E72 National Statement March 2014 141126

National Statement on Ethical
Conduct in Human Research

2007 (Updated March 2014)
Developed jointly by
National Health and Medical Research Council
Australian Research Council
Australian Vice-Chancellors Committee
Amendments Amendment details Start date
Revoke existing Chapter 2.3 New Chapter 2.3 27 March 2014
Revoke existing Chapter 3.4 and Chapter 3.6 New Chapter 3.4 11 December 2013
Revoke existing paragraph 4.1.11 New paragraph 4.1.11 28 May 2013
Details of Amendments: see National Statement Amendments Table on the NHMRC website
at: http://www.nhmrc.gov.au/guidelines/publications/e72 for a complete history of updates
to this document.
Australian Government 2007

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ISBN Print: 1864962690
Australian Government 2007

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Suggested citation
National Statement on Ethical Conduct in Human Research 2007 (Updated March 2014).
The National Health and Medical Research Council, the Australian Research Council and
the Australian Vice-Chancellors Committee. Commonwealth of Australia, Canberra.
To obtain details regarding NHMRC publications contact:
Email: nhmrc.publications@nhmrc.gov.au
Phone: Toll Free 13 000 NHMRC (13 000 64672) or call 02 6217 9000
Internet: http://www.nhmrc.gov.au
CONTENTS
CONTENTS
The National Statement : A User Guide 1
Preamble 3
Purpose, scope and limits of this document 6
Section 1 Values and principles of ethical conduct 9
Section 2 Themes in research ethics: risk and benefit, consent 12

Chapter 2.1 Risk and benefit 12
Chapter 2.2 General requirements for consent 16
Chapter 2.3 Qualifying or waiving conditions for consent 19
Section 3 Ethical considerations specific to research methods or fields 23

Chapter 3.1 Qualitative methods 23
Chapter 3.2 Databanks 27
Chapter 3.3 Interventions and therapies, including clinical and non-clinical
trials, and innovations 30
Chapter 3.4 Human biospecimens in laboratory based research 36
Chapter 3.5 Human genetics 41
Section 4 Ethical consideration specific to participants 46

Chapter 4.1 Women who are pregnant and the human fetus 46
Chapter 4.2 Children and young people 50
Chapter 4.3 People in dependent or unequal relationships 53
Chapter 4.4 People highly dependent on medical care who may be unable
to give consent 55
Chapter 4.5 People with a cognitive impairment, an intellectual disability,
or a mental illness 58
Chapter 4.6 People who may be involved in illegal activities 60
Chapter 4.7 Aboriginal and Torres Strait Islander Peoples 62
Chapter 4.8 People in other countries 65
NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED MARCH 2014) |iii
iii
CONTENTS
Section 5 Processes of research governance and ethical review 68

Chapter 5.1 Institutional responsibilities 68
Chapter 5.2 Responsibilities of HRECs, other ethical review bodies,
and researchers 74
Chapter 5.3 Minimising duplication of ethical review 78
Chapter 5.4 Conflicts of interest 79
Chapter 5.5 Monitoring approved research 81
Chapter 5.6 Handling complaints 83
Chapter 5.7 Accountability 84
Appendix: Process Report 85
Glossary 87
Index 91
iv
iv | NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED MARCH 2014)
THE NATIONAL STATEMENT: A USER GUIDE
THE NATIONAL STATEMENT:

A USER GUIDE
This National Statement on Ethical Conduct manage that risk, and (with reference to
in Human Research (National Statement) is Chapter 5.1) what level of ethical review is
intended for use by: suitable.
any researcher conducting research with Chapters 2.2 and 2.3 will help to identify
human participants; the information that needs to be disclosed
to participants. It will help researchers to
any member of an ethical review body
draft information for participants and plan
reviewing that research;
the consent process (or develop a proposal
those involved in research governance; for waiver of consent). And it will help
and reviewers to assess the suitability of the
proposed consent process.
potential research participants.
All of Section 2 will help participants
This brief guide describes the structure of the
understand what information they
document and suggests how each of these groups
are entitled to receive, and what
might use it. Note that review body refers both to
their participation in research will
Human Research Ethics Committees (HRECs) and
characteristically involve.
to non-HREC review bodies.
Section 3: Ethical considerations specific
The Preamble sets out the historical context
to research methods or fields will help
of the National Statement. This is followed by
researchers and reviewers to identify
a brief explanation of its purpose, scope and
ethical matters specific to the research
limits. The document then has five sections, with
methods proposed.
multiple chapters in Sections 2 to 5.
Section 4: Ethical considerations specific
Section 1: Values and principles of ethical
to participants will help researchers
conduct sets out values and principles that
and reviewers to identify ethical matters
apply to all human research. It is essential
relating to specific categories of research
that researchers and review bodies
participants. Participants in these categories
consider these values and principles and
will also find this Section valuable.
be satisfied that the research proposal
addresses and reflects them. Section 5: Processes of research governance
and ethical review will help those involved
Section 2: Themes in research ethics:
in research governance to understand
risk and benefit, consent discusses the
their responsibilities for research ethics
concept of risk in research and the role
and ethical review and monitoring of
of participants consent themes in all
human research, and provides criteria for
human research and is again essential
their accountability. Chapter 5.2 will help
for all users.
researchers and reviewers to identify their
Chapter 2.1 will help researchers and responsibilities in relation to the ethical
reviewers to understand and describe review of research.
the level of risk involved in the planned
research, and how to minimise, justify and
NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED MARCH 2014) | 1
THE NATIONAL STATEMENT: A USERES GUIDE
This National Statement does not exhaust the

ethical discussion of human research. Even
a single research field covers a multitude of
different situations about which the National
Statement will not always offer specific
guidance, or to which its application may
be uncertain.Where other guidelines and
codes of practice in particular research fields
are consistent with the National Statement,
researchers and members of ethical review
bodies should draw on them when necessary
to clarify researchers ethical obligations in
particular contexts.
2 | NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED MARCH 2014)
PREAMBLE
PREAMBLE
ETHICAL BACKGROUND Since earliest times, human societies have

pondered the nature of ethics and its
All human interaction, including the interaction requirements and have sought illumination on
involved in human research, has ethical ethical questions in the writings of philosophers,
dimensions. However, ethical conduct is more novelists, poets and sages, in the teaching of
than simply doing the right thing. It involves religions, and in everyday individual thinking.
acting in the right spirit, out of an abiding respect Reflection on the ethical dimensions of medical
and concern for ones fellow creatures. This research, in particular, has a long history,
National Statement on ethical conduct in human reaching back to classical Greece and beyond.
research is therefore oriented to something more Practitioners of human research in many
fundamental than ethical dos and donts other fields have also long reflected upon
namely, an ethos that should permeate the way the ethical questions raised by what they do.
those engaged in human research approach all There has, however, been increased attention
that they do in their research. to ethical reflection about human research
Human research is research conducted with since the Second World War. The judgment
or about people, or their data or tissue. It has of the Nuremberg military tribunal included
contributed enormously to human good. Much ten principles about permissible medical
human research carries little risk and in Australia experiments, since referred to as the Nuremberg
the vast majority of human research has been Code. Discussion of these principles led the
carried out in a safe and ethically responsible World Medical Assembly in 1964 to adopt what
manner. But human research can involve came to be known as the Helsinki Declaration,
significant risks and it is possible for things to revised several times since then. The various
go wrong. Sometimes risks are realised despite international human rights instruments that
the best of intentions and care in planning and have also emerged since the Second World
practice. Sometimes they are realised because War emphasise the importance of protecting
of technical error or ethical insensitivity, neglect human beings in many spheres of community
or disregard. On rare occasions the practice life. During this period, written ethical
of research has even involved the deliberate guidelines have also been generated in many
and appalling violation of human beings areas of research practice as an expression of
notoriously, the Second World War experiments professional responsibility.
in detention and concentration camps. But what is the justification for ethical research
This range of possibilities can give rise to guidelines as extensive as this National Statement,
important and sometimes difficult ethical and for its wide-reaching practical authority?
questions about research participation. Two The National Statement has been extended
considerations give further weight to those to address many issues not discussed in the
questions. First, research participants may enter previous version, or discussed in less detail.
into a relationship with researchers whom they This is in response to requests for clearer
may not know but need to trust. This trust adds guidance for those conducting research and
to the ethical responsibility borne by those those involved in its ethical review. At the same
in whom it is placed. Secondly, many who time, without compromising the protection of
contribute as participants in human research do participants, the revised National Statement
so altruistically, for the common good, without provides for greater flexibility in the practice of
thought of recompense for their time and effort. ethical review, depending on the type and area
This underscores the importance of protecting of research and the degree of risk involved.
research participants.
PREAMBLE
Research often involves public interaction In addition to this National Statement, the
between people that serves a public good. There Australian code for the responsible conduct
is, therefore, a public responsibility for seeing of research 20071 (the Research Code) has
that these interactions are ethically acceptable an essential role in promoting good research
to the Australian community. That responsibility governance. The Research Code sets down
is acknowledged and given effect in the wide- the broad principles of responsible and
reaching authority of this National Statement, accountable research practice, and identifies the
which sets out national standards for the ethical responsibilities of institutions and researchers
design, review and conduct of human research. in areas such as data and record management,
Its content reflects the outcome of wide publication of findings, authorship, conflict of
consultation with Australian communities who interest, supervision of students and research
participate in, design, conduct, fund, manage trainees, and the handling of allegations of
and publish human research. research misconduct.
Research governance Authors of this National Statement

The National Statement should be seen in This National Statement has been jointly
the broader context of overall governance of developed by the National Health and Medical
research. It not only provides guidelines for Research Council (NHMRC), the Australian
researchers, Human Research Ethics Committees Research Council (ARC) and the Australian
(HRECs) and others conducting ethical review Vice-Chancellors Committee (AVCC). This joint
of research, but also emphasises institutions undertaking reflects a widely shared conviction
responsibilities for the quality, safety and ethical that there is a need for ethical guidelines that are
acceptability of research that they sponsor or genuinely applicable to all human research; and
permit to be carried out under their auspices. it gives expression to the shared responsibility
for ethically good research described above.
Responsibility for the ethical design, review and
conduct of human research is in fact exercised at The National Health and Medical Research
many levels, by: researchers (and where relevant Council Act 1992 (NHMRC Act) establishes the
their supervisors); HRECs and others conducting NHMRC as a statutory body and sets out its
ethical review of research; institutions that set functions, powers and obligations. Section 10(1)
up the processes of ethical review, and whose of the Act requires the Chief Executive Officer
employees, resources and facilities are involved to issue human research guidelines precisely
in research; funding organizations; agencies as developed by the Australian Health Ethics
that set standards; and governments. While Committee (AHEC) and provided to the CEO by
the processes of ethical review are important the Council. AHEC is established by the NHMRC
in this field, individual researchers and the Act as a Principal Committee of the NHMRC. All
institutions within which they work hold primary the guidelines in this National Statement that are
responsibility for seeing that their research is applicable to the conduct of medical research
ethically acceptable. involving humans are issued by the NHMRC in
fulfilment of this statutory obligation.
1
This is the proposed revision of the Joint NHMRC/
AVCC Statement and Guidelines on Research
Practice (1997)
PREAMBLE
The Australian Research Council Act 2001

(ARC Act) establishes the ARC to provide
the responsible Minister with advice and
recommendations about research, including
which research programs should receive
financial assistance. The functions of the ARC
also include administering the regimes of
financial assistance for research and providing
for the funding of research programs.
The Australian Vice-Chancellors Committee
(AVCC) is the council of Australias university
vice-chancellors (or presidents). Its purpose is
to advance higher education through voluntary,
cooperative and coordinated action, and to serve
the best interests of Australias universities and,
through them, the nation. The AVCC acts as a
consultative and advisory body for all university
affairs, making submissions to public inquiries
of interest to the university sector, and preparing
statements on major issues.
PURPOSE, SCOPE AND LIMITS OF THIS DOCUMENT
PURPOSE, SCOPE AND LIMITS OF THIS

DOCUMENT
PURPOSE What is research?

The purpose of this National Statement is There is no generally agreed definition of
to promote ethically good human research. research; however, it is widely understood to
Fulfilment of this purpose requires that include at least investigation undertaken to
participants be accorded the respect and gain knowledge and understanding or to train
protection that is due to them. It also involves researchers. The British Research Assessment
the fostering of research that is of benefit to the Exercise (RAE) definition of research is
community. somewhat wider:
The National Statement is therefore designed to Research includes work of direct

clarify the responsibilities of: relevance to the needs of commerce,
industry, and to the public and voluntary
institutions and researchers for the ethical sectors; scholarship; the invention
design, conduct and dissemination of and generation of ideas, images,
results of human research; and performances, artefacts including design,
review bodies in the ethical review of where these lead to new or substantially
research. improved insights; and the use of
existing knowledge in experimental
The National Statement will help them to meet development to produce new or
their responsibilities: to identify issues of ethics substantially improved materials, devices,
that arise in the design, review and conduct of products and processes, including design
human research, to deliberate about those ethical and construction. It excludes routine
issues, and to justify decisions about them. testing and routine analysis of materials,
components and processes such as for
Use of this National Statement the maintenance of national standards,
as distinct from the development of new
This National Statement must be used to inform analytical techniques. It also excludes the
the design, ethical review and conduct of human development of teaching materials that do
research that is funded by, or takes place under not embody original research.2
the auspices of, any of the bodies that have
developed this National Statement (NHMRC, To enable comparative assessment of academic
ARC, AVCC). activity, this definition sought to include the
widest range of creative and experimental
In addition, the National Statement sets national activities. Many items in the definition are
standards for use by any individual, institution uncontentious, but there may be disagreement
or organisation conducting human research. about some for example, the invention and
This includes human research undertaken by generation of newimages, performances,
governments, industry, private individuals, artefactswhere these lead to new or
organisations, or networks of organisations. 2
Higher Education Funding Council for England,
Scottish Higher Education Funding Council,
Higher Education Funding Council for Wales, &
Department for Employment and Learning Northern
Ireland (2005) RAE 2008: Guidance to Panels, p.28.
At http://www.rae.ac.uk/pubs/2005/01/rae0105.doc,
accessed 27th October 2006
substantially improved insights since this In addition, the conduct of human research often
could count poetry, painting and performing arts has an impact on the lives of others who are
as research. not participants. When this impact is reasonably
foreseeable, it may raise ethical questions for
For the purposes of this National Statement, two
researchers and for those ethically reviewing
further questions are more important than any
research.
definition of research:
What is human research? When is ethical review needed?
When and by what means does human Institutions are responsible for establishing
research, or other activities such as quality procedures for the ethical review of human
assurance or improvement, or clinical research. That review can be undertaken at
audit, need ethical review? (See Ethical various levels, according to the degree of risk
Considerations in Quality Assurance and involved in the research (see Section 2: Themes
Evaluation Activities, NHMRC 2014) in research ethics: risk and benefit, consent, and
Chapter 5.2: Responsibilities of HRECs, other
What is human research? ethical review bodies, and researchers). Research
with more than a low level of risk (as defined in
Human research is conducted with or about
paragraph 2.1.6,) must be reviewed by an HREC.
people, or their data or tissue. Human
Research involving no more than low risk may
participation in research is therefore to be
be reviewed under other processes described in
understood broadly, to include the involvement
paragraphs 5.1.18 to 5.1.21. Institutions may also
of human beings through:
determine that some human research is exempt
taking part in surveys, interviews or focus from ethical review (see paragraphs 5.1.22 and
groups; 5.1.23).
undergoing psychological, physiological A judgement that a human research proposal
or medical testing or treatment; meets the requirements of this National
Statement and is ethically acceptable must be
being observed by researchers;
made before research can begin and before full
researchers having access to their funding for the proposal is released.
personal documents or other materials;
the collection and use of their body Ethics and law in human research
organs, tissues or fluids (eg skin, blood, Human research is governed by Australian
urine, saliva, hair, bones, tumour and law that establishes rights for participants and
other biopsy specimens) or their exhaled imposes general and specific responsibilities
breath; on researchers and institutions. Australian
access to their information (in common law obligations arise from the
individually identifiable, re-identifiable relationships between institutions, researchers
or non-identifiable form) as part of an and participants. Contractual arrangements may
existing published or unpublished source impose obligations on research funders and
or database. institutions.
The term participants is therefore used very This National Statement focuses on the ethical
broadly in this National Statement to include aspects of the design, review and conduct of
those who may not even know they are the human research. Research ethics is only part
subjects of research; for example, where the of an institutions responsibilities for research
need for their consent for the use of their tissue governance. Compliance with legal obligations
or data has been waived by a Human Research (statutory or otherwise) forms another part,
Ethics Committee (HREC). which is not within the scope of the National
Statement.
Some human research is subject to specific

statutory regulation, at Commonwealth and State
and Territory levels. The National Statement
identifies some specific Commonwealth
legislation that refers to the National Statement.
The National Statement does not identify State
and Territory laws that may be relevant to
human research, such as those relating to use of
information held by state or territory authorities,
use of human tissues, guardianship, and illegal
and unprofessional conduct.
The responsibilities set out in this National
Statement are intended to be consistent with
the international human rights instruments that
Australia has ratified.
It is the responsibility of institutions and
researchers to be aware of both general and
specific legal requirements, wherever relevant.
SECTION 1: VALUES AND PRINCIPLES OF ETHICAL CONDUCT
SECTION 1: VALUES AND PRINCIPLES

OF ETHICAL CONDUCT
INTRODUCTION Reference to these values throughout the

National Statement serves as a constant reminder
The relationship between researchers and that, at all stages, human research requires
research participants is the ground on which ethical reflection that is informed by them. The
human research is conducted. The values order in which they are considered reflects the
set out in this section respect for human order in which ethical considerations commonly
beings, research merit and integrity, justice, and arise in human research.
beneficence help to shape that relationship as
Research merit and integrity are discussed first.
one of trust, mutual responsibility and ethical
Unless proposed research has merit, and the
equality. For this reason, the National Statement
researchers who are to carry out the research have
speaks of research participants rather than
integrity, the involvement of human participants in
subjects.
the research cannot be ethically justifiable.
While these values have a long history, they
At a profound level, justice involves a regard
are not the only values that could inform a
for the human sameness that each person
document of this kind. Others include altruism,
shares with every other. Human beings have
contributing to societal or community goals,
a deep need to be treated in accordance with
and respect for cultural diversity, along with the
such justice, which includes distributive justice
values that inform Values and Ethics: Guidelines
and procedural justice. In the research context,
for Ethical Conduct in Aboriginal and Torres
distributive justice will be expressed in the
Strait Islander Health Research (NHMRC 2003).
fair distribution of the benefits and burdens of
However, the values of respect, research merit research, and procedural justice in fair treatment
and integrity, justice, and beneficence have in the recruitment of participants and the review
become prominent in the ethics of human of research. While benefit to humankind is an
research in the past six decades, and they important result of research, it also matters that
provide a substantial and flexible framework benefits of research are achieved through just
for principles to guide the design, review means, are distributed fairly, and involve no
and conduct of such research. This National unjust burdens.
Statement is organised around these values, and
Researchers exercise beneficence in several
the principles set out in paragraphs 1.1 to 1.13
ways: in assessing and taking account of
give them practical expression.
the risks of harm and the potential benefits
Among these values, respect is central. It of research to participants and to the wider
involves recognising that each human being has community; in being sensitive to the welfare and
value in himself or herself, and that this value interests of people involved in their research;
must inform all interaction between people. Such and in reflecting on the social and cultural
respect includes recognising the value of human implications of their work.
autonomy the capacity to determine ones own
Respect for human beings is the common thread
life and make ones own decisions. But respect
through all the discussions of ethical values.
goes further than this. It also involves providing
Turning to it as the final value is a reminder that
for the protection of those with diminished or no
it draws together all of the ethical deliberation
autonomy, as well as empowering them where
that has preceded it.
possible and protecting and helping people
wherever it would be wrong not to do so. The design, review and conduct of research
must reflect each of these values.
GUIDELINES 1.3 Research that is conducted with integrity

is carried out by researchers with a
commitment to:
Research merit and integrity
(a) searching for knowledge and
1.1 Research that has merit is: understanding;
(a) justifiable by its potential benefit, (b) following recognised principles of
which may include its contribution research conduct;
to knowledge and understanding,
to improved social welfare and (c) conducting research honestly; and
individual wellbeing, and to the (d) disseminating and communicating
skill and expertise of researchers. results, whether favourable or
What constitutes potential benefit unfavourable, in ways that permit
and whether it justifies research may scrutiny and contribute to public
sometimes require consultation with knowledge and understanding.
the relevant communities;
(b) designed or developed using Justice
methods appropriate for achieving
1.4 In research that is just:
the aims of the proposal;
(a) taking into account the scope and
(c) based on a thorough study of the
objectives of the proposed research,
current literature, as well as previous
the selection, exclusion and inclusion
studies. This does not exclude the
of categories of research participants
possibility of novel research for
is fair, and is accurately described in
which there is little or no literature
the results of the research;
available, or research requiring a
quick response to an unforeseen (b) the process of recruiting participants
situation; is fair;
(d) designed to ensure that respect for (c) there is no unfair burden of
the participants is not compromised participation in research on
by the aims of the research, by particular groups;
the way it is carried out, or by the
results; (d) there is fair distribution of the
benefits of participation in research;
(e) conducted or supervised by
persons or teams with experience, (e) there is no exploitation of
qualifications and competence that participants in the conduct of
are appropriate for the research; and research; and
(f) conducted using facilities and (f) there is fair access to the benefits of
resources appropriate for the research.
research. 1.5 Research outcomes should be made
1.2 Where prior peer review has judged that a accessible to research participants in a
project has research merit, the question of way that is timely and clear.
its research merit is no longer subject to
the judgement of those ethically reviewing Beneficence
the research.
1.6 The likely benefit of the research must
justify any risks of harm or discomfort to
participants. The likely benefit may be to
the participants, to the wider community,
or to both.
1.7 Researchers are responsible for: 1.12 Respect for human beings involves giving
due scope, throughout the research
(a) designing the research to minimise
process, to the capacity of human beings
the risks of harm or discomfort to
to make their own decisions.
participants;
1.13 Where participants are unable to make
(b) clarifying for participants the
their own decisions or have diminished
potential benefits and risks of the
capacity to do so, respect for them
research; and
involves empowering them where
(c) the welfare of the participants in the possible and providing for their protection
research context. as necessary.
1.8 Where there are no likely benefits to
participants, the risk to participants Application of these values and
should be lower than would be ethically principles
acceptable where there are such likely
Research, like everyday life, often generates
benefits.
ethical dilemmas in which it may be impossible
1.9 Where the risks to participants are no to find agreement on what is right or wrong.
longer justified by the potential benefits In such circumstances, it is important that all
of the research, the research must be those involved in research and its review bring
suspended to allow time to consider a heightened ethical awareness to their thinking
whether it should be discontinued or and decision-making. The National Statement
at least modified. This decision may is intended to contribute to the development of
require consultation between researchers, such awareness.
participants, the relevant ethical review
This National Statement does not exhaust the
body, and the institution. The review
ethical discussion of human research. There
body must be notified promptly of such
are, for example, many other specialised ethical
suspension, and of any decisions following
guidelines and codes of practice for specific
it (see paragraphs 5.5.6 to 5.5.9).
areas of research. Where these are consistent
with this National Statement, they should be
Respect used to supplement it when this is necessary for
the ethical review of a research proposal.
1.10 Respect for human beings is a recognition
of their intrinsic value. In human research, These ethical guidelines are not simply a
this recognition includes abiding by the set of rules. Their application should not be
values of research merit and integrity, mechanical. It always requires, from each
justice and beneficence. Respect also individual, deliberation on the values and
requires having due regard for the principles, exercise of judgement, and an
welfare, beliefs, perceptions, customs appreciation of context.
and cultural heritage, both individual and
collective, of those involved in research.
1.11 Researchers and their institutions should
respect the privacy, confidentiality and
cultural sensitivities of the participants
and, where relevant, of their communities.
Any specific agreements made with the
participants or the community should be
fulfilled.
SECTION 2: THEMES IN RESEARCH ETHICS: RISK AND BENEFIT, CONSENT
CHAPTER 2.1 : RISK AND BENEFIT
SECTION 2: THEMES IN RESEARCH

