patients to the risk of suffering from that disease. Such a research design does not
offer any beneits to patients who are recruited only for the beneit of science and the beneit of future patients. This produces
a serious imbalance in the risk-beneit ratio. This imbalance does not get corrected even when researchers are conident of
obtaining written and witnessed informed consent from patients for participation. This inherent imbalance in risks and beneits
to participants caused harm to patients; and so the public furore it aroused was fully justiied. This situation could have been
prevented only by questioning this harmful research design, which could have forced the researchers to look for alternative
research designs to generate the kind of evidence they needed.
It has been argued that research of the kind described in the case study was essential for making treatment available to those
who needed it the most. However, the government, which sponsored the research, did not follow this up with a genuine
implementation of the universal cervical screening programme. Even a quarter century after the completion of the research, and
15 years after the reporting of the ethics controversy in the media, the universalisation of cervical screening with the provision of
treatment to those who need it the most remains a distant dream. If the research is described as sacriicing a few now in order
to save many millions later an argument deeply problematic in ethics and indeed unacceptable in this case sacriice did not
usher in the provision of real care for all women who needed it, though some did beneit from it.
Unethical research, even when it is on correctly identiied health problems and produces useful outcomes, not only poses
potentially serious harm to the participants, but also sometimes affects the priority accorded to these health problems. When a
few scientists and physicians show lack of respect for vulnerable participants, future potential participants and society in general
become suspicious of the motives and credibility of all researchers. Therefore, a short-lived media controversy on such research
is not suficient to correct the situation. What is needed is eficient and transparent investigation of such cases to bring out the
facts in public, making those responsible for violations accountable. Further there is a need to use the indings of these inquires
to improve the governance of research and ethics education of all stakeholders. Apparently, nothing of the sort that New Zealand
did was done in India. And despite the numerous other controversies in biomedical research after this study more so after 2005
when corporate- sponsored clinical trials increased in number the governance of research and ethics education remain abysmal
in India.
We have recently witnessed another controversy about ethics violations arising out of research into carcinoma of the cervix. This
relates to the manner in which the phase IV clinical trials and demonstration project on HPV vaccines used for the prevention of
carcinoma of the cervix were conducted. The public outcry surrounding it resulted in the suspension of the project and institution
of an inquiry to investigate ethics violations and the deaths of participants. Of course, the institution of an inquiry is a step forward
[5]
when compared with the handling of the earlier controversy on the research into this disease. However, the report of the inquiry
has still not been made public, though it was formally submitted to government by the committee. The facts of that research
still remain disputed due to such secrecy; nobody is held accountable for violations, and of course no learning for researchers
emerges from even such a controversial case (9).
Learning from history and ethics cases

On October 1, 2010, the United States secretary of state, Hilary Clinton, and the health and human services secretary, Kathleen
Sebelius, expressed regret and tendered their apologies to Guatemalans who were harmed by the US Public Health Service
sexually transmitted disease inoculation study of 1946-1948 (10). This was an outcome of painstaking research on the subject
done by a historian, Susan Reverby, which exposed the deliberate inoculation of infective agents into many Guatemalan people
as a part of a research project sponsored by US government agencies (11). One may say that an apology is insuficient to provide
solace to those who suffered, and to bring back respect to the community and the country. But an admission of error, and the
reaching out to those who suffered and their community, is a good beginning. One will want such apologies in all cases where
nations have violated ethics in research.
However, ethical practices and review in research, and the ability to learn from past mistakes, cannot be limited to a irst world
initiative, when the potential for unethical practices is universal. If we do not dust off old books on our own medical research,
identify lapses, document them and discuss them, we will fail the stakeholders of such research those who will participate either
as subjects or as researchers in future initiatives or as regulators of such research in India. It is for this reason that we decided to
publicise this case study and initiate discussion on it-- many decades after the event -- to obtain a better understanding of the
need for ethics in research, and to facilitate an understanding of the issues among future researchers within the country. A case
study of the kind published in this journal may not be suficient to go into all the issues in the actual research, but it should be a
suficient trigger for historians to re-examine these concerns.
References
1. Cash R, Wikler D, Saxena A, Capron A, editors. Casebook on ethical issues in international health research [Internet]. Geneva:World Health Organisation;2009
[cited 2011 Dec 13];124-5. Available from: http://whqlibdoc.who.int/publications/2009/9789241547727_eng.pdf
2. Macklin R. Casebook on ethical issues in international health research. Bull World Health Organ [Internet]. 2010 [cited 2011 Dec 13];88:716. Available from:
http://www.who.int/bulletin/volumes/88/9/10-078469/en/index.html
3. Rosier P. The speculum bites back: feminists spark an inquiry into the treatment of carcinoma in Situ at Aucklands National Womens Hospital. Reprod
Genet Eng [Internet].1989[cited 2011 Dec 13];2(2):121-32. Available from: http://www.inrrage.org/pdf_iles/RepTech%20General/Carcinoma_In_Situ.
pdf
4. Cartwright S. The report of the committee of inquiry into allegations concerning the treatment of cervical cancer at National Womens hospital and into other
related matters [Internet]. Auckland (New Zealand): Government Printing Ofice, Auckland; 1988 Aug 5[cited 2011 Dec 13]. 288p. Report No.:ISBN0-473-
00664-2. Available from: http://www.nsu.govt.nz/Current-NSU-Programmes/3233.aspx
5. Paterson R. The Cartwright legacy: shifting the focus of attention from the doctor to the patient. N Z Med J [Internet]. 2010 Jul 30 [cited 2011 Dec
13];123(1319):6-10. Available from: journal.nzma.org.nz/journal/123-1319/4239
6. Bunkle P. Patient-centred ethics, the Cartwright Inquiry and feminism: identifying the central fallacy in Linda Bryder, A history of theunfortunate
experiment at National Womens Hospital (2009, 2010). Womens Studies Journal [Internet]. 2010[cited 2011 Dec 13];24(2):8-24. Available from: http://www.
wsanz.org.nz/journal/docs/WSJNZ242Bunkle8-24.pdf
7. Mudur GS. ICMR let women guinea pigs get cancer. The Telegraph (New Delhi Ed). 1997 Mar 22.
8. Mudur GS. Gynaecologists refuse to buy no one died argument: Cancer trial stroke ethics debate. The Telegraph (New Delhi Ed). 1997 Mar 23.
9. Sarojini N, Shenoi A, Srinivasan S, Jesani A. Undeniable violations and unidentifiable violators. Econ Pol Wkly. 2011 Jun 11;46(24):17-9.
10. US Department of Health and Human Services [Internet].Washington DC: US Department of Health and Human Services. Joint Statement by Secretaries
Clinton and Sebelius on a 1946-1948 study; 2010 Oct 1[cited 2011 Dec 13];[about 2 screens]. Available from: http://www.hhs.gov/news/press/2010pres/
10/20101001a.html
11. Reverby SM. Normal exposure and inoculation syphilis: a PHS Tuskegee doctor in Guatemala, 1946-1948. J Policy Hist. 2011;23(1):6-28.
[6]
MCIs VISION 2015 and PG medical selection: continuing to produce square

pegs for round holes?
PRABHA S CHANDRA1, SOWMYASHREE2
1
Professor of Psychiatry, 2 PhD student, Neurosciences, National Institute of Mental Health and Neurosciences, Bangalore 560 029 INDIA Author for correspondence:
Prabha S Chandra e-mail: prabhasch@gmail.com
The need for better methods of selection for postgraduate (PG) medical seats in different specialties has never been more keenly
felt than in the current scenario. Multiple entrance exams, management quota and paid seats, the urgency to get into a PG seat
at any cost and the mushrooming of PG entrance exam coaching centres have added to the angst and woes of medical students.
Currently the Indian medical education system is one of the largest in the world with around 250 colleges fully recognised by the
Medical Council of India (MCI). The increasing demand for doctors trained in basic skills and the need to maintain the educational
system on par with global standards is quite challenging, considering all the hurdles which come in the way of improving quality.
One author of this editorial is a postgraduate teacher who has been involved in PG entrance examinations for several years and
the other a medical student who has appeared for 30 entrance exams in the last two years! We have also taken the opinions of
several students who have either got or not got a PG medical seat after going through several entrance exams across the country.
Based on this, we speculate on the problems of the current system, review the VISION 2015 proposed by the Medical Council of
India (MCI) to see if it improves the situation, and suggest some alternative strategies based on a review of literature on advanced
and superior methods of selection in some other countries (1).
Regarding the paper pattern for entrance exams, the current preference for multiple choice questions (MCQs) as a method of
selection was initiated to enhance objectivity. However, even as late as the 1980s and 90s, many institutions had recognised
the need for getting to know the candidate either through an interview or through a brief clinical assessment. If candidates
had qualiied in the theory entrance exam, they had to undergo a face to face interview or some form of clinical assessment in
several institutions. The suitability and aptitude of the candidate for the particular specialty would be discussed before the actual
selection. While not being entirely fool proof, it was probably more gratifying for the selection panel and the student and resulted
in a better it.
However, all these initiatives had to be abandoned in the name of objectivity and the use of only the MCQ test was proposed by
the MCI as the preferred method. An ability to solve MCQs, however, does not relect the abilities of a good doctor.
Unfortunately, what was considered as the best method has now resulted in a bit of a Frankenstein-like situation. Students start
worrying about a PG seat in the inal year of medicine, and the internship is spent not in gaining clinical skills but in preparing
for the entrance examinations. There are many students who, by their own admission, have not touched a patient during their
internship, nor written a single prescription.
Objectivity -- but at what cost?

The scope of the PG centralised entrance test (CET), as it is conducted today, does not include assessment for aptitude in the
specialty desired by the candidate. Hence, students tend to neglect their undergraduate education and concentrate on the CET.
The only deciding factor is the marks obtained in the CET, with the entrant accepting the subject available to her, not necessarily
the subject she has an aptitude for, or the one she likes. As a result, many students drop out of courses that they join and several
continue half-heartedly. All manner of scams are being revealed because of this method, including impersonation, students with
high marks giving up their seats for a price, and of course much money changing hands. This is unheard of in most developed
countries. Pursuing a medical specialty should be a calling and not a inancial deal, and the consequence should not be the
demoralisation of the medical student community.
Is there an alternative?
Several options exist and we have models from several countries which we can emulate. One possibility is to use marks obtained
in the MBBS exams. Since it would be dificult to assess in depth the expertise of the student in the desired subject, it would
be useful to consider the marks obtained by the student in that subject at the university examination. Monitoring the growth
in knowledge of students indicates the contributions made by the different training phases (2). An aptitude test would also be
useful, because that would match students to courses that require special skills, such as surgical courses, or those that require an
abiding interest and aptitude, such as psychiatry (3).
[7]
VISION 2015 does it provide any solutions?

The VISION 2015 document of the MCI suggests having an entrance examination soon after the inal MBBS examination and just
before internship. This has been proposed so that students are not preoccupied by the entrance exams during internship, and
focus more on clinical skills (1). Several students we spoke to felt that the new policy of having an exam after the inal MBBS will
only add to the students burden, as the exam is in an MCQ pattern while the inal MBBS exam is in a different format. They felt
that two months of preparation time would be insuficient and, in the process, students might neglect the inal MBBS exam and, in
turn, perform poorly at both exams. Most students we spoke to, including the second author of this paper, had written an average
of 30 entrance exams in a span of two years before getting admission into a PG course. In their experience, preparation to answer
MCQs is completely different from that for a theory paper. It is an interesting observation because it gives us some idea that MCQs
may not actually be testing the three attributes that they should be: knowledge, skills and aptitude of the doctor. Instead they
seem to test the ability to think in a multiple choice format.
VISION 2015 also states that, at the end of internship, the licentiate examination would assess skills. A laudable goal indeed and
much needed. However, this may not solve all the problems. It is not yet clear if this would happen as a common exam or would
be assessed at the level of individual medical colleges. What of students who did not qualify for PG seats before internship?
What if students who feel they are not completely prepared for entrance exams take a year off before exams for studies? These
situations may again lead to a waste of resources, with the hospitals lacking interns and patient care being affected.
VISION 2015 is silent about assessing aptitude, matching courses to candidates and also about enhancing objectivity in
assessment by methods other than the MCQ format of entrance examinations. There is also a lack of recognition of the
postgraduate as a professional and a leader, and a focus only on technical knowledge. Ideally, students who have some leadership
experience and those who have participated regularly in social/community health outreach programmes should receive extra
credit in selection criteria. This will bring recognition to non-academic activities, which positively hone the personality and outlook
of a doctor and are as important as knowledge. Research experience, conference presentations and/or publications in journals
should also provide bonus points to PG examination candidates. This will help encourage more medical student involvement in
research activities (4, 5). Rural work experience for a minimum number of years after completion of the MBBS is already being
used as a criterion by some state governments for providing priority in PG course admissions. This is one way of encouraging
fresh doctors to spend some time serving in underprivileged rural areas.
VISION 2015 addresses various reforms which have to be implemented to improve the existing educational system. However, the
students we spoke to felt that it would only minimally help in decreasing the existing burden on students in the race to get a PG
seat. More exams would only mean more stress.
The idea of having a new pattern of examinations with clinical questions is encouraging. However, we strongly feel that more
evidence is needed regarding the nature of questions and responses that actually tap knowledge and skills. Even though
hundreds of PG entrance exams have been conducted over the last several years, there is no database or research to guide
examiners who set questions for these exams. Which questions appear to be the more discerning, what is the distribution of the
nature of questions, what should be the right proportion of clinical versus theoretical questions and should all the questions
simply be in the `one of four choices format, or will any other format of MCQ work better? It is time that the MCI actually looked at
some of these issues and gathered evidence to guide future examiners.
Examinations at this level need to focus on an in-depth assessment of the students knowledge and competency. Questions with
multiple responses (with the possibility of more than one answer being correct) are much better than single correct response
MCQs in this regard (5). When a candidate attempts such a question with multiple answer options, it tests her in-depth knowledge,
observation skills and eficiency in time management. It often simulates a clinical situation where patients might present with co-
morbid conditions or multiple symptoms and signs relating to a medical condition.
Students also felt that the newer changed terms in the VISION 2015, for various courses will not help to improve the quality of
education. The proposed framework suggests introduction of a two year Master of Medicine (M Med) programme as the irst level
of specialisation with the focus on skill development and providing care to the community. These PG students will be trained
mainly to enhance clinical skills rather than being engaged in basic research. A second exam after M Med will select students for
an MD/MS. This would be a burden for students and many M Med students may again neglect learning skills in the process of
trying to get a good score for an MD/MS seat. Another issue not clearly addressed is whether M Med is like a diploma course in a
particular specialty, or a general training course in basic skills. If students have to prepare for another common exit exam after M
Med, they will have no time to learn anything in a particular specialty in a period of one year after M.Med. Some of them might
spend more than a year preparing for the PG entrance exam again.
Some questions, which are not addressed by the VISION 2015, but are important in the lives of medical students we interviewed
included:
[8]
l Would entry to all seats come through the common entrance test?
l Would there be reservations for seats as in the current selection pattern?
l What is the pattern of counselling?
l What would the fee structure be? Would each states fee structure be different?
l Will the current management quota for seats in private colleges continue?
l What about the private deemed universities and their seats?
l What if some states do not want to be bound by the common entrance exam?
l How will transparency be monitored?
Well-planned methods of selection in other countries

Most other countries with well-planned postgraduate or residency programmes focus on the assessment of clinical skills and
aptitude in addition to an MCQ paper for theory.
Several centres in the United States have one exam related to clinical skills. Here, they video record the whole exam session and
assess the student for all aspects of patient care -- history taking and examination, arriving at a diagnosis, explaining the prognosis
and also prescribing treatment. The US is also planning to introduce new guidelines and more marks for communication skills
from 2012. Students write letters to their universities of interest and once they get good percentile marks in the irst and second
steps of the medical licensing examination, they have interviews with deans of the various universities or the experts in the ield.
They are also required to send a letter of recommendation from doctors with whom they have previously worked. This process,
which is called `matching, is a good practice because candidates get to choose the subject of specialisation and also the university
where they want to study, and the universities are allowed to choose the students who they feel will it in with their system.
In some other countries, while there is no separate live assessment of clinical skills, there is an exam which includes interpretation
of videos, data tables, pathological slides and other investigations. This is a particularly good method for assessing aptitude and if
one uses the objective structured clinical examination format this can be objective.
However, this will require much thought, planning and training of large numbers of examiners across the country and some form
of standardisation. It is sad to see the medical graduates plight, following soon after a rigorous course like MBBS. The anxiety of
getting a PG seat and the inadequacies in the process of selection are a daunting combination.
It is customary in many decision-making bodies the world over to have consumers as part of the process. Maybe it is time to have
students and junior faculty as part of the VISION 2015 committee, to give an insiders view about what is actually happening in
the ield. This may help the potential PG student and bring about more modern and evidence-based methods of selection.
References
1. Medical Council of India. VISION 2015 [Internet]. New Delhi:2011 Mar [cited 2011 Dec 1]; Available from: www.mciindiia.org
2. van Leeuwen YD, Mol SS, Pollemans MC, van der Vleuten CP, Grol R, Drop MJ. Selection for postgraduate training for general practice: the role of
knowledge tests. Br J Gen Pract. 1997 June;47(419):35962.
3. Parulekar SV. Postgraduate entrance test reforms. J Postgrad Med. 2011;57:263-4.
4. Bhan A. Conduct of postgraduate medical entrance examinations: Amendments needed. J Postgrad Med. 2010;56:332-3.
5. Iyer DS, Bhan A. Postgraduate medical entrance system needs reforms. Natl Med J India. 2009 May-Jun;22(3):162-3.
[9]
FROM THE PRESS
Horror in hospital from: http://news.in.msn.com/national/article.aspx?cp-

In a shocking tale of medical negligence, a 28-year-old woman documentid=5563140. The Times of India, November 3,
suffered burn injuries after being cleaned with a toxic chemical 2011. Available from: http://timesofindia.indiatimes.
following her delivery. co m / c i t y / ko l k a t a - / Tox i c - w a s h - N u r s e - s u s p e n d e d /
articleshow/10600340.cms. Indo Asian News Service, Six
The incident occurred at Lalbag sub-divisional hospital in more babies die in Bengal Hospital, NDTV, November 11,
Murshidabad district of West Bengal on November 1, 2011 after 2011. Available from: http://www.ndtv.com/article/india/
the woman, Sikha Biwi, apparently delivered a dead child. six-more-babies-die-in-bengal-hospital-148773
Initially it was suspected that carbolic acid was used to rub

Gujarats polluted fields
her clean. Deputy chief medical oficer health Birendra Kumar
In some villages of Gujarat, borewells spew reddish brown
Show issued a statement: It was not done intentionally. The
water. Irrigated ields are contaminated with industrial efluents.
attendants washed the patient with the acid by mistake. The
Yet, say the villagers, the authorities have failed to bring to book
colour of the acid and the anti-infectant is almost similar. The
those responsible for this situation.
bottles somehow got mixed. A sweeper must have kept the
bottle of the acid there. It now seems that the liquid may not Residents of Nodhana in Bharuch district complain that seepage
have been acid but some other toxic chemical. from a nearby efluent channel has been contaminating their
ields for the last two decades. The Mukteshwar Mahadev
Even as the hospital claimed that the child was born dead;
Temple lake in Bharuch district has turned violet. 46 industries,
allegations that the baby boy died due to the toxicity of the mainly manufacturing chemicals and dyes, in Bharuch and
chemical have forced the Lalbag sub-divisional oficer to probe Vadodara districts, release treated efluent into the channel.
further into the matter. Residents claim that a number of these industries discharge
Meanwhile, West Bengal continues to hog the news for the untreated or partially treated wastewaters into the efluent
highest number of reported infant deaths in its state-run channel.
hospitals. In a re-run of the July 2011 incident when 21 babies The channel was built by Efluent Channel Project Limited
died in three days at the B C Roy Hospital, Kolkata, 45 babies (ECPL) in 1983 to carry treated efluent to the Gulf of Khambhat.
died in one week at two state-run hospitals in Kolkata and Currently, it is said to discharge 300 million litres of efluent
Burdwan from October 25 to 28, 2011. While 16 babies died at treated at a common plant, every day into the Gulf.
the BC Roy Childrens Hospital, the Burdwan Medical College
and Hospital reported 12 infant deaths. Following complaints from the villagers, the ECPL was reduced
from 55 km to 46.5 km in 2004 and the route of the remaining
Giving the hospitals a clean chit, the Minister of State for part of the channel passing through Nodhana was diverted
Health, Sudip Bandopadhyay, said, Ive totally given them a using an underground PVC pipeline. In May 2011, following a
clean chit because I believe that this is not due to negligence complaint from Nodhana panchayat that the pipeline had put
of the authorities . . . . Infant mortality rate in West Bengal is irrigated ields and water sources at risk, the Bharuch district
33 per thousand live births which is much better than other administration, along with the Gujarat Pollution Control Board,
states. Hospital authorities too maintain that there is nothing sent a notice to ECPL. ECPL, on the other hand, denies receiving
abnormal or unusual in the deaths because the babies, they any such notice.
claim, were brought in in an extremely critical condition.
Luna, a village situated along the 55 km long efluent channel,
However, underlining the poor health infrastructure in the State once known as the vegetable basket of western India, tells a
once again, six more babies died in a Malda district hospital similar story. The residents of the village and its surrounding
between November 9 and 10, 2011. areas in Padra taluk, Vadodara district, claim that their borewells
are not just contaminated but also illed with industrial
While probes are routinely ordered, the government is busy efluents. Luna, in fact, faces pollution not only from the channel
defending the hospital authorities, amidst the rising public but also from the industries located nearby. In May 2011, the
frustration at medical negligence. Central Pollution Control Board tested the groundwater and
surface water in the region and found that of the 108 borewells,
NDTV Correspondent, 45 infant deaths in one week in
as many as 45 were contaminated by efluents comprising lead,
West Bengal, Mamata silent NDTV, November 1, 2011.
mercury and ammoniacal nitrogen.
Available from: http://www.ndtv.com/article/india/45-
infant-deaths-in-one-week-in-west-bengal-mamata- However, according to the local administration in both the
silent-145579&cp. PTI, Nurses clean woman with acid districts, a survey on the health effects of the contamination is
after childbirth, msn News, November 2, 2011. Available still pending.
[ 10 ]
Anupam Chakravartty, Stinking for two decades, Down complications, the FDA said, thus opening up debates about
to Earth, November 30, 2011. Available from: http://www. newer contraceptives available for women.
downtoearth.org.in/content/stinking-two-decades.
Jef Feeley and Margaret Cronin Fisk, Bayer may have
Anupam Chakravartty, Polluters get away by making ad hoc
payments to farmers. Down to Earth, November 29, 2011. pitched birth control pill for unapproved use, Bloomberg,
Available from: http://www.downtoearth.org.in/content/ November 22, 2011. Available from: http://www.bloomberg.
polluters-get-away-making-ad-hoc-payment-farmers com/news/2011-11-21/bayer-may-have-touted-birth-
control-pills-for-unapproved-use-e-mails-show.html. Tracy
Staton, FDA study: newer contraceptives carry higher
Pill of contention
risks, Fierce Pharma, October 28, 2011. Available from:
Yasmin and Yaz, Bayer Pharmaceutical Companys popular http://www.fiercepharma.com/story/fda-study-newer-
oral contraceptives, also prescribed in India, are fast gathering contraceptives-carry-higher-risks/2011-10-28
lawsuits in the West. Several women have taken the company
to court for misleading them about the health risks posed by
Nursing their discontent
the pills. While Yasmin has been available in the US market
since 2004, Yaz, a spin-off of Yasmin, was approved by the US Around 250 nurses of the Asian Heart Hospital and
Food and Drug Administration (FDA) in 2006. neighbouring hospitals in Mumbai went on strike on October
19, following the suicide of a 22-year-old nurse, Beena Bebi,
Research on the pills has reportedly revealed that women of the same hospital. Beena was said to have been driven to
consuming them are prone to blood clots, heart attacks and suicide following harassment after she misplaced a patients
strokes. Bayer faces more than 10,000 lawsuits over problems ultrasound report. However, the tragedy set off a wave of
allegedly caused by these pills. The latest in the string of frustration among the nursing staff on issues such as a two-
accusations against Bayer is that it may have pitched the year bond they were compelled to sign, the coniscation of
Yasmin family of birth-control pills for unapproved use. their original certiicates, and the condition that they pay Rs
50,000 in case they wished to leave their jobs at the hospital
According to company emails that were made public following
before completing two years of service. They also complained
litigation, Bayer oficials had discussed how to promote Yaz as
of abusive treatment from their seniors at work.
a treatment for all kinds of premenstrual syndromes (PMS) not
just for premenstrual dysphoric disorder, for which regulators During the strike period the nurses were lathi-charged by the
had approved it. Apparently Bayer oficials sent emails to their police and 20 on-call nurses were evicted from their residential
sales people in 2006 saying that they should cite a Womens quarters at the hospital. As the majority of nurses were from
Day magazine article which said that Yaz was a safe PMS Kerala, two Members of Parliament from that state visited
treatment. Mumbai in an attempt to intervene and settle the dispute. They
also wanted the management to take responsibility for Beenas
According to the copy of the email produced, Matt Sample, a
death and send her body to her home in Kerala for the last
Bayer unit sales consultant wrote, This article is a nice way of
rites. Ultimately, the strike was called off after four days, with
using Yaz for PMS treatment instead of just focusing on the
some demands being granted: the revocation of the two-year
speciic class of women struggling against the most severe
bond and work experience certiicates to those with less than
form of PMS, that is.
two years service. These certiicates had earlier been given only
Besides the off-label marketing allegations, lawyers to those with more than two years of service at the hospital.
representing women suing Bayer have alleged that company However, the nurses are said to have had to undergo interviews
oficials withheld information from patients, doctors and and sign fresh contracts at the end of the strike, as also pay a
regulators about the drugs risk of causing blood-clots in their deposit of Rs 10,000. This was to be further supplemented by
rush for proit. Apparently, Bayers contraceptives generated Rs 1,000 being cut from their salaries every month, the whole
$ 1.58 billion in sales last year, making them the companys amount being forfeit in case they gave up their jobs in less than
biggest-selling drugs after Betaseron, a multiple sclerosis two years. The strike brought out the simmering resentment
medication. among the nursing cadre in even the more reputed private
hospitals in the city.
An FDA study reveals that contraceptives that contain a
particular synthetic hormone called drospirenone carry higher- DNA correspondent, Mumbais Asian Heart Hospital nurse
than-previously-thought-of risks of blood clots. Drospirenone commits suicide; others strike work, DNA October 19,
is an active ingredient in Bayers line of products. A study 2011. Available from: http://www.dnaindia.com/mumbai/
of 1.3 million Danish women revealed that pills containing report_mumbai-s-asian-heart-hospital-nurse-commits-
drospirenone were linked to a six-fold increase in dangerous suicide-others-strike-work_1600768 HT Correspondent,
blood clots. In a review of 800,000 American womens medical Asian Heart Hospital nurses call off four-day-long strike,
histories, the FDA found that women using Yaz had signiicantly Hindustan Times, October 23, 2011. Available from: http://
higher rates of blood clots than women using the older pills. www.hindustantimes.com/India-news/Mumbai/Asian-
However, women using Johnson & Johnsons patch, Ortho Heart-Hospital-nurses-call-off-four-day-long-strike/
Evra, and Mercks NuvaRing also experienced a higher rate of Article1-760527.aspx
[ 11 ]
Whats the right age for bariatric surgery? the next day, apparently of exhaustion. Balajis family said
Bariatric surgery on an eleven-month-old child in Mumbais he received medical aid only after a couple of hours. While
Breach Candy Hospital has set off a heated debate among thousands took part in this archaic test, 1,240 candidates
doctors on the ethics of such surgery on an infant. The child, fainted in the heat, according to Kishore Tiwari of the Vidarbha
already weighing 19 kgs at eleven months, was suffering severe Jan Andolan Samiti. Tiwari stated this to counter the forest
respiratory problems. She is said to have monogenic syndrome, oficials claim that Balaji may have died due to a kidney ailment.
a genetic disorder, which claimed the life of her brother at the The Samiti has approached the state human rights commission
age of 18 months. Given the loss of one child in the family, and to review the case and recommend compensation for Balajis
the inability to control the weight gain as she grew older, the family. It has also demanded that the Forest Department revise
family decided to go in for a sleeve gastrectomy, performed its recruitment rules and cut the length of the race.
by Dr Sanjay Borude. The doctor is quoted as saying that the On the intervention of the state human rights commission, the
surgery should control the babys weight gain for at least the department has now agreed to check all candidates after the
next three or four years. irst ive km before allowing them to continue. It will also make
However, others in the profession have expressed the view it compulsory for applicants to produce a itness certiicate
that since this is not a case of overeating, bariatric surgery before running. The department has defended itself saying that
may not have been the best option. They have said that since the stringent provisions of the Forest Conservation Act and
the genetic disorder continues to exist, merely reducing the the Wildlife Protection Act prohibit the building of roads in the
size of the stomach is unlikely to do much good. Another area forest area, hence the work requires men who are it enough
of doubt relates to the age of the patient. While India has no to function under such conditions. They claim such tests help
guidelines in place on the minimum age for bariatric surgery, in them to gauge a persons capacity for the job. The Commission
the US the minimum prescribed age is 18 years. is said to have asked for the rules to be revised in writing.
According to Dr Borude, She has already developed Meanwhile, the department has paid compensation of Rs two
respiratory problems due to which she has been suffering from lakh to Balajis family.
breathlessness. A little more weight can prove bad for her. He Yogesh Naik, 5-km risk test in forest job marathon,
added, The surgery could have been done later but the child Mumbai Mirror, October 26, 2011. Available
has to survive till then. We did not want to take any chances. from: http://www.mumbaimirror.com/article/2/
The childs parents, who are not well off, are happy that the 2011102620111026020201404bc6fe9f5/5km-%E2%
surgery, which was done free of charge, seems to have given 80%98risk-test%E2%80%99-in-forest--job-marathon.
her some hope of a normal future. html Mumbai Mirror Bureau, Yavatmal youth dies while
chasing forest job, Mumbai Mirror.com, September 21,
Jyoti Shelar, Infants fat surgery leaves docs divided,
2011. Available from: http://www.mumbaimirror.com/
Mumbai Mirror.com, November 25, 2011. Available from:
article/2/2011102620111026020201404bc6fe9f5/5km-
http://www.mumbaimirror.com/index.aspx?page=article&
%E2%80%98risk-test%E2%80%99-in-forest--job-
sectid=15&contentid=2011112520111125090939157b01b
marathon.html?pageno=1
23a8
Surviving an archaic test

Contributions from Maithreyi and from Meenakshi Dcruz
Desperate for a job, Balaji Trimanwar, the son of a Yavatmal
farmer, took part in a 26-km run, a required test for aspirants Compiled by Meenakshi Dcruz e-mail: meenakshidcruz@
to jobs as forest guards. Just 23, he collapsed in a pit and died gmail.com
[ 12 ]
ARTICLES
International collaborative trials, placebo controls and The Declaration of

Helsinki: need for clariication in Paragraph 32
AY MALIK1, F GHAFOOR 2
1
Wellcome Trust D Phil student, Ethox Centre, Department of Public Health, University of Oxford, Oxford, OX3 7LF UNITED KINGDOM e-mail: aisha.malik@ethox.ox.ac.
uk 2 Pakistan Medical Research Council, Sheikh Zayed Medical Complex, Lahore PAKISTAN e-mail: fghafoor99@hotmail.com
Abstract countries is of interest to pharmaceutical companies. These

