Australian National Statement in Ethical Conduct 2018

National Statement on Ethical
Conduct in Human Research
2007 (Updated 2018)

National Statement on Ethical
Conduct in Human Research
2007 (Updated 2018)
Developed jointly by
National Health and Medical Research Council
Australian Research Council
Universities Australia
Amendments Amendment details Start date
Revoke existing Section 3 and Glossary New Section 3 July 2018
and Glossary
Changes to Section 5 Changes to Chapters July 2018
5.1, 5.2 and 5.5
Revoke existing Chapter 2.3 New Chapter 2.3 14 May 2015
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: https://www.nhmrc.gov.au/_files_nhmrc/file/publications/e72_national_statement_
summary_updates_v6_150514.pdf for a complete history of updates to this document.
Publication Details
Publication title: National Statement on Ethical Conduct in Human Research 2007
(Updated 2018)
Published: 2007 (Updated 2018)
Publisher: National Health and Medical Research Council
NHMRC Publication reference: E72
Online version: www.nhmrc.gov.au/guidelines/publications/e72
ISBN Print: 1864962690
ISBN Online: 1864962755
Suggested citation: National Statement on Ethical Conduct in Human Research 2007
(Updated 2018). The National Health and Medical Research
Council, the Australian Research Council and Universities Australia.
Commonwealth of Australia, Canberra
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CONTENTS
CONTENTS
The National Statement: A User Guide 1
Preamble3
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 in the design, development,

review and conduct of research 23
Chapter 3.1: The elements of research 25
Chapter 3.2: Human biospecimens in laboratory based research 42
Chapter 3.3: Genomic research 47
Chapter 3.4: Animal-to-human xenotransplantation 56
Section 4 Ethical considerations specific to participants 61

Chapter 4.1: Women who are pregnant and the human fetus 61
Chapter 4.2: Children and young people 65
Chapter 4.3: People in dependent or unequal relationships 68
Chapter 4.4: People highly dependent on medical care who may be
unable to give consent 70
Chapter 4.5: People with a cognitive impairment, an intellectual disability,
or a mental illness 73
Chapter 4.6: People who may be involved in illegal activities 75
Chapter 4.7: Aboriginal and Torres Strait Islander peoples 77
Chapter 4.8: People in other countries 80
NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED 2018) | iii
CONTENTS
Section 5 Processes of research governance and ethical review 83

Chapter 5.1: Institutional responsibilities 83
Chapter 5.2: Responsibilities of HRECs, other ethical review bodies, and researchers 89
Chapter 5.3: Minimising duplication of ethical review 93
Chapter 5.4: Conflicts of interest 94
Chapter 5.5: Monitoring approved research 96
Chapter 5.6: Handling complaints 98
Chapter 5.7: Accountability 99
Glossary100
Index104
iv | NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED 2018)
THE NATIONAL STATEMENT: A USER GUIDE
THE NATIONAL STATEMENT:

A USER GUIDE
This National Statement on Ethical Conduct Chapter 5.1) what level of ethical review
in Human Research (‘National Statement’) is is suitable.
intended for use by:
Chapters 2.2 and 2.3 will help to
• any researcher conducting research with identify the information that needs to
human participants; be disclosed to participants. It will help
researchers to draft information for
• any member of an ethical review body
participants and plan the consent process
reviewing that research;
(or develop a proposal for waiver of
• those involved in research governance; consent). And it will help reviewers to
and 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
are entitled to receive, and what
groups might use it. Note that ‘review body’
their participation in research will
refers both to Human Research Ethics
characteristically involve.
Committees (HRECs) and to non-HREC
review bodies. • Section 3: Ethical considerations in
the design, development, review and
The Preamble sets out the historical context
conduct of research 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,
methods proposed.
with 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
and reviewers to identify ethical
that apply to all human research. It is
matters relating to specific categories
essential that researchers and review
of research participants. Participants
bodies consider these values and principles
in these categories will also find this
and be satisfied that the research proposal
Section valuable.
addresses and reflects them.
• Section 5: Processes of research governance
• Section 2: Themes in research ethics:
and ethical review will help those involved
risk and benefit, consent discusses the
in research governance to understand
concept of risk in research and the role
their responsibilities for research ethics
of participants’ consent – themes in all
and ethical review and monitoring of
human research – and is again essential
human research, and provides criteria for
for all users.
their accountability. Chapter 5.2 will help
Chapter 2.1 will help researchers and researchers and reviewers to identify their
reviewers to understand and describe responsibilities in relation to the ethical
the level of risk involved in the planned review of research.
research, and how to minimise, justify and
manage that risk, and (with reference to
NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED 2018) | 1

THE NATIONAL STATEMENT: A USER 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 2018)

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 one’s 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 ‘do’s’ and ‘don’ts’ – 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
since the Second World War. The judgment
Human research is research conducted with
of the Nuremberg military tribunal included
or about people, or their data or tissue. It has
ten principles about permissible medical
contributed enormously to human good. Much
experiments, since referred to as the Nuremberg
human research carries little risk and in Australia
Code. Discussion of these principles led the
the vast majority of human research has been
World Medical Assembly in 1964 to adopt what
carried out in a safe and ethically responsible
came to be known as the Helsinki Declaration,
manner. But human research can involve
revised several times since then. The various
significant risks and it is possible for things to
international human rights instruments that
go wrong. Sometimes risks are realised despite
have also emerged since the Second World
the best of intentions and care in planning and
War emphasise the importance of protecting
practice. Sometimes they are realised because
human beings in many spheres of community
of technical error or ethical insensitivity, neglect
life. During this period, written ethical
or disregard. On rare occasions the practice
guidelines have also been generated in many
of research has even involved the deliberate
areas of research practice as an expression of
and appalling violation of human beings –
professional responsibility.
notoriously, the Second World War experiments
in detention and concentration camps. But what is the justification for ethical research
guidelines as extensive as this National Statement,
This range of possibilities can give rise to
and for its wide-reaching practical authority?
important and sometimes difficult ethical
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, 2018 (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.
R esearch 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 Universities
(HRECs) and others conducting ethical review Australia (UA). This joint undertaking reflects a
of research, but also emphasises institutions’ widely shared conviction that there is a need for
responsibilities for the quality, safety and ethical ethical guidelines that are genuinely applicable
acceptability of research that they sponsor or to all human research; and it gives expression
permit to be carried out under their auspices. 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 in to issue human research guidelines precisely
research; funding organizations; agencies that set as developed by the Australian Health Ethics
standards; and governments. While the processes Committee (AHEC) and provided to the CEO by
of ethical review are important in this field, the Council. AHEC is established by the NHMRC
individual researchers and the institutions within Act as a Principal Committee of the NHMRC.
which they work hold primary responsibility for All the guidelines in this National Statement
seeing that their research is ethically acceptable. that are applicable to the conduct of medical
research involving humans are issued by the
NHMRC in fulfilment of this statutory obligation.

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.
Universities Australia (UA) is the peak body
representing Australia’s 39 comprehensive
universities in the public interest, both nationally
and internationally. Its primary role is to
advocate for regulatory, policy and fiscal settings
conducive to a world-class university system.

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 Exercise (RAE) definition of research is
the community. somewhat wider:
The National Statement is therefore designed ‘Research’… includes work of direct

to 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 where these lead to new or substantially
of research. improved insights; and the use of
existing knowledge in experimental
The National Statement will help them to development to produce new or
meet their responsibilities: to identify issues substantially improved materials, devices,
of ethics that arise in the design, review and products and processes, including design
conduct of human research, to deliberate about and construction. It excludes routine
those ethical issues, and to justify decisions testing and routine analysis of materials,
about them. components and processes such as for
the maintenance of national standards,
Use of this National Statement as distinct from the development of new
analytical techniques. It also excludes the
This National Statement must be used to development of teaching materials that do
inform the design, ethical review and conduct not embody original research.1
of human research that is funded by, or takes
place under the auspices of, any of the bodies To enable comparative assessment of academic
that have developed this National Statement activity, this definition sought to include the
(NHMRC, ARC, UA). widest range of creative and experimental
activities. Many items in the definition are
In addition, the National Statement sets national uncontentious, but there may be disagreement
standards for use by any individual, institution about some – for example, ‘the invention and
or organisation conducting human research. generation of new…images, performances,
This includes human research undertaken by
governments, industry, private individuals, 1
Higher Education Funding Council for England,
organisations, or networks of organisations. 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

artefacts…where these lead to new or In addition, the conduct of human research

substantially improved insights’ – since this often has an impact on the lives of others
could count poetry, painting and performing arts who are not participants. When this impact
as research. is reasonably foreseeable, it may raise ethical
questions for researchers and for those ethically
For the purposes of this National Statement, two
reviewing research.
further questions are more important than any
definition of research:
When is ethical review needed?
• What is human research?
Institutions are responsible for establishing
• When and by what means does human procedures for the ethical review of human
research, or other activities such as quality research. That review can be undertaken at
assurance or improvement, or clinical various levels, according to the degree of risk
audit, need ethical review? (See Ethical involved in the research (see Section 2: Themes
Considerations in Quality Assurance and in research ethics: risk and benefit, consent, and
Evaluation Activities, NHMRC 2014) Chapter 5.2: Responsibilities of HRECs, other
ethical review bodies, and researchers). Research
What is human research? with more than a low level of risk (as defined in
paragraph 2.1.6,) must be reviewed by an HREC.
Human research is conducted with or about
Research involving no more than low risk may
people, or their data or tissue. Human
be reviewed under other processes described in
participation in research is therefore to be
paragraphs 5.1.18 to 5.1.21. Institutions may also
understood broadly, to include the involvement
determine that some human research is exempt
of human beings through:
from ethical review (see paragraphs 5.1.22 and
• taking part in surveys, interviews or focus 5.1.23).
groups;
A judgement that a human research proposal
• undergoing psychological, physiological meets the requirements of this National
or medical testing or treatment; Statement and is ethically acceptable must be
made before research can begin and before full
• being observed by researchers;
funding for the proposal is released.
• researchers having access to their
personal documents or other materials; Ethics and law in human research
• the collection and use of their body Human research is governed by Australian
organs, tissues or fluids (eg skin, blood, law that establishes rights for participants and
urine, saliva, hair, bones, tumour and imposes general and specific responsibilities on
other biopsy specimens) or their exhaled researchers and institutions. Australian common
breath; law obligations arise from the relationships
• access to their information (in individually between institutions, researchers and participants.
identifiable, re-identifiable or non- Contractual arrangements may impose obligations
identifiable form) as part of an existing on research funders and institutions.
published or unpublished source or This National Statement focuses on the ethical
database. aspects of the design, review and conduct of
The term ‘participants’ is therefore used very human research. Research ethics is only part
broadly in this National Statement to include of an institution’s responsibilities for research
those who may not even know they are the governance. Compliance with legal obligations
subjects of research; for example, where the need (statutory or otherwise) forms another part, which
for their consent for the use of their tissue or data is not within the scope of the National Statement.
has been waived by a Human Research Ethics
Committee (HREC).

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 research that, at all stages, human research requires
participants is the ground on which human ethical reflection that is informed by them. The
research is conducted. The values set out in this order in which they are considered reflects the
section – respect for human beings, research order in which ethical considerations commonly
merit and integrity, justice, and beneficence – arise in human research.
help to shape that relationship as one of trust,
Research merit and integrity are discussed first.
mutual responsibility and ethical equality. For this
Unless proposed research has merit, and the
reason, the National Statement speaks of research
researchers who are to carry out the research have
‘participants’ rather than ‘subjects’.
integrity, the involvement of human participants in
While these values have a long history, they are the research cannot be ethically justifiable.
not the only values that could inform a
At a profound level, justice involves a regard
document of this kind. Others include altruism,
for the human sameness that each person
contributing to societal or community goals,
shares with every other. Human beings have
and respect for cultural diversity, along with the
a deep need to be treated in accordance with
values that inform Ethical conduct in research
such justice, which includes distributive justice
with Aboriginal andTorres Strait Islander Peoples
and procedural justice. In the research context,
and communities: Guidelines for researchers
distributive justice will be expressed in the
and stakeholders.
fair distribution of the benefits and burdens
However, the values of respect, research merit of research, and procedural justice in ‘fair
and integrity, justice, and beneficence have treatment’ in the recruitment of participants
become prominent in the ethics of human and the review of research. While benefit to
research in the past six decades, and they humankind is an important result of research,
provide a substantial and flexible framework it also matters that benefits of research are
for principles to guide the design, review and achieved through just means, are distributed
conduct of such research. This National fairly, and involve no unjust burdens.
Statement is organised around these values,
Researchers exercise beneficence in several
and the principles set out in paragraphs 1.1
ways: in assessing and taking account of
to 1.13 give them practical expression.
the risks of harm and the potential benefits
Among these values, respect is central. of research to participants and to the wider
It involves recognising that each human being community; in being sensitive to the welfare and
has value in himself or herself, and that this interests of people involved in their research;
value must inform all interaction between and in reflecting on the social and cultural
people. Such respect includes recognising the implications of their work.
value of human autonomy – the capacity to
Respect for human beings is the common thread
determine one’s own life and make one’s own
through all the discussions of ethical values.
decisions. But respect goes further than this.
Turning to it as the final value is a reminder that
It also involves providing for the protection
it draws together all of the ethical deliberation
of those with diminished or no autonomy, as
that has preceded it.
well as empowering them where possible and
protecting and helping people wherever it The design, review and conduct of research
would be wrong not to do so. 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
studies. This does not exclude the
inclusion of categories of research
possibility of novel research for
participants is fair, and is accurately
which there is little or no literature
described in the results of the
available, or research requiring a
research;
quick response to an unforeseen
situation; (b) the process of recruiting participants
is fair;
(d) designed to ensure that respect for
the participants is not compromised (c) there is no unfair burden of
by the aims of the research, by participation in research on
the way it is carried out, or by the particular groups;
results;
(d) there is fair distribution of the
(e) conducted or supervised by benefits of participation in research;
persons or teams with experience,
qualifications and competence that (e) there is no exploitation of
are appropriate for the research; and participants in the conduct of
research; and
(f ) conducted using facilities and
resources appropriate for the (f) there is fair access to the benefits of
research. research.
1.2 Where prior peer review has judged that 1.5 Research outcomes should be made
a project has research merit, the question accessible to research participants in a
of its research merit is no longer subject way that is timely and clear.
to the judgement of those ethically
reviewing the research. Beneficence
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
(b) clarifying for participants the
make their own decisions or have
potential benefits and risks of the
diminished capacity to do so, respect
research; and
for them involves empowering them
(c) the welfare of the participants in the where possible and providing for their
research context. protection 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 5.5.7 to 5.5.10).
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 set of
this recognition includes abiding by the rules. Their application should not be mechanical.
values of research merit and integrity, It always requires, from each individual,
justice and beneficence. Respect also deliberation on the values and principles, exercise
requires having due regard for the of judgement, and an appreciation of context.
welfare, beliefs, perceptions, customs
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 minimised;
these 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 participant’s 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
No list of harms can be exhaustive, but one on family or friends, or infectious disease
helpful classification identifies the following risks to the community. Some social research
kinds of potential harms in research2: may carry wider social or economic risks; for
example, research in a small community into
• physical harms: including injury, illness, attitudes to specific subpopulations may lead
pain; to unfair discrimination or have effects on
• psychological harms: including feelings social cohesion, property values, or business
of worthlessness, distress, guilt, anger or investment.
fear related, for example, to disclosure Harms that may arise from research misconduct
of sensitive or embarrassing information, or fraud, and harms to members of research
or learning about a genetic possibility of teams from other forms of misconduct (for
developing an untreatable disease; example, harassment or bullying) are addressed
• devaluation of personal worth: including primarily in the Australian code for the
being humiliated, manipulated or in other responsible conduct of research. These forms of
ways treated disrespectfully or unjustly; misconduct may, of course, also lead to potential
harms to participants.
• social harms: including damage to social
networks or relationships with others;
discrimination in access to benefits, Low risk and negligible risk research
services, employment or insurance; social The expression ‘low risk research’ describes
stigmatisation; and findings of previously research in which the only foreseeable risk is
unknown paternity status; one of discomfort. Research in which the risk for
• economic harms: including the imposition participants is more serious than discomfort is
of direct or indirect costs on participants; not low risk.
• legal harms: including discovery and The expression ‘negligible risk research’
prosecution of criminal conduct. describes research in which there is no
foreseeable risk of harm or discomfort; and any
Less serious than harm is discomfort, which can foreseeable risk is no more than inconvenience.
involve body and/or mind. Discomforts include,
for example, minor side-effects of medication, Requirements for the ethical review of low risk
the discomforts related to measuring blood research and negligible risk research are set out
pressure, and anxiety induced by an interview. in paragraphs 5.1.18 to 5.1.23.
Where a person’s reactions exceed discomfort

and become distress, they should be viewed as Gauging risk
harms. Gauging risk involves taking into account:
Less serious again is inconvenience. Examples • the kinds of harm, discomfort or
of inconvenience may include filling in a form, inconvenience that may occur;
participating in a street survey, or giving up time
to participate in research. • the likelihood of these occurring; and
• the severity of any harm that may occur.
These judgements should be based on the
available evidence. The evidence may be
Adapted from National Bioethics Advisory
2
quantitative or qualitative. In either case, the
Commission, Ethical and Policy Issues in Research process needs to be transparent and defensible.
Involving Human Participants, Bethesda, 2001
pp.71–72

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
participants will be relevant. and 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,
justified by the benefits, either the research the more certain it must be both that the risks
aims or the methods by which they are to be will be managed as well as possible, and that
achieved, or both, will need to be reconsidered the participants clearly understand the risks
if the research is to proceed. they are assuming.
Do the benefits justify the risks?