ETHICS: RISK AND BENEFIT, CONSENT
Two themes must always be considered in this section, before discussion in the following
human research: the risks and benefits of sections of ethical considerations specific to
research, and participants consent. For this different research methods and categories of
reason, the two themes are brought together in participants.
CHAPTER 2.1: RISK AND BENEFIT
INTRODUCTION Assessment of risk

The conduct of research in Australia is Assessment of risks involves:
characterised by high ethical and scientific identifying any risks;
standards, and the dangers to participants have
been few. The continued promotion of ethically gauging their probability and severity;
good human research the purpose of this assessing the extent to which they can be
National Statement will help to maintain these minimised;
standards.
determining whether they are justified by
Application of the values in Section 1, in the potential benefits of the research; and
particular the value of beneficence, requires that
risks of harm to research participants, and to determining how they can be managed.
others, be assessed. Research will be ethically Assessment of risks engages:
acceptable only if its potential benefits justify
those risks. researchers, who need to identify, gauge,
minimise and manage any risks involved
While this chapter provides guidance on the in their project;
assessment of risk, such assessment inevitably
involves the exercise of judgment. institutions, in deciding the appropriate
level of ethical review for research
projects;
What is risk?
Human Research Ethics Committees
A risk is a potential for harm, discomfort or (HRECs) and other ethical review bodies
inconvenience (discussed below). It involves: (see paragraph 5.1.7), in reviewing
the likelihood that a harm (or discomfort research proposals and making
or inconvenience) will occur; and judgements on whether risks are justified
by potential benefits; and
the severity of the harm, including its
consequences. participants perceptions of risks and
benefits. These perceptions are a factor
to be considered by review bodies in
deciding whether the risks are justified by
the benefits.
Harm, discomfort and inconvenience Examples of risks to non-participants include

the risk of distress for a participants family
Research may lead to harms, discomforts and/or member identified with a serious genetic
inconveniences for participants and/or others. disorder, the possible effects of a biography on
No list of harms can be exhaustive, but one family or friends, or infectious disease risks to
helpful classification identifies the following the community. Some social research may carry
kinds of potential harms in research3: wider social or economic risks; for example,
research in a small community into attitudes
physical harms: including injury, illness, to specific subpopulations may lead to unfair
pain; discrimination or have effects on social cohesion,
psychological harms: including feelings property values, or business investment.
of worthlessness, distress, guilt, anger or Harms that may arise from research misconduct
fear related, for example, to disclosure or fraud, and harms to members of research
of sensitive or embarrassing information, teams from other forms of misconduct (for
or learning about a genetic possibility of example, harassment or bullying) are addressed
developing an untreatable disease; primarily in the Australian code for the
devaluation of personal worth: including responsible conduct of research. These forms of
being humiliated, manipulated or in other misconduct may, of course, also lead to potential
ways treated disrespectfully or unjustly; harms to participants.
social harms: including damage to social

networks or relationships with others; Low risk and negligible risk research
discrimination in access to benefits, The expression low risk research describes
services, employment or insurance; social research in which the only foreseeable risk is
stigmatisation; and findings of previously one of discomfort. Research in which the risk for
unknown paternity status; participants is more serious than discomfort is
economic harms: including the imposition not low risk.
of direct or indirect costs on participants; The expression negligible risk research
legal harms: including discovery and describes research in which there is no
prosecution of criminal conduct. foreseeable risk of harm or discomfort; and any
foreseeable risk is no more than inconvenience.
Less serious than harm is discomfort, which can
involve body and/or mind. Discomforts include, Requirements for the ethical review of low risk
for example, minor side-effects of medication, research and negligible risk research are set out
the discomforts related to measuring blood in paragraphs 5.1.18 to 5.1.23.
pressure, and anxiety induced by an interview.
Where a persons reactions exceed discomfort Gauging risk
and become distress, they should be viewed as Gauging risk involves taking into account:
harms.
the kinds of harm, discomfort or
Less serious again is inconvenience. Examples inconvenience that may occur;
of inconvenience may include filling in a form,
participating in a street survey, or giving up time the likelihood of these occurring; and
to participate in research. the severity of any harm that may occur.
These judgements should be based on the
available evidence. The evidence may be
quantitative or qualitative. In either case, the
process needs to be transparent and defensible.
Adapted from National Bioethics Advisory Commis-
3
sion, Ethical and Policy Issues in Research Involving

Human Participants, Bethesda, 2001 pp.7172
For those gauging the severity of the harm, Managing risks

the choices, experience, perceptions, values
and vulnerabilities of different populations of When risks have been identified, gauged and
participants will be relevant. minimised, and the research has been approved,
the risks must then be managed. This requires
that:
Minimising risk
researchers include, in their research
In designing a research project, researchers design, mechanisms to deal adequately
have an obligation to minimise the risks with any harms that occur; and
to participants. Minimising risk involves
an assessment of the research aims, their a monitoring process is in place and
importance, and the methods by which they can carried out (see Chapter 5.5: Monitoring
be achieved. approved research).
Where a researcher or review body judges that The greater the risk to participants in any
the level of risk in a research proposal is not research for which ethical approval is given, the
justified by the benefits, either the research more certain it must be both that the risks will
aims or the methods by which they are to be be managed as well as possible, and that the
achieved, or both, will need to be reconsidered participants clearly understand the risks they are
if the research is to proceed. assuming.
Do the benefits justify the risks?

GUIDELINES
Research is ethically acceptable only when its
potential benefits justify any risks involved in the 2.1.1 Institutions that choose to establish levels
research. of ethical review other than by HREC for
Benefits of research may include, for example, research that carries low or negligible risk
gains in knowledge, insight and understanding, (see paragraphs 5.1.18 to 5.1.23) should
improved social welfare and individual use this chapter (i.e. Chapter 2.1) to
wellbeing, and gains in skill or expertise for inform their identification of the level of
individual researchers, teams or institutions. risk.
Some research may offer direct benefits to the 2.1.2 Risks to research participants are ethically
research participants, their families, or particular acceptable only if they are justified by the
group/s with whom they identify. Where this is potential benefits of the research.
the case, participants may be ready to assume a 2.1.3 Steps to arriving at a judgement on
higher risk than otherwise. For example, people the ethical acceptability of risks should
with cancer may be willing to accept research include:
risks (such as treatment side-effects) that would
be unacceptable to well people. Those ethically (a) identifying the risks, if any;
reviewing research should take such willingness (b) assessing the likelihood and severity
into account in deciding whether the potential of the risks;
benefits of the research justify the risks involved.
(c) identifying whom (participants and/
For ethical review bodies, there can be a or others) the risks may affect;
profound tension between the obligation
on the one hand to give maximum scope to (d) establishing the means for
participants freedom to accept risk, and on the minimising the risks;
other to see that research is conducted in a way (e) identifying the potential benefits; and
that is beneficent and minimises harm.
(f) identifying to whom benefits are
likely to accrue.
2.1.4 In determining the existence, likelihood

and severity of risks, researchers and
those reviewing the research should
base their assessments on the available
evidence, whether qualitative or
quantitative. They should consider
whether to seek advice from others
who have experience with the same
methodology, population and research
domain.
2.1.5 In considering whether the potential
benefits of the research justify the risks
involved, those reviewing research should
take into account any willingness by
participant populations to assume greater
risks because of the potential benefits to
them, their families, or groups to which
they belong.
2.1.6 Research is low risk where the only
foreseeable risk is one of discomfort.
Where the risk, even if unlikely, is more
serious than discomfort, the research is
not low risk.
2.1.7 Research is negligible risk where there is
no foreseeable risk of harm or discomfort;
and any foreseeable risk is no more than
inconvenience. Where the risk, even if
unlikely, is more than inconvenience, the
research is not negligible risk.
2.1.8 The greater the risks to participants in
any research for which ethical approval
is given, the more certain it must be both
that the risks will be managed as well as
possible, and that the participants clearly
understand the risks they are assuming.
CHAPTER 2.2 : GENERAL REQUIREMENTS FOR CONSENT
CHAPTER 2.2: GENERAL REQUIREMENTS

FOR CONSENT
INTRODUCTION GUIDELINES
Respect for human beings involves giving due 2.2.1 The guiding principle for researchers is
scope to peoples capacity to make their own that a persons decision to participate in
decisions. In the research context, this normally research is to be voluntary, and based
requires that participation be the result of on sufficient information and adequate
a choice made by participants commonly understanding of both the proposed
known as the requirement for consent. This research and the implications of
requirement has the following conditions: participation in it. For qualifications
consent should be a voluntary choice, and should of this principle, see Chapter 2.3:
be based on sufficient information and adequate Qualifying or waiving conditions for
understanding of both the proposed research and consent.
the implications of participation in it.
2.2.2 Participation that is voluntary and based
What is needed to satisfy these conditions on sufficient information requires an
depends on the nature of the project, and adequate understanding of the purpose,
may be affected by the requirements of the methods, demands, risks and potential
codes, laws, ethics and cultural sensitivities of benefits of the research.
the community in which the research is to be
2.2.3 This information must be presented in
conducted.
ways suitable to each participant (see
Variations of these conditions may be ethically paragraph 5.2.16).
justified for some research. Respect for human
2.2.4 The process of communicating
beings must, however, always be shown in any
information to participants and seeking
alternative arrangements for deciding whether
their consent should not be merely a
potential participants are to enter the research.
matter of satisfying a formal requirement.
It should be noted that a persons consent to The aim is mutual understanding between
participate in research may not be sufficient to researchers and participants. This aim
justify his or her participation. requires an opportunity for participants
to ask questions and to discuss the
This chapter provides guidelines on the
information and their decision with others
requirement for consent. Chapter 2.3: Qualifying or
if they wish.
waiving conditions for consent then discusses and
provides guidelines on conditions under which the 2.2.5 Consent may be expressed orally, in
requirement may be qualified or waived. writing or by some other means (for
example, return of a survey, or conduct
implying consent), depending on:
(a) the nature, complexity and level of
risk of the research; and
(b) the participants personal and
cultural circumstances.
2.2.6 Information on the following matters Renegotiating consent

should also be communicated to
participants. Except where the information 2.2.8 In some research, consent may need to
in specific sub-paragraphs below is be renegotiated or confirmed from time
also deemed necessary for a persons to time, especially where projects are
voluntary decision to participate, it should complex or long-running, or participants
be kept distinct from the information are vulnerable. Research participants
described in paragraphs 2.2.1 and 2.2.2: should be told if there are changes to the
terms to which they originally agreed, and
(a) any alternatives to participation; given the opportunity to continue their
(b) how the research will be monitored; participation or withdraw (see paragraphs
5.2.16 and 5.2.17).
(c) provision of services to participants
adversely affected by the research;
Coercion and pressure
(d) contact details of a person to receive
2.2.9 No person should be subject to coercion
complaints;
or pressure in deciding whether to
(e) contact details of the researchers; participate. Even where there is no overt
coercion or pressure, consent might
(f) how privacy and confidentiality will
reflect deference to the researchers
be protected;
perceived position of power, or to
(g) the participants right to withdraw someone elses wishes. Here as always,
from further participation at any a person should be included as a
stage, along with any implications of participant only if his or her consent is
withdrawal, and whether it will be voluntary.
possible to withdraw data;
(h) the amounts and sources of funding Reimbursing participants
for the research;
2.2.10 It is generally appropriate to reimburse
(i) financial or other relevant the costs to participants of taking part in
declarations of interests of research, including costs such as travel,
researchers, sponsors or institutions; accommodation and parking. Sometimes
participants may also be paid for time
(j) any payments to participants; involved. However, payment that is
(k) the likelihood and form of disproportionate to the time involved,
dissemination of the research results, or any other inducement that is likely to
including publication; encourage participants to take risks, is
ethically unacceptable.
(l) any expected benefits to the wider
community; 2.2.11 Decisions about payment or
reimbursement in kind, whether to
(m) any other relevant information, participants or their community, should
including research-specific take into account the customs and
information required under other practices of the community in which the
chapters of this National Statement. research is to be conducted.
2.2.7 Whether or not participants will be
identified, research should be designed so Where others need to be involved in
that each participants voluntary decision participation decisions
to participate will be clearly established.
2.2.12 Where a potential participant lacks
the capacity to consent, a person or
appropriate statutory body exercising
lawful authority for the potential The necessarily limited information

participant should be provided with and understanding about research
relevant information and decide whether for which extended or unspecified
he or she will participate. That decision consent is given can still be sufficient
must not be contrary to the persons and adequate for the purpose of
best interests. Researchers should bear consent (see paragraph 2.2.2).
in mind that the capacity to consent may
2.2.15 Extended or unspecified consent may
fluctuate, and even without that capacity
sometimes need to include permission
people may have some understanding of
to enter the original data or tissue into a
the research and the benefits and burdens
databank or tissuebank (see paragraph
of their participation. For implications of
3.2.9).
these factors, see Chapter 4.2: Children
and young people, Chapter 4.4: People 2.2.16 When unspecified consent is sought,
highly dependent on medical care who its terms and wide-ranging implications
may be unable to give consent, and should be clearly explained to potential
Chapter 4.5: People with a cognitive participants. When such consent is given,
impairment, an intellectual disability, or a its terms should be clearly recorded.
mental illness.
2.2.17 Subsequent reliance, in a research
2.2.13 Within some communities, decisions about proposal, on existing unspecified
participation in research may involve consent should describe the terms of that
not only individuals but also properly unspecified consent.
interested parties such as formally
2.2.18 Data or tissue additional to those covered
constituted bodies, institutions, families
by the original extended or unspecified
or community elders. Researchers need to
consent will sometimes be needed for
engage with all properly interested parties
research. Consent for access to such
in planning the research.
additional data or tissue must be sought
from potential participants unless the
Consent to future use of data and need for this consent is waived by an
tissue in research ethical review body.
2.2.14 Consent may be:
Declining to consent and withdrawing
(a) specific: limited to the specific
consent
project under consideration;
2.2.19 People who elect not to participate in a
(b) extended: given for the use of data
research project need not give any reason
or tissue in future research projects
for their decision. Researchers should
that are:
do what they can to see that people
(i) an extension of, or closely who decline to participate will suffer no
related to, the original project; disadvantage as a result of their decision.
or
2.2.20 Participants are entitled to withdraw
(ii) in the same general area from the research at any stage. Before
of research (for example, consenting to involvement in the research,
genealogical, ethnographical, participants should be informed about
epidemiological, or chronic any consequences of such withdrawal.
illness research);
(c) unspecified: given for the use of
data or tissue in any future research.
CHAPTER 2.3 : QUALIFYING OR WAIVING CONDITIONS FOR CONSENT
CHAPTER 2.3: QUALIFYING OR WAIVING

CONDITIONS FOR CONSENT
INTRODUCTION information provided, and they understand that

they are able to act on this information in order
Consent to participate in research must be to decline to participate.
voluntary and based on sufficient information
When neither consent nor an opt-out approach
and adequate understanding of both the
are appropriate, the requirement for consent
proposed research and the implications of
may sometimes be justifiably waived. When an
participation in it.
HREC grants a waiver of consent for research
Limited disclosure to participants of the aims conducted prospectively or retrospectively,
and/or methods of research may sometimes research participants will characteristically not
be justifiable. This is because in some know that they, or perhaps their tissue or data,
human research (for example, in the study of are involved in the research.
behaviour), the aims of the research cannot
A single research project may involve discrete
be achieved if those aims and/or the research
elements or participant groups where different
method are fully disclosed to participants.
recruitment approaches can be used. For
Research involving limited disclosure covers a example, a project may involve some elements
spectrum, from simply not fully disclosing or or participant groups where explicit consent
describing the aims or methods of observational must be sought and other elements where an
research in public contexts, all the way to actively opt-out approach may be considered or where
concealing information and planning deception a waiver of the consent requirement may be
of participants. Examples along the spectrum applied.
include: observation in public spaces of everyday
Importantly, the opt-out approach does
behaviour; covert observation, for example of the
not constitute consent when applying
hand-washing behaviour of hospital employees;
commonwealth privacy legislation for the use of
undisclosed role-playing by a researcher to
identifiable information. Consequently, methods
investigate participants responses; telling
of achieving the aims of the project by collecting
participants the aim of the research is one thing
information that does not identify the participant
when it is in fact quite different.
should be considered when planning research,
Depending upon the circumstances of an statistical or management initiatives.
individual project it may be justifiable to employ
an opt-out approach or a waiver of consent.
The opt-out approach is a method used in the GUIDELINES
recruitment of participants into research where
information is provided to the potential participant
regarding the research and their involvement and Limited disclosure
where their participation is presumed unless they 2.3.1 Where limited disclosure does not
take action to decline to participate. involve active concealment or planned
While an opt-out approach makes it possible deception, ethical review bodies may
for people to make an informed choice about approve research provided researchers
their participation, this choice can only be can demonstrate that:
made if participants receive and read the
a) there are no suitable alternatives 2.3.3 Where research involving limited

involving fuller disclosure by which disclosure aims to expose illegal activity
the aims of the research can be (see paragraph 4.6.1), the adverse effects
achieved on those whose illegal activity is exposed
must be justified by the value of the
b) the potential benefits of the research
exposure.
are sufficient to justify both the
limited disclosure to participants and 2.3.4 Only a Human Research Ethics Committee
any risk to the communitys trust in (HREC) can review and approve
research and researchers research that:
c) the research involves no more a) involves active concealment or
than low risk to participants (see planned deception; or
paragraph 2.1.6), and the limited b) aims to expose illegal activity.
disclosure is unlikely to affect
participants adversely
Opt-out approach
d) the precise extent of the limited
disclosure is defined 2.3.5 An opt-out approach to participant
recruitment to research may be
e) whenever possible and appropriate, appropriate when, unlike waiver, it is
after their participation has ended, feasible to contact some or all of the
participants will be: participants, but where the project is of
(i) provided with information about such scale and significance that using
the aims of the research and an explicit consent is neither practical nor
explanation of why the omission feasible.
or alteration was necessary 2.3.6 Before approving the use of an opt-out
(ii) offered the opportunity to approach for research, an HREC must be
withdraw any data or tissue satisfied that:
provided by them. a) involvement in the research
2.3.2 Where limited disclosure involves active carries no more than low risk (see
concealment or explicit deception, and paragraphs 2.1.6 and 2.1.7) to
the research does not aim to expose participants
illegal activity, researchers should in b) the public interest in the proposed
addition demonstrate that: activity substantially outweighs the
a) participants will not be exposed to public interest in the protection of
an increased risk of harm as a result privacy
of the concealment or deception c) the data on outcomes generated by
b) a full explanation, both of the real the research activity is likely to be
aims and/or methods of the research, compromised if the participation
and also of why the concealment rate is not near complete, and the
or deception was necessary, will requirement for explicit consent
subsequently be made available to would compromise the necessary
participants level of participation
c) there is no known or likely reason d) reasonable attempts are made for

for thinking that participants would all prospective participants to be
not have consented if they had been provided with appropriate plain
fully aware of what the research language information explaining
involved. the nature of the information to be
collected, the purpose of collecting
it, and the procedure to decline personal health information. Other review
participation or withdraw from the bodies may grant waiver of consent for
research other research.
e) a reasonable time period is allowed 2.3.10 Before deciding to waive the requirement
between the participant receiving for consent (other than in the case of
such information and the use of their research aiming to expose illegal activity),
data so that an opportunity for them an HREC or other review body must be
to withdraw is provided before the satisfied that:
research begins
a) involvement in the research
f) a mechanism for prospective carries no more than low risk (see
participants to obtain further paragraphs 2.1.6 and 2.1.7) to
information and register their participants
intention for non-participation is
b) the benefits from the research justify
provided
any risks of harm associated with not
g) the data collected will be managed seeking consent
and maintained in accordance with
c) it is impracticable to obtain consent
relevant security standards
(for example, due to the quantity,
h) there is a governance process in place age or accessibility of records)
that delineates specific responsibility
d) there is no known or likely reason
for the project and for the appropriate
for thinking that participants would
management of the data
not have consented if they had been
i) the opt-out approach is not asked
prohibited by State, federal, or
e) there is sufficient protection of their
international law.
privacy
2.3.7 For guidance on the use of an opt-out
f) there is an adequate plan to protect
approach in activities other than research,
the confidentiality of data
such as quality assurance and evaluation,
refer to Ethical Considerations in Quality g) in case the results have significance
Assurance and Evaluation Activities, 2014. for the participants welfare there is,
where practicable, a plan for making
2.3.8 When considering the provision of
information arising from the research
information to prospective participants
available to them (for example, via a
and the mechanism by which individuals
disease-specific website or regional
can decline participation, the ethical
news media)
review body should consider the
sensitivity and the risks, the potential h) the possibility of commercial
participant pool, the context in which exploitation of derivatives of the
the research and opt-out approach will data or tissue will not deprive the
occur, and whether withdrawal from participants of any financial benefits
participation is feasible once identifiers to which they would be entitled
have been removed from data.
i) the waiver is not prohibited by State,
federal, or international law.
Waiver
2.3.11 Before deciding to waive the requirement
2.3.9 Only an HREC may grant waiver of for consent in the case of research aiming
consent for research using personal to expose illegal activity, an HREC must
information in medical research, or be satisfied that:
a) the value of exposing the illegal

activity justifies the adverse effects
on the people exposed (see
paragraph 4.6.1)
b) there is sufficient protection of their
privacy
c) there is sufficient protection of the
confidentiality of data
d) the waiver is not otherwise
prohibited by State, federal, or
international law.
2.3.12 Given the importance of maintaining
public confidence in the research
process, it is the responsibility of each
institution to make publicly accessible
(for example in annual reports) summary
descriptions of all its research projects for
which consent has been waived under
paragraphs 2.3.10 and 2.3.11. Waiver
decisions under paragraph 2.3.11 should
not be made publicly accessible until the
research has been completed.
SECTION 3: ETHICAL CONSIDERATIONS SPECIFIC TO RESEARCH METHODS OR FIELDS
CHAPTER 3.1 : QUALITATIVE METHODS
SECTION 3: ETHICAL CONSIDERATIONS