Inequities in socio-economic and healthcare systems between companies reduce their costs substantially by conducting
developed and developing countries have been thrown into trials in developing countries. These factors together raise
sharp relief by globalisation. At the same time, pharmaceutical the possibility that patients in developing countries may be
companies have started conducting clinical trials in developing exploited (6-9), posing ethical challenges for researchers as well
countries in order to reduce their costs substantially. Together, as sponsors of clinical trials. Some of the challenges are related
these two developments create ethical challenges for sponsors to the provision of post-trial beneits to the host community,
and researchers of these trials. One such challenge is that the use of a placebo in the control arm, and treatment and
of placebo-controlled trials (PCTs). In this paper we analyse compensation for research-related injuries.
Paragraph 32 of the Declaration of Helsinki referring to PCTs, The Declaration of Helsinki (DoH) is a key document in the
identifying ambiguities in the wording, and then examine three ethics of international research involving human participants.
arguments presented by sponsors of PCTs in developing countries, It has been revised many times and each time important
in defence of such trials. These arguments are: (i) a placebo control questions of clariication have arisen. Paragraph 32 of the DoH
provides a definitive answer, and is therefore methodologically refers to the use of a placebo control.
superior; (ii) placebo-controlled trials are ethical because they
serve the principle of utility, and (iii) interpreting the best current In this paper we focus on the use of placebo-controlled trials
proven intervention as the local standard of care allows PCTs to (PCTs) in developing countries. It begins with an analysis of
be conducted, if the local standard of care is no treatment. We Paragraph 32 of the DoH, and is followed by the enumeration of
argue that PCTs are not methodologically superior; nor are they three justiications given in favour of PCTs, and our arguments
ethically defensible. Other trial designs conforming to the ethics of against them.
research are feasible; the reason for conducting PCTs is expediency.
We use the paradigm case of the short course azidothymidine
We further propose that, given the global applicability of the
Declaration of Helsinki, it is imperative to remove the ambiguities (AZT) trials in Africa as a backdrop to examine the arguments. In
in Paragraph 32. In the context of collaborative trials, when a 1994, more than 12,000 HIV positive pregnant women in Sub-
treatment exists, conducting PCTs is ethically unacceptable, Saharan Africa were enrolled in randomised controlled trials of
irrespective of the geographic location of the trial. Universal a treatment regimen to prevent mother-to-child transmission
standards ought to be applied universally. of HIV. Randomised controlled trials are considered the gold
standard of research in order to establish the safety and
eficacy of a drug. This treatment regimen using a short course
Introduction
of the drug AZT was based on the 076 regimen that had been
Globalisation has brought to the fore inequities in socio- found effective, a little earlier, by the AIDS Clinical Trials Group
economic and healthcare systems in the developed and study 076. The 076 regimen was available to patients in the
developing worlds (1-2). Health spending in the least developed world. However, the short course regimen would be
developed countries is US$11 per person per annum compared much cheaper than 076. Of the 12,000 women, half were given
to US$1,900-2,000 per person per annum in high income the test drug (short course AZT) and half were given placebo.
countries. The expenditure in the former is well short of the This provoked a heated international controversy on the ethics
US$30-40 per person per annum recommended by the World of conducting placebo-controlled trials when an effective
Health Organisation (3), required to cover basic treatment treatment 076 existed in the sponsoring country (10-11)
and care for major communicable diseases like HIV/AIDS, TB and eventually led to a number of revisions in the Declaration
and malaria (4). Thus, in resource-poor countries, the meagre of Helsinki.
amount allocated for healthcare results in minimum healthcare
provision sometimes none for its citizens. This creates a Finally, we conclude that Paragraph 32 of the DoH must state
situation in which patients may view enrolling in a trial as the unequivocally that conducting a PCT when treatment exists
only way to access healthcare (5). From another point of view, is ethically tenuous, irrespective of the geographic location of
the large pool of potential research participants in developing the trial.
[ 13 ]
The Declaration of Helsinki trials is permissible, even though the proven intervention exists
The Declaration of Helsinki is the leading international in the sponsoring country.
standard of ethical principles for medical research involving Third, the confusion is further aggravated if we permit PCTs for
human participants (12). Since it was irst issued in 1964, it has compelling and scientiically sound methodological reasons.
undergone a number of revisions. The latest revision addresses These reasons too can be arbitrary. For example, some sponsors
issues related to post-trial beneits, research-related injuries and researchers may have dificulty in designing non-placebo-
and the use of a placebo control. controlled trials for developing countries.
However, the DoH has not resolved the question of whether Following from the discussion above, depending on the
the use of placebos in collaborative trials is ethical when interpretation of the phrases, placebo-controlled trials may or
there is a proven intervention in the sponsoring country for may not conform to the DoHs ethical guidelines.
the condition that the experimental drug will treat. (This is
of concern because in such circumstances, participants on Various arguments are made to support the use of PCTs in
placebo would be deprived of an effective treatment, thus developing countries even though an effective intervention
subjecting them to harm.) As a result, PCTs are still conducted exists for the condition to be treated. We discuss these below.
and the debate on the ethics of PCTs is ongoing (13-17).
I. Placebo control and definitive answers
The DoH was last revised in October 2008. One important
clariication was in Paragraph 32 concerning PCTs. The One argument in support of a placebo control is that comparing
paragraph now reads: the test drug with a placebo provides a deinitive answer to
the eficacy of that drug; PCTs will show an absolute beneit.
The beneits, risks, burdens and effectiveness of a new Interpreting paragraph 32 as referring to the geographic
intervention must be tested against those of the best current location where no treatment exists and supporting it for a
proven intervention except in the following circumstances: compelling and scientiically sound methodological reason,
l The use of placebo, or no treatment, is acceptable in studies
it is argued that a PCT, unlike an active control trial (in which
the control group is given another, effective drug), provides
where no current proven intervention exists; or
a deinitive answer to the eficacy of the test drug (19). This
l Where for compelling and scientifically sound methodological implies that PCTs are able to distinguish between active and
reasons the use of placebo is necessary to determine the inactive treatments and therefore methodologically superior
efficacy or safety of an intervention and the patients who (20). Any study that shows the superiority of a treatment to a
receive placebo or no treatment will not be subject to any control (whether placebo or active therapy) provides strong
risk of serious or irreversible harm. Extreme care must be evidence of the effectiveness of the new treatment (21).
taken to avoid abuse of this option. (18: para.32)[emphasis Therefore, conducting a PCT would provide a deinitive answer
added] and validate the provision of a proven effective test drug in
Below, we argue that the interpretation of these phrases is not the host country (as in the PCTs of short course treatment
self-evident and, in the context of international collaborative to prevent HIV transmission in Africa); governments require
research, these guidelines do not provide clear guidance. convincing evidence about treatment eficacy in order to make
sound public health policy decisions regarding allocation of
First, it is not clear what the locale is of the best current proven
funds (22-23). However, a concern here is that since PCTs can
intervention against which the new intervention is to be tested.
only answer the question of whether something is better than
It could be the current proven intervention in the sponsoring
nothing, even minimal eficacy would appear magniied.
country or the current (usual and available) intervention in the
host community where the patients are enrolled. We suggest that alternative trial designs can be formulated
in which an effective treatment (available in the sponsoring
Second, it is not clear whether the phrase studies where no
country) is provided to the control group. Conducting this
current proven intervention exists refers to the geographic
active control trial would establish whether the investigational
location of the study, that is, when a study is conducted in
intervention is better or worse than, or equivalent to, the
locations where no current proven intervention or treatment
standard treatment in eficacy and safety (24-25). And that is
exists. It can also be interpreted to refer to the disease under
what needs to be known: how does the new drug fare when
investigation for which no current treatment exists anywhere,
compared with what we are using at present?
and the purpose of the trial is to ind a treatment. If the phrase
means the latter, then the use of a placebo for the control group A second alternative to PCT is using information sources
is acceptable. However, if the phrase refers to the geographic external to the trial, which can provide a valid and reliable basis
location of the studies, then it feeds into the assumption for evaluation of the new drug (21). This information can be
that a placebo control is permissible in studies conducted in from historical controls. Yet another methodology could be to
locations where no treatment for that particular disease exists. start with a small cohort of patients and as soon as the eficacy
In the context of international collaborative trials, it leads to the of the intervention is determined, the data monitoring and
inappropriate conclusion that in countries where no proven safety board could expedite the use of the new drug for the
intervention currently exists, conducting placebo-controlled rest of the patients. We suggest this possibility based on the
[ 14 ]
protocol followed by Sperling et al (26). in developing countries was used by researchers in developed
countries to create more effective treatment regimens for
Therefore, if paragraph 32 were interpreted to refer only to
patients in developed countries (38).
diseases for which no treatment exists anywhere, this would
represent a justiiable, ethical, use of placebo controls. Once a Placebos and non-maleficence
treatment becomes established, the new drug regimen must
be tested against it (27-28).This ought to be implemented PCTs are also beset by another consideration that is both
wherever collaborative research is conducted, reiterating the practical and ethical: participants in a trial need to be informed
ethical interpretation of the phrase; to deny patients effective that during randomisation they may be assigned to the
treatment in order to inluence health policy is as bad in placebo arm. However, potential participants may be more
developing countries as it is in developed countries (13). likely to consent to a trial where they are certain to receive an
active treatment than they are if they might get a placebo
(31: 43). There may be problems of noncompliance when
II. Placebo controls and ethics
these patients either do not take the placebo medicine, or
The second argument in favour of conducting a PCT is based on withdraw, or covertly seek treatment (31). As stated earlier, it
a principle of ethics, that of utility, which is to always produce is the provision of treatment that impels patients to enrol in
the maximal balance of positive value over negative value. many trials in developing countries (5, 39-41). Even Miller and
Resnik argues that PCTs provide quicker and more reliable Brody who are proponents of PCTs write: placebo controlled
answers to scientiic questions PCTs are more eficient (29). trials raise ethical concerns insofar as they have the potential to
However, using a utilitarian calculation to justify placebo use exploit the research participants by exposing them to excessive
in conditions that result in morbidity, and/or mortality, violates risks from placebo assignment.(42:8).
the principle of beneicence, even if consent is obtained (30).
Resnik further argues that ethical principles sometimes conlict Placebo and equipoise
with the scientiic rigour of the trial: this argument was based
An ethical prerequisite for starting a randomised controlled trial
on the assumption that PCTs are methodologically superior
is clinical equipoise, a state in which the medical community, on
and hence beneicence and informed consent may be trumped
the basis of available data, is equally poised between the two
by scientiic rigour, justice and social utility(29:298).
treatments being tested. According to Freedman et al:
However, as shown above, in order that the principle of utility
(and beneicence) is not compromised, alternative trial designs As a normative matter, it deines ethical trial design as
can be formulated. Moreover, statistical analysis shows that the prohibiting any compromise of a patients right to medical
number of participants required in an active control trial and a treatment by enrolling in a studythese principles allow for
placebo-controlled one is similar (17, 31-32). testing new agents. At the same time they foreclose the use
of placebos in the face of established treatment. (32: 244-5)
It is noteworthy that the phenomenon of placebo effect,
wherein the placebo mimics the active drug response (33), If the phrase studies where no current proven intervention
can contribute to the variability in outcome data (34). This has exists is interpreted to mean the location of the trial where no
implications: if the placebo effect is strong then the number of treatment exists, then by conducting PCTs, the indeterminacy of
patients required to overcome this effect will increase (35). treatment options is lost; that is, equipoise does not exist because
when one compares the test drug with no treatment (placebo)
Placebos and justice then the advantages of the former over the latter are already
established: placebos cannot treat a disease. Furthermore,
The principle of justice may be violated by conducting PCTs.
randomised controlled trials are phase 3 trials (phase 1 being
It is plausible that if an active control trial in developing
primarily for safety and phase 2 for safety and eficacy on small
countries identiied effective but less expensive and less toxic
numbers of participants) by which time preliminary data from
drugs, then these regimens would be implemented in the
earlier phases provides some information about the potential
developed world (36). Or if the superiority of one drug were
beneits of the test drug (43) that would suggest that the new
to be established over the other when both ran against each
therapy is better than placebo (44). We argue that conducting a
other, the result could have implications, both therapeutic
PCT in the light of such evidence -- where equipoise is lost -- is
and economic, in developed countries (37). This can have
ethically tenuous. Since science and ethics are not separate, it is
major inancial implications for companies that have already
necessary that in conducting research on human participants
established a market for one drug. If the cheaper regimen turns
out to be more effective than the established treatment, or if the scientiic merit of the research must be matched by the
it turns out to be equally effective, then the companies could ethical merit of the work (45-46).
lose substantially. In the case of the HIV/AIDS trials, the success
rate in reducing mother-to-child transmission was considerably III. Placebo control and standard of care
higher in developed countries where the 076 regimen was in This argument in favour of PCTs depends on ambiguities in the
use; but not in developing countries, where a short regimen DoH. In the past the current proven method was interpreted
was in use. However, the point to note here is that the as standard of care (in its narrow interpretation) which was
knowledge generated through the use of the short regimen again subjected to varied interpretations. Depending on the
[ 15 ]
frame of reference, it meant either standard medical practice boards. Therefore, if conducting placebo-controlled trials in
in the host country or the universal standard of care if the the sponsoring country is unethical, then exporting them to
frame of reference was a practice with widespread acceptance developing countries is also unethical (53); in other words, the
among the medical profession worldwide. In other words, researchers and sponsors are guilty of double standards.
it was a normative standard set by the judgement of experts
Sponsors of collaborative trials, interpreting the phrase
in the medical community, and not a description of the local
studies where no current proven intervention exists as the
practice (47).
locale of the study where no treatment exists and buttressing
Similarly, if the phrase studies where no current proven it on scientiically sound methodological reasons could
intervention exists is interpreted by sponsors as: studies then conduct a PCT(6). As established earlier, this claim is not
conducted at locations where no treatment exists; by based on scientiically sound reasoning, nor is it ethically
deduction, placebo control is acceptable. This argument valid, hence its removal brings to the surface other reasons
resonates with the claims that in Sub-Saharan Africa, the for misinterpreting Paragraph 32 and conducting PCTs in the
local standard of care was no treatment and hence use of developing world. These are exclusively based on expediency:
placebo was justiied (37) and left no woman worse off; on inancial advantage and ease in enrolling patients (7, 9,
the contrary at least some beneited from the test drug (23, 30,50,54). In developing countries, research participants lack
48). An argument like this would be unacceptable to ethics of knowledge regarding disease and their rights places them
committees in a developed country which do not allow PCTs in a position where the interests of science and the common
when effective treatment exists, even though these treatments good can take precedence over the research participants
are not accessible to a substantial number of their people own well being (55-56). However all research subjects are
(49). If antibiotics are not available in a community, it does not entitled to minimum guarantees that are transnational and
mean that the standard care for infections in this community non-negotiable (57:545). Concerns have been raised that some
is no treatment; since the standard care for infections is sponsors and researchers, by conducting unethical research,
antibiotics. All it means is that the drugs are not available in denigrate the integrity of those who perform ethical research
that community, and this non-availability is determined by (58). In the HIV/AIDS trials conducted in Sub-Saharan Africa, of
vested interests driven by economic considerations (50). No the 12,000 women participating, 6,000 received the test drug
standard can be set in circumstances of deprivation and iscal and beneited. The other 6,000 received placebos -- in others
constraint, and the argument that no treatment is standard words they received nothing. Thus, the researchers knowingly
care at a certain locale is a misinterpretation of Paragraph 32 failed to minimise harm to those research participants (53).
of DoH, used to substantiate the use of placebos in the control
group. When the reason for conducting PCTs in a developing country
is inancial, it is necessary to remember that healthcare
The phrase studies where no current proven intervention provision in developing countries is minimal and sparse. In
exists could be misinterpreted to strengthen the arguments such circumstances, it has been argued, high standards should
for conducting PCTs in developing countries (as did the be set by bringing in new resources to deal with old problems
standard of care debate) but this would contravene the DoHs (59). The wide disparities in the healthcare systems of the
more unambiguous paragraph: it is the duty of the physician developed and developing countries require a commitment
in medical research to protect the life, health and dignity of the so that people in the latter also beneit from scientiic and
subject(18: para.11). The guidelines have been formulated so economic progress and not just peripheral beneits (60). A step
that the subjects welfare is not subordinated to the objectives forward would be if each successive research project were to
of the research and came into being as a consequence of leave the host community beneitted; over a period of time a
(some) scientists misadventures. Now, the moral obligation is to cumulative effect would help reduce this inequity (30).
avoid acts that would contravene the deontological imperative
of the medical profession to do no harm. Conclusion
Although Ellenberg and Temple make exceptions to the use of Pursuing the path of least resistance in order to expedite
placebo controls in conditions where temporary discomfort trials jeopardises the lives (and liberty) of patients living in
may occur; omitting proven therapy is not an option where developing countries; it is morally (and ethically) commendable
morbidity and mortality may result (51). A trial which places to design trials (and policies) that help reduce inequities
the trial participants life and health in jeopardy by using less between developed and developing countries and do not
than the effective standard treatment would not be permitted promote double standards. The purpose of revising the
in the sponsoring country; because the local standard of care Declaration of Helsinki is to remove ambiguities and prevent
is the same as the universal standard of care so anything less the conduct of unethical trials. Members of the scientiic
would not have suficient social value to justify its risks(48:926). community and ethics review committees ought to be
Arguably, there are marginalised people in sponsoring sensitive to the health needs (and rights) of their fellow citizens.
countries who do not have access to standard healthcare (52). They should enter into deliberations so that each successive
Even so, the use of a placebo (in the presence of a proven trial reduces health inequities between the developed and the
intervention) would not be approved by their ethics review developing worlds. It is a normative requirement that universal
[ 16 ]
standards ought to be applied universally. 22. Crouch R, Arras JD. AZT trials and tribulations. Hastings Cent Rep. 1998
Nov-Dec;28(6):26-34.
References 23. Grady C. Science in the service of healing. Hastings Cent Rep. 1998 Nov-
1. Wagstaff A. Poverty and health sector inequalities. Bull World Health Dec; 28(6):34-8.
Organ. 2002;80(2):97-105. 24. Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJ. CONSORT Group.
2. Rosenfeld R, Tongia R, Sherwani J. HealthLine offers speech-based Reporting of non inferiority and equivalence randomised trials: an
access to health information [Internet]. Microsoft Research. 2007 [cited extension of the CONSORT statement. JAMA. 2006 Mar 8;295(10):1152-
2011 Nov 28]. Available from: http://research.microsoft.com/en-us/ 60.
collaboration/papers/carnegie_mellon.pdf 25. Testing equivalence of two binomial proportions. In: Machin D, Campbell
3. Population reference bureau. Improving the health of the worlds poorest MJ. Statistical tables for the design of clinical trials. Oxford, England: Black-
people [Internet]. Population reference bureau. 2004 [cited 2011 Nov 28]. well Scientiic.1987.35-53.
Available from: http://www.prb.org/pdf04/ImprovingtheHealthbrief_ 26. Sperling RS, Shapiro DE, Coombs RW, Todd JA, Herman SA, McSherry GD,
Eng.pdf OSullivan MJ, Van Dyke RB, Jimenez E, Rouzioux C, Flynn PM, Sullivan JL.
4. Anyanwu J, Erhijakpor AO. Health expenditures and health outcomes Maternal viral load, zidovudine treatment, and the risk of transmission of
in Africa. Economic research working paper no 91[Internet]. African human immunodeiciency virus type 1 from mother to infant. Pediatric
Development Bank; Tunisia:2007 Dec[cited 2011 Nov 28]. Available AIDS Clinical Trials Group Protocol 076 Study Group. N Engl J Med. 1996
from: http://www.afdb.org/ileadmin/uploads/afdb/Documents/ Nov 28;335(22):1621-9.
Publications/26820442-EN-ERWP-91.PDF 27. Weijer C. The ethical analysis of risk. J Law Med Ethics. 2000
5. Kahn J. A nation of guinea pigs [Internet]. Wired: [place unknown]; 2006 Winter;28(4):344-61.
[cited 2011 Nov 28]. Available from: http://www.wired.com/wired/ 28. Weijer C. Anderson JA. The ethics wars. Disputes over international
archive/14.03/indiadrug.html research. Hastings Cent Rep. 2001 May-Jun;31(3):18-20.
6. Rowland C. Clinical trials seen shifting overseas. Int J Health Serv. 29. Resnik DB. The ethics of HIV research in developing nations. Bioethics.
2004;34(3):555-6. 1998 Oct;12(4):286-306.
7. Glickman SW, McHutchison JG, Peterson ED, Cairns CB, Harrington 30. Benatar SR, Fleischer T. Ethical and policy implications of clinical drug
RA, Califf RM, Schulman KA. Ethical and scientiic implications the trials conducted in developing countries. Harvard Health Pol Rev.
globalization of clinical research. N Engl J Med[Internet].2009 Feb 2005;6(1):97-105.
19[cited 2011 Dec 13];360(8):816-23. Available from: http://www.nejm. 31. Howick J. Questioning the methodologic superiority of placebo over
org/doi/full/10.1056/NEJMsb0803929 active controlled trials. Am J Bioeth. 2009 Sep;9(9):34-48.
8. Hundley K. The latest industry being outsourced to India: clinical 32. Freedman B, Weijer C, Glass KC. Placebo orthodoxy in clinical research.
drug trials. Tampa Bay Times [Internet]. 2008 Dec 14[cited 2011 Nov I: Empirical and methodological myths. J Law Med Ethics. 1996
25]. Available from: http://www.tampabay.com/news/business/ Fall:24(3):243-51.
article934677.ece 33. Benedetti F, Mayberg HS, Wager TD, Stohler CS, Zubieta JK.
9. Bailey W, Cruickshank C, Sharma N. Make your move: taking clinical trials Neurobiological mechanisms of the placebo effect. J Neurosci. 2005 Nov
to the best location [Internet]. 2009[cited 2011 Nov 28];56-62. Available 9;25(45):10390-402.
from: http://graphics.eiu.com/upload/gtf/1571871942.PDF 34. Oken BS. Placebo effects: clinical aspects and neurobiology. Brain. 2008
10. Angell M. The ethics of clinical research in the Third World. N Engl J Nov; 131(Pt11): 2812-23. Epub 2008 Jun 21.
Med. 1997 Sep 18;337(12):847-9. 35. Friedman JH, Dubinsky R. Patient page. The placebo effect. Neurology,
11. Lurie P, Wolfe S. Unethical trials of interventions to reduce perinatal 2008 Aug 26;71(9):e25-6.
transmission of the human immunodeiciency virus in developing 36. Annas GJ, Grodin MA.Human rights and maternal- foetal HIV transmission
countries. N Engl J Med. 1997 Sep 18;337(12):853-6. prevention trials in Africa. Am J Public Health. 1998 April;88(4):560-3.
12. Kimmelman J, Weijer C, Meslin EM. Helsinki discords: FDA, ethics, and 37. Levine RJ. The best proven therapeutic method standard in clinical
international drug trials. Lancet. 2009 Jan 3;373(9657):13-4. trials in technologically developing countries. IRB.1998 Jan-Feb;
13. Rennie S, Sturmer T. Strengthening Howicks argument against the 20(1):5-9.
methodological superiority of placebo-controlled trials. Am J Bioeth.2009 38. Landes M. Can context justify an ethical double standard for clinical
Sep;9(9):62-4. research in developing countries? Global Health. 2005 Jul 26;1(1):11.
14. Mudur G. Indian study sparks debate on the use of placebo in psychiatry 39. French HW. AIDS research in Africa: juggling risks and hopes. New York
trials. BMJ. 2006 Mar 11;332(7541):566. Times[Internet]. 1997 Oct 9][cited 2011 Nov 27]. Available from: http://
15. Polman C, Reingold S, Barkhof F, Calabresi PA, Clanet M, Cohen JA, Cutter www.nytimes.com/1997/10/09/world/aids-research-in-africa-juggling-
GR, Freedman MS, Kappos L, Lublin FD, McFarland HF, Metz LM, Miller risks-and-hopes.html?pagewanted=all&src=pm
AE, Montalban X, OConnor PW, Panitch H, Richert JR, Petkau J, Schwid 40. Edejer TT. North-south research partnership: the ethics of carrying out
SR, Sormani MP, Thompson AJ,Weinshenker BG, Wolinsky JS. Ethics of research in developing countries. BMJ. 1999 Aug 14;319(7207):438-41.
placebo controlled clinical trials in multiple sclerosis: a reassessment. 41. Lemmens T, Miller PB. Avoiding a Jekyll and Hyde approach to the ethics
Neurology. 2008 Mar 25;70(13Pt 2):1134-40. of clinical research. Am J Bioeth. 2002 Spring;2(2):14-7.
16. Valeo T. Trialists Debate: Are randomised placebo-controlled trials 42. Miller FG, Brody H. What makes placebo-controlled trials unethical? Am
always ethical. Neurology Today. 2010 Jul 15;10(14):20-1. J Bioeth. 2002 Spring;2(2):3-9.
17. Michels K B, Rothman KJ. Update on unethical use of placebos in 43. Malik AY. Physician-researchers experiences of the consent process
randomised trials. Bioethics.2003 Apr;17(2):188-204. in the asociocultural context of a developing country. AJOB Prim
18. World Medical Association. Declaration of Helsinki. Ethical principles Res[Internet].2011[ cited 2011 Dec 11];2(3):38-46. Available from: http://
for medical research including human subjects [Internet]. France: dx.doi.org/10.1080/21507716.2011.616183
WMA;2008 [cited 2011 Nov 28]. Available from: http://www.wma.net/ 44. Levine C, Dubler NN, Levine RJ. Building a new consensus; ethical
en/30publications/10policies/b3/index.html principles and policies for clinical research on HIV/ AIDS. IRB. 1991 Jan-
19. Varmus H, Satcher D. Ethical complexities of conducting research in the Apr;13(1-2):1-17.
developing countries. New Engl J Med. 1997 Oct 2;337(14):1003-5. 45. Koski G, Nightingale SL. Research involving human subjects in
20. ICH expert working group. ICH harmonized tripartite guideline- developing countries. N Engl J Med. 2001 Jul 12;345(2):136-8.
choice of control group and related issues in clinical trials- current 46. Benatar SR. Relections and recommendations on research ethics in
step 4 version [Internet]. ICH; 2000 [cited 2011 Nov 28]. 35p. Available developing countries. Soc Sc Med. 2002Apr;54(7):1131-41.
from: http://www.ich.org/ileadmin/Public_Web_Site/ICH_Products/ 47. Macklin R. Double standard in medical research in developing countries.
Guidelines/Eficacy/E10/Step4/E10_Guideline.pdf Cambridge: Cambridge University Press;2004 Jun 21.263p.
21. Temple R, Ellenberg S. Placebo-controlled trials and active-controlled 48. Wendler D, Emanuel EJ, Lie RK. The standard of care debate: can research
trials in the evaluation of new treatments. Part I: ethical and scientiic in developing countries be both ethical and responsive to those
issues. Ann Intern Med. 2000 Sep 19;133(6):455-63. countries health needs? Am J Public Health. 2004; 94(6):923-8.
[ 17 ]
49. Kottow MH. Who is my brothers keeper? J Med Ethics. 2002 Feb;28(1):24- in developing countries. J Clin Ethics.1998 Summer;9(2):156-66.
7. 57. Studdert DM, Brennan TA. Clinical trials in developing countries: scientiic
50. Schuklenk U. The standard of care debate: against the myth of an and ethical issues. Med J Aust. 1998 Nov 16;169(10):545-8.
international consensus opinion. J Med Ethics. 2004 Apr;30(2):194-7. 58. Glickman SW, Cairns CB, Schulman KA. Ethical and scientiic implications
51. Ellenberg SS, Temple R. Placebo-controlled trials and active-control trials of the globalisation of clinical research. Correspondence:
in the evaluation of new treatments. Part 2: practical issues and speciic The authors reply. N Engl J Med [Internet]. 2009 June
cases. Ann Intern Med. 2000 Sep 19;133(6):464-70. 25[cited 2011 Dec 13];360(26): 2793.[C1] Available from:
52. Shapiro K, Benatar SR., HIV prevention research and global inequality:
http://www.nejm.org/doi/pdf/10.1056/NEJMc090588
steps towards improved standards of care. J Med Ethics.2005 Jan;31(1):39-
59. Farmer P, Frenk J, Knaul FM, Shulman LN, Alleyne G, Armstrong L, Atun
47.
R, Blayney D, Chen L, Feachem R, Gospodarowicz M, Gralow J, Gupta
53. Levine C. Placebos and HIV. Lessons learned. Hastings Cent Rep. 1998
Nov-Dec;28(6):43-8. S, Langer A, Lob-Levyt J, Neal C, Mbewu A, Mired D, Piot P, Reddy KS,
54. Malik AY. Research ethics in the context of a developing country - Sachs JD, Sarhan M, Seffrin JR. Expansion of cancer care and control in
perspectives from Pakistan. 2011. Unpublished data. countries of low and middle income: a call to action. Lancet. 2010 Oct
55. Abbas EE. Industry-sponsored research in developing countries. 2;376(9747):1186-93.
Contemp Clin Trials.2007 Nov;28(6):667-83. 60. Farmer P, Campos NG. New malaise: bioethics and human rights in the
56. Clark PA. The ethics of placebo controlled trials for perinatal trials of HIV global era. J Law Med Ethics. 2004 Summer;32(2):243-51.
Less equal than others? Experiences of AYUSH medical oficers in primary

health centres in Andhra Pradesh
JK LAKSHMI
Indian Institute of Public Health, Hyderabad (Public Health Foundation of India), Plot # 1, A N V Arcade, Amar Co-operative Society, Kavuri Hills, Madhapur, Hyderabad
500 081 INDIA e-mail: jklakshmi@iiphh.org
Abstract indigenous to different cultures, whether

The National Rural Health Mission (NRHM) includes, inter alia, the explicable or not, used in the maintenance of
establishment of an AYUSH (Ayurveda, Yoga and Naturopathy, health as well as in the prevention, diagnosis,
Unani, Siddha and Homoeopathy) component (practitioner, improvement or treatment of physical and
trained assistants, drugs and equipment) in every primary health mental illness.
centre (PHC). However, five years following the launch of the Complementary/alternative medicine (CAM): The
NRHM, the AYUSH mainstreaming scenario is below expectations, terms complementary medicine or alternative
riddled with ethical and governance issues. Accounts from medicine are used inter-changeably with
AYUSH practitioners at PHCs in various regions of the state of traditional medicine in some countries. They
Andhra Pradesh reveal enormous lacunae in implementation: refer to a broad set of health care practices that
unfilled positions, inequitable emoluments, inadequate or absent are not part of that countrys own tradition and
infrastructure, assistance and supplies, unethical interpersonal are not integrated into the dominant health care
arrangements, and limited support from non-AYUSH personnel. system.
The widespread negative impact of these conditions undermines
the value of AYUSH, demotivating both practitioners and patients, Based on its provenance, context and employment, a system
and failing to provide the intended support to the public health may be traditional, complementary or alternative, or a
system. . combination of these. For example, ayurveda used concurrently
with allopathy in India is traditional and complementary;
homoeopathy used instead of allopathy in India is alternative.
Introduction
Traditional, complementary and alternative medicine (TCAM)
TCAM in the Indian health system
are therapeutic systems distinct from the dominant allopathic
system followed in mainstream medical practice. They are Allopathy is the dominant health care system in India.Non-
classiied as complementary when employed in tandem allopathic therapeutic systems ind a place in the formal health
with the dominant system, and alternative when employed system in the country under a department of the ministry
instead of it. The World Health Organisation deines traditional, of health and family welfare (MoHFW). This department was
complementary and alternative medicine (TCAM) as follows (1): established as the department of Indian systems of medicine
and homoeopathy (ISMandH) in 1995, and renamed the
Traditional medicine: Traditional medicine is the department of ayurveda, yoga and naturopathy, unani,
sum total of the knowledge, skills, and practices siddha and homoeopathy (AYUSH) in 2003 (2). It governs the
based on the theories, beliefs, and experiences education, research, practice and quality of all the systems
[ 18 ]
represented in the acronym AYUSH, and in addition, a naturopathy, homoeopathy, and unani were approached and
therapeutic system known as sowa-rigpa, or amchi, practised communicated with. No siddha practitioner could be accessed
in the Himalayan regions and some parts of north east India. as there are none appointed in PHCs in Andhra Pradesh at
The years since the establishment of the department of AYUSH present. Responses were gathered from discussions in dyads, or
have witnessed considerable growth in AYUSH educational in small groups of three to six doctors, yielding rich accounts of
institutions (undergraduate and post graduate), hospitals, the experiences of AYUSH doctors in the NRHM. Thirty AYUSH
dispensaries and drug manufacturing units (3). doctors in all participated in 10 of these discussions, each
of which lasted between 10 and 30 minutes. The narratives,
The rational use of TCAM is increasingly recognised as a vital
besides highlighting a few good practices in certain PHCs,
public health need. Some of the reasons are: escalation in non-
point to numerous lacunae in the implementation of the
communicable and chronic diseases; resurgence of certain
mainstreaming initiatives in the NRHM. Data gathered on
communicable diseases and emergence of new diseases;
these shortcomings were interpreted, and grouped into ive
drug resistance; and a growing consciousness of the need
major categories: recruitment, remuneration, facilities, technical
to incorporate healthy behaviours into our daily lives. This
support, and interpersonal relationships.
awareness is expressed in international and national policies to
mainstream TCAM(4), including promoting research, education,
Recruitment
licensing, drug-standardisation and regulation, and awareness-
raising. The NRHM in India is a case in point. It incorporates The 1,525 PHCs in Andhra Pradesh entail the appointment of
policies and strategies for the mainstreaming of AYUSH, with an equal number of AYUSH medical oficers. The positions
special emphasis on skill development and infrastructural were mandated to be illed in three phases by the year 2009.
support for AYUSH personnel. However, over 50 percent of the AYUSH medical oficer
positions in Andhra Pradesh were unilled in the year 2010, the
AYUSH in the NRHM majority through never having been illed, and a few through
the dismissal of the serving AYUSH medical oficer. A recent
The NRHM, launched in 2005 to fortify public health in India,
review of the NRHM (6) reports that only 29 percent of PHCs
sought to revitalise and mainstream AYUSH, speciically to
across India have integrated AYUSH staff into their personnel.
strengthen human resources, infrastructure and drug quality
The low proportion of illed AYUSH medical oficer positions
and standardisation, supported by advocacy for AYUSH,
in Andhra Pradesh, (approximately 43 percent according
and the establishment of inter-sectoral linkages to facilitate
to a 2010 report (7)) though not as bleak as the national
AYUSH practice. Activities under this initiative include
average, is nevertheless a cause for concern. But, although
facilitation of specialised AYUSH practice, integration of AYUSH
the quantum of recruitment is well below the target, the
practitioners in national health programmes, integration of
process of recruitment is commended by AYUSH doctors as
AYUSH modalities in primary health care, strengthening the
transparent and in accordance with stated policy, beginning
governance of AYUSH practice, supporting AYUSH education,
with advertising in leading newspapers, and guided by merit,
establishing laboratories and research facilities for AYUSH, and
and the governments categories of reservations.
providing infrastructural support (5).
The contracts, under which AYUSH doctors are recruited to PHCs
Actions pertaining to human resources and practice include
under the NRHM initiative, which are meant to be renewed
contractual appointment of AYUSH doctors in community
annually, are often not renewed in a timely manner. Many
health centres (CHCs) and PHCs; appointment of paramedics,
doctors report their continuing to work for months, despite the
compounders, data assistants, and managers to support
lapse of their contracts, with the implicit understanding that
AYUSH practice; establishment of specialised therapy
the delay in renewal is an expression of administrative inertia,
centres; involvement of AYUSH doctors in national disease
rather than a herald of dismissal. The delay, sometimes over six
control programmes; and incorporation of AYUSH drugs into
months, in the renewal of contracts is observed to be a feature
community health workers primary healthcare kits.
only of the AYUSH personnel appointments, and not of other
contractual executives of the NRHM.
Experiences of AYUSH practitioners under the NRHM
The observations made here were generated from interactions The contractual AYUSH medical oficers report to the
with a cross-section of AYUSH doctors contracted to medical regional deputy director of their respective zone, under the
oficer posts in PHCs in Andhra Pradesh. This was supplemented commissioner of AYUSH of the state. Despatches include
by a visit to a PHC staffed by an AYUSH doctor, and the the regular attendance report (attested by the allopathic
perusal of the limited formal literature on the evaluation medical oficer at the PHC), and the out-patient report of the
of the integration of AYUSH into mainstream public health consultations performed. The regional deputy director is also
in India. AYUSH medical oficers were contacted informally the oficial who disburses the AYUSH medical oficers salaries.
over several weeks, from March to June 2010, during training
programmes that they attended, in batches drawn from all Remuneration
the districts of the state, and asked about their experiences AYUSH medical oficers unvaryingly lament their meagre
in their PHCs. Medical oficers practising ayurveda, yoga and salaries, as being well below the emoluments of allopathic
[ 19 ]
colleagues. The current consolidated monthly salary of Rs being pressed into service as consulting, drug storage, and drug
9,300 (8) is reported to be based on a previous calculation of dispensing spaces. Besides space, furniture and equipment are
the basic pay of allopathic medical oficers, and precludes both reported to be in short supply in several PHCs.
the increments in said basic pay over the years, as well as all the
The supply and replenishment of medications, across systems
substantial allowances which are added to the basic pay to form
of AYUSH, leave a lot to be desired at many PHCs. While
the allopathic medical oficers salary. AYUSH medical oficers
some doctors complained of the delay of several months, in
in PHCs in Andhra Pradesh cite the comparatively higher
the initial stocking of medications, others reported prompt
emoluments of certain unskilled support staff in allopathic
primary stocking followed by months without replenishment.
hospitals to underscore their frustration at the low salaries that
Considering that many AYUSH medications, eg certain
they receive. The insuficiency of the salary is acknowledged
ayurvedic and unani formulations, are too expensive for PHC
in several submissions to the government, by AYUSH medical
patients to afford to procure from private pharmacies, this
oficer associations as well as their administrative superiors, for
inadequate supply may mean the difference between receiving
enhancement of pay, and an approach to parity with AYUSH
AYUSH treatment and being denied it. The inability to obtain
medical oficers salaries in other states, as well as the basic stocks of appropriate medication is a common grievance of
(unconsolidated) pay of allopathic medical oficers, which is Rs. AYUSH doctors in PHCs across the nation, as revealed by an
15,600 at present (8,9). evaluation of service delivery under the NRHM in four states
There are very few contractual allopathic medical oficer (11).
positions for comparison: These positions come with a
salary equal to the basic pay of regular allopathic medical Technical support
oficers, which, as detailed above, is considerably higher than Every PHC is expected to be populated with a trained AYUSH
the contractual AYUSH medical oficers salary. Other (non- compounder, an assistant to dispense medication and provide
AYUSH) contractual employees salaries are regularly revised therapeutic services on the prescription of the medical oficer.
in accordance with Pay Commission recommendations, unlike Reports reveal that the position of an assistant is not illed in
contractual AYUSH doctors salaries. The contractual position some PHCs, and that assistants appointed at certain PHCs are
does not offer any perquisites, such as beneits or allowances not appropriately skilled, leaving the doctor to undertake the
for family, health, housing, education, and geographic dispensing in addition to the prescription. For instance, some
location. The working hours of AYUSH medical oficers are individuals appointed to assist unani medical oficers, are
the same as those of allopathic medical oficers. The range of not literate in Urdu, and thereby not competent to decipher
responsibilities is different however: AYUSH personnel are prescriptions in Urdu and dispense medications labelled in
not assigned emergency duties and obstetric duties. AYUSH Urdu. Besides the compounder, every AYUSH medical oficer
doctors are justiiably exempt from the emergency allowance is assigned a sweeper and nursing orderly, to help with the
over their basic pay, but the denial of a rural allowance for maintenance of the AYUSH facility at the PHC and with patient
geographic location is not defensible. There is no overlap or low during consultation hours: This post is also unilled in
express sharing of responsibilities between the AYUSH and some cases. It bears mentioning that the emoluments of the
non-AYUSH departments of the PHC. AYUSH support staff are low, speciically Rs. 4800 per month
for a compounder, and Rs. 3900 per month for a sweeper and
In addition to the salary, each AYUSH medical oficer is nursing orderly (9).
allocated a contingency fund to cover expenses not already
accounted for. This contingency fund, ostensibly usable for Interpersonal relationships
some equipment, stationery, repairs etc, is not conveyed in a
A few AYUSH medical oficers enjoy collegial and cordial
timely manner to all the AYUSH medical oficers. Some report
relationships with their allopathic counterparts, as well as the
not receiving the fund at all, and going to the extent of using
other personnel working at the PHC. Some report minimal
their personal funds to institute minor repairs, and installation
interaction, and no adverse communication, with the allopathic
of equipment, such as signboards, in the PHC.
medical oficer and other PHC personnel. Several others
recount unpleasant interactions with the allopathic medical
Facilities oficer, and several of the other PHC personnel. These range
Each medical oficer is expected to be furnished with a from tacit disapproval and deprecatory references by the non-
consultation chamber, a dispensing zone, and a waiting area for AYUSH personnel at the PHC, to verbal discouragement of
patients, adding up to a minimum of 800 square feet of space potential patients from visiting the AYUSH doctor, and blatantly
(10). This includes provision for fresh construction of a building unethical interpersonal arrangements between the allopathic
in situations where the existing structure cannot accommodate and AYUSH doctors. For instance, the allopathic medical oficer
the AYUSH facility, and the PHC site has enough space. While may fraudulently document the attendance of the absent
some AYUSH doctors report satisfactory, and a small minority, AYUSH medical oficer, in exchange for a inancial consideration,
excellent, infrastructural provision, numerous doctors describe or as part of a reciprocal arrangement. Some AYUSH doctors are
the premises provided to them as grossly inadequate. Accounts reported to have been asked to perform case-taking, diagnosis
were communicated of verandahs and cramped storerooms and prescription of allopathic medications on behalf of the
[ 20 ]
absent allopathic medical oficer. This is clearly against the law, The dissonance between the stated goals of revitalising
not to mention unethical, as not all AYUSH students are trained and mainstreaming AYUSH and the reality of inequitable
in allopathic pharmacology and licensed to prescribe allopathic implementation is patent. The injustice to AYUSH practitioners,
medications. In premises shared by allopathic and AYUSH and patients, and by extension to the national community,
medical oficers, it is reported that the sweeper and nursing calls for a systematic evaluation of the integration (particularly
orderly assigned to the centre, although notionally able to work the underlying structural and social issues) of AYUSH into the
for the AYUSH facility as well as the allopathic, may not work at public health mainstream in India, and the implementation of
the AYUSH facility. AYUSH medical oficers cite interpersonal prompt remedial measures.
tension and an antagonistic attitude towards AYUSH as reasons
for this. Acknowledgement
The author is grateful to the AYUSH medical officers who
The NRHM envisages the participation of AYUSH personnel
articulated their experiences in PHCs, raised her consciousness of
in national health programmes(5). However, the guidelines
the technical, administrative and ethical issues encountered in the
for such participation are not elucidated, with the result
mainstreaming of AYUSH in PHCs in Andhra Pradesh, and present
that the involvement of AYUSH personnel in national
an inspiration in perseverance and dedication to their systems of
programmes is predicated on the interpersonal equation
medicine.
between the allopathic medical oficer and the AYUSH doctor.
Thus, some PHCs see a high level of involvement of AYUSH Competing interests: none
personnel in national health programmes, some moderate, eg,
participation in the pulse polio programme, and many others Funding support: The author was supported by the Indian
see no participation of AYUSH personnel in national health Institute of Public Health, Hyderabad, during the process of
programmes. Clear guidelines on the roles of AYUSH medical gathering information and writing. No other funds were received
oficers in national health programmes are urgently needed to or expended for this work.
resolve this, to harness all health personnel appropriately, and References
strengthen national health programmes. 1. World Health Organisation. Traditional medicines: definitions [Internet].
Geneva: WHO;2011[cited 2011 Nov 8]. Available from: http://www.who.
int/medicines/areas/traditional/deinitions/en/index.html
Conclusion 2. Department of AYUSH,Ministry of Health and Family Welfare,Government
In summary, few AYUSH doctors report positive experiences of India. Welcome to AYUSH [Internet]. New Delhi: Government of India;
of technical and social support in their work at PHCs. The 2011[cited 2011 Nov 8]. Available from: http://indianmedicine.nic.in/
index.asp?lang=1
straitened economic situation is universally lamented, by 3. Department of AYUSH, Ministry of Health and Family Welfare,
those with positive, as well as those with negative, social and Government of India. AYUSH in 2008 [Internet]. New Delhi; Government
infrastructural circumstances. AYUSH doctors observe that of India;2010[cited 2011 Nov 8]. Available from: http://indianmedicine.
besides the few patients sceptical from the start, numerous nic.in/index3.asp?sslid=388&subsublinkid=136&lang=1
4. World Health Organisation. WHO traditional medicine strategy 2002
patients enthusiastic at irst get discouraged with time from
- 2005[Internet]. Geneva:WHO;2005[cited 2011 Nov 8]. Available from:
using AYUSH treatments, under the conditions prevalent at http://whqlibdoc.who.int/hq/2002/who_edm_trm_2002.1.pdf
several PHCs. 5. National Rural Health Mission. Department of Health & Family Welfare,
Government of Orissa. Mainstreaming AYUSH under NRHM [Internet].
The procedures to mainstream AYUSH in PHCs have New Delhi: Government of India; [cited 2011 Nov 25]. Available from:
placed AYUSH and allopathic systems in a largely parallel http://203.193.146.66/hfw/PDF/ayus.pdf
coniguration with separate reporting channels, iscal and 6. Husain Z. Health of the National Rural Health Mission. Econ Pol Wkly.
2011 Jan 22;46(4):53-60.
logistical structures, and distinct duties not providing optimal 7. Planning and Evaluation Cell, Department of AYUSH, Ministry of Health
scope for the deployment and development of AYUSH. The and Family Welfare. Government of India. AYUSH Report 2010 [Internet].
negative impact of the circumstances of AYUSH in PHCs is New Delhi: Government of India 2010; [cited 2011 Nov 15]. Available
widespread, affecting practitioners, patients, and eventually from: http://www.similima.com/pdf/ayush-complete-report-2010.pdf
8. AYUSH Medical Oficers Association, a. 2010 [Internet]. AYUSH
the nation at large. The effects range from minor delays in Medical Oficers Association: 2010[cited 2011 Jul 20]. Available from:
treatment, to job-dissatisfaction, interpersonal tension and the http://apayushmosassnnrhm.com/pages/Pogroms_7.html
calling into question of the professional integrity of medical 9. AYUSH Medical Oficers Association, b. 2010 [Internet]. AYUSH
practitioners. The value and practice of AYUSH are undermined, Medical Oficers Association: 2010[cited 2011 Jul 20]. Available from:
http://apayushmosassnnrhm.com/pages/Pogroms_2.html
demotivating both practitioners and patients. The injury to 10. AYUSH Medical Oficers Association, c. 2010 [Internet]. AYUSH Medical
public health lies in the denial of proper AYUSH treatment to Oficers Association: 2010[cited 2011 Jul 20]. Available from: http://
the many who may desire, and beneit from, it; the denial of a apayushmosassnnrhm.com/pages/Pogroms_5.html
platform to AYUSH practitioners to contribute to public health; 11. Gill KA. Primary evaluation of service delivery under the National
Rural Health Mission: indings from a study in Andhra Pradesh,
and the denial to the nation of the public health gains to be Uttar Pradesh, Bihar and Rajasthan. Working Paper 1/2009, Planning
made from the optimal application of AYUSH to public health Commission[Internet]. 2009[cited 2011 Nov 11]. Available from:
challenges, including health promotion and disease prevention. http://planningcommission.nic.in/reports/wrkpapers/wrkp_1_09.pdf
[ 21 ]
Continuing oversight through site monitoring: experiences of an institutional

ethics committee in an Indian tertiary-care hospital
YASHASHRI C SHETTY1, PADMAJA MARATHE 2, SANDHYA KAMAT3, URMILA THATTE4
1
Assistant Professor, 2 Associate Professor,3 Professor, Department of Pharmacology and Therapeutics, 4 Professor and head, Department of Clinical Pharmacology,
Seth G S Medical College and K E M Hospital, Parel, Mumbai 400 012 INDIA Author for correspondence: Yashashri C Shetty e-mail: yashashrirajit@gmail.com
Abstract monitoring. Additionally, and perhaps as relevant, is the fact

