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RESEARCH PROPOSALS
( Indian contest )
Adopted by
Dr.T.V.Rao MD
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Dr.T.V.Rao MD
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Dr.T.V.Rao MD
Ethical guidelines
The Ethical guidelines for biomedical
research on human participants prepared
by the Indian Council of Medical Research
in 2006 came as a welcome step in the
process of regulation of search on human
subjects, since clear cut Indian guidelines
were absent earlier
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Declaration of Human
Rights (adopted by the
General Assembly of the
United Nations)
expressed concern about
rights of human beings
being subjected to
involuntary
maltreatment
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Helsinki Declaration
Based on the preliminary efforts
of the Council for International
Organisations of Medical
Sciences (CIOMS) in 1964 at
Helsinki, the World Medical
Association formulated general
principles and specific
guidelines on use of human
subjects in medical research,
known as the Helsinki
Declaration, which was revised
from time to time.
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biomedical research on
human participants" prepared
by the Indian Council of
Medical Research in 2006
came as a welcome step in the
process of regulation of
research on human subjects,
since clear cut Indian
guidelines were absent earlier
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been accepted as
the standard
operating manual by
Institutional Ethics
Committees (IEC) in
India
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GENERAL PRINCIPLES
The welfare of the individual has to be balanced
against the welfare of the community and
society at large. The C.I.O.M.S / W.H.O
Guidelines for Epidemiological Research
assume that the individuals or populations
being studied are capable of giving informed
consent understanding the implications of the
study.
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Regime of EVALUATION
Such research must be subjected to a regime of
EVALUATION at all stages of the proposal i.e., research
design and experimentation, declaration of results and use
of the results thereof, and that each such evaluation shall
bear in mind the objects to be achieved, the means by
which they are sought to be achieved, the anticipated
benefits and dangers, the potential uses and abuses of the
experiment and its results, and above all, the premium that
civilised society places on saving and ensuring the safety of
each human life as an end in itself.
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COMPOSITION of Ethical
Committee
The IECs should be
multidisciplinary and multi
sectorial in composition.
Independence and
competence are the two
hallmarks of an IEC. The
number of persons in an
ethics committee should be
kept fairly small
(8 - 12 members).
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Eligible to be a Chairman
The IEC should appoint from
among its members a
Chairman who should be
from outside the Institution
and not head of the same
members or Institute not
head of the same Institution
to maintain the
independence of the
Committee.
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SUBMISSION OF APPLICATION
The researcher should submit an application in a prescribed
format along with the study protocol as prescribed in SOP of
IEC concerned. The protocol should include the following : 1. The title with signature of Principal Investigator (PI) and
Co investigators as attestation for conducting the study.
2. Clear research objectives and rationale for undertaking the
investigation in human participants in the light of existing
knowledge
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SUBMISSION OF APPLICATION
3. Recent curriculum vitae of the Investigators indicating qualification
and experience.
4. Participant recruitment procedures and brochures, if any.
5. Inclusion and exclusion criteria for entry of participants.
6. Precise description of methodology of the proposed research,
including sample size (with justification), type of study design
(observational, experimental, pilot, randomized, blinded etc.),
intended intervention, dosages of drugs, route of administration,
duration of treatment anddetails of invasive procedures if any.
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SUBMISSION OF APPLICATION
7.Plan to withdraw or withhold standard therapies in the course of
research.
8.Plan for statistical analysis of the study.
9.Procedure for seeking and obtaining informed consent with sample
of patient information sheet and informed consent forms in English
and local languages.
10. Safety of proposed intervention and any drug or vaccine to be
tested, including results of relevant laboratory, animal and human
research.
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SUBMISSION OF APPLICATION
11. For research involving more than minimal risk, an
account of
management of such risk or injury.
12. Proposed compensation and reimbursement of
incidental expenses and management of research related
and unrelated injury/ illness during and after research
period.
13. An account of storage and maintenance of all data
collected during the trial
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SUBMISSION OF APPLICATION
14. Plans for publication of results - positive or negative - while
maintaining
the privacy and confidentiality of the study participants.
15. A statement on probable ethical issues and steps taken to tackle the
same like justification for washout of standard drug, or the use of placebo
control..
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SUBMISSION OF APPLICATION
17.Agreement to comply with national and international Good Clinical
Practices (GCP) protocols for clinical trials.
18. Details of Funding agency/ Sponsors and fund allocation.
19. For international collaborative study details about foreign collaborators
and documents for review of Health Ministry's Screening
Committee(HMSC) or appropriate Committees under other
agencies/authority like Drug Controller General of India (DCGI)
20. For exchange of biological material in international collaborative study
aMoU/ Material Transfer Agreement between the collaborating partners.
21.A statement on conflict-of-interest (COI), if any.
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Cohort Studies
These are longitudinal or prospective studies of a group of
individuals with differing exposure levels to suspected risk
factors. They are observed over a long period usually several
years. The rate of occurrence of the condition of interest is
measured and compared in relation to identified risk factors.
It requires a study of large number of participants for a long
time and involves asking questions, checking of records, routine
medical examination and sometimes laboratory investigations.
Individuals are being followed up as the cohort and it is
essential to identify precisely every individual to be studied.
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Waiver of consent
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I am thankful to ..
Iam thankful to The Principal, Vice
principal, Medical Director, the great
efforts of Dr Sudha and Dr Vivek and all
the members of the Ethical committee
of Azezia Medical College Kollam Kerala
for making my job easier, and inspires
me to do work ethically
Dr.T.V.Rao MD
Chairman Intuitional Ethical Committee
Azezia Medical College Kollam Kerala
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References
Ref 1 ETHICAL GUIDELINES FOR BIOMEDICAL RESEARCHON HUMAN
PARTICIPANTS, NDIAN COUNCIL OF MEDICAL RESEARCH NEW DELHI2006 ; M. S.
Valiathan Chairman Central Ethics Committee on Human Research ICMR, New
Delhi
2 ICMRs Ethical guidelines for biomedical research on human participants: need
for clarification N Ananthakrishnan, Shanthi AK ETHICS OF ETHICS COMMITTE.
Indian Journal of Medical Ethics Vol IX No 3 July - September 2012
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