SPECIFIC TO RESEARCH METHODS OR
FIELDS
This section discusses various research methods discussed in Chapter 3.3: Interventions and
and fields. Some chapters are a result of the therapies, including clinical and non-clinical
further expansion of this revised National trials, and innovations, and Chapter 3.5: Human
Statement beyond health and medical research. genetics, as well as for research discussed in
The focus is on general principles the section several chapters of Section 4.
is not intended to be exhaustive. It reflects
As stated at the end of Section 1, this National
the interdisciplinary nature of many types of
Statement does not exhaust the ethical
research and the use, in some research projects,
discussion of human research. Even a single
of a number of different research methods.
research field covers a multitude of different
Human research may be conducted only situations about which the National Statement
with ethical approval. Section 5 describes the will not always offer specific guidance, or to
processes that institutions may use to provide which its application may be uncertain.Where
that approval. Those processes include ethical other guidelines and codes of practice in
review by Human Research Ethics Committees particular research fields are consistent with the
(HRECs) or other ethical review bodies, National Statement, researchers and members
according to the risks of the research (see of ethical review bodies should draw on them
paragraphs 5.1.6 to 5.1.8). when necessary to clarify researchers ethical
obligations in particular contexts.
Ethical review by an HREC is required for
any research that involves more than low risk
(paragraph 5.1.6). It is also required for research
CHAPTER 3.1: QUALITATIVE METHODS
INTRODUCTION observations, and cultural texts. It may bring

new insights into the experiences of individuals,
Qualitative research involves disciplined groups or communities, or into issues such
inquiry that examines peoples lives, as environmental change, public policies and
experiences and behaviours, and the stories planning. Qualitative research may also have
and meanings individuals ascribe to them.4 It quantitative elements or aspects.
can also investigate organisational functioning,
Qualitative research contributes to the
relationships between individuals and groups,
development of new knowledge by:
and social environments.
This approach to research can involve the
enabling researchers to gain a better
understanding of complex concepts or
studied use and collection of a variety of
social processes;
empirical materials such as case studies,
personal experience, life stories, interviews, investigating how communities and
individuals interpret and make sense of
Denzin NK & Lincoln YS (eds) 2000 Handbook of
4
their experiences;
Qualitative Research, Sage: California
eliciting contextual data in order to group; for example, interviews

improve the validity of quantitative tools with ordinary people about their
such as surveys. experiences during a time of social
turmoil or difficulty, or interviews
with employees of a particular firm.
Commonly used approaches to data
collection in qualitative research Life story or oral history can involve
structured, semi-structured or unstructured
Data in qualitative research can be collected interviews. This is a form of research
using a range of approaches. The following are commonly undertaken in the humanities.
some common examples.
Focus groups of participants discuss a set
Interviews involve researchers talking of research questions or topics. This may
to one or more participants, where entail the researcher acting as a moderator
the categories of response are focused for the discussion.
but not necessarily pre-determined.
Interviews are usually recorded by Observation involves the researcher
audio- or video-tape, or notes. These observing participant/s in their own
records are research data in themselves, environment, or in the environment
but also may be transcribed. Interviews being studied. Data collection through
are usually conducted in locations observation can be structured or
mutually acceptable to participants and unstructured, with the observer as a
interviewers. collaborative participant (participant
observation) or external to the
Interviews can take many forms, environment.
including:
Archival research refers to materials that
> structured interviews, which follow a are usually but not necessarily deposited
set list of questions; in official or private libraries or archives.
> semi-structured interviews, which On-line research includes conducting
use an interview guide listing a set on-line real-time group discussions using
of issues to be explored; web-based chat-room technology (also
> unstructured interviews, which known as E-groups) through the use of
involve spontaneous generation electronic bulletin boards and moderated
of questions in the natural flow of email groups. On-line recruitment of
interaction, and where the interview participants provides the opportunity for
is driven by the interviewee rather extensive global participation in research.
than the interviewer. Data collection and dissemination can
also be utilised on-line.
The reason for choosing an informant for
interview may vary. For example: Action research is often community- or
organisation-based and is carried out in
> Key informant interviews are the field. This approach involves testing
conducted with individuals or groups ideas in practice as a means of improving
with specific knowledge or expertise social, economic or environmental
about the issue being investigated; conditions and increasing knowledge.
for example, interviews with political Action research proceeds in a spiral of
leaders about historical events in steps consisting of planning, action, and
which they played important roles. evaluation. It provides a basis for further
> Sample informant interviews are planning of critically informed action.
conducted with people whose Values, principles and themes that must inform
experience or expertise is taken as the design, ethical review and conduct of all
representative of a broader human research are set out in Sections 1 and
2 of this National Statement. The guidelines in qualitative studies, many sampling

and headings below show how those values, frames are grounded in the specific aims
principles and themes apply specifically in of the research question.
research that is the subject of this chapter.
3.1.6 The rigour of a qualitative study should
not be judged on sample size. When
sampling is appropriate, the objectives
GUIDELINES and theoretical basis of the research
should determine the size of the sample
and the sampling strategy. For example,
Research merit and integrity some qualitative methods use a principle
3.1.1 A range of relationships between of saturation, where sampling occurs
participants and researchers may develop until no new information is being
as a result of the duration and nature of obtained. This is only one of several
the interaction. Where such relationships criteria for assessing sample size.
threaten to compromise the research role, 3.1.7 Research proposals that include sampling
researchers must consider whether to should clearly describe the recruitment
modify those relationships, or to modify strategy and criteria for selecting
or even discontinue the research. participants.
3.1.2 Where a researcher has professional 3.1.8 The rigour of qualitative research should
skills (for example, counselling) that be assessed primarily by criteria of quality
become relevant to the relationship with and credibility of data collection and
a participant, the researcher needs to analysis, and not by matters of validity
decide, when continuing the research, and reliability as defined in research
whether: designs that employ quantitative methods.
(a) it is ethically acceptable to exercise
those skills; or Justice
(b) to refer that participant to another 3.1.9 The criteria for inclusion and exclusion
professional. of participants in qualitative research
3.1.3 Researchers have a duty to inform are often complex. For this reason,
participants whenever they are acting in a researchers should state these criteria
non-research professional role. clearly and be able to justify them (see
also paragraphs 3.1.14 to 3.1.16).
3.1.4 Qualitative research emphasises the
significance of particular contexts and
settings. It is not necessary to be able
Beneficence
to generalise the results of qualitative 3.1.10 Participants are often easily identifiable
research. Even so, qualitative research (for example, as members of small
should aim to provide a sufficiently communities or groups, or as key
detailed account and/or analysis to enable informants), and the information they
others to determine whether there are provide may be sensitive. For these
other circumstances to which the findings reasons, care should be taken that
may be applicable. participants are not identifiable by the
information they provide, unless they
3.1.5 If a sampling strategy is used, the
have agreed to be identified. Special care
most common type is purposive
should be taken to protect the identity
sampling, which aims at the selection
of participants when disseminating
of information-rich cases relevant to the
information and storing material.
research question. While random and
representative sampling are not precluded
3.1.11 Where possible, participants should

be informed about any potential to be
identified in the results of research even if
identifiers, such as name and address, are
removed.
3.1.12 Qualitative research that explores sensitive
topics in depth may involve emotional
and other risks to both participant
and researcher. There should be clear
protocols for dealing with distress that
might be experienced by participants.
3.1.13 Predicting what topics are likely to
lead to distress will not always be easy.
Researchers should have sufficient training
to help them in making such predictions.
3.1.14 Qualitative research may involve methods
of data collection that require the
development of personal relationships
with participants. Researchers should
reflect on the impact that they may have
on the participants and vice versa, and
as far as possible should describe in the
research proposal any anticipated impact
of this nature.
Respect
3.1.15 Researchers should consider whether
respect for the participants requires that
the accuracy or completeness of each
interview transcript should be verified by
the relevant participant before analysis is
complete.
3.1.16 The method of providing consent in
qualitative research depends on various
factors, including the type of research,
its level of sensitivity, its cultural context,
and the potential vulnerability of the
participants. In some contexts, the
protection of vulnerable participants
may favour a formal, written process
of consent; in other contexts, an oral
process.
3.1.17 In some circumstances, consent may be
implied by participation, for example the
return of a survey, or the answering of a
verbal question (see also paragraph 2.2.5).
CHAPTER 3.2 : DATABANKS
CHAPTER 3.2: DATABANKS
INTRODUCTION permanently removed, and by means

of which no specific individual can be
This chapter covers a wide range of data types identified. A subset of non-identifiable
and methodologies. Given that the nature of data are those that can be linked with
data, data collection, research methodologies other data so it can be known that they
and data usage may change over time, the are about the same data subject, although
chapter presents principles rather than the persons identity remains unknown.
prescriptions.
This National Statement avoids the term
Types of research that commonly make use of de-identified data, as its meaning is unclear.
databanks include epidemiology, pathology, While it is sometimes used to refer to a
genetics and social sciences. record that cannot be linked to an individual
(non-identifiable), it is also used to refer to a
The term databanks, as used in this National
record in which identifying information has been
Statement, includes databases.
removed but the means still exist to re-identify
the individual. When the term de-identified
What are data? data is used, researchers and those reviewing
research need to establish precisely which of
Data are pieces of information, for example:
these possible meanings is intended.
what people say in interviews, focus
groups, questionnaires, personal histories
Tissue and data
and biographies;
With advances in genetic knowledge and data
analysis of existing information (clinical,
linkage, and the proliferation of tissue banks
social, observational or other);
of identified material, human tissue samples
information derived from human tissue should always be regarded as, in principle,
such as blood, bone, muscle and urine. re-identifiable.
The increased ability to link data has greatly
Data identifiability enhanced the contribution that collections
of data can make to research, as it enables
Data may be collected, stored or disclosed in
researchers to match individuals in different data
three mutually exclusive forms:
sets without being able to identify the person.
individually identifiable data, where For example, in epidemiological research
the identity of a specific individual can (concerned with the study of populations),
reasonably be ascertained. Examples of information about individuals and groups may
identifiers include the individuals name, be collected so that features of groups of people
image, date of birth or address; can be investigated. These data may or may
not have originally been obtained for research
re-identifiable data, from which
purposes.
identifiers have been removed and
replaced by a code, but it remains
possible to re-identify a specific individual Banking
by, for example, using the code or linking
While most data are collected, aggregated
different data sets;
and stored for a single purpose or activity.
non-identifiable data, which have never Permission may sometimes be sought from
been labelled with individual identifiers or participants to bank their data for possible use
from which identifiers have been in future research projects.
Banked data may be deposited in a warehouse, Data usage

similar to an archive or library, and aggregated
over time. The Australian Social Science Data 3.2.3 Researchers use of data from databanks
Archive, for example, collects computer-readable must comply with conditions specified
data on social, political and economic affairs by the providers of the data; in particular,
and makes them available for further analysis. any conditions on the identifiability of the
Archived data can usually be made available for data (see paragraphs 2.2.14 to 2.2.18).
secondary analysis, unless access is constrained 3.2.4 Where research involves linkage of data
by restrictions imposed by the depositor/s. sets, approval may be given to the use
of identifiable data to ensure that the
Use of the National Statements values linkage is accurate, even if consent has
and principles not been given for the use of identifiable
data in research. Once linkage has been
The values and principles of this National completed, identifiers should be removed
Statement apply to data collection by from the data to be used in the research
researchers, and by others whom they authorise unless consent has been given for its
to collect data or to whom they outsource the identifiable use.
collection.
3.2.5 It is the duty of the custodian to ensure
These ethical principles for the use of databanks that the data are used responsibly and
should be applied in the guidelines and respectfully, and that the privacy of
procedures established by institutions for the participants is safeguarded.
setting up of data collections.
3.2.6 Whenever research using re-identifiable
Values, principles and themes that must inform data reveals information that bears on
the design, ethical review and conduct of all the wellbeing of participants, researchers
human research are set out in Sections 1 and have an obligation to consider how to
2 of this National Statement. The guidelines make that information available to the
and headings below show how those values, participants. Where individual notification
principles and themes apply specifically in is warranted, the custodian of the data
research that is the subject of this chapter. will need to take all reasonable steps to
re-identify those data.
3.2.7 In most situations, the custodian of data
GUIDELINES will be the individual researcher or
agency who collected the information,
or an intermediary such as a data
Research merit and integrity warehouse that manages data coming
3.2.1 When planning a databank, researchers from a number of sources. In some
should clearly describe how their research cases, an independent custodian may
data will be collected, stored, used and be necessary. For example, when coded
disclosed, and outline how that process data are stored in a databank, a custodian
conforms to this National Statement, independent of both the data collectors
particularly the requirements for consent and the researchers may be appointed,
set out in paragraphs 2.2.14 to 2.2.18. to maintain the data in coded form while
enabling individual participants to access
3.2.2 To promote access to the benefits of their own identified results or data.
research, such data should be collected,
stored and accessible in such a way 3.2.8 Some uses of data in a databank may be
that they can be used in future research detrimental to people to whom the data
projects. relate. Researchers and/or custodians should
consider denying or restricting access to
some or all of the data for those uses.
Consent
3.2.9 When collecting data for deposit in a
databank, researchers should provide clear
and comprehensive information about:
(a) the form in which the data will be
stored (identifiable, re-identifiable,
non-identifiable);
(b) the purposes for which the data will
be used and/or disclosed; and
(c) whether they will seek:
(i) specific, extended or unspecified
consent for future research (see
paragraphs 2.2.14 to 2.2.16); or
(ii) permission from a review body
to waive the need for consent
(see paragraphs 2.3.5 and 2.3.6).
3.2.10 Researchers should recognise that data
stored in an identifiable form cannot be
used in research that is exempt from
ethical review.
3.2.11 Any restrictions on the use of participants
data should be recorded and the record
kept with the collected data so that it
is always accessible to researchers who
want to access those data for research.
3.2.12 Researchers and custodians of
the databank should observe any
confidentiality agreement about stored
data with the participant, and custodians
should take every precaution to prevent
the data becoming available for uses to
which participants did not consent.
CHAPTER 3.3 : INTERVENTIONS AND THERAPIES, INCLUDING CLINICAL AND NONCLINICAL TRIALS, AND INNOVATIONS
CHAPTER 3.3: INTERVENTIONS AND THERAPIES,

INCLUDING CLINICAL AND NON-CLINICAL
TRIALS, AND INNOVATIONS
INTRODUCTION Whether a change in an individuals investigation

or treatment is simply an innovation or actually
constitutes clinical research is generally a matter
Clinical research for the responsible clinicians judgement, guided
by institutional policies. Systematic evaluation
Clinical research increasingly involves a range
of an innovation is research and requires ethical
of different health professionals studying a wide
review.
range of matters, including disease prevention
and causation, diagnostic methods, treatments,
and effects of and response to illness. Such Clinical and other trials
research can occur in a number of settings,
A clinical trial is a form of human research
including public and private hospitals and
designed to find out the effects of an
clinics, other institutions or organisations,
intervention, including a treatment or diagnostic
community settings, and general or specialist
procedure. A clinical trial can involve testing a
medical practices.
drug, a surgical procedure, other therapeutic
This chapter focuses especially on randomised procedures and devices, a preventive procedure,
clinical trials, even though clinical trials are not or a diagnostic device or procedure.
always randomised. Further, as noted below,
Clinical trials of new therapeutic substances are
randomisation may be used in other areas of
typically categorised into Phase I, II , III or IV
human research (eg education research) and
trials. The following definitions, adapted from
therefore some of the ethical issues outlined will
the Therapeutic Goods Administration (TGA),
be relevant to such research.
describe these phases in trials of medications:
At times it may be difficult to distinguish clinical
and related research from quality improvement
Phase I studies involve the first
administration of the medicine to
and clinical audit. In such situations, guidance is
humans. Medicines are usually given to
available from the NHMRC publication Ethical
small numbers of healthy volunteers,
Considerations in Quality Assurance and
but sometimes to people affected by
Evaluation Activities, NHMRC 2014.
the disease the medicine is intended to
treat. The purpose may be to determine
Innovations in clinical practice the medicines safety, pharmacokinetics,
pharmacological activity, side effects,
Innovations in clinical practice and
preferred routes of administration, or
complementary medicine include new diagnostic
appropriate doses (for later studies). The
or therapeutic methods that aims to improve
studies are usually undertaken in centres
health outcomes but have not yet been fully
equipped for specialised monitoring and a
assessed for safety and/or efficacy. The spectrum
high degree of surveillance.
of innovations may range widely from minor
variations or extensions of existing methods, to Phase II studies are typically the first
new indications, through to completely novel trials of the medicine in people with
technologies. Where a proposed intervention the health condition for which the
is innovative and/or experimental, this should medicine is intended. The principal aim
always be made clear to those who might be is to determine efficacy and safety and
subject to it. establish an appropriate dosing regimen.
These studies are undertaken in a small Application of randomised trial

number of closely supervised patients methods to other areas of human
and conducted by researchers regarded as
research
specialists in the health condition and its
treatment. Research methods intended to avoid or reduce
bias include randomisation and blinding
Phase III studies are undertaken if the
participants and researchers to the identity
Phase II studies indicate the medicine
of agents being compared. These research
has potential benefits that outweigh any
methods were first applied to the study of new
hazards. The studies involve greater
therapies, and are now used in various other
numbers of patients with the health
fields including, for example, psychology and
condition under study, and aim to
education. Researchers who propose to use
determine whether the medicine confers
such methods should be aware of the ethical
clinical benefit in that health condition
issues that may arise in the design and conduct
and whether the incidence and nature of
of such research. In particular, paragraphs 3.3.3
adverse effects are acceptable.
and 3.3.6 will apply in all situations, while other
Phase IV studies are those undertaken paragraphs may be relevant depending on the
after the medicine has been approved nature of the research and the relationship
for marketing for the treatment of a between the researcher and potential
particular disease or for a particular participants.
indication. They may include studies
Research to which this chapter applies must be
to compare the medicine with a wider
reviewed and approved by a Human Research
range of therapies, and may also further
Ethics Committee (HREC) rather than by one of
investigate the use of the medicine in
the other processes of ethical review described
the normal clinical setting of the disease
in paragraphs 5.1.7 and 5.1.8.
(which may differ markedly from the
conditions under which pre-marketing Values, principles and themes that must inform
trials were conducted). Such studies also the design, ethical review and conduct of all
gather more comprehensive safety data, human research are set out in Sections 1 and
adding to the information known from the 2 of this National Statement. The guidelines
pre-marketing studies. and headings below show how those values,
principles and themes apply specifically in
In pharmaceutical and medical device trials
there are established codes of good clinical
research practice that define clearly what is
meant by a clinical trial for those purposes (see
the Australian code for the responsible conduct GUIDELINES
of research). This chapters main application is
to biomedical clinical trials, but it also applies
to any other interventions claiming therapeutic Research merit and integrity
benefit. Trials involving experimentation with 3.3.1 Health care and medical institutions
therapeutic goods, whether drugs or devices, should establish standards to determine
that are not yet registered, listed or entered on when an innovative intervention requires
the Australian Register of Therapeutic Goods systematic investigation to determine its
(ARTG) are subject to regulation by the TGA. safety and efficacy.
3.3.2 When such systematic investigation is
required, it should be treated as clinical
research needing formal consideration by
an HREC.
3.3.3 Researchers should show that: Justice

(a) the research is directed to answering 3.3.6 The research methodology should provide
a specific question or questions; a rationale for the selection of participants
(b) there is a scientifically valid hypothesis and a fair method of recruitment (see
being tested that offers a realistic paragraph 1.4).
possibility that the interventions being
studied will be at least as beneficial Risks
overall as standard treatment, taking
3.3.7 In research without likely benefit
into account effectiveness, burdens,
to participants, any known risk to
costs and risks;
participants should be lower than
(c) the size and profile of the sample to would be ethically acceptable where
be recruited is adequate to answer there are such likely benefits. In first-
the research question; and time-in-humans research projects, risks
are uncertain, and recruitment into the
(d) the research meets the relevant
study should therefore be gradual and
requirements of the CPMP/ICH
monitored with special care.
Note for Guidance on Good Clinical
Practice (CPMP/ICH-135/95), ISO 3.3.8 In clinical research, where patient care
14155 Clinical Investigation of is combined with intent to contribute
Medical Devices, and the TGA. to knowledge, any risks of participation
should be justified by potential benefits to
3.3.4 Researchers must inform the HREC of:
which the participants attach significance.
(a) any business, financial or other
3.3.9 The prospect of benefit from research
similar association between a
participation should not be exaggerated,
researcher and the supplier of a drug
either to justify to an HREC a higher risk
or surgical or other device to be
than that involved in the participants
used in the trial;
current treatment or to persuade a
(b) any other possible conflicts of participant to accept that higher risk.
interest; and
3.3.10 The use of a placebo alone or the
(c) any restrictions on publication. incorporation of a non-treatment control
group:
3.3.5 In any clinical research, especially clinical
trials, an HREC should be satisfied that: (a) is ethically unacceptable in a
controlled clinical trial where:
(a) funding is sufficient to conduct and
complete the trial as designed; (i) other available treatment has
already been clearly shown to
(b) any payment in money or kind,
be effective; and
whether to institutions, researchers
or participants, will not adversely (ii) there is known risk of significant
influence the design, conduct, harm in the absence of
findings or publication of the treatment;
research; and
(b) may be considered if there is
(c) the facilities, expertise and genuine uncertainty as to whether
experience available are sufficient for currently available treatments have a
the trial to be conducted safely. net clinical benefit.
Records (c) the possible effects of an unequal

or dependent relationship between
3.3.11 Data should be accurately recorded in the treating health professional
a durable and appropriately referenced or researcher and the potential
form that complies with established participant (see Chapter 4.3:
legislation, policies and guidelines. Where People in dependent or unequal
a trial is using materials of biological relationships).
origin, or other materials where there
is limited experience of their long-term 3.3.17 Where the researcher is also the
use, records should be preserved for long treating health professional, it should
enough to enable participants to be traced be considered whether an independent
in case evidence emerges of late or long- person should seek the consent of
term effects (see Australian code for the potential participants.
responsible conduct of research, paragraph 3.3.18 An HREC should be satisfied that:
2.1.1).
(a) payment in money or incentives of
3.3.12 Before beginning the clinical phase of any kind, whether to researchers
the research, researchers should register or participants, does not result in
clinical trials in a publicly accessible pressure on individuals to consent
register. to participate (see paragraphs 2.2.10,
and 2.2.11);
Respect (b) research participants are
3.3.13 Due to the potential complexity of adequately informed of the funding
information to be provided to participants, arrangements of the research and
the requirements of paragraphs 2.2.2 to given the option of knowing the
2.2.6 should be carefully considered and details of any capitation payments to
followed. Written information should not researchers or clinicians; and
be unduly long or complex. Adequate
(c) it has been made clear to
time should be allowed for prospective
participants whether they will have
participants to read and take in what is
continued access after the trial to
proposed, and they should be encouraged
treatments they have received during
to ask questions.
the trial, and on what terms.
3.3.14 Particular care should be taken in clinical
trials to make it clear to participants Monitoring of approved clinical
whether there is intended to be any
research
therapeutic benefit to them from the trial.
3.3.19 The ultimate responsibilities of institutions
3.3.15 It should always be made clear to those
for monitoring the conduct of approved
who might be subject to a proposed
research are described in Chapter
intervention whether it is innovative and/
5.5: Monitoring approved research. In
or experimental.
clinical research, and especially clinical
3.3.16 In clinical research, where patient care is trials, research sponsors also have such
combined with an intent to contribute to responsibilities.
knowledge, the following matters should
3.3.20 Institutions responsible for the conduct of
be carefully weighed:
clinical research should require that:
(a) the seriousness of the condition
(a) monitoring arrangements are
being treated;
commensurate with the risk, size and
(b) the risks involved in the proposed complexity of the trial;
research; and
(b) for each project, there are (ii) may increase the risks to
mechanisms for reporting and participants; or
reviewing:
(iii) significantly affect the conduct
(i) serious adverse events at any of the trial;
site for which the institution is
(d) notifies, in the manner and form
responsible;
specified by the HREC, any serious
(ii) serious adverse drug reactions adverse events at any of those trial
(ADRs), serious unexpected sites;
suspected adverse reactions
(e) informs the HREC as soon as
(SUSARs), and serious adverse
possible of any new safety
device events from any site
information from other published or
for which the institution is
unpublished studies that may have
responsible;
an impact on the continued ethical
(c) for a large multi-centre trial, a Data acceptability of the trial or may
and Safety Monitoring Board (DSMB) indicate the need for amendments to
is used and there is a mechanism for the trial protocol;
informing the HREC of any relevant
(f) informs the HREC, giving reasons, if
emerging data from the DSMB;
the trial is discontinued before the
(d) for a local trial, there is an identified expected date of completion; and
person/s or committee with suitable
(g) for trials with implantable medical
expertise to assist and advise the
devices, confirms the existence of, or
HREC about reports of serious
establishes, a system for
adverse events.
(i) tracking the participant, with
3.3.21 HRECs should review approved projects
consent, for the lifetime of the
in light of information provided to them
device; and
under paragraph 3.3.20.
(ii) reporting any device incidents to
3.3.22 In addition to the requirements outlined
the TGA.
in Chapter 5.5: Monitoring approved
research, the granting and continuation of
ethical approval of clinical research must Discontinuance of trials
be on the condition that, for any trial
3.3.23 It may be unethical for a researcher to
site under the HRECs responsibility, the
continue a trial if:
researcher:
(a) there are or have been substantial
(a) conducts the trial in compliance with
deviations from the trial protocol;
the approved protocol;
(b) side-effects of unexpected
(b) provides reports of the progress of
type, severity, or frequency are
the trial to the HREC, at a frequency
encountered; or
directed by the HREC (but at least
annually), and related to the degree (c) as the trial progresses, one of several
of risk to participants; treatments or procedures being
compared appears to be so much
(c) informs the HREC, and seeks its
better or worse than the other/s
approval, of amendments to the
that the continuation of the trial
protocol including amendments that:
would disadvantage some of the
(i) are proposed or undertaken in participants.
order to eliminate immediate
risks to participants;
The clearer it becomes that one treatment

is substantially better or worse than the
others, the stronger the need to consider
discontinuing the trial.
Insurance
3.3.24 Institutions must be satisfied that
sponsors of trials have made the
indemnity or insurance and compensation
arrangements required by CPMP/ICH Note
for Guidance on Good Clinical Practice
(CPMP/ICH-135/95), ISO 14155 Clinical
Investigation of Medical Devices and the
TGA.
3.3.25 In addition to the requirements in
paragraph 3.3.24, institutions must
also have arrangements to compensate
participants for harm resulting from
negligence in research to which this
chapter applies.
CHAPTER 3.4 : HUMAN BIOSPECIMENS IN LABORATORY BASED RESEARCH
CHAPTER 3.4: HUMAN BIOSPECIMENS IN