WHO-TDR and the Indian Council of Medical Research recommend that all medical institutions take up investigator-initiated
site visits by institutional ethics committees (IECs) for continued studies where sponsor-driven routine monitoring may not
oversight, to ensure the ethical conduct of research. Our IEC be carried out, emphasising the greater need for continued
conducted seven site visits in 2008-2009 using a standardised monitoring by IECs (6).
format to monitor adherence to protocol and the informed As a strategy to address this issue, our IEC (located in a tertiary
consent process. care hospital in India) conducted site monitoring visits
The study identified issues related to informed consent (6/7), according to pre-drafted standard operating procedures (SOPs)
deviation from protocol (5/7), reporting of study progress to the (7). Visits to different study sites were organised to monitor the
IEC (3/7), recruiting additional participants without IEC approval conduct of the ongoing studies. The objectives of these visits
(2/7), reporting of serious adverse events (1/7), investigators lack were to check compliance of investigators with the protocol
of awareness of protocol and the informed consent document and the informed consent process approved by the IEC as
(2/7) and other findings. well as to assess the level of understanding of the research
participants. This paper discusses the observations made
Investigators were informed about the findings and were asked during site visits and the subsequent recommendations made
to submit an explanation. The IEC issued warnings about not to the investigators as also action taken by the IEC.
repeating such lapses in the future(5/7), restricted enrollment
of new participants(2/7), recommended continued good
Methodology
clinical practice training to the study team (4/7), advised the
recruitment of additional study coordinators(2/7), and requested Seven sites were monitored by members of the IEC between
the submission of adverse event reports(2/7) or sponsors audit January 2008 and December 2010, using a standardised pre-
reports(2/7). Our study showed that the ethical conduct of studies decided format based on the SOPs (Appendix 1). The sites
can be ensured by conducting routine site monitoring. were selected for monitoring either for cause (n=5) including
incomplete communication from the principal investigator
Introduction (PI) regarding study progress, a large number of SAEs (deaths)
reported from a site, large numbers of protocol deviations,
The continuing review of approved research by institutional
recruitment of additional participants without approval of the
ethics committees (IECs) is essential to ensure the ethical
IEC and a large number of studies undertaken by the PI at one
conduct of clinical research. IECs perform this duty primarily
site or routine (n=2) for investigator-initiated studies.
by reviewing data submitted to them during the conduct
of a trial at pre-speciied regular intervals. This data includes The site visits were conducted according to the IECs SOP
serious adverse event (SAE) reports, progress reports, reviews number 15 (7). The PIs were informed in writing two weeks in
of protocol violations, and of amendments of protocol, and advance about the schedule of site visits, and their acceptance
related documents submitted by the investigators etc, as and availability were conirmed before conducting the visits.
recommended under national and international guidelines and A team of two IEC members conducted the visits and noted
legislation (1-3). This is generally a form of passive monitoring. down the observations in the site monitoring report (Appendix
In order to ensure the safety and well being of participants ,as 1).The approval of the IEC was obtained to compile and analyse
well as to ascertain that potential risks have not altered, these the site visit reports. The reports were analysed for violations
same guidelines also recommend site visits as one of the and categorised under seven themes: (1) informed consent;
methods for continuing review by IECs (1-3). (2) deviation from investigational plan , (3) non-reporting of
study progress to IEC, (4) IEC approval (5) lack of investigator
Site monitoring is a routine activity in the United Kingdom
and research ECs carry out proactive monitoring through understanding of protocol and informed consent documents
questionnaires and/or by visiting research sites for (ICD), (6) SAE reporting, and (7) other indings.
pharmaceutical industry-sponsored trials (4). However, IECs in
India have neither the mechanisms in place nor the manpower Results
or resources to meet this requirement, and therefore cannot Of the seven studies selected for monitoring, ive were
fulil this obligation (5). Consequently, they rely upon passive pharmaceutical industry-sponsored and two were investigator-
[ 22 ]
initiated studies. All seven were drug trials. The most common in Marathi (local language) and had signed the English consent
indings in these audits were related to the informed form in Marathi. The explanation given by the investigator
consent process (6/7). Others included deviations from the was that the patients signatures were obtained only after
investigational plan (5/7), non-reporting of the studys progress explaining everything to them. In one case, the ICD was signed
to the IEC (3/7), recruiting additional participants without 10 days after obtaining the participants signature by the PI
IEC approval (2/7), lack of investigator awareness regarding and co-investigator (Co-I). In one ICD, a nurse of the Institute
the protocol and informed consent document (3/7), and was used as an impartial witness. In one study, names of all the
serious adverse event reporting (1/7). In addition to the above, 30 participants and dates had been illed in by the PI. Without
some other indings were also noted, all of which have been documenting the participants consent on the ICD, all the data
summarised in Table 1. had been illed in into the case record forms. In one study,
informed consent was re-obtained from participants with
Table 1: an amended (approved by IRB) version of the ICD containing
Violation themes observed during site monitoring by IEC information on important new side effects after a delay of 1-3
Monitoring sites months. The informed consent addendum was signed by the
Violation theme PI and the Co-I 10 days later, and in the case of 30 participants,
(n=7)
a copy of the ICD had not been given to any of them.
Informed consent issues 6/7
In order to assess the participants understanding of the
Deviation from investigational plan 5/7 study, one participant of each of three studies (a total of three
participants) was interviewed. Since the participants were not
Non-reporting of study progress to IEC 3/7 familiar with the English language, they were interviewed in
the local language. It was observed that the participants had
Deiciencies in study supervision 2/7 a good understanding of the study and the drugs given. They
could explain the risks and discomforts of participation in the
IEC approval 2/7
study. One of the participants relatives conided that they were
Lack of investigators understanding participating in the study as they received free treatment.
about protocol and informed consent 3/7
document Deviations from the investigational plan
Serious adverse event reporting 1/7 At one of the sites, investigators were using an older version
of the study protocol. For the investigator-initiated study,
Other indings
participants were not randomised as required in the protocol.
No source documents found;
Failure to report study progress to IEC
No coded drugs used; 1/7
As per the SOP, our IECs grant approval for a period of one year
Documents not kept under lock and [ one observation and then extension of approval after reviewing the annual
key; Auditors monitoring report was noted in each status report of the study. There was a lapse in submitting the
missing; of the 7 studies annual status report and taking extension of approval by one
monitored] of the PIs and 85/125 patients were recruited during the period
PI reported SAE late;
not covered by valid approval of the IEC.
Biodata of investigators in the project
ile not signed Recruitment of additional participants without IEC
approval
The informed consent process In one of the sponsored studies, the IEC had given permission
Six of the seven sites monitored had issues concerning the for recruiting 25 patients while the PI had recruited 30 patients.
process of documenting informed consent. Copies of the
informed consent documents (ICD) were not available at the Lack of investigator awareness regarding the protocol
site. The explanation given by the investigator was that as it and informed consent document
was a collaborative study, the ICDs were archived with the
At six sites, investigators were interviewed to verify their
other institution, in spite of the fact that the patients had been
awareness of the protocol. In one study, the PI did not know
recruited from our institution. Other indings included missing
the inclusion criteria. At another study site, a ready-reckoner
signatures of patients (n=1) and principal investigator (n=2).
of selection criteria prepared by investigators to facilitate
The consent of four participants had been obtained using the
recruitment of participants was found incomplete. This could
vernacular (Hindi) consent form which had not been approved
have led to protocol violations in recruitment.
by the IEC, while only the English version had approval. In one
study, we found that six participants had been administered At three sites, when Co-Is were interviewed in the absence of
the English version of the ICD when they were actually literate PIs, it was observed that answers given by Co-Is to questions
[ 23 ]
on inclusion criteria were inappropriate. One Co-I commented training of resident doctors in clinical research. PIs who did not
that an elaborate consent process would deter patients from keep their documents securely under lock and key were asked
participating in the study. In two investigator-initiated studies, to make arrangements to do so.
the investigators (post-graduate students) were not aware
that source documents had to be maintained; patients were Table 2: Action taken by IEC against monitoring sites.
not being randomised according to the charts; ICDs that were Violation theme Action taken by IEC
administered to the participant were not in the language that
Explanation asked for with a clear
the patient understood; and participants had not been given a Protocol deviation
warning against future repetition
copy of the ICD.
Deviation from Restriction on future recruitment,
investigational plan submission of audit reports from
SAE reporting
sponsor
A total of 20 SAEs from the 1/7 sites were reported to the IEC
after seven working days. Non-reporting of Explanation asked for with a clear
study progress to IEC warning against future repetition
Other findings Deiciencies in study Recruitment of additional members
supervision in the study team advised
All the case record forms were found to be incompletely illed
in with pencil [25/25] at one site. One of the sites had been SAE reporting Submission of AE reports
monitored by the sponsor, but the monitoring report was
Lack of investigator
missing. The bio-data of the investigators in the project ile Continued GCP training of study
awareness (protocol
had not been signed. No source documents were found at two recommended
and ICD)
study sites. Documents were not kept under lock and key. A
single study co-ordinator was handling multiple studies. At one
Discussion
site, the study had been initiated without having received the
approval of the directorate general of foreign trade, India, for The site monitoring visits carried out by the IECs of a
shipping of samples abroad. teriary care hospital in India revealed innumerable
protocol violaions, which would not otherwise have
Action taken by IEC been ideniied. The indings relaing to violaions
of the informed consent process were paricularly
After monitoring the sites, the teams presented their reports at disturbing as they violated the basic principle of
the next IEC meeting. After the presentation of each report, the autonomy, a fact that needs to be viewed seriously.
indings of monitoring visits were conveyed in writing to the PIs There were discrepancies between the consent forms
with a request to demonstrate compliance within a speciied approved by the IEC and the forms used at the site;
time. The compliance report was again presented to the IEC and in some cases, ICDs, or the signatures of paients and
recommendations were given to the PIs. If the PI was found to /or PIs were missing. These violaions were similar to
have deviated from the investigational plan frequently, the IEC thoseobservedinthestudiescarriedoutbyMcCusker
put temporary (till PIs gave evidence of taking recommended et al(8), in which an audit of 188 consent forms of 33
corrective actions like training of staff ) restrictions on protocols revealed that consent forms were missing
further recruitment. In case of protocol violation and lack of from the site, non-approved consent forms had been
reporting of study progress, the IEC asked for an explanation, used, and the signatures of paricipants, witnesses
with a clear warning not to repeat the violation in future and and invesigator were found missing in many forms.
ensured that corrective actions were implemented. Additional AnotherstudybySmith et al (9) in 1997 showed that,
AE reports were asked for from investigators who had failed of the 39 projects reviewed; a quarter had protocol
to submit them in time. For the SAEs not reported earlier, deviaions in relaion to the consent process. The same
follow-up reports and outcome were called for from the PIs
study had found that, though adverse events had been
and reviewed. Continued GCP training of all investigators was
reported, projects which were abandoned or late to
made compulsory and PIs were asked to submit a copy of the
start were vastly underreported to the IEC (9). In our
certiicate at the time of submission of a new project. Moreover,
study, delayed reporing of serious adverse events was
in certain studies where it was felt that patients safety and well-
a common inding.
being were compromised, IECs asked for monitoring reports
from the sponsors and the recommendations of the data safety Qualitaive interviews with invesigators for 16 research
monitoring board, if relevant. projects conducted by Douglass et al (10) concluded
that an acive monitoring programme can detect
At sites with inadequate study supervision, the IEC advised
deviaions from the approved protocol not disclosed in
recruitment of additional GCP trained members in the study
the annual report. The same was observed in our study
team. It was recommended that at least one study coordinator
during the interviews with the PIs.
per trial be appointed. In many investigator-initiated studies,
resident doctors were the PIs, so the IEC recommended the An encouraging inding in our study was that the
[ 24 ]
paients understanding of the research study, including ime for passive monitoring, ie, reviewing SAE reports,
the beneits and risks involved, was adequate. It was periodic status reports, etc. There is very litle ime let
therefore felt that most of the protocol violaions, to carry out site monitoring. Another aspect is the lack
including those related to the ICD, were due to an of training. IEC members are not trained to conduct
overload of clinical work rather than the unethical monitoring.
behaviour of the PI.
In India, there is no central body which ofers
The results of this study reveal that there is an urgent accreditaion, trains IEC members to monitor studies,
need for an acive monitoring programme by IECs for and monitors IECs for their compliance. In the studies by
the coninuing review of ongoing projects. Currently, Demets and Weijer (5, 11) the authors have discussed
lack of infrastructure, manpower, funds and ime is the problems involved in carrying out coninuing review
a major hurdle for conducing acive site monitoring. by IECs. Smith et al (9) have reported that each detailed
Most IECs spend a substanial amount of ime in review takes six person hours at a cost of 120.
reviewing and approving protocols and reserve some
Appendix1: Site monitoring visit report Is it approved by the IEC? Comment:
No. of participants approved at site by IEC: ______ o Yes o No
Total participants recruited since protocol began: ______

Any adverse event found? Comment:
o Yes o No
New participants recruited since last year:
No. of patients screened: ____ Any SAEs found? Comment:
No. of patients enrolled: ____ o Yes o No
No. of patients completed: ____

Was the IEC informed about SAEs within 7 Comment:
working days?
No. of patients ongoing: ____
o Yes o No
No. of patient drop-outs: ____ Has any death occurred? Comment:
No. of patients who withdrew consent: ____ (State reasons) o Yes o No

Was the IEC informed about this death within 24 Comment:
hrs?
No. of patients withdrawn by PI: ____ (State reasons) o Yes o No

Any protocol non-compliance /violation? Comment:
o Yes o No
Are all case record forms up to date? Comment:
Are site facilities appropriate? Comment: o Yes o No
o Yes o No Are storage of data and investigating products Comment:
Are informed consents of recent version Comment: locked?
used? o Yes o No
o Yes o No Are necessary life-saving equipments/drugs Comment:
Is it approved by the IEC? Comment: present at the site?
o Yes o No o Yes o No
Whether consent has been taken Comment: Are the site personnel adequate? Comment:
from all patients? o Yes o No

How well are participants protected? Comment:
o Yes o No
Whether appropriate vernacular consent Comment: o Good o Fair o Not good
has been taken? Any other relative observations :
o Yes o No
Comments of the monitor
Duration of visit: .hours Starting from: Finish:
Are protocols of recent version used? Comment: Name of IEC/ Independent Monitor
o Yes o No Completed by: Date:
[ 25 ]
The need for recogniion and ailiaion of IRBs is 2. Ministry of Health and Family Welfare, Department of Health. Drugs and
currently not mandatory in India and depends, not Cosmetics (II amendment) rules, 2005 [Internet]. New Delhi: Government
of India; 2005 Jan 20 [cited 2011 Nov 23]. Available from: http://
only on the enthusiasm and moivaion of an IEC, but dbtbiosafety.nic.in/act/Schedule_Y.pdf
also on the funds that it receives. Many IECs in India 3. World Health Organisation. Operational guidelines for ethics committees
do not receive suicient funding and the insitutes in that review biomedical research [Internet]. Geneva:WHO;2000[cited 2011
which they are situated are not keen to provide funding Mar 26]. Available from: www.who.int/tdr/publications/publications/
on a priority basis. IECs therefore coninue to struggle 4. Pickworth E. Should local research ethics committees monitor research
to meet the responsibility of accreditaion, coninued they have approved? J Med Ethics. 2000 Oct 26; 26(5):3303.
5. DeMets DL, Fost N, Powers M. An institutional review board dilemma:
training, and staing. responsible for safety monitoring but not in control. Clin Trials.
Acive on-site monitoring helped our IEC to idenify 2006;3(2):142-8.
6. Morse MA, Califf RM, Sugarman J. Monitoring and ensuring safety during
problems related to the implementaion of GCP which clinical research. JAMA. 2001 Mar 7;285(9):1201-5.
could not have been detected by the passive ongoing 7. Ethics committee for research on human subjects. Seth GS Medical
review of study-related documents carried out rouinely College and KEM Hospital, Mumbai. Site monitoring visit [Intranet]
by our IECs. Thus IECs need to have mechanisms for site 2009 Jun 26[cited 2011 Nov 11]. Available from: www.kem.edu/dept/
monitoring in place so as to ensure that GCP is followed ethicscommittee/SOP15.PDF
in leter as well as spirit. 8. McCusker J, Kruszewski Z, Lacey B, Schiff B. Monitoring clinical research:
report of one hospitals experience. CMAJ. 2001 May 1;164(9):1321-5.
Declaraion: No compeing interests nor funding from 9. Smith T, Moore EJH, Tunstall-Pedoe H. Review by a local medical research
any external agency to be declared. ethics committee of the conduct of approved research projects, by
examination of patients case notes, consent forms, and research records
References and by interview. BMJ. 1997 May 31;314:1588-90.
1. Indian Council of Medical Research. Ethical guidelines for biomedical 10. Douglass AJ, Jarvis A, Bloore S. Monitoring of health research by research
research in human participants[Internet]. New Delhi:ICMR;2006 [cited ethics committees. N Z Med J. 1998 Mar 13;111(1061):79-81.
2011 Nov 9].p.111. Available from: http://www.icmr.nic.in/ethical_ 11. Weijer C, Shapiro S, Fuks A, Glass KC, Skrutkowska M. Monitoring clinical
guidelines.pdf research: an obligation unfulilled. CMAJ. 1995;152(12):1973-80.
Thank you, reviewers
All submissions to the journal undergo extensive review by internal reviewers from within the journals editorial boards
as well as by external peer reviewers. We would like to thank all our editorial and advisory board reviewers, and also
name the following external experts who have reviewed articles for the journal during 2011:
Aamir Jafarey, Akash Bang, Akoijam Joy, Amita Dhanda, Amita Pitre, Anant Bhan, Anant Phadke, Anirudh Kala, Anoop
Thekkuveetil, Bhushan Shukla, C Adithan, Chinu Srinivasan, David Thambu, Devadasan, Dhanwanti Nayak, Gagandeep
Kang, Gopal Dabhade, Indu PS, J Divatia, Joe Varghese, Kajal Bhardwaj, Kalpana Kannabiran, Laxmi Murthy, Leela
Visaria, Leigh Turner, MR Hariharan Nair, Nalini Rao, Nandini Kumar, Nithya Gogtay, Prabir Chatterjee, Premila Lee,
Rajeev Kumar, Rakesh Aggarwal, Ramakumar, Raman Kutty, Ravi Duggal, Ravindra RP, Renu Addlakha, SP Kalantri, S
Srinivasan, Samiran Nundy, Shailaja Tetali, Soumitra Pathare, Sridhar S, Subha Sri, Suneeta Krishnan, Sunita Bandewar,
Sunita Simon Kurpad, VR Joshi, Vineesh Mathur.
[ 26 ]
COMMENTS
Finding and using evidence that you can trust

PRATHAP THARYAN
Professor of Psychiatry, Director, South Asian Cochrane Network and Centre, Professor BV Moses and ICMR Centre for Advanced Research in Evidence-Informed
Healthcare, Christian Medical College, Vellore 632 002, Tamil Nadu INDIA e-mail: prathap@cmcvellore.ac.in
Abstract The least biased evidence that addresses these issues

Much of the evidence-base from research is biased. Systematically regarding the effects of interventions comes from well-
assembled, quality-appraised, and appropriately summarised conducted systematic reviews and meta-analyses of all RCTs
reviews of the effects of interventions from all relevant intervention conducted that compare an intervention to no intervention (or
studies are needed, in order to use research evidence to reliably placebo), and to other interventions commonly used for that
inform health decisions. The Cochrane Library is an online health condition. If RCTs are not ethical, practical, or feasible,
collection of six searchable, up-to-date, evidence-based databases then systematic reviews of particular types of well-conducted
that is available free to access by anyone in India, thanks to a observational studies could provide alternative sources of
national subscription purchased by the Indian Council of Medical evidence.
Research. This valuable resource contains the worlds single largest Systematic reviews use explicit and systematic methods to
collection of systematic reviews and controlled clinical trials, search for, locate, and retrieve; critically appraise for the risk of
as well as bibliographic details and records of methodological bias; reliably extract and analyse data from all relevant research
research, health technology assessments and economic analyses. studies addressing a focused clinical question, and summarise
The robust and transparent methods pioneered and used in the overall results. They, therefore, provide information that
Cochrane systematic reviews, and independence from industry individual trials cannot. Many systematic reviews, though not
funding facilitate the detection of biased, deceptive and fraudulent all, synthesise their results using meta-analyses. Meta-analysis
research, and have earned these reviews the reputation of being is the statistical technique that aggregates the numerical data
trusted sources of evidence to inform health decisions. Cochrane for each relevant outcome from the primary studies that are
reviews have had considerable impact on academic medicine; suficiently similar in their participants, interventions, methods,
have informed health practices, policies and guidelines; improved and outcomes to combine in a clinically meaningful manner.
health outcomes; and saved numerous lives.
Systematic reviews in the Cochrane Database of Systematic
An editorial in the previous issue of this journal summarised Reviews (CDSR), one of six evidence-based databases that form
the results of empirical research revealing that much of the part of The Cochrane Library (www.thecochranelibrary.com),
evidence from research that is integral to the practice of are particularly reliable sources of evidence, as are systematic
evidence-based medicine cannot be trusted(1). This does not reviews that use the methods pioneered by the Cochrane
mean that none of the evidence can be trusted. However, Collaboration (www.cochrane.org). The resources in The
it does require a special effort to identify sources of reliable Cochrane Library are free to access by anyone in India with a
evidence, to understand how this should be assessed, and the computer and an internet connection, thanks to a national
amount of conidence one can place in this evidence. subscription purchased by the Indian Council of Medical
Research (ICMR) since 2007, and renewed for a further three
Finding the right evidence years in 2010. More than half the worlds population also has
The irst step in evidence-informed healthcare is to ind free access to this valuable resource due to various sponsored
relevant evidence that is free of the risk of bias. Randomised initiatives or licensing agreements(5).
controlled trials (RCTs) are considered the type of study design
that is least likely to provide biased estimates when assessing The impact of Cochrane systematic reviews
the effects of interventions. However, the language of research Only about 20% of reviews published each year are Cochrane
facilitates deception, through the use of descriptive terms systematic reviews. However, empirical research reveals that
that are widely employed to describe studies that have not Cochrane systematic reviews are scientiically more rigourous,
necessarily used, or used adequately, the methods required to more likely to be up to date, and less biased in their methods
provide Gold Standard evidence that RCTs are assumed to and interpretation than non-Cochrane systematic reviews (6,
provide (2-4). Moreover, the results of a single RCT are unlikely 7). The 2010 impact factor for the CDSR was 6.186. The CDSR is
to be generalisable to all situations where the intervention may now ranked in the top 10 of the 151 journals in the medicine,
be used. The results of different RCTs of the same intervention general, and internal category, and receives the seventh highest
and control comparison may also differ substantially. number of citations in its category.
[ 27 ]
Other more important examples of the impact of Cochrane more likely to show statistically signiicant results; be
reviews include informing the guidelines of many agencies, published in high-impact, mostly English-language journals;
including those of the World Health Organisation, and be sponsored by the pharmaceutical industry and, be
inluencing global, national and regional health policies. published sooner than unpublished studies (17, 18). If one
Cochrane reviews in many topic areas have provided clinicians, were to rely only on the results of these published trials,
patients and their care-givers access to reliable evidence that without balancing the evidence from unpublished trials
have improved health outcomes and saved numerous lives. (often smaller and with negative or inconclusive results), one
would be seriously misled(19).
Why are Cochrane systematic reviews and meta- Hence, apart from searching different online databases,
analyses regarded as reliable sources of evidence? Cochrane reviews routinely search the Cochrane Central
The major reasons that contribute to the reliability of Cochrane Register of Controlled Clinical Trials (CENTRAL), the worlds
systematic reviews stem from the rigourous methods used largest repository of information regarding clinical trials
in their preparation. These methods are described in the that forms part of The Cochrane Library. It includes details
Cochrane Handbook for Systematic Reviews of Interventions of published articles taken from multiple bibliographic
(www.cochrane-handbook.org). They include: databases, other published resources, and from unpublished
sources. Cochrane reviews also routinely search the
1. Transparent, reproducible methods: Systematic reviews specialised registers of the respective collaborative review
commence with a methods section or protocol that is groups supporting the review. Experts in the ield and drug
unusual in traditional review articles. Protocols of Cochrane manufacturers are contacted for further, often unpublished,
systematic reviews are peer-reviewed, editorially vetted and information, as well as the authors of identiied studies;
published online in the CDSR before the review commences. and the cross references of these studies are searched for
The protocol outlines in detail the scope and methods further references. Clinical trials registries are also searched
planned for undertaking the review. for on-going trials. No language restrictions are applied in
2. Striving for relevance: The topics selected for Cochrane the search strategy in order to avoid language bias; regional
systematic reviews are agreed in advance by the authors databases are also searched, and retrieved reports are
and editorial team as relevant to health care, and are translated, if needed.
often selected in response to the expressed needs of 4. Minimising biases in the review process: The review teams
relevant stakeholders. Cochrane review topics cover not are assembled to balance the views of all authors and to
only pharmacological interventions but a variety of non- avoid inancial and academic conlicts.Bias in selecting
pharmacological interventions and aspects of health-service trials is minimised in Cochrane reviews by involving at least
delivery. The pre-stated primary outcomes in Cochrane two authors who independently apply pre-stated, explicit
reviews may not be the primary outcomes used in the inclusion and exclusion criteria. They also independently
included trials. Thus, the primary outcome of a systematic assess quality; extract data and contribute to writing the
review that compared reduced osmolality oral rehydration results and discussion. Disagreements are resolved by
solution (ORS) versus the WHO-recommended, standard discussion or contacting authors of trials. Inputs are provided
ORS to treat acute dehydration due to diarrhoea in children, from two editors, a lay reviewer and peer reviewers. Excluded
was the frequency of unscheduled intravenous saline studies are listed with reasons for exclusion; studies awaiting
infusions used. This was considered by the review team assessment are also listed, and ongoing trials are described.
as a real-world indicator of the failure of either solution to Any changes between the published protocol and the inal
effectively treat diarrhoea (8). This was not a primary eficacy review are documented, discussed, and justiied. Authors
outcome in most of the 11 included trials and was obtained are supported by editorial teams from conception, through
not from the description of the main results or tables, but development, completion, and publication of the review,
from elsewhere in the paper; in three other included trials, and upto updating of the review, ideally every two years, or
it was not reported. In this review, reduced osmolality ORS when new trials are located or published.
required signiicantly fewer unscheduled intravenous saline 5. Minimising conflicts of interest: The Cochrane Collaborations
infusions than standard ORS, and is now the recommended polices prohibit industry funding of review teams or
standard. Many other examples exist where Cochrane collaborative review groups and methods groups earning
reviews have challenged the received wisdom and changed Cochrane reviews the reputation of being independent
established practices and health policy by demonstrating sources of reliable evidence.
that interventions in common use were ineffective(9-13) or 6. Assessing the risk of bias in included studies: Including studies
even harmful(14-16). at high risk of bias that are likely to have erroneous effect
3. Comprehensive search strategy: Systematic reviews attempt to estimates, are unpredictable in magnitude and direction
locate all relevant studies that have addressed the reviews (20), will result in systematic reviews with misleading
objectives, and not only a biased sub-set of published results. Hence, RCTs are preferred in most Cochrane reviews.
studies, or ones that were easily available. Empirical research Quasi-randomised (where allocation to treatments can
has demonstrated that studies published in journals are be predicted) and non-randomised trials are usually not
[ 28 ]
included, if RCTs were thought feasible for the intervention(s) provided the most information (largest sample size and
reviewed. In addition, all Cochrane reviews assess each most deaths) and had the most precise results (narrow
included primary study for the risk of bias across six conidence intervals), and hence is assigned the most weight
dimensions empirically shown to inluence outcomes. They (66.6%)(column four) in the meta-analysis. Jessani 2005 had
are: generation of the randomisation sequence; concealment the next largest sample size and next highest number of
of allocation; blinding (often assessed separately for deaths, but gets the least weight (6.9%) since it had the least
subjectively reported outcomes, where lack of blinding deaths in the control group (drug B), and the least precise
could introduce bias; and for objectively ascertained results. The rows in the sixth column display the numerical
outcomes, where lack of blinding usually does not introduce values of the relative (RR) and 95% CI for the comparisons
bias); incomplete outcome reporting (again often assessed from each trial (without differential weighting). This is
separately for eficacy measures; and for harms that are less also graphically displayed in the last column as a forest
often reported adequately); selective reporting; and other of horizontal lines (hence the name forest plot; if there
biases such as conlicts of interest. Many non-Cochrane were many more trials, the resemblance to a forest of lines
reviews either do not routinely evaluate the risk of bias, or would be even more apparent) scattered around the vertical
use unreliable quality scales to assess study quality(6).These line that touches the base of the plot at the RR of 1(no
methods used in Cochrane systematic reviews also facilitate signiicant difference). The rectangular blob in the middle of
the detection of scientiic misconduct, misinformation, and the horizontal lines represents the RR estimate for each trial.
redundant publications (21). The size of the blob is proportionate to the weight assigned
7. Pooling the results of trials instead of counting votes: A meta- to each trial. The width of the horizontal lines depicts the
analysis averages the results of individual trials that provided upper and lower limits of the 95% conidence intervals.
data for the proportions of participants randomised to The pooled results of the ive trials (proportionately
the intervention versus the comparison that experience a weighted in the formula used for the meta-analysis to
particular outcome. This is done in order to provide a pooled yield the weighted average) are provided in the last row.
common estimate of relative effects. The results of the The pooled RR is 0.70 [95% CI 0.50 -0.99], and represents
individual trials are commonly expressed as risk ratios (RR) the average risk of death with drug A compared to drug B.
or odds ratios, along with their 95% conidence intervals The diamond at the bottom of the graph in the last column
(CI)(22).For the pooled effect estimate in a meta-analysis, includes the pooled RR and conidence limits of the ive
each trial is proportionately weighted so that larger trials, trials. The lower limit of the pooled 95% CI in the diamond
and trials where more people experienced the outcome [RR = 0.99] stops short of touching the vertical line [RR = 1].
of interest, particularly with the control intervention 8. Ensuring the results are statistically significant and clinically
or comparison arm (indicating a high baseline risk of important:
developing the outcome), are given more weight in the In conventional terms, these results are statistically
pooled estimate. The proportionate weight assigned to each signiicant as the p value is < 0.05 (The last row in the forest
trial is the inverse of its variance (a measure that combines plot tests the overall effects and reveals the actual p value
the two parameters described above and indicates more to be 0.04; indicating that one can be 96% certain that
precise estimates of the likely range of results). Thus trials the difference in the effects of the two drugs is not due to
that provide more information with more precise results chance). From a clinical perspective, an RR of 0.70 means
get more weight in the pooled results of all the trials. This that drug A reduces the risk of death by 30%, and while we
is instinctively more appealing than counting the number think this is the actual estimate of relative risk reduction
of trials where the result favoured the intervention over the (RRR), the upper and lower limits of the CI of the estimate
comparison, versus the number of trials where the reverse suggests that the risk of death could be reduced by as much
occurred, or where the results were inconclusive. In this as 50%, or as little as 1%. If the higher estimate were true, this
traditionally used vote-counting method, the results of a would be even better than what we think the estimate is,
large trial and a small trial would each be counted as one for but if it were the lower estimate, then the clinical usefulness
and one against the intervention being effective. of drug A over drug B in averting 1% fewer deaths is less
An example is provided in Figure 1 that displays a (ictitious) encouraging, given that 51 (6%) of people given drug A in
meta-analysis (or forest plot) comparing drug A with drug the ive trials died versus 72 (8%) with drug B; unacceptably
B for the treatment of obesity. The outcome assessed in the high rates of death with both drugs. If one evaluated the
igure is the risk of death. actual number of deaths averted with drug A (51/930)
In this hypothetical example, the ive trials (identiied in compared to drug B (72/928), the Absolute Risk Difference
the rows in column 1 by the last name of the irst author (ARR) is 0.0227; 95% CI 0.0001-0.0457. This indicates that
and year of publication) included in the meta-analysis drug A averted just two deaths out of 1000 people treated
randomised 930 adults to anti-obesity drug A, of whom compared to 1000 people given drug B; and this could be
51 died, (columns two and three), and 928 adults to anti- as few as 1/1000 treated or as many as 5/1000 treated, again
obesity drug B, of whom 72 died (columns three and four). not very impressive achievements.
The variance in the trial by Pai 2010 was the least since it This example highlights the importance of evaluating
[ 29 ]
effect sizes such as the RR and 95% CI, rather than only of 5.60; 95% CI 2.27 13.81 indicates that drug B was far
rely on p values <0.05 to denote that the differences in the more effective than drug A; a result that is in the opposite
results are signiicant. The p value will continue to be <0.05, direction to the RR estimates of the other four trials. In
even if the RR was 0.30, 95% CI 0.20 0.40; a result that is the graphical display and the numerical description, the
both statistically signiicant (both limits of the CI < 1), and conidence limits in Jessani 2005 also clearly do not overlap
clinically important (we estimate that drug A would reduce with those of the other trials. Non-overlapping conidence
the risk of death by 70%, though it could be as low as 60% intervals, especially if accompanied by effect estimates
or as much as 80%). This example also emphasises the need that differ in the direction of effects, are clear indications
to examine the absolute effects to understand the true that the results from all the trials included in the meta-
beneits and harms of interventions, in addition to the more analysis are inconsistent with the pooled result, raising the
impressive relative estimates of effects. possibility of statistical heterogeneity. It is possible (though
9. Detecting, quantifying, and explaining inconsistency in the unlikely given the clear difference in the direction of effects)
results across studies: An oft-repeated criticism of meta- that this inconsistency in results is due to chance. The chi-
analysis is that combining the results of dissimilar trials square test for homogeneity shown in the second last row
is akin to mixing apples and oranges and is likely to yield reveals a very small p value, indicating that one can be
no meaningful results (unless one is interested in fruit- 99.99999% sure that this inconsistency is not due to chance
salad!). If the effects are virtually identical in all trials in the but due to differences in the trials (clinical or methodological
meta-analysis, then conidence in the pooled weighted heterogeneity).
summary estimate as representing the average effect of Just as with the previous example, the p value from the
the intervention versus the control is strengthened. If there chi-square test only provides us the certainty of excluding
is inconsistency in the direction, magnitude and precision chance as an explanation of a result, and does not reveal
of the effect estimates in meta-analyses, suggesting the how much of this inconsistency is actually important. The
intervention worked better in some trials than in others, inal notation in the second last row of the igure reveals
conidence that the pooled estimate accurately describes an I2 value of 87%. The I2statistic is derived from the chi-
the average effect of the intervention is diminished. square test and reinterprets this to indicate the proportion
Clinical heterogeneity; Clinical heterogeneity arises from of inconsistency that is due to true heterogeneity in the
differences in the clinical aspects of trials. Trials carried out trials. The I2value of 87% indicates that only 13% of the
in different countries; in different years or even decades; inconsistency observed is due to chance and 87% is due
on different populations; with different deinitions and to differences in the way the drug works in the trials. This
thresholds for diagnosis; and varying grades of severity of degree of inconsistency is too large to ignore; and it would
the health condition; are likely to yield results that differ be unreasonable to assume that the pooled effect estimates
considerably. Similarly trials using interventions that differ provide a realistic average effect of drug A. Had this value
in doses, formulations, combinations, routes, regimens, and been less than 25%, one might be less worried about
durations of treatment; and comparing them with placebo heterogeneity in the meta-analysis since more than 75%
or no treatment, and a myriad of alternative treatments of the differences in results of the ive trials occurred by
with the same dizzying array of variations, will also yield chance.
differing results. Trials that use outcomes that are deined, 10.Explaining heterogeneity: It is assumed that combining the
and ascertained in different ways, and at different time- results of different studies is likely to result in heterogeneity,
points will add to the possibility of yielding results that are should the trials differ signiicantly in clinical characteristics
inconsistent in a meta-analysis. and methods. Review authors, therefore attempt to ensure
Trials in meta-analyses whose methods increase the risk that the trials in a meta-analysis are suficiently similar in
of bias often differ in their results from those at low risk their methods, participants, interventions and outcomes to
of bias, resulting in methodological heterogeneity. Finally meaningfully combine. Cochrane review protocols also pre-
the results may be inconsistent purely by chance. Clinical specify ways in which the reasons for heterogeneity would
and methodological reasons for heterogeneity can result be explored, should the above tests indicate the presence
in statistical heterogeneity that is not uncommon. What of substantial inconsistency in results not accounted for by
is important is to identify if observed inconsistency in chance [I2>50%]. One method of exploring inconsistency
the results is due to chance (random error), and to what is to pre-specify a limited number of subgroups, based on
extent important differences in the trials contribute to the features of the participants, interventions, comparisons,
inconsistency. This will help determine if the results of the outcomes, or the methods used that could explain why drug
individual trials can be still be pooled and presented as an A might work better than drug B in some trials and not in
average, or ixed effect, of the intervention across all the others that did not share these features.
trials (hence the use of the term ixed effect meta-analysis in For example, let us assume that the review authors had pre-
the igure legend and at the top of the last column). speciied that if substantial heterogeneity was detected, the
However, if one inspects the graphical display of results trials would be sub-grouped by the presence of pre-existing
in Figure 1, it is easily apparent that in Jessani 2005, the RR risk factors for cardiac disease in participants. If Jessani 2005
[ 30 ]
had included many participants with previous episodes the inconsistency in the pooled results of the ive trials
of angina or cardiac disease who were on medications, helped us in understanding the differential effects of drugs
while the other trials had excluded such participants, A and B in those with cardiac risk factors that would not
the sub-group analysis of the forest plot would look have been so apparent from the results of a single trial.
different (Figure 2).
Conclusions
The meta-analysis now shows that the pooled results in
the subgroup of trials where participants had no cardiac These and other methods described in detail in the Cochrane
risk factors, drug A was far more effective than drug B in Handbook, ensure that the results of Cochrane systematic
reducing the risk of death. There is no inconsistency in the reviews are robust and reliable. However, the numerical
results within this subgroup of trials [I2 = 0%]. Death was results alone may be insuficient to inspire conidence in the
more likely with drug A than drug B for those with previous effects of the intervention, or to require a change in practice.
angina on medications, and this could be due to the heart Systematic reviews differ in the numbers of included trials
condition and / or to medication interactions. It would that met inclusion criteria, or that provided data for each
be meaningless to pool the results of the ive trials now in outcome in the reviews. They also differ in the risk of bias in
the face of such substantial heterogeneity, and signiicant the included studies; and even in those that contributed data
differences in effect estimates in the sub-groups. However, for different outcomes within a review. Two systematic reviews
Figure 1: Forest plot depicting a meta-analysis of a (hypothetical) comparison of two anti-obesity drugs: Outcome: death during treatment (Fixed
effect meta-analysis)
Figure 2: Forest plot depicting a meta-analysis of a (hypothetical) comparison of two anti-obesity drugs: Outcome: death during treatment sub-
grouped by cardiac risk factors (Fixed effect meta-analysis)
[ 31 ]
addressing the same question may yield different conclusions 6. Moher D, Tetzlaff J, Tricco AC, Sampson M, Altman DG. Epidemiology
and differ in the way they selected outcomes and deined and reporting characteristics of systematic reviews. PLoS Med. 2007 Mar
27;4(3):e78.
outcome thresholds. A systematic review may conclude that 7. Tricco AC,Tetzlaff J, Pham B, Brehaut J, Moher D. Non-Cochrane vs. Cochrane
drug A is recommended; and another systematic review may reviews were twice as likely to have positive conclusion statements: cross-
subsequently conclude that the drug is harmful, due to hitherto sectional study. J Clin Epidemiol. 2009 Apr;62(4):380-6 e1.
undisclosed adverse effects. The review may ind that drug A 8. Hahn S, Kim S, Garner P. Reduced osmolarity oral rehydration solution for
treating dehydration caused by acute diarrhoea in children. Cochrane
causes fewer deaths than drug B but is less effective in treating
Database Syst Rev. 2002(1):CD002847.
obesity. Future comments in this journal will describe methods 9. Duley L, Henderson-Smart D. Magnesium sulphate versus phenytoin for
of integrating the numerical results with other important eclampsia. Cochrane Database Syst Rev. 2003(4):CD000128.
information when summarising the results of meta-analyses 10. Duley L, Henderson-Smart D. Magnesium sulphate versus diazepam for
in systematic reviews, so that one can understand how much eclampsia. Cochrane Database Syst Rev. 2003(4):CD000127.
11. Enayati AA, Hemingway J, Garner P. Electronic mosquito repellents for
conidence to place in the overall evidence provided to reliably preventing mosquito bites and malaria infection. Cochrane Database
inform health decisions. Syst Rev. 2007(2):CD005434.
12. Volmink J, Garner P. Directly observed therapy for treating tuberculosis.
Competing interests The author is a contributor to the Cochrane Cochrane Database Syst Rev. 2007(4):CD003343.
Collaboration (www.cochrane.org) and director of one of the 13. Galappaththy GN, Omari AA, Tharyan P. Primaquine for preventing
14 independent Cochrane Centres (www.cochrane-sacn.org) relapses in people with Plasmodium vivax malaria. Cochrane Database
Syst Rev. 2007(1):CD004389.
worldwide. He has received research funding, travel support, and
14. Farquhar C, Marjoribanks J, Lethaby A, Suckling JA, Lamberts Q. Long
hospitality from organisations that support evidence-based term hormone therapy for perimenopausal and postmenopausal
healthcare. women. Cochrane Database Syst Rev. 2009(2):CD004143.
15. Alderson P, Roberts I. Corticosteroids for acute traumatic brain injury.
Funding support The author is a salaried employee of the Cochrane Database Syst Rev. 2005(1):CD000196.
Christian Medical College, Vellore. 16. Alderson P, Bunn F, Lefebvre C, Li WP, Li L, Roberts I, et al. Human albumin
solution for resuscitation and volume expansion in critically ill patients.
Declaration This article has not been previously published or Cochrane Database Syst Rev. 2004(4):CD001208.
submitted for publication elsewhere 17. Hopewell S, Loudon K, Clarke MJ, Oxman AD, Dickersin K. Publication
bias in clinical trials due to statistical signiicance or direction of trial
References results. Cochrane Database Syst Rev. 2009(1):MR000006.
1. Tharyan P. Evidence-based medicine: can the evidence be trusted? 18. Dwan K, Altman DG, Arnaiz JA, Bloom J, Chan AW, Cronin E, et al.
Indian J Med Ethics. 2011;8(4):201-7. Systematic review of the empirical evidence of study publication bias
2. Wu T, Li Y, Bian Z, Liu G, Moher D. Randomized trials published in some and outcome reporting bias. PLoS One. 2008;3(8):e3081.
Chinese journals: how many are randomised? Trials. 2009;10:46. 19. Nassir Ghaemi S, Shirzadi AA, Filkowski M. Publication bias and the
3. Zhang D, Freemantle N, Cheng KK. Are randomised trials conducted in pharmaceutical industry: the case of lamotrigine in bipolar disorder.
China or India biased? A comparative empirical analysis. J Clin Epidemiol. Medscape J Med. 2008;10(9):211.
2011 Jan;64(1):90-5. 20. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empir ical evidence of bias.
4. Tharyan P, Premkumar TS, Mathew V, Barnabas JP, Manuelraj. Editorial Dimensions of methodological quality associated with estimates of
policy and the reporting of randomized controlled trials: a survey of treatment effects in controlled trials. JAMA. 1995 Feb 1;273(5):408-12.
instructions for authors and assessment of trial reports in Indian medical 21. Vlassov V, Groves T. The role of Cochrane Review authors in exposing
journals (2004-05). Natl Med J India. 2008 Mar-Apr;21(2):62-8. research and publication misconduct. Cochrane Database Syst Rev.
5. Tharyan P. Evidence of the people, by the people, and for the people. 2010;8:ED000015.
Cochrane Database Syst Rev. 2010;8:ED000013. 22. Selvan MS, Subbian S, Cantor SB, Rodriguez A, Smith ML, Walsh GL. Ethics
of transparency in research reports. Indian J Med Ethics. 2011;8(1):31-6.
Hunger, ethics and the right to food