GUIDELINES
Research is ethically acceptable only when its
potential benefits justify any risks involved in 2.1.1 Institutions that choose to establish levels
the 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 people’s capacity to make their own that a person’s decision to participate
decisions. In the research context, this normally in research is to be voluntary, and
requires that participation be the result of based on sufficient information and
a choice made by participants – commonly adequate understanding of both the
known as ‘the requirement for consent’. This proposed research and the implications
requirement has the following conditions: of participation in it. For qualifications of
consent should be a voluntary choice, and should this principle, see Chapter 2.3: Qualifying
be based on sufficient information and adequate or waiving conditions for consent.
understanding of both the proposed research and 2.2.2 Participation that is voluntary and based
the implications of participation in it. on sufficient information requires an
What is needed to satisfy these conditions adequate understanding of the purpose,
depends on the nature of the project, and methods, demands, risks and potential
may be affected by the requirements of the benefits of the research.
codes, laws, ethics and cultural sensitivities of 2.2.3 This information must be presented in
the community in which the research is to be ways suitable to each participant (see
conducted. paragraph 5.2.17).
Variations of these conditions may be ethically 2.2.4 The process of communicating
justified for some research. Respect for human information to participants and seeking
beings must, however, always be shown in any their consent should not be merely a
alternative arrangements for deciding whether matter of satisfying a formal requirement.
potential participants are to enter the research. The aim is mutual understanding between
It should be noted that a person’s consent to researchers and participants. This aim
participate in research may not be sufficient to requires an opportunity for participants
justify his or her participation. to ask questions and to discuss the
information and their decision with others
This chapter provides guidelines on the if they wish.
requirement for consent. Chapter 2.3:
Qualifying or waiving conditions for consent 2.2.5 Consent may be expressed orally, in
then discusses and provides guidelines on writing or by some other means (for
conditions under which the requirement may be example, return of a survey, or conduct
qualified or waived. implying consent), depending on:
(a) the nature, complexity and level of
risk of the research; and
(b) the participant’s personal and
cultural circumstances.
2.2.6 Information on the following matters Renegotiating consent

should also be communicated to
participants. Except where the 2.2.8 In some research, consent may need to
information in specific sub-paragraphs be renegotiated or confirmed from time
below is also deemed necessary for a to time, especially where projects are
person’s voluntary decision to participate, complex or long-running, or participants
it should be kept distinct from the are vulnerable. Research participants
information described in paragraphs 2.2.1 should be told if there are changes to the
and 2.2.2: terms to which they originally agreed, and
given the opportunity to continue their
(a) any alternatives to participation; participation or withdraw (see paragraphs
(b) how the research will be monitored; 5.2.17 and 5.2.19).
(c) provision of services to participants

adversely affected by the research;
Coercion and pressure
2.2.9 No person should be subject to coercion
(d) contact details of a person to receive
or pressure in deciding whether to
complaints;
participate. Even where there is no overt
(e) contact details of the researchers; coercion or pressure, consent might
reflect deference to the researcher’s
(f) how privacy and confidentiality will
perceived position of power, or to
be protected;
someone else’s wishes. Here as always,
(g) the participant’s right to withdraw a person should be included as a
from further participation at any participant only if his or her consent is
stage, along with any implications of voluntary.
withdrawal, and whether it will be
possible to withdraw data;
Reimbursing participants
(h) the amounts and sources of funding
2.2.10 It is generally appropriate to reimburse
for the research;
the costs to participants of taking part in
(i) financial or other relevant research, including costs such as travel,
declarations of interests of accommodation and parking. Sometimes
researchers, sponsors or institutions; participants may also be paid for time
involved. However, payment that is
(j) any payments to participants; disproportionate to the time involved,
(k) the likelihood and form of or any other inducement that is likely to
dissemination of the research results, encourage participants to take risks, is
including publication; ethically unacceptable.
(l) any expected benefits to the wider 2.2.11 Decisions about payment or
community; reimbursement in kind, whether to
participants or their community, should
(m) any other relevant information, take into account the customs and
including research-specific practices of the community in which the
information required under other research is to be conducted.
chapters of this National Statement.
2.2.7 Whether or not participants will be Where others need to be involved in
identified, research should be designed so participation decisions
that each participant’s voluntary decision
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 and
participant should be provided with understanding about research for which
relevant information and decide whether extended or unspecified consent is given
he or she will participate. That decision can still be sufficient and adequate for the
must not be contrary to the person’s purpose of consent (see paragraph 2.2.2).
best interests. Researchers should bear
2.2.15 Extended or unspecified consent may
in mind that the capacity to consent may
sometimes need to include permission
fluctuate, and even without that capacity
to enter the original data or tissue into a
people may have some understanding of
databank or tissuebank (see paragraph
the research and the benefits and burdens
3.2.9).
of their participation. For implications of
these factors, see Chapter 4.2: Children 2.2.16 When unspecified consent is sought,
and young people, Chapter 4.4: People its terms and wide-ranging implications
highly dependent on medical care who should be clearly explained to potential
may be unable to give consent, and participants. When such consent is given,
Chapter 4.5: People with a cognitive its terms should be clearly recorded.
impairment, an intellectual disability, or
2.2.17 Subsequent reliance, in a research
a mental illness.
proposal, on existing unspecified
2.2.13 Within some communities, decisions consent should describe the terms of that
about participation in research may unspecified consent.
involve not only individuals but also
2.2.18 Data or tissue additional to those covered
properly interested parties such as
by the original extended or unspecified
formally constituted bodies, institutions,
consent will sometimes be needed for
families or community elders.
research. Consent for access to such
Researchers need to engage with all
additional data or tissue must be sought
properly interested parties in planning
from potential participants unless the
the research.
need for this consent is waived by an
ethical review body.
Consent to future use of data and
tissue in research Declining to consent and withdrawing
2.2.14 Consent may be: consent
(a) ‘specific’: limited to the specific 2.2.19 People who elect not to participate in a
project under consideration; research project need not give any reason
for their decision. Researchers should
(b) ‘extended’: given for the use of data
do what they can to see that people
or tissue in future research projects
who decline to participate will suffer no
that are:
disadvantage as a result of their decision.
(i) an extension of, or closely
2.2.20 Participants are entitled to withdraw
related to, the original project;
from the research at any stage. Before
or
consenting to involvement in the research,
(ii) in the same general area participants should be informed about
of research (for example, any consequences of such withdrawal.
genealogical, ethnographical,
epidemiological, or chronic
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 The opt-out approach is a method used in

the recruitment of participants into research
Consent to participate in research must be where information is provided to the potential
voluntary and based on sufficient information participant regarding the research and their
and adequate understanding of both the involvement and where their participation is
proposed research and the implications of presumed unless they take action to decline to
participation in it. participate.
‘Limited disclosure’ to participants of the aims While an opt-out approach makes it possible
and/or methods of research may sometimes for people to make an informed choice about
be justifiable. This is because in some their participation, this choice can only be made
human research (for example, in the study of if participants receive and read the information
behaviour), the aims of the research cannot provided, and they understand that they are
be achieved if those aims and/or the research able to act on this information in order to
method are fully disclosed to participants. decline to participate.
Research involving limited disclosure covers a Importantly, the opt-out approach is unlikely
spectrum, from simply not fully disclosing or to constitute consent when applying
describing the aims or methods of observational commonwealth privacy legislation to the
research in public contexts, all the way to actively handling of sensitive information, including
concealing information and planning deception health information. Therefore, where it is
of participants. Examples along the spectrum impracticable to obtain an individual’s explicit
include: observation in public spaces of everyday consent to the use of their information and the
behaviour; covert observation, for example of the purpose of the research cannot be served by
hand-washing behaviour of hospital employees; using non-identifiable information, researchers
undisclosed role-playing by a researcher to must comply with the Guidelines under Section
investigate participants’ responses; telling 95 of the Privacy Act 1988 (s95 guidelines)
participants the aim of the research is one thing or the Guidelines approved under Section
when it is in fact quite different. 95A of the Privacy Act 1988 (s95A guidelines)
(as applicable) to ensure that their handling
Depending upon the circumstances of an
of personal information does not breach the
individual project it may be justifiable to
Privacy Act 1988. Where researchers need
employ an opt-out approach or a waiver of the
approval to use an opt-out approach for
requirement for consent, rather than seeking
research to which the s95 or 95A guidelines
explicit consent.
apply, only an HREC may grant this approval.
A single research project may involve discrete Other review bodies may approve an opt-out
elements or participant groups where different approach for other research.
recruitment approaches can be used. For
The Australian Privacy Principles Guidelines
example, a project may involve some elements or
contain further information about consent and
participant groups where explicit consent must
the handling of personal information.
be sought and other elements where an opt-out
approach may be considered or where a waiver
of the consent requirement may be applied.

When neither explicit consent nor an opt-out 2.3.2 Where limited disclosure involves active
approach are appropriate, the requirement concealment or explicit deception, and
for consent may sometimes be justifiably the research does not aim to expose
waived. When an HREC or, where appropriate, illegal activity, researchers should in
another review body grants a waiver of addition demonstrate that:
consent for research conducted prospectively
a) participants will not be exposed to
or retrospectively, research participants will
an increased risk of harm as a result
characteristically not know that they, or perhaps
of the concealment or deception
their tissue or data, are involved in the research.
b) a full explanation, both of the
real aims and/or methods of the
research, and also of why the
GUIDELINES concealment or deception was
necessary, will subsequently be
Limited disclosure made available to participants
2.3.1 Where limited disclosure does not c) there is no known or likely reason
involve active concealment or planned for thinking that participants would
deception, ethical review bodies may not have consented if they had been
approve research provided researchers fully aware of what the research
can demonstrate that: involved.
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, page 67), the
achieved adverse effects on those whose illegal
activity is exposed must be justified by
b) the potential benefits of the research the value of the 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 community’s trust in (HREC) can review and approve research
research and researchers 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, page 18), and the b) aims to expose illegal activity.
limited 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 it is feasible to contact
after their participation has ended, some or all of the participants, but
participants will be: where the project is of such scale and
(i) provided with information about significance that using explicit consent is
the aims of the research and an neither practical nor feasible.
explanation of why the omission
or alteration was necessary
(ii) offered the opportunity to
withdraw any data or tissue
provided by them.
2.3.6 Before approving the use of an opt-out 2.3.7 For guidance on the use of an opt-out
approach for research, an HREC or, where approach in activities other than research,
appropriate, another review body must be such as quality assurance and evaluation,
satisfied that: refer to Ethical Considerations in Quality
Assurance and Evaluation Activities,
a) involvement in the research
2014.
carries no more than low risk (see
paragraphs 2.1.6 and 2.1.7, page 18) 2.3.8 When considering the provision of
to participants information to prospective participants
and the mechanism by which individuals
b) the public interest in the proposed
can decline participation, the ethical
activity substantially outweighs the
review body should consider the
public interest in the protection of
sensitivity and the risks, the potential
privacy
participant pool, the context in which
c) the research activity is likely to be the research and opt-out approach will
compromised if the participation occur, and whether withdrawal from
rate is not near complete, and the participation is feasible once identifiers
requirement for explicit consent have been removed from data.
would compromise the necessary
level of participation Waiver
d) reasonable attempts are made to 2.3.9 Only an HREC may grant waiver of
provide all prospective participants consent for research using personal
with appropriate plain language information in medical research, or
information explaining the nature personal health information. Other review
of the information to be collected, bodies may grant waiver of consent for
the purpose of collecting it, and the other research.
procedure to decline participation or
withdraw from the research 2.3.10 Before deciding to waive the requirement
for consent (other than in the case of
e) a reasonable time period is research aiming to expose illegal activity),
allowed between the provision an HREC or other review body must be
of information to prospective satisfied that:
participants and the use of their data
so that an opportunity for them to a) involvement in the research
decline to participate is provided carries no more than low risk (see
before the research begins paragraphs 2.1.6 and 2.1.7, page 18)
to participants
f) a mechanism is provided for
prospective participants to obtain b) the benefits from the research justify
further information and decline to any risks of harm associated with
participate not seeking consent
g) the data collected will be managed c) it is impracticable to obtain consent
and maintained in accordance with (for example, due to the quantity,
relevant security standards age or accessibility of records)
h) there is a governance process in place d) there is no known or likely reason
that delineates specific responsibility for thinking that participants would
for the project and for the appropriate not have consented if they had been
management of the data asked
i) the opt-out approach is not e) there is sufficient protection of their
prohibited by State, federal, or privacy
international law.

f) there is an adequate plan to protect

the confidentiality of data
g) in case the results have significance
for the participants’ welfare there is,
where practicable, a plan for making
information arising from the research
available to them (for example, via a
disease-specific website or regional
news media)
h) the possibility of commercial
exploitation of derivatives of the
data or tissue will not deprive the
participants of any financial benefits
to which they would be entitled
i) the waiver is not prohibited by State,
federal, or international law.
2.3.11 Before deciding to waive the requirement
for consent in the case of research aiming
to expose illegal activity, an HREC must
be satisfied that:
a) the value of exposing the illegal
activity justifies the adverse effects
on the people exposed (see
paragraph 4.6.1, page 67)
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 IN THE DESIGN, DEVELOPMENT, REVIEW AND CONDUCT OF RESEARCH
SECTION 3: ETHICAL CONSIDERATIONS

IN THE DESIGN, DEVELOPMENT,
REVIEW AND CONDUCT OF RESEARCH
INTRODUCTION The guidance in Chapter 3.1 is broadly

applicable to all fields of research,
The aim of this section is to provide guidance including those types of research for which
on the ethical considerations that are additional specific guidance is provided in
relevant to the way that research is designed, Chapters 3.2, 3.3 and 3.4.
reviewed and conducted. This material should
Chapter 3.1 is designed around seven elements
be read in conjunction with the Preamble
that are common to most – if not all – forms of
(Purpose, scope and limits, p.6) and Section 2
research. The chapter starts with considering
(Themes in research ethics: risk and benefit,
the ethical issues associated with developing
consent, pp 12‑22).
the research scope, aims, themes, questions and
This section aims to be compatible with and methods, and ends with ethical considerations
relevant for many different ways of doing that pertain after the project comes to an end.
human research. It requires those who conduct
The elements are:
and approve human research to consider:
Element 1 – Research Scope, Aims, Themes,
• how the research question/theme is
Questions and Methods
identified or developed
Element 2 – Recruitment
• the alignment between the research aims
and methods Element 3 – Consent
• how the researchers and the participants Element 4 – Collection, Use and Management of
will engage with one another Data and Information
• how the research data or information are Element 5 – Communication of Research
to be collected, stored, and used Findings or Results to Participants
• how the results or outcomes will be Element 6 – Dissemination of Research Outputs
communicated, and and Outcomes
• what will happen to the data and Element 7 – After the Project
information after the project is completed.
Researchers who are designing a research
The guidance in this section identifies common project should read all of Chapter 3.1,
ethical issues that arise in the various phases noting which parts of the guidance are relevant
of research. It is up to each researcher and for their project. In addition, if research involves
HREC to apply the guidance to each project, biospecimens, genomics or xenotransplantation,
taking account of the four principles of research they should also consult the specific chapters on
merit and integrity, justice, beneficence and these topics.
respect. This guidance facilitates consideration
of the risks and benefits of the research and the
level of ethical oversight required.