LABORATORY BASED RESEARCH
INTRODUCTION Ethics Committee (HREC) as part of a licence

application to the Embryo Research Licensing
Human biospecimens is a broad term that, Committee (see Part C of the ART guidelines).
for the purposes of this chapter, refers to any The legislation and ART guidelines do not
biological material obtained from a person regulate the use of these products after they
including tissue, blood, urine, sputum and any have been derived.
derivative from these including cell lines. It does
Once human biospecimens have been derived
not include non-human biological material such
from human embryos, gametes or fetuses, the
as micro-organisms that live on or in a person.
requirements of this Chapter apply for any
Research involving human biospecimens often subsequent use in research.
involves special ethical considerations because of:
the way that human biospecimens are Sources of human biospecimens
obtained; Sources of human biospecimens include
the information that may be derived from voluntary donation, material taken for clinical
human biospecimens and the implications purposes, and material collected post-mortem
of that information for the individual (after death).
donor, their blood relatives and their Human biospecimens are commonly collected,
community; and stored and distributed by researchers, biobanks,
the significance that may be attached to clinical pathology services, health care providers,
the human biospecimens by individuals research institutes and commercial entities, such
donors and/or communities. as pharmaceutical and biotechnology companies.
This chapter provides guidance to researchers,
institutions and HRECs on the matters that Other chapters, legislation and documents
require ethical consideration. that should be considered
Additional ethical guidance that may be relevant
Specific considerations for human to research uses of human biospecimens is
embryos, gametes and fetal tissue provided in this National Statement at:
Specific requirements for research involving Chapter 3.2: Databanks
fetal tissue are detailed in Chapter 4.1: Women Chapter 3.3: Interventions and therapies,
who are pregnant and the human fetus. including clinical and non-clinical
Research involving human embryos and trials, and innovations, which provides
gametes, including the derivation of human ethical guidance on the use of human
embryonic stem cell lines, is separately governed biospecimens for therapeutic purposes
by the Research Involving Human Embryos Chapter 3.5: Human genetics, which offers
Act 2002 (Cth) and the Ethical guidelines on additional guidance on specific aspects
the use of assisted reproductive technology in of the use of human biospecimens for
clinical practice and research (2007) (ART research purposes
guidelines), issued by the NHMRC. Research
involving the derivation of embryonic stem cell Chapters 4.1 4.8: Ethical consideration
lines or other products from a human embryo specific to participants, which offer
must be considered by a Human Research additional guidance on ethical
issues arising from collecting human research in order to meet the requirements
biospecimens from particular categories of Chapter 2.2: General requirements for
ofparticipants consent.
and in 3.4.3 Before potential participants consent
to donation of their biospecimens, they
Values and Ethics - Guidelines for Ethical
should be given sufficient information
Conduct in Aboriginal and Torres Strait
about:
Islander Health Research (NHMRC, 2003).
(a) the research for which their
Researchers and institutions must also meet any
biospecimens are to be used
relevant legislative requirements that relate to the
and, where extended or
collection, retention, use and disposal of human
unspecified consent is sought,
biospecimens, including the general prohibition
sufficient information to meet the
on trade in human tissue.
requirements of paragraphs 2.2.1
Values, principles and themes that must inform and 2.2.16;
the design, ethical review and conduct of all
(b) how their biospecimens will be
human research are set out in Sections 1 and
stored, used and disposed of,
2 of this National Statement and are applicable
including any processes to be
to research involving human biospecimens.
adopted to respect their personal
or cultural sensitivities;
(c) the extent to which their
GUIDELINES biospecimens will be reasonably
identifiable, and how their
Prospective collection of human privacy and confidentiality will
biospecimens for research be protected;
3.4.1 Those proposing to collect human (d) whether or not research using their
biospecimens for research should: biospecimens is likely to provide
information that may be important
(a) ensure that the burdens of the to their health or to the health
biospecimen collection on the of their blood relatives or their
donor(s) are justified by the potential community;
benefits of the proposed research;
(e) if information of the kind referred
(b) ensure that those involved in the to in (d) is likely to be revealed,
collection of the biospecimens are whether or not they will have the
suitably qualified or experienced, choice to receive this information,
and follow current best practice; and how this will be managed
and (see paragraph 3.4.10);
(c) ensure that suitable provisions, (f) if information of the kind referred
including financial and governance to in (d) is likely to be revealed,
arrangements, have been made for whether or not they will have the
the intended processing, storage, choice for it to be provided to their
distribution and/or use, and blood relatives or their community;
disposal of the biospecimens. and how this will be managed
(see paragraph 3.4.10);
3.4.2 The consent of donor(s) should be
obtained and recorded when collecting
human biospecimens specifically for
(g) whether their biospecimens and Ethical review of research involving

associated data may be distributed human biospecimens
to other researchers, including those
outside Australia (see paragraphs 3.4.6 Institutions, researchers and other
3.4.13 3.4.15); organisations that conduct research
involving the use of human biospecimens
(h) their right to withdraw consent have a responsibility to ensure that the
for the continued use of their research is designed, reviewed, approved
biospecimens or associated data in and conducted in accordance with this
research (see paragraph 2.2.6(g)), National Statement and other relevant
and any limitations that may guidelines and legislation.
be relevant to their withdrawal
of consent; for example, as a 3.4.7 The ethical review of proposed research
consequence of the removal of involving the use of human biospecimens
identifiers, or the prior distribution must consider the circumstances in which
and/or use of their biospecimens; the biospecimens were obtained and any
known limitations the donor(s) placed on
(i) any relevant financial or personal their use during the consent process.
interests that those engaged in
the collection, processing, storage 3.4.8 In determining the level of ethical review
and distribution and use of their appropriate for the research involving
biospecimens may have (see Chapter the use of human biospecimens, the
5.4: Conflicts of interest); and responsible institution and researcher
should consider:
(j) any potential for commercial
application of any outcomes (a) whether the research involves any
of the research involving their risks to the donors, their blood
biospecimens, how this will be relatives or their community that are
managed and to whom the benefits, more serious than discomfort (see
if any, will be distributed. Chapter 2.1: Risk and Benefit); and
3.4.4 For human biospecimens collected for (b) whether the research may give
research purposes (including biobanks), rise to information that may be
there should be ethical review and important for the health of the
approval by an HREC of the proposed donors, their blood relatives or their
consent, collection, processing, storage community where the identity of
and distribution or disposal. the donors will be known to, or can
reasonably be ascertained by, those
conducting the research or with
Human biospecimens obtained after access to health or research data
death for research related to donors.
3.4.5 Any wish expressed by a person about the 3.4.9 If the research involves no more than low
use of their biospecimens post-mortem risk, then the provisions of paragraphs
should be respected. If no such wish 5.1.18 5.1.21 for non-HREC levels of
is discovered, researchers seeking to review may apply.
obtain human biospecimens post-mortem
should obtain consent from the person(s)
authorised by relevant legislation.
3.4.10 Where proposed research involving the (h) whether the findings of specific
use of human biospecimens may reveal tests being undertaken as part of
information that may be important for the research have been produced
the health of the donor(s), their blood or validated in an accredited
relatives or their community, whether laboratory; and
anticipated or incidental to the scope
(i) who will take responsibility for any
of the research, researchers should
subsequent care requirements.
prepare an ethically defensible plan
to describe the management of any
proposed disclosure or non-disclosure Use of human biospecimens collected
of that information. This plan must be for clinical purposes
approved by an HREC and should include
consideration of the following: 3.4.11 Where human biospecimens were
obtained for clinical purposes and have
(a) The circumstances in which the been retained by an accredited clinical
biospecimens were obtained, pathology service, the biospecimens may
including the type of consent be used for research purposes if:
provided (see paragraph 2.2.14)
and the manner in which the (a) the identity of the donor is not
consent was obtained; necessary for the activity (see
paragraph 3.4.9); or
(b) the likelihood of the research
generating information that may (b) where the identity of the donor
be important for the health of the is required for the purposes of
donor(s), their blood relatives or the research, a waiver of consent
their community; (see paragraph 3.4.12) has been
obtained.
(c) whether a recognised intervention
exists that can benefit or reduce the
Waiver of consent
risk of harm to the donor(s), their
blood relatives or their community 3.4.12 Where it is contemplated that proposed
from any health impact revealed research will involve the use of human
by this information; biospecimens that have been obtained
without specific consent for their use
(d) the resource requirements and
in research (e.g. where biospecimens
infrastructure in place to support
were collected for clinical investigation),
the return of information of the kind
or where the proposed research is not
referred to in (b) and (c) in
consistent with the scope of the original
an ethically appropriate manner;
consent, the biospecimens may be
(e) whether participants will be given a used only if an HREC is satisfied that
choice to receive such information; the conditions for waiver of consent
are met (see Chapter 2.3: Qualifying or
(f) whether there is a pathway to
waiving conditions for consent). Particular
identify and recontact the donor(s),
consideration should be given to:
their blood relatives or their
community, taking into account (a) whether there is a pathway to
the relationship between the identify and recontact the donor(s)
researchers and the donor(s), if any; in order to seek their informed
consent to the use of their
(g) the potential for sampling or coding
biospecimens in research; and
errors that may compromise the
certainty that the biospecimens
came from a particular donor;
(b) whether there is a known or likely (a) there is sufficient evidence that the
reason for thinking that the donor(s) samples were obtained in a manner
would not have consented if they consistent with any prior guidelines
had been asked. and/or the accepted ethical practice
at the time of collection; and
Importation and exportation of (b) the proposed research for which the
human biospecimens for research biospecimens will be used is within
the scope of the consent provided
3.4.13 Where it is intended that human
by the donor(s).
biospecimens will be, or where the
biospecimens have been imported from
another country for use in research in Conscientious Objection
Australia, researchers must establish 3.4.17 Those who conscientiously object to being
whether these human biospecimens involved in conducting research using
were obtained in a manner consistent with human biospecimens derived from human
the requirements described in embryos, gametes, fetuses or embryonic
this National Statement and relevant or fetal tissue should not be obligated to
Australian legislation. participate, nor should they be put at a
3.4.14 Where it cannot be established that disadvantage because of
the human biospecimens described in their objection.
paragraph 3.4.13 were obtained in a
manner consistent with the requirements
described in this National Statement
and relevant Australian legislation the
biospecimens should not be used for
research in Australia.
3.4.15 Human biospecimens obtained for
research in Australia may be sent
overseas for research in accordance
with institutional policy, if:
(a) ethical approval by an appropriate
ethical review body for importation
of the biospecimens is submitted; or
(b) the exportation of the biospecimens
is consistent with the original
consent and ethical approval is
provided by an HREC.
Transition provisions for existing

biospecimens
3.4.16 Where biospecimens were obtained
domestically or via importation prior to
the effective date of this guideline
(December 2013), the biospecimens
may continue to be used in Australia
for approved research provided that
the researchers institution ensures that:
CHAPTER 3.5 : HUMAN GENETICS
CHAPTER 3.5: HUMAN GENETICS
INTRODUCTION this chapter differentiate between research that

necessitates special precautions in that respect,
The genome is an individuals biological and research that is unlikely to be of concern
inheritance.An individuals biological to individual participants, their families or their
characteristics are determined by the interaction communities.
of his or her genome with the environment.
For genetic research using stored data, see also
An individuals genome contains all of his or
Chapter 3.2: Databanks; and for genetic research
her genes.
using human tissue samples, see Chapter 3.4:
Genetics is the study ofthe structure, location, Human biospecimens in laboratory based
function, expression, interaction, abnormalities research.
and effects of the genes or genetic material and
There are ethical issues specific to genetic
their products, including but not limited to studies
research because:
of the structure of the nucleic acids and other
molecules that make up the genetic material. many of an individuals genes are shared
with close genetic relatives (commonly
Genes and genetic information are being studied
called blood relatives) and with unrelated
increasingly in clinical, epidemiological and
people in the population; and
social research, as well as in basic research.
Genetic research may involve study of:
genetic research can reveal information
about predispositions to disease. Although
single or multiple genes, gene-to- people with such a predisposition may
gene interaction or gene-environment not develop the disease, the information
interaction; may have implications for their access
to employment and education and to
acquired somatic variation;
benefits or services, including financial
inherited gene sequences, and their services such as banking, insurance and
variants or their products; superannuation. The information may
also have similar implications for blood
gene expression, including the influence
relatives.
on those genes of environmental factors,
pharmaceutics and other therapeutic Research results and genetic material and
products; information collected for genetic research may
be significant for blood relatives of research
the genes of individuals, families or
participants. These family members may have
populations;
an interest in their relatives genetic material, or
epigenetics; in information the research generates, because
testing that material or acquiring that information
use of informatics and genetic
may create new options for life decisions,
information; and
including those with potential to improve health.
clinical phenotypes. However, some family members may prefer
not to be given such information, or even not
Some research that falls within this broad to know of its existence. In addition, other
description of genetic research does not involve family members who are not blood relatives,
information that is relevant to the future health such as partners and spouses, may have an
of the individual participant and does not interest because of concerns about the health
generate sensitivities for the individual, or his of offspring. Genetic research can also reveal
or her family or community. The guidelines in information about previously unknown paternity
or maternity. Genetic research also has uses (iii) include procedures to inform
outside health, such as for tracing migration participants that the information
patterns and in studies of cultural relatedness. would remain potentially
identifiable;
reviewed and approved by a Human Research (iv) include measures to protect the
Ethics Committee (HREC) rather than by degree of confidentiality that
one of the other processes of ethical review participants wish to maintain.
described in paragraphs 5.1.7 and 5.1.8,
(b) When participants or their relatives
except where that research uses collections of
are to be given or notified of genetic
non-identifiable data and involves negligible
information that may be important
risk, and may therefore be exempted from
for their health, the plan should
ethical review.
either provide access to genetic and
Values, principles and themes that must inform clinical advice and counselling, or
the design, ethical review and conduct of all clearly recommend to participants
human research are set out in Sections 1 and that they seek these services. Such
2 of this National Statement. The guidelines advice and counselling should be
and headings below show how those values, provided by professionals with
principles and themes apply specifically in appropriate training, qualifications
research that is the subject of this chapter. and experience.
(c) Where participants or relatives prefer
not to receive genetic information
GUIDELINES that is important for their health,
they should be advised that they
will be approached to confirm this
Research merit and integrity decision when the results of the
3.5.1 Where research may discover or generate research are available.
information of potential importance to (d) Where the potential relevance of
the future health of participants, or their genetic information to participants
blood relatives, researchers must prepare health is not clear until after interim
and follow an ethically defensible plan to analysis of the research information,
disclose or withhold that information. participants should again be given:
3.5.2 This plan must take into account the (i) the option of being notified of
clinical relevance of the research the existence of that information;
information, the types of genetic test used
in the research, and the results of those (ii) the option of receiving the
tests. In addition: information; and/or
(a) The plan should: (iii) access to, or a recommendation

to seek, advice or counselling
(i) enable participants to decide about the implications of these
whether they wish to receive the decisions.
information and who else may
be given the information; 3.5.3 Advice about the results of genetic research
needs to include a clear explanation of the
(ii) set out a process for finding difference between research and clinical
out whether those other people testing, and to clarify any need for clinical
want to receive information; testing of research results.
Justice in the use and disclosure of 3.5.7 Researchers should not transfer genetic
genetic information material or related information to any
researcher not engaged in the research
3.5.4 Researchers should consider the potential project unless:
psychological, social and cultural
significance of their research. Where (a) either
complex socially significant characteristics (i) participants have been informed
or the genetic characteristics of about and have specifically
communities are being investigated, consented to that transfer
there is a risk that the research may be and, where the material or
misrepresented or misused in ways that information is identified, there
lead to prejudice, disrespect or other is a defensible plan as specified
harm to participants or communities. in paragraphs 3.5.1 and 3.5.2 for
In designing, conducting and reporting withholding or disclosing it; or
research of this nature, researchers should
consider how to counter the possibility of (ii) the provisions for extended or
such harm. unspecified consent set out in
paragraph 2.2.14 have been met;
or
Beneficence
(iii) an HREC has judged that the
3.5.5 Identifiers of genetic material or related conditions for waiver of consent
information: have been met (see paragraph
(a) should not be removed without 2.3.6), and has approved the
the consent of participants, if transfer;
removal would make it difficult to (b) the transferring and receiving
communicate personal results; researchers are conducting research
(b) should be removed if participants that has been ethically approved
request it, provided they have in Australia or through an equally
been informed that the material or stringent process in another country;
information would remain potentially and
identifiable. (c) the receiving researcher/s
3.5.6 Genetic information can sometimes undertake/s not to permit attempts
be misused to stigmatise people or to re-identify the material or
to discriminate against them unfairly. information or otherwise reduce
Researchers should therefore take the protection of the privacy of the
special care to protect the privacy participants or of the confidentiality
and confidentiality of this information. of the information.
Statutory or contractual duties may
require participants to disclose the Family involvement
results of genetic tests or analysis to
third parties (for example, insurance 3.5.8 Where people are asked to consent to
companies, employers, financial and the collection of their genetic material or
educational institutions), particularly information for research, they should be
where results provide information about given information required by paragraph
health prospects. Genetic research should 2.2.2 and, in addition, be advised:
be designed to minimise any resultant (a) that genetic material is in principle
risk that participants will be deprived re-identifiable, even if identifiers are
of benefits available to others in the removed;
community. Potential research participants
should be advised of any such risks.
(b) that they are free to decline without 3.5.10 Where a participant has given consent
giving reasons; to approach relatives, the opportunity to
make initial contact should be given to
(c) about arrangements to ensure the
the participant or someone else he or she
privacy and confidentiality of their
chooses.
genetic information with regard to
both family members and others,
in accordance with the defensible Community involvement
plan for disclosing and withholding
3.5.11 Consent should be sought from
information (see paragraph 3.5.2);
appropriate community representatives
(d) whether information from or about as well as from the individuals concerned
family members, in addition to that (see paragraph 2.2.13, where:
provided by participants, is required
(a) researchers propose to collect
for the research;
genetic material and information
(e) whether the research may reveal from individuals who are chosen
information of potential importance because of their membership of a
to their future health, or the future particular community;
health of their blood relatives;
(b) the research involves sensitivities for
(f) that, if it is proposed to approach that community; and
blood relatives, consent to do so will
(c) there is known to be a culturally
first be sought from the participant;
relevant community structure
(g) that, if the research discloses that involved in such matters.
a family member may be at risk of
a life-threatening or serious illness Other information to be given
for which treatment is available or
pending, this information may, with 3.5.12 Those whose consent is being sought
the approval of an HREC, be offered for collection of identified or potentially
by a clinician to the family member, identifiable genetic material or related
even if the research participant does information should also be informed:
not consent to this; and (a) if the research has potential
(h) whether the research has the to generate information that a
potential to detect previously participant may be legally required
unknown paternity or maternity, or to disclose to a third party, for
non blood-relationship to siblings, instance, for the purposes of
and whether, how and to whom insurance, employment, finance or
this information will be disclosed, education;
according to the approved plan. (b) that genetic material and data may
3.5.9 In deciding if relatives should be have uses unrelated to research.
approached, researchers should consider: Participants should be advised that
their material and data will not be
(a) the privacy and any known released for such uses without their
sensitivities of the relatives; consent, unless required by law;
(b) accepted habits of communication (c) about any proposal, subject to
within the family; and participants consent, to store
(c) whether the harms that might result their genetic material and data
from the relatives participation because it might be useful for as yet
in the research are justified by unspecified future research;
the potential benefits of their
participation.
(d) that, if such consent is not given,

the genetic material and data will
be disposed of at the end of the
research, once the sample storage and
record-keeping requirements of good
research practice have been met;
(e) that any wishes about the method
of disposal will be recorded at the
start of the research and taken into
account at the time of disposal;
(f) that they are free to withdraw from
the research at any time. Participants
should be informed of any
consequences of such withdrawal,
including that they may request
their genetic material and data to
be disposed of, if the samples can
be identified. They should also be
clearly informed of any practical
limitations on the granting of this
request; and
(g) that, in research studying large
numbers of genes simultaneously,
participants will not be given the
names of all the individual genes to
be studied.
Confidentiality
3.5.13 Researchers must ensure the
confidentiality and privacy of stored
genetic information or research results
relating to identified or re-identifiable
participants. Such information or research
results should be disclosed to treating
clinicians only in accordance with the
consent given for the research.
3.5.14 The rarity of some genetic disorders
might allow certain families or individuals
to be identified by other researchers,
and in some cases by members of the
community, even if information is given to
others in non-identifiable form.
For this reason, where genetic data are
stored, confidentiality might sometimes
require restrictions on the release of data
for research use (see paragraph 3.2.8).
SECTION 4: ETHICAL CONSIDERATIONS SPECIFIC TO PARTICIPANTS
CHAPTER 4.1 : WOMEN WHO ARE PREGNANT AND THE HUMAN FETUS
SECTION 4: ETHICAL CONSIDERATIONS

SPECIFIC TO PARTICIPANTS
In addition to the ethical considerations chapters of this section: Chapter 4.1: Women
pertaining to all research participants, specific who are pregnant and the human fetus, Chapter
issues arise in the design, conduct and ethical 4.4: People highly dependent on medical care
review of research involving the categories of who may be unable to give consent, Chapter
participants identified in this section. 4.5: People with a cognitive impairment, an
intellectual disability, or a mental illness,
The Introduction to this National Statement
Chapter 4.6: People who may be involved in
contains a definition of participants and notes
illegal activities, Chapter 4.7: Aboriginal and
that the impact of research on wider populations
Torres Strait Islander Peoples and Chapter 4.8:
is an important ethical consideration in the
People in other countries.
design, review and conduct of human research.
As stated at the end of Section 1, this National
Human research may be conducted only
Statement does not exhaust the ethical
with ethical approval. Section 5 describes the
discussion of human research. Even a single
processes that institutions may use to provide
research field covers a multitude of different
that approval. Those processes include ethical
situations about which the National Statement
review by Human Research Ethics Committees
will not always offer specific guidance, or to
(HRECs) or other ethical review bodies,
which its application may be uncertain.Where
according to the risks of the research (see
other guidelines and codes of practice in
paragraphs 5.1.6 to 5.1.8).
particular research fields are consistent with the
Ethical review by an HREC is required for any National Statement, researchers and members
research that involves more than low risk (see of ethical review bodies should draw on them
paragraph 5.1.6). It is also required for research when necessary to clarify researchers ethical
discussed in several chapters of Section 3, as obligations in particular contexts.
well as for research discussed in the following
CHAPTER 4.1: WOMEN WHO ARE PREGNANT