SRIJIT MISHRA
Associate Professor, Indira Gandhi Institute of Development Research, General AK Vaidya Marg, Goregaon (E), Mumbai 400 065 INDIA e-mail: srijit@igidr.ac.in
Abstract Introduction
The management of hunger has to look into the issues of The problem of hunger arises, more often than not, not from
availability, accessibility and adequacy of food supply. From an the non-availability of food; but from the inaccessibility of the
ethical perspective, this paper argues in favour of the right to available food (1:1). Again, provisioning of food for the hungry
food. But, for this to become viable, the state has to come up with is not just to ensure that people eat. It is also important to know
an appropriate and effective bill on food and nutrition security, how much, and what food, people eat - an adequate, balanced
address the issue of inadequate provisioning of storage space and nutritious diet is vital. The recent global food crisis brought
by state agencies leading to rotting of food grains - a criminal into focus spiralling prices and some reduction in availability
waste when people are dying of hunger; and rely on local level (2-3), but these cannot be separated from accessibility and
institutions involving the community, that complement the nutritional adequacy (4-5). Bringing together these divergent
administrative structure to identify the poor and reduce exclusion issues is a challenge for economic thinking, public policy and
and inclusion errors. ethics.
[ 32 ]
It is in this context that this paper proposes to raise issues The argument in favour of Raes right to food can also be
concerning the food security of vulnerable sections of the viewed from a Rawlsian difference principleperspective, that
population, the crisis in Indian agriculture, inadequate storage is, it should be of the greatest beneit to the least advantaged
and rotting of food grains procured by the public agencies, a members of society (7: 42-3). This emanates from an original
national food security bill, updating of the poverty line for position where people are under a veil of ignorance , an
2004-05 by the Planning Commission based on a new method, abstract position where people representing different
and some concomitant ethical challenges. The last will be stakeholders come together to frame rules but they do not
an issue cutting across other themes, which needs some know which group they belong to, and hence, all of them agree
independent discussion focusing on the predicament of who to rules that are in line with the difference principle. . It is akin
should get the fruit to begin with. to the maxmin outcome of game theory where the players irst
ind out the minimum possible value in each of the strategies
Who should get the fruit? then choose the strategy that gives the maximum from all
these minimum values, which indicates that at least this much
There are three children who want a fruit, say an apple, which
is assured. . However, the Rawlsian difference principle is much
according to the old adage, if consumed every day will keep
more than maxmin because it is based on mutuality and trust.
the doctor away. The irst child, Kwo, has a special liking for the
More importantly, the difference principle is the concluding
apple and enjoys eating it the most (the other two children
part of Rawls second principle of justice. It is preceded in
accept this); the second child, Dhu, is the one who put in the
priority by the irst part which refers to fair equal opportunities
effort into nurturing and tending the plant of which this is the
for all to choose the most suitable person(s) to positions of
irst fruit (the other two children do not deny this); and the third
power and authority. These are preceded by the irst principle,
child, Rae, is undernourished and without access to enough
which has an overarching priority and refers to equal liberties
food (the other two concede that they are well supplied with
for all.
food). Now the question is: who should get the fruit? This is
similar to the situation indicated by Amartya Sen where three A similar, but much more profound social thought echoes from
children were quarrelling over a lute the irst child knew how Mahatma Gandhis talisman: when in doubt, recall the face of
to play it, the second child had made it and the third child did the most vulnerable person and contemplate the implications
not have any amenities to engage with. A classic philosophical of your actions on that person and you will ind your answers.
question with at least three possibilities the utilitarian This can be applied as a test for any intervention that one plans,
position favouring the irst child, the libertarian argument public policy or otherwise. Its advantage over Rawls lies in two
linking property rights with effort favouring the second child, aspects. First, one need not be under a veil to be in the original
and the egalitarian point of view favouring the third child (6). position, one can be oneself. Second, one need not be in the
realm of abstract thought, one can be grounded in practical
In different forums and discussions where the fruit question
reality. There will then be no doubt about Raes right to food.
has been raised by this author, there has been a convergence
of opinion in favour of Rae, the malnourished child, getting the
Food security and vulnerability
fruit. This position seems to be egalitarian, but the agreement
could have a different reasoning for different individuals. Some India ranks 66th among 88 countries in the Global Hunger
taking the philanthropic position of giving food to the needy, Index (GHI) of 2010 (8). GHI is a multidimensional measure
and others arguing from the rights perspective that every using three equally weighted indicators-- the proportion of
individual has a right to food. The latter differ from the former undernourished population for 2004-06, the proportion of
in stating that it is not a dole that is being given to the poor underweight children below the age of ive for 2003-08, and the
and needy out of sympathy; it is their right. mortality rate of children under-ive for 2008. With a GHI value
of 23.7 the situation is considered alarming for India. What is
A libertarian perspective could say that the person who put in more, a similar calculation for 17 major states indicates that
the effort should own the fruit, has a property right, and should the situation is serious in four, alarming in 12, and extremely
be compensated for this in some form. If the compensation has alarming in one (9: 16). More and more individuals are like Rae.
a public policy provisioning and the fruit is given to Rae then This indicates the vital importance of the right to food.
this does not contradict the right to food perspective.
There are two points of concern in the calculation of
There are utilitarian arguments in favour of Kwo being given undernourished population being based on 1800 kilocalorie
the apple, who then, gives some other food to Rae. This may as an adequate requirement. First, this seems to have emerged
not violate the right to food, but it could lead to Rae consuming from the thinking that such people will receive state support
some unhealthy food with adverse implications for bodily under some social security arrangement, as in some Western
health. This, in a sense, still violates Raes right to food, with societies, to meet their minimum food requirements; and that
reference to health and nutrition. Independent of the health they do not have to put in hard labour. But, this norm will be
implications, compensation with some other food means that seriously inadequate for those individuals whose occupation
Rae will have to make do with a second-best preference, a and other contingencies require greater energy intake, as is
compromise. generally the case with the poor in many parts of the world.
[ 33 ]
Second, even when one agrees with the norm, a more identiied with Rae) are lactating and pregnant mothers,
appropriate interpretation would be that it represents children particularly the girl child- and school dropouts, the
the proportion of underfed population; because besides elderly, single and destitute women, those with ailments and
deiciencies in energy, undernourishment also includes physical disabilities, dalits and tribals, and the unemployed
deiciencies in protein, vitamins and minerals, among other among others. Similarly, some sectors have not beneited as
things (8: 9). Such an interpretation also its in with the inal much as others have. One such sector is agriculture.
index being a measure of hunger, not undernourishment. Even
for the poor, the irst priority would be to meet a minimum Crisis in Indian agriculture
energy requirement to avoid starvation. But, once this is Indian agriculture is undergoing a crisis that is manifested
met, there are other priorities in life such as the educational in twin dimensions agricultural and agrarian (12-13). The
requirements of children, or the immediate health needs of former is indicative of a developmental failure on account of
some family members that could take precedence over food poor public provisioning to the agricultural sector. This resulted
and nutritional adequacy. But, shortfalls in adequate food and in a deceleration in production and productivity of almost all
nutrition will have adverse long term implications on health crops in the 1990s (triennium ending (TE) 1994-95 to TE 2007-
that can also have an intergenerational impact: the poor health 08) when compared to the 1980s (TE 1981-82 to TE 1993-94);
of the mother being translated into poor health of the child. the per annum growth rates in production during the 1990s for
Thus, not giving the fruit to Rae takes us beyond the domain of foodgrains, oilseeds and sugarcane at 1.1 per cent, 1.2 per cent
the right to food to issues of inequities in health and nutrition and 1.4 per cent, respectively, being lower than the per annum
(10). population growth rate of 1.9 per cent for 1991-2001 (12: 49-
The total cereal consumption for all deciles, excluding that of 50) or 1.6 per cent for 2001-11, according to the latest census.
the lowest decile, has declined from 1972-73 to 2004-05 (11: The latter underlines the threat to the livelihood base of the
43). A closer look reveals that the decline has largely been for mass of small and marginal farmers and agricultural labourers.
nutri-cereals (like bajra and jowar among others) across all The annual per capita availability of foodgrains has come
decile groups, which in some sense have been replaced by rice down from 177 kilograms in TE 1992 to 159 kilograms in
and wheat for the lower decile groups. What could give the TE 2007. Using the norm of 2400 kilocalories per consumer
impression of a changing consumption pattern over time is unit (this is lower than per capita, as it adjusts for age and
actually an outcome of the larger agricultural policy following sex composition), the incidence of calorie poor in rural India
the green revolution, with an excessive focus on rice and wheat, is 43 per cent; it is even higher for the occupational group of
to the neglect of other crops. This has also coincided with agricultural labourers at 58 per cent and the land size group of
the poverty norm being linked with a calorie requirement or marginal holding (0-1 hectare) households at 47 per cent (12:
energy consumption. Thus, Raes right to food has to go beyond 54). A cruel irony is that those whose hands grow the nations
cereals and also include, among other things, fruits. food do not have enough to eat.
Between the years 1972-73 and 2004-05, one also observes Further, the nemesis of the Indian farmer has been poor returns
that energy consumption of the richest and the poorest deciles on cultivation, which based on a nation-wide survey conducted
are converging, but a substantial gap still remains, with the during 2003, is less than eight rupees per person per day
energy consumption of the latter as a proportion of the former (14). To contextualise from our fruit analogy, this relects the
being 53 per cent in rural areas, and 56 per cent in urban areas, sorry predicament of Dhu. What is more, Dhus situation, like
in 2004-05 (11: 44). While the positive relationship between that of Rae, falls short of the adequate food and nutritional
energy intake and expenditure deciles is understandable from requirement. The farmers have been getting some relief with
an income perspective, there is an ethical imperative because recent increases in minimum support prices for foodgrains. This,
the energy requirement is likely to have an inverse relationship however, has brought into focus the need for proper storage
with expenditure deciles. Then again, the average food and distribution of foodgrains.
consumption does not capture the uncertainty that the poor
face in terms of access to food, which could mean some days Rotting foodgrains
of starvation. Such a struggle for food on a daily basis will, most
In recent times, the rotting of foodgrains in storage facilities of
likely, exclude other things essential for the development of a
the Food Corporation of India (FCI) and other public agencies
healthy body and mind.
such as the Central and State Warehousing Corporations has
The study further shows that the growth of per capita received much attention. Between 1997 and 2007, 1.83 lakh
expenditure for the bottom ive decile groups compared to tonnes of wheat, 6.33 lakh tonnes of rice, 2.20 lakh tonnes of
the all India average is higher when 2004-05 is compared with paddy and 111 lakh tonnes of maize were damaged in different
1972-73, but lower when it is compared with 1993-94 (11: 42). FCI godowns, revealed a right to information petition (15). The
This means that the poorer groups have had relatively lower Supreme Court of India in an order also pointed out that: In
increments in recent years, also identiied as a post-reforms a country where admittedly people are starving, it is a crime
period, where the economy has witnessed a higher growth to waste even a single grain (16). It further advised that the
path. Some of the other vulnerable populations (or those Government take different steps including that of distributing
[ 34 ]
the food to those who deserve it. This, in a sense, relects Raes the constitution and international covenants, but begins by
right to food, but more importantly, it underlines the states stating that the bill will ... provide for food and nutritional
duty to fulil that right. security, in human life cycle approach, by ensuring access to
adequate quantity of quality food at affordable prices (21).
The Ministry of Consumer Affairs, Food and Public Distribution
Thus, in a sense both agree to the relevance of nutrition in this
in a recent press release indicated that, as of 1 June 2011, the
exercise and one feels that this primacy should be explicitly
capacity of FCI and other public agencies to store grains is
mentioned in the title, which should read as the National Food
623.65 lakh tonnes, of which 28.5 per cent (or 177.69 lakh
and Nutrition Security Bill, 2011.
tonnes) is under the open sky covered by a tarpaulin. What
is worrying is that this combined capacity is only 95.3 per At some point, the EGOM version refers to cash transfers in lieu
cent of the stocks at 654.73 lakh tonnes (17). A letter to the of entitlement and leverages it with unique identiication. Both
Supreme Court of India further highlights poor food grains these points have been under discussion in policy circles for
management from two additional aspects (18). First, there are quite some time and have a common origin. They are likely to
instances of storage of food grains under cover and plinth in do away with leakages and bring about effective targeting. The
the open for more than a year, exposing them to two or three intentions are to address Raes right to food. But, they suffer
monsoons and thereby rendering a substantial amount of it from a common problem - they miss the real issue.
unit for consumption. Second, the FCI let go of hired space
because of adverse remarks from the Comptroller and Auditor Cash transfer is a money-centric approach that ignores the
General (CAG) and then could not hire back the same when the need to make food available where people need it. If food
situation warranted. is made available and there exists an effective food grains
distribution mechanism then cash transfer (if that is pegged
A parliamentary committee report on similar concerns begins to the real amount of food, note that this is different from
by invoking the Universal Declaration of Human Rights and being conditional to food purchases only) could make it
the International Covenant on Economic, Social and Cultural accessible. Unique identiication is a techno-centric approach
Rights while reiterating the States obligation to ensure to the real world problem of identifying individuals with food
for everyone under its jurisdiction access to the minimum and nutritional insecurity. Independent of the issue of privacy
essential food which is suficient, nutritionally adequate and under unique identiication, which is equally important in a
safe to ensure their freedom from hunger (19: paragraph 1.1). democratic polity, any technology for identifying people should
The report goes on to suggest the need to construct additional be leveraged only after it is in place. This is not to belittle either
storage spaces in a decentralised and time-bound manner the relevance of money or technology. They are very important,
without compromising on modern scientiic technology, have but as means and not as ends. One has to be cautious in the
more frequent physical veriication of the stored food grains approach, otherwise exclusion and inclusion errors can take
stocks, introduce the National Food Security Bill (NFSB) at different forms and dimensions (22).
an early date, and inalise the poverty estimates so as to help
reduce exclusion and inclusion errors among others (19). The Counting the poor
National Food Security Bill (NFSB) has been introduced in the
An exclusion error is considered more serious than an inclusion
ongoing winter session of parliament in 2011 and the Planning error. This is particularly so in a welfare state, especially when
Commission has now accepted the new poverty estimates for the excluded person is well below the poverty line, whereas
2004-05 suggested by an expert group that it had constituted. the included person is just slightly above that line. Then again,
Both these issues need some further discussion. the norm used as a poverty line could refer to one aspect of
vulnerability, whereas the intervention measure through public
National Food Security Bill policy could be intended for something else.
A debate on the proposed NFSB has already been initiated in
In India, food and nutrition interventions have taken different
the press and other forums because of two versions - one that
forms. Some of these are: the Integrated Child Development
the National Advisory Council (NAC) has suggested (20), and Scheme through Anganwadis for children below six years, and
another one that the Empowered Group of Ministers (EGOM) pregnant and lactating mothers, the Mid-day Meal (MDM)
seeks to introduce (21). Both the versions have oficial sanction, scheme for children going to government and government-
and hence, it is good to see a discussion within the government assisted primary schools, and the Targeted Public Distribution
itself. However, it is noteworthy that the NAC version also System (TPDS) under which below poverty line households
has the involvement of civil society, particularly a network of receive food rations at a subsidised price through the fair price
individuals and associations working jointly to implement the shops.
right to food. Some remarks on this are in order.
Under TPDS it is essential to know the list of people below the
The NAC version begins with a preamble, which ends indicating poverty line. The Planning Commission has now accepted the
that ... a set of core entitlements within the universal right to recommendation of the expert group where the incidence of
food and nutrition are provided to be enjoyed and progressively poverty is 41.8 per cent for rural areas and 25.7 per cent for
expanded until universal access to adequate nutrition is urban areas in 2004-05 (23). While calculating this, the expert
achieved (20: 2). The EGOM does not have a preamble invoking group did away with benchmarking the incidence of poverty
[ 35 ]
with a calorie norm. The report of the expert group does compensating Dhu and providing for Rae, in which Kwo ends
mention that around the poverty line, people in urban India up with positive externalities, while both Dhu and Rae become
can afford the existing norm. But, their observed intake of 1776 better off. It satisies Mahatma Gandhis talisman and Rawlsian
kilocalories is closer to a norm of 1770 kilocalories indicated fairness. The state should come up with an appropriate and
by the Food and Agriculture Organisation (FAO). If the latter is effective bill on food and nutrition security, address the issue of
being used as a justiication in support of the observed intake, rotting food grains -- a criminal waste when people still die of
then it misses the point that once basic hunger is satisied, starvation-- and rely on bottom-up methods that complement
people will have other priorities that could compromise the top-down administrative structure to identify the poor and
with food and nutrition security. It could be the education of reduce both exclusion and inclusion errors in targeting.
children, the health care needs of family members, and social
events (marriage, birth and death) among others; or, as in Adam Note
Smiths England, the need to buy a pair of leather shoes so as
to be able to go out without shame (24: V.2.148). It is another The Draft National Food Security Bill, 2011, has now been put
matter that the FAO norm is for light and sedentary activities up for public scrutiny and is available from: http://fcamin.nic.
and not for medium to heavy activities that the poor in India in/dfpd_html/Draft_National_Food_Security_Bill.pdf.
may be associated with. Thus, the claim that the new poverty Conflict of interest: None.
line goes beyond calorie needs and incorporates the health
care and education requirement is invalid (25-27). Acknowledgements: The author thanks the anonymous peer
reviewer, Upasak Das, Sarthak Gaurav, GN Rao and VM Rao for
There are a few other concerns arising out of this new estimate.
their comments on earlier versions. The usual disclaimers apply.
It uses median expenditure of health and education as a
norm, which could be an underestimate because expenditure References
distribution is positively skewed (25, 28). It is not easy to 1. Sen A. Poverty and famines: an essay on entitlement and deprivation.
replicate or to come up with comparable poverty lines for Clarendon: Oxford University Press; 1981, p.xii+257.
2. Headey D, Fan S. Reflections on the global food crisis: How did it happen?
earlier years (29). Thus, time series analysis, beyond what is
How has it hurt? And how can we prevent the next one? [Internet].
given in the report, is dificult. And, the acceptance of the Washington DC: International Food Policy Research Institute; 2010[cited
poverty ratio for urban India from the old method as a starting 2011 Jul 25]. Available from: http://www.ifpri.org/sites/default/iles/
point and then using it to compute a poverty line basket, has publications/rr165.pdf
no other basis than the pragmatic consideration of starting 3. Naylor RL, Falcon WP. Food security in an era of economic volatility. Popul
Dev Rev. [Internet]. 2010 Dec [cited 2011 Jul 25];36(4):693-723. Available
from somewhere (30-31). More importantly, it changes the from: http://iis-db.stanford.edu/pubs/23058/Volatility_inal_12_10.pdf
share of the poor across states, and if absolute numbers are not 4. Dev SM, Kadiyala S. Pro-nutrition agriculture in India: entry points and
taken into consideration for increasing the budget, then poorer policy options. India Health Beat [Internet]. 2011 Jun[cited 2011 Sep
states will get lower amounts under some centrally sponsored 1];5(8):4p. Available from: http://www.phi.org/images/pdf/Policy_
Note_Vol5_8.pdf
poverty reduction schemes (32).
5. Dev SM. Rising food crisis and inancial crisis in India: impact on women
and children and ways of tackling the problem. Working Paper No. WP-
As the estimates of the expert group are based on a sample
2011-003[Internet]. Mumbai: Indira Gandhi Institute of Development
survey of consumption expenditure from households, it cannot Research; 2011 Jan [cited 2011 Jul 25]. Available from: http://www.igidr.
be used to identify poor households in the population. Before ac.in/pdf/publication/WP-2011-003.
providing food or fruit, Rae needs to be identiied. It is for this 6. Sen A. What do we want from a theory of justice? Journal of Philosophy.
purpose that an independent census of below poverty line 2006 May; 103(5):215-38.
7. Rawls J. Justice as fairness: a restatement. Cambridge, Massachusetts: The
households in rural areas is underway in 2011. This should be Belknap Press; 2001, p.xx+214.
an independent exercise. The incidence calculated using the 8. von Grebmer K, Ruel MT, Menon P, Nestorova B, Oloinbiyi T, Fritschel
national sample survey data cannot be imposed on the census H, Yohannes Y, von Oppeln C, Towey O, Golden K, Thompson J. 2010
data to limit the number of households which are poor, even if global hunger index, the challenge of hunger: focus on the crisis of child
undernutrition[Internet]. Bonn:Welthungerhilfe, Washington D C:
one allows a margin to address for some exigencies (33). This
International Food Policy Research Institute, and Dublin: Concern
top-down approach may reduce the inclusion errors, but is also Worldwide;2010[cited 2011 Jul 25]. Available from: http://www.ifpri.
likely to increase the exclusion errors. org/sites/default/iles/publications/ghi10.pdf
9. Menon P, Deolalikar A, Bhaskar A. India state hunger index: comparison of
What is required is a bottom-up approach, grounded in hunger across states [Internet]. Washington DC: International Food Policy
reality, to complement the top-down administrative structure Research Institute, Bonn: Welthungerhilfe, and Riverside: University of
and implementing mechanism. There is a strong case for California; 2009 [cited 2011 Jul 25]. Available from: http://www.ifpri.org/
sites/default/iles/publications/ishi08.pdf
involvement of the community at various levels, strengthening 10. Sardeshpande N, Shukla A, Scott K, editors. Nutritional crisis in
transparency to evaluate processes at every stage from policy Maharashtra [Internet]. Pune: SATHI; 2009 [cited 2011 Sep1]. Available
formulation till the achievement of the policy objectives, and from: http://www.sathicehat.org/uploads/PastProjects/Nutritional_
improving accountability (34-35). Crisis_in_Maharashtra_Report.pdf
11. Suryanarayana MH. Food security: beyond the eleventh plan iction. In:
Nachane DM, editor. India Development Report 2011. New Delhi: Oxford
Conclusion University Press; 2011. p. 40-7.
12. Mishra S, Reddy DN. Persistence of crisis in Indian agriculture: need for
Any analysis of hunger has to take into consideration the
technological and institutional alternatives. In: Nachane DM, editor.
availability, accessibility and adequacy of food among other India development report 2011. New Delhi: Oxford University Press; 2011.
conditions. In our fruit analogy, a win-win situation lies in p. 48-58.
[ 36 ]
13. Reddy DN, Mishra S, editors. Agrarian crisis in India. New Delhi: Oxford 25. Swaminathan M. The new poverty line: a methodology deeply lawed.
University Press; 2009. Indian Journal of Human Development [Internet]. 2010[cited 2011 Sep
14. Mishra S. Agrarian scenario in post-reform India: a story of distress, 1]; 4(1):121-5. Available from: http://www.ihdindia.org/ihdjournal/
despair and death. Orissa Economic Journal- 2007-; 39(1&2): 53-84. Abstract1.aspx?id=136
15. Indo-Asian News Service. Food grains rot in FCI godowns across 26. Shah G. The poor: beneiciaries to citizens. Indian Journal of Human
India. The Hindustan Times, New Delhi. 2010 Jul 27 [cited 2011 Jul 25]. Development [Internet]. 2010 [cited 2011 Sep 1];4(1):127-32. Available
Available from: http://www.hindustantimes.com/Food-grains-rot-in- from: http://www.ihdindia.org/ihdjournal/Abstract1.aspx?id=137
FCI-godowns-across-India/Article1-578444.aspx 27. Kannan KP. Estimating and identifying the poor in India. Indian Journal
16. Supreme Court of India. Writ petition (civil) No. 196 of 2001. Peoples of Human Development [Internet].2010 [cited 2011 Sep 1]; 4(1):91-
Union for Civil Liberties (petitioner) versus Union of India & ors. 8. Available from: http://www.ihdindia.org/ihdjournal/Abstract1.
(respondents)[Internet]. 2010 Jul 27 [cited 2011 Jul 25]. Available from:
aspx?id=134
http://www.sccommissioners.org/CourtOrders/Orders/TPDS_270710.
28. Subramanian S. Identifying the income-poor: some controversies in
pdf
India and elsewhere[Internet]. Discussion Paper, Courant Research
17. Ministry of Consumer Affairs, Food and Public Distribution. Efforts being
taken to create additional foodgrains storage capacity[Internet]. New Centre. 2010 Nov [cited 2011 Sep 1]. Available from: http://www2.vwl.
Delhi: Press Information Bureau, Government of India. 2011 Jun 29 wiso.uni-goettingen.de/courant-papers/CRC-PEG_DP_46.pdf
[cited 2011 Jul 25]. Available from: http://pib.nic.in/newsite/erelease. 29. Raveendran G. New estimates of poverty in India: a critique of the
aspx?relid=72933 Tendulkar committee report. Indian Journal of Human Development
18. Saxena NC, Mander H. Report on the excess food grains in the godowns of [Internet]. 2010[cited 2011 Sep 1];4(1):75-89. Available from: http://
the Food Corporation of India and the State Civil Supplies Corporations www.ihdindia.org/ihdjournal/Abstract1.aspx?id=133
[letter][Internet]. Ofice of the Supreme Court Commissioners, in the 30. Alagh YK. The poverty debate in perspective: moving forward with the
case: PUCL Vs UOI and ORS. Writ Petition (Civil) No. 196 of 2001. 2010 Tendulkar committee. Indian Journal of Human Development [Internet].
Aug 10 [cited 2011 Jul 25]. Available from: http://sccommissioners.org/ 2010[cited 2011 Sep1]; 4(1):33-44. Available from: http://www.ihdindia.
Correspondence/ExcessGrain_100810.pdf org/ihdjournal/Abstract1.aspx?id=131
19. Standing Committee on Food, Consumer Affairs and Public Distribution 31. Datta KL. Index of poverty and deprivation in the context of inclusive
(2009-10, Fifteenth Lok Sabha). Food subsidy and its utilisation. Eighth growth. Indian Journal of Human Development[Internet]. 2010 [cited
report [Internet]. New Delhi: Lok Sabha Secretariat; 2010 Aug [cited 2011 2011 Sep1];4(1):45-73. Available from: http://www.ihdindia.org/
Jul 25]. Available from http://164.100.47.134/lsscommittee/Food,%20C ihdjournal/Abstract1.aspx?id=132
onsumer%20Affairs%20&%20Public%20Distribution/Report.pdf 32. Pathak DC, Mishra S. Poverty estimates in India: old and new methods,
20. National Advisory Council. National Food Security Bill, 2011[Internet]. 2004-05[Internet]. Working Paper No. WP-2011-015. Mumbai: Indira
New Delhi: Government of India. 2011 Jul 7 [cited 2011 Jul 25]. Available Gandhi Institute of Development Research. 2011 Aug [cited 2011
from: http://nac.nic.in/foodsecurity/nfsb_inal.pdf Aug16]. Available from; http://www.igidr.ac.in/pdf/publication/WP-
21. Empowered Group of Ministers. National Food Security Bill, 2011[Internet]. 2011-015.pdf
2011 Jul [cited 2011 Jul 25]. Available from: http://www.righttofoodindia. 33. Breman J. A poor deal. Indian Journal of Human Development [Internet].
org/data/right_to_food_act_data/July_2011_egom_nfsb_draft.pdf
2010[cited 2011 Sep 1]; 4(1):133-42. Available from: http://www.ihdindia.
22. Cornia GA, Stewart F. Two errors of targeting. J Int Devel.[Internet].
org/ihdjournal/Abstract1.aspx?id=138
1993 Sep-Oct [cited 2011 Sep 1];5(5):459-96.Available from: http://
34. Rao VM. Policy making in India for rural development: data base and
onlinelibrary.wiley.com/doi/10.1002/jid.3380050503/abstract
23. Government of India. Report of the expert group to review the methodology indicators for transparency and accountability. Int J Economic Policy in
for estimation of poverty (Chairperson: SD Tendulkar) [Internet]. New Emerging Economies [Internet]. 2010 Sep [cited 2011 Sep1];3(3):222
Delhi: Planning Commission. 2009 [cited 2011 Jul 25]. Available from: 36. Available from: http://inderscience.metapress.com/link.
http://planningcommission.nic.in/reports/genrep/rep_pov.pdf asp?id=u180x07562m105n5
24. Smith A.An inquiry into the nature and causes of wealth of nations[Internet]. 35. Rao VM.Upward revision of the poverty line:some implications for poverty
Edwin Cannan, editor. London: Methuen & Co., Ltd. Library of Economics analysis and policies. Indian Journal of Human Development[Internet].
and Liberty. 1904 [cited 2011 Aug 29]. Available from: http://www. 2010 [cited 2011 Sep1];4(1):143-55. Available from: http://www.ihdindia.
econlib.org/library/Smith/smWN21.html org/ihdjournal/Abstract1.aspx?id=139
Attempts at regulation of medical education by the MCI: issues of unethical

and dubious practices for compliance by medical colleges and some possible
solutions
ANANTHAKRISHNAN N1, SHANTHI AK 2
1
Director and Professor of Surgery (Retired), Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER), Pondicherry 605 006 INDIA 2 Associate
Professor of Paediatrics, Indira Gandhi Medical College and Research Institute, Pondicherry 607 402 INDIA. Author for correspondence N Ananthakrishnan
e-mail: n.ananthk@gmail.com
Introduction resources to invest for this purpose Many of these private