Each subsequent chapter in this section provides Researchers planning to do any type of research
guidance on additional ethical considerations involving Aboriginal and Torres Strait Islander
that may apply to: peoples must consult and follow the advice
in the most contemporary versions of Ethical
• the use of human biospecimens in
conduct in research with Aboriginal and
laboratory based research (Chapter 3.2)
Torres Strait Islander Peoples and communities:
• genomic research (Chapter 3.3) Guidelines for researchers and stakeholders
and Keeping research on track II as well as the
• xenotransplantation research
Guidelines for Ethical Research in Australian
(Chapter 3.4).
Indigenous Studies (GERAIS) produced by
This guidance applies to research, but the Australian Institute of Aboriginal and
sometimes the distinction between research Torres Strait Islander Studies. These guidelines
and innovative clinical practice is unclear. embody the best standards of ethical research
For example, innovative clinical practice occurs and human rights and seek to ensure that
on a spectrum from minor changes at the border research with and about Aboriginal and Torres
of established practice that pose little change Strait Islander peoples follows a process of
in risk to patient safety to novel interventions meaningful engagement and reciprocity between
that should only be introduced as part of an the researcher and the individuals and/or
ethically approved research protocol. communities involved in the research.
Whether an innovative clinical practice should Researchers should also consult the most
be undertaken only as clinical research contemporary version of NHMRC’s Statement
may depend on the extent to which the on Consumer and Community Participation in
procedure departs from established practice. Health and Medical Research.
Importantly, even if the introduction of an
innovative practice falls within existing clinical
guidance, its implementation and the associated
collection of data for monitoring and reporting
may require notification to the institution/s
where the practice is taking place.
When it is not clear whether an innovation
should be implemented only as research,
it may be necessary to seek advice from a
Human Research Ethics Committee or other
institutional review process on the review
required for the new intervention.
CHAPTER 3.1 : THE ELEMENTS OF RESEARCH
CHAPTER 3.1: THE ELEMENTS OF RESEARCH
INTRODUCTION Researchers may have an impact on research

participants and vice versa and this impact
Human research projects must adhere to the may compromise a researcher’s role or
core ethical principles described in Section 1 of professionalism. If this is anticipated and/or
this National Statement. These principles apply occurs, it may become necessary to modify
at all stages of a research project from inception those relationships, or to modify or discontinue
to post-completion. the research.
Human research can involve a wide range of Additionally, a researcher may have other
methods and practices: it can be qualitative, professional skills (for example, counseling or
quantitative or mixed; interventional, clinical care) that become relevant to the
experimental or observational in nature; relationship with a participant. In this event,
and involve various degrees of collaboration it is important to consider whether it is
between researchers and participants. ethically acceptable to exercise those skills
Each research project is shaped by the field to or, alternatively, to refer that participant to
which the research question relates, the research another professional.
question itself, the desired outcome, and the
The guidance provided in Chapters 4.3 and 5.4
context in which it is conducted.
is relevant to the researcher’s duty to inform
Effective research ethics review incorporates participants that they are acting in a professional
appropriate expertise related to relevant methods role other than the research role.
or areas of practice. Reviewers should be aware
Research may involve risks to participants.
of expectations and apply requirements that
To the extent that it is appropriate,
are relevant to the areas of practice or methods
the development of clear protocols for managing
used in projects that they review. This requires
any distress that might be experienced by
becoming familiar with methods or areas of
participants during the process of data collection
practice that are unfamiliar or novel.
or conduct of research procedures is an
A range of relationships between participants important component of planning research.
and researchers may develop as a result Predicting what topics are likely to lead to
of the duration and nature of the research distress and how to manage this distress will not
interaction. Some methodological approaches always be easy. Access to sufficient training to
require careful boundaries to be maintained help researchers and reviewers in making such
between researchers and research participants. predictions is valuable. Refer to Chapter 2.1 for
In contrast, other research fields require data a further discussion about the identification and
collection methods that involve the development handling of risk in research.
of close personal relationships with participants,
or degrees of collaboration that blur the
lines between researcher and participant
(e.g. co‑researchers in action research).

This chapter discusses the manner in which the GUIDELINES

core principles of this National Statement should
be reflected in the elements of research project
design. The chapter should be considered as Element 1: Research Scope, Aims,
a whole; however, the order in which these Themes, Questions and Methods
elements are discussed does not imply a
A critical feature of good research is clarity
hierarchy or a sequence, or that all of these
regarding how the research project will meet
elements will have equal relevance in every
the ethical requirement that research has
design. The elements are:
merit, as described in paragraph 1.1 of the
• Element 1: Research Scope, Aims, National Statement. This Element of Chapter 3.1
Themes, Questions and Methods offers advice and guidance about meeting
this obligation.
• Element 2: Recruitment
• Element 3: Consent Key questions include:
• Element 4: Collection, Use and • What is the research theme or
Management of Data and Information question that this project is designed
• Element 5: Communication of Research to explore?
Findings or Results to Participants • Why is the exploration of this
• Element 6: Dissemination of Research theme or answer to this question
Outputs and Outcomes worth pursuing?
• Element 7: After the Project • How will the planned methods

explore the theme or achieve the
Chapter 3.1 should be read in conjunction with aims of the research?
other sections of the National Statement and is
supplemented by the guidance in Chapters 3.2,
3.3 and 3.4. 3.1.1 In an application for review of their
research, researchers should determine and
Researchers conducting clinical interventional state in plain language:
research should also refer to additional guidance
in Chapters 5.2 and 5.5. (a) the research question or questions that
the project is intended to explore;
(b) the potential benefit of exploring the
question or questions including:
(i) to whom that potential benefit is
likely to flow, and
(ii) whether that benefit is a
contribution to knowledge or
understanding, improved social or
individual wellbeing, or the skill
and expertise of researchers;
(c) the basis for that potential benefit
as described in either relevant
literature or a review of prior research
unless, due to the novelty of the
question, there is scarce literature or
prior research;
(d) how the design and methods of (b) if the research involves exposure to
the project will enable adequate an intervention for which the safety or
exploration of the research questions efficacy, or both, is not well understood:
and achieve the aims of the research;
(i) whether it is likely or possible
(e) how the design of the project will that the intervention will be of
maintain respect for the participants; therapeutic benefit and
(f) where relevant, that the research (ii) whether there is a realistic
meets the requirements of any possibility that the intervention
relevant regulations or guidelines being studied will be at
authorised by law (such as those least as beneficial overall as
related to privacy and reporting standard treatment, taking into
requirements for disclosure of child account effectiveness, burden,
abuse); and costs and risks;
(g) whether or not the project has (c) where patient care is combined with
been reviewed by a formally intent to contribute to knowledge,
constituted academic, scientific or that any risks of participation should
professional review process, and, if so, be justified by potential benefits
the outcome of that review. to which the participants attach
significance. The prospect of benefit
3.1.2 The merit and integrity of research should
from research participation should not
be assessed by criteria and standards
be exaggerated, either to justify to the
relevant to the research field/s and
reviewing body a higher risk than that
methodology/ies, such as:
involved in the participant’s current
(a) the objectives and conceptual basis of treatment or to persuade a participant
the research; to accept that higher risk;
(b) the quality and credibility of data (d) whether the intervention or other
collection and analysis; and research procedures are without
likely benefit to participants. For such
(c) how to assure validity and reliability
research to be ethically acceptable,
of results, taking account of relevant
any known or emerging risks to the
statistical, thematic and other forms
participants must not be greater than
of generalisability.
the risks that would be associated with
3.1.3 Reviewers should be aware that some the health condition and its usual care.
research designs will be informed and
3.1.5 Where current and available treatments are
shaped by the experience, insights and/or
known or widely believed to be effective
needs of participants. Such designs can be a
and/or there is known risk of significant
valid and powerful way to collect qualitative
harm in the absence of treatment, placebo
information and to inform practice.
or non-treatment groups are not ethically
3.1.4 For interventional research conducted in acceptable. Non-treatment (including
the context of health care or public health, placebo alone) groups may only be used:
researchers should additionally determine
(a) where the existing standard of care
and state:
comprises or includes the absence
(a) whether the project involves the of treatment (of the type being
systematic investigation of the safety, evaluated); or
efficacy and/or effectiveness of
(b) where there is evidence that the
an intervention;
harms and/or burdens of an existing
standard treatment exceed the
benefits of the treatment.

3.1.6 In health research involving an Element 2: Recruitment

intervention, the risks of an intervention
should be evaluated by researchers and When research will involve the direct
reviewers in the context of the risks of participation of people (e.g. testing, surveys,
the health condition and the treatment or interviews, focus groups, observation and health
treatment options that would otherwise or behavioural interventions) the recruitment
be provided as part of usual care. phase of a project is fundamental to the success
of the research. Depending upon the design of a
3.1.7 For any research project that project, this element can include such matters as
prospectively assigns human participants identifying individuals as potential participants,
or groups of humans to one or more contact between the research team and potential
health-related interventions to evaluate participants, screening or exclusion of some
the effects on health outcomes, individuals, and preparing to seek consent from
researchers must register the project as the potential participants.
a clinical trial on a publicly accessible
register complying with international A single project may employ more than one
standards (see information on the recruitment strategy, especially where discrete
International Clinical Trials Registry cohorts are required to meet the objectives
Platform (ICTRP) on the World Health of the research. For some research designs,
Organisation website) before the the recruitment and consent strategies occur
recruitment of the first participant. concurrently; for others, they are separate. It is
essential that recruitment strategies adhere to the
3.1.8 Where the total project cannot be ethical principles of justice and respect.
described in advance because the design
and detail of successive stages will be
informed by preceding stages, researchers Key questions include:
should provide a description of the stages • Who will be recruited?
that are foreseen and how they intend to
seek ethics approval for each stage. • How will participants be identified
and recruited?
3.1.9 Researchers should confirm and reviewers
should be satisfied that: • Will the potential participants
be screened?
(a) a plan is in place to ensure that
resources are sufficient to conduct • What is the impact of any
and complete the research as relationship between researchers and
designed; and potential participants on recruitment?
(b) the facilities, expertise and experience • How will the recruitment strategy
available seem to be appropriately facilitate obtaining the consent
allocated and sufficient for the of participants?
research to be completed safely.
• How will the recruitment strategy
3.1.10 Researchers should provide assurance that ensure that participants can make
any proposed payment in money or kind, an informed decision about
whether to institutions, researchers or participation?
participants, will not adversely influence
• Are there any risks associated with
the design, conduct, findings or
the recruitment strategy for potential
publication of the research.
participants or for the viability of
3.1.11 Researchers seeking approval for a the project?
program of research (i.e. a series of
related research projects), or to establish
infrastructure for research such as a
database or a biobank, should adequately
describe their plans to reviewers.
3.1.12 Research proposals should clearly 3.1.18 In developing and implementing

describe the recruitment strategy their recruitment strategy, researchers
and the criteria for the selection of should consider:
potential participants.
(a) the potential for coercion/
3.1.13 The recruitment strategy for a project exploitation;
should be relevant to the research
(b) any risks to participants related to
methodology, topic/subject matter, the
recruitment (see Chapter 2.1) and
potential participants and the context.
how the pattern of recruitment might
3.1.14 The criteria for the selection of potential be structured to mitigate any risks
participants for a project and the cohort to participants;
that is recruited should align with both
(c) any privacy matters relating to the
the objectives and theoretical basis of
recruitment of participants;
the research.
(d) the potential impact of existing
3.1.15 The inclusion/exclusion criteria for
relationships on recruitment
the potential participants in a project
(including, but not limited to,
must be justifiable and should be fair.
hierarchical relationships that may
The exclusion of some groups may
generate an unequal or dependent
amount to unfair discrimination, and/
relationship, such as teacher and
or exclude individuals and groups
student, manager and employee,
from the potential benefits of research.
supervisor and team member or
Researchers should consider the degree
treating health care professional
to which including/excluding groups
and patient);
may limit (or compromise) the value of
the results of a project, with consequent (e) the potential impact of participation
impact on the merit of the project. on existing relationships;
3.1.16 Researchers and reviewers should (f) whether participants will be
consider the degree to which potential recruited by co-researchers or
participant populations might be other members of the project
over‑researched or may require special team who are unfamiliar with the
consideration or protection and the guidance provided by this National
degree to which the flow of benefits Statement; and
to that population (or to individual
(g) whether the research requires
participants) justify the burdens.
community engagement or
Equally, people should not be denied
agreements related to the
the opportunity to exercise self-
research to be in place prior to
determination or obtain the potential
individual recruitment.
benefits of research solely because
they are a member of a population that 3.1.19 Researchers should describe and justify
might be over-researched or may require their approach to potential participants
special consideration or protection, (i.e. how do they find out about the
such as Aboriginal and Torres Strait possibility of participating, or not,
Islander peoples. in the research). The level of detail
that is required by reviewers should be
3.1.17 The recruitment strategy must be
proportional to the foreseeable risks and
respectful of potential participants and
appropriate to the methodology selected.
their culture, traditions and beliefs and
facilitate their voluntary participation.