AND THE HUMAN FETUS
INTRODUCTION This chapter does not apply to research

involving:
This chapter provides guidelines for the ethical
conduct of research involving women who are
gametes, embryos and/or participants
in assisted reproductive treatments
pregnant, the human fetus ex utero, and human
this research is covered by the
fetal tissue after the separation of the fetus from
Ethical guidelines on the use of assisted
the woman. The chapter is arranged to reflect the
reproductive technology in clinical
following established categories of such research:
practice and research (NHMRC 2004);
research on the woman who is pregnant
and the fetus in utero; and
embryos excess to the needs of those for
whom they were created using assisted
research on the separated human fetus or reproductive technology this research is
on fetal tissue. covered by Australian legislation.
For the purpose of this chapter, the term fetus The risks and benefits to each should be
applies to the developing human being from carefully considered in every case, and
fertilisation to delivery, and whether alive or should be discussed with the woman. This
dead at delivery. must include the effect of the research on
the fetus in utero (including consideration
Fetal tissue includes membranes, placenta,
of fetal stress) and on the child who may
umbilical cord, amniotic fluid, and other tissue
subsequently be born.
that contains the genome of a fetus. Fetal
tissue is regarded as part of the fetus prior to 4.1.4 The possibility of providing access to
separation of the fetus from the woman. counselling for the woman about these
issues should be part of this discussion.
After separation, the following chapters of this
National Statement may also be relevant to the 4.1.5 Researchers should ask the woman
design and conduct of research involving fetal whether, in her decisions about the
tissue: Chapter 3.4: Human biospecimens in research, she wishes to involve others
laboratory based research. for whom the research may have
implications.
reviewed and approved by a Human Research 4.1.6 Except in the case of therapeutic
Ethics Committee (HREC) rather than by innovative therapy, the process of
one of the other processes of ethical review providing information and obtaining
described in paragraphs 5.1.7 and 5.1.8, consent for involvement in research
except where that research uses collections of should be separate from clinical care.
non-identifiable data and involves negligible Information about research projects
risk, and may therefore be exempted from should also be separate from information
ethical review. about routine clinical care.
Values, principles and themes that must inform 4.1.7 If it is consistent with promoting the life
the design, ethical review and conduct of all and health of the fetus, research on the
human research are set out in Sections 1 and fetus in utero may be ethically acceptable.
2 of this National Statement. The guidelines Such research may, for example, provide
and headings below show how those values, information about the health of the fetus.
4.1.8 Research should be designed so as to
minimise pain or distress for the fetus,
and should include steps for monitoring
for signs of fetal pain or distress, and steps
GUIDELINES for suspending or ceasing the research
if necessary.
The woman who is pregnant and the 4.1.9 Innovations in clinical practice, in
fetus in utero Chapter 3.3: Interventions and therapies,
including clinical and non-clinical trials,
4.1.1 The wellbeing and care of the woman and innovations, should be considered
who is pregnant and of her fetus for any innovative therapy involving the
always takes precedence over research fetus. See also paragraph 3.3.15.
considerations.
4.1.10 It is ethically unacceptable to conduct
4.1.2 The research participation of a young non-therapeutic research that involves
person who is pregnant should be guided administering drugs or carrying out a
by the requirements of Chapter 4.2: procedure on the woman or her fetus,
Children and young people. where the research carries risk for
4.1.3 Research involving the woman may affect the fetus.
the fetus, and research involving the fetus
will affect the woman.
The human fetus, or fetal tissue, 4.1.15 Where research involves a separated
after separation fetus, researchers should ask the woman
whether, in her decisions about the
4.1.11 Research involving a fetus or fetal tissue research, she wishes to involve others
should be conducted in a manner that for whom the research may have
maintains a clear separation between the implications.
womans clinical care and the research. 4.1.16 A fetus or fetal tissue may become
Where a treating health professional available for research as the result of
is also involved in the research, any termination. The process through which
conflict of interest (for example, one the woman is approached, informed
which may arise from a financial or about, and her consent sought for
contractual relationship) will need to be research on that fetus should be separate
managed in accordance with paragraph from the process under which she decides
5.4.3 of this National Statement. In cases whether to terminate her pregnancy, and
where pregnancy is to be terminated, the should not begin until a decision to
possibility of contributing fetal tissue to terminate has been made. Consenting to
research must not be raised until a decision the research must not compromise the
to terminate has been made. Proposals for womans freedom to change that decision.
research must include procedures to ensure
that the process of providing information 4.1.17 Where research involves her separated
and obtaining consent for involvement in fetus or its fetal tissue, arrangements
the research should be made for the woman to have
is clearly separated from clinical care. access to counselling and support.
For example: 4.1.18 Research on a terminated fetus or its
A researcher who is also the treating tissues, including the timing and content
health professional should not be the of the process of seeking the womans
person who seeks the consent of the consent for the research, should be
potential participant unless there is a designed so as not to compromise the
specific justification for doing so womans decisions about the timing and
(see paragraph 3.3.17). method of termination.
Information sheets for research 4.1.19 Consideration of a womans wishes

projects must be completely and her physical, psychological and
separate from, and capable of being emotionalwelfare should inform:
read independently of, written (a) a decision whether to approach her
information provided to a patient in about proposed research involving
the course of routine clinical care. her, her separated fetusor its tissue;
4.1.12 Researchers should demonstrate that there and
are no suitable alternatives by which the (b) if she is approached, the way
aims of research using the separated information is provided about the
human fetus or fetal tissue can be research and her consent for it
achieved. sought.
4.1.13 There should be no trade in human 4.1.20 In addition to the information required
fetal tissue. to be disclosed under paragraph 2.2.2
4.1.14 Those who conscientiously object to and 2.2.6 of this National Statement, the
being involved in conducting research woman should also be informed:
with separated fetuses or fetal tissue (a) that she should consider whether
should not be compelled to participate, to seek consent to the proposed
nor should they be put at a disadvantage research from any other person (see
because of their objection. paragraphs 4.1.5 and 4.1.15);
(b) whether it is possible to store the

fetus or fetal tissues for later use in
research;
(c) that she is free to withdraw her
consent to the research at any time,
whether before or after a termination
or other loss of a fetus;
(d) whether there is potential for
commercial application of outcomes
of the research, including the
development of cell lines;
(e) that she will not be entitled to
a share in the profits of any
commercial applications; and
(f) whether fetal organs or stem cell
lines developed from them will be
exported to another country.
4.1.21 A fetus delivered alive is a child, and
should be treated as a child and receive
the care that is due to a child.
4.1.22 Organs and tissues may be removed
from a fetus delivered dead and used
for research only if the conditions of
paragraphs 4.1.11 and 4.1.12 are met, and:
(a) the woman and any others she
wishes to involve (see paragraph
4.1.15) have given consent to the
removal and the research;
(b) the fetus is available for research
only as a result of separation by
natural processes or by lawful
means; and
(c) death of the fetus has been
determined by a registered medical
practitioner who has no part (or
financial interest) in the research.
4.1.23 If, for research purposes, fetal cells are
to be derived from the fetal tissue and
stored or propagated in tissue culture, or
tissues or cells are to be used in human
transplantation, the womans consent
is required. Others whom the woman
identifies (see also paragraph 4.1.15) may
also need to be involved in decisions
about these matters.
CHAPTER 4.2 : CHILDREN AND YOUNG PEOPLE
CHAPTER 4.2: CHILDREN AND YOUNG PEOPLE
INTRODUCTION these young people is required, but

is not sufficient to authorise research;
Research involving children and young people and
raises particular ethical concerns about:
(d) young people who are mature
their capacity to understand what the enough to understand and consent,
research entails, and therefore whether and are not vulnerable through
their consent to participate is sufficient for immaturity in ways that warrant
their participation; additional consent from a parent or
guardian.
their possible coercion by parents, peers,
researchers or others to participate in It is not possible to attach fixed ages to each
research; and level they vary from child to child. Moreover,
a child or young person may at the one time be
conflicting values and interests of parents
at different levels for different research projects,
and children.
depending on the kind and complexity of the
These considerations apply to all research research. Being responsive to developmental
involving children and young people. However, levels is important not only for judging when
they assume special prominence in educational children or young people are able to give their
and health research, where there are particular consent for research: even young children
tensions between not placing children at risk in with very limited cognitive capacity should be
studies of new interventions and the need for engaged at their level in discussion about the
knowledge about how such interventions are research and its likely outcomes.
best used for children.
Values, principles and themes that must inform
Researchers must respect the developing the design, ethical review and conduct of all
capacity of children and young people to be human research are set out in Sections 1 and
involved in decisions about participation in 2 of this National Statement. The guidelines
research. The child or young persons particular and headings below show how those values,
level of maturity has implications for whether principles and themes apply specifically in
his or her consent is necessary and/or sufficient research that is the subject of this chapter.
to authorise participation. Different levels of
maturity and of the corresponding capacity to be
involved in the decision include:
GUIDELINES
(a) infants, who are unable to take part
in discussion about the research and
its effects; Research merit and integrity
(b) young children, who are able 4.2.1 The research and its methods should be
to understand some relevant appropriate for the children or young
information and take part in limited people participating in the research.
discussion about the research, but 4.2.2 In the research design researchers should:
whose consent is not required;
(a) specify how they will judge the
(c) young people of developing childs vulnerability and capacity to
maturity, who are able to understand consent to participation in research;
the relevant information but whose
relative immaturity means that they
remain vulnerable. The consent of
(b) describe the form of proposed (i) one parent, except when, in
discussions with children about the the opinion of the review body,
research and its effects, at their level the risks involved in a childs
of comprehension; and participation require the consent
of both parents; or where
(c) demonstrate that the requirements of
applicable
this chapter will be satisfied.
(ii) the guardian or other primary
4.2.3 In educational research, discussion with
care giver, or any organisation or
the school community should be built
person required by law.
into the research design.
4.2.8 An ethical review body may approve
research to which only the young person
Justice
consents if it is satisfied that he or she
4.2.4 When children and young people are is mature enough to understand and
not of sufficient maturity to consent to consent, and not vulnerable through
participation in research, it is justifiable to immaturity in ways that would warrant
involve them only when: additional consent from a parent or
guardian.
(a) it is likely to advance knowledge
about the health or welfare of, or 4.2.9 A review body may also approve research
other matters relevant to, children to which only the young person consents
and young people; or if it is satisfied that:
(b) childrens or young peoples (a) he or she is mature enough to
participation is indispensable to the understand the relevant information
conduct of the research. and to give consent, although
vulnerable because of relative
Beneficence immaturity in other respects;
4.2.5 The circumstances in which the research (b) the research involves no more than
is conducted should provide for the child low risk (see paragraph 2.1.6);
or young persons safety, emotional and (c) the research aims to benefit the
psychological security, and wellbeing. category of children or young
people to which this participant
Respect belongs; and
4.2.6 Researchers should be attentive to the (d) either

developmental level of children and (i) the young person is estranged
young people when engaging them or separated from parents or
in understanding the nature and likely guardian, and provision is made
outcomes of research, and when judging to protect the young persons
their capacity to consent to the research. safety, security and wellbeing
4.2.7 Except in the circumstances described in the conduct of the research
in paragraphs 4.2.10 and 4.2.11, specific (see paragraph 4.2.5). (In
consent to a childs or young persons this case, although the childs
participation in each research project circumstances may mean he or
should be obtained from: she is at some risk, for example
because of being homeless, the
(a) the child or young person whenever research itself must still be low
he or she has the capacity to make risk); or
this decision; and
(ii) it would be contrary to the best
(b) either interests of the young person to
seek consent from the parents,
and provision is made to protect research (see levels of maturity (c) and
the young persons safety, (d) in the Introduction to this chapter).
security and wellbeing in the Where a child or young person lacks
conduct of the research (see this capacity, his or her refusal may be
paragraph 4.2.5). overridden by the parents judgement as
to what is in the childs best interest.
Standing parental consent
4.2.10 Standing parental consent enables parents
to give standing consent (for example
at the beginning of each school year) to
their childs involvement in certain types
of research in the school setting during
that year. Under standing consent, parents
are notified of each project, but are not
required to give further consent for each
project. They should be reminded with
each notification that they may withdraw
their consent for that project, and also may
withdraw their standing consent at any
time.
4.2.11 Schools may arrange for standing
parental consent to be given for a childs
participation in research that:
(a) is for the benefit of children; and
(b) comprises no more than overt
observation in school classrooms or
anonymous or coded (potentially
identifiable) questionnaires or
surveys on subject matters not
involving sensitive personal
information or personal or family
relationships.
4.2.12 For any other research, except under the
conditions described in paragraphs 4.2.8
and 4.2.9, specific parental consent is
needed for each project.
Best interests of the child

4.2.13 Before including a child or young person
in research, researchers must establish
that there is no reason to believe that
such participation is contrary to that
childs or young persons best interest.
4.2.14 A child or young persons refusal
to participate in research should be
respected wherever he or she has the
capacity to give consent to that same
CHAPTER 4.3 : PEOPLE IN DEPENDENT OR UNEQUAL RELATIONSHIPS
CHAPTER 4.3: PEOPLE IN DEPENDENT OR

UNEQUAL RELATIONSHIPS
INTRODUCTION GUIDELINES
This chapter is about pre-existing relationships
between participants and researchers or between Research merit and integrity
participants and others involved in facilitating or
4.3.1 Being in a dependent or unequal
implementing the research. These relationships
relationship may influence a persons
may compromise the voluntary character of
decision to participate in research.
participants decisions, as they typically involve
While this influence does not necessarily
unequal status, where one party has or has
invalidate the decision, it always
had a position of influence or authority over
constitutes a reason to pay particular
the other. Examples may include relationships
attention to the process through which
between:
consent is negotiated.
carers and people with chronic conditions
4.3.2 In the consent process, researchers
or disabilities, including long-term
should wherever possible invite potential
hospital patients, involuntary patients, or
participants to discuss their participation
people in residential care or supported
with someone who is able to support
accommodation;
them in making their decision. Where
health care professionals and their potential participants are especially
patients or clients; vulnerable or powerless, consideration
should be given to the appointment of a
teachers and their students; participant advocate.
prison authorities and prisoners; 4.3.3 In the research design, researchers should
governmental authorities and refugees; identify and take steps to minimise
potentially detrimental effects of:
employers or supervisors and their
employees (including members of the (a) an unequal or dependent
Police and Defence Forces); relationship on the conduct of the
research; and
service-providers (government or private)
and especially vulnerable communities to (b) the research on participants involved
whom the service is provided. in the relationship.
Those mentioned first in each of these examples

will sometimes be involved as researchers, Justice
as well as being involved in facilitating or 4.3.4 People in the categories of relationship
implementing the research. described in the Introduction to this
Values, principles and themes that must inform chapter are vulnerable to being over-
the design, ethical review and conduct of all researched because of the relative ease of
human research are set out in Sections 1 and access to them as research populations.
2 of this National Statement. The guidelines Researchers should take account of this
and headings below show how those values, vulnerability in deciding whether to seek
principles and themes apply specifically in out members of these populations as
research that is the subject of this chapter. research participants.
CHAPTER 4.3 : PEOPLE IN DEPENDENT OR UNEQUAL RELATIONSHIPS
4.3.5 Where participants are in a relationship of

dependency with researchers, researchers
must take particular care throughout the
research to minimise the impact of that
dependency.
Beneficence
4.3.6 Researchers need to be mindful that
in some relationships of dependency,
participants may have an unrealistic
expectation of the benefits of research.
4.3.7 A person declining to participate
in, or deciding to withdraw from,
research should not suffer any
negative consequences, such as unfair
discrimination, reduction in the level of
care, dismissal from employment, or any
other disadvantage (see paragraphs 2.2.19
and 2.2.20).
Respect
4.3.8 The design of research involving those
in dependent relationships should not
compromise respect for them.
4.3.9 Where the researcher has a pre-existing
relationship with potential participants, it
may be appropriate for their consent to
be sought by an independent person.
4.3.10 Researchers should take special care to
safeguard confidentiality of all information
they receive, particularly in settings such
as shared workplaces, hospital rooms or
rooms in residential care.
CHAPTER 4.4 : PEOPLE HIGHLY DEPENDENT ON MEDICAL CARE WHO MAY BE UNABLE TO GIVE CONSENT
CHAPTER 4.4: PEOPLE HIGHLY DEPENDENT ON

MEDICAL CARE WHO MAY BE UNABLE TO GIVE
CONSENT
INTRODUCTION of this National Statement. The guidelines and

headings below show how those values,
Medical care increasingly offers interventions principles and themes apply specifically in
or treatment for people at times of serious research that is the subject of this chapter.
risk to their life or wellbeing. These risks
may be temporary or permanent. People
can become highly dependent on those
interventions and treatments and may be
GUIDELINES
incapable of comprehending their situation or
of communicating about it. At the same time, Research merit and integrity
research on those interventions and treatments is
necessary to assess and improve their efficacy. 4.4.1 Research involving people who are highly
dependent on medical care may be
This chapter describes conditions under which approved where:
research involving people highly dependent
on medical care might proceed although (a) it is likely that the research will lead
their capacity to give consent is limited or to increased understanding about,
non-existent. or improvements in, the care of this
population;
In every instance, relevant jurisdictional laws will
need to be taken into account. (b) the requirements of relevant
jurisdictional laws are taken into
Significant ethical issues are raised by research account; and
conducted in the following settings:
(c) either
neonatal intensive care;
(i) any risk or burden of the
terminal care; proposed research to this
emergency care; particular participant is justified
by the potential benefits to him
intensive care; and or her; or
the care of unconscious people. (ii) where participants have capacity
Research to which this chapter applies must be to consent, any risk or burden is
reviewed and approved by a Human Research acceptable to them and justified
Ethics Committee (HREC) rather than by by the potential benefits of the
one of the other processes of ethical review research.
described in paragraphs 5.1.7 and 5.1.8,
except where that research uses collections of Justice
risk, and may therefore be exempted from 4.4.2 People highly dependent on medical care
ethical review. may be exposed to severe threats to their
lives, so that recruiting them into
human research are set out in Sections 1 and 2
research might seem unfair. However, 4.4.6 In emergency care research, recruitment
those people are entitled to participate into a research project often has to be
in research and, when the conditions of achieved rapidly. Where the research
paragraph 4.4.1 are met, their involvement involves emergency treatment and meets
is not unfair. the requirements of 4.4.1, consent for the
research may be waived provided the
conditions of paragraph 2.3.6 are satisfied.
Beneficence
4.4.7 In intensive care research, heavy sedation
4.4.3 The distinguishing features of neonatal
may impair participants cognition, and
intensive care research are the small size
communication is difficult with people
and unique developmental vulnerability
receiving ventilatory assistance. Whenever
of the participants and the potential
possible, consent to intensive care
for very long-range impact on their
research, based on adequate information,
growth, development and health. In this
should be sought from or on behalf of
research, risks and potential benefits
potential participants before admission
should be assessed with particular care
to that level of treatment. When prior
by individuals or groups with relevant
consent to research is not possible, the
expertise.
process described in paragraphs 4.4.9 to
4.4.4 The distinguishing features of terminal 4.4.14 should be followed.
care research are the short remaining
4.4.8 In research with unconscious people, the
life expectancy of participants and their
participants cannot be informed about
vulnerability to unrealistic expectations of
the research and their wishes cannot be
benefits. Terminal care research should be
determined. Those who are unconscious
designed so that:
should be included only in minimally
(a) the benefits of research to invasive research, or in research designed
individual participants or groups of both to be therapeutic for them and to
participants, or to others in the same improve treatment for the condition from
circumstances, justify any burden, which they suffer.
discomfort or inconvenience to the
participants;
Process to be followed
(b) the prospect of benefit from research
4.4.9 Consent should be sought from people
participation is not exaggerated;
highly dependent on medical care
(c) the needs and wishes of participants wherever they are capable of giving
to spend time as they choose, consent and it is practicable to approach
particularly with family members, are them.
respected; and
4.4.10 Where it is not practicable to approach a
(d) the entitlement of those receiving person highly dependent on medical care,
palliative care to participate is or the person is not capable of making
recognised. such a decision, consent should be sought
from the participants guardian, or person
or organisation authorised by law, except
Respect
under the circumstances described in
4.4.5 People involved in research to paragraph 4.4.13.
which this chapter applies may have
4.4.11 When consent is to be sought, either from
impaired capacity for verbal or written
the potential participant or another on his
communication. Provision should be made
or her behalf, steps should be taken to
for them to receive information, and to
minimise the risk that:
express their wishes, in other ways.
(a) stress or emotional factors may 4.4.14 As soon as reasonably possible, the
impair the persons understanding participant and/or the participants
of the research or the decision to relatives and authorised representative
participate; and should be informed of the participants
inclusion in the research and of the
(b) the dependency of potential
option to withdraw from it without any
participants and their relatives on
reduction in quality of care.
the medical personnel providing
treatment may compromise the
freedom of a decision to participate.
4.4.12 Where the researcher is also the
treating health professional, it should
be considered whether an independent
person should make the initial approach
and/or seek consent from potential
participants or from others on their behalf.
4.4.13 When neither the potential participant nor
another on his or her behalf can consider
the proposal and give consent, an HREC
may, having taken account of relevant
jurisdictional laws, approve a research
project without prior consent if:
(a) there is no reason to believe
that, were the participant or the
participants representative to be
informed of the proposal, he or she
would be unwilling to consent;
(b) the risks of harm to individuals,
families or groups linked to the
participant, or to their financial or
social interests, are minimised;
(c) the project is not controversial
and does not involve significant
moral or cultural sensitivities in the
community;
and, where the research is interventional,
only if in addition:
(d) the research supports a reasonable
possibility of benefit over standard
care;
(e) any risk or burden of the
intervention to the participant is
justified by its potential benefits to
him or her; and
(f) inclusion in the research project is
not contrary to the interests of the
participant.
CHAPTER 4.5 : PEOPLE WITH COGNITIVE IMPAIRMENT, AN INTELLECTUAL DISABILITY, OR A MENTAL ILLNESS
CHAPTER 4.5: PEOPLE WITH A COGNITIVE

IMPAIRMENT, AN INTELLECTUAL DISABILITY,
OR A MENTAL ILLNESS
INTRODUCTION uses collections of non-identifiable data and

involves negligible risk, and may therefore be
The three kinds of condition discussed in this exempted from ethical review.
chapter are different. They are discussed in
the one chapter, however, because many of
the ethical issues they raise about research
participation are very similar.
2 of this National Statement. The guidelines
People with a cognitive impairment, an and headings below show how those values,
intellectual disability, or a mental illness are principles and themes apply specifically in
entitled to participate in research. While research research that is the subject of this chapter.
involving these people need not be limited to
their particular impairment, disability or illness,
their distinctive vulnerabilities as research
participants should be taken into account.
GUIDELINES
The capacity of a person with any of these
conditions to consent to research, and the ability Research merit and integrity
to participate in it, can vary for many reasons, 4.5.1 The research design should take into
including: account factors that may affect the
the nature of the condition; capacity to receive information, to consent
to the research, or to participate in it.
the persons medication or treatment; These factors may be permanent or may
the persons discomfort or distress; vary over time.
the complexity of the research project; 4.5.2 Care should be taken to determine
whether participants cognitive
fluctuations in the condition. For example, impairment, intellectual disability or
while intellectual disability is usually mental illness increases their susceptibility
permanent, cognitive impairment and to some forms of discomfort or distress.
mental illness are often temporary or Ways of minimising effects of this
episodic. susceptibility should be described in the
Even when capable of giving consent and research proposal.
participating, people with these conditions may
be more-than-usually vulnerable to various Justice
forms of discomfort and stress.
4.5.3 People with a cognitive impairment, an
Research to which this chapter applies must intellectual disability, or a mental illness
be reviewed and approved by a Human are entitled to participate in research, and
Research Ethics Committee (HREC) rather to do so for altruistic reasons.
than by one of the other processes of ethical
review described in paragraphs 5.1.7 and
5.1.8, except where that research
CHAPTER 4.5 : PEOPLE WITH COGNITIVE IMPAIRMENT, AN INTELLECTUAL DISABILITY, OR A MENTAL ILLNESS
Beneficence opportunity to continue participation