There are, at present, over 335 medical colleges in the country institutions are managed by organisations and trusts which are
conducting the MBBS course (1). Of these, well over 50 per cent recent entrants to the ield and do not have a long history of
are run by private organisations. Further, an overwhelming experience in running educational institutions, leading one to
majority of institutions set up within the last two decades are suspect that altruism and a drive to promote education is not
privately run and not state sponsored. This itself indicates that the sole factor guiding the start of these institutions. Medical
governments, both central and state, do not have adequate education has become a promising and proitable business.
[ 37 ]
The problems that plague medical education in the country dificult to come by, since the monetary transaction is in cash
are related to these twin facts: the mushrooming of medical and without a receipt, and parents / guardians are reluctant to
colleges in the last two decades, and the shift of medical testify since this would expose their wards to the wrath of the
education from public to private hands. In 2009, there were 284 management.
colleges listed on the Medical Council of India (MCI) website
(2). This igure has risen over two years to 335. The problems There are essentially two issues: lack of quality in admission and
and dificulties with ensuring quality in the medical education the matter of raising suficient funds to run an institution and
system in India, run across institutions and are not speciic to allow for proit. Running a medical college in the private sector
any. The regulatory agency is aware of these issues and has is not mere philanthropy. It is a business like any other. Strict
often responded by what can be best be described as knee regulation of the fee structure and setting aside a large quota
jerk reactions, without making serious attempts to correct the of seats for government-sponsored candidates, as happens in
malady at its root. It is not surprising that these measures have some states, compounds the issue. Since only a small pool is
little, if any, effect. Sometimes, the problems are worsened by left to the managements of these institutions, abnormally high
these attempts. capitation fees are ixed for this group and quality becomes
the casualty. In deemed universities, which are not compelled
This paper will attempt to analyse the deiciencies in regulatory to give any quota to the government, these capitation fees can
control of medical education in the country and the measures apply to all candidates.
that are taken by individual institutions to beat the system
and suggest possible solutions to cure the malady. If urgent These issues can easily be resolved, provided there is a
measures are not instituted, the quality of physicians in the strong political will. During the tenure of the previous
country in future will fall far short of the ideal. It must be board of governors of the MCI, this matter was discussed in
emphasised that the problems listed here are not universal to great depth in the working groups for undergraduate and
all private institutions, and that many of the issues pertain to postgraduate medical education, for well over a year. One of
government institutions as well. the recommendations made was that all admissions to medical
colleges should take place through a single national entrance
Current problems examination which takes into account the syllabi of all the +2
boards in the country. This entrance examination would be
Absence of quality in admissions and high capitation fees
held two weeks after completion of the inal year examination,
These two issues are closely linked and must be dealt with before the start of internship. This change in scheduling was
together. The poor quality of many of the students admitted suggested since the existing system results in the whole
to private institutions is well known. This occurs because one year-period of internship being spent by candidates in
admissions to these institutions are linked, not to the merit preparing for the entrance examination, without focusing on
of the candidates in a competitive examination, but to their the acquisition of skills for which the internship is meant. A
ability to pay the capitation fees, which currently may run up single national examination would also avoid the strain on
to as much as Rs 40 lakh for the MBBS course in some colleges. candidates of having to apply and appear for multiple entrance
Running medical colleges is an expensive proposition and the examinations at several institutes / states. The national ranking
managements have to raise suficient funds to do so. The fee list would comprise all candidates who have secured the
structure ixed by the government is not realistic. The hospitals minimum prescribed marks by the current guidelines and
attached to the medical colleges often do not have enough would also provide information on their states of nativity
patient intakes and do not make enough money to support and eligibility for any reservation. This single national ranking
the college for several years. Hence, colleges have to resort examination would be used by all states, universities and
to alternative methods of collecting funds. The only solution institutions for their admission process. The existing reservation
that seems viable to them is to hike the fees to astronomical system would not be affected, since seats can still be illed up
levels to allow for both sustenance and proit. Since entrance from the list by admitting students of the appropriate reserved
examinations are mandatory they are conducted, but the marks category according to their ranking in the all-India merit list.
and the rank lists are not often displayed until the negotiations The candidates can join their respective postgraduate courses
for admissions are complete. Since there is no strict monitoring on satisfactory completion of their internship by a process of
of these entrance examinations, particularly in deemed counselling.
universities, such a practice escapes detection.
In order to allow institutes to raise inance, 50% of the overall
The fact of high capitation fees is well known and has been seats should be provided to the government for illing up the
subjected periodically to exposs in the media and half- government quota with ixed fees and the remaining 50%
hearted attempts at investigation. Recently, The Times of India should be free of any regulatory control on fees; provided
mentioned that as much as Rs two thousand crore may be the candidates are admitted from the national ranking list on
generated this year as black money because of these capitation merit. The government should ensure liberal conditions for
fees in the state of Tamil Nadu alone, with advance booking these candidates to obtain loans from nationalised banks for
being taken for postgraduate seats at the time of MBBS their education. As regards the government quota, this should
admissions (3).However, for obvious reasons, hard evidence is be legally ensured at the time of issue of the no-objection
[ 38 ]
certiicate by the state health authority, and not left to annual another. This process of clustering has an enormous impact
negotiations every year between the government and the both on the availability of faculty in these medical colleges
managements. and on the patient load, since there are neither enough trained
faculty nor enough patients requiring health care to meet the
Adoption of this system would ensure that:
requirements of all the medical colleges in terms of MCI norms.
a. internship is restored to its rightful place as a period of Until a proper policy is laid down by the Government of India in
development of skills; this regard, and the NOC criteria are strictly enforced, clustering
b. quality would be ensured in admissions; will continue to occur. The problem that clustering of medical
colleges causes to the availability of clinical material and faculty
c. the farce of closing ones eyes to capitation fees would be is dealt with subsequently.
abolished;
d. black money transactions would be eliminated; Shortage of faculty
e. managements would have suficient funds to run their One of the major issues where dubious practices are adopted
institutions; and by institutions at the time of MCI inspection is regarding
f. multiple examinations and the consequent strain on the presence of an adequate number of faculties according
candidates would be avoided. to requirements. It is well known that large-scale import of
Delayed admissions teachers occurs in private institutions on the day before, or
on the day of, inspection to be presented to the assessors as
Although the last date for admissions has been mandated by existing faculty. Government institutions are not without fault
the Supreme Court, in point of fact there is no way this can as they deal with this issue by large-scale transfers of teachers
be regulated or enforced, particularly in deemed universities. from one institute to another just before inspection, only for
This results in students being admitted several months after the teachers to be returned to their parent institution after the
the last date with a consequent loss of curricular time. The inspection is over. The practice has, unfortunately, extended
records are corrected to make it appear as if the candidates even to super-specialty courses and there are examples,
have been admitted prior to the last date. In postgraduate though not common, of the MCI having sanctioned super-
courses, occasionally, the admissions are given as late as nine specialty courses based entirely on imported faculty with not
months after the last date. As can be understood, this seriously a single permanent faculty member who works full time in the
compromises the available period of time for the course to be institute concerned. Allotment of postgraduates to an institute
completed for the candidate and consequently affects quality. based on the number of professors and associate professors
in that institution is an added incentive to the institutions to
The regulatory agency should ensure that all admissions
import more faculty for inspection to increase their quota of
are reported to it the day after the last date prescribed by
postgraduate seats. The impact on education in the long term
the Supreme Court. The database including biometric data
can well be understood.
should be maintained by the MCI and no admissions should
be permitted after this date. Once the admissions are frozen Shortage of faculty is the direct result of an enormous increase
by record in the MCI on the last date, the institutions would in the number of medical colleges, particularly in the last couple
not have the option of admitting candidates late and then of decades, with the increase in postgraduate seats not keeping
correcting the records to show that they have been admitted pace with this increase. The reluctance of postgraduates
prior to the last date. to enter the teaching profession has compounded the
problem. Measures by the MCI such as physical veriication,
Skewed distribution of medical colleges
ignominiously referred to as head counting, at the time
The 335+ medical colleges in the country are distributed of inspection (assessment) and maintenance of a national
in a skewed fashion, with nearly 70% falling in the states of database of teachers and their institutions have not entirely put
Maharashtra, Karnataka, Kerala, Tamil Nadu, Andhra Pradesh an end to the problem. These measures only ensure, to some
and Pondicherry, and only 30% in the rest of the country. This, extent, that no teacher is presented by two or more colleges
in spite of the MCIs requirement that to start a new medical in the same year. Even this is only a half measure. During the
college at any site, one would have to obtain a no-objection current year itself many teachers are under investigation by
certiicate from the concerned state health authorities which the MCI, because their names appear in more than one college
would be issued after making a need appraisal for another faculty (5).The vast majority of teacher imports consists of
medical college at that site. The state authority would have private practitioners not attached to any medical college who
to certify that there is suficient clinical load in that area make their services available at an exorbitant fee to present
to sustain a medical college (4). Perhaps because of easier themselves as teachers for a couple of days during inspection.
access to these NOCs in the southern states or the greater This is not prevented by the MCIs database of teachers. Since
proitability potential of starting an institution in these states, their names are not recorded in any other institution, they
medical colleges have got clustered in these states. In the city escape detection. Year after year, the same practitioners are
of Pondicherry with a population of less than 10 lakhs there called by the concerned institutions during inspection. The
are eight medical colleges, some within a stones throw of one second measure adopted by the MCI to overcome the shortage
[ 39 ]
of teachers is to marginally reduce the number of teachers syllabus of both courses is essentially the same); and
required by some departments (6). This measure compounds 10.Recognition of all qualiications given by the National Board
the problem since it is an admission that the earlier norms were of Examinations as equal to the corresponding postgraduate
not ixed after proper application of mind. Further, it ignores degrees.
the fact that many of these teachers, particularly in the basic
These short term measures have already been recommended
sciences, are involved not only in teaching the MBBS course,
to the MCI over a year ago. No speciic action has been
but also in allied disciplines like nursing and dental courses run
taken although the shortage of teachers has reached critical
by the same private institution. Hence reduction in the number
dimensions.
required only adds to the workload of the existing teachers.
The problem is not impossible to solve. . An increase in the Long term measures
postgraduate seats, which is the strategy adopted by the MCI, Three measures are proposed. First, there must be an alteration
would take several years to make up for the deiciency of
of the student teacher ratio from the current ixed norm of 1:1
teachers, by which time the number of medical colleges would
for an associate professor and 1:2 for a professor, depending
have increased further, since there is no moratorium on new
on the needs of individual departments and their capacity
medical colleges. To make up the teacher shortage, there must
to train postgraduate students. These current norms may
be an increase in availability of teachers in the short term and
be appropriate for a clinical discipline but a teacher in a pre-
in the long term. Several measures can be adopted for this
clinical or a para-clinical discipline may be allowed to take more
purpose.
postgraduate students.
Short term measures as an immediate solution Second, special incentives should be given to postgraduate
These measures are: students joining the basic disciplines where there is a shortage
of teachers, such as a lower fee, immediate appointment to the
1. Relaxing the eligibility criteria for teachers as a temporary faculty on qualiication or joining the faculty with a higher rank,
measure; etc.
2. Giving special weightage and incentives for teachers in
critically short subjects by higher increments, accelerated Third, there must be a critical review and ixing of fresh norms
promotion or starting with a higher designation; for teachers in various pre and para-clinical and clinical
disciplines which are realistic and take into account the current
3. Allowing doctors with postgraduate degrees who have
numbers of teachers available.
worked in medical colleges without teaching designations
to be recruited as teachers, subject to fulilling a minimum Strict action on the part of the regulator to implement some of
number of years in that specialty; these suggestions supported by strong political backing will
4. Recognising foreign qualiications and degrees which are go a long way towards eliminating the unhealthy practice of
now under reciprocal de-recognition largely for political importing teachers to fool the assessors.
reasons;
5. Employing retired teachers on a part time basis; Shortage of clinical material for teaching purposes
6. Sharing of faculty in critical departments such as Forensic A medical college draws its sustenance and its reputation
Medicine between adjacent medical colleges; for excellence as a teaching institution from the quality and
quantity of clinical material available therein for training
7. Allowing adjunct faculty from the clinical side to teach
undergraduates and postgraduates. It is well known that there
pre- and paraclinical disciplines where there is a critical
shortage of faculty as a temporary measure; Some examples is a tremendous shortage of clinical material in many of the
of this would be surgeons teaching anatomy, physicians medical colleges, since treatment is not free or only nominally
or paediatricians teaching physiology, pharmacologists free. Clustering of medical colleges has worsened this problem.
teaching toxicology and pathologists teaching forensic Hence the number of patients available for teaching is sub-
medicine. optimal. This is sought to be overcome by the unhealthy
practice of bringing in truckloads of patients on the day prior to
8. Allowing honorary faculty to ill the gaps on a temporary
inspection from the neighbouring villages, who are then paid
basis (these can be from the pool of private practitioners
for their services once the assessment is over. Several inspectors
who have postgraduate qualiications);
have stated to me that many of the so-called patients lying in
9. Removal of all restrictions on teachers with non-medical the wards do not have any speciic illness and they may not
qualiications in the basic disciplines (these are now subject even have been admitted in the relevant disciplines called for
to several restrictions as regards promotional avenues, by their symptoms. In one institution, I was told, removal of the
number allowed as a percentage of the total faculty strength sheet covering an apparently sleeping patient in one of the
of the department, and source of non-medical postgraduate gynaecological wards revealed a male!
qualiication whether from a faculty of medicine or a
faculty of science- the former being allowed and the latter Together with this practice, igures for daily outpatient
prohibited from joining a medical college although the attendance are falsiied and inpatient records and operation
[ 40 ]
and procedure statistics are doctored to show suficiency as resources required to run it. Exemption, of course, would have
per MCI norms. Since the inspection by the MCI is not really a to be made for equipment for departments such as radiology
surprise inspection, there is suficient time for the institutions and pathology which necessarily have to be done in-house.
to resort to this practice. One way of rectifying this is to make Even here, one would have to seriously consider whether
sure that the inspection is really an unannounced surprise costly services, such as magnetic resonance imaging, should
inspection without prior notice. Alternatively, a re-inspection be permitted to be shared with other health care facilities, with
may be carried out without notice shortly after the irst, to students being sent offsite for training purposes. The central
ensure that the igures shown at irst inspection are genuine. government should also consider whether the duty on medical
Also, the MCI inspectors may verify the genuineness of the college equipment can be reduced or waived in view of the
operation lists and other procedures by crosschecking them countrys need to increase the doctor- patient ratio to 1:1,000
with investigation data, pathology records, etc. Unfortunately, which is the goal sought to be achieved.
MCI inspectors would then have to work not only as assessors
but as detectives and spies as well! As regards library facilities, permitting electronic libraries
instead of hard copies would tremendously reduce the capital
The provision of a well-equipped skill laboratory can to some
expense on purchase of books and journals. Through the
extent mitigate the problem although it would not be suficient
Union Ministry of Health, arrangements can be made with
to substitute for a lack of clinical material. Skill laboratories can
the National Medical Library to procure and supply electronic
serve for training students and allowing them to practice prior
learning resources at subsidised rates for medical colleges
to handling patients, but can in no way simulate real patients.
and permit them to subscribe to journals through national
Yet another method of increasing availability of clinical material facilities such as Electronic Resources in Medicine in India . In
is to make it mandatory that 50% of beds are earmarked fact, what the MCI should insist on is not suficient numbers
for free patients who would not have to pay for admissions, of hard copies of books and journals but a greater availability
procedures or investigations. The state can ensure this in return of computer hardware and terminals to permit e-learning.
for permitting another medical college. The major reason why Investment on this will certainly be cheaper in the long term
patient load is minimal at several of these institutions is the for the institutions.
fact that treatment becomes prohibitively costly and beyond
the reach of the common person. Neglect of research
An earlier publication from one of the authors had pointed
Shortage of equipment and learning resource
out the woeful dearth of research activities in medical colleges
facilities
(7). This is in spite of the fact that a research laboratory has
To those in the medical education profession it is well known been made a mandatory requirement for all departments
that much of the life-saving equipment is brought on hire in medical colleges (8). However, the equipment for these
for the MCI inspection. In fact, this has now almost become research laboratories has not been clearly speciied. The MCI
a cottage industry with several agents contacting medical is aware of the lack of research in medical colleges and has
colleges to supply equipment and books as per the MCI list for recently revised the guidelines for criteria for the promotion of
a few days during the inspection process. A major reason for
teachers to include publication of research papers (9). However,
this lacuna is the prohibitive cost of equipment, medical books
enforcement has been postponed for some years and the old
and journals. In fact, the annual subscription for journals alone
system has been allowed to continue for unknown reasons.
in a medical college may run as high as Rs 50 lakh or more.
With rapid advancement in medical knowledge, research
Much of the equipment is not indigenously manufactured and
training has to become compulsory for all medical graduates,
is very expensive. Customs duty exemption is not available for
if not faculty.
all the items on the MCI list. The institutes hesitate to procure
the items since substantial investment is required and the One method of ensuring this is done is to ensure that the
returns are not guaranteed in the short term. guidelines for promotion mandating a minimum number of
Solutions are not hard to come by. The irst priority is to revisit research papers are strictly enforced and strengthened. Medical
the list of required instruments in the MCI list, which has not postgraduates with PhD degrees should be encouraged to
been revised for years. A drastic revision is called for, removing join medical colleges to give a illip to research activities. For
all obsolete equipment which is particularly prominent in the enabling this, one may have to consider incentives such as
list required for the basic science departments. As regards allowing them to join in a higher post compared to those
equipment required for clinical facilities, MCI should seriously without research degrees, or giving weightage to the period
consider whether outsourcing of some investigations which are spent in acquiring a PhD degree for promotion purposes. Also,
not required to be done in-house for training purposes, should a minimum number of indexed publications from the college
be allowed. This list will include many types of equipment should be insisted upon at the time of mandatory renewal of
required for biochemical investigations. Implementation of permission which now takes place, or is supposed to, once in
this suggestion would go a long way in reducing expenses on ive years. Postgraduate dissertations need to be taken up with
purchase and maintenance of this equipment and the human a lot more seriousness than is done at present.
[ 41 ]
Unhealthy practices in evaluation Conclusion

The most odious, and perhaps the most dangerous, of the In conclusion, it may be stated that there are a number of ills
unhealthy practices in medical education is the interference and unethical practices which plague the medical education
in the evaluation system. Ever since internal assessment system in the country at present. There is a total system failure
became compulsory and was included in the summative and blame cannot be apportioned to the managements of
evaluation process, manipulation of internal assessment the colleges alone. The Union Government and the political
marks has become the norm in many institutions. It is not class have not exhibited awareness of the issue, nor responded
uncommon to see that almost all candidates get more than with vigourous corrective measures; and the erstwhile MCI,
90% in internal assessment so that they may get a push in the before it was superseded, had reacted with half measures
inal examinations, should they fall on the borderline between without thinking through the issue, implementing solutions
passing and failing. which sometimes compounded the problem. The regulatory
The Central University of Pondicherry, at one time, tried to agency in the past has also not shown the will power or the
investigate the genuineness of internal assessment in the ability to enforce the rules, such as they are. The profession is
afiliated colleges after seeing the high scores obtained by apparently apathetic to the state of affairs and the public is
almost all candidates. In spite of the liberal internal assessment totally ignorant of the downhill slide in the quality of doctors.
marks, there was a hue and cry from the candidates about A greater awareness in the medical community of the danger
possible bias in internal assessment, since they did not trust of ignoring these issues and their impact on the health of
the system to be fair due to lack of transparency. As usual, the the nation would go a long way towards correcting some of
MCI acted tangentially. Instead of correcting the deiciencies these deiciencies. The new board of governors of the MCI has
in the system, it responded by reducing the weightage for an unenviable task ahead of it as did its predecessor board.
internal assessment in the summative process (10). In a skill- However, there are solutions to many of these issues. These
based profession such as medicine, where comprehensive need to be enforced straightaway if medical education is not to
assessment is not possible in the summative process due to fall in to a bottomless pit.
paucity of time, one would have expected the weightage given References
to internal assessment to be increased rather than decreased. 1. Medical Council of India. List of Colleges teaching MBBS [Internet].
The interference in the assessment process has now permeated NewDelhi: MCI;2010[cited 2011 Nov 1]. Available from: http://
to the inal examinations although only in a limited number www.mciindia.org/InformationDesk/MedicalCollegeHospitals/
of institutes. Due to the large number of medical colleges ListofCollegesTeachingMBBS.aspx
2. Ananthakrishnan N. Medical education in India: is it still possible to
becoming deemed universities, the same administration has
reverse the downhill trend? Natl Med J India. 2010;33:100-4.
control both of the teaching-learning process and evaluation, 3. Narayan P, Ramya M. BE, MBBS courses are long term investment
with no external monitoring. This makes manipulation of the plans [Internet]. 2011 Jun 24 [cited 2011 Nov 1]. Available from: http://
inal results easier. However, manipulation of the inal results is timesoindia.indiatimes.com/home/education/BE-MBBS-courses-are-
not seen exclusively in private universities. Recently, there was long-term-investment-plans/articleshow/8971071.cms
4. Medical Council of India. Procedure to start a new college
an investigation into the addition of as many as 45 marks in the
[Internet]. NewDelhi: MCI;2010 [cited 2011 Nov 1]. Available
inal year examination to the marks of individual candidates from: http://www.mciindia.org/InformationDesk/ForColleges/
to enable them to pass in the Tamil Nadu Dr MGR Medical ProceduretostartaNewCollege.aspx
University, , whereas the MCI permits only a maximum of ive 5. Medical Council of India. Urgent notice [Internet]. NewDelhi: MCI;2011
marks. This happened in a premier medical university in the Jun 13 [cited 2011 Nov 1]. Available from: http://www.mciindia.org/
tools/announcement/URGENT_NOTICE_Faculty.pdf
country. Closing ones eyes to this process would result in the 6. Medical Council of India. Minimum standard requirements for the
release of a large number of sub-standard graduates into the medical college, for 100 admissions annually, regulations 1999 [Internet].
healthcare system. New Delhi:MCI;1999 Apr 29 [cited 2011 Nov 1]. Available from: http://
www.mciindia.org/for-colleges/Minimum%20Standard%20Requireme
There are no easy solutions to this problem. Proper internal nts%20for%20100%20Admissions.pdf
assessment is a question of the attitude of the faculty to this 7. Ananthakrishnan N. Acute shortage of teachers in medical colleges:
important modality of evaluation in the medical ield and existing problems and possible solutions. Natl Med J India. 2007;20:25-
9.
development of a trust in the system by the candidates. The 8. Medical Council of India. Requirements to be fulilled by the Applicant
institution of more objective and transparent methods of Colleges for obtaining Letter of Intent and Letter of Permission for
evaluation can, to some extent, reduce this problem. Surprise Establishment of the new Medical Colleges and Yearly Renewals
inspections by the regulatory agency to see the internal under Section 10-A of the Indian Medical Council Act, 1956 [Internet].
NewDelhi:MCI;2009 Oct 13[cited 2011 Nov1]. Available from: http://
assessment record may also mitigate this evil. Quality control
www.mciindia.org/for-colleges/LOI,LOP,Renewal.pdf
in the summative process is easier and one can seriously 9. Medical Council of India. Minimum qualiications for teachers in medical
think of having either total external evaluation or three institutions regulations, 1998 [Internet]. NewDelhi:MCI;1998 [cited 2011
external examiners, instead of two, as at present. Examiners Nov 1]. Available from: http://www.mciindia.org/RulesandRegulations/
may be appointed centrally, from a national list of approved TeachersEligibilityQualiications1998.aspx
10. Medical Council of India. Salient feature of regulations on graduate
examiners. Likewise, attendance rules must be made stricter medical education 1997 [Internet]. NewDelhi:MCI;1997 [cited 2011
and exemption from minimum mandatory attendance should Nov 1]. Available from: http://www.mciindia.org/RulesandRegulations/
be the exception rather than the rule. GraduateMedicalEducationRegulations1997.aspx
[ 42 ]
Disability certiicates in India: a challenge to health privacy

NN MISHRA1, LS PARKER2, VL NIMGAONKAR3, SN DESHPANDE1
1
Department of Psychiatry, PGIMER-Dr RML Hospital, New Delhi 110 001 INDIA e-mail: indusszgenes@gmail.com 2 Center for Bioethics and Health Law, University of
Pittsburgh, Pittsburgh, PA 15213 USA e-mail: lisap@pitt.edu 3 WPIC, University of Pittsburgh Medical Center, Pittsburgh, PA 15213 USA e-mail:VishwajitNL@upmc.
edu Corresponding author NN Mishra e-mail: drmishrarml@yahoo.com
Abstract concessions and tax rebates are also available for the disabled
and their escorts or caregivers.
A disability certificate is necessary to access benefits afforded
under the Persons with Disabilities Act (1995) in India. This paper
Impact of disability certificates on privacy and
analyses this requirement and concludes that it constitutes a
welfare
major challenge to maintaining privacy of health information
especially for persons with mental health disabilities in India and Despite the advantages it affords, the Act also presents a
recommends modifications in the certificates format and use, to challenge for the disabled in another area of their health and
reduce the magnitude of privacy infringement for those using the rightsnamely, the protection of their privacy. These privacy
disability certificate to access benefits to which they are legally concerns arise because of the way the Act is implemented and
entitled. what individuals must do in order to qualify for beneits under
its provisions. Speciically, individuals seeking beneits must
Background on disability in India obtain a disability certiicate from a speciied government
healthcare provider. The certiicate itself needs to display a
Disability can be painful and burdensome for individuals
photograph (certiied by due authority), as well as the name
and may present special challenges for their families. When
and address of the individual, which can increase the risk of
employing social and political tools to address these burdens,
conidentiality breach should the certiicate be misplaced or
it may best be conceived according to a social model (1),
stolen, or merely viewed by unauthorised persons. Further, the
whereby disability results from the relationship or it between
certiicate details not only the diagnosis, but also the duration
an individuals abilities and the social as well as physical
of illness and degree of disability.
environment in which she lives (2). Every society must attempt
to address the disabilities of its members in a way that respects The effective utilisation of the various provisions of this Act
the autonomy and human rights of disabled people and allows plays an integral part in ultimate socio-economic beneits that
them to pursue a satisfying quality of life. Yet, each country disabled individuals may obtain (4), and yet many who would
must address the disabilities of its residents according to its qualify for these beneits are prevented by their disability
strengths or capacity. Indeed, conditions that are disabling from obtaining the disability certiicate without assistance.
in one society may not be so, or not to the same degree, in Therefore, it is necessary that family members or caretakers
another because of cultural and local differences (e.g., physical of the affected individuals help them obtain a disability
disabilities in a rural context may not be so restrictive in an certiicate. This need for assistance requires that the disabled
urban setting with ample resources). Moreover, different person share information that she or he might prefer to keep
societies have different levels of resources available to help private. While some disabilities are readily apparent and cannot
individuals compensate for or accommodate disability. be kept from others, some disabilities could be kept largely
private. Obsessive compulsive disorder, depression, and many
In India, the 2001 census identiied 21.9 million people with
other mental illnesses, for example, are not as readily apparent
disabilities, though the number has been estimated to be
as impairments of sight or mobility. Nevertheless, those with
as high as 70 million (3, 4). One social provision intended to
such disorders may need assistance in obtaining a disability
alleviate the burden of disability for these individuals is the
certiicate, perhaps because their disorder prevents them from
Persons with Disabilities (Equal Opportunities, Protection
being suficiently motivated to apply for beneits on their own.
of Rights and Full Participation) Act of 1995 [PWD Act] (5).
Other mental illnesses may be cognitively impairing so that a
According to the Act, disability includes blindness, low vision,
person cannot, at least at some times, complete the tasks of
cured leprosy, hearing impairment, locomotor disability, mental
applying for a certiicate. Symptoms of paranoia might prevent
retardation, and mental illness. The PWD Act constitutes an
a mentally ill person from approaching a doctor for certiication
important step towards enabling the disabled in India. Based
and then subsequently approaching a government ofice for
on the provisions of the Act those who are 40 per cent disabled,
speciic beneits. So, even to apply for a disability certiicate,
as certiied by a governmental medical authority, are entitled
some disabled individuals will have to suffer the invasion of
to receive particular beneits from the government of India
privacy of their health information by sharing the information
(GoI). A certain percentage of government jobs, for example,
with a family member or other interested party.
is reserved for those with certiied disabilities. Educational
institutions that receive aid from the GoI must reserve at least Of course, this is not the only context in which individuals with
three per cent of their seats for persons with disabilities. Travel health conditions must disclose private information in order to
[ 43 ]
seek help. Patients do this when they seek healthcare at a clinic beneits to which they are entitled. Further, the certiication
or from a physician. Healthcare professionals are then ethically of the mentally ill person may not only stigmatise the patient,
and legally obligated to keep such information conidential but also his family members. The labeling of the person can
both to respect patients privacy and autonomy and to protect affect marriage prospects of family members (especially female
them from possible harms that could result from the disclosure siblings and offspring), as well as business opportunities and
of private health information. In order for healthcare delivery to access to private health or life insurance for family members.
be effective, patients must feel comfortable disclosing private
Moreover, other agenciese.g., the railway ministryissue
information to professionals without fear of social or economic
certiicates affording concessions for a wider range of
repercussions, embarrassment, or stigma (6).
disabilities than those covered by the PWD Act. A person
Similarly, people with illnesses and disabilities are often with cancer, for example, may receive a discounted railway
dependent on family or nonprofessional caregivers for fare. Yet the price to be paid for this otherwise valuable and
assistance and care. They must share private informatione.g., well-intentioned beneit is exposure of her cancer condition,
about their condition, bodily functions, and needswith these something that could otherwise be kept largely private beyond
nonprofessionals in order to receive help, sometimes including her immediate family and healthcare settings. In some cases,
help with activities of daily living. While family members even the train ticket itself will state the cancer diagnosis. While
and nonprofessional caregivers do not have legal duties to cancer may now be less stigmatising than mental illness or
respect the privacy of their charges, and certainly do not leprosy, some people still retain erroneous beliefs that cancer
have a professional code of ethics that mandates respect for is contagious or that having cancer is a relection of a persons
privacy, they do have ethical obligations to respect the privacy character. Thus revelation of ones cancer diagnosis to a ticket
of those they love or provide care for (7). So, the unavoidable checker or fellow passenger can be stigmatising and lead to
need to disclose a disability to a family member in order to social shunning as well as more oficial forms of discrimination.
receive help in applying for a disability certiicate may not be
that different from asking family members for aid in going Recommendations to increase privacy protection
to the doctor, taking medicine, or accomplishing daily tasks. while maintaining safeguards against fraud
Ideally, family members then assume the ethical obligation to
The unnecessarily cumbersome and humiliating process of
respect their relatives privacy and keep her health information
declaring the nature of ones disability in multiple documents
conidential. Moreover, family members may have an interest in
at multiple ofices should be streamlined to protect individuals
safeguarding information about non-obvious disabilities that
privacy as much as possible. Furthermore, it is unnecessary to
are present in their family, because of concerns about stigma
state the nature of the individuals disability on each of these
and discrimination that attach to such conditions, especially as
documents. The process for obtaining and using a disability
the familial and genetic aspects of some conditions become
certiicate to avail of legally provided beneits should be
better understood.
revised.
Regarding the disability certiicate, however, what is a
Both the union and state governments issue guidelines
distinctive and largely avoidable invasion of privacy is the
regarding issue of disability certiicates. At present, certiication
subsequent use of the certiicate, once it is obtained. Currently,
of a persons disability for purposes of receiving beneits
the disability certiicate must be presented in government and
under the PWD Act, 1995, is only obtainable from designated
private ofices to receive a variety of concession certiicates
physicians at government facilities. While only doctors with
or tax beneits. The concession certiicate, in turn, must be
seniority and experience, and only government hospitals with
presented to a variety of non-health professionals in order to
requisite facilities at the district level and above, can issue
obtain beneits. The ticket clerk at any Indian railway station, for
certiicates, concerns may be raised about the possibility of
example, must be presented the concession certiicate in order
physicians issuing erroneous or even fraudulent disability
to obtain a discounted ticket or monthly pass.
certiicates to persons without a qualifying disability.
Each of these documentse.g., the travel concession certiicate
At present, very little is taught about disability and disability
and ticket itselfunnecessarily documents the nature of the
certiication at the post graduate level in India. Training
disability and links the persons name and disability on a form
regarding the disability certiication process should be a
that may go astray and that is certainly viewed by people who
mandatory component of a doctors curriculum, and hospitals
are not bound by any regulation or code of ethics to keep the
should offer continuing education to maintain an up-to-date
persons health information conidential. For individuals with
understanding of the process and regulations among doctors.
less obvious disabilitiese.g., mental illness or retardation,
Such training would serve to reduce error. Intentional fraud
or cured leprosy that leaves no obvious disigurementit is
may be more dificult to address.
seeking the beneits to which the PWD Act entitles them that
exposes them to the greatest risks of stigma and discrimination. Disability certiicates are issued only by designated doctors
Because mental illness and mental retardation (and leprosy) are using a prescribed form, and a doctor who signs these
highly stigmatising (8), individuals with these conditions may certiicates must include his Medical Council registration
justiiably have some hesitation in using the certiicate to seek number. This measure is designed to ensure accountability
[ 44 ]
and minimise the potential for fraudulent certiicates to A revised, more appropriate processrespectful of privacy
be issued. Two additional measures could enhance these and mindful of risk of fraudwould proceed in the following
preventive measures. First, it could be required that all manner. Upon presentation of the initial medical certiication
disability certiicates be crosschecked by a second doctor of disability, and veriication of her identity, the individual
of the same institution so that a single individual cannot should be issued a document stating the concessions or
wrongly issue disability certiicates without being detected. beneits for which she is qualiied without any further detail
Disputes between those physicians would be resolved about the nature of her condition. Such a document regarding
by a designated hospital administrator. Ideally, this would
concessions might bear the individuals photograph if
be the same hospital administrator who countersigns the
identiication of the document holder is necessary to prevent
certiicate. Doctors who are repeatedly found to be issuing
fraud (and no other form of photo identiication is available
certiicates in error (inadvertently or intentionally) could be
required to complete training on the certiication of disability and reliable). However, following certiication of disability, the
and penalised, if necessary. If their inappropriate issuing of nature of the disability need not be publicly linked with the
certiicates continued, they could be penalised by the hospital document, photo, or individual. Further, there is no need for a
administration, as their error or fraud places the institution itself travel ticket, for example, to state the nature of the individuals
at risk of accusations of fraud. Moreover, when certiication of condition. There should be no requirement that the individual
disability is undertaken, patients and their family members carry with her a copy of her initial certiication of disability or
should be informed, and required to acknowledge that they are that she supply it upon demand to government workers and
legally responsible for any misrepresentation or misinformation ticket checkers throughout her daily life. This is an unnecessary
they offer regarding the disability. ordeal that presents multiple daily breaches of privacy for
Second, the directorate general of health services, the agency those whose disabilities could otherwise be kept more private.
responsible for implementation of the disability certiicate Preservation of such privacy is an individuals right as a matter
provision of the Disability Act, 1995, could institute a process of of respect for her autonomy. It is also critically important in
auditing institutions for the appropriateness of their issuing of order to avoid stigma, discrimination, and other negative social,
disability certiicates. Records of the issue of certiicates should economic, and psychological consequences (6).
be retained by the hospital and made available for periodic
Acknowledgment: We would like to acknowledge the support
audit, which would involve review of the medical record,
including laboratory test results, history and physical notes, or of the Fogarty International Center NIH Training Program for
results of assessment questionnaires developed to assess the Psychiatric Genetics in India, Grant #5D43 TW006167-02. We are
duration and type of symptoms and degree of impairment, in grateful to Dr R P Beniwal and Dr T. Bhatia for their suggestions on
the case of mental disability. Details of such an audit process preventing fraud and formulating guidance about false disability
would need to be developed by the ofice of the directorate certificates.
general. References
It may be thought that the greatest threat of fraud occurs not at 1. Morris J. Impairment and disability: constructing an ethics of care that
the level of doctors certifying disability and issuing a disability promotes human rights. Hypatia. 2001;16(4):116.
2. United Nations. United Nations Convention on the Rights of Persons
certiicate, but subsequently when perhaps fraudulent (fake)
with Disabilities (UNCRPD)[Internet]. UN; 2006 Dec 13[cited 2011
documents are presented in government or private ofices to Mar 13]. Available from: http://www.un.org/disabilities/convention/
receive a concession certiicate or tax beneit, or later, when the conventionfull.shtml
concession certiicate is presented for the particular beneit, 3. Sridhar L. 70 million disabled in India, and only 2% are educated and 1%
such as a discounted train ticket. Linking the certiicate, the employed. Infochange features [Internet]. 2003 Jun [cited 2011 Mar 13];
bearers photo, and a description of the disability may be Available from: infochangeindia.org/.../70-million-disabled-in-India-
and-only-2-are-educated-and-1-employed.html
considered necessary in order to prevent fraud at this level. In
4. Vijaykumar S, Singh U. PWD Act: awareness among beneiciaries and
effect, those issuing concessions or checking train tickets are members of rehabilitation team. IJPMR. 2004 Apr;15:12-16.
turned into agents of fraud prevention by asking them to verify 5. Ministry of Welfare, Government of India. The Persons with Disabilities
that the person in front of them is truly disabled. But railway (Equal Opportunities, Protection of Rights and Full Participation)
employees, for example, are not qualiied to assess whether the Act, 1995 (PWD Act, 1995): Ministry of Welfare, in the Gazette of India,
person before them truly has cancer or mental illness; therefore, Extraordinary, Part II Section 3.
requiring production of a statement describing the nature of 6. Mishra NN, Parker LS, Nimgaonker VL, Deshpande SN. Privacy and Right
to Information Act, 2005. Indian J Med Ethics, 2008;5(4):158-161.
the disability at these levels is not warranted. At most, they
7. Buchanan A. Testing and telling?: implications for genetic privacy, family
should be required to verify identity by matching names on disclosure and the law. J Health Care Law. 1998;1(2):391-420.
documents or matching a photo on a document to the person 8. Corrigan PW, Penn DL. Lessons from social psychology on discrediting
presenting herself. psychiatric Stigma. Am Psychol. 1999 Sep;54(9):765-76.
[ 45 ]
Ethical aspects of public health legislation: The Mental Health Care Bill, 2011
HARISH THIPPESWAMY 1, KAUSIK GOSWAMI 2, SANTOSH CHATURVEDI 3
1 Assistant Professor,2 Senior Resident, 3 Professor, Department of Psychiatry, National Institute of Mental Health and Neurosciences, Bangalore 560 029 INDIA
Corresponding author: Harish Thippeswamy e-mail: docharisht@gmail.com
Abstract and marks a signiicant change in attitudes and approaches

to persons with disabilities (5). India, as a signatory to the
A legal framework is essential to promote and safeguard the
UNCRPD, is obligated to bring its existing laws into congruence
interests of persons with mental illness. Since the Indian Lunacy
with the basic principle of the UNCRPD which views persons
Act, 1912, mental health legislation has come a long way. Currently
with disabilities as subjects with rights, not objects of charity.
efforts are underway to modify the existing Mental Health Act
Hence, the Government of India (GOI) initiated the process of
taking into account the resolutions under the UN Convention on
developing the National Health Bill, revision of the existing
the Rights of Persons with Disabilities. The proposed Mental Health
Mental Health Act of 1987, and amending the Persons with
Care Bill, 2011 incorporates promising modifications, like care-
Disabilities Act. The task of amending the existing MHA 1987
giver, nominated representative, consent, support for decision
was assigned by the Ministry of Health and Family Welfare
making, and advance directive for persons with mental illness
(MOHFW), GOI (6) to the Indian Law Society, Pune. The draft of
in its rubric, which seems potentially beneficial to the patients.
The Mental Health Care Bill, 2011, referred to as the draft Bill
The proposed new bill should facilitate and strengthen a mental
in this article, has undergone several modiications through
health policy which provides acceptable, accessible, and equitable
consultative processes. It is felt that the new legislation should
mental health care. A law becomes meaningful when it is realistic,
facilitate and strengthen a mental health policy which provides
implementable and ethical in provisions. In this comment, we take
acceptable, accessible and equitable mental health care (7). The
a critical look at the proposed The Mental Health Care Bill, 2011
importance of ethical issues in public health policy is being
through the lens of ethical principles.
increasingly recognised worldwide. A law becomes meaningful
when it is realistic, implementable and ethical in its provisions.
Background
Historically, legislation has played an important role in The US National Commission for the Protection of Human
protecting and promoting the rights and interests of persons Subjects of Biomedical and Behavioural Research published
with mental illness. Mental healthcare in India was brought the Belmont Report in 1979 (8). This report is an articulation
under the purview of legislation for the irst time in the year of the key ethical principles for research and clinical care
1858, through the Indian Lunacy Act. This facilitated the involving human subjects. The key ethical principles according
setting up of mental asylums to admit and segregate those to the Belmont Report are respect for persons, beneicence
who by reason of insanity were perceived to be troublesome and non-malfeasance, and justice. Respect for persons involves
and dangerous. The Act was amended in 1912 putting honouring the autonomy of an individual to deliberate
civil surgeons in charge of the mental hospitals instead of upon and act according to his/her goals and protecting the
the Inspector General of Prisons, as in the Act of 1858. The autonomy of each individual. Beneicence involves acting to do
amended Act of 1912 laid out the rules and procedures for good for participants or to act for their well-being while also
admission to and discharges from hospitals and asylums and taking steps to avoid and minimise harm (i.e., non-malfeasance).
guided mental health care in India for the next 75 years (1). In These concepts of beneicence and non-malfeasance are
the year 1987, the Indian Parliament passed the Mental Health commonly understood as expressed in the Hippocratic Oath
Act (MHA) which came into force in the year 1991. The MHA and, thus, extend from the typical doctorpatient relationship
focused largely on administrative aspects and institutional to the context of clinical research. Justice involves fairness in
care. Since the time of its implementation, the MHA, 1987, has the distribution, care, and service to equals in equal manner.
been criticised for focusing heavily on administrative aspects, Hence, it is of paramount importance to look critically at
and institutional care, and for ignoring community psychiatric the draft bill from an ethical perspective, with reference to
care (2). The Act has also been criticised for failure to comply respect and conidentiality, along with the core principles
with the guidelines of the National Mental Health Programme of autonomy, beneicence, non-malfeasance and justice (9).
and the World Health Organisation on discharge care and In this commentary, we examine the provisions of the draft
rehabilitation, and for being unsuccessful in addressing the Bill available on the website of Ministry of Health and Family
problem of social stigma (3, 4). Welfare, Government of India (6)
On March 30, 2007, India joined the community of 82 countries
which are signatories to the United Nations Convention on Analysis
the Rights of Persons with Disabilities (UNCRPD) which is the The draft Bill incorporates several new important provisions
irst comprehensive human rights treaty of the 21st century under its fold. It lays emphasis on human respect. The
[ 46 ]
prejudicial term mentally ill gets replaced with person with Confidentiality
mental illness in order to separate the person from the illness.
The draft emphasises the conidentiality of patient-related
This avoids branding an individual and helps in reducing
information in both the virtual and real spaces. Conidentiality
the stigma. New provisions like nominated representative,
in research settings and during the proceedings of the mental
consent, supported admission, and advance directives have
health review commission is emphasised in the draft Bill.
been introduced for persons with mental illness.
Standard of care
Nominated representative
The Central Mental Health Authority has prescribed minimum
Any person who is 18 years of age, and above, and is standards for facilities, personnel training, and services. This
competent can appoint a person who is above 18 years age as should help to bring equal treatment into care and also ensure
a nominated representative (NR). The representative helps the that every patient receives a basic minimum standard of care,
patient to interact with the mental health system and also acts thus fulilling the principle of justice.
as a legal guardian for the patient. However, there is a possibility
of conlict with the autonomy of the patient if the nominated Legal capacity
representative does not act according to the patients wishes.
According to the draft Bill, all patients with mental illness have
Hence, it is of great importance that the competence of the
legal capacity and may/ may not require support to exercise
patient to appoint a representative needs to be assessed with
their legal capacity. The level of safeguards provided is based
care and concern by a mental health professional trained
on the level of support needed, with a rider that the support
in assessing competence. It would be better if a structured
should be treated as a temporary phenomenon. There is
instrument is used to assess competence in order to bring in
provision for a review at the end of a prescribed period to check
objectivity. Inadequate assessment of competence leads to
for the ability to make independent decisions and for further
erroneous decisions and hence compromises the autonomy of
need of a high level of support. These provisions emphasise the
the person thereafter.
autonomy of patients.
Consent Supported admissions