3.1.20 For many research projects, researchers The guidance in Element 3 should be
should provide reviewers with proposed considered in the context of the guidance
recruitment materials (e.g. notices, flyers, provided in Chapters 2.2 and 2.3. These chapters
advertisements, and social media posts) provide essential guidance on the selection and
prior to use, including those materials framing of a consent strategy or alternatives to
that are developed subsequent to the consent, such as an opt-out approach or waiver
initial review of the research proposal. of the requirement for consent.
However, for some research designs or
The guidance in Chapters 2.2, 2.3, and this
where recruitment material needs to be
Element should be considered in applying the
ad lib, adapted or tailored to the context
guidance on consent included in Chapters 3.2,
(such as some social media, radio or
3.3 and 3.4.
other oral communication) a description
of the strategy and broad messages
is sufficient. Key questions include:
3.1.21 Researchers and reviewers should • What strategy(ies) for obtaining
consider the potential impact of the consent, or alternatives to consent are
recruitment strategy upon the consent appropriate for the specific project?
process (e.g. the degree to which the
• Does the nature of the project
recruitment strategy might undermine
design, the participants or the context
the voluntary nature of the consent of
necessitate the use of more than
individual potential participants).
one strategy?
3.1.22 Researchers and reviewers should
• Do the proposed strategy(ies) satisfy
consider the degree to which any
the relevant requirements of Chapters
payment in money or incentives of
2.2 and 2.3?
any kind, whether to researchers,
participants or others involved in • Are there any project-specific matters
recruitment, could result in pressure that warrant specific attention (e.g.
on individuals to consent to participate whether the research could generate
(see paragraphs 2.2.10, and 2.2.11). results of significance to participants,
This is especially important with respect whether the data will be added to an
to research that involves more than a low open or mediated access repository
risk of harm. or whether the data or materials will
be used for any other purpose)?
Element 3: Consent
Well-designed consent strategies are 3.1.23 Researchers should ensure that any
appropriately tailored to the potential proposed consent strategy:
participants, the research design, the topic and (a) provides all of the required
the context. Obtaining consent in a manner that information and assurances as
shows respect for participants facilitates valid set out in Chapters 2.2 and 2.3,
consent. This may involve obtaining consent as as relevant to the proposed
part of an ongoing process. Obtaining consent research; and
may be a component of broader processes
of consultation, engagement and negotiation, (b) uses tools and language that
such as in the context of research involving are appropriate, respectful and
Aboriginal and Torres Strait Islander Peoples relevant to the research design,
(see Chapter 4.7). objectives, potential participants
and context, including relevant
cultural sensibilities.
3.1.24 Researchers and reviewers should 3.1.28 In circumstances where there may be
recognise that research involving multiple significant risks if the participatory
methods or different groups of potential status of individuals becomes known,
participants may require more than one researchers must select a consent strategy
consent strategy or may require consent to that masks the identity of participants.
be revisited and renegotiated over time.
3.1.29 When those who are recruiting
3.1.25 There is a range of strategies that may participants will receive some form of
be appropriate for obtaining consent. payment per recruited individual or other
While these may include the provision benefit, this must be disclosed to potential
of a written information and consent participants during the consent process.
document, other strategies may be more
3.1.30 Researchers should explain to potential
appropriate. It is not a requirement of
participants that their access to any
the National Statement that participants’
services or supports normally provided by
consent must, routinely, be witnessed.
the person trying to recruit them will not
3.1.26 An information and consent document be affected by their decision to accept or
or other consent strategy should decline research participation.
be appropriate to the needs of
3.1.31 In any information provided to potential
the participants and proportional
participants during the consent process,
to the project’s risks and ethical
researchers should include information
sensitivity. Specifically:
on data management and storage and
(a) information provided in any format any relevant intellectual property and
should not be unnecessarily long copyright arrangements.
or detailed, even for complex
3.1.32 Researchers should describe to potential
interventional research;
participants any limitations on/
(b) strategies such as the use of consequences of withdrawing consent
staged or tiered information and whether or not it will be possible to
should be considered in order to withdraw their data or information.
address variations in the needs
3.1.33 Where research may yield findings that
or characteristics of potential
are potentially significant for individuals,
participants; and
the consent strategy should clarify
(c) adequate time should be allowed whether participants will be provided
for prospective participants to with these findings or whether individuals
understand and consider what is will have a choice about receiving
proposed and for their questions the findings.
and expression of concerns to be
3.1.34 Researchers should disclose to potential
addressed by those obtaining their
participants whether, and under what
consent (See 2.2.2 – 2.2.6).
circumstances, research results or
3.1.27 Researchers should ensure that information that has been collected may
participants understand whether or not be reported to relevant authorities.
third parties (including supervisors of
3.1.35 During the consent process, researchers
participants) will know who has been
should advise participants whether, and,
approached about participating, who has
if so, in what form, they will receive or
been selected from the participant pool,
can obtain access to a summary of the
and which individuals have chosen
outcomes of the research.
to participate.
3.1.36 If researchers are planning to add data
obtained in a research project to an open
or mediated access repository or make
the data or materials available for re-use,

any implications of these plans should Element 4: Collection, Use and

be provided to participants. The use Management of Data and Information
of ‘extended consent’ or ‘unspecified
consent’ (see 2.2.14 to 2.2.16) may be This section addresses ethical issues related
appropriate for this purpose. to generation, collection, access, use, analysis,
disclosure, storage, retention, disposal,
3.1.37 When researchers seek consent to collect sharing and re-use of data or information.
information that is considered to be of
historical, cultural or other long term Human research projects incorporate one or
value, they should obtain consent for more methods to generate, collect, or access
its perpetual retention, including any data or information so as to achieve the
planned re-use and sharing with others. objectives of the research. Collection, use and
management of data and information must be in
3.1.38 When a project relates to a health accordance with the ethical principles discussed
intervention or treatment, researchers in Section 1 of this National Statement.
must make it clear to potential
participants, if relevant: Research may involve access to large volumes
of data or information not explicitly generated
(a) that it is a novel intervention that for research purposes. The size and accessibility
has not yet been approved for any of such sources make them attractive for
health condition, or an intervention some research designs, the use of which may
that is not used in the usual care raise difficult privacy and consent questions.
of the relevant health condition, However, because research using population-
or an intervention that is being wide datasets is inclusive of all members of
investigated for use in a new the population in question, it promotes the
health condition or in a new or core principle of justice. In addition, benefits
modified setting; and burdens may be spread more evenly than
(b) whether there is likely to be any research based on selected participants.
therapeutic benefit to them from The increased ability to link data in ways that
the intervention and whether access preserve privacy has greatly enhanced the
to the intervention is available contribution that collections of data can make to
only through participation in the generating knowledge, as it enables researchers
research; and to match individuals in different data sets
(c) whether they will have access after without explicitly identifying them.
completion of the project or active
treatment phase of the project
Key questions include:
to the intervention, treatment or
information that they have received, • What data or information are
and, if so, with what limitations, required to achieve the objectives of
if any. the project?
3.1.39 For research that is not explicitly • How and by whom will the data
or primarily genomic, but that may, or information be generated,
during recruitment or data collection, collected and/or accessed?
generate information with hereditary
• How and by whom will the data or
implications, consent processes should be
information be used and analysed?
designed to take account of this potential
(see Chapter 3.3: Genomic Research). • Will the data or information be
disclosed or shared and, if so,
with whom?
• physical specimens or artefacts;

• How will the data or information be
stored and disposed of? • information generated by analysis
of existing personal information
• What are the risks associated with (from clinical, organizational, social,
the collection, use and management observational or other sources);
of data or information and how can
they be minimised? • observations;
• What is the likelihood and severity of • results from experimental testing and
any harm/s that might result? investigations; and
• How will the collection and • information derived from human

management of the data or biospecimens such as blood, bone,
information adhere to the ethical muscle and urine.
principles in Section 1 of this
National Statement? Identifiability of information 3
Researchers and reviewers must consider the
identifiability of data and information in order to
What is data and what is information? assess the risk of harm or discomfort to research
The terms ‘data’ and ‘information’ are often participants or others who may be at risk.
used interchangeably. Data can refer to raw The risks related to identifiability of data and
data, cleaned data, transformed data, summary information in research are greatest where the
data and metadata (data about data). It can identity of a specific individual can reasonably
also refer to research outputs and outcomes. be ascertained by reference to an identifier
Likewise, information takes many different or a combination of identifiers (examples
forms. Where information is in a form that can of identifiers include the individual’s name,
identify individuals, protecting their privacy image, date of birth or address, attribute or
becomes a consideration. group affiliation). Risk may also arise where
For the purposes of the National Statement, identifiers have been removed from the data or
‘data’ is intended to refer to bits of information information and replaced by a code, but where
in their raw form, whereas ‘information’ it remains possible to re-identify a specific
generally refers to data that have been individual (by, for example, unlocking the
interpreted, analysed or contextualised. code or linking to other data sets that contain
identifiers). Due to technological advances, risks
Data and information may include, but not be may arise in relation to data and/or information
limited to: that has never been labelled with individual
• what people say in interviews, focus identifiers or from which identifiers have been
groups, questionnaires/surveys, permanently removed.
personal histories and biographies; The identifiability of information is a characteristic
• images, audio recordings and other that exists on a continuum. This continuum is
audio‑visual materials; affected by contextual factors, such as who has
access to the information and other potentially
• records generated for administrative related information, and by technical factors that
purposes (e.g. billing, service
provision) or as required by legislation 3
The National Statement does not use the terms
(e.g. disease notification);
‘identifiable’, ‘potentially identifiable’, ‘re-
• digital information generated directly identifiable’, ‘non-identifiable’ or ‘de-identified’ as
by the population through their use of descriptive categories for data or information due to
mobile devices and the internet; ambiguities in their meanings. Re-identification and
de-identification are best understood as processes
that change the character of information and are
only used with this meaning.

have the potential to convert information that has increased commercial accessibility, proliferation
been collected, used or stored in a form that is of data sets, data breaches or degradation of
intended to protect the anonymity of individuals privacy protections and other developments
into information that can identify individuals. on access to and use of data and information.
Additionally, contextual and technical factors In this increasingly complex environment,
can have a compound effect and can increase researchers are encouraged to consult guidance
the likelihood of re-identifiability and the risk of promulgated by expert bodies such as the Office
negative consequences from this in ways that are of the Australian Information Commissioner and
difficult to fully anticipate and that may increase its state and territory equivalents, the Australian
over time. Bureau of Statistics and the Australian
National Data Service in addition to this
Furthermore, the identifiability of information
National Statement.
may change during the life of a research
project, e.g. data or information might 3.1.40 The removal of personal identifiers
initially be collected in a form that could may or may not be ethically required.
identify individuals, then coded for analysis Some research projects may legitimately
and correlation to other collected data or require the retention of personal
information, and, finally, once all the data identifiers, for example, to link
or information has been collected, the code information or data from a number of
key might be destroyed, rendering the data different sources or to return results to
or information anonymous. Therefore, it is participants. In addition, some research
important for researchers and reviewers to focus populations (e.g. academics, activists and
on the risk of harm to affected individuals if some public figures) are amongst those
their identity is ascertained and the effort that who may prefer to be identified in the
would be required to achieve this at each stage collection, use, and reporting of research
of a research project. data. Where participants choose to be
Factors that should be taken into consideration identified, researchers and participants
when determining the degree of identifiability of should collaboratively determine and
information and when evaluating the associated agree upon whether all research data or
risks include the type and quantity of the information collected from them will be
information, any other information held by the identified, or only certain components of
individual who receives the information and the collected data or information.
the capacity (skills and technology) available to 3.1.41 Researchers should adopt methods to
the individual who receives it. Identifiability of reduce the risk of identification during
information is also conditioned by contextual collection, analysis and storage of data
factors, such as whether only the person/s who and information. Methods to reduce
collected the information could use it to identify identifiability and the consequent risks
(an) individual/s, or whether those to whom it is may include:
disclosed or with whom it is shared for research
purposes could also use it for this purpose. (a) minimising the number of variables
Identifiability may also reflect features of the collected for each individual;
project such as the nature of the participant (b) separation and separate storage
cohort: for example, whether it includes of identifiers and content
high-profile individuals or members of small information; and
communities versus larger populations.
(c) separating the roles of those
Data and information that is contained in responsible for management of
data sets, such as those held in government identifiers and those responsible for
databases and by social media organisations, analysing content.
may be used (in sum or in part) to identify
individuals. This potential is due to the impact
of predictive analytics, machine learning,
3.1.42 In any publications, researchers should be developed as early as possible in the

ensure that the identity of participants research process and should include,
cannot be reasonably ascertained from but not be limited to, details regarding:
the data or information that they use or
(a) physical, network, system security
report, unless they have agreed to be
and any other technological
identified. This may require minimising,
security measures;
obscuring, or changing identifiers,
either in the collection process or (b) policies and procedures;
when presenting and publishing the
(c) contractual and licensing
research results.
arrangements and
3.1.43 Where research involves linkage of data confidentiality agreements;
sets with the consent of participants,
(d) training for members of the project
researchers should advise participants that
team and others, as appropriate;
use of data or information that could be
used to identify them may be required (e) the form in which the data or
to ensure that the linkage is accurate. information will be stored;
They should also be given information
(f) the purposes for which the data
about the security measures that will be
or information will be used and/
adopted, for example the removal of
or disclosed;
identifiers once linkage is completed.
(g) the conditions under which access
Data management to the data or information may be
granted to others; and
3.1.44 When multiple researchers are
collaborating on collection, storage (h) what information from the
and/or analysis of data or information, data management plan, if any,
they should agree to the arrangements needs to be communicated to
for custodianship, storage, retention and potential participants.
destruction of those materials, as well Researchers should also clarify whether
as to rights of access, rights to analyse/ they will seek:
use and re-use the data or information
and the right to produce research outputs (i) extended or unspecified consent
based upon them. Researchers should for future research (see paragraphs
consider whether any intellectual property 2.2.14 to 2.2.16); or
will be generated by the project and (j) permission from a review body to
agree on the ownership of any intellectual waive the requirement for consent
property created. Agreements on such (see paragraphs 2.3.9 and 2.3.10).
arrangements and ownership need not
necessarily be in the form of a contractual 3.1.46 The security arrangements specified
document, but should facilitate a clear in the data management plan should
resolution of these issues. be proportional to the risks of the
research project and the sensitivity of
3.1.45 For all research, researchers should the information.
develop a data management plan that
addresses their intentions related to 3.1.47 Researchers must comply with all relevant
generation, collection, access, use, legal and regulatory requirements
analysis, disclosure, storage, retention, that pertain to the data or information
disposal, sharing and re-use of data and collected, used or disclosed as well as
information, the risks associated with the conditions of the consent provided
these activities and any strategies for by participants.
minimising those risks. The plan should