(under the terms of paragraph 4.5.6) or to
4.5.4 Because of the participants distinctive withdraw.
vulnerability, care should be taken to
ensure that the risks and any burden 4.5.10 Researchers should inform HRECs how
involved in the proposed research are they propose to determine the capacity of
justified by the potential benefits of the a person with a cognitive impairment, an
research. intellectual disability, or a mental illness to
consent to the research. This information
should include:
Respect
(a) how the decision about the persons
4.5.5 Consent to participation in research by
capacity will be made;
someone with a cognitive impairment, an
intellectual disability, or a mental illness (b) who will make that decision;
should be sought either from that person
(c) the criteria that will be used in
if he or she has the capacity to consent,
making the decision; and
or from the persons guardian or any
person or organisation authorised by law. (d) the process for reviewing, during the
research, the participants capacity
4.5.6 Where the impairment, disability or illness
to consent and to participate in the
is temporary or episodic, an attempt
research.
should be made to seek consent at a time
when the condition does not interfere 4.5.11 Refusal or reluctance to participate in
with the persons capacity to give consent. a research project by a person with a
cognitive impairment, an intellectual
4.5.7 The process of seeking the persons
disability, or a mental illness should be
consent should include discussion of
respected.
any possibility that his or her capacity to
consent or to participate in the research
may vary or be lost altogether. The
participants wishes about what should
happen in that circumstance should be
followed unless changed circumstances
mean that acting in accordance with
those wishes would be contrary to the
participants best interests.
4.5.8 Consent under paragraph 4.5.6 should
be witnessed by a person who has
the capacity to understand the merits,
risks and procedures of the research, is
independent of the research team and,
where possible, knows the participant and
is familiar with his or her condition.
4.5.9 Where consent has been given by a
person authorised by law, the researcher
should nevertheless explain to the
participant, as far as possible, what the
research is about and what participation
involves. Should the participant at any
time recover the capacity to consent, the
researcher should offer him or her the
CHAPTER 4.6 : PEOPLE WHO MAY BE INVOLVED IN ILLEGAL ACTIVITIES
CHAPTER 4.6: PEOPLE WHO MAY BE INVOLVED

IN ILLEGAL ACTIVITIES
INTRODUCTION ethical review body to provide legal advice on

the existence or performance of any of those
Research may in some instances discover obligations.
illegal activity (including notifiable activity)
Research that is intended to study or expose
by participants or others, or may discover
illegal activity or that is likely to discover it
information indicating future illegal activity. Such
must be reviewed and approved by a Human
research may:
Research Ethics Committee (HREC) rather
be intended to study, and perhaps to than by one of the other processes of ethical
expose, illegal activity; review described in paragraphs 5.1.7 and 5.1.8,
except where that research uses collections of
be not specifically intended to discover
illegal activity, but likely to do so;
risk, and may therefore be exempted from
discover illegal activity inadvertently and ethical review.
unexpectedly.
In the first category there may be particular the design, ethical review and conduct of all
ethical questions about participants consent (see human research are set out in Sections 1 and
Chapter 2.2: General requirements for consent). 2 of this National Statement. The guidelines
In all three categories both ethical and legal and headings below show how those values,
questions for researchers and institutions might principles and themes apply specifically in
arise from: research that is the subject of this chapter.
what researchers might be obliged to
disclose;
the vulnerability of participants and
GUIDELINES
researchers because of discovery of
participants illegal activity (see paragraph Research merit and integrity
5.1.2(b)(ii)).
4.6.1 Research designed to expose illegal
Legal implications may include: activity should be approved only where
a statutory obligation for a researcher the illegal activity bears on the discharge
to disclose information revealed or of a public responsibility or the fitness to
discovered; hold public office. Variation of consent
requirements for such research must
legal orders that compel disclosure of comply with either paragraph 2.3.3 or
information obtained by a researcher. paragraph 2.3.7.
This chapter is not concerned with investigation 4.6.2 Participants may be subject to risks
conducted as part of law enforcement. Nor does because of their involvement in research
it contain information or guidance about legal that discovers illegal activity. It should
obligations of researchers arising from their be clearly established that these risks are
conduct of any research that discovers illegal justified by the benefits of the research.
activity. Further, it is not the role of a Human Where the research is designed to expose
Research Ethics Committee (HREC) or other
CHAPTER 4.6 : PEOPLE WHO MAY BE INVOLVED IN ILLEGAL ACTIVITIES
illegal activity under paragraph 4.6.1, (b) the extent to which the researcher
that exposure may sometimes be benefit will keep confidential any
enough. information about illegal activity
by participants or others, and the
response the researcher will make
Justice
to any legal obligation or order to
4.6.3 Where research discovers information disclose such information.
about illegal activity by participants or
4.6.7 Researchers should be satisfied that
others, researchers and institutions may
participants who are subject to criminal
become subject to orders to disclose
justice processes:
that information to government agencies
or courts. Decisions by researchers and (a) are aware that the research may
institutions about how to respond to discover illegal activity; and
those orders should have regard to values
and principles set out in this National (b) do not have unrealistic expectations
Statement and to scholarly values of of benefit from their participation.
academic freedom and inquiry.
Beneficence
4.6.4 Consideration should be given to the use
of pseudonyms, or to the removal of links
between names and data, for participants
whose illegal activity may be revealed or
discovered in research.
Respect
4.6.5 Researchers may have contact with
those participants in other professional
roles. Where this is the case, researchers
should make every effort to ensure both
that the research is not compromised
by contact in those other roles, and that
other obligations to participants are not
compromised by the research activity. In
research that is likely, but not designed, to
discover illegal activity, researchers should
also make clear to participants when a
contact or intervention is part of research
and when it is not.
4.6.6 In research that may foreseeably discover
illegal activity but is not designed to
expose it, researchers should explain to
participants as clearly as possible:
(a) the likelihood of such discovery and
of any resulting legal obligation of
disclosure the researcher may incur;
and
CHAPTER 4.7 : ABORIGINAL AND TORRES STRAIT ISLANDER PEOPLES
CHAPTER 4.7: ABORIGINAL AND TORRES

STRAIT ISLANDER PEOPLES
INTRODUCTION In applying Sections 1 and 2 of this National

Statement, researchers from other disciplines,
Research with Aboriginal and Torres Strait HRECs and other ethical review bodies may also
Islander Peoples spans many methodologies and find the Values and Ethics guidelines informative.
disciplines. There are wide variations in the ways
The Values and Ethics guidelines are based on
in which Aboriginal and Torres Strait Islander
six core values identified as being important to
individuals, communities or groups are involved
Aboriginal and Torres Strait Islander Peoples.
in or affected by research to which this chapter
The message for researchers is that there is great
applies. The variations depend on the scope of
diversity across the many Aboriginal and Torres
the project, the demographics of participants, the
Strait Islander cultures and societies. Application
illnesses or social phenomena under study, and
of these core values, and of additional cultural
their historical, social and cultural context and
and local-language protocols, should be
connections.
determined by the Aboriginal and Torres Strait
Researchers should address relevant issues of Islander communities or groups involved in the
research design, ethics, culture and language. research. The six core values are:
Depending on the field of study and complexity
of the proposed research, these issues might be
Reciprocity
addressed in numerous ways. A cornerstone of Respect
an ethical research relationship with Aboriginal
and Torres Strait Islander Peoples is respect for
Equality
and valuing of cultural and language diversity. Responsibility
For health research fitting the above description, Survival and protection
researchers must consult Values and Ethics:
Guidelines for Ethical Conduct in Aboriginal and
Spirit and integrity.
Torres Strait Islander Health Research (NHMRC Research to which this chapter applies must be
2003) (Values and Ethics). reviewed and approved by a Human Research
Ethics Committee (HREC) rather than by
Other documents that might provide useful
one of the other processes of ethical review
guidance for researchers are Keeping research on
described in paragraphs 5.1.7 and 5.1.8. The
track: A guide for Aboriginal and Torres Strait
HREC process must have included assessment
Islander peoples about health research ethics
by or advice from:
(NHMRC 2005) and the Guidelines for Ethical
Research in Indigenous Studies (Australian people who have networks with
Institute of Aboriginal and Torres Strait Islander Aboriginal and Torres Strait Islander
Studies 2002). Peoples and/or knowledge of research
with Aboriginal and Torres Strait
Human Research Ethics Committees (HRECs)
Islander Peoples; and
are also required to apply the Values and Ethics
guidelines as the basis for assessing proposals people familiar with the culture and
for health research with Aboriginal and Torres practices of the Aboriginal and Torres
Strait Islander participation. Strait Islander people with whom
participation in the research will be
discussed.
Values, principles and themes that must inform 4.7.6 Where:

(a) the geographic location of the
research is such that a significant
2 of this National Statement. The guidelines
number of the population are likely
and headings below show how those values,
to be Aboriginal and Torres Strait
Islander, and/or
(b) the research is focused on a topic
or disease/health burden identified
as being of specific concern to
GUIDELINES Aboriginal and Torres Strait Islander
Peoples and the population base has
Research merit and integrity a significant proportion of Aboriginal
and Torres Strait Islander people,
4.7.1 The researcher should ensure that
research methods are respectful and the research should provide fair
acknowledge the cultural distinctiveness opportunity for involvement of Aboriginal
of discrete Aboriginal and Torres and Torres Strait Islander Peoples, and the
Strait Islander communities or groups guidelines in this chapter apply to those
participating in the research including participants.
national or multi-centre research.
4.7.2 There should be evidence of support Beneficence
for the research project from relevant 4.7.7 The benefits from research should include
Aboriginal and Torres Strait Islander the enhancement or establishment of
communities or groups and the research capabilities, opportunities or research
methodology should engage with their outcomes that advance the interests of
social and cultural practices. Aboriginal and Torres Strait Islander
4.7.3 The researcher should ensure that Peoples.
research methods provide for mutually 4.7.8 The described benefits from research
agreed mechanisms for such matters as: should have been discussed with and
(a) appropriate recruitment techniques; agreed to by the Aboriginal or Torres
Strait Islander research stakeholders.
(b) suitable information about the
research; 4.7.9 The realisable benefits for Aboriginal and
Torres Strait Islander participants from the
(c) notification of participants consent research processes, outcomes and outputs
and of research progress; and should be distributed in a way that is
(d) final reporting. agreed to and considered fair by these
participants.
4.7.4 The researcher should seek to identify
any potential negative consequences
of the proposed research, to design
Respect
processes to monitor them, and to advise 4.7.10 The research proposal should
steps for minimising them. demonstrate evidence of respectful
engagement with Aboriginal and Torres
Justice Strait Islander Peoples. Depending on
the circumstances, this might require
4.7.5 The research methods and processes letters of support from Aboriginal and/
should provide opportunities to develop or Torres Strait Islander community
trust and a sense of equal research Councils or other organisations accepted
partnerships. by the participating communities (see
Chapter 2.1: Risk and benefit and Chapter

2.2: General requirements for consent,
especially paragraph 2.2.13). The research
processes should foster respectful, ethical
research relationships that affirm the right
of people to have different values, norms
and aspirations.
4.7.11 The research approach should value
and create opportunities to draw on the
knowledge and wisdom of Aboriginal
and Torres Strait Islander Peoples by
their active engagement in the research
processes, including the interpretation of
the research data.
4.7.12 National or multi-centre researchers
should take care to gain local level
support for research methods that risk
not respecting cultural and language
protocols.
CHAPTER 4.8 : PEOPLE IN OTHER COUNTRIES
CHAPTER 4.8: PEOPLE IN OTHER COUNTRIES
INTRODUCTION 4.8.3 As far as is necessary to satisfy the

requirements of paragraphs 1.10 to 1.13,
When a researcher from an Australian institution the design and conduct of the research
proposes to conduct research in another country, should reflect continuing consultation
additional ethical considerations may arise. In with the local participant population and
some situations, regard for the beliefs, customs the communities to which they belong (
and cultural heritage of participants will require paragraph 4.8.19).
recognition of values other than those of this
4.8.4 Researchers should inform ethical review
National Statement. Sometimes these values will
bodies in Australia:
be in tension with one or more of the ethical
values of this National Statement. Sometimes (a) whether, in the country in which
the legal, regulatory or ethical review processes they intend to do research, there
of another country may also demand conduct are ethics approval processes that
that is in tension with the ethical values of are relevant to that research, and
this National Statement. The guidelines in this whether any such processes are
chapter must inform any resolution of these mandatory or voluntary in relation to
tensions. the proposed research; and
Values, principles and themes that must inform (b) how such processes function, the
the design, ethical review and conduct of all values and principles on which
human research are set out in Sections 1 and they rely, and whether they require
2 of this National Statement. The guidelines reporting of the Australian review
and headings below show how those values, bodys approval.
4.8.5 Where there are no ethics approval
processes in an overseas country, this
National Statement may provide the only
applicable process for ethical approval.
GUIDELINES In this case, the Australian ethical review
body should take account of the available
resources and means to conduct the
Research merit and integrity research and avoid imposing unrealistic
4.8.1 Research conducted overseas by requirements, providing always that
researchers from Australian institutions research participants are accorded no less
must comply with this National Statement. respect and protection than this National
Statement requires.
4.8.2 Local cultural values should be
acknowledged in the design and conduct 4.8.6 Some funding or national requirements
of the research. It should be clearly will direct researchers and review bodies
established that such acknowledgement to conform to the ethics guidelines
will result in participants being accorded of local institutions or to recognised
no less respect and protection than this international guidelines or instruments.
National Statement requires. Research conducted under those
guidelines or instruments should be
approved only if participants will be
accorded no less respect and protection
than this National Statement requires.
4.8.7 Researchers should have enough 4.8.13 Institutions and researchers should find
experience or access to expertise to out whether research they are planning
enable them to engage with participants to do in another country is lawful in that
in ways that accord them due respect and country.
protection.
4.8.8 When research is to be conducted Beneficence
overseas by a researcher who is subject to
4.8.14 Researchers need to inform review
academic supervision, researchers should
bodies when participants will be in
inform the Australian ethical review body
dependent relationships with researchers,
of how that supervision is to be effected
whether through previous or proposed
so that due respect and protection will be
arrangements (see Chapter 4.3: People in
accorded to participants.
dependent or unequal relationships).
4.8.9 When co-researchers are to be recruited
4.8.15 Researchers need to know enough about
in an overseas country, researchers should
the communities, and how to engage
inform a review body of how the capacity
with them, to be able to assess the
and expertise to conduct that part of the
burdens and benefits of their research
research assigned to the co-researchers
to the communities. Political and social
will be established.
factors that may jeopardise the safety
4.8.10 It is the responsibility of researchers of participants need to be taken into
to satisfy themselves that those account. Researchers should inform
co-researchers will carry out the research review bodies about these likely burdens
in a way that accords participants no less and benefits.
respect and protection than this National
4.8.16 A local, readily accessible contact should
Statement requires.
be available to participants to receive
responses, questions and complaints
Justice about the research. Responses and
questions should be handled by the
4.8.11 The distribution of the burdens and
researcher. Researchers should ensure
benefits of research in overseas countries,
that there is a process independent of the
for the participants and in some instances
researcher for dealing with complaints
the broader community, should be
(see Chapter 5.6: Handling complaints).
fair and the research should not be
exploitative. 4.8.17 In proposing mechanisms for monitoring
research, researchers should take account
4.8.12 The conduct of the research in other
of local circumstances.
countries should take into account the
opinions and expectations of participants 4.8.18 Conducting research in other countries
and their communities about the effect of can expose researchers to risks of harm.
any limits of resources on: Institutions and researchers should try to
identify and evaluate any such risks, and
(a) the way the research will be
make provision for dealing with them, for
conducted;
instance by establishing local academic or
(b) participants post-research welfare; institutional affiliations.
and
(c) application of the results of the
research.
Respect
4.8.19 Respect for participants in other countries
requires having due regard for their
beliefs, customs and cultural heritage, and
for local laws.
4.8.20 Local beliefs and practices regarding
recruitment, consent, and remuneration
to participants or contributions to
communities for participating in research
should be taken into account in the
design and the conduct of the research,
and in the ethical review process.
4.8.21 It should be clearly established that the
processes to be followed in recruiting
participants and through which they
choose whether to be involved are
respectful of their cultural context.
SECTION 5: PROCESSES OF RESEARCH GOVERNANCE AND ETHICAL REVIEW
CHAPTER 5.1 : INSTITUTIONAL RESPONSIBILITIES
SECTION 5: PROCESSES OF RESEARCH

GOVERNANCE AND ETHICAL REVIEW
Human research encompasses a wide range of different levels of ethical review, and includes
activities with an equally wide range of risks the operations of Human Research Ethics
and potential benefits. The National Statement Committees (HRECs). The section also describes
allows for different levels of ethical review of other processes of research governance that
research, reflecting the difference in degree of must be in place if the ethical review of research
risk involved (see Chapter 2.1: Risk and benefit). is to be undertaken well. These are considered
only briefly, as they are more fully set out in the
This Section sets out the processes by which
Australian code for the responsible conduct of
institutions establish, conduct and oversee those
research.
CHAPTER 5.1: INSTITUTIONAL RESPONSIBILITIES
GUIDELINES (iii) are free to withdraw from

research on conscientious
grounds.
Research governance
5.1.3 Institutions may establish their own
5.1.1 Institutions must see that any human processes for ethical review of research,
research they conduct or for which they or use those of another institution.
are responsible is:
5.1.4 Whichever option under 5.1.3 is adopted,
(a) designed and conducted in institutions need to be satisfied that
accordance with the Australian processes are in place for:
code for the responsible conduct of
research; and (a) managing conflicts of interest
(Chapter 5.4);
(b) ethically reviewed and monitored
in accordance with this National (b) monitoring research (Chapter 5.5);
Statement. (c) handling complaints (Chapter 5.6);
5.1.2 Each institution needs to be satisfied that: and
(a) its human research meets relevant (d) ensuring accountability (Chapter 5.7).
scholarly or scientific standards; 5.1.5 Institutions should use and promote
(b) those conducting its human research: clearly formulated, documented,
accessible and current policies and
(i) are either adequately procedures for research governance and
experienced and qualified, or ethical review.
supervised;
(ii) understand the need to assess
risks to their own safety and that
of participants; and
Processes for ethical review Legal protection for those involved in

5.1.6 The following types of research require ethical review of research
review by a Human Research Ethics 5.1.9 Institutions should provide an assurance
Committee (HREC): of legal protection to all those involved
(a) all research that involves more than in ethical review of research, for liabilities
low risk; that may arise in the course of bona fide
conduct of their duties in this capacity.
(b) research falling under the following
chapters (except where research
on collections of non-identifiable
Oversight and review of ethical review
data under these chapters satisfies procedures
the conditions for exemption from 5.1.10 Institutions that set up levels of ethical
review see paragraphs 5.1.22 and review other than HREC, as described
5.1.23): in paragraphs 5.1.18 to 5.1.23, must
Chapter 3.3: Interventions and establish criteria for allocating research to
therapies, including clinical and these different levels of review (including
non-clinical trials, and innovations exemption from review), taking into
Chapter 3.5: Human genetics, account Chapter 2.1: Risk and benefit.
Chapter 4.1: Women who are These criteria must be readily accessible
pregnant and the human fetus, to all those involved in the conduct and
Chapter 4.4: People highly dependent review of research.
on medical care who may be unable
to give consent, 5.1.11 The ethical values and principles in this
Chapter 4.5: People with a cognitive National Statement should be the basis on
impairment, an intellectual which institutions establish different levels
disability, or a mental illness, of ethical review, allocate different kinds
Chapter 4.7: Aboriginal and Torres of research to them, and review those
Strait Islander Peoples, allocations.
and some categories of research 5.1.12 Institutions must monitor any processes
falling under Chapter 4.6: People who of ethical review of low risk research
may be involved in illegal activities to ensure those processes continue
(see first bolded paragraph for to provide sufficient protection for
details). participants.
5.1.7 For research that carries only low risk (see 5.1.13 Institutions should regularly assess all
paragraph 2.1.6) and does not fall under their ethical review processes, including
any of the chapters listed in paragraph the criteria for allocating research to
5.1.6, institutions may choose to establish different levels of review, to ensure that
other levels of ethical review. These levels those processes continue to enable the
are described in paragraphs 5.1.18 to institution to meet its responsibilities
5.1.21. under this National Statement.
5.1.8 Research that carries only negligible risk 5.1.14 Where possible this assessment should
(see paragraph 2.1.7) and meets the be informed by the documented
requirements of paragraphs 5.1.22 and experience of research participants and/
5.1.23 may be exempted from ethical or by involving participants or the wider
review. community in the assessment.
5.1.15 Institutions should also remain alert 5.1.20 The levels of ethical review referred to in
to emerging ethical issues in any area paragraph 5.1.18 may include, but need
of human research that may warrant not be limited to:
changing the level of ethical review
(a) review or assessment at departmental
required.
level by the head of department;
5.1.16 To enable assessment of their ethical
(b) review or assessment by a
review processes, institutions should
departmental committee of peers
prepare and make readily accessible
(with or without external or
regular reports on all of those processes.
independent members);
5.1.17 Institutions should have in place an
(c) delegated review with reporting to
auditing process to confirm that:
an HREC; or
(a) research in their institution is being
(d) review by a subcommittee of an
reviewed at the levels of review their
HREC.
criteria require;
5.1.21 Those reviewing research at a non-HREC
(b) research is being exempted from
level must refer to an HREC any research
review only in accordance with the
they identify as involving more than low
criteria set out in paragraphs 5.1.22
risk.
and 5.1.23.
Research that can be exempted