The draft Bill gives great importance to free and fully informed This measure was earlier known as admission under special
consent. The autonomy of the individual takes precedence over circumstances under which a patient could be admitted
the best interest principle, with the exception of certain clinical for up to 90 days under a single admission process. Under
situations. Unilateral decision making by the clinician citing the the draft Bill, this period has been reduced to 30 days, and
best interest principle has been discouraged. may be extended up to 90 days. Further admission beyond
this period of 90 days can be extended up to 180 days
In situations where there is lack of full capacity to give consent,
subject to certain conditions. This has been done to ensure
the new draft allows a nominated representative, whose bona
the safety of the person. Treatment shall only be provided
ides and credentials are clear to the service provider, to be part
after taking into account any existing advance directive
of the supported decision making. This gives greater autonomy
or with the support of the nominated representative. This
to the patient. The draft Bill makes it mandatory for the health
covers the important ethical principle of non-malfeasance.
service provider to proactively empower the patient to either
accept or refuse treatment. However, during emergency
medical interventions, the principle of beneicence, i.e. doing Prohibited treatment
good, takes precedence over autonomy. In such situations,
the consent may be presumed unless there is a previous The draft Bill makes a provision for prohibition of certain
declaration to the contrary. treatments. The policy seems to have been derived from the
principle of non-malfeasance. There is a prohibition on electro-
The draft Bill requires a personal assessment of each individual convulsive therapy (ECT) without the use of muscle relaxants
case whenever there is a hint of lack of full capacity to give and anaesthesia (unmodiied ECT). However, the practical
consent. The thorough assessment of evolving capacity implications of this prohibition need consideration. In routine
and intellectual maturity and documentation involves the clinical practice, there are often situations like life-threatening
investment of a signiicant amount of time by the clinician. catatonia wherein a patient may need urgent electroconvulsive
Though this is in keeping with the ethical tenet of autonomy, therapy. Moreover, modiied ECT is expensive and requires the
we feel that this might amount to additional workload, specialised services of an anaesthetist. Given the manpower
involving a considerable amount of time for the clinician. and inancial constraints in our country, a complete ban on
Moreover, clinicians need to be trained to assess the above; unmodiied ECT may result in failure to provide this effective
in the absence of adequate training and standardised and life-saving treatment to all those who need it. This goes
instruments, the objective may not be achieved. Given the against the ethical principle of beneicence. Serious adverse
inadequacy of infrastructure and resources in our country, this effects are a rarity with unmodiied ECT, and we feel that it
needs to be examined from a pragmatic angle. should be allowed under rare circumstances.
[ 47 ]
The draft disallows the administration of ECTs in any form to individual. However, this might give rise to a dilemma for the
minors. Severe mental disorders such as schizophrenia and clinician as certiication of advance directive may potentially
bipolar illness often set in during adolescence and can present lead to legal entanglement. As previously discussed, the
as catatonia which can be life threatening. It is well known, and caveat of allowing any medical practitioner who may not have
a scientiically established fact, that catatonia responds very formal training to assess competency apply here also. The
well to treatment with ECT. A blanket ban on ECT in minors treating practitioner is bound to honour the advance directive
can be potentially dangerous to the life of the patient. Hence, as expressing the wishes of the patient. The draft allows the
provision should be made to allow administration of ECTs in provision of amending, cancelling or revoking the advance
minors only during exceptional clinical circumstances. directive to the individual at any point of time. This substantially
strengthens the principle of autonomy. However, keeping to
The draft Bill puts signiicant restrictions on psychosurgery the principle of beneicence, a blanket refusal of all kinds of
by making it mandatory to acquire approval from the State treatment in the advance directive is considered invalid unless
Mental Health Authority (SMHA). Psychosurgery is rare and approved by the district panel of the Mental Health Review
is still an unexplored area. It is a complicated decision which Commission (MHRC).
should be taken by a well informed clinical team comprising of
experienced neurosurgeons, anaesthetists and psychiatrists. We Advance directives give a greater degree of autonomy to
are not sure whether the panel of SMHA has enough expertise the patient; but they could come into conlict with the best
to decide on such complicated clinical issues. Elaborate interest principle. The treating doctor may hesitate to treat
procedures are likely to discourage a clinician from offering a the patient in a crisis situation where the choice of treatment
potentially beneicial clinical procedure to a patient. We agree is contrary to the directive, unless an appeal is made before the
that safeguards need to be in place to avoid the exploitation of MHRC for overruling of the same.
patients. To ensure the same, we feel that the decision should Though advance directives have been implemented in many
be at the discretion of the local institutional ethics committee. countries and happen to be a salient feature of the draft Bill,
Moreover, the ield of neurosurgery has advanced with the this measure is often differently deined and interpreted in
application of newer techniques with greater accuracy and different countries. The distinguishing features are the extent to
fewer complications. We feel that the process of making it which they are legally binding, whether health care providers
mandatory to obtain permission from the SMHA could impair are involved in their preparation and whether an independent
the progress of research in psychosurgery and also may cause facilitator assists in their preparation. The differing nature of
delay in the treatment for certain patients. advance statements is related to the diverse models of care
upon which they are based and the legislative and service
Discharge planning
contexts in which they have been developed (10). In this
In another welcome change, the new draft makes provision for regard, it would be appropriate to evaluate this new provision
discharge planning to ensure continuity of care with a proper with respect to existing advance directives in other countries
referral and brieing of the caregiver/family member of the like the USA and UK.
patient.
In the United States, the Patient Self-Determination Act of 1990
Advance directives followed legislation for medical advance directives and cleared
the way for psychiatric advance directives. Unlike in India, the
One new feature of the draft Bill, which needs to be evaluated federal nature of the US constitution translates into variations
in greater detail, is the inclusion of the provision of advance in formulation and implementation of laws among the different
directives. Advance statements documenting mental health states. However all U.S. states permit competent adults to
service consumers preferences for treatment during a future use generic health care decision laws to make at least some
mental health crisis or period of incapacity have gained psychiatric treatment choices in advance, typically through
salience in recent years in the United States and some the use of a durable power of attorney (11). Additionally, 25
European countries, including the United Kingdom. The new states have, since the early 1990s, enacted speciic psychiatric
draft Bill makes a deinite effort to incorporate this practice. advance directive statutes (12).
The new provision of advance directives is in keeping with
the principle of autonomy. Every person, irrespective of their While the speciic features of psychiatric advance directive
mental health status has a right to make a written statement laws vary considerably by state, there are some commonalities.
known as an advance directive. The advance directive is a legal Under the Patient Self-Determination Act, any hospital
document which provides the individual with the autonomy receiving federal funds must notify admitted patients of their
to decide the manner in which he/she wishes to be cared for right to make an advance directive, inquire whether patients
during a future period of illness. A patient can appoint a person have advance directives, adopt written policies to implement
in the order of precedence as nominated representative during advance directives under state law, and notify patients of
his period of illness. what those policies are. No such compulsion for notiication is
present in the current draft in India. Another feature which is
In the present draft, the advance directive needs to be certiied present in US advance directives, but absent in the Indian draft,
by a medical practitioner regarding the competence of the is the provision of detailed checklist forms including different
[ 48 ]
options of admission and treatment to help consumers prepare admissions. These changes help enhance the degree of
advance directives. These might be useful inclusions in the autonomy for patients which was not adequately addressed
Indian draft as they uphold the principle of informed decision in the original act. The draft mentions the practice of non-
making and thus autonomy. The principle of beneicence is discrimination while treating patients with mental illness,
highlighted in both countries by making it possible to override which, in turn, relects the principle of justice. In the case
an advance directive if it is deemed to be against the best of research involving patients with mental illness, the draft
interest of the consumer (13). mandates the obtaining of free and informed consent, and the
upholding of the ethical principles mentioned above. The draft
In the United Kingdom, Scotland has pursued a different
Bill details the conidentiality issues of patients. It has tried to
policy from that prevailing in England and Wales. In Scotland,
protect the rights of users and family members taking ethical
parliament has included advance statements in recent
principles into account. The section on prohibited treatments
mental health legislation, that is, the Mental Health (Care and
and psychosurgery needs to be re-examined. Overall, the
Treatment) (Scotland) Act, 2003. The written statement may be
proposed amendments highlight the role of ethical issues in
invoked or revoked only in the presence of a witness who must
formulating a public health policy to protect the rights and
certify the capacity and intent of the consumer. The Indian
draft has improved upon this clause by requiring a medical interests of users, especially those of the vulnerable groups.
practitioner to certify the competence of the individual. Under Rules framed over such an ethical matrix are more likely to be
the Scotland Act, if treatment is given that conlicts with the acceptable to the community.
advance statement, the responsible clinician under the Act References
must provide the reasons in writing to the person concerned, 1. Ganju V. The mental health system in India: history, current system, and
ie the person named under the Act, the guardian, the welfare prospects. Int J Law Psychiatry. 2000 May-Aug;23 (3-4): 393-402.
attorney, and the Mental Welfare Commission; as well as ile a 2. Seshadri H, Seshadri H. Needed: new Mental Health Act [Internet]. The
Hindu. 2005 Jan 30 [cited 2011 Nov 22].Available from: http://hindu.
copy in the persons medical records. This is slightly different com/2005/01/30/stories/2005013000951100.htm
from the Indian draft, wherein prior application has to be made 3. Rastogi P. Mental Health Act, 1987 - an analysis. JIAFM [Internet]. 2005
to the district Mental Health Review Commission. In England [cited 2001 Nov 22];27(3):176-9. Available from: http://medind.nic.in/jal/
and Wales, on the other hand, advance statements have been t05/i3/jalt05i3p176.pdf
4. Trivedi JK. Mental Health Act, salient features, objectives, critique and
recognised under common law for some years, and their
future directions. Indian J Psychiatry [Internet]. 2009 [cited 2011 Nov
place has now been deined by statute in the Mental Capacity 22]. 51: 11-19. Available from: http://www.indianjpsychiatry.org/cpg/
Act, 2005. However, in the case of mental disorders, mental cpg2009/article7.pdf
health legislation (currently the Mental Health Act 1983) takes 5. United Nations. Convention on the Rights of Persons with Disabilities
precedence over any provisions in the Mental Capacity Act. [Internet]. 2007[cited 2011 Nov 22]. Available from: http://www.un.org/
esa/socdev/enable/conventioninfo.htm
Advance statements can thus be overridden. Concern over 6. Ministry of Health and Family Welfare, Government of India. The Mental
public protection has outweighed concerns about patient Health Care Bill 2011 [cited 2011 Nov 22]. Available from: http://mohfw.
autonomy. Advance statements have therefore taken an nic.in/WriteReadData/l892s/6420662643DRAFT%20 THE%20MENTAL%
essentially clinical form, independent of their statutory basis 20HEALTH%20CARE%20BILL.pdf
7. Murthy P. The Mental Health Act 1987: Quo Vadimus? Indian J Med Ethics.
(10).
2010 Jul-Sep;7(3): 152-5.
8. National Institute of Health. National Commission for the Protection of
In Germany, Austria and Switzerland, advance directives are
Human Subjects of Biomedical and Behavioural Research. The Belmont
legally binding upon the clinician, and can be overridden only report: ethical principles and guidelines for the protection of human
by means of a court order (10). subjects of research [Internet]. Washington, DC: US Government Printing
Ofice; 1979 Apr 18 [cited 2011 Nov 22]. Available from: http://ohsr.
To conclude, in comparison with other countries, the provision od.nih.gov/guidelines/belmont.html
of advance directives in India seems well formulated and 9. Lawrence DJ. The Four Principles of Biomedical Ethics: A Foundation for
justiies the principle of autonomy, even as it gives due Current Bioethical Debate. J Chiropr Humanit. 2007;14:34-40.
10. Henderson C, Swanson JW, Szmukler G, Thornicroft G, Zinkler M. A
importance to the principle of beneicence. typology of advance statements in mental health care. Psychiatr Serv.
2008 Jan;59(1): 6371.
Conclusion 11. Fleischner R: Advance directives for mental health care: an analysis of
state statutes. Psychol Public Policy Law.1998 Sep; 4(3):788804.
The proposed The Mental Health Care Bill, 2011 makes 12. Swanson J, Swartz M, Ferron J, Elbogen E, Van Dorn R. Psychiatric
several provisions which are beneicial to patients. It upholds advance directives among public mental health consumers in ive US
supported decision making over the best interests principle cities: prevalence, demand, and correlates. J Am Acad Psychiatry Law.
and offers the option to make an advance directive on 2006;34(1):4357.
13. Swanson J, McCrary SV, Swartz MS, Van Dorn RA, Elbogen EB. Overriding
treatment issues. This is in accordance with the principle of psychiatric advance directives: factors associated with psychiatrists
respect for persons and helps protect the autonomy of the decisions to preempt patients advance refusal of hospitalization and
individual. The draft also makes a provision for supported medication. Law Hum Behav.2007 Feb;31(1):7790.
[ 49 ]
CASE STUDY
Observational study of cervical cancer

FROM: CASEBOOK ON ETHICAL ISSUES IN INTERNATIONAL HEALTH RESEARCH
major cities participated. Most of these hospitals provided

Although this case study is based on research that took both general and specialized gynaecological care but were
place in the 1970s, the questions that it raises remain busy and did not have adequate facilities to manage patients
relevant today. with cancer. Patients with cancer were, therefore, referred to
the nearest regional cancer centre for treatment and follow up,
Cervical cancer causes at least 273 000 deaths globally every with a standard 6-month waiting period to begin treatment.
year, and about 85% of these deaths occur in developing The researchers elicited the help of community health workers
countries. The incidence of invasive cervical cancer has to inform women about the study and encourage them to go
decreased in countries where women have access to regular to the city hospitals for Pap smears. Women who presented at
Papanicolaou (Pap) smears(1) and subsequent treatment of the eight government hospitals were informed about the study,
pre-malignant cervical dysplasias(2) readily available. Most and were asked to give a Pap smear with informed consent.
often, women with fatal cases of cervical cancer have never Since most women in the study were illiterate, the researchers
had a Pap smear or have to wait long intervals between Pap provided information in simple, non-medical language and
screenings. obtained verbal consent. The researchers did not inform the
Cervical dysplasia ranges from low grade squamous women that their lesions might progress to cancer. Women
intraepithelial lesion (SIL) to high grade SIL.(3) The next stage is were not made aware that treatment was available.
carcinoma in situ, indicating that although cancerous cells are By the ninth year, researchers had identiied more than 1000
present they have not yet spread. In the 1970s, there was lack women with varying degrees of cervical dysplasia. Women
of consensus in the medical community about which types found to have a positive Pap smear at intake were followed up
of dysplasia would progress and become cancerous. Many every 3 months, to record the progression of their disorder on
countries with adequate health facilities took an aggressive the basis of the Pap smear. The end-point for treatment was
position and treated early dysplasia. In many developing deined as the development of carcinoma in situ, at which time
countries, however, decisions about when to treat were guided they were referred to the nearest regional cancer centre, which
by the belief that not all dysplasias progress to cancer, and had a very long waiting list. By the time some of these women
this position was supported by previous studies of the natural were seen by an oncologist, the lesion had progressed to a
history of cervical cancer. Thus, in developing countries the higher level.
most widely accepted stage at which to begin treatment was
that of carcinoma in situ, indicating that the cells had become Midway through the study, a leading North American medical
cancerous but remained limited to the cervix. journal published the results of a longitudinal study of
cervical cancer. The study concluded that cervical dysplasia
If doctors could more accurately predict which dysplasias was a precursor for cervical cancer, and thus that all forms of
would progress to carcinoma in situ, they could be more dysplasia warranted treatment. Despite these new indings,
speciic in deciding which cases to treat early. The development the researchers continued with the study. By the end of the
of a more precise diagnostic method that could detect study, 71 women had developed malignancies. In nine of these
whether a dysplasia was of the type that progresses to cancer women, the disease had already spread to other parts of their
would save money and ensure that more women would body. The research team provided no treatment to the women
receive treatment. To design guidelines for a national control once the study had ended.
programme for cervical cancer, the national medical research
council of a South Asian country funded an observational study Questions
of cervical cancer to determine which dysplasias were most 1 Discuss the ethical issues raised by this observational study.
likely to progress to cancer.
2 Given the shortage of staff, facilities, and equipment in the
The study, approved by the research ethics committee of the government-run hospitals, was the medical research council
research council, took place over 12 years, beginning in the justiied in conducting this study? Could national guidelines
mid-1970s. Eight government hospitals in one of the countrys have been set up without conducting this study?
[ 50 ]
3 Should continuing services have been offered to participants changes of the uterine cervix, together with viral, bacterial,
after completion of the study? If so, what services should and fungal infections of the cervix and vagina. Cervical
have been offered? screening is a relatively simple, low-cost, and non-invasive
4 Does diagnosing a condition or disease during research method. Regular screening for cervical cancer reduces both
result in a duty (obligation) to provide care and follow-up for the mortality from and incidence of cervical carcinoma.
that condition? Is this duty the same whether the condition (2) Abnormal development or growth of tissues, organs, or
is diagnosed to include patients in the study or to exclude cells. It is the earliest form of precancerous lesion. Dysplasia
them? can be diagnosed as either high or low grade, with high
5 Do the researchers have any responsibility to take stock grade dysplasia indicative of a more advanced progression
of the situation at least mid-way through such longitudinal towards malignant transformation.
studies? Should the sponsors ask for such an evaluation? (3) A general term for the abnormal growth of squamous
6 Should this study have had some stopping rules, or a cells on the surface of the cervix. The changes in the cells
monitor? are described as low grade (LSIL) or high grade (HSIL),
depending on how much of the cervix is affected and how
7 Should this study be accepted for publication? If not, how
abnormal the cells are. HSIL is regarded as a signiicant
should the results of this study be made generally known to
precancerous lesion, whereas low-grade SIL (LSIL) is more
others?
benign, since most of these lesions regress.
Notes: Reprinted from: Cash R, Wikler D, Saxena A, Capron A, editors. Casebook
(1) A routine screening test used for the detection of early on ethical issues in international health research. Geneva: World Health
cervical abnormalities, namely precancerous dysplastic Organisation 2009: 124-5.
CASE STUDY RESPONSES
Knowledge vs ethics in clinical research in resource-poor settings: a clinicians

perspective
B SUBHA SRI
Rural Womens Social Education Centre, 61, Karumarapakkam, District Kancheepuram, Tamil Nadu 603 109 INDIA e- mail: subhasrib@gmail.com
This case study of the 1970s (1) no doubt raises several ethical Since I have no personal knowledge of the clinical scenario
questions. I will however try to look at the case study from the in the period of the study, I looked through literature on
perspective of a gynaecologist and primary care physician the history of cervical cancer treatment and also spoke to
attempting to establish a community-based cervical cancer two senior gynaecologists who were working in premier
screening and care programme in rural Tamil Nadu. medical institutions in India at that time. I understand that
the progressive nature of cervical dysplasias (as they were
There is enough knowledge today that cervical cancer is
caused by the Human Papilloma Virus and progresses through called then) to cervical carcinoma was well known by the early
stages of cervical intraepithelial neoplasia (CIN), carcinoma 1970s. In 1968, Richart (2) indicated that all dysplasias have
in situ (CIS) to invasive cervical cancer. This knowledge the potential for progression. However, there seems to have
determines the modalities of screening and treatment been a lack of clarity on how exactly each grade of dysplasia
recommended today for cervical cancer and its precursors. behaved and what proportion actually progressed to invasive
However, while attempting to analyse the case study to cancer. This was an important issue, especially while evolving
draw lessons for current practice, one needs to start from the guidelines for treatment in high disease-prevalent resource-
scientiic evidence that was available regarding cervical cancer poor settings like India. Based on existing understanding, while
precursors at the time of the study, to consider whether a carcinoma in situ was most often treated with hysterectomy,
study to understand the natural history of cervical cancer was severe forms of dysplasia were often treated with an excisional
necessary, and whether the study was justiied in its design cone biopsy of the cervix. Treatment for mild and moderate
of following up women with proven dysplasia without any dysplasia did not seem to have any standard protocol and
intervention, given the evidence available at that time. varied between individual facilities. Answers to questions
[ 51 ]
regarding the natural history of dysplasia would therefore, at case, the initial consent also seems to have glossed over several
that point, deinitely have helped in evolving context-speciic important facts well known to the researchers at that time, such
guidelines for clinical decision making. as the lesions potential to progress to invasive cancer. Patient
autonomy cannot be overridden even if the clinician believes
Also, there seems to have been a widely held view that since in good faith that what s/he is doing is best for the patient
cervical cancer was highly prevalent in the developing though even this does not seem to have been the case here.
countries of south Asia, and there was a possibility of ethnic Also, the least the clinicians could have done was to expedite
variations in disease pathology, studies on South Asian women treatment for these women once they developed carcinoma.
were needed. While these arguments may be used to justify That they failed to do so reveals a total lack of concern for the
planning a study to understand the natural history of dysplasia women in the study as compared to the research outcomes.
and cervical cancer, how does one decide if such studies are
really needed? How does one decide when the evidence Then, what about public health ethics? How does one strike
generated in developed countries is relevant to the question a balance between clinician and public health researcher?
at hand, and when indigenous studies are in fact needed? What if, truly, this study had uncovered a different pattern of
progression of dysplasias in south Asian women? Would it then
Moving on, even if one were to accept that the study was have been justiied in its design and methodology? Would the
indeed justiied, was the methodology planned appropriate larger good of understanding cervical dysplasia in south Asian
and ethical? First, did the institutions carrying out the study women to beneit women in the future have been justiication
have the necessary infrastructure to take on a study of this enough for following up women with dysplasia in this study
magnitude? The study involved following up women with without intervention? I do not think so. Even if the study
possible cancer precursors with the potential of developing were justiied in terms of the larger public good, adequate
into a serious, life-threatening disease. Were the institutions safeguards should have been built in, so that women in this
capable of the stringent recall and follow-up required in such study also received the beneits of existing and emerging
cases? Given that they could not handle the inal disease if it knowledge, whether from this study or elsewhere. Interim
developed, were they even justiied in taking on the study? monitoring of results, terminating the study in the face of the
Given the signiicant false negative rates of Pap smears, well results of the other study, expediting treatment for women
known in the 1970s, were they justiied in relying on Pap smears whose dysplasias progressed in severity - all of these should
alone to reach an end point of CIS to begin treatment when it have been necessarily built into the study.
was likely that this already meant foci of invasive carcinoma
were present in the woman? This was a time when modalities This case study brings up several concerns on the regulation
like colposcopy were being used in other countries (3,4). Other of research studies in developing countries including India.
technologies were thus known and available to evaluate While the situation now is vastly changed from the era of
women with cervical dysplasia, while this study relied solely this study, it is also true that there is an explosion of clinical
on Pap smears. Was it okay to agree on CIS as the end point for trials happening now in India. Questions such as what kinds
follow-up when it seems to have been common knowledge of trials may be carried out in developing countries like
then that severe dysplasia or CIN III and CIS were part of the India, and what kinds of problems they should address,
same continuum? Should there not have been systems for gain relevance. Even if one were to accept that certain
interim monitoring of such a long-term study so that changes problems relevant to our country need clinical research
in global clinical practice, such as those inluenced by the other based here, how does one safeguard the interests of trial
participants? This gains signiicance especially given the
study published in the North American journal, would have
large scale poverty, marginalisation, and lack of literacy and
been taken into account? If the questions that the study had
information in countries like ours. How does one ensure that
set out to achieve were already answered by another study,
the marginalised are not exploited and are in a position to
should this study not have been terminated? Shouldnt women
negotiate safeguards for their beneit in a research setting?
in this study have been given the beneit of knowledge gained
from that study and offered treatment? Research priorities in developing countries need to be driven
by the sometimes unique clinical needs of these countries.
There are also some other questions that I would pose as a
However, carrying out research studies in resource-poor
clinician. How does one balance the roles of a clinical caregiver
settings can be challenging. This can very often result in
and researcher, especially when these may be in conlict? In this
compromises in ethical standards for reasons of practicality.
study, the researchers were mostly clinicians whose primary
The role of regulation and regulatory bodies is, therefore,
responsibility was patient care. Shouldnt the basic principles
crucial in such settings. This is all the more critical given that,
of clinical ethics of beneicence, non maleicence and patient
most often, research subjects in these settings are the very
autonomy apply in these settings too? Arent these also ethical
marginalised.
principles guiding research? If one accepts this, then, in view
of the long-term nature of the follow-up and the implications Acknowledgement: I wish to acknowledge the contributions
of not intervening, the women should have been consulted at of Dr Asha Oumachigi, Retired Professor of Obstetrics and
every stage in decision-making regarding their care, regardless Gynaecology, JIPMER Pondicherry; Dr Lakshmi Seshadri, Retired
of their initial consent to be part of the study. In this particular Professor of Obstetrics and Gynaecology, CMC, Vellore, and Dr
[ 52 ]
Rakhal Gaitonde, Public Health Researcher, Chennai, during the Obstet Gynecol. 1968:10:748-84.
development of this comment. 3. Coppleson M. The value of colposcopy in the detection of preclinical
carcinoma of the cervix (Three years experience at King George V
References Memorial Hospital, Sydney). BJOG: An International J Obstet Gynaecol Br
1. Cash R, Wikler D, Saxena A, Capron A, editors. Casebook on ethical issues Emp. 1960 Feb; 67:1123. doi:10.1111/j.1471-0528.1960.tb06945.
in international health research. Geneva: World Health Organisation 4. Navratil E. Colposcopy. In: Gray L A, editor. Dysplasia, carcinoma in situ
2009;124-5. and microinvasive carcinoma of the cervix uteri. Springield, IL: CC Thomas;
2 Richart RM. Natural history of cervical intraepithelial neoplasia. Clin 1964. p. 228-83.
Lost opportunities
PRIYA SATALKAR
Independent researcher,12A Fruitstraat, 974 1AN, Groningen THE NETHERLANDS e-mail: drprivasatalkar@gmail.com
Do we need different ethical standards for observational vary in severity, as can the potential harms and beneits. One
research as compared to experimental study designs like can argue that in case of an RCT, participants are at risk of
randomised controlled trials (RCT)? Should we allow different receiving a less effective drug, or experiencing the previously
standards of care if the research is funded and carried out unknown adverse effects of a new drug. It is often argued that
by local research councils in developing countries without observational studies by their very nature pose less risk and
external sponsors? How could we carry out clinical research harm to participants as compared to experimental studies. In
in resource-constrained, publicly-funded healthcare facilities the study under discussion, however, more than 1,000 women
without compromising the quality of care given to research were diagnosed with cervical dysplasia or premalignant lesion
participants? These questions are discussed against the of cervical cancer. Though these women were entitled to
backdrop of an observational research study undertaken by standard treatment and care for their cervical lesions diagnosed
the national medical research council in a south Asian country during this observational research, they received only a referral
in the 1970s to determine which lesions of cervical dysplasia to a regional cancer hospital with a long waiting period to
gradually progress to malignant changes (1). begin their treatment. Thus they did not get any beneits out of
their study participation except the early diagnosis of cervical
Observational research versus experimental research lesions and in fact had to face the emotional and physical
designs suffering associated with diagnosis of cancer. This is particularly
This particular observational study, to understand the important because these women were not informed that their
progression of cervical dysplasia to malignancy, was expected lesions could be cancerous before obtaining their informed
to guide a national cervical cancer control programme in consent. This was similar to the other infamous Tuskegee
resource-constrained settings in a south Asian country in the study, which is acknowledged to be unethical observational
1970s. In the absence of conclusive scientiic evidence that research.
could adequately predict the progression of cervical lesions
Research is carried out to advance scientiic knowledge in
to cancer, such research was justiied, rather commended, for
the hope that it will beneit humankind. There are numerous
it promised the rational use of available resources to detect
and treat cancers in a timely fashion. Nonetheless, we can reasons and motivations for individuals to participate in
discuss a number of ethical issues in this study, ranging from research (3). One reason is altruism -- to contribute to the
informed consent and the standard of care to researchers production of knowledge. Are we willing to distinguish
responsibility towards research participants at the end of a between knowledge produced through experimental studies
study and the role of external study monitors. It must be noted and that through observational research? If not, why should
that most of these issues have been debated extensively in the individuals who may have enrolled due to the desire to
context of experimental study designs, particularly RCTs, and beneit humankind -- be treated differently and protected by
standards established (2). Can we apply the same standards to different ethical standards and guidelines based on the type of
an observational study? I argue that irrespective of the nature study in which they have participated?
of the study design, one must aim for the highest ethical
There are common elements in the design and implementation
standards for any research that involves human subjects and I
of various research studies, particularly around the involvement
elaborate my reasons below.
of human subjects. Few researchers have made attempts to
When an individual agrees to participate in research, s/he improve reporting of observational research to give it the
should have been informed about the risks involved, and there same scientiic rigour as in experimental studies. The initiative
should be evidence that s/he has understood them. Depending Strengthening The Reporting of Observational Studies in
on the subject of study, and the study design, the risks could Epidemiology (STROBE) has developed a checklist of 22
[ 53 ]
items to improve the quality and reporting of observational medical information is provided in culturally and linguistically
studies (4). Eighteen out of these 22 points are common to appropriate terms. This requires collaborative efforts between
experimental study designs such as case control, cohort and researchers and community members. In this case, before
cross-sectional studies. Though STROBE is intended to improve enrolling in the study, the women should have been informed
the quality of reporting in observational studies, it paves the that their cervical lesions could progress to cancer and of the
way for a similar exercise with ethical guidelines across various various treatment options available. They should also have
study designs. been informed that they could choose not to be part of the
study, and there would be no adverse consequences of their
Below, I discuss some aspects of the cervical cancer study,
refusal. These steps in obtaining informed consent protect
drawing upon ethical standards and guidelines recommended
women from coercion to participate in research and respect
for experimental studies.
their free choice (9).
Informed consent
Standard of care
Any research enterprise is a collaborative activity involving
The other contentious issue in this situation concerns the
various stakeholders such as researchers, health professionals,
standard of care that the researchers and sponsors are
study participants, communities or institutes where the study
expected to provide to study participants during and at the end
takes place, and sponsors. Each stakeholder has different
of the study. This gets further complicated when an external
interests, and different motivations to be part of the study. This
sponsor conducts a clinical trial in a developing country, where
can lead to conlicts of interest and even adversely affect the
people have limited access to any form of therapy let alone the
partnership (5). The researchers in this case were healthcare
global standard of care (10). In case of an RCT, it is expected that
providers (doctors, nurses and other staff including laboratory
the beneits of a study will be made available to participants
personnel) in eight public hospitals providing general and
and the entire community; in case resources are limited, they
specialised gynaecological care. Being staff of the public health
will be made available for a reasonable time according to
system, they were guided and bound by the instructions and
protocols issued by the ministry of health and national medical CIOMS, Guideline 10 (2).
research council. The study participants were women in the The case study we are discussing here is an observational study
reproductive age group, most of whom were illiterate and and not a clinical trial but the issue of the standard of care is
belonged to the urban communities around these hospitals. We still important. The absence of an external sponsor does not
do not have any other socio-demographic information about change the obligation of local researchers towards study
these women, but it is possible that they had limited access to participants (11). The debate on the global single standard of
the healthcare system. They may have believed that enrolment care and the need for double standards is ongoing; there are
in the research study would give them access to, and medical no universally accepted solutions (10,12, 13). How do we deine
attention from, qualiied doctors in public health facilities. Thus, the standard of care through the public healthcare system in a
we are analysing the interactions between researchers and south Asian country? Let us examine what could be considered
study participants in the macrocosm of the health system (6), the standard of care in this particular case study.
including the larger socio-political context.
We do not know the exact details of this countrys health
While obtaining informed consent from the participating expenditure and budget, but the fact that the study was
women, the researchers would have used simple, nonmedical commissioned by the national medical research council in
language to explain the nature of the study and the role of order to design a cost effective cancer control programme
study participants. This is important given the fact that most suggests that resources were limited. As per national
women were illiterate and even otherwise, general literacy guidelines, this country did not aggressively treat lesions of
may not always facilitate medical literacy. But the researchers cervical dysplasia, though this was a common practice in other,
did not inform the participants that their lesions could be of resource-rich, western countries. The city in which the study
cancer, nor did they inform them of the available treatment took place had at least eight large publicly-funded hospitals
and care options. This can be interpreted as intentional providing general and specialised gynaecological care.
withholding of information essential for the women to make However, these hospitals were overburdened and did not have
an informed decision regarding their participation in the study. adequate facilities for managing cancer cases. The city also had
In most south Asian countries, there is a clear hierarchical a regional cancer facility but it had an average waiting period of
power relationship between healthcare providers and patients/ six months before a patient could see an oncologist and begin
healthy volunteers (as it is in this study) (7). It is often believed treatment. It seems that the local standard of care for women
that the doctor knows what is best for the patient, and this with cervical dysplasia in this particular country was referral
trust can compel persons to participate in research if the to the regional cancer institute following diagnosis, and a six
doctor advises it, particularly if the same physician is involved month wait before they could start treatment. Thus, whether or
in regular care as well as research activities (8). not a woman was a study participant, there was no proactive
management of cervical dysplasia in this health system, and the
To ensure that research participants consent only after being regional cancer hospital was clearly overworked and unable
adequately informed, it is essential that comprehensive to manage patients in a timely fashion. Further, this study was
[ 54 ]
designed, funded, approved and conducted by the various of their study. Half-way through this observational study, a
agencies and institutes within the national ministry of health. North American journal published clear evidence that cervical
No external agency was involved in this study. The researchers dysplasia is premalignant and should be treated aggressively
could argue that they provided the participants with the best to prevent cancers. This was a point at which the researchers
available local treatment options. In fact, the women beneited should have reassessed the objective of their study. If the
from their participation in the study as screening ensured new evidence was convincing, it should have been used to
early diagnosis of cervical carcinoma in situ, and those with ask the medical research council to discontinue the study.
this diagnosis got immediate referral to the regional cancer Moreover, continuing the study in spite of available evidence
hospital. If they were not part of the study, they would have against it meant causing more harm to the study participants.
reached the regional cancer hospital at a later stage of their This is where an external monitor of the study plays an
cervical cancers, possibly when the cancer had spread to other important role (14). Having no direct stake or involvement
parts of the body. in the research, an external monitor is in a neutral position
to recommend discontinuation of the study in the light of
This referral also marked the end of the researchers conclusive evidence generated from the same study or through
responsibility towards the study participants. Once referred to other publications.
the regional cancer institute, the women were left on their own
to negotiate access to further treatment and care. Stopping the study at the right time is essential but not
enough. The researchers also needed to develop a system to
Here we have two groups of women with different healthcare manage about 1,000 patients needing aggressive treatment
needs, those in various stages of cervical dysplasia, and those as per available evidence. This could have been achieved
with cervical carcinoma in situ who were referred to the through collaboration between the recruiting hospitals and
regional cancer hospital. the regional cancer facility. A triage of study participants
Midway through the study, evidence became available that all distributing patients between the recruiting hospital and the
stages of cervical dysplasia are essentially premalignant and regional cancer institute based on urgency, other risk factors,
warranted treatment to prevent progression to cancer. By this and underlying complications could have been a step towards
time, the investigators had identiied more than 1,000 women effective and timely management of the large number of
with varying degrees of cervical dysplasia. These women patients who needed to be treated as an entitlement of their
should have been treated according to the new therapeutic study participation.
gold standard: aggressive treatment of cervical dysplasia in
order to prevent cervical cancer. Conducting ethical clinical research in resource-
constrained public hospitals
Is it possible for a south Asian country with limited resources Most publicly funded hospitals in developing countries have
to provide treatment which is more feasible in the developed limited inancial, material and technical resources, and the eight
world? Even if we talk only about 1,000 women from the public hospitals which were recruiting women in this cervical
study with lesions of cervical dysplasia who should have cancer study were no exception. There are three questions
been aggressively treated as per the new evidence; neither that need to be considered while involving such resource-
the recruiting hospitals nor the regional cancer hospital was constrained public hospitals in clinical research. First, what
capable of responding to the treatment needs of 1,000 women are the ethical challenges faced while conducting research in
in a timely fashion. The national medical research council such settings? Second, what are the consequences faced by
should have anticipated this situation, given the fact that it the hospitals due to their participation in research in terms of
was carrying out a large, long-term observational study, and care provision to the research participants. Finally, is there a
was expected to provide study participants with treatment, potential to strengthen health systems through participation
not just early diagnosis. The medical research council could in research?
have negotiated better functioning referral links between
recruiting hospitals and the regional cancer facility to create All eight hospitals recruiting women for this study were in urban
fast-track access to cancer management for the study settings and provided general and specialised gynaecological
participants. A functional referral link would also have meant care. They were clearly overworked and understaffed, and did
that the researchers continued to follow women referred to not provide cancer care and treatment. Recruiting patients
the regional cancer facility. It can be argued that the national through public hospitals ensured that women who were likely
medical research council should have ensured that all the to beneit through the study participation got represented
recruiting hospitals were capable of managing lesions of in the study. Women were required to visit the centre every
cervical dysplasia as per the available standards, that is to treat three months for a Pap smear. Since this was a gynaecological
these lesions aggressively. This gained even more importance hospital, Pap smears were routinely conducted, and one could
when the evidence became available to support this strategy. be conident that the hospital staff was trained to properly
collect and accurately interpret the smears without harming
Role of the external study monitor and terminating the patients.
the study However, it seems that the researchers underestimated the
Researchers are also responsible for keeping themselves hospitals ability to meet their obligation to provide aggressive
updated on evidence that becomes available during the course treatment to large numbers of women with cervical dysplasia
[ 55 ]
if research found this to be the best way to manage such cases. be drawn up even before recruiting participants. Researchers
There does not seem to have been adequate discussion of are obliged to make their best efforts to provide the highest
how the hospitals were going to manage study participants attainable care to research participants, irrespective of whether
apart from providing referrals to the regional cancer institute. the study sponsor is external or local. It is advisable to assess
One beneit of conducting research through the public health the study periodically and check if the study objectives are
system is its strengthening as a consequence of research still relevant. An external and neutral study monitor could play
participation (). However, one must ensure that hospitals are a crucial role in monitoring the studys implementation and
equipped to provide standard care and treatment to research recommend continuation or discontinuation of the research
participants before starting such research activities. based on the available evidence. Observational research can
draw upon the same ethical principles and standards that
In fact, this study created an opportunity for the eight public have been developed for experimental studies, though speciic
hospitals to build their capacity in the management of early details may be needed to incorporate speciic challenges
cases of cervical dysplasia. This was particularly important when posed by the observational nature of the study. As in the
it became evident that all lesions of cervical dysplasia need to STROBE checklist, a structured analysis could be carried out to
be aggressively treated. By the ninth year of the study, they had guide the ethical conduct of observational studies, drawing
about 1,000 women with various stages of cervical dysplasia upon existing guidelines for experimental research like the
who should have been aggressively treated. The regional cancer CIOMS guidelines or the Declaration of Helsinki. Resource-
institute alone would not have been able to handle this sudden constrained publicly funded hospitals should be involved
increase in patient load without assistance from the recruiting in research activities provided they are equipped with the
hospitals. Women with locally spread cancers and other necessary resources and skills to implement scientiically and
complications could have been given priority treatment at the ethically sound research. Research participation could, in fact,
regional cancer institute whereas other uncomplicated and strengthen the public health system by improving the quality
early cervical lesions could have been successfully managed of its services. Involving communities in designing, planning
at the recruiting hospitals with support and mentoring from and implementing research can empower these communities
cancer specialists. These skill-building activities should have and protect participants against exploitation.
taken place before starting the study. Once the staff of these References
hospitals had enough experience in managing the research 1. Cash R, Wikler D, Saxena A, Capron A, editors. Casebook on ethical issues
participants with cervical dysplasia, these services could have in international health research. Geneva: World Health Organisation
been provided to other women through these hospitals. This 2009;124-5.
would have achieved institutional capacity building, with eight 2. Council for International Organisations of Medical Sciences; World
Health Organisation. International ethical guidelines for biomedical
hospitals becoming able to diagnose early cases of cervical research involving human subjects. Geneva: World Health Organization;
dysplasia and manage them appropriately with monitoring 2002.
and technical support from the regional cancer hospital. 3. Fry C, Dwyer R. For love or money? An exploratory study of why injecting
drug users participate in research. Addiction. 2001Sep; 96(9):1319-25.
The aim of the national medical research council was to 4. Vandenbroucke JP, von Elm E, Altman DG, Gtzsche PC, Murlow CD.
develop a national cancer control programme through this STROBE Initiative. Strengthening the Reporting of Observational Studies
in Epidemiology (STROBE): Explanation and Elaboration. PLoS Med. 2007
research. If it had built the infrastructure and expertise of these Oct 16; 4(10): e297.
eight hospitals during and after the research, the medical 5. Cash R, Wikler D, Saxena A, Capron A, editors. Casebook on ethical issues
research council could have actually paved the way for future in international health research. Geneva: World Health Organisation
implementation of a national cancer control programme. In 2009;118.
6. McLaren L, Hawe P. Ecological perspectives in health research. J Epidemiol
summary, we can conclude that the public hospitals should Community Health. 2005 Jan; 59(1): 6-14.
be involved in research provided they are equipped with 7. Kottow M. The battering of informed consent. J Med Ethics. 2004 Dec;
the resources and skills to implement ethical and scientiic 30(6): 565-9.
8. Benatar SR. Relections and recommendations on research ethics in
research, and to provide standard care and treatment for
developing countries. Soc Sci Med. 2002 Apr; 54 (7):1131-41.
research participants. Research activities can build the 9. Emanuel EJ, Wendler D, Killen J, Grady C. What makes clinical research
institutional capacity, infrastructure, expertise and staff skills to in developing countries ethical? The benchmarks of ethical research. J
provide better health services in the future, thus strengthening Infect Dis. 2004 Mar 1; 189(5): 930-7. Epub 2004 Feb 17.
10. London AJ. The ambiguity and the exigency: clarifying standard of care
health systems.
arguments in international research. J Med Philos. 2000 Aug; 25(4): 379-
97.
What can we learn from this observational study 11. Bandewar SV, John TA. SEARCHS HBNC trial: towards a broader debate
conducted in the 1970s? on the ethics of social intervention research. Indian J Medical Ethics. 2011
Apr-Jun; 8(2): 78-85.
Researchers and recruiting hospitals should be equipped to 12. Benatar SR, Singer PA. Responsibilities in international research: a new
provide care and treatment to the study participants, and look revisited. J Med Ethics. 2010 Apr; 36(4):194-7.
13. Macklin R. After Helsinki: Unresolved issues in international research.
not just stop at the diagnosis of disease as an endpoint of Kennedy Inst Ethics J. 2001 Mar; 11(1):17-36.
the research. Systematic plans to provide care to participants 14. Silverman H. Ethical issues during the conduct of clinical trials. Proc Am
during and after the study, within reasonable limits, need to Thorac Soc. 2007 May; 4 (2):180-4. discussion 184.
[ 56 ]
Observational research where it is most needed