3.1.48 In relevant research, particularly that but not limited to, community consultation,
which involves the use of materials of ensuring that the research results are translated
biological origin, records should be into improvements in services and practices,
preserved for long enough to enable acknowledging the source of the data or
participants to be traced in the event that information in publications and/or publishing
evidence emerges of late or long-term the research results in a location and language
health-related effects, taking into account suitable for the general community. In particular,
the conditions of consent that apply. using data or information without consent may
undermine public trust in the confidentiality of
3.1.49 Data, information and biospecimens
their information.
used in research should be disposed
of in a manner that is safe and secure, Privacy concerns arise when the proposed
consistent with the consent obtained and access to or use of the data or information does
any legal requirements and appropriate to not match the expectations of the individuals
the design of the research. from whom this data or information was
obtained or to whom it relates. These issues are
3.1.50 In the absence of justifiable ethical
especially complex in the context of the access
reasons (such as respect for cultural
to or use of information relating to individuals
ownership or unmanageable risks to
that is available on the internet, including social
the privacy of research participants)
media posts, tweets, self‑generated ‘lifelogging’
and to promote access to the benefits
data emitted from mobile phones and other
of research, researchers should collect
‘smart’ appliances and data or information
and store data or information generated
generated through applications and
by research projects in such a way that
devices related to personal pursuits, such
they can be used in future research
as fitness activity, gambling, dating and
projects. Where a researcher believes
web‑based gaming.
there are valid reasons for not making
data or information accessible, this must Data or information available on the internet
be justified. can range from information that is fully in the
public domain (such as books, newspapers and
journal articles), to information that is public,
Secondary use of data or information
but where individuals who have made it public
Research may involve access to and use of data may consider it to be private, to information
or information that was originally generated that is fully private in character. The guiding
or collected for previous research or for principle for researchers is that, although data or
non‑research purposes, including routinely information may be publicly available, this does
collected data or information. This is commonly not automatically mean that the individuals with
called ‘secondary use of data or information’. whom this data or information is associated
The main ethical issue arising from this use is have necessarily granted permission for
the scope of consent provided or, alternatively, its use in research. Therefore, use of such
the impracticability of obtaining consent. information will need to be considered in the
context of the need for consent or the waiver
Administrative data or information is data or
of the requirement for consent by a reviewing
information routinely collected during the
body and the risks associated with the use of
delivery of a service e.g. by a government
this information.
department or private service provider and
may involve collections of data or information
from large numbers of people or whole
populations. It is usually impractical to obtain
consent from individuals for secondary
use of this data or information. In these
circumstances, respect for participants can
be demonstrated in other ways, including,
3.1.51 For research involving the secondary use To this end, data or information may be
of data or information, researchers should deposited in an open or mediated access
make study designs publically available, repository or data warehouse, similar to an
including information about: archive or library, and aggregated over time.
Archived data or information can then be
(a) the form in which the data
made available for later analysis, unless access
or information will be stored
is constrained by restrictions imposed by the
(i.e. whether it can identify
depositor/s, the original data custodian/s or the
individuals); and
ethics review body.
(b) the purposes for which the data or
3.1.55 All data collections should have an
information will be used.
identified custodian to enable access
3.1.52 Unless a waiver of the requirement for by researchers or participants to the
consent is obtained, any research access data while maintaining it in a protected
to or use of publicly available data or form. The custodian of the data may
information must be in accordance with be the individual researcher or agency
the consent obtained from the person to who collected the information, or an
whom the data or information relates. intermediary that manages data coming
from a number of sources.
3.1.53 Researchers should understand the
context in which data or information 3.1.56 When planning to share data or
was collected or disclosed, including information with other researchers
the existence of any relationship of or to establish or add them to a
confidence or, if available on the databank, researchers must develop data
internet, the privacy settings that management plans in accordance with
apply. This includes avoiding the use the guidance provided in 3.1.45. This plan
or disclosure of information that was should enable the sharing of data and
obtained unethically or illegally. information and propose appropriate
conditions on the sharing of data
3.1.54 Researchers should take account of
and information.
any terms and conditions applicable
to social media platforms when using 3.1.57 Researchers must make data custodians
data or information from these sources aware of the data management plans
or platforms and other web-based for banking or sharing of the data or
communities that do not permit the information, and, in particular, of any
removal of the name of the author of a confidentiality agreements or other
post or any changes to the wording of conditions on the identifiability or re-use
a post. of the data or information.
3.1.58 Any sharing of data or information
Sharing of data or information between research collaborators and
research sites must be secure and
While data or information may be collected,
proportional to the risks associated
aggregated and stored for an initial purpose or
with, and the ethical sensitivity of
activity, it is common for researchers to ‘bank’
the information.
their data or information for possible use in
future research projects or to otherwise share 3.1.59 In any proposals to share or disclose
it with other researchers. It is also increasingly research data or information, researchers
common for funding agencies to require the should distinguish between disclosure
sharing of research data either via open access to specific third parties, sharing with
arrangements or via forms of mediated access other researchers and disclosure to the
controlled by licenses. public and clarify whether the sharing or
disclosure of data or information is subject
to participant consent, other voluntary
agreements or mandatory requirements.

3.1.60 Researchers should be aware of Element 5: Communication of research

expectations and policies regarding findings or results to participants
the sharing or re-use of participant
data or information in any form and Research across a range of fields and
should consider the value of the data or methodologies can generate findings or
information for future research. At the results of significance to participants and
time of initial consent, participants should others. Some research (e.g. analysis of human
be informed of these expectations and biospecimens) can generate findings or results
given appropriate options, including of significance to the health of individual
the potential to provide extended or participants, and, potentially, their relatives and
unspecified consent (see paragraphs other family members.
2.2.14 to 2.2.16). If consent to future use Providing research findings or results to
was not obtained at the time of collection, participants can be a benefit, but it can also be a
then reviewers considering the proposed source of risk (e.g. psychological, social, legal).
re-use of this data or information in The approach taken to communicating findings
further research may consider a waiver of and results should reflect principles of good
the requirement for consent or whether it science and adhere to the ethical principles of
is appropriate to seek additional consent justice, respect and beneficence discussed in
for the sharing or re-use of the data or Section 1, including consideration of the values
information. Whether there is an ongoing and preferences of traditional custodians, such
relationship with the participants and the as Aboriginal and Torres Strait Islander peoples.
burden on the participants of re-contact
should be considered in this decision. Communicating findings or results may
be required or optional, appropriate
3.1.61 Before publishing data or information, or inappropriate, and/or intentional or
or adding data or information to a unintentional depending on the nature of the
repository, researchers should consider research and other circumstances.
the degree to which it may be possible
for the data or information to enable
participants to be identified through Key questions include:
efforts made by other researchers or • Could the research generate findings
third parties. or results of interest to participants?
3.1.62 Shared or banked data or information • Could the findings or results be of
that is stored in a form that can identify significance to the current or future
individuals can sometimes be used in welfare or wellbeing of participants
research that qualifies as negligible or low or others?
risk research; however, it cannot be used
in research that is exempt from ethics • Are potential participants in
review (see paragraph 5.1.22). the research forewarned of
this possibility?
• Will the consent of participants be
obtained to enable any planned
or necessary disclosure of findings
or results?
• Who will communicate the findings
or results and how?
• Will the findings or results be
disclosed to third parties and/or
the public?
3.1.63 In considering whether to return results (e) in appropriate circumstances, set out
of research, researchers should distinguish a process for finding out whether
between individual research results and family members wish to receive
overall research results and, if individual the information;
and/or overall results will be provided
(f) outline how the findings or results
to participants:
will be provided in a manner that is
(a) how these results will be provided appropriate and accessible;
to participants;
(g) include the relevant expertise of the
(b) how the process of returning results person who may be communicating
will be managed; and the findings or results; and
(c) the risks of the return of individual (h) include measures to protect the level
research results and overall of privacy desired by participants.
research results.
3.1.64 Where information could be of Disclosure to third parties of findings
significance to the health of participants, or results
relatives or other family members,
There can be situations where researchers have
researchers should prepare and follow
legal, contractual or professional obligations
an ethically defensible plan to disclose
to disclose findings or results to third parties.
or withhold findings or results of
Additionally, researchers may believe that they
research (see Chapters 3.2: Use of
have a moral obligation to disclose findings or
Human Biospecimens in Laboratory
results to third parties.
Based Research and 3.3: Genomic
Research). Ethically defensible plans may 3.1.66 Where the potential disclosure of
be required for other types of research findings or results to third parties can be
addressing, for example, any significant anticipated, researchers should identify:
social, economic or psychological
(a) whether, to whom and under what
implications of the research.
circumstances the findings or results
3.1.65 An ethically defensible plan for research will be disclosed;
other than that described in Chapters 3.2
(b) whether potential participants will
and 3.3 should:
be forewarned that there may be
(a) indicate whether the research will such a disclosure;
be likely to generate findings or
(c) the risks associated with such a
results of significance to participants
disclosure and how they will be
or others;
managed; and
(b) clarify whether the researchers
(d) the rationale for communicating
intend to disclose any findings or
and/or withholding the findings
results to participants directly and
or results and the benefits and/or
which types of findings or results,
risks to participants of disclosure/
if any, are returnable to participants
non‑disclosure.
or others (e.g. clinicians or relatives);
3.1.67 Researchers should be aware of situations
(c) confirm that participants will be
where a court, law enforcement agency
advised in advance whether they
or regulator may seek to compel the
will be offered the option to receive
release of findings or results. In such
their findings or results;
circumstances, researchers should:
(d) if applicable, enable participants to
(a) have a strategy in place to address
decide whether they wish to receive
this possibility; and
the findings or results and who else
may be given the findings or results;

(b) advise reviewers of the potential for 3.1.69 Researchers should consider and advise
this to occur. reviewers as to whether
3.1.68 In circumstances where the imperative (a) they intend to disseminate the
to disclose findings or results emerges outputs or outcomes widely in order
after the research has commenced, to contribute to scientific, academic,
researchers must develop a strategy for professional or general knowledge
addressing this and promptly advise and or practice;
seek advice from reviewers.
(b) there are any risk factors or
commercial interests that might
Element 6: Dissemination of project legitimately delay or restrict the
outputs and outcomes dissemination of the outputs or
outcomes; and
It is consistent with the ethical principles of
respect, beneficence and justice to make the (c) the risks of dissemination of the
outputs or outcomes of research publicly outputs or outcomes are justified
available. Doing so is also a requirement for by the benefits of dissemination
research merit and integrity. A principal goal of (e.g. the public interest).
dissemination of outputs/outcomes is to make
3.1.70 Researchers should ensure that reports
a contribution to knowledge or practice or to
of their research outputs or outcomes
serve a public good. Common mechanisms for
adhere to prevailing standards for ethical
achieving this objective include publication in
reporting, referencing and authorship
peer-reviewed journals or books, conference
(e.g. the Australian Code for the
presentations, commissioned reviews for public
Responsible Conduct of Research).
bodies, or dissemination via other forms of
media such as creative works and performances. 3.1.71 Researchers should advise participants
The form of the disseminated outputs (e.g. a on the format and medium or media that
conference paper) will be shaped by the research will be used to disseminate outputs or
field, the topic, the research design, researcher outcomes of research to them (such as
preference and experience. Publication of a lay summary, a research manuscript
outcomes should not be withheld on the or published paper, or both) and, to the
basis that they are negative or inconclusive. extent known, when such information
However, there may be justifiable reasons to about the outcomes will be made
delay or restrict the dissemination of the outputs available to them. Dissemination of
or outcomes out of consideration for the privacy outputs or outcomes of research should
of the participants or other risk factors. occur in a timely fashion.
3.1.72 Researchers should ensure that any
Key questions include: outputs or outcomes disseminated to
participants are provided in language
• What is the plan for reporting,
that is clear and understandable
publishing or otherwise disseminating
to participants.
the outputs/outcomes of the research?
• Will participants in the research
be offered a timely and
appropriate summary of the
project outputs/outcomes?
• How will the planned dissemination
of the outputs/outcomes contribute
to knowledge or practice or serve
the public?
Element 7: After the project 3.1.73 With respect to the retention, storage
and subsequent disposal of the data and
Researchers continue to have ethical
information, researchers:
responsibilities after projects are completed.
These responsibilities relate to disposal (a) must adhere to the ethical principle of
or retention of data and information, respect for persons (e.g. with regard to
potential secondary (future) use of data or culture and beliefs of the participants);
information and any necessary follow up or long
(b) should maintain the confidentiality
term monitoring of research participants.
of individuals in accordance
with any assurances made to
Key questions include: them (e.g. during the consent
process); and
• Will the data or information be
retained only for the minimum period (c) should be aware of and adhere to
required by relevant policy? applicable national and/or state
or territory codes and legislation,
• Do the data or information
as well as to relevant international
have cultural, historical or other
guidelines and regulation.
significance that could warrant
longer, or perpetual retention? 3.1.74 Data and information may be of cultural,
historical or other significance such that
• Are the arrangements regarding
they should be retained beyond the
intellectual property (individual,
minimum retention period. Disposing of
community, organisational,
these data or information without
commercial) and copyright related
consideration of these factors violates the
to the outputs of the research clearly
ethical principle of respect. These matters
understood and communicated?
should be appropriately addressed in the
• Will the data or information be research plan and in consent processes
banked or added to a repository, and documentation.
such as an open or mediated access
facility, for future use?
• Is any follow up or monitoring of
research participants required and
is this clear in the research plan and
consent information?

CHAPTER 3.2 : HUMAN BIOSPECIMENS IN LABORATORY BASED RESEARCH
CHAPTER 3.2: HUMAN BIOSPECIMENS IN

LABORATORY BASED RESEARCH
INTRODUCTION Specific considerations for human

embryos, gametes and fetal tissue
‘Human biospecimens’ is a broad term that,
for the purposes of this chapter, refers to any Specific requirements for research involving fetal
biological material obtained from a person tissue are detailed in Chapter 4.1: Women who
including tissue, blood, urine and sputum; it also are pregnant and the human fetus.
includes any derivative of these, such as cell Research involving human embryos and
lines. It does not include non-human biological gametes, including the derivation of human
material such as micro-organisms that live on or embryonic stem cell lines, is separately
in a person. governed by the Research Involving Human
Research involving human biospecimens often Embryos Act 2002 (Cth) and the Ethical
involves special ethical consideration because of: guidelines on the use of assisted reproductive
technology in clinical practice and research
• the way that human biospecimens (2017) (ART guidelines), issued by the NHMRC.
are obtained; Research involving the derivation of embryonic
• the information that may be derived stem cell lines or other products from a human
from human biospecimens and the embryo must be considered by a Human
implications of that information for the Research Ethics Committee (HREC) as part of
individual donor, their relatives and their a licence application to the Embryo Research
community; and Licensing Committee (see Part C of the ART
guidelines). The legislation and ART guidelines
• the significance that may be attached to do not regulate the use of these products after
the human biospecimens by individual they have been derived.
donors and/or communities.
Once human biospecimens have been derived
Chapter 3.2 should be read in conjunction from human embryos, gametes or fetuses, the
with Chapter 3.1 and other parts of the requirements of this chapter apply for any
National Statement. subsequent use in research.
Researchers and institutions must also meet
any relevant legislative requirements that relate Conscientious Objection
to the collection, retention, use and disposal
of human biospecimens, including the general Those who conscientiously object to being
prohibition on trade in human tissue. involved in conducting research using human
biospecimens derived from human embryos,
gametes, fetuses or embryonic or fetal tissue
should not be obligated to participate,
nor should they be put at a disadvantage
because of their objection.
Element 1: Research Scope, Aims, Element 2: Recruitment

Themes, Questions and Methods Sources of human biospecimens include
Ethical considerations related to laboratory voluntary donation, material taken for clinical
based research involving human biospecimens purposes, and material collected post-mortem
vary according to whether the biospecimens are (after death).
being collected prospectively for the research Human biospecimens are commonly collected,
or whether the biospecimens to be used in stored and distributed by researchers,
the research are stored biospecimens that biobanks, clinical pathology services,
have been previously collected for research or health care providers, research institutes and
non‑research purposes. commercial entities, such as pharmaceutical and
biotechnology companies.
Prospective collection of human For the purposes of this chapter, the concept
biospecimens for research of ‘recruitment’ includes the acquisition or
3.2.1 For human biospecimens collected for collection of human biospecimens.
research purposes (including biobanks),
there should be ethics review and Prospective collection of human
approval by an HREC of the proposed biospecimens for research
consent, collection, processing, storage
and distribution or disposal. 3.2.4 Those proposing to collect human
biospecimens for research should:
Use of stored human biospecimens (a) ensure that the burdens of the
for research biospecimen collection on the
donor(s) are justified by the potential
3.2.2 In determining the level of ethics review benefits of the proposed research;
appropriate for the research involving
the use of human biospecimens, (b) ensure that those involved in the
the responsible institution and researcher collection of the biospecimens are
should consider: suitably qualified or experienced,
and follow current best practice; and
(a) whether the research involves any
risks to the donors, their relatives (c) ensure that suitable provisions,
or their community that are more including financial and governance
serious than discomfort (see Chapter arrangements, have been made for
2.1: Risk and Benefit); and the intended processing, storage,
distribution and/or use, and disposal
(b) whether the research may give rise of the biospecimens.
to information that may be important
for the health of the donors,
their relatives or their community Human biospecimens obtained after
where the identity of the donors will death for research
be known to, or can reasonably be
3.2.5 Any wish expressed by a person about
ascertained by, those conducting the
the use of their biospecimens post-
research or with access to health or
mortem should be respected. If no such
research data or information
wish is discovered, researchers seeking to
related to donors.
obtain human biospecimens post-mortem
3.2.3 If the research involves only the use of should obtain consent from the person(s)
stored biospecimens and involves no authorised by relevant legislation.
more than low risk, then the provisions of
paragraphs 5.1.18 – 5.1.21 for non-HREC
levels of review may apply.