Research involving no more than
from review
low risk
5.1.22 Institutions may choose to exempt from
5.1.18 Institutions that establish any non-HREC
ethical review research that:
levels of ethical review for low risk
research must have the resources and (a) is negligible risk research (as defined
capacity to carry out such review in paragraph 2.1.7); and
competently and professionally.
(b) involves the use of existing
5.1.19 Where institutions establish such collections of data or records that
non-HREC levels of ethical review for low contain only non-identifiable data
risk research, that review must: about human beings.
(a) be carried out by people who are 5.1.23 Institutions must recognise that in
familiar with this National Statement deciding to exempt research from ethical
and have an understanding of the review, they are determining that the
ethical issues that can arise in the research meets the requirements of
research under review; this National Statement and is ethically
acceptable.
(b) be informed by Section 1: Values
and Principles of Ethical Conduct,
Section 3: Ethical Considerations HRECs: research involving more than
Specific to Research Methods or Fields low risk
and Section 4: Ethical Considerations
Specific to Participants; 5.1.24 Each institution that conducts human
research involving more than low risk
(c) take account of researchers must ensure that this research is reviewed
judgements as to whether their and approved by an HREC that is
research is suitable for review by a constituted and functioning in accordance
non-HREC process; with this National Statement, whether
or not that HREC is established by the
(d) have due regard to relevant privacy
institution.
regulation.
5.1.25 Institutions5 that establish HRECs are (i) appropriate induction, which
responsible for ensuring that those HRECs could include mentoring by a
are established and continue to operate in current HREC member, and
accordance with this National Statement.
(ii) continuing education;
Establishment of HRECs (c) review of research proposals is

thorough;
5.1.26 Institutions that individually or jointly
establish HRECs should adequately (d) review processes and procedures are
resource and maintain them. Resourcing expeditious;
should be sufficient to enable HRECs: (e) decisions are transparent, consistent,
(a) to satisfy the requirements for and promptly communicated;
sound ethical review (see paragraph (f) actual and potential conflicts of
5.1.37); interest that may affect research
(b) to communicate well with and its review are identified and
researchers (see paragraphs 5.2.13 managed (see Chapter 5.4: Conflicts
to 5.2.15); of interest);
(c) not to charge fees where doing (g) membership of the HREC is made
so would discourage research the public in annual reports or by other
institution has an obligation to routine processes, and is available
support. to researchers submitting research
proposals to that HREC;
5.1.27 When establishing an HREC, an institution
should set out and publicise its terms of (h) good communication between
reference, including: the institution/s, the HREC and
researchers is promoted;
(a) the scope of its responsibilities for
ethical review; (i) the workload of the HREC does
not compromise the quality and
(b) its relationship to other processes of timeliness of ethical review; and
research review;
(j) any institution using the HREC can
(c) its relationship to non-affiliated be assured the HREC is operating
researchers; in accordance with this National
Statement.
(d) its institutional accountability;
(e) its mechanisms of reporting;
Composition of HRECs
(f) categories of minimum membership;
5.1.29 The minimum membership of an HREC is
and
eight. As far as possible:
(g) remuneration, if any, for members.
(a) there should be equal numbers of
5.1.28 Where an institution has established an men and women; and
HREC, the institution is responsible for
(b) at least one third of the members
ensuring that:
should be from outside the
(a) members have relevant experience institution for which the HREC is
and/or expertise; reviewing research.
(b) members undertake:
Where the context is the establishment and
5
maintenance of an HREC, institutions also includes

any body or agency that establishes an HREC but
does not conduct human research.
5.1.30 This minimum membership is: 5.1.33 The institution should ensure that
the HREC has access to the expertise
(a) a chairperson, with suitable
necessary to enable it to address the
experience, whose other
ethical issues arising from the categories
responsibilities will not impair
of research it is likely to consider. This
the HRECs capacity to carry out
may necessitate going outside the HREC
its obligations under this National
membership.
Statement;
(b) at least two lay people, one man Appointment of HREC members
and one woman, who have no
affiliation with the institution and 5.1.34 Members should be appointed to an
do not currently engage in medical, HREC using open and transparent
scientific, legal or academic work; processes. Institutions should consider
reviewing appointments to the HREC at
(c) at least one person with knowledge least every three years.
of, and current experience in, the
professional care, counselling or 5.1.35 Members should be appointed as
treatment of people; for example, a individuals for their knowledge,
nurse or allied health professional; qualities and experience, and not as
representatives of any organization, group
(d) at least one person who performs a or opinion.
pastoral care role in a community,
for example, an Aboriginal elder, a 5.1.36 Members should be provided with a
minister of religion; formal notice of appointment.
(e) at least one lawyer, where possible
one who is not engaged to advise HREC procedures
the institution; and 5.1.37 An institution that establishes an HREC
(f) at least two people with current should ensure that the HREC establishes,
research experience that is relevant implements and documents working
to research proposals to be procedures to promote good ethical
considered at the meetings they review, including procedures for:
attend. These two members may be (a) frequency of meetings;
selected, according to need, from
an established pool of inducted (b) attendance at meetings;
members with relevant expertise. (c) conduct and structure of meetings
5.1.31 No member may be appointed in and deliberations;
more than one of the categories listed (d) preparation of agendas and minutes;
in paragraph 5.1.30, but institutions
are encouraged to establish a pool of (e) timely distribution of papers before
inducted members in each category. meetings;
These members may attend meetings (f) presentation of applications for
as needed to meet minimum HREC ethical review;
requirements, and may also be available
to provide expertise for the research (g) timely consideration and review of
under review. applications;
5.1.32 Wherever possible one or more of the (h) managing conflicts of interest (see
members listed in 5.1.30 should be paragraphs 5.4.1 to 5.4.6);
experienced in reflecting on and analysing
ethical decision-making.
(i) communicating with researchers,

including face to face, by telephone
and in writing (including email) (see
paragraphs 5.2.13 to 5.2.15);
(j) reporting on its activities to the institution;
(k) methods of decision making;
(l) prompt notification of decisions;
(m) record keeping (see paragraphs 5.2.23 to
5.2.27);
(n) monitoring of approved research (see
(o) reporting and handling of adverse events;
(p) receiving and handling of complaints (see
(q) advising the institution/s of decisions to
withdraw ethical approval of a research
project (see paragraphs 5.5.7 to 5.5.9);
(r) attendance, as observers, of people
other than members or researchers (see
paragraph 5.2.18) at meetings;
(s) fees, if any, to be charged; and
(t) appropriate confidentiality of the content
of applications and the deliberations of
review bodies.
CHAPTER 5.2 : RESPONSIBILITIES OF HRECS, OTHER ETHICAL REVIEW BODIES, AND RESEARCHERS
CHAPTER 5.2: RESPONSIBILITIES OF HRECS,

OTHER ETHICAL REVIEW BODIES, AND
RESEARCHERS
GUIDELINES Researcher responsibilities
5.2.5 In each research proposal, the
Review body procedures researcher/s should demonstrate that the
research has merit and reflects the ethical
5.2.1 Institutions that set up non-HREC levels values of justice, beneficence and respect
of ethical review should ensure that for humans (see paragraph 1.1).
they have good working procedures
for those levels. These should include 5.2.6 Research proposals should be clear
the procedures from paragraph 5.1.37 and comprehensive, and written in lay
and paragraphs 5.2.24 to 5.2.27 that are language.
necessary for sound review at each of 5.2.7 A researcher should disclose to the review
those levels. body the amount and sources or potential
sources of funding for the research.
Review body member responsibilities 5.2.8 A researcher developing or designing a
5.2.2 Each member of an ethical review body research proposal involving two or more
is responsible for deciding whether, in his institutions should inform them all at an
or her judgement, a proposal submitted to early stage in this process.
the review body meets the requirements 5.2.9 A researcher should keep an auditable
of this National Statement and is ethically record of any research he or she is
acceptable. undertaking that is exempted from ethical
5.2.3 To fulfil that responsibility, each member review in accordance with paragraphs
of a review body should: 5.1.22 and 5.1.23.
(a) become familiar with this National 5.2.10 A researcher should disclose to the review
Statement, and consult other body any actual or potential conflicts of
guidelines relevant to the review of interest, including any financial or other
specific research proposals; interest or affiliation, that bears on the
research (see Chapter 5.4: Conflicts of
(b) prepare for and attend scheduled interest).
meetings of the review body or, if
unavailable, provide opinions on 5.2.11 When reporting the research, a researcher
the ethical acceptability of research should again disclose any actual or
proposals before meetings, subject to potential conflicts of interest, including
institutional policies on absences; and any financial or other interest or
affiliation, that bears on the research.
(c) attend continuing education or
training programs in research ethics 5.2.12 For researcher responsibilities in
at least every three years. relation to monitoring, see Chapter 5.5:
Monitoring approved research.
5.2.4 Members of a review body should disclose
to it any actual or potential conflict of
interest, including any financial or other
interest or affiliation, that bears on any
research coming before the review body
(see paragraph 5.4.5).
Good communication between review (e) age;

bodies and researchers (f) visual, hearing or communication
5.2.13 Good ethical review requires open impairment.
communication between review 5.2.17 A review body should consider consulting
bodies and researchers, and a shared a participant advocate to help it assess
commitment to the review process. whether a proposal under consideration
The process should not be adversarial. adequately provides for participants
Institutions should encourage this shared decision making and understanding.
commitment by promoting:
(a) awareness of this National Statement Researchers or experts at review body
among researchers; and meetings
(b) ready accessibility of review bodies 5.2.18 A review body (HREC or other) may
and their staff to researchers. invite researcher/s, and researchers may
5.2.14 Misunderstandings can often arise when request, to be present for discussion of
only written communication is used. their proposed research.
From the outset review bodies should 5.2.19 A review body may seek advice from
encourage informal communication experts to help in considering a research
with researchers, and should consider proposal (eg, as in paragraph 5.1.33).
face-to-face meetings to resolve issues Such experts should be bound by the
about research proposals that have not same confidentiality requirements as the
been resolved by written or telephone review body members. Any conflicts
communication. of interest they may have should be
5.2.15 Open communication of these kinds disclosed and managed (see paragraphs
has implications for the resourcing of 5.4.1 to 5.4.6).
review bodies (see paragraphs 5.1.18, and 5.2.20 Communication between a research
5.1.26). sponsor and a review body should
be avoided where it may, or may be
Participants interests perceived to, influence the ethical review
and approval of the project.
5.2.16 Information about research should be
presented to participants in ways that
help them to make good choices about Making and communicating decisions
their participation, and support them in 5.2.21 A review body may approve, request
that participation. These ways must take amendment of, or reject a research
into account: proposal on ethical grounds.
(a) whether the information is best 5.2.22 The review body must clearly
communicated through speech, communicate its decision to the
writing, some other way, or a researcher/s:
combination of these;
(a) Where a proposal is approved,
(b) the need for accurate and reliable communication must be in writing
translation (written and/or oral) (which may include email)
into a participants first language or and should include an explicit
dialect; statement that the proposal meets
(c) culture and its effects on how the requirements of this National
language (English or other) is Statement.
understood;
(d) educational background and level;
(b) Where amendments are requested, (m) relevance, if any, of the

communication may be written Commonwealth, State or Territory
or, where appropriate, informal legislation or guidelines relating
(see paragraph 5.2.14). Reasons to privacy of personal or health
should be given for the requested information.
amendments.
5.2.25 In addition, a review body should retain
(c) Where a proposal is rejected, on file a copy of each research proposal
communication of the rejection must and application for ethical approval,
be in writing (which may include including any information sheets, consent
email) and should include reasons forms or relevant correspondence, in the
linked to this National Statement. form in which they were approved.
5.2.26 A review body should record decisions
Documents and records about approval, amendment or rejection
of proposals in written or electronic form,
5.2.23 All documents and other material used in
with reasons for those decisions, linking
recruiting potential research participants,
those reasons to this National Statement.
including advertisements, letters of
invitation, information sheets and consent 5.2.27 Where more than one review body has
forms, should be approved by the review reviewed a research proposal, each such
body. review body should record, as far as
possible (see paragraph 5.3.3):
5.2.24 A review body should maintain a record
of all research proposals received and (a) details of other review body/ies
reviewed, including at least the: involved;
(a) name/s of the institution/s to which (b) the decision/s of each other review
the research approval is provided; body; and
(b) project identification number/s; (c) details of any amendments required
by each other review body.
(c) name/s of principal researcher/s;
(d) title of the project;
HREC meetings
(e) correspondence between the review
5.2.28 As far as possible, each HREC meeting
body and the researcher about the
should be arranged to enable at least
review;
one member in each category to attend
(f) acceptance or rejection of any (see paragraphs 5.1.29 to 5.1.32). Meeting
changes to the proposal; papers should be provided enough in
advance to enable members to be fully
(g) proposed date of completion of the
informed.
proposal;
5.2.29 Decisions by an HREC about whether a
(h) formal advice of final ethical
research proposal meets the requirements
approval or non-approval, with date;
of this National Statement must be
(i) terms and conditions, if any, of informed by an exchange of opinions
approval of any proposal; from each of those who constitute the
minimum membership (see paragraph
(j) duration of the approval;
5.1.30). This exchange should, ideally,
(k) name of any other review body take place at a meeting with all those
whose opinion was considered; members present.
(l) mechanisms to be used to monitor
the conduct of the research; and
5.2.30 Where there is less than full attendance of

the minimum membership at a meeting,
the Chairperson should be satisfied,
before a decision is reached, that the
views of those absent who belong to
the minimum membership have been
received and considered.
5.2.31 An HREC should endeavour to reach
decisions by general agreement. This
need not involve unanimity.
CHAPTER 5.3 : MINIMISING DUPLICATION OF ETHICAL REVIEW
CHAPTER 5.3: MINIMISING DUPLICATION OF

ETHICAL REVIEW
INTRODUCTION 5.3.3 Where an institution decides to rely

on ethical review by a body it has not
Research projects that may generate duplication established, it should undertake:
of ethical review in Australia include:
(a) to identify any local circumstances
a research project conducted at more relevant to the ethical review
than one institution, either by the same or of its research, disclose these
different researchers; circumstances to the review
body/ies, and provide for their
a research project conducted jointly
management;
by researchers affiliated with different
institutions; (b) to exchange relevant information
and advice with the review body/ies;
a research project conducted at one
institution by a researcher affiliated (c) not to duplicate an existing, duly
with another institution, for example, a authorised scientific/technological/
university-based researcher conducting methodological assessment of the
research at a hospital; research;
a research project approved at one (d) to establish the roles, if any, the
institution and transferred to another, institution and the review body/ies
for example, when a researcher changes may have in monitoring the research;
institutions; and
(e) to inform participants if the research
any other research for which more than is discontinued; and
one institution has responsibility for
(f) to adopt any other administrative
ethical review and approval.
procedures that will avoid
unnecessary duplication of ethical
review.
GUIDELINES 5.3.4 Where paragraphs 5.3.1 to 5.3.3 apply,
5.3.1 Wherever more than one institution has researchers should inform the ethical
a responsibility to ensure that a human review body that reviews and approves
research project is subject to ethical the research:
review (see paragraph 5.1.1), each (a) of all other sites at which the
institution has the further responsibility research will be conducted, and of
to adopt a review process that eliminates the name and location of any other
any unnecessary duplication of ethical body that will conduct an ethical
review. review of the research; and
5.3.2 Different institutions that regularly have (b) of any previous decisions made
review responsibilities for the same about the research by other review
research (for example, universities and bodies (in Australia or elsewhere).
related teaching hospitals) should agree
on a single review body to review the
research.
CHAPTER 5.4 : CONFLICTS OF INTEREST
CHAPTER 5.4: CONFLICTS OF INTEREST
INTRODUCTION 5.4.3 Ethical review bodies should see that

measures are adopted to manage conflicts
A conflict of interest in the context of research of interest involving researchers (see
exists where: paragraph 5.2.10). These measures may
include requiring that:
a persons individual interests or
responsibilities have the potential to (a) the information be disclosed to
influence the carrying out of his or research participants;
her institutional role or professional
(b) a person other than the researcher
obligations in research; or
make the initial approach to
an institutions interests or responsibilities participants;
have the potential to influence the
(c) the information be disclosed in any
carrying out of its research obligations.
report of the research;
While a conflict may relate to financial interests,
(d) the research be conducted by
it can also relate to other private, professional or
another researcher; or
institutional benefits or advantages that depend
significantly on the research outcomes. (e) the research not be conducted.
A conflict of interest may compromise the 5.4.4 Where an ethical review body becomes
research process itself and/or the institutional aware that there may be a conflict of
processes governing research, and may lead interest involving the institution, the
researchers or institutions to base decisions review body should notify the institution.
about the research on factors outside the
5.4.5 An ethical review body should require
research requirements.
its members, and also any experts whose
A perception that a conflict of interest exists advice it seeks, to disclose any actual or
can be as serious as an actual conflict, raising potential conflict of interest in research to
concerns about an individuals integrity or an be reviewed, including any:
institutions management practices.
(a) personal involvement or participation
in the research;
GUIDELINES (b) financial or other interest or

affiliation; or
5.4.1 Institutions should establish transparent
(c) involvement in competing research.
processes to identify and manage
actual and potential conflicts of interest The review body should adopt measures
involving: to manage such conflicts. In the case of
members these measures may include
(a) the institution itself;
exclusion from a meeting, or from some
(b) researchers; or or all of the bodys deliberations, or in the
case of expert advisors, requesting only
(c) ethical review bodies, their members
written advice from them.
or advisors.
5.4.2 An institution with a conflict of interest
bearing on research should inform
relevant ethical review bodies about the
conflict.
CHAPTER 5.4 : CONFLICTS OF INTEREST
5.4.6 Sometimes a researcher who discloses

the fact that he or she has a conflict of
interest may have an ethically acceptable
reason for not disclosing what the conflict
is, for example, that this might breach
another persons privacy. The researcher
may then remain involved in the research
only if the review body is satisfied that
the conflict can be managed without its
nature being disclosed.
CHAPTER 5.5 : MONITORING APPROVED RESEARCH
CHAPTER 5.5: MONITORING APPROVED

RESEARCH
INTRODUCTION steps to deal with any unexpected risks.

For monitoring of approved clinical
Monitoring of research here refers to the research, see paragraphs 3.3.19 to 3.3.22.
process of verifying that the conduct of
5.5.4 Researchers are responsible for notifying
research conforms to the approved proposal.
the review body that mechanisms for
Responsibility for ensuring that research is
monitoring are in place, and for satisfying
reliably monitored lies with the institution under
the review body that the mechanisms are
which the research is conducted.
appropriate to the research.
Mechanisms for monitoring can include:
5.5.5 At regular periods reflecting the degree
(a) reports from researchers; of risk, and at least annually and at the
completion of the project researchers
(b) reports from independent agencies
should provide reports to the relevant
(such as a data and safety monitoring
review body/ies and institution/s,
board);
including information on:
(c) review of adverse event reports;
(a) progress to date, or outcome in the
(d) random inspections of research sites, case of completed research;
data, or consent documentation; and
(b) maintenance and security of records;
(e) interviews with research participants
(c) compliance with the approved
or other forms of feedback from them.
proposal; and
(d) compliance with any conditions of
approval.
GUIDELINES
Suspension or cessation of research
Monitoring approved research
5.5.6 Researchers should inform the relevant
5.5.1 Each institution has ultimate responsibility institution/s, the review body/ies that
for ensuring, via its research governance approved the research and, wherever
arrangements, that all its approved possible, the research participants, if the
research is monitored. research project is to be discontinued
5.5.2 The frequency and type of monitoring before the expected date of completion,
should reflect the degree of risk to and why. For research at more than
research participants. one site, or research where there has
been multiple ethical review, it must be
5.5.3 Researchers have a significant clearly established, before the research
responsibility in monitoring, as they are in begins, how this information will be
the best position to observe any adverse communicated.
events or unexpected outcomes. They
should report such events or outcomes 5.5.7 Where a review body finds reason to
promptly to the relevant institution/s and believe that continuance of a research
ethical review body/ies, and take prompt project will compromise participants
welfare, it should immediately seek to
establish whether ethical approval for the
CHAPTER 5.5 : MONITORING APPROVED RESEARCH
project should be withdrawn. This process

should ensure that researchers and others
involved in the project are treated fairly
and with respect.
5.5.8 Where ethical approval for a research
project is withdrawn:
(a) the researcher, the institution/s and,
where possible, the participants
should be informed of the
withdrawal;
(b) the institution must see that the
researcher promptly suspends the
research and makes arrangements to
meet the needs of participants; and
(c) the research may not be resumed
unless either
(i) the researcher subsequently
establishes that continuance will
not compromise participants
welfare; or
(ii) the research is modified to
provide sufficient protection for
participants, the modification
is ethically reviewed, and the
modified research is approved.
5.5.9 If an institution or review body considers
that urgent suspension of research is
necessary before the process described in
paragraphs 5.5.7 and 5.5.8 is undertaken,
the instruction to stop should come via
the management of the institution.
5.5.10 In the light of reports received under
paragraph 5.5.3 and paragraph 5.5.5,
review bodies may require researchers
to amend research procedures to protect
participants. If such amendments cannot
achieve that end, a review body may rely
on the provisions of paragraphs 5.5.6 to
5.5.9.
CHAPTER 5.6 : HANDLING COMPLAINTS
CHAPTER 5.6: HANDLING COMPLAINTS
INTRODUCTION 5.6.2 Where such complaints raise the

possibility of research misconduct as
Institutions may receive complaints about described in the Australian code for the
researchers or the conduct of research, or responsible conduct of research, they
about the conduct of a Human Research Ethics should be handled in accordance with the
Committee (HREC) or other ethical review research misconduct processes specified
body. Complaints may be made by participants, in that document.
researchers, staff of institutions, or others. All
5.6.3 Where complaints about researchers
complaints should be handled promptly and
allege serious misconduct that falls
sensitively.
outside the range of research misconduct
The Australian code for the responsible conduct as described in the Australian code for
of research describes research misconduct the responsible conduct of research, they
and specifies institutional processes for dealing should be dealt with under institutional
with it. Where complaints about researchers processes for dealing with other forms of
or research raise the possibility of misconduct misconduct, for example harassment or
fitting this description, they should be dealt bullying.
with under those processes. Where complaints
5.6.4 Institutions should also establish
about researchers are serious and fall outside
procedures for receiving, handling and
that description of research misconduct, they
seeking to resolve complaints about the
should be handled under institutional processes
conduct of review bodies in reviewing
for dealing with other forms of misconduct, for
research proposals.
example harassment or bullying.
5.6.5 Where these complaints cannot be readily
There can be justifiable differences of opinion
resolved by communication between the
as to whether a research proposal meets the
complainant and the review body that is
requirements of this National Statement. For
the subject of the complaint, complainants
this reason, while this chapter provides for
should have access to a person external to
complaints about the process of review, it does
that review body to handle the complaint.
not provide for appeals by researchers against a
final decision to reject a proposal. 5.6.6 Institutions should identify a person
or agency external to the institution to
whom a person can take a complaint that
has not been resolved by the processes
GUIDELINES referred to in paragraphs 5.6.1 to 5.6.5.
5.6.1 To handle complaints about researchers 5.6.7 Institutions should publicise their
or the conduct of research, institutions complaints-handling procedures.
should:
(a) identify a person, accessible to
participants, to receive these
complaints; and
(b) establish procedures for receiving,
handling and seeking to resolve such
complaints.
CHAPTER 5.7 : ACCOUNTABILITY
CHAPTER 5.7: ACCOUNTABILITY
INTRODUCTION also have responsibilities under the

Australian code for the responsible
Responsibility for the ethical design, review conduct of research.
and conduct of human research is exercised
5.7.2 Review bodies have responsibilities
at different levels, from the detail of research
for the ethical review of research. The
conduct to the more general oversight of review
measures of accountability by which
and funding. Accordingly, responsibility is
review bodies demonstrate to institutions
exercised at the different levels by:
their fulfilment of those responsibilities
researchers (and where relevant their appear in Chapter 5.2: Responsibilities of
supervisors); HRECs, other ethical review bodies, and
researchers.
Human Research Ethics Committees
(HRECs) and other ethical review bodies; 5.7.3 Institutions have responsibilities:
institutions whose employees, resources (a) to ensure that ethical review
or facilities are involved; of research occurs. These
responsibilities are set out in Chapter
funding organisations;
5.1: Institutional responsibilities; and
agencies that set standards; and
(b) for the conduct of research. These
governments. responsibilities are set out in the
Australian code for the responsible
The line of accountability for these
conduct of research. They include
responsibilities runs:
ensuring that research is both
from researchers to review bodies and sound and lawful, and is conducted
institutions; or supervised by educated and
experienced researchers.
from review bodies and institutions to
funders and other agencies; 5.7.4 In addition to providing information
annually, institutions shall, on reasonable
from agencies to government; and
request, provide other information about
from government to the Australian public. their ethical review processes to the
NHMRC.
Typically, this accountability involves reporting
from one level to the next. 5.7.5 Institutions that are in receipt of NHMRC
research funding, or intend to remain
eligible for it, must be registered with
GUIDELINES the NHMRC. Registration will include
information about any HREC/s or other
5.7.1 Researchers have responsibilities for the review bodies which the institution has
ethical design and conduct of research. decided to use or has established.
The measures of accountability by which
researchers demonstrate, to institutions 5.7.6 The deed of agreement attached to any
and to review bodies, fulfilment of those NHMRC funding requires that institutions
responsibilities appear in Chapter 5.1: attest annually to the NHMRC in writing
Institutional responsibilities, Chapter 5.2: that their research governance and ethical
Responsibilities of HRECs, other ethical oversight processes remain compliant
review bodies and researchers, and with this National Statement and the
paragraph 3.3.22, on the monitoring of Australian code for the responsible
approved clinical research. Researchers conduct of research.
APPENDIX: PROCESS REPORT