SUJIT D RATHOD
Division of Epidemiology, 101 Haviland Hall, University of California, Berkeley, CA 94720 USA e-mail: sujit.rathod@yahoo.com
Study rationale and justice this approach is questionable(3). It is possible, then, to consider
The rationale for this study was the identiication of prognostic the conduct of this cervical cancer research study through both
factors among women with cervical dysplasia. It was the guidelines in place at that time, and those that have been
conducted in a south Asian country in the 1970s. Given the developed since.
unknowns with regard to cervical dysplasia and development
of carcinoma at the time, and the lack of consensus about Standard of care and beneficence
which types of dysplasia would progress and become The most ethically contentious aspect of this study was the
cancerous (1) it was appropriate to observe the natural history absence of treatment provision by the researchers for women
of dysplasia. found to have cervical carcinoma.
At that time, there was a similar ongoing study, also indicating To require that treatment be readily available for conditions
that clinical equipoise was evident; its results were yet to be that are diagnosed as part of non-therapeutic health
published. This study involved another combination of funders, research creates a standard that effectively precludes much
researchers and research ethics boards. Aside from equipoise, observational research in the settings where it is most needed.
additional ethical criteria must be considered, namely: justice, Additional complications would immediately arise: Must the
beneicence and respect for persons. researchers increase the treatment capacity at the regional
cancer centre? Or must they start offering cancer treatment at
Justice the local hospitals? Would participants be put ahead of non-
The importance of this sort of basic scientiic investigation participants on the waiting list, and/or have their treatment
cannot be overstated. In the absence of evidence from paid for? In fact, it is not the responsibility of the public health
randomised control trials, guidelines around cancer screening researchers to rectify the shortcomings of the public health
rely on data generated from observational studies. By system; that is the appropriate jurisdiction of elected oficials
determining the incidence and prevalence of women with and civil society. It is, however, the researchers responsibility to
carcinoma in situ, and identifying the features of dysplasia describe the distribution, determinants and consequences of ill
associated with progression to carcinoma in situ, this research health, and to identify potential means of intervention.
could support health policy makers efforts to increase capacity Thus, the limited treatment capacity in the study area is not
and to precisely target the treatment of cervical cancer. The ethically problematic. Frequently, it is the case that health
primary beneiciaries of the indings of this kind of research research is conducted in areas of limited resources, where the
would be those populations most affected by cervical cancer - de facto standard of care is below the standards in high-income
who happen to be women in developing countries. The burden settings. Though it may appear that the investigators were
of research participation should be borne by a sample drawn exploiting the participants lack of access to treatment -- an
from populations expected to beneit from the results of the ethically unsound strategy made infamous by the Tuskegee
research indings. Thus it is just and appropriate that women in study of untreated syphilis -- they were not exacerbating the
developing countries were enrolled in this study. situation for purposes that would not beneit participants. It
At the time of this study, the regulatory framework for medical must be re-emphasised that the researchers were attempting
research ethics was still developing. The Nuremberg Code to address a critical gap in the knowledge base around the
(1949) and the World Medical Associations Declaration of development of cervical cancer. The knowledge gained could
Helsinki (1964 and 1975) were both in existence , while the enable more eficient allocation of cervical treatment in these
publication of the Belmont Report (1979) was imminent. The areas of limited resources.
latter document - with its ethical criteria of justice, beneicence, Some may question whether this study satisied the ethical
and respect for persons - has particular relevance to this requirement for beneicence, as many women referred for
case study, as it was created in response to an observational treatment of carcinoma experienced deteriorating prognoses
research study. Yet, all three cover circumstances applicable during their lengthy wait before the initiation of treatment.
to either or both intervention and observational research. Of By virtue of the study design, the delays that participating
the current major research ethics regimes, only the Council for women experienced between the development of carcinoma,
International Organisations of Medical Sciences has created a the diagnosis of carcinoma, and their entry on the cancer
separate guideline speciically for epidemiologic research -- centre waiting list would certainly have been far shorter than
most recently revised in 2008 (2) -- although the necessity for for women who were not participating in this study. In spite of
[ 57 ]
the long wait at the regional cancer center, the post-diagnosis Although investigators and sponsors are generally careful to
prognosis was undoubtedly enhanced for the 71 participating conduct high-quality research, it is infrequently the case that
women diagnosed with malignancies in the study -- a clear the result of a single study is suficient to conclusively answer
beneit of participation. a research question: replication is at the heart of science. Not
only for observational research, but even with randomised
Informed consent and respect for persons controlled trials, consideration of results from several studies is
It is not clear what information was provided to the women as necessary to resolve clinical equipoise. Statistically signiicant
part of their recruitment and enrolment process. That women results from early studies of a research question are frequently
were not aware that treatment was available, on the face of incorrect(6), and even when correct, the strength of the early
it, appears incriminating. But in the light of the local standard indings is often attenuated as the studies are replicated
of care, it is irrelevant that women in other countries would (7). Therefore, in medical research, the conclusions from a
be immediately treated upon detection of cervical dysplasia. systematic review or a meta-analysis, drawing from multiple
The relevant standard is the established, local one: women high-quality studies, are considered the most compelling.
with carcinoma in situ are candidates for treatment, and these Stopping rules feature most prominently in randomised
participating women found to have carcinoma were in fact controlled trials, when there is typically a single exposure
referred to the regional cancer centre. In the 1970s, as now, that is being assessed for a primary outcome. Studies can be
the Declaration of Helsinki makes clear a medical researchers halted if an external assessment group judges that at least one
primary interest is the well-being of the individual participant(4, pre-speciied criterion has been reached. This could be so if
5); this ethical standard is satisied by researchers providing interim analysis produced a statistically signiicant result which
immediate referral to the cancer centre upon detection of is unlikely to be overturned with additional data collection.
carcinoma, as a non-research clinician in this setting would Another criterion might be that low enrollment or retention
have done. igures indicate a high likelihood that the study will not fulill
One aspect of this case study requiring additional detail is its objectives. A third is that there is evidence of adverse events
what women were told with regard to the research question. associated with participation (8). A recent example in HIV
Informed consent, by deinition, must be informative; women prevention (9) demonstrates that even when one intervention
need the necessary information to make the decision of study is halted early, other similar studies may continue, so that
whether or not to participate in the research study. These the effect of the intervention can be demonstrated consistently
women would have to be told that: a) they were being asked and conclusively. In observational research, where multiple
to be participants in a research study; b) the research question exposures and outcomes are typically being assessed, and the
concerned identiication of cervical features that might predict exposures are not being allocated by the investigator, these
development of cervical cancer; and c) participants found considerations are frequently moot.
to have developed cervical cancer would be referred to the
In conclusion, it is crucial that health researchers continue
regional cancer centre. Some women might have decided that
to focus on the health needs of medically underserved
they prefer not to have their cervical health tracked, or that if
populations. Here, the investigators were conducting
diagnosed, they would not or could not avail themselves of the
observational research in response to a local reality shared
treatment offered at the cancer centre. Respecting individual
by nearly all women in developing countries at that time:
autonomy entails provision of the kind of information necessary
that there was an unknown prognosis for women with
for a recruited individual to make an informed decision about
cervical dysplasia. By virtue of the marginalised status of
participation. Insuficient information is available here to assess
such populations, they are also typically at greater risk of
whether this ethical imperative was satisied.
exploitation. In this case study, the research was conducted
primarily with regard to the needs of the local population, and,
Equipoise and stopping rules most importantly, beneited those women who consented to
Clinical equipoise is again a concern after the publication of participate. Researchers and their respective research ethics
a longitudinal study which had been investigating a similar committees are obliged to consider clinical equipoise before
research question as in the south Asian country. Now, the and during the trial, though observational research studies
research gap concerning cervical dysplasia and development are unlikely to involve early stopping rules. When multiple
of cervical cancer is occupied by a single observational study. studies have considered a similar research question, those
In this situation, investigators of contemporaneous studies responsible for crafting health care guidelines can draw from
concerning the same research question are faced with a the strengthened knowledge base; changing policy requires
dilemma: whether they would have had justiication to start a resolution of clinical equipoise, and multiple studies are
their own study had they known those results. In other words, generally required to provide that resolution.
once the longitudinal study had been published, was there
References
still a state of uncertainty around the study question within
1. Cash R, Wikler D, Saxena A, Capron A, editors. Casebook on ethical issues
the clinical community? If a reasonable clinician could believe in international health research. Geneva:World Health Organisation:2009.
some uncertainty remained, then continuation of the ongoing 124-5.
study would be justiied. 2. Council for International Organisations of Medical Sciences. International
[ 58 ]
ethical guidelines on epidemiological studies [Internet]. World Health 6. Ioannidis JP. Why most published research indings are false. PLoS Med.
Organization; 2009. [cited 2011 Nov 2]. Available from: http://books. 2005 Aug;2(8):e124. Epub 2005 Aug 30.
google.com/books?id=R3pkPgAACAAJ 7. Ioannidis JP. Why most discovered true associations are inlated.
3. Rose S. International ethical guidelines for epidemiological studies. Am Epidemiology. 2008 Sep;19(5):6408.
J Epidemiol. 2009;170(11):1451-2. 8. Malmqvist E, Juth N, Lyne N, Helgesson G. Early stopping of clinical trials:
4. Rickham PP. Human experimentation. Code of Ethics of the World Medical charting the ethical terrain. Kennedy Inst Ethics J. 2011 Mar;21(1):5178.
Association. Declaration of Helsinki. BMJ. 1964 Jul 18;2(5402):177. 9. Bailey RC, Moses S, Parker CB, Agot K, Maclean I, Krieger JN, Williams CF,
5. World Medical Association. Declaration of Helsinki [Internet]. 2008 [cited Campbell RT, Ndinya-Achola JO. Male circumcision for HIV prevention in
2011 Nov 2]. Available from: http://www.wma.net/en/30publications/ young men in Kisumu, Kenya: a randomised controlled trial. Lancet. 2007
10policies/b3/index.html Feb 24;369(9562):64356.
Some ethical issues here: demands of informed consent and ethical

justiication for research
PRAVESH JUNG G
Department of Humanities and Social Sciences, IIT-Bombay, Powai, Mumbai, 400 076 INDIA e-mail: pgjung@iitb.ac.in
In this comment, I intend to highlight some of the bases of forth the demand to recognise the possibility of asymmetry of
the ethical concerns behind the study in question (1). I argue information between the researcher and the participants of the
that these concerns should be viewed not merely with alarm study. The second constituent, consent, sets forth the demand
but also with a sense of urgency for a demand for some to recognise the principle of autonomy.
ethical imperativeness. The study, I argue, either misreads or
To accept the possibility of asymmetry of information is to
downplays the role and signiicance of certain principles which
acknowledge the fact that individuals may differ in terms of the
I posit are fundamental to the framework of medical ethics
scope and extent of information that they possess about the
(the justiication for considering these principles fundamental
world. The principle of autonomy acknowledges, on the other
demands a separate essay)
hand, the view that individuals are ends in themselves, and
The concerns that I raise here are based on two characteristics therefore, have the right to self-determination. To recognise
of the study in question: this demand made by the principle of autonomy is to recognise
that individuals have the right to choose.
First, though such studies are labelled observational studies as
opposed to controlled experiments, they are not mere armchair However, the principle of autonomy only assures us that all
introspective observations of ones thoughts. They are carried individuals have the right to choose; it does not ascertain that
out in a social space, where the object being observed is an their autonomy also enables them to understand their choices
other, rather than the self that is doing the observation. (The when they actually confront them. In itself, the principle
researcher-subject dichotomy can be seen as an instance of the ascertains the attribution of autonomy to an agent at the
self-other dichotomy.) formal level alone. Therefore, the demand of informed consent
brings into operation the related demand for recognising the
Second, the legitimacy of such a study is derived from the end possible fact of asymmetry of information. The recognition of
or the projected result that the study aims to attain. That is to this possible fact poses a duty for the researcher to provide
say that the study is not self-justiicatory. the necessary information to enable agents to understand the
options that they are to choose from. Thus, it is required that the
These two characteristics respectively form the basis for two principle of autonomy be supplemented by acknowledgement
pivotal demands of medical ethics -- informed consent and of the possibility of asymmetry of information. Without this,
ethical justiication for research. These twin demands constitute the autonomy of an agent may merely remain a formal notion
the major challenges pertaining to the ethicality of a research. without being translated into an actuality.
The paper will briely deal with these twin demands in light of
the study in question. Thus the term informed consent posits two distinct though
related demands upon the researcher: the duty to recognise
The demand of informed consent the autonomous status of an individual, and the duty to provide
the information that would enable agents to understand their
It is often overlooked that though the term informed
choices and consciously exercise their autonomy.
consent grammatically operates as a single unit, it is
constituted by two terms that signify two distinct, though This also provides agents (in this case potential study subjects)
interrelated, demands. The irst constituent, informed, sets the following rights: the right to be treated as autonomous
[ 59 ]
agents, and the right to be provided information to enable extent that it provided the minimum information required to
them to understand their choices and exercise their autonomy enable the researchers to draw out a predetermined choice
consciously. from the potential subject, namely, that of consenting to be
a part of the study. I assume the researchers thought this
Here it is important to recognise that the demands of informed
was an ethical choice for the potential subjects. Thus in their
consent do not logically entail a duty for the agent making the
enthusiasm to uphold a duty that they assumed to be entailed
choice- who in this case is the potential subject of the study
by the principle of informed consent, they actually violated
to make an ethical choice, even after the relevant information
the principle and fell short of fulilling the actual dual duties
has been provided. It must also be recognised that any form imposed upon them by the principle. (This exposition assumes
of coercion or incentive to inluence the agents choice would that the researchers had agreed to uphold the principle of
be a breach of the researchers duty to recognise the agents informed consent and can be justiied by the fact that the
autonomous status and, correspondingly, a breach of the researchers took oral informed consents from the subjects.
agents right to be treated as autonomous. However, the principle of autonomy can be and has been
The confusion resulting in non-compliance of the principle challenged, and subjected to examination through the lens of
of informed consent in the spirit demanded by the principle, other principles of biomedical ethics such as beneicence or
apart from actions due to callousness or sheer ignorance on non-maleicence.)
the part of the researcher, lies in the researchers inability to see
informed consent as constituted of these two distinct demands. The demand of ethical justification in research
This is true irrespective of the mode (written or oral) by which By and large, biomedical research cannot be self-justiicatory (as
informed consent is sought. The confusion worsens due to the opposed to say research in pure mathematics, or speculative
mistaken reading of the principle of informed consent to entail mathematics, that engage with abstract problems as ends in
a duty for the researcher (the one obtaining the informed themselves, though it may be appropriated later by applied
consent) to shoulder the moral burden of ensuring that the research). By and large, biomedical research must answer the
autonomous agent (the potential subject) makes an ethical question: Why this study? The question itself has two distinct,
choice (Of course this assumes that there can be a determinate though related, elements: technical and ethical. The recognition
ethical choice amongst a range of available choices.) that the ethical aspect of the question is as relevant as the
technical aspect, if not more, is the basis for the growth of the
The principle of informed consent does not, and cannot, pose
ield of medical ethics.
such a moral demand upon the researcher. Doing so would be
in conlict with the demand of recognition of the autonomous To recognise that study x is not self-justiicatory is to recognise
status of the agent (the potential subject). By and large, I that its justiication resides in something other than the study
suspect, researchers -- wrongly -- take this to be the duty itself -- y, which is the end that the study projects it would
entailed by the principle of informed consent, while ignoring achieve in its completion. Hence, the form of such justiication
the actual dual demands of duties placed on them by this is of the nature of a conditional or hypothetical statement (as
principle. opposed to a categorical statement). The justiication of x is
conditional on the justiication provided by y for x. The formal
If one misreads the principle of informed consent to entail
structure of these justiications would be: If y, then x stands
a duty to draw out a speciic choice, even if this choice is an
justiied.
ethical one, then upholding this duty would not only breach
the duty of recognising the autonomous status of the agent, It is to be noted here that y cannot then derive its justiication
it would, apart from raising questions about the legitimacy from x (this would be a fallacious, circular justiication). Given
of terming it as a choice of the agent, also legitimise the the necessary independence of y (the justiication for x) from
modiication of the demand posed by the possible fact of x (the study), y can change independently of x. However,
asymmetry of information by legitimising the extent, scope and given that x derives its justiication from y, any change in
nature of the information to be provided to potential subjects. y can have a direct impact upon x and the justiication it
That is to say that it would legitimise withholding, and/or derives from y. This is why, I would argue, the demand of
overemphasis on certain information since the researchers ethical justiication of research obliges the researcher to follow
duty would be to extract an ethical choice from potential developments in research that could change an understanding
subjects rather than to provide the information necessary of the projected end.
to enable them to understand their choices and consciously
In the case of the study in question, the end was to understand
exercise their autonomy by making a choice, irrespective of the
the relation between cervical dysplasia and cervical cancer; it
ethicality of the choice made.
sought to ind out whether the former evolved into the latter
The study in question, I suspect, confuses the duties entailed and if it did, to develop better therapy to prevent cervical
by the principle of informed consent with the (ictitious) duty cancer. Thus, when the study was approved by the ethics
of ensuring that the agent makes a choice that has been committee of the research council, the study might arguably
predetermined as the ethical choice by the researcher. The have been justiied on the basis of this projected end which in
consent taken, in the study in question, was informed, to the itself may be granted a fair review.
[ 60 ]
However, as already discussed, the projected end of a study is scepticism is justiiable. An unjustiied sceptical stance would
independent of the study itself. Thus, when mid-way through be hollow and unworthy of critical attention.
this study, the north American medical journal published
The ethical justiication for such a sceptical stance can be
the results of another longitudinal study of cervical cancer,
based upon the principle of non-maleicence. The studys
concluding that cervical dysplasia was a precursor for cervical
proponents can justify their sceptical stand arguing that the
cancer, and thus all forms of dysplasia warranted treatment, the
aforementioned principle entails a duty to ensure that they be
projected end of the study under question was achieved. The
certain about the other studys conclusions before accepting
publication would invalidate the justiication of this study, and
them to be a deinitive understanding of cervical cancer and
consequently its ethical justiication.
its relation to cervical dysplasia. They are duty-bound to do
However, one could still have argued for the continuance of the this, so as to ensure that no harm was done (principle of non-
study on other grounds. maleicence) to women with cervical dysplasia (possible cases
of cervical cancer) by virtue of the conclusion that the study
One such ground might be that the researchers were ignorant
would generate.
of the study published in the north American medical journal.
However, if this were so, it would raise serious concerns Though it would be hasty to conclude that no genuine reasons
regarding their credibility given the nature and potential social pertaining to the scientiic or technical aspect of the published
impact of their research. It would suggest that they breached study could have made the researchers sceptical and therefore
their duty to take stock of things regularly, a duty posed by the led them to continue the study, these reasons would have to be
demand of ethical justiication and that they overlooked the brought out and defended.
fact that a change in that which justiies (the projected end)
Acknowledgement: I thank all the reviewers for their comments
can have an impact, and a crucial one, upon that which is being
and suggestions.
justiied (the study).
Reference
One could also argue that though the researchers were aware
1. Cash R, Wikler D, Saxena A, Capron A, editors. Casebook on ethical issues
of the other study, they were sceptical about the deinitiveness in international health research. Geneva: World Health Organisation
of its indings. Such a sceptical stance is legitimate provided the 2009;124-5.
A Film on Clinical Ethics
Call for ideas

Clinical ethics remains at the core of the bioethics movement. It is the ethics practiced by clinicians and those in the medical
profession at large. However, ethics is not a set of written-down rules and practitioners often have to use their own judgment
and discretion, and take critical decisions for the patient. Clinical ethics concerns run the range between questions of decision-
making, ensuring privacy and conidentiality, taking consent, and negotiating between doing what is in the best interest of
the patient, respecting patients judgment and autonomy, considering end-of-life issues and more. Yet, the path to making a
decision is not always smooth and often remains marked by dilemmas, anxieties, hesitations and also certainties and triumphs.
The Centre for Studies in Ethics and Rights (www.cser.in), a premier bioethics research organisation in India that has been
researching the various aspects of clinical ethics, invites creative minds to make a ilm on any aspect of clinical ethics in an
Indian context a documentary, a montage or a creative mix from footage archives!
Purpose of the film: The ilm would form part of the syllabus for the medical humanities course for doctors.
The tentative budget for the ilm will be 2.5 lacs (inclusive of all expenses borne by the director), provided in three installments.
We would want the inished ilm in 90 days from the date of the irst installment.
To apply, please send the following:
l A concept note (maximum 500 words) mentioning the duration of your film,
l A break-up of the budget
l Your CV (and the CVs of other personnel who might work with you).
to clinicaleics.cser@gmail.com before January 31, 2012.
For any queries that you might have, mail Deapica at clinicalethics.cser@gmail.com
.................... Join us on this exciing journey of translaing philosophy into a visual narraive ...........................
[ 61 ]
SELECTED SUMMARY
William Oslers medical ethics in the 21st century

RICHARD L GOLDEN
State University of New York at Stony Brook; Curator, Osler Library, McGill University, Montreal, Quebec H3A 2T5 CANADA e-mail: r.golden@pol.net
Mark W Millard. Can Osler teach us about 21st-century and pathology in the laboratories and clinics of London, Berlin,
medical ethics? Baylor University Medical Centre and Vienna. Returning to McGill he quickly rose to become
Proceedings. 2011; 24(3) 227-35. Professor of the Institutes of Medicine and with an ever growing
reputation went on to successive professorships at the medical
The ineluctable allure and wisdom of Sir William Osler, which
faculties of the University of Pennsylvania (Philadelphia), Johns
now spans three centuries, is elegantly put to the test by
Hopkins University (Baltimore) where he served as the irst
Mark Millard in determining its applicability to the medical
Physician-in-Chief of the Johns Hopkins Hospital, and capped
ethics of the 21st century. While there is little doubt that our
his career as Regius Professor of Medicine at Oxford University;
current technical knowledge and capabilities will be regarded
an unprecedented journey spanning two continents and
as primitive by the end of the century, if not well before its
three nations. It was at Johns Hopkins that he published
midpoint, how will our current ethical standards be viewed?
his renowned single-authored textbook, The Principles and
Are the teachings of William Osler, the preeminent physician of
Practice of Medicine, that went through 16 editions (1892-1947)
his time, applicable to modern ethical dilemmas?
encompassing over 500,000 copies and inluencing successive
The author raises the issues of treatment of irreversible illness; generations of students and practitioners. Its inluence was not
medical error and patient awareness; disagreement among limited to the English-speaking world which saw American,
consultants; and third-party payers limiting access, continuity of British, Australian and Indian (Calcutta) editions, but had a
care, or denial of service. He further cites a survey of physicians global impact as a result of translations into Russian, French,
that selected as major problems those of the incompetent or German, Chinese, Spanish and Portuguese (1).
impaired colleague; confession of medical error; physician-
Osler had over 1,600 publications including books, articles and
patient conidentiality in couples when one partner is HIV
essays on medical, philosophical, historical, educational and
positive; the prolongation of futile care in a terminal patient;
biographical topics. His enduring inluence rests on a legacy
denial of care to those who cannot pay; whether to honour a
of clinical, scientiic, literary, educational and intra-professional
familys request not to tell a patient that he/she has a terminal
achievements, linked to the lodestone of a remarkable
disease; exaggerating a patients condition to obtain insurance
personality, and bound together by ethical principles and an
coverage; and writing prescriptions for friends or family
extraordinary humanism.
members.
In considering William Oslers medical ethics, we must
A hierarchy of ethical principles is cited that offers guidance:
acknowledge that in many ways he was a man of his
patient autonomy (the right to refuse treatment); beneicence
Victorian-Edwardian times, but tempered by his historical and
(the adjuration to do good); non-maleicence (the instruction
philosophical studies and an innate humanism that left him far
to do no harm); and justice (both doing the right thing and
ahead of his time and remarkably free of prejudice. His cousin,
ensuring distributive fairness); ethical principles that include
Norman Gwyn, commented that the seed of prejudice must
the right to know and informed consent, differing from the
have fallen on stony ground in Sir Williams case... (2). Osler
paternalistic beneicence of earlier times. The caveat is given
declared:
that the rank, order, and deinition of these ethical principles
are subject to temporal interpretation and may change from What I inveigh against is a cursed spirit of intolerance,
one era to another. Examples are cited of Oslers teachings conceived in distrust and bred in ignorance, that make the
and personal approach to some of these problems, including mental attitude antagonistic, even bitterly antagonistic,
euthanasia and assisted suicide, and the economics of medical to everything foreign, that subordinates everywhere the
practice. race to the nation, forgetting the higher claims of human
brotherhood (3).
William Osler (1849-1919), the foremost physician of the
English-speaking world, was born in Bond Head (Ontario), In a more pithy statement he proclaimed: The great republic of
Canada, one of the nine children of an Anglican clergyman. medicine knows, and has known no national boundaries. This
After graduating MD from McGill University (Montreal) he spent is the heartening theme of todays altruistic Doctors Without
the usual wanderjahre in Europe, honing his skills in medicine Borders (4).
[ 62 ]
Humanism in its broad sense was not part of the idiom of There is no doubt that, in general, Sir William Oslers ethical
Oslers time, although its concept was well known. It is a word standards and approach to the practice of medicine remain
that is often glibly used and dificult to deine. Osler was pertinent and fresh. In a world where doctors have become
once questioned as to why he merrily whistled after leaving providers and patients consumers; where cost containment
the bedside of a gravely ill patient. He revealed the depths of and third party payers limit choices; where access to medical
his humanistic empathy in responding: I whistle that I may care is limited or non-existent, and life-saving drugs marketed
not weep. (5) Another poignant example occurred during
at egregiously high cost, the example of Osler and virtue
Oslers Oxford tenure when he was called to the home of a
ethics are a beacon in an evolving, and frequently, disturbing
colleague to see a child with very severe whooping cough
practice of medicine.
and bronchitis, unable to eat and wholly unresponsive to the
blandishments of parents and devoted nurses alike. Clinically it Listen to Oslers own words:
was not an abstruse case, but weapons were few, and recovery
seemed unlikely. Osler, on his way to graduation ceremonies in I have three personal ideals. One, to do the days work
his academic robes, stopped and saw the child and after a brief well and not to bother about to-morrowThe second
examination peeled, cut, and sugared a peach which he fed ideal has been to act the Golden Rule, as far as in me
bit by bit to the enthralled patient. Although he felt recovery lay, towards my professional brethren and towards the
was unlikely, he returned every day for the next 40 days, each patients committed to my care. And the third has been
time dressed in his robes, and personally fed the small patient to culture such a measure of equanimity as to enable
some nourishment. In a short time the tide began to turn and me to bear success with humility, the affections of my
recovery became evident (6). This is humanism that is readily friends without pride and to be ready when the day
understood on a visceral level. of sorrow and grief came to meet it with the courage
Oslers medical ethics derived in part from his upbringing as beitting a man. (13)
the son of a clergyman, his early mentors, his philosophical For those who wish to learn more of William Osler and his
and historical studies, and his fascination with the concepts ethics than can be offered in this brief review, read Dr Millards
and principles of the ancient Greeks from whom he embraced insightful article and then, if the spark successfully ignites the
the Hippocratic philanthropia and philotechniathe kindling of intellectual curiosity, proceed to the delightful
love of humanity coupled with the love of his craft. (7)
biographies of Michael Bliss (15) and Harvey Cushing (16).
Osler particularly adopted the lessons and standards of the
Hippocratic Oath and its ethical obligations. While the spirit of References
the Oath remains intact, a newer Declaration of Geneva now 1. Golden RL. A History of William Oslers The Principles and Practice of
embraces some more modern concepts. He often quoted from Medicine. Montreal: Osler Library, McGill University and the American
Poe of the glory that was Greece, and the grandeur that was Osler Society; 2004.
2. Gwyn NB. The boyhood of Sir William Osler. CMAJ. 920:10:24-7.
Rome. (8)
3. Osler W. Chauvinism in medicine. In: Aequanimitas with other addresses
Among Oslers aphorisms and postulates he inveighed: to medical students, nurses and practitioners of medicine. Philadelphia, Pa:
P Blakistons Son and Co; 1906: 277-306.
You are in the profession as a calling, not as a business; 4. Osler W. The importance of post-graduate study. Lancet. 1900; ii:73-5.
as a calling which exacts from you at every turn self- 5. Osborne M. Recollections of Sir William Osler. Int. Assoc. Med. Mus. Bull.
sacriice, devotion, love and tenderness to your fellow 1926; 9: 171-4.
6. Mallam P. Billy O. JAMA.1969;210:2236-39.
man. (9)
7. Osler W. The old humanities and the new science. Boston and New York:
Distinctions of race, nationality, colour, and creed Houghton Miflin & Co;1920:63-4.
are unknown within the portals of the temple of 8. Poe, EA. To Helen (1846 revision). In: The Raven and Other Favorite Poems.
Aesculapius. (10) Mineola, NY: Dover Publications;1994:12.
9. Osler W. The reserves of life. St. Marys Hosp Gazette.1907;13:96-8.
No one should approach the temple of science with 10. Osler W. British medicine in Greater Britain. In: Aequanimitas with other
the soul of a moneychanger. (attributed to Sir Thomas addresses to medical students, nurses and practitioners of medicine.
Browne) (11) Philadelphia, Pa: P Blakistons Son and Co;1904:167-96.
Care more particularly for the individual patient than for 11. Osler W. Valedictory address to the graduates in medicine and surgery,
McGill University. Can Med Surg J. 1874-1875;31:433-42.
the special features of the disease. (12)
12. Osler W. Address to the students of the Albany Medical College. Albany
At a farewell dinner in New York in 1905, before leaving to Med Ann. 1899;20:307-9.
assume the Regius Professorship in Oxford, he candidly 13. Osler W. LEnvoi. In: Aequanimitas with other addresses to medical students,
discussed his ethics (13) (quoting Matthew Arnold) confessing: nurses and practitioners of medicine. Philadelphia, Pa: P Blakistons Son &
Co;1906:467-74.
I have made mistakes, but they have been mistakes of 14. Arnold M. Empedocles on Etna. In: The poems of Matthew Arnold, 1840-
the head not of the heart. I can truly say, and I take upon 1867. London: Henry Frowde, Oxford University Press; 1909:124. (Act II,
Lines 400-403).
myself to witness, that in my sojourn among you:
15. Bliss M. William Osler: A Life in medicine. New York: Oxford University
I have loved no darkness, Sophisticated no truth, Press; 1999.
Nursed no delusion, Allowd no fear! (14) 16. Cushing H. The life of Sir William Osler. Oxford: Clarendon Press;1925.
[ 63 ]
REVIEWS
Book review: Back to the future

DHRUV MANKAD
Director VACHAN, Nashik 422 002 INDIA e-mail: dhrvmankad@gmail.com
Anand Zachariah, R Srivatsan, Susie Tharu, editors, on illnesses ranging from malnutrition to depression?
behalf of Christian Medical College and Anveshi Collective.
Towards a critical medical practice: reflections on the The essays discuss ive central themes:
dilemmas of medical culture today. Hyderabad: Orient l The dichotomy between modern medical knowledge, whose
Blackswan; 2010. Pp 392 ISBN 978-81-250-4091-0 495.00 perspectives and content are influenced or determined
We have been on the threshold of transition in our health by the state, and medical practice. This leads to frustration,
status and healthcare system for the past 64 years. The infant burnout and even conflict between doctors and patients,
mortality rate has been reduced substantially. However, the or between government protocols and the need to tailor
declining sex ratio points to the widespread practice of sex treatment to the patients needs;
selective abortion. There has been no change in the body mass l The dichotomy between medical technologies transplanted
index of children and women, which points towards a looming from the West, with doctors trained in their use in
epidemic of hunger. The health infrastructure has improved but sophisticated tertiary care hospitals, and the doctors
its utilisation by the poor has not. There is greater availability inability to apply their knowledge in less sophisticated, even
of state-of-the-art technologies and trained human power for rudimentary settings;
treating patients. But is it relevant, affordable and based on the l The dichotomy between curative care services and public
needs of sufferers? Are the number and quality of healthcare health services in India that sends most doctors to private
services - public and private- appropriate? What are the hospitals in India or abroad since these are in line with their
historical, political, cultural and ethical dimensions of these backgrounds and the investment they have made in their
problems? education;
l The dichotomy between diseases and their manifestation
Towards a critical medical practice: reflections on dilemmas of
in India and their presentations in classical (western)
medical culture today explores the answers to these questions,
medical education, that leads to innovative and inexpensive
looking at them through the lenses of the knowledge,
diagnostic and treatment methods; and
attitudes and experiences of medical academicians and
l The dichotomy between medical knowledge and its day-to-
practitioners. The book is based on a consultation on
medical education; doctors concerned about the structure day practice.
of medical knowledge participated in a consultative process While such dichotomies exist in reality, my contention is that
for improvement in medical education initiated by Christian the dilemmas remain even if one takes a patient-centric view.
Medical College, Vellore. The non-governmental organisation Some examples of such dilemmas are:
Anveshi was an observer in this process. The book is a result 1. Do people give their consent to choose an appropriate
of critical discussions about history, culture, institutions, the treatment source? Do poor patients approach unqualiied
assumptions behind medical theory and practice, and the practitioners out of choice or out of compulsion because
dimensions of a crisis of medical knowledge. there is no other affordable option?
The introduction is a discussion of the ethical dilemmas in 2. Whose interest is served when a patient is treated at a primary
medical practice as presented by Anand Zachariah and R care centre by a general physician and not by an expert?
Srivatsan through two cases. These frame the fundamental Should the clinician have the autonomy to use a trial and
ethical dilemmas that teachers-activists-researchers- error method that takes into account the patients context,
practitioners face. Some of the questions that emerge from in place of a well-tested clinical guideline that is developed
these two cases will have been asked by all medical providers. elsewhere?
What was the best line of treatment: by a general physician 3. Who benefits from cost reduction in a private healthcare
or by an expert? What did the patient desire? Was the clinical setting? Did the private hospital proit by cost reduction,
diagnosis appropriate? Did a new protocol have to be applied using comparatively cheaper humanpower (such as
for each patient? Who is responsible for avoiding exposure employing paramedics, who are paid less, rather than
to the environmental causes of illness? What is to be done medical staff ) and treatment protocols (fewer investigations,
when social determinants like poverty are the main causes of fewer staff per patients, fewer services)?
[ 64 ]
4. Conflict of interest: What is the interest of the various and practical examples, taking the readers back into the history
stakeholders involved in deciding the types of public health of medical science and the political and cultural context of
measures to be introduced? This is particularly important problems of public health in India. The perspective and lessons
when the model is competing with another one which has of the book are essential if our society is to avoid the pitfalls in
the same intention. the future course of medical technology and public health.
5. Policy and guidelines as coercive documents in practice: If a One may have expected more guidelines, solutions and
guideline generated by the government of India loses its preventive steps for health practitioners, to tackle the ethical
guiding nature and becomes a mandatory clinical order dilemmas they face in medical practice. However, the authors
then it is certainly a violation of the principle of formal have done an important job in emphasising the complexities
justice of applying it as per the patients need. and dilemmas of decision making in such situations, and this
In essence, the book is a rich source of theoretical perspectives point is made in the title itself.
Film review: Medical students as guinea pigs