Use of human biospecimens collected Transition provisions for

for clinical purposes existing biospecimens
3.2.6 Where human biospecimens were 3.2.10 Where biospecimens were obtained
obtained for clinical purposes and have domestically or via importation prior
been retained by an accredited clinical to December 2013, the biospecimens
pathology service, the biospecimens may may continue to be used in Australia
be used for research purposes if: for approved research provided that the
researcher’s institution ensures that:
(a) the identity of the donor is not
necessary for the activity; or (a) there is sufficient evidence that the
samples were obtained in a manner
(b) where the identity of the donor is
consistent with any prior guidelines
required for the purposes of the
and/or the accepted ethical practice
research, a waiver of consent (see
at the time of collection; and
paragraph 3.2.14) has been obtained.
(b) the proposed research for which the
biospecimens will be used is within
Importation and exportation of human
the scope of the consent provided
biospecimens for research by the donor(s).
3.2.7 Where it is intended that human
biospecimens will be, or where the Element 3: Consent
biospecimens have been imported from
another country for use in research in
Australia, researchers must establish Prospective collection of human
whether these human biospecimens were biospecimens for research
obtained in a manner consistent with the
3.2.11 Those involved in the collection of
requirements of this chapter and relevant
human biospecimens specifically for
Australian legislation.
research should obtain and record the
3.2.8 Where it cannot be established that consent of donor(s) in order to meet the
the human biospecimens described requirements of Chapter 2.2.
in paragraph 3.2.7 were obtained in a
3.2.12 Before potential participants consent
manner consistent with the requirements
to donation of their biospecimens,
described in this chapter and relevant
they should be given sufficient
Australian legislation, the biospecimens
information about:
should not be used for research
in Australia. (a) the research for which their
biospecimens are to be used
3.2.9 Human biospecimens obtained for
and, where extended or
research in Australia may be sent
unspecified consent is sought,
overseas for research in accordance with
sufficient information to meet the
institutional policy, if:
requirements of paragraphs 2.2.1
(a) evidence of ethics approval by an and 2.2.16;
appropriate ethics review body for
(b) how their biospecimens will be
importation of the biospecimens is
stored, used and disposed of,
submitted; or
including any processes to be
(b) the exportation of the biospecimens adopted to respect their personal or
is consistent with the original cultural sensitivities;
consent and ethics approval is
provided by an HREC.
(c) the extent to which their (j) any potential for commercial

biospecimens will be reasonably application of any outcomes
identifiable, and how their privacy of the research involving their
and confidentiality will be protected; biospecimens, how this will be
managed and to whom the benefits,
(d) whether or not research using their
if any, will be distributed.
biospecimens is likely to provide
information that may be important to
their health or to the health of their Use of stored human biospecimens
relatives or their community; for research
(e) if information of the kind referred 3.2.13 Reviewers of proposed research involving
to in (d) is likely to be revealed, the use of human biospecimens must
whether or not they will have the consider the circumstances in which the
choice to receive this information, biospecimens were obtained and any
and how this will be managed known limitations the donor(s) placed on
(see paragraph 3.2.14); their use during the consent process.
(f) if information of the kind referred 3.2.14 Where it is contemplated that proposed
to in (d) is likely to be revealed, research will involve the use of human
whether or not they will have the biospecimens that have been obtained
choice for it to be provided to without specific consent for their use
their relatives or their community; in research (e.g. where biospecimens
and how this will be managed were collected for clinical investigation),
(see paragraph 3.2.14); or where the proposed research is not
consistent with the scope of the original
(g) whether their biospecimens and
consent, the biospecimens may be
associated data may be distributed
used only if an HREC is satisfied that
to other researchers, including those
the conditions for waiver of consent
outside Australia (see paragraphs
are met (see Chapter 2.3). In particular,
3.2.7 – 3.2.9);
reviewers should consider:
(h) their right to withdraw consent
(a) whether there is a pathway
for the continued use of their
to identify and re-contact the
biospecimens or associated data in
donor(s) in order to seek their
research (see paragraph 2.2.6(g)),
informed consent to the use of their
and any limitations that may be
biospecimens in research; and
relevant to their withdrawal of
consent; for example, as a (b) whether there is a known or likely
consequence of the removal of reason for thinking that the donor(s)
identifiers, or the prior distribution would not have consented if they
and/or use of their biospecimens; had been asked.
(i) any relevant financial or personal
interests that those engaged in
the collection, processing, storage
and distribution and use of their
biospecimens may have (see Chapter
5.4); and

Element 5: Communication of research (f) whether there is a pathway

findings or results to participants to identify and re-contact the
donor(s), their relatives or their
3.2.15 Where proposed research involving the community, taking into account the
use of human biospecimens may reveal relationship between the researchers
information that may be important for and the donor(s), if any;
the health of the donor(s), their relatives
or their community, whether anticipated (g) the potential for sampling or coding
or incidental to the scope of the errors that may compromise the
research, researchers should prepare an certainty that the biospecimens came
ethically defensible plan to describe the from a particular donor;
management of any proposed disclosure (h) whether the findings of specific
or non-disclosure of that information. tests being undertaken as part of
This plan must be approved by an HREC the research have been produced
and, in reviewing this plan, the HREC or validated in an accredited
should consider: laboratory; and
(a) the circumstances in which the (i) who will take responsibility for any
biospecimens were obtained, subsequent care requirements.
including the type of consent
provided (see paragraph 2.2.14)
and the manner in which the
consent was obtained;
(b) the likelihood of the research
generating information that may
be important for the health of
the donor(s), their relatives or
their community;
(c) whether a recognised intervention
exists that can benefit or reduce the
risk of harm to the donor(s),
their relatives or their community
from any health impact revealed by
this information;
(d) the resource requirements and
infrastructure in place to support
the return of information of the
kind referred to in (b) and (c) in an
ethically appropriate manner;
(e) whether participants will be given a
choice to receive such information;
CHAPTER 3.3 : GENOMIC RESEARCH
CHAPTER 3.3: GENOMIC RESEARCH
INTRODUCTION Genomic research can reveal information about

predispositions to disease. Although people
This chapter is about generating, gathering, with such a predisposition may not develop the
collecting, conveying or using genomic data disease, the information may have implications
or information that has hereditary implications for their access to employment and education
and/or is predictive of future health in research and to benefits or services, including financial
involving participants, relatives and other family services such as banking, insurance and
members. It applies irrespective of the nature of superannuation. Genomic information can
the source material for the research, such as data sometimes be misused to stigmatise people
or biological materials such as germline/germ or to discriminate against them unfairly.
cells or somatic cells. The information may also have similar
implications for close relatives. In addition,
Genomic research is characterised by the
genomic research can reveal information about
original intention of the investigation and
previously unknown or misattributed paternity
the potential hereditary and/or future health
or maternity or familial relationship.
implications, if any, of the information that is
collected or generated by the investigations. Genomic research is frequently considered to be
Genomic research is rapidly evolving and is not greater than low risk, especially in the context
constrained by current methods or techniques of research involving Indigenous peoples.
for obtaining the information; however, For this reason, relevant on-going community
a common element of genomic research is the consultation and active agreement on the
sequencing of data or its use. part of communities and traditional owners is
an essential component of the planning and
Genomic information can be predictive,
conduct of this research.
unchanging, sensitive and familial.
Genomic information has the unique character This chapter is relevant to different types
of being both specific to an individual and of genomic research (e.g. family studies,
specific to relatives of that individual and, in clinical research, population health research,
some cases, of significance to human population health service research). Some research that
groups such as groups that define themselves falls within the broad description of genomic
via their ancestral lineages. research does not involve information that is
relevant to the future health of the individual
Research results and information collected
participant and does not generate sensitivities
for genomic research may be significant for
for the individual, or his or her family or
relatives of research participants. Relatives and
community. An example of this research is a
other family members, such as partners and
population survey of preferences regarding
spouses, may have an interest in the participants’
disclosure of genomic information where
genomic material, or in information the research
identifiers related to survey results are
generates, because testing that material or
not disclosed.
acquiring that information may create new
options for life decisions, including those with As a general principle, research including
the potential to improve their health or the genomics will require review by an HREC;
health of their offspring. However, some family however, if no information that can identify
members may prefer not to be given an individual is used and no linkage of data is
such information, or even not to know of planned, the research may be determined to
its existence. carry low risk.

In genomic investigations, there may be a Element 2: Recruitment

strong relationship between the research and
clinical contexts such that there may be clinical 3.3.4 In addition to participants in genomic
implications of research results or findings. research identified as index cases
Nevertheless, differences between results that (probands), relatives of these individuals
are associated with research and results that are who provide information or biospecimens
associated with clinical investigations should for genomic research become participants
be clear, especially when the researcher is also in the research in their own right.
a clinician and where clinical care is ongoing. Therefore, researchers should be aware
Where appropriate, researchers should refer to of the possibility of the involvement of
clinical practice guidelines such as the NHMRC’s relatives by virtue of association with a
Principles for the translation of ‘omics’– participant or other family member who
based tests from discovery to health care and has been recruited.
applicable legislation. 3.3.5 HRECs must consider the rationale
Chapter 3.3 should be read in conjunction for and review the information to be
with Chapter 3.1 and other parts of the used in recruiting family members of
National Statement. a participant.
3.3.6 Where a potential research participant is
not already known to the research team,
GUIDELINES it may be ethically preferable for the
participant (rather than the researcher)
to make the initial contact with a family
Element 1: Research Scope, Aims, member for purposes of recruitment
Themes, Questions and Methods into research.
3.3.1 Genomic research that uses sequenced 3.3.7 Researchers should respect differences
information should be designed with between and within families regarding
attention to what information is necessary the willingness to communicate health
to achieve the aims of the research and to information, the relative importance
ensure that ethical issues that arise from of privacy versus sharing of health
activity outside the intended scope of the information and other matters that may
research are minimised by, for example, reflect cultural values (whether shared
developing a list of genes that are within the family or not).
excluded from analysis. 3.3.8 Where researchers propose to generate
3.3.2 Genomic research should be or collect genomic information from
designed to minimise the potential for individuals who are chosen because
misunderstanding and misuse of genomic of their membership of a particular
information by those who may wish to community, they should consult with
use it for unrelated purposes. appropriate community representatives.
3.3.3 Methods used in genomic research 3.3.9 The recruitment process should avoid
are not a static set, but are constantly disclosure of genomic information to
evolving and, as they are developed a potential research participant as an
and applied, may require ethical inadvertent consequence of that process.
consideration on an ongoing basis.
Therefore, the ethical principles and
guidance in this chapter should be
considered with reference to the new
technologies as they are developed
and applied.
Element 3: Consent 3.3.13 Participants should be advised of the

practical limitations associated with a
3.3.10 In considering the appropriate form decision to withdraw from genomic
and scope of consent and the most research after analysis of data has been
appropriate process for obtaining consent, conducted or biospecimens have been
researchers should consider: shared with other researchers as well as
(a) what information will be generated any other consequences that may follow
by the research; from their withdrawal from the research.
(b) what may be discovered by 3.3.14 Consent specific to the research

the research; may not be required or a waiver of
the requirement for consent may be
(c) what will be deliberately excluded considered by an HREC if:
from the scope of the research;
(a) the data or information to be
(d) which, if any, of the findings of the accessed or used was previously
research will be communicated to collected and either aggregated or
participants and, if so, how; had identifiers removed; or
(e) what the health implications are of (b) prior consent for the use of the data
the information for participants and or information was provided under
their relatives; the scope of a research program that
(f) whether there are any other encompasses the proposed research
implications for participants and project; or
their families of being given (c) prior consent for the use of the data
this information (e.g. insurance, or information was provided in the
employment, social stigma); clinical context for research that
(g) the potential for the information encompasses the proposed research
generated by or used in the research project; or
to result in participants being (d) unspecified consent has
re‑identified; been provided.
(h) whether information generated by 3.3.15 An opt-out approach (see 2.3.5), should
the research will be shared with not be used in genomic research.
other research groups; and
3.3.16 Collection of information about family
(i) potential future use of information history for genomic research may involve
and biospecimens, including the collection of information about
commercial applications. family members who are not aware that
3.3.11 Participants should be advised that information about them is being collected
information that they may be given and it may not be practicable to obtain
about the likely impact of the genomic consent from all family members in a
information may change over time as new pedigree. Therefore, researchers should
knowledge/insight is gained and how to consider documenting who provided the
obtain updated information. family history and any presentation of
research outcomes should acknowledge
3.3.12 Participants should be advised that that self-reported information about
publication or funding requirements may individuals and their families may not be
require submission of data or information accurate or complete.
to controlled access repositories that meet
international security and safety standards
for sharing with researchers globally.