BACKGROUND
The National Statement on Ethical Conduct in Research Involving Humans (the National Statement)
1999 has been revised in line with the National Health and Medical Research Council (NHMRC) policy
that all its guidelines be reviewed at least every five years. In September 2003 the Australian Health
Ethics Committee (AHEC), a principal committee of the NHRMC, established a working committee
to review the National Statement. The revision was undertaken jointly by the NHMRC, the Australian
Research Council (ARC), and the Australian Vice Chancellors Committee (AVCC), and the Working
Committee consisted of the following members from AHEC, the ARC and the AVCC:
Working Committee
Dr Christopher Cordner (Chair) Member of AHEC 2003 - 2006 triennium
Dr Kerry Breen Chair of AHEC 2003 - 2006 triennium
Mr Christopher Coyne Member of AHEC 2003 - 2006 triennium, Member of AHEC
2006 - 2009 triennium
Professor Joy Damousi AVCC Nominee
Associate Professor Terry Dunbar Member of AHEC 2003 - 2006 triennium, Member of AHEC
Professor Graeme Hugo ARC Nominee
Reverend Professor John Morgan Member of AHEC 2003 - 2006 triennium
Professor Elim Papadakis ARC Nominee
Associate Professor Wendy Rogers Member of AHEC 2003 - 2006 triennium
Professor Doreen Rosenthal AO Member of AHEC 2003 - 2006 triennium
Mr Noel Spurr OAM Member of AHEC 2003 - 2006 triennium
Professor Jane Stein-Parbury AVCC Nominee.
Ms Fiona Stoker Member of AHEC 2003 - 2006 triennium
Professor Colin Thomson NHMRC consultant 2003 - 2006 triennium, Chair AHEC
2006 - 2009 triennium.
Dr Nicholas Tonti-Filippini Member of AHEC 2003 - 2006 triennium, Member of AHEC
Reverend Bill Uren Member of AHEC 2003 - 2006 triennium
Secretariat
Ms Nerida Lawrentin September 2003 - June 2005
Ms Nicola Cooper June 2005 - December 2006
Mr Matthew Sammels May 2006 - March 2007
Consultant
Dr Angela Kirsner Technical Writer
Process
Following the development of a first draft, and
in accordance with section 13 of the National
Health and Medical Research Council Act 1992,
Australian Health Ethics Committee (AHEC)
undertook public consultation from January to
March 2005. This consultation resulted in 178
submissions. A second draft was then prepared
taking into account the submissions received.
A further consultation was undertaken from
January to March 2006, which resulted in 184
submissions. These submissions informed the
final draft. Details of the submissions that were
not confidential were placed on the website
during the revision process at:
http://www.nhmrc.gov.au/ethics/human/ahec/
consultation/submissions/statement.htm
http://www.nhmrc.gov.au/ethics/human/ahec/
consultation/submissions/statementsec.htm.
Experts were consulted throughout the redrafting
process on a number of issues. A workshop was
also held with several institutions that are known
to have developed models for devolving review
of low risk research, to determine the methods
of streamlining ethical review of research.
After completion of the final draft and agreement
by the AHEC from the 2006 2009 triennium,
both the Australian Research Council and the
Australian Vice Chancellors Committee were
invited to approve the final draft. This agreed
version was then presented to the Council of the
NHMRC at its 164th Session in March 2007 for
consideration.
At that Session the Council agreed to advise the
CEO that the final draft should be issued.
GLOSSARY
GLOSSARY
accountability benefit
The measures by which researchers, That which positively affects the interests
review bodies and institutions can or welfare of an individual or group.
demonstrate that their responsibilities
have been, or are being, fulfilled. Typical blood relatives
accountability measures involve reporting Close genetic relatives.
from one level of the hierarchy to a capitation payments
higher (or more general) level. Per capita payments to researchers,
adverse device event usually from sponsors of clinical trials, for
A clinical sign, symptom or condition recruiting participants for research.
that is causally related to the device cell line
implantation procedure, the presence of A term used by scientists to describe
the device, or the performance of the cells grown in the laboratory over an
device system. extended period. Cell lines can be created
adverse drug reaction from many different types of tissues and
Any noxious and unintended response to include those that will only grow for a
an unapproved medicinal product, related limited period of time as well as those
to any dose. The phrase response to an that may become immortal through
unapproved medicinal product means alteration of their genomes either through
that a causal relationship between the mutations arising naturally or induced
product and an adverse event is at least a artificially. Cell lines usually comprise a
reasonable possibility, i.e. the relationship stable population of cells, although some
cannot be ruled out. (Unapproved heterogeneity is generally present and
medicinal product here includes changes in the characteristics of the cells
approved products used at levels or in may occur over time.
ways that are unapproved). child
or Subject to law in the relevant jurisdiction,
a minor who lacks the maturity to make a
A noxious and unintended response to decision whether or not to participate in
a drug that occurs at doses of marketed research.
medical products normally used in See also young person
humans for prophylaxis, diagnosis or
therapy of diseases or for modification of clinical trial
physiological function. A form of research designed to find out
the effects of an intervention, including a
adverse event (device) treatment or diagnostic procedure.
Any undesirable clinical occurrence in
a subject, whether it is considered to community
be device-related or not, that includes a A collection of individuals, which may
clinical sign, symptom or condition and/or extend from the whole population to a
an observation of an unintended technical smaller grouping associated by cultural,
performance or performance outcome of ethnic, geographical, social or political
the device. factors or some other commonality.
beneficence
Doing good to others: here also includes
non-maleficence, avoiding doing harm.
GLOSSARY
confidentiality ethics
The obligation of people not to use The concepts of right and wrong, justice
private information whether private and injustice, virtue and vice, good
because of its content or the context of its and bad, and activities to which these
communication - for any purpose other concepts apply.
than that for which it was given to them.
genetic material
conflict of interest Any source of DNA or RNA that can be
In the research context: where a persons tested to obtain genetic information. It
individual interests or responsibilities have includes cells (whether isolated or as part
the potential to influence the carrying of tissues) and extracted DNA and RNA.
out of his or her institutional role or
harm
professional obligations in research;
That which adversely affects the
or where an institutions interests or
interests or welfare of an individual or
responsibilities have the potential to
a group. Harm includes physical harm,
influence the carrying out of its research
anxiety, pain, psychological disturbance,
obligations.
devaluation of personal worth and social
consent disadvantage.
A persons or groups agreement,
HREC
based on adequate knowledge and
Human Research Ethics Committee.
understanding of relevant material, to
participate in research. human tissue
The substance, structure, and texture
data
of human organs or body parts when
Pieces of information.
separated from human beings; includes
databank blood, blood components and waste
A systematic collection of data, whether products.
individually identifiable, re-identifiable or
non-identifiable. identifier
Details attached to data, such as name
deception and/or contact information, that identify
Where relevant material is withheld from an individual.(It may remain possible
research participants. and/or they are to identify an individual even after all
intentionally misled about procedures identifiers have been removed, if a code
and/or purposes of research. number has been assigned and there is
discomfort access to the code, or if the data or tissue
A negative accompaniment or effect of can be cross-linked to other data or tissue
research, less serious than harm. banks).
ethical / unethical inconvenience

Right or morally acceptable / wrong or A minor negative accompaniment or
morally unacceptable. effect of research, less serious than
discomfort.
ethical review
Review of research by an HREC or other individually identifiable data
body. Data from which the identity of a specific
individual can reasonably be ascertained.
ethical review body
Body set up to carry out ethical review of
human research.
GLOSSARY
integrity Opt-out approach

Honesty and probity as qualities of A method used in the recruitment
character and behaviour. of participants into research where
information is provided to the potential
justice
participant regarding the research and
Regard for the human sameness shared
their involvement and where their
by all human beings, expressed in a
participation is presumed unless they take
concern for fairness or equity. Includes
action to decline to participate.
three aspects of justice: procedural
justice, involving fair methods of participant (in research)
making decisions and settling disputes; Anyone who is the subject of research in
distributive justice, involving fair any of the ways set out in Purpose, scope
distribution of the benefits and burdens of and limits of this document.
society; and corrective justice, involving
personal information
correcting wrongs and harms through
Information by which individuals can
compensation or retribution.
be identified.
limited disclosure
placebo (in research)
Not disclosing to research participants
A substance not containing an active
all of the aims and/or methods of the
agent under study, administered to some
research.
participants to compare the effects of
low risk (research) the active agent administered to other
Research in which the only foreseeable participants.
risk is one of discomfort.
privacy
monitoring (of research) A domain within which individuals and
The process of verifying that the conduct groups are entitled to be free from the
of research conforms to the approved scrutiny of others.
proposal.
protocol
negligible risk A document that provides the
Research in which there is no foreseeable background, rationale and objectives of
risk of harm or discomfort, and any the research and describes its design,
foreseeable risk is of inconvenience only. methodology, organisation and the
conditions under which it is to be
non-identifiable data
performed and managed.
Data that have never been labelled with
individual identifiers or from which qualitative research
identifiers have been permanently Research involving the studied use
removed, and by means of which no of empirical materials such as case
specific individual can be identified. studies, personal experience, life
A subset of non-identifiable data are stories, interviews, observations,
those that can be linked with other data and cultural texts.
so it can be known they are about the
same data subject, although the persons re-identifiable data
identity remains unknown. Data from which identifiers have been
removed and replaced by a code, but it
non-therapeutic (intervention) remains possible to re-identify a specific
An intervention not directed towards individual by, for example, using the code
the benefit of the individual but rather or linking different data sets.
towards improving scientific knowledge
or technical application, or the benefit of
others.
GLOSSARY
research serious unexpected suspected adverse reaction

Includes at least investigation undertaken A serious adverse event (see definition
to gain knowledge and understanding or above) for which there is some degree of
to train researchers. probability that the event is an adverse
reaction to the administered drug, and the
research misconduct
adverse reaction is unexpected.
Includes fabrication, falsification,
plagiarism or deception in proposing, sponsor
carrying out or reporting the results of An individual, company, institution or
research, and failure to declare or manage organisation that takes responsibility
a serious conflict of interest. Also includes for the initiation, management, and/or
failure to follow research proposals financing of research.
approved by a research ethics committee,
therapeutic (intervention)
particularly where this failure may result
Intervention directed towards the
in unreasonable risk or harm to humans,
wellbeing of the individual concerned.
other animals or the environment. Also
includes the wilful concealment or unexpected adverse drug reaction
facilitation of research misconduct by An adverse reaction, the nature or
others severity of which is not consistent with
the applicable scientific information (e.g.
respect for human beings
Investigators Brochure for an unapproved
Recognition that each human being has
investigational product or Product
value in himself or herself.
Information (PI) document or similar for
risk an approved, marketed product).
The function of the magnitude of a harm
voluntary participation
and the probability that it will occur.
Participation that is free of coercion and
serious adverse event pressure.
Any untoward medical occurrence that:
young person
results in death; In the context of this National Statement,
a minor who (subject to the law in
is life-threatening (NOTE: The term
the relevant jurisdiction) may have the
life-threatening refers to an event/ maturity to make a decision whether or
reaction in which the patient was not to participate in research.
at risk of death at the time of the See also child
event/reaction; it does not refer to an
event/reaction which hypothetically
might have caused death if it were
more severe);
requires inpatient hospitalisation
or prolongation of existing
hospitalisation;
results in persistent or significant
disability/incapacity;
is a congenital anomaly/birth defect;
or
is a medically important event or
reaction.
INDEX
INDEX
Aboriginal participants, Chapter 4.7 blood relatives
accountability, Chapter 5.7 ethical issues for, 3.5.14
action research, Chapter 3.1 (Introduction) standing parental consent, 4.2.104.2.12
adverse drug reactions (ADRs), 3.3.20
application of values and principles, Section 1
cessation of research, 5.5.65.5.10
appointment of HREC members, 5.1.345.1.36
children, Chapter 4.2, see also fetal involvement
approval withdrawn after review, 5.5.75.5.10 in research
archival research, Chapter 3.1 (Introduction) neonates, 4.1.21, 4.4.3
ART Guidelines, Chapter 3.4 clinical research, Chapter 3.3 (Introduction)
assessment of risk, Chapter 2.1 coercion of consent, 2.2.9
Australian code for the responsible conduct of cognitively impaired participants, Chapter 4.5
research, Preamble (Research govenance)
commercial tissue use, Chapter 3.4
Australian Health Ethics Committee, Preamble
(Authors of this National Statement) communication with review bodies, 5.2.135.2.22
Australian Research Council Act 2001, Preamble complaint handling, Chapter 5.6
(Authors of this National Statement) composition of HRECs, 5.1.295.1.33
Australian Vice-Chancellors Committee confidentiality in genetic research, 3.5.133.5.14
(AVCC), Preamble (Authors of this National
Statement) conflicts of interest, Chapter 5.4
autonomy, value of, Section 1 (Introduction) conscientious objection, 3.4.17
consent
banked data, 3.2.93.2.12
banked data, Chapter 3.2
prospective collections of human
beneficence, 1.61.9 biospecimens for research, 3.4.13.4.4
central to ethical conduct, Section 1 qualifying or waiving, Chapter 2.3, 3.4.12
(Introduction)
qualitative methods, 3.1.163.1.17
cognitively impaired participants, 4.5.4
requirements for, Chapter 2.2
dependent or unequal relationships,
4.3.64.3.7 standing parental consent, 4.2.104.2.12
illegal activities, participants involved in, cross-border research, Chapter 4.8
4.6.4 custodians of data, 3.2.93.2.12
Indigenous participants, 4.7.74.7.9
medically dependent participants, 4.4.34.4.4
overseas research, 4.8.144.8.18 data
paediatric research, 4.2.5 in databanks, Chapter 3.2
qualitative methods, 3.1.103.1.14 qualitative collection, Chapter 3.1

(Introduction)
benefits of research, Chapter 2.1
usage of, 2.2.142.2.18, 3.2.3-3.2.7
best interests of the child, 4.2.134.2.14
INDEX
Data and Safety Monitoring Boards, 3.3.20

databanks, Chapter 3.2 families, see blood relatives
de-identified data, Chapter 3.2 (Introduction) focus groups, Chapter 3.1 (Introduction)
decision making by review bodies, 5.2.215.2.22 fetal involvement in research, Chapter 4.1
declining consent, 2.2.192.2.20 future use of data or tissue, 2.2.142.2.18
dependent relationships, Chapter 4.3
devaluation of personal worth, Chapter 2.1
(Introduction) gamete research, Chapter 3.4 (Introduction)
disclosure gauging risk, Chapter 2.1 (Introduction)
limiting, 2.3.12.3.4 genetic research, Chapter 3.5
that research has ceased, 5.5.65.5.10 genomes, Chapter 3.5 (Introduction)
discomfort from research, Chapter 2.1 governance and ethical review, Section 5
(Introduction)
discontinuance of trials, 3.3.23
handling complaints, Chapter 5.6
distributive justice, Section 1, see also justice
Helsinki Declaration, Preamble
documentation by review bodies, 5.2.235.2.27
human genetics, Chapter 3.5
DSMBs, 3.3.20
human research, Preamble; Purpose, scope and
duplication, minimising, Chapter 5.3 limits of this document
Human Research Ethics Committees, The
National Statement: A user guide, Chapter 5.1
E-groups, Chapter 3.1 (Introduction)
human biospecimens, Chapter 3.4
economic harms, Chapter 2.1 (Introduction)
embryos, Chapter 3.4, Chapter 4.1
see also fetal involvement in research illegal activities, participants involved in,
Chapter 4.6
emergency care research, 4.4.6
imported human biospecimens, 3.4.133.4.15
establishment of HRECs, 5.1.265.1.28
inconvenience from research, Chapter 2.1
ethical conduct (Introduction)
background to, Preamble Indigenous participants, Chapter 4.7
values and principles, Section 1 individually identifiable data, Chapter 3.2
Ethical guidelines on the use of assisted (Introduction)
reproductive technology in clinical practice infants, see children
and research, Chapter 3.4
innovations in clinical practice, Chapter 3.3
ethical review (Introduction)
approval withdrawn after, 5.5.65.5.10 institutional responsibilities, Chapter 5.1
governance and, Section 5 insurance requirements, 3.3.243.3.25
when needed?, Purpose, scope and limits of integrity in research, Section 1, see also merit and
this document integrity
exempted research, 5.1.225.1.23 intellectually disabled participants, Chapter 4.5
experts at review body meetings, 5.2.185.2.20 intensive care research, 4.4.7
extended consent, 2.2.142.2.18 international research, Chapter 4.8
INDEX
interventions, Chapter 3.3 databanks, 3.2.13.2.2

interviews, Chapter 3.1 (Introduction) dependent or unequal relationships,
4.3.14.3.3
justice, 1.41.5 genetic research, 3.5.13.5.3
central to ethical conduct, Section 1 illegal activities, participants involved in,
(Introduction) 4.6.14.6.2
clinical trials, 3.3.6 Indigenous participants, 4.7.14.7.4
cognitively impaired participants, Chapter 4.5 medically dependent participants, 4.3.14.3.3
dependent or unequal relationships, overseas research, 4.8.14.8.10
4.3.44.3.5 paediatric research, 4.2.14.2.3
genetic research, 3.5.4 qualitative methods, 3.1.13.1.8
illegal activities, participants involved in, minimising duplication, Chapter 5.3
4.6.3
minimising risk, Chapter 2.1 (Introduction)
Indigenous participants, 4.7.54.7.6
monitoring
medically dependent participants, 4.4.2
approved research, Chapter 5.5
overseas research, 4.8.114.8.13
clinical trials, 3.3.193.3.22
paediatric research, 4.2.4
qualitative methods, 3.1.9
National Health and Medical Research Council
Act 1992, Preamble
key informant interviews, Chapter 3.1 negligible risk research, Chapter 2.1
(Introduction) (Introduction)
neonatal intensive care research, 4.4.3
legal issues, Purpose, scope and limits of this non-identifiable data, Chapter 3.2 (introduction)
document non-participants, risks to, Chapter 2.1
harm from research, Chapter 2.1 (Introduction), see also third parties
(Introduction) Nuremberg Code, Preamble
protection for ethical review team, 5.1.9
life story, Chapter 3.1 (Introduction)
observational studies, Chapter 3.1 (Introduction)
limited disclosure, Chapter 2.3
on-line research, Chapter 3.1 (Introduction)
limits of National Statement, Purpose, scope and
limits of this document opt-out approach, Chapter 2.3
low risk research, Purpose, scope and oral history, Chapter 3.1 (Introduction)
limits of this document, Chapter 2.1
(Introduction), 5.1.185.1.25 overseas research, Chapter 4.8
oversight of research, 5.1.105.1.17
medical care, patients dependent on, Chapter 4.4

paediatric research, Chapter 4.2
meetings of HRECs, 5.2.285.2.31
participants in research
mentally ill participants, Chapter 4.5
defined, Purpose, scope and limits of
merit and integrity, 1.11.3 this document
clinical trials, 3.3.13.3.5 ethical issues for, Section 4
cognitively impaired participants, 4.5.14.5.2 interests of, 5.2.165.2.17
INDEX
payment of, 2.2.102.2.11 respect, 1.101.13

patients dependent on medical care, Chapter 4.4 clinical trials, 3.3.133.3.18
payment for participants, 2.2.102.2.11 cognitively impaired participants, 4.5.54.5.11
Phase I, II, III and IV trials, Chapter 3.3 dependent or unequal relationships,
(Introduction) 4.3.84.3.10
physical harm, Chapter 2.1 (Introduction) illegal activities, participants involved in,
4.6.54.6.7
placebos, 3.3.10
Indigenous participants, 4.7.10-4.7.12
pregnant women, Chapter 4.1
medically dependent participants, 4.4.5-4.4.8
pressure to consent, 2.2.9
overseas research, 4.8.19-4.8.21
principles of ethical conduct, Section 1
paediatric research, 4.2.6-4.2.9
process report, Appendix
qualitative methods, 3.1.15-3.1.17
psychological harm, Chapter 2.1
review body procedures, Chapter 5.2
purpose of National Statement, Purpose scope
and limits of this document rigour of research, Chapter 3.1.8
risk management, Preamble, Chapter 2.1,
3.3.73.3.10
qualifying consent, Chapter 2.3
qualitative methods, Chapter 3.1
sample informant interviews, Chapter 3.1
sampling strategy, 3.1.5
randomised clinical trials, Chapter 3.3 saturation, 3.1.6
(Introduction)
scope of National Statement, Purpose, scope and
re-identifiable data, Chapter 3.2 (Introduction) limits of this document
record-keeping, 3.3.113.3.12, 5.2.235.2.27 semi-structured interviews, Chapter 3.1
reimbursement of participants, 2.2.102.2.11 serious unexpected serious adverse reactions,
relatives, see blood relatives, third parties 3.3.20 (b)
renegotiating consent, 2.2.8 social harms, Chapter 2.1
requirements for consent, Chapter 2.2 specific consent, 2.2.14 (a)

(Introduction) standing parental consent, 4.2.104.2.12
research structured interviews, Chapter 3.1 (Introduction)
defined, Purpose, scope and limits of SUSARs, 3.3.20
this document
suspension of research, Chapter 5.5
governance and ethical review, Section 5
harm from, Chapter 2.1 (Introduction)
merit and integrity, Section 1 terminal care research, 4.4.4
researcher responsibilities, 5.2.55.2.12 termination of pregnancy, 4.1.114.1.23
risks and benefits, Chapter 2.1 therapies, Chapter 3.3
Research Code, Preamble, Chapter 5.6 third parties, Chapter 2.1 (Introduction);
2.2.122.2.13, see also blood relatives;
research governance, Preamble non-participants, risks to
Research Involving Human Embryos Act 2002,
Chapter 3.4
INDEX
tissue
fetal, Chapter 4.1
future use of, 2.2.142.2.18
human biospecimens Chapter 3.4
tissue banks, Chapter 3.2 (Introduction)
Torres Strait Islander participants, Chapter 4.7
unconscious people, research with, 4.4.8

unequal relationships, Chapter 4.3
unspecified consent, 2.2.142.2.18
unstructured interviews, Chapter 3.1
(Introduction)
Values and Ethics guidelines, Chapter 4.7

(Introduction)
values of ethical conduct, Section 1
waiving consent, 2.3.92.3.12

withdrawal
of approval, 5.5.65.5.10
of consent, 2.2.192.2.20
young people, Chapter 4.2

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National Statement on Ethical

Conduct in Human Research

Australian Government 2007

Australian Government 2007

Purpose, scope and limits of this document 6

Section 1 Values and principles of ethical conduct 9

Section 2 Themes in research ethics: risk and benefit, consent 12

Section 3 Ethical considerations specific to research methods or fields 23

Section 4 Ethical consideration specific to participants 46

Section 5 Processes of research governance and ethical review 68

Appendix: Process Report 85

THE NATIONAL STATEMENT:

This National Statement does not exhaust the

ETHICAL BACKGROUND Since earliest times, human societies have

Research governance Authors of this National Statement

The Australian Research Council Act 2001

PURPOSE, SCOPE AND LIMITS OF THIS

PURPOSE What is research?

The National Statement is therefore designed to Research includes work of direct

Some human research is subject to specific

SECTION 1: VALUES AND PRINCIPLES

INTRODUCTION Reference to these values throughout the

GUIDELINES 1.3 Research that is conducted with integrity

SECTION 2: THEMES IN RESEARCH

CHAPTER 2.1: RISK AND BENEFIT

INTRODUCTION Assessment of risk

Harm, discomfort and inconvenience Examples of risks to non-participants include

social harms: including damage to social

sion, Ethical and Policy Issues in Research Involving

For those gauging the severity of the harm, Managing risks

Do the benefits justify the risks?

2.1.4 In determining the existence, likelihood

CHAPTER 2.2: GENERAL REQUIREMENTS

2.2.6 Information on the following matters Renegotiating consent

lawful authority for the potential The necessarily limited information

CHAPTER 2.3: QUALIFYING OR WAIVING

INTRODUCTION information provided, and they understand that

a) there are no suitable alternatives 2.3.3 Where research involving limited

c) there is no known or likely reason d) reasonable attempts are made for

a) the value of exposing the illegal

SECTION 3: ETHICAL CONSIDERATIONS

CHAPTER 3.1: QUALITATIVE METHODS

INTRODUCTION observations, and cultural texts. It may bring

eliciting contextual data in order to group; for example, interviews

2 of this National Statement. The guidelines in qualitative studies, many sampling

3.1.11 Where possible, participants should

CHAPTER 3.2: DATABANKS

INTRODUCTION permanently removed, and by means

Banked data may be deposited in a warehouse, Data usage

CHAPTER 3.3: INTERVENTIONS AND THERAPIES,

INTRODUCTION Whether a change in an individuals investigation

These studies are undertaken in a small Application of randomised trial

3.3.3 Researchers should show that: Justice

Records (c) the possible effects of an unequal

The clearer it becomes that one treatment

CHAPTER 3.4: HUMAN BIOSPECIMENS IN

INTRODUCTION Ethics Committee (HREC) as part of a licence

(g) whether their biospecimens and Ethical review of research involving

Transition provisions for existing

CHAPTER 3.5: HUMAN GENETICS

INTRODUCTION this chapter differentiate between research that

(a) The plan should: (iii) access to, or a recommendation

(d) that, if such consent is not given,