VIVEK JAIN1, RASHMI NAUDIYAL 2
1
Vardhman Mahavir Medical College and Safdarjung Hospital, Safdarjung, New Delhi, Delhi 110 029 INDIA e-mail: docvivekjain@gmail.com 2 Senior Resident,
Department of Paediatrics, ESI Hospital, Department of Paediatrics, ESI Hospital, Sector-15, Rohini, Delhi 110 085 INDIA
404 Error not found. Producers: Nameeta Nair, Kapil Mattoo, teachers, including the lecturer wife of Professor Aniruddh
2011. Director: Prawaal Raman. Hindi, 114 minutes. himself Dr Mira (Tisca Chopra) and Professor Vaidya (Satish
Kaushik), try their best to restore his sanity, the hapless student
Developing countries like India and Sri Lanka are trying to
gets ever more deeply involved in the clash between illusion
tackle the problem of ragging, the practice, in educational
and reality. The egotism of Professor Aniruddh, coupled with
institutions, of senior students bullying new students. The
problem is more noticeable in medical colleges in India where his desire to rationalise paranormal activity, ultimately drives
it has assumed serious dimensions with psychological, physical Abhimanyu to the point of no return.
and sexual harassment. 404 Error not found is a ilm that tries to The movie raises several key ethical issues in medical
offer an insight into this menace and its impact on its victims. practice. Professor Aniruddh fails to respect the autonomy of
There is a sub-plot regarding a psychiatry teacher with bipolar Abhimanyu, the individual, and his ability to make decisions
disorder who attempts to use one of his students as a guinea with regard to his own health and future. He acts in total
pig for its cure. The reference to paranormal phenomena
disregard of the principle of beneicence, as well as the
adds another dimension. One key issue viewers, especially
prohibition on maleicence, both key principles of medical
medical professionals or students, cannot afford to miss is the
ethics. Abhimanyu does not give his voluntary consent to being
discussion of ethics.
the study subject for the experiment. As far as biomedical
The male protagonist, Abhimanyu (Rajvvir Aroraa), is a bright research is considered, the professor does possess professional
new medical student who daringly volunteers to stay in Room competence to conduct such an experiment but he is not
404, the infamous haunted room of the college hostel. His able to justify how he minimised the risks involved for the
self conidence and determination seem admirable and his subject. He tries to rationalise his actions by saying that he was
teacher, Professor Aniruddh (Nishikant Kamath), is impressed acting to maximise public interest, but is unable to establish
with Abhimanyus efforts to promote rational science among transparency and total responsibility.
his fellow students. Meanwhile, Abhimanyu has to face the
wrath of his seniors for defying their bullying, and starts to lose Although the ilm tries to deal with too many issues in a
his mental composure. He begins to see the spirit of Gaurav, short span of time, it is realistic in its portrayals. Powerful
an earlier occupant of Room 404 who had committed suicide performances by the actors force viewers to empathise with
in that very room. Professor Aniruddh, who, incidentally, himself both victim and perpetrator, at one point or the other. Long
suffers from bipolar disorder, decides to use Abhimanyu as his after its unexpected climax, one continues to think about
guinea pig to prove to the world that there is no such thing as the issues raised by the ilm. It manages to highlight
paranormal activity. He involves Chris (Imaad Shah), a senior abhorrent practices such as ragging and unethical human
student of the college in his sinister plans. As Abhimanyus experimentation in the ield of medicine.
[ 65 ]
FROM OTHER JOURNALS
Out-of-pocket health expenses and Indias poor has been done to provide useful inputs at the policy level.
Out-of-pocket (OOP) expenditure in health is a major The author points out that along with recording the success
component of the household expenditure of health service stories of PPPs in primary healthcare, it is equally important to
users, and a source of concern especially for developing look into the failures. Through implementation research it is
countries like ours. In India the structural adjustment essential to explore the mechanisms through which it works
programmes of the 1990s led to the central and state or does not work. The author establishes the importance of
governments limiting the funding for the social sector. scientiic evaluation and evidence of what works for whom and
User fees were introduced in the public healthcare sector under what conditions, rather than just focusing on whether or
in the 1990s. Despite progressive efforts like the Drug Price not it works. This will help formulate more innovative policies
Control Order which was meant to ensure affordability of some in this ield.
commonly used drugs, liberalisation, including liberalisation Prashanth NS. Public-private partnerships and health
of the pharmaceutical sector in 2002, has sent prices spiralling policies. Econ Pol Wkly. 2011 Oct 15;46(42):13-5.
upwards. When 90% of the population has no health insurance
coverage, rising prices have left a large number of people
Should doctors recommend kidney donation?
unable to access healthcare.
Kidney transplants are required for persons suffering from end
These policy changes, along with growing poverty nationwide, stage renal disease or acute renal failure. Due to increasing
have stretched the spending capacities of poor Indians. public awareness, the availability of kidneys from deceased
or live donors has increased somewhat, but the demand for
The author uses quantitative data from various national surveys
to measure the extent to which household living standards kidney transplants still far outstretches the supply, and many
have been affected, across income groups and states. It is found patients with renal disease die while waiting for a transplant. To
that the richer states have an increased OOP expenditure for meet this demand and for better acceptability of the recipient,
healthcare, and the overall OOP expenditure for healthcare doctors may sometimes encourage their patients to donate
has increased over the past one decade. However, this their kidneys while alive, as living donors, to a stranger.
increase is primarily due to higher expenses among the rich. The risk of death associated with kidney donation is minimal
This emphasises the fact that the poor must choose between (1 in 3,000). Other risks are post-operative complications and a
medical care and other essentials such as food. reduction in renal function. Younger donors are able to recover
Ghosh S. Catastrophic payments and impoverishment due faster, and the remaining kidney can more than compensate for
to out-of-pocket health spending. Econ Pol Wkly. 2011 Nov; the lost one.
19(25):63-70. Since the doctor-patient relationship is paternalistic, patients
may feel that whatever the doctor advises them is good for
Evidence-based policy and healthcare models in them. In such a situation it is easy for doctors to misguide
India their patients or not provide full information about the pros
In this article the author, who has been part of a successful and cons of living donation, thereby leading patients to opt to
public private partnership (PPP) model in healthcare, discusses donate, without knowing the consequences.
the importance of implementation research in developing a
Doctors should not recommend that their patients donate,
successful model of PPP in healthcare. In his experience, the
for the simple reason that it may affect the post-operative life
key to success lies in innovations. This is evident in healthcare
of the donor. The primary responsibility of doctors is to do no
PPPs in India through community health insurance, mental
harm to their patients. In order to do good to one patient, they
healthcare at primary health centres (PHCs) through trained
should not harm another. A healthy individual can express the
doctors, tele-electrocardiography services, mainstreaming
autonomy to donate one kidney to a stranger, but this should
traditional medicines and availability of staff. The state should
not be the result of coercion by the doctor.
also ensure its active participation in the process.
Glannon W. Is it unethical for doctors to encourage
In many parts of India PHCs are not used either because they
are too far away or because their service delivery is of poor healthy adults to donate a kidney to a stranger? Yes.
quality. In this situation, it is easy to opt for a partnership BMJ. 2011; 343 doi: 10.1136/bmj.d7179
between the state and the private sector in which the latter
provides partial or full support to need-based primary Shielding healthcare workers from TB
healthcare services, or even to emergency obstetric care. Tuberculosis is a major public health problem in India, and this
Though the involvement of the private sector has gained is also a problem faced by healthcare workers. Doctors and
importance among policy makers in India, very little research nurses get exposed to TB early in their clinical rotations, and
[ 66 ]
infection can progress into full blown TB during the course of of maternal health, states have launched a range of PPPs to
their work. Nursing trainees are at the highest risk because they tackle maternal mortality. However, many of these programmes
are at the bedsides of patients in overcrowded wards. have failed, and this article analyses the reasons for these
failures: the barriers posed by user fees, the lack of specialised
The incidence of TB among healthcare workers is much
facilities and services such as blood banks, no provision for
higher in developing countries than in developed countries.
tackling emergencies in obstetrics, and an imbalance in the
The prevalence of latent and active TB is much higher among
geographical distribution of services. Further, in the PPP model
healthcare workers than in the general population in the same
the balance of power between the public and the private
area. Isoniazid preventive therapy (IPT) is recognised as an
partners is often tilted in favour of the latter, and the former
essential component of TB infection control. IPT programmes
becomes a marginal player. This adversely affects service
targeted at younger healthcare workers have worked better to
delivery. Regular assessments have not been conducted
prevent active TB.
for most PPPs, and there is a lack of transparency as to their
This paper suggests that tuberculin skin testing of doctors and effectiveness. The article stresses the urgent need for regular
nurses be done on an annual basis. Those who have contracted and proper evaluation of the nature and quality of PPPs before
the disease can be started on a dose of IPT after ruling out they are replicated by other states. It also calls attention to the
active TB disease. Preventive therapy should be monitored by need for these systems to be accountable to the general public.
experienced doctors and follow-up should be regularly done,
Ravindran STK. Public-private partnerships in maternal
with monitoring for adverse reactions to treatment. Further,
maintaining hygiene, ventilating TB wards, and isolating TB health services. Econ Pol Wkly. 2011 Nov 26-Dec 2:43-52.
patients would go a long way in controlling the spread of TB.
Change needed in medical examination formats
Raj R, Prasad H, Arya BK, Bhattacharya SD. Isoniazid There is much discussion on the need for revamping the
preventive therapy programmes for healthcare workers
current medical education sector in India. The authors discuss
in India: translating evidence into policy. Natl Med J India.
concerns related to the use of true/false examination formats
2011;24(4):101-7.
to assess the knowledge of students in medical examinations.
They point out that when candidates choose the answer
Somalias struggle for basic healthcare from two options, there is a high probability of guesswork
This report paints a grim picture of the realities faced by Somalis being used. This considerably reduces the reliability of the
and the helplessness of international aid organisations working test and the assessment of the real knowledge of the student.
in conlict zones. The civil war raging in Somalia since 1991 The authors suggest that even awarding negative marks for
has impoverished the country so much that even basic health incorrect answers may not resolve the problem; punishments
services are a luxury. The drought in the region has pushed the do not aid in modifying behaviour and may instead add to
population further into a state of despair. Migration, fuelled by students confusion about their performance. The true/ false
the conlict, to neighbouring countries and to relatively stable question answer format rewards students for taking risks,
areas within the same country, has resulted in overcrowded which is unwarranted. The system also fails to understand the
refugee camps which act as a hotbed for infectious diseases. ability of the student to judge and resolve a particular clinical
Emergency assistance is always delayed. The health system is situation.
in a shambles and the lack of routine surveillance data makes
the implementation of preventive and control measures all Alternative systems of assessment such as the Single Best
the more dificult. The efforts of international agencies are the Answer (SBA) and Extended Matching Items (EMI) systems
only source of support in the area. There is an urgent need for are also discussed in the article. Both these systems provide
people to overcome political differences and mistrust, and a greater number of options to choose from, which reduces
reach out to a nation and her people who are struggling for the probability of guesswork. They test students cognitive
their survival and basic human rights. abilities better. They also distinguish between high and low
performers more accurately. While the true /false method
Carbol JC. War, drought, malnutrition, measles- a report has the advantage of covering a lot of content with fewer
from Somalia. N Engl J Med. 2011 Nov 17;365(20):1856-8. questions it is also less reliable and fails to capture the level of
understanding of the student.
Public-private-partnerships in maternal healthcare
Madawa C, Margery D, Gominda P. Assessment of medical
Healthcare policy in India encourages the public-private-
knowledge: the pros and cons of using true/false multiple
partnership (PPP), with the state or no-proit agency tying up
with a private/proit-making agency to disburse healthcare. choice questions. Natl Med J India. 2011;24(4):225-8.
The National Rural Health Mission speciically talks about
the importance of such schemes. States have entered into Confidentiality, autonomy and beneficence
different partnerships to provide tertiary and specialised care. The case study and commentaries look into the issue of
The PPP may be set up as a contract, as a voucher scheme, or conidentiality and its breach in the patients best interests.
as networks and social franchises between partners. In the area It describes the decision of a patient to undergo surgery in
[ 67 ]
another country against her physicians strict instructions, the patients safety should be the primary concern. They also
in the hope that this will improve her quality of life. To note that it is necessary to consider the relationship between
complicate matters further, the eficacy of the procedure has the physician and the patient. Lantos and Gowda also suggest
not been fully proven. Now back in her home country, with an alternative: the therapist can reveal the information to the
her original physician, she chooses to disclose the information physician who can make necessary alterations in the treatment
to the physical therapist of the medical team treating her. regime and not inform the patient about the disclosure. The
The therapist now faces the dilemma of whether or not to best route would be to encourage the patient to reveal the
reveal this information to the treating physician. Revealing information to her treating doctor, or take her consent to reveal
this information may breach the conidentiality of the patient. the information to the physician.
However, not revealing it may cause complications in the
treatment and harm the patient. Lalibert M argues that the Lalibert M, Lantos JD, Gowda S. Confidentiality and its
decision of the patient to withhold the information from limits. Should one member of a medical team keep a
her physician should be respected if there are no imminent patient secret from the rest? Hastings Cent Rep. 2011 Nov-
and life-threatening complications that could arise out of Dec;41(6): 12-3.
the foreign procedure and if the patient is competent to take
the decision to undergo that procedure. The author further Contributions from Bhasyati Sinha, Rakhi Ghoshal,
points out that a breach of conidentiality would endanger the
Divya Bhagianadh, Mahua Ray and Sweta Surve
patients trust in the medical team and could force the patient
to discontinue her treatment altogether. Lantos JD and Gowda Compiled by Divya Bhagianadh
S suggest that the foreign treatment might warrant certain
changes in the present treatment plan and in such a scenario, e-mail: drdivyabhagianadh81@gmail.com
Join IJME on FaceBook and Twitter
As we move into the 20th year of publication, we plan to use social media to engage more actively with our
readers and supporters. We have initiated a Facebook group (http://www.facebook.com/groups/IndJMedEthics/)
which will be used as a platform to discuss the content from the journal and issues of relevance to bioethics in our
context. We urge our readers who are on Facebook to join the group and initiate and participate in the discussions.
We also now have a Twitter account: @IndJMedEthics; please follow us to get regular updates on journal content
and news of interest in bioethics.
[ 68 ]
LETTERS
Universal Immunisation Programme In 2000, I had stated, Checking of HBs Ag status is not a
This refers to a very thought-provoking article by Jayakrishnan very expensive or dificult procedure. If it is checked for the
(1). I fully agree with the statement, Immunisation matters are prospective marriage partners, the problem of horizontal and
left to manufacturers and international organisations, to guide later vertical transmission of the virus to the new born can be
and decide what is to be introduced in our market.(1). eradicated (6).
There is an acute need to protect adolescents and young adults I had emphasised the importance of blood testing by stating: If
from the economically poor sections against pertussis and a person is already infected, administration of the vaccine (by
diphtheria. In 2008, the Indian Academy of Pediatrics Committee routine schedule) will not alter the course of the disease. The
on Immunisation (IAPCOI), in the consensus recommendations infected person may act as a source of infection, while having
on immunisation, stated: There is no reason to believe that the false assurance that he or she has been immunised against
the disease burden of pertussis is low in adolescents in India. A hepatitis B disease(6). This point was raised since, sometimes,
safe and eficacious vaccine is available. The IAPCOI , therefore, hepatitis B vaccination is carried out as a campaign, providing
recommends offering Tdap vaccine instead of Td/TT vaccine in vaccine free or at subsidised cost.
all children/adolescents who can afford to use the vaccine (2). I fully agree with Dr Jayakrishnans views that the national
Tdap contains acellular pertussis antigen, and is very expensive vaccination policy should be disease-oriented. In addition,
(MRP Rs 699) while Td costs Rs 10.08 only. In 2006, the author it needs to be stressed that tuberculosis, measles, polio,
and a colleague had suggested the use of a reduced quantity diphtheria, tetanus, pertussis, and typhoid should be given
of the whole cell pertussis component (3). priority before including hepatitis B, haemophilus b inluenzae,
Adolescents and young adults belonging to the weaker pneumucoccal and varicella diseases in the National
economic groups are more prone to infections, but they would Immunisation Programme.
not be able to afford such a costly vaccine. On November 5, References
2008, this author had written to the Serum Institute of India, 1. Jayakrishnan T. Newer vaccines in the universal immunisation
a leading vaccine manufacturer, with copies to the convener, programme. Indian J Med Ethics. 2011 Apr - Jun;8(2):107-12.
IAPCOI and other functionaries of the IAP, to take the initiative 2. Indian Academy of Pediatrics Committee on Immunisation (IAPCOI).
Consensus recommendations on immunisation 2008; Indian Pediatr.
and come out with a combination vaccine of tetanus with 2008 Aug; 45(8):635-48.
reduced quantity of diphtheria and whole cell pertussis 3. Paul Y, Marwah P. Immunisation in adolescents. In Recent Advances in
components. This is needed for the masses that also need Pediatrics, Special Volume 17, Adolescence Gupta S, Bhave SY, , editors.
protection against pertussis but cannot afford the current Tdap New Delhi: Jaypee Brothers Medical Publishers (P) LtdIndia;2006:356-
70.
vaccine. There was no response from any one. 4. Paul Y. Legacy of Jenner and Pasteur needs to be carried forward. Journal
of Pediatric Sciences [Internet]. 2010;5;e43 JSP1 to JPS6. Available from:
However, the drug manufacturers alone are not at fault. Under http://www.pediatricsciences.com/ojs/index.php?journal=jps&page=a
the existing system, tetanus toxoid with reduced quantities rticle&op=view&path%5B%5D=131
of diphtheria antigen and whole cell pertussis antigen is 5. Universal Hepatitis B vaccination. In National Coordination Committee,
considered as a new molecule, and needs to be studied afresh Jan Swasthya Abhiyan. New technologies in public health-who pays and
who beneits? JSA. 2007 Jan; 41-57.
for safety and eficacy before even applying for a licence. All
6. Paul Y. Is Hepatitis B immunisation necessary for all? Indian J Pract
this would require heavy investment, while the permitted price Pediatr. 2000;2:188.
cannot exceed that of the DTP vaccine. This will discourage
any manufacturer to go for a vaccine which may be the need Yash Paul, Consultant paediatrician, A-D-7, Devi Marg, Bani Park,
of the hour but is bound to act as a loss incurring venture. The Jaipur 302 016, INDIA, email: dryashpaul2003@yahoo.com
solution to bail out industry should come from the authorities
and the medical profession.(4) Regarding the administration
of hepatitis B vaccine, I quote from a 2007 publication of Jan
Swasthya Abhiyan which maintains Considering the low
prevalence of hepatitis B, and the resource constraints, this
vaccine should be limited to babies born to hepatitis B+
mothers. For this purpose, all pregnant women should undergo
testing for Hepatitis B as part of other tests for anaemia and Saving lives, or styling them?
blood grouping. This does not require any additional effort The past few years have witnessed the rise of highly publicised
or equipment and the test kit can be bought in bulk by the lifestyle drugs. They are used to alter our appearance, physical
government for, say Rs 15-20. (5). and mental capabilities, the effects of aging, and so on. As the
[ 69 ]
availability of a treatment can convert a lifestyle wish into a Department of Community Medicine, Government Medical
health need, the pharmaceutical industry becomes a key player College, Calicut 673 008 Kerala, INDIA e-mail: jayanjeeja@yahoo.
in the process of medicalisation, where normal conditions get co.in
pathologised.
It appears that when drug therapy is available, physicians are

less willing to consider non drug treatments, even when there
is no evidence that the former is superior (1). One reason is
the pressure from the pharmaceutical industry. One example is
the use of Orlistat for treating obesity. Although people taking
Orlistat lose a little more weight than those controlling their Ethics in animal experiments
dietary intake (about 8.9% with pharmaceutical aids vs. 5.6 %
Ethics is very important to any research. Authors are expected
with placebo over 1 year), there is no evidence that the drug
to report if the research was done in an ethical manner. Various
is any more effective than diet in reducing the morbidity and
studies have highlighted the fact that reports of research
mortality due to obesity(2). Orlistat is available in India and
involving human participants do not always give adequate
the prices range from Rs 95 to 390 for 10 tablets. Its reported
information on ethical aspects of the study, such as how
adverse drug reaction (ADR) varies from mild to severe like
informed consent was obtained, and details of the ethics review
oily spotting, increased bowel movements, abdominal pain,
(1-3). This has been reiterated in studies on articles published in
headache, rashes and severe liver damage (3).
Indian medical journals (4-6).
A number of anti-aging drugs are now available in the market.
While reporting of ethical parameters in clinical studies is
One of them is Botulinum toxin type A, used for ironing the
discussed widely, the issue of ethical reporting in animal
wrinkles on the face and neck. It can produce paralysis of the
studies seems to have been ignored.
small muscles of the face by blocking cholinergic transmission
(4). The present study was designed with the primary aim of
analysing the reporting of ethical parameters in animal
While there is doubt about the beneits of many modern
studies published in Indian journals. The secondary aim was to
lifestyle drugs, there are also concerns about how the compare the reporting of ethical parameters between Indian
pharmaceutical market operates. Drug development is often and international journals. Most animal studies are published
driven by potential proitability rather than by public health in pharmacology journals. Studies published in two leading
needs. Once a drug is available, industry campaigns may seek indexed pharmacology journals, Indian Journal of Pharmacology
to redeine the illness in the minds of doctors and potential (IJP) and Indian Journal of Physiology and Pharmacology (IJPP),
patients, converting wishes into healthcare problems that were selected for the study. The British Journal of Pharmacology
require treatment. (BJP) was selected as a comparator international journal.
In India where preventable and treatable diseases like malaria All the articles published in IJP and IJPP between 2002 and Jan
and tuberculosis thrive and kill millions of people and many March issue of 2010 were downloaded from the journals
new diseases emerge without any known treatment, the drug websites (www.ijp-online.com, www.ijpp.com). Animal
development is skewed towards unimportant lifestyle drugs. studies published in BJP from 2002 to September 2009 were
The increasing use of lifestyle drugs raises, among several downloaded from the journals website (http://onlinelibrary.
others, one pertinent question: are we trying to homogenise wiley.com/journal/10.1111/%28ISSN%291476-5381). In the
society? There is a need to study the concept and impact of case of BJP, articles published after September 2009 were not
these drugs on society particularly in India. India needs to available for open access. As for IJPP, articles published since
focus more on life saving and essential medicines rather than 2002 were available on the website. So, to maintain uniformity,
lifestyle drugs. In a free market system, proits may not be the all articles published in or after 2002 were downloaded. Only
best indication of what drugs we need as a society. original animal studies were considered for the study. Short
communications, research letters and letters to the editor were
References not taken into account. Of the studies downloaded, 50 animal
1. Everitt DE, Avorn J, Baker MW. Clinical decision-making in the evaluation studies each from IJP and IJPP were selected randomly (by
and treatment of insomnia. Am J Med 1990;89:357-62.
computer-generated random numbers) and 100 animal studies
2. Therapeutic letter. New drugs V [Internet]. Therapeutics initiative.
2000 Apr 13 [cited 2011 Dec 30]. Available from: www.ti.ubc.ca/pages/ were selected randomly from BJP by the irst author. For equal
letter34.htm comparison, animal studies only related to pharmacology were
3. US National Library of Medicine. Orlistat: MedlinePlus drug information downloaded from IJPP. Each author evaluated these animal
[cited 2010 Sep 10]. Available from: http://www.nlm.nih.gov/
studies on the basis of reporting of animal ethics committee
medlineplus/druginfo/meds/a601244.html
4. Jeeja MC. Botulinum toxin. Its cosmetic applications. Paper presented approval and reporting of ethical guidelines. Discrepancies in
during CME on Cosmoceutical pharmacology at Medical College evaluation were resolved by consensus.
Thrissur. 2009 Oct 23.
Values were shown in the form of frequencies, and comparison
Jeeja MC, Department of Pharmacology, Jayakrishnan T, between various ethical parameters between the Indian
[ 70 ]
journals (IJP, IJPP) and the international journal (BJP) was done 8. Bavdekar SB, Gogtay NJ, Chavan R. Reporting ethical processes:
with the help of Chi Square test through excel sheet. survey of instructions to authors provided by Indian journals. Indian
J Med Sciences. 2009 Jun;63(6): 260-2.
Our study revealed that 79% of animal studies published in
the two Indian journals reported permission from an ethics
Jaykaran, Assistant Professor, Department of Pharmacology,
committee, which is more than the comparator international
Government. Medical College, Surat 395 001 INDIA e-mail:
journal (62% in BJP). Information related to various guidelines
drjaykaran@yahoo.co.in Preeti Yadav, Associate Professor,
was reported more often in BJP (58%) as compared to the
Department of Pharmacology, Government Medical College, Surat
Indian journals (38%). Regarding ethics committee approval
395 001 INDIA N D Kantharia, Professor and Head, Department of
and information related to ethical guidelines, there was no
Pharmacology, Government Medical College, Surat 395 001 INDIA
signiicant difference between the two journals.
Our indings show that reporting of ethical parameters such
as institutional ethics committee approval is better in animal
studies published in Indian journals as compared to clinical
studies published in Indian journals. In a study by Chaturvedi
et al of articles published in the Indian Journal of Psychiatry, it
was observed that permission from an ethics committee was
reported in 25% of the articles (5). In a similar study undertaken Bridging the ethics gaps
for articles published in two Indian paediatrics journals, Sir, I have already collected 15 cases in my research project,
permission from an ethics committee was reported in 29.5% of and have not taken consent from any of the participants.
the articles (4). What should I do now? asked a postgraduate student in an
In a new guideline ARRIVE (Animal Research: Reporting In Vivo ethics committee meeting that I happened to be attending,
Experiments) for reporting animal studies, authors of articles several years ago. Promptly came the reply from the head of
reporting research are instructed to report on: the nature of the institution, who also happened to be the chairperson of
ethics review permission; the relevant licence, and the national the ethics committee there: No problem, just go to any patient
and institutional guidelines related to the care and use of who is admitted in the ward and take his thumb print on the
animals (7). This study shows that though reporting of ethical consent form. This encounter rudely awakened me to the
parameters is better in animal studies as compared to clinical huge gap between knowledge and practice in medical ethics.
studies, there is room for improvement and authors should be
encouraged to report these ethical parameters in the articles. In keeping with the advances in medical technology, the world
has moved forward in the area of bioethics, but in India we are
Though efforts have been made by journal editors towards still rooted in outdated concepts. In the four and a half year
improving the reporting of ethical parameters (8), there is MBBS course, students cover a very limited ethics syllabus,
a need for more in animal as well as clinical studies. Young inadequate in todays context. The course content in ethics
researchers and students working in the ield of biomedical at the undergraduate level stresses deontological theories
research involving animal studies should be trained in ethical and lacks in applications or skill development. The focus is
aspects of research while conducting experiments and on the doctor-patient relationship, issues of negligence and
reporting the same in publications. Journal editors and peer
the Consumer Protection Act. In other words, medical ethics
reviewers should make sure that information regarding ethical
is taught on the premise that the law is breathing down a
parameters is incorporated in the manuscript.
medical practitioners neck and one should be careful not to
References cross the legal boundary.
1. Ruiz-Canela M, Gomez-Gracia E. Informed consent and approval by
institutional review boards in published reports on clinical trials. N Engl The past decade has seen an astronomical rise in clinical
J Med. 1999 Apr 8;340:1114-5. research in India. The lure of money that has inevitably
2. Yank V, Rennie D. Reporting of informed consent and ethics committee accompanied this has not only attracted human participants
approval in clinical trials. JAMA. 2002 Jun 5;287:2835-8.
3. Schroter S, Plowman R, Hutchings A, Gonzalez A. Reporting ethics
from vulnerable populations, as research participants, but also
committee approval and patient consent by study design in ive general many graduates of medicine or related disciplines, who decide
medical journals. J Med Ethics. 2006 Dec;32 (12):718-23. to engage in a career in clinical research. Many of them come
4. Bavdekar SB, Gogtay NJ, Wagh S. Reporting ethical processes in two from disciplines like homeopathy, and other Indian systems
Indian journals. Indian J Med Sci. 2008 Apr;62 (4):134-40.
5. Chaturvedi SK and Somashekar BS. Reporting ethical aspects in
of medicine, besides allopathy. These youngsters lack the
published research articles in the Indian Journal of Psychiatry. Indian J exposure to and competence in research ethics. Even principal
Psychiatry. 2009 Jan - Mar;51(1):34. investigators of clinical trials are not well grounded in the basic
6. Jaykaran, Gohiya S, Gohiya V, Sharma G, Saurabh MK,Yadav P. Reporting of issues of research ethics. Often, ethics committees, which give
the methodological quality and ethical aspects in clinical trials published
in Indian journals: a survey. J Pharm Research.2010 Mar;3(2):307-9.
ethical clearance to myriad clinical research protocols involving
7. Kilkenny C, Browne WJ, Cuthill IC, Emerson M, Altman DG. Improving human subjects, lack qualiied or even knowledgeable
bioscience research reporting: The ARRIVE guidelines for reporting members.
animal research. PLoS Biol. 2010 Jun;8(6):e1000412. doi:10.1371/journal.
pbio.1000412. The undergraduate curriculum should be covering areas
[ 71 ]
of skill-building in ethics such as identifying ethical issues Through a nurses eyes

and violations, and focusing on remedies and ethical I sincerely appreciate the editorial Life and Death after Aruna
case resolutions. Currently, this is not being done. At the Shanbaug written by Dr Roop Gursahani in the Indian Journal
postgraduate level, ethical deliberations, end-of-life decisions, of Medical Ethics (IJME) dated April-Jun 2011. The editorial is
ethical conlicts resolution and clinical ethics consultation are very well written and articulated and the author has very aptly
not touched upon. discussed every part of the judgment delivered by Justices
Markandey Katju and Gyan Sudha Misra of the Supreme Court
To bridge this gap, the Centre for Ethics was established
of India. I would like to add that had the euthanasia plea been
by Yenepoya University, in Mangalore, Karnataka. The irst
granted it would have led not only to intense resentment
programme launched by the Centre was the Postgraduate
among all the doctors and nurses of KEM hospital, but would
Diploma in Bioethics and Medical Ethics, a year-long course
have opened a new avenue for unscrupulous people in our
with six contact programmes, supplemented by projects,
society, who for the sake of property and money, could go
online assignments and group discussions, culminating in a to the extent of getting their parents and relatives killed by
summative written exam. The course exposes the student to bribing and conspiring with unethical, and greedy doctors.
the basics of ethics, morality, theology and philosophy and Hence, there are strong chances of euthanasia being prone to
their inter-relatedness in healthcare, technology and research misuse. Moreover, there may be a cure in future for a medical
involving human subjects. The main objective is to train state perceived as incurable today. I strongly oppose the plea
enough people in the basics of healthcare and research ethics by Ms.Pinki Virani. One must understand that in all these
issues so as to do justice to their positions on institutional years, the nurses caring for her have not tired, but in fact, feel
ethics committees or as members of clinical research teams. greatly privileged to care for her. Why, then, should the views
of a third party, who has not even cared her for a single day, be
In 2011, the Centre signed a memorandum of understanding
considered? .Hence, there is no point in worrying unnecessarily
with the Department of History, Philosophy and Ethics in
about Aruna, writing a book on her life story, or even paying
Medicine at the Johannes Gutenberg Medical University,
visits to her, as all these things cannot be a substitute for the
Mainz, Germany, and another with the Duquesne University,
high quality, holistic nursing care being rendered to her by our
Pittsburgh, USA. These collaborations promote staff and
fellow nurses working ceaselessly day and night. I must agree
student exchange and take up joint research ventures in the
with Dr Sanjay Oak, Dean, KEM Hospital, when he said , in his
ield of trans-cultural clinical ethics. The six-month certiicate testimony, I must put on record that in the world history of
course in clinical ethics consultation conducted by our centre medicine there would not be another single case where such
utilises the services of the faculty members of both these a person is cared and nurtured in bed for 33 long years and has
universities. Two one-week long intensive contact programmes not developed a single bed sore. This speaks volumes of the
in each trimester are supplemented with online assignments excellence of nursing care that KEM nursing staff has given to
and group discussions. This is designed to train participants in her (1). Once again I salute the spirit of all the nurses of KEM
the basics of ethics, its applications in healthcare and how to Hospital, Mumbai.
conduct a clinical ethics consultation. The objective is to bring
Reference
into India the concept of clinical ethics consultation that will
1. Ibnlive.com. Full text: Supreme Courts judgment on Aruna Shanbaug
have an impact on the ethics of healthcare practices in our euthanasia petition. IBN Live [Internet].2011 May 18[cited 2011 Dec
country. 13]. Available from: http://ibnlive.in.com/news/full-text-supreme-
courts-judgment-on-aruna-ramachandra-euthanasia-petition/145201-
Vina Vaswani, Director, Centre for Ethics, Professor and Head, 53.html
Department of Forensic Medicine and Toxicology, Yenepoya Radha Saini, Head, Dept. of Community Health Nursing, Rayat
University, Deralakatte, Mangalore 575 018 Karnataka INDIA e- and Bahra College of Nursing, Sahauran village, Mohali, Punjab
mail: bioethics@yenepoya.edu.in 140 104 INDIA e-mail: radha_s26@yahoo.co.in
[ 72 ]
CLINICAL TRIALS WATCH
This issue of the Clinical Trials Watch provides data exclusively settings in highly urbanized cities as compared to other cities
on trials that were registered in the Clinical Trials Registry of in India. This may be due to the infrastructural facilities, higher
India (CTRI) during the year 2010. The factsheet was prepared patient population or ease of access to healthcare facilities
with a manually created database using data retrieved from that these cities are endowed with. This makes it preferable
the CTRI website. However, as cautioned in the previous issue of to conduct trials in these Class A cities as compared to other
Clinical Trials Watch, the data is subject to the dynamic nature areas. Other independent research conducted at the CSER
of the CTRI website, which allows users to add, edit and remove indicates a migration of trial settings from Class A to Class B
records. and Class C cities.
The data was collected from October to November, 2011, using Table 1. Trial status v/s Sponsor type
search functions available in the CTRI website and identifying Trial status Sponsor type
the trials that were registered in CTRI during 2010. Private Non-proit Public Unknown
Not yet recruiting 52 4 18 8
A new development in this issues factsheet is the introduction
Not applicable 62 0 0 0
of classiication of cities in which the trials are being conducted.
Completed 195 8 20 20
The classiication scheme used here is a modiied version of
Suspended 8 0 0 0
the system developed by the Government of India (Ministry
Open to recruitment 203 6 46 9
of Finance) for the classiication of cities/towns on the basis
Other/terminated 11 0 0 0
of 2001 Census (No.2(21)/E.II.(B)/2004). In the modiied Total 531 18 84 37
classiication scheme used for this factsheet, we have only used
one criterion- the House rent allowance parameter, to classify Table 2. City type v/s Trial Phase
the cities. Also, we have considered the Class A and A-1 cities as City type Trial Phase
Class A which include metros and highly urbanised cities and Phase I Phase II Phase III Phase IV N/A
Class B-1 and B-2 cities as Class B which include medium sized Class A 62 371 1645 641 162
cities and the Class C cities as Class C which include smaller Class B 12 68 437 167 36
towns. Others which are not listed are counted as Unknown. Class C 6 27 118 28 12
Unknown/other 8 52 251 219 44
Among the 670 trials registered in CTRI in 2010, 88% of the Total 88 518 2451 1055 254
trials were sponsored by private organizations, most of them
being pharmaceutical companies (Table 1). This is indicative Table 3. Sponsor type v/s City type
of the dominance of pharmaceutical companies on the clinical Sponsor type City type
trials scene in India. Class A Class B Class C Unknown
Non-proit 32 12 14 1
Phase III trials occupied the highest percentage (56%) of total Private 2688 577 277 559
trial settings registered in 2010. Among these trial settings, Public 116 19 7 19
67% were set in Class A cities (Table 2). These cities are highly Unknown 30 2 3 10
urbanised and include all the metro cities in India. Total 2866 610 301 589
Among these trial settings, a substantial proportion (94%) was

privately funded trials (Table 3).
Compiled by: Vivian David Jacob, Deapica Ravindran, Kinjal
The data suggests a general trend of large number of trial Ved, Centre for Studies in Ethics and Rights, Mumbai
[ 73 ]

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ENTERING OUR 20TH YEAR

Hunger, ethics and the right to food

FROM THE PRESS ...................................................................................................................................................................................................................................10

IJMEs 20th year: some new directions

The broadening of horizons around bioethics

Bioethics training and international case studies

Research similar to that described in the case study

The perils of ignoring history

Learning from history and ethics cases

MCIs VISION 2015 and PG medical selection: continuing to produce square

Objectivity -- but at what cost?

VISION 2015 does it provide any solutions?

Well-planned methods of selection in other countries

FROM THE PRESS

Horror in hospital from: http://news.in.msn.com/national/article.aspx?cp-

Initially it was suspected that carbolic acid was used to rub

Surviving an archaic test

International collaborative trials, placebo controls and The Declaration of

Abstract countries is of interest to pharmaceutical companies. These

Less equal than others? Experiences of AYUSH medical oficers in primary

Abstract indigenous to different cultures, whether

Continuing oversight through site monitoring: experiences of an institutional

Abstract monitoring. Additionally, and perhaps as relevant, is the fact

Appendix1: Site monitoring visit report Is it approved by the IEC? Comment:

No. of participants approved at site by IEC: ______ o Yes o No

Total participants recruited since protocol began: ______

No. of patients screened: ____ Any SAEs found? Comment:

No. of patients enrolled: ____ o Yes o No

No. of patients completed: ____

No. of patients who withdrew consent: ____ (State reasons) o Yes o No

No. of patients withdrawn by PI: ____ (State reasons) o Yes o No

from all patients? o Yes o No

Thank you, reviewers

Finding and using evidence that you can trust

Abstract The least biased evidence that addresses these issues

Hunger, ethics and the right to food

Attempts at regulation of medical education by the MCI: issues of unethical

Introduction resources to invest for this purpose Many of these private

Unhealthy practices in evaluation Conclusion

Disability certiicates in India: a challenge to health privacy

Abstract and marks a signiicant change in attitudes and approaches

Consent Supported admissions

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major cities participated. Most of these hospitals provided

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Observational research where it is most needed

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A Film on Clinical Ethics

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William Oslers medical ethics in the 21st century

Book review: Back to the future

Director VACHAN, Nashik 422 002 INDIA e-mail: dhrvmankad@gmail.com

Film review: Medical students as guinea pigs

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It appears that when drug therapy is available, physicians are

of skill-building in ethics such as identifying ethical issues Through a nurses eyes

CLINICAL TRIALS WATCH

Among these trial settings, a substantial proportion (94%) was