3.3.17 Researchers should not presume that 3.3.22 Researchers receiving genomic
the decision to participate in genomic information should not undertake
research includes a decision to receive the nor permit attempts to re-identify the
results of that research. Where researchers material or information or otherwise
consider that the results must be provided reduce the protection of the privacy of
to participants, the project should be the participants.
designed to include the mandatory return
3.3.23 Information generated or collected
of results and this condition should be
through genomic research should
clear in any information materials.
not be disclosed by researchers
for uses unrelated to research;
Element 4: Data Collection and however, statutory or contractual
Management duties may require participants to
disclose the results of genetic tests or
This section covers the access to and collection,
analysis to third parties (for example,
use, analysis, disclosure, storage, retention,
insurance companies, employers,
sharing and disposal of genomic data and
financial and educational institutions),
information. The potential return of findings and
particularly where results provide
results of genomic research is covered in 3.3.26
information about health prospects.
to 3.3.35, below.
Participants should be advised of
3.3.18 Researchers should recognise and account these duties.
for the potentially predictive and sensitive
3.3.24 Researchers may share genomic data or
nature of genomic information.
information provided that:
3.3.19 Researchers should be sensitive to the
(a) sharing information is consistent
contextual factors that determine the
with the consent that has been
identifiability of genomic information,
obtained for the research project or
in particular the impact of the rarity of a
for clinical purposes; or
genetic disorder or mutation on whether
individuals or families could be identified. (b) an HREC has judged that the
conditions for waiver of the
3.3.20 For the purposes of a specific research
requirement for consent have been
project, the identification of individuals
met (see 2.3.9 to 2.3.10); and
or family members can be considered
impracticable if: (c) the HREC has approved the transfer
in principle, subject to any transfer
(a) there is no plan in the research
agreement that has been established
proposal to link or match the
for this purpose.
information in such a way as to
permit re-identification; and 3.3.25 Subject to the requirements of good
research practice, genomic information
(b) storage of biospecimens and project
and related biospecimens should be
information is secure.
stored or disposed of in accordance with
3.3.21 If inclusion of information in databases the project-specific consent provided
is a necessary component of the or the governance policies of the
research or if information is to be relevant biobank.
shared for other research, efforts should
be made to minimise the potential for
re‑identification.
Element 5: Communication of research 3.3.31 Any plan to return individual research

findings or results to participants results should include linkage with a
clinical service and access to genetic
3.3.26 In considering whether to return counselling. The plan should specify any
results of research, researchers should expertise to which the project team might
distinguish between individual research require access.
results and overall research results.
Researchers should consider how these 3.3.32 The return of results or findings of
results will be provided to participants, significance for the health of the
how the process of returning results will participant or relative is the responsibility
be managed and the risks of the return of the appropriate clinical service or,
of individual research results and overall where such a service is not available,
research results. the participant’s clinician in consultation
with the research team.
3.3.27 Return of findings and results relating
to an individual participant depends on 3.3.33 Where a result or finding may be of
the contextual relevance of the findings; relevance to one or more relatives, it is
some genomic research findings must the remit of the appropriate clinical
be returned, some findings may be service or the participant’s clinician
returned and some findings should not to discuss with the participant the
be returned. appropriateness of communicating these
results or findings to relatives.
3.3.28 While participants may have a strong
interest in their own information, 3.3.34 Over time there may be a substantive
researchers are not expected to return change in the understanding of the
raw genomic data to participants. significance of the research results
or findings. For the duration of the
3.3.29 Once there is sufficient evidence and research project, researchers have a
agreement that a finding or result is responsibility to provide the research
clinically significant, participants should cohort with the opportunity for each
be advised that research results or participant to re-consider their decision
findings that may be returned will first related to receiving results or findings
need to be confirmed according to (see 3.3.53‑3.3.55).
applicable guidelines, e.g. at a National
Association of Testing Authorities 3.3.35 In all other cases, any obligation to
(NATA)‑accredited laboratory. further analyse or interpret genomic data
related to participant information ceases
3.3.30 When designing the research project and at the end of the project.
in considering whether to return findings
to participants, researchers should refer to
the Decision tree for the management of
findings in genomic research and health
care for the principles/framework and
then refer to the guidance in the section
Guidance for the Development and
Evaluation of an Ethically Defensible Plan
for the Potential Return of Findings and
Individual Results from Genomic Research
that follows for developing an ethically
defensible plan.

Decision tree for the management of findings Question Action

in genomic research and health care Relevant for clinical practice only
Yes Was the investigation No

requested by or on behalf of
a primary treating clinician?
(see Note 1)
Was the investigation a Was the investigation
validated test performed performed as part of an
in a NATA accredited lab or No approved research project?
overseas equivalent?
No (see note 3) Yes
Yes
Does the protocol
permit the return
Do not return findings of any findings
Are the results pertinent to
the indication for testing? from the research?
Yes No
Yes No (see note 2)
Does the protocol include
criteria and a process for the Do not
Did the patient consent return of findings, including return
Follow standard to the return of findings, secondary and/or incidental findings
clinical practice including secondary and/or findings? (See Note 4)
incidental findings?
Yes No
Yes No
Are the findings Consult HREC re: establishment
Consult current best pertinent of a process for review of
Follow policy findings, consultation with
practice or national findings?
and/or patient clinicians and criteria for contact
clinical genomics
preferences with research participants
guidelines
Yes
No (see note 5)
Do not return findings (unless

Did the participant
national / international
consent to the
standard or protocol is for
return of pertinent
mandatory return of some or
findings?
all incidental findings)
Yes (see note 6)

No
Follow process Do not return findings

as described in (unless protocol mandates
protocol return of pertinent findings)
Note 1: Clinicians who do not request an investigation or on whose behalf an investigation was not requested or who subsequently refer a patient to a different primary
treating clinician do not have an obligation with respect to management of the findings of the investigation.
Note 2: The patient must be advised of the policy +/- options addressing the return of findings including incidental findings.
Note 3: A “no” answer includes scenarios in which a non-validated test is performed in a NATA accredited lab or overseas equivalent AND in which a validated test is
performed in a non-accredited lab. Situations in which this might occur include the development of diagnostic tests and research testing that has not been approved as part
of a research project. In the first situation (test development), findings should not be returned. The second situation (unapproved testing) is contrary to ethical standards.
Note 4: The criteria and process must specify: 1) that any findings must be verified by a NATA accredited lab; 2) which findings will be returned; 3) who will be consulted
prior to the return of the findings; 4) who will return the findings; and 5) to whom the findings will be returned.
Note 5: If the findings are not pertinent findings, then any return of findings will be based on the policy established by the research protocol and/or by international
standards.
Note 6: Refer to guidance in this chapter regarding requirements related to consent for the return of findings from genomic research.
Key Terms
Pertinent findings: Also known as primary findings, pertinent findings are those that were the primary objects of the investigation.
Secondary findings: Findings that were not the primary target of the investigation, but were either specifically sought or are related to the primary target and anticipated
as likely to arise.
Incidental findings: Findings of potential clinical significance unexpectedly discovered during the investigation. NB: With respect to full spectrum
‘discovery’investigations and direct-to-consumer testing, one is explicitly searching for any and all findings and so no findings can be considered ‘unexpected’.
GUIDANCE FOR THE Step 1: Determination of Whether

DEVELOPMENT AND EVALUATION Findings Will Be Returned
OF AN E THICALLY DEFENSIBLE Genomic research falls into three categories:
PLAN FOR THE POTENTIAL (a) research with findings that must
RE TURN OF FINDINGS AND be returned;
INDIVIDUAL RESULTS FROM (b) research with findings that may be
GENOMIC RESEARCH returned; and
(c) research with findings that should
General Requirements not be returned.
3.3.36 Researchers must prepare and follow an The relevant factors to be considered to
ethically defensible plan to manage the determine whether findings must, may or should
disclosure or non-disclosure of genomic not be returned include:
information of potential importance for
the health of research participants or (a) analytic (scientific) and
their relatives. clinical validity;
3.3.37 The ethically defensible plan must be (b) significance to the health of the
approved by an HREC. participants/relatives; and
(c) clinical utility.
The Nature of Research Findings 3.3.41 Where there will be any return of findings
3.3.38 Researchers should describe how to participants, they should be advised
potentially returnable findings may arise as to which findings will be returned and
(where applicable). This description which will not be returned, as follows:
may include reference to the types of (a) that researchers have an obligation
technologies that will be used to generate to have a process in place for the
the findings. return of findings that are of proven
3.3.39 As relevant, descriptions should include validity and of health significance to
information on distinctions between: the participant or relative, subject to
participant consent;
(a) findings related to primary aims of
the research (including individual (b) that if researchers plan to return
test results); and findings during the project that are
of proven validity but are not of
(b) findings related to secondary aims health significance to the participant
of the research or findings that or relative, they will need to justify
are unintended, unanticipated, this plan;
inadvertent, incidental to or beyond
the aims of the research. (c) that there is no obligation on
researchers to look at or assess
3.3.40 Researchers should include information findings outside of the scope of the
on the difference between clinical and research; and
research testing/findings and the need
for further validation of any research (d) that there is no ongoing
findings and assessment of their responsibility on researchers to
clinical significance. review findings of a research
project after the project has been
completed in order to discover
or assess findings that may have
become returnable due to later
scientific advances.

3.3.42 Where unspecified collections by (b) recommendations for finding the

biobanks are involved, researchers should necessary expertise for making
describe the role, if any, that any biobank these judgements, if not within the
involved in the collection, management or expertise of the research team –
storage of any biospecimens used in a process that must:
genomic research will have in the return
(i) include the involvement of a
of findings. Researchers should note that
clinical service with qualified
there is no general expectation that there
genetics practitioners before
is a role for a biobank in the return of
and/or after the assessment; and
findings of genomic research.
(ii) be independent of the research
3.3.43 Researchers must provide evidence in
team; and
their research proposal of their awareness
of any relevant institutional policies (c) how the confirmed findings will
or procedures related to the return of be communicated to those whose
findings to participants, including those expertise is required.
of associated familial cancer centres or
their equivalent.
Step 3: Consent to Disclosure
3.3.44 Researchers should describe the resource of Findings and Notification
requirements and infrastructure that Requirements
are or will be put in place to support
the process of return of findings, 3.3.47 Researchers should describe how consent
including resources that the research for return of findings will be obtained and
team, institution or external parties how it will enable participants’ decisions
(e.g. clinicians and other experts) will to receive or not to receive findings,
need related to the provision of advice or including when, how and by whom
counselling, the coordination of services the consent will be obtained and with
and administrative matters. recognition of:
(a) the iterative character of consent
Step 2: Validation and Assessment (i.e. obtained at multiple time
of Findings points) for return of this type of
findings; and
This section applies to individual test results and
any findings, whether primary, secondary or (b) the familial character of information
beyond the intended scope of the research. and the consequent implications
for relatives.
3.3.45 Researchers should describe how any
individual findings will be confirmed 3.3.48 Researchers should describe the proposed
including reference to where the validated process for communication with
tests will ordinarily be conducted and any (a) the participant;
relevant distinctions between different
types of validity (i.e. analytic (scientific) (b) the appropriate clinical service or
validity and clinical validity). participant’s clinician (regarding
the communication of the
3.3.46 Researchers should describe how the implications of the findings to the
validated findings will be assessed for participant); and
their potential health significance and
clinical utility for the participant and/or (c) the authorised decision maker in the
relatives, including: event of the death or incapacity of
the participant.
(a) who will be responsible for making
these judgements, including any
intention to refer participants to a
clinician for this purpose;
3.3.49 The communication process 3.3.55 Researchers should advise participants

should include: that, if they change their preference and
wish to receive the information, they may
(a) who will be involved in
contact the research team to request it
communicating with the participant/
and that the researchers will provide the
clinician/authorised decision makers;
information if it is practicable to do so.
(b) to whom the participant/clinician/
3.3.56 Researchers should describe the
authorised decision makers can
access to genetic and clinical advice
address any follow up questions or
and counselling that will be provided,
concerns; and
or clearly recommend to participants that
(c) what mechanisms and formats will they seek these services. Such advice
be used to communicate information and counselling should be provided by
(including potential notification, professionals with appropriate training,
disclosure and referral). qualifications and experience.
3.3.50 Researchers should provide participants 3.3.57 Researchers should specify where
with qualitative and, if available, quantitative the genetic and clinical advice and
information regarding the likelihood that counselling services are located and
returnable findings will be discovered confirm that sufficient resources
and whether an effective and beneficial are available.
(or harm reducing) intervention exists for
the condition related to the findings. Privacy Issues Specific to Genetic
3.3.51 If the participant has agreed to be notified Information
of the existence of potentially relevant
3.3.58 Researchers should consider the
information and the option to receive
identifiability of information and data
this information, they should only be
linkage issues in the context of the
notified after the test validity and the
return of genomic research findings,
potential utility of the information have
with specific attention to the impact of
been established.
the design and implementation of the
3.3.52 Where feasible, researchers should research and other current or projected
indicate the timeframe for establishing activities that may require the use
the validity and potential utility of the of the information/findings that are
relevant information. potentially returnable.
3.3.53 Researchers should respect the decision 3.3.59 Researchers should advise participants of
of a participant not to receive information the potential for genetic information to
on the research findings, including become re-identified.
information that is important for their
3.3.60 Researchers should describe the
health, and should not routinely seek to
process for protection of privacy in
confirm the preference at a later point
accordance with participant preferences,
in time.
how differences in the preferences of
3.3.54 As the nature of information may participants will be accommodated and
change during a research project, how any conflicts (e.g. between family
researchers should be prepared to members) will be managed.
provide information to participants who,
3.3.61 Researchers should consider how
after indicating that they prefer not to
genomic research data or information
receive information, later change their
will be stored in the event of the need
preference and request to receive the
for future analysis/testing and disclosure
information (see 3.3.17 and 3.3.34).
to participants.

CHAPTER 3.4 : ANIMAL-TO-HUMAN XENOTRANSPLANTATION
CHAPTER 3.4: ANIMAL-TO-HUMAN

XENOTRANSPLANTATION
INTRODUCTION • the requirement for long-term or lifelong

monitoring for safety. Monitoring may
Xenotransplantation includes any procedure include the participant and, potentially,
that involves the transplantation, implantation or their close contacts; and
infusion of live cells, tissues or organs from
• limitations on the participant’s ability to
another species, or body fluids, cells, tissues or
withdraw consent. This may be due to the
organs that have ex vivo contact with live cells,
inability to remove the animal material or
tissues or organs from another species.
withdraw from long-term monitoring.
Some animal materials are already used to
HRECs must adopt a cautious approach
treat humans, such as porcine heart valves.
when assessing the ethical acceptability
However, in these cases the materials are
of xenotransplantation research.
chemically preserved so they contain no living
Xenotransplantation research will only be
cells or tissue. In contrast, xenotransplants are
ethically acceptable if the potential benefits
living cells that can perform the same functions
justify the risks. HRECs responsible for
as the organ, tissue or cells that they replace.
approving xenotransplantation research must
This chapter provides guidance for the ethical consider the extent to which risks are unknown
review and conduct of animal-to-human in the context of public safety and whether
xenotransplantation research, hereafter referred the proposed research should proceed in view
to as xenotransplantation research. Researchers of potential unknown risks. An assessment
should seek advice from an HREC if they are of the risks and benefits associated with
unsure if their proposed research is covered by xenotransplantation research may be particularly
this chapter. complex due to:
Chapter 3.4 should be read in conjunction • the potential risk not just to the
with Chapter 3.1 and other parts of the individual, but also to close contacts and
National Statement. other non-participants;
In addition to the ethical considerations • the potential for catastrophic harm if an
identified in Chapter 3.1 that are applicable to adverse event, such as xenozoonosis,
all research, there are ethical considerations that were to eventuate; and
are particularly relevant to xenotransplantation
• unknown risks.
research. These include:
• the potential risk of disease transmission
Specific considerations for
from animals to humans (xenozoonosis),
including the risk of novel xenozoonoses;
xenotransplantation research
All research to which this chapter applies must
• the risk of the transmission of a
be ethically reviewed and approved by an
xenozoonosis from the participant to their
HREC, with consideration of any requirements
close contacts or other non-participants;
of the Therapeutic Goods Administration (TGA).
• the need to balance the interests and
safety of close contacts and other
non‑participants with the interests of
the participant;
Conscientious objection GUIDELINES

Those who conscientiously object to being
involved in xenotransplantation research should Element 1: Research Scope, Aims,
not be obligated to participate, nor should Themes, Questions and Methods
they be put at a disadvantage because of
their objection.
The use of animals in research • Does the HREC have
appropriate expertise to assess
The use of animals in research raises significant
xenotransplantation research?
ethical issues. The care and use of animals in
xenotransplantation research must comply with • What are the potential risks to
the requirements of the Australian code for the participants, close contacts and other
care and use of animals for scientific purposes non-participants?
8th edition, 2013 and relevant state and territory
• Are there risks that are not currently
legislation, and also applies to animal materials
known or not well understood?
imported for use in xenotransplantation
research. Xenotransplantation research must • How is the research ethically justified
be ethically reviewed and approved by an in the context of these risks?
institutional animal ethics committee.
• How will the planned methods
Source animals for xenotransplantation that are minimise the risks of the research?
genetically modified are regulated by the Office
• How are public interests
of the Gene Technology Regulator (OTGR)
balanced against private and/or
under the Gene Technology Act 2000 (Cth).
commercial interests?
The use of hybrid embryos or chimeras • What type of monitoring will

be required?
Research involving human embryos and
gametes, including the creation of hybrid and • For how long will participants
chimeric embryos, is separately governed by the be monitored and under what
Research Involving Human Embryos Act 2002 circumstances, if any, would the
(Cth) and the Prohibition of Human Cloning for monitoring plan change?
Reproduction Act 2002 (Cth). • How will adverse events be managed?
• Under what circumstances would the
research be discontinued?
3.4.1 HRECs responsible for approving

xenotransplantation research should be
satisfied that:
(a) all necessary information, as outlined
in this chapter, has been received;
(b) appropriate expertise is available
for the assessment of the research
(see paragraph 5.1.33);
(c) the proposed research is
scientifically valid, and independent
expert advice has been sought
(see paragraph 5.2.21);

(d) the proposed research activities, (f) alternative treatment options

level of risk and proposed benefits available, including other clinical
have been considered in relation to trials, which may pose greater
public interest and safety; and benefit to the participant or less risk
to the participant, close contacts and
(e) all possible mechanisms to
other non-participants.
reduce the risks to the participant,
close contacts and to other 3.4.5 An ethically defensible plan for
non‑participants have been explored the management of risks related to
and, where possible, introduced. xenotransplantation research must be
developed for consideration by an HREC.
3.4.2 Researchers should develop a definition
In reviewing this plan, the HREC should
of ‘close contacts’ for each research
be satisfied that the following have
proposal with consideration of an
been considered:
individual participant’s circumstances.
The definition of ‘close contacts’ may (a) the requirements outlined in
vary depending on the specific research this chapter;
and identified risks. Close contacts may
(b) a risk management plan, including a
include the participant’s immediate family,
plan for proposed monitoring
close friends, work colleagues, or any
and a justification for the
person who is in intimate or frequent
proposed monitoring;
contact with the participant or the
xenotransplantation material. (c) the availability of the required
resources to sustain the proposed
3.4.3 If there are options that pose less risk
research, including evidence of
or greater benefit to the participant,
adequate financial resources for
the HREC must be satisfied that the
long-term monitoring (see 3.1.9);
research is ethically justified.
(d) the likelihood of the research
3.4.4 When assessing risk to the participant,
generating information, such as the
close contacts and other non-participants,
diagnosis of a xenozoonosis, which
researchers and HRECs should consider:
may be relevant to the participant’s
(a) the type of material intended for close contacts and/or other
transplantation, including whether non‑participants;
the material will be encapsulated in
(e) the circumstances under which the
synthetic, animal or human material;
participant’s personal information
(b) the measures in place to minimise may be disclosed to close contacts
the potential for xenozoonoses. and the process for managing such
These measures may include the use a disclosure;
of specific pathogen-free herds or
(f) the procedure for the transfer of
genetically modified animals;
responsibility for monitoring and
(c) the anticipated level and duration care, should the researchers move or
of immunosuppression required for discontinue the research activities,
the participant; or in the event of institution closure;
(d) the likelihood of psychological and/ (g) the procedure to be followed at
or social harm to the participant; the conclusion of the monitoring,
including the conclusion of
(e) current clinical and/or theoretical
monitoring following the death of
evidence, including evidence of
a participant;
xenozoonoses and the likely disease
types, associated severity, infectious
potential and likely mode of
transmission; and
(h) any required psychosocial assessment Element 3: Consent

of the potential participant.
For example, an assessment to
determine the likelihood of long-
term compliance by the participant, • How will consent for long-term
and their ability to cope with the monitoring be managed?
identified risks; and
• What are the limitations for
(i) the existence and availability of withdrawal of consent?
a recognised state or territory
public health containment plan
commensurate with the level 3.4.7 Before potential participants consent to
of risk associated with the xenotransplantation research, researchers
proposed research. should provide them with sufficient
written information regarding:
Element 2: Recruitment (a) the potential risks to the

participant, including an explicit
acknowledgment when the risks
Key questions include: are unknown;
• How will participant suitability be (b) alternatives to participation,
assessed (including, potentially, including participation in other
an assessment of the likelihood available clinical trials;
of long‑term compliance with the
monitoring plan)? (c) the potential risks to the
participant’s close contacts or other
• Will individuals who come non‑participants;
into frequent or close contact
with animals be excluded from (d) the proposed strategy for the
the research? management of these risks,
including required monitoring,
• How will risks that are not currently the reasons for monitoring and the
known or not well understood be expected duration of monitoring;
explained to potential participants?
(e) the required action to be taken if an
• If a participant’s close contact adverse event occurs, particularly in
does not support the participant’s the event that a xenozoonosis is
involvement in the research, detected. This may include changes
how will this be managed? to participant monitoring, contact
tracing and/or in extreme cases,
3.4.6 Prior to obtaining consent from potential participant isolation; and
participants, information relating to the (f) any requirement for the participant
research and the associated risks should to disclose their participation in
be provided to close contacts. xenotransplantation research to
close contacts, health professionals
or others.

3.4.8 Researchers should provide participants

involved in xenotransplantation research
with information about their right to
withdraw consent to participate in the
research, including any limitations that
may be relevant to their withdrawal of
consent. Limitations may include:
(a) the requirement to agree to
long‑term monitoring for safety;
(b) the potential absence of an option to
remove implanted materials; and
(c) cooperation with any required
contact tracing.
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 • research on the separated human fetus or

on fetal tissue.
This chapter provides guidelines for the ethical
This chapter does not apply to research involving:
conduct of research involving women who are
pregnant, the human fetus ex utero, and human • gametes, embryos and/or participants
fetal tissue after the separation of the fetus from in assisted reproductive treatments
the woman. The chapter is arranged to reflect the – this research is covered by the
following established categories of such research: Ethical guidelines on the use of assisted
reproductive technology in clinical
• research on the woman who is pregnant
practice and research (NHMRC 2004);
and the fetus in utero; and

• embryos excess to the needs of those for 4.1.2 The research participation of a young
whom they were created using assisted person who is pregnant should be guided
reproductive technology – this research is by the requirements of Chapter 4.2:
covered by Australian legislation. Children and young people.
For the purpose of this chapter, the term fetus 4.1.3 Research involving the woman may affect
applies to the developing human being from the fetus, and research involving the
fertilisation to delivery, and whether alive or fetus will affect the woman. The risks
dead at delivery. and benefits to each should be carefully
considered in every case, and should be
Fetal tissue includes membranes, placenta,
discussed with the woman. This must
umbilical cord, amniotic fluid, and other tissue
include the effect of the research on the
that contains the genome of a fetus. Fetal tissue
fetus in utero (including consideration
is regarded as part of the fetus prior to
of fetal stress) and on the child who may
separation of the fetus from the woman.
subsequently be born.
After separation, the following chapters of this
4.1.4 The possibility of providing access to
National Statement may also be relevant to the
counselling for the woman about these
design and conduct of research involving fetal
issues should be part of this discussion.
tissue: Chapter 3.2: Human biospecimens in
laboratory based research. 4.1.5 Researchers should ask the woman
whether, in her decisions about the
Research to which this chapter applies must be
research, she wishes to involve others
reviewed and approved by a Human Research
for whom the research may have
Ethics Committee (HREC) rather than by one of
implications.
the other processes of ethical review described
in paragraphs 5.1.7 and 5.1.8, except where that 4.1.6 Except in the case of therapeutic
research uses collections of non-identifiable data innovative therapy, the process of
and involves negligible risk, and may therefore be providing information and obtaining
exempted from ethical review. consent for involvement in research
should be separate from clinical care.
Values, principles and themes that must inform
Information about research projects
the design, ethical review and conduct of all
should also be separate from information
human research are set out in Sections 1 and
about routine clinical care.
2 of this National Statement.The guidelines
and headings below show how those values, 4.1.7 If it is consistent with promoting the life
principles and themes apply specifically in and health of the fetus, research on the
research that is the subject of this chapter. fetus in utero may be ethically acceptable.
Such research may, for example, provide
information about the health of the fetus.
GUIDELINES 4.1.8 Research should be designed so as to
minimise pain or distress for the fetus,
and should include steps for monitoring
The woman who is pregnant and the for signs of fetal pain or distress, and
fetus in utero steps for suspending or ceasing the
research if necessary.
4.1.1 The wellbeing and care of the woman 4.1.9 ‘Innovations in clinical practice’ should
who is pregnant and of her fetus be considered for any innovative therapy
always takes precedence over research involving the fetus. See also paragraph
considerations. 3.1.38.
4.1.10 It is ethically unacceptable to conduct 4.1.13 There should be no trade in human fetal
non-therapeutic research that involves tissue.
administering drugs or carrying out a
4.1.14 Those who conscientiously object to
procedure on the woman or her fetus,
being involved in conducting research
where the research carries risk for the
with separated fetuses or fetal tissue
fetus.
should not be compelled to participate,
nor should they be put at a disadvantage
The human fetus, or fetal tissue, after because of their objection.
separation 4.1.15 Where research involves a separated
4.1.11 Research involving a fetus or fetal tissue fetus, researchers should ask the woman
should be conducted in a manner that whether, in her decisions about the
maintains a clear separation between the research, she wishes to involve others
woman’s clinical care and the research. for whom the research may have
Where a treating health professional implications.
is also involved in the research, any
4.1.16 A fetus or fetal tissue may become
conflict of interest (for example, one
available for research as the result
which may arise from a financial or
of termination. The process through
contractual relationship) will need to be
which the woman is approached,
managed in accordance with paragraph
informed about, and her consent sought
5.4.3 of this National Statement. In cases
for research on that fetus should be
where pregnancy is to be terminated,
separate from the process under which
the possibility of contributing fetal tissue
she decides whether to terminate her
to research must not be raised until a
pregnancy, and should not begin until
decision to terminate has been made.
a decision to terminate has been made.
Proposals for research must include
Consenting to the research must not
procedures to ensure that the process
compromise the woman’s freedom to
of providing information and obtaining
change that decision.
consent for involvement in the research
is clearly separated from clinical care. 4.1.17 Where research involves her separated
For example: fetus or its fetal tissue, arrangements
should be made for the woman to have
• A researcher who is also the
access to counselling and support.
treating health professional
should not be the person who 4.1.18 Research on a terminated fetus or its
seeks the consent of the potential tissues, including the timing and content
participant unless there is a of the process of seeking the woman’s
specific justification for doing so consent for the research, should be
(see Introduction to Chapter 3.1: designed so as not to compromise the
Elements of Research). woman’s decisions about the timing and
method of termination.
• Information sheets for research
projects must be completely 4.1.19 Consideration of a woman’s wishes
separate from, and capable of and her physical, psychological and
being read independently of, emotional welfare should inform:
written information provided to
(a) a decision whether to approach her
a patient in the course of routine
about proposed research involving
clinical care.
her, her separated fetusor its tissue;
4.1.12 Researchers should demonstrate that and
there are no suitable alternatives by
which the aims of research using the
separated human fetus or fetal tissue can
be achieved.

(b) if she is approached, the way (c) death of the fetus has been
information is provided about the determined by a registered medical
research and her consent for it practitioner who has no part (or
sought. financial interest) in the research.
4.1.20 In addition to the information required 4.1.23 If, for research purposes, fetal cells are
to be disclosed under paragraph 2.2.2 to be derived from the fetal tissue and
and 2.2.6 of this National Statement, the stored or propagated in tissue culture, or
woman should also be informed: tissues or cells are to be used in human
transplantation, the woman’s consent
(a) that she should consider whether
is required. Others whom the woman
to seek consent to the proposed
identifies (see also paragraph 4.1.15) may
research from any other person
also need to be involved in decisions
(see paragraphs 4.1.5 and 4.1.15);
about these matters.
(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
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 involving children and young people research; 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.
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 person’s 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 child’s 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 child’s
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
the school community should be built
or 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) children’s or young people’s (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 person’s 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 person’s
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 child’s or young person’s this case, although the child’s
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
(b) either
(ii) it would be contrary to the best 4.2.14 A child or young person’s refusal
interests of the young person to to participate in research should be
seek consent from the parents, respected wherever he or she has the
and provision is made to protect capacity to give consent to that same
the young person’s safety, research (see levels of maturity (c) and
security and wellbeing in the (d) in the Introduction to this chapter).
conduct of the research (see Where a child or young person lacks
paragraph 4.2.5). this capacity, his or her refusal may be
overridden by the parents’ judgement as
to what is in the child’s 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 child’s 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 child’s
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
child’s or young person’s best interest.

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 person’s
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 principles and themes apply specifically in

research that is the subject of this chapter.
Medical care increasingly offers interventions
or treatment for people at times of serious
risk to their life or wellbeing. These risks
may be temporary or permanent. People GUIDELINES
can become highly dependent on those
interventions and treatments and may be Research merit and integrity
incapable of comprehending their situation or
of communicating about it. At the same time, 4.4.1 Research involving people who are highly
research on those interventions and treatments is dependent on medical care may be
necessary to assess and improve their efficacy. approved where:
This chapter describes conditions under which (a) it is likely that the research will lead
research involving people highly dependent to increased understanding about,
on medical care might proceed although their or improvements in, the care of this
capacity to give consent is limited or non-existent. population;
In every instance, relevant jurisdictional laws (b) the requirements of relevant

will need to be taken into account. jurisdictional laws are taken into
account; and
Significant ethical issues are raised by research
conducted in the following settings: (c) either
• neonatal intensive care; (i) any risk or burden of the

proposed research to this
• terminal care; particular participant is justified
• emergency care; by the potential benefits to him
or her; or
• intensive care; and
(ii) where participants have capacity
• the care of unconscious people. to consent, any risk or burden is
Research to which this chapter applies must be acceptable to them and justified
reviewed and approved by a Human Research by the potential benefits of the
Ethics Committee (HREC) rather than by one of research.
in paragraphs 5.1.7 and 5.1.8, except where that Justice
research uses collections of non-identifiable data
and involves negligible risk, and may therefore be 4.4.2 People highly dependent on medical care
exempted from ethical review. may be exposed to severe threats to their
lives, so that recruiting them into research
Values, principles and themes that must inform might seem unfair. However, those people
the design, ethical review and conduct of all are entitled to participate in research and,
human research are set out in Sections 1 and when the conditions of paragraph 4.4.1
2 of this National Statement.The guidelines are met, their involvement is not unfair.
and headings below show how those values,
Beneficence 4.4.7 In intensive care research, heavy sedation

may impair participants’ cognition, and
4.4.3 The distinguishing features of neonatal communication is difficult with people
intensive care research are the small size receiving ventilatory assistance. Whenever
and unique developmental vulnerability possible, consent to intensive care
of the participants and the potential research, based on adequate information,
for very long-range impact on their should be sought from or on behalf of
growth, development and health. In this potential participants before admission
research, risks and potential benefits to that level of treatment. When prior
should be assessed with particular care consent to research is not possible, the
by individuals or groups with relevant process described in paragraphs 4.4.9 to
expertise. 4.4.14 should be followed.
4.4.4 The distinguishing features of terminal 4.4.8 In research with unconscious people, the
care research are the short remaining participants cannot be informed about
life expectancy of participants and their the research and their wishes cannot be
vulnerability to unrealistic expectations of determined. Those who are unconscious
benefits. Terminal care research should be should be included only in minimally
designed so that: invasive research, or in research designed
(a) the benefits of research to both to be therapeutic for them and to
individual participants or groups of improve treatment for the condition from
participants, or to others in the same which they suffer.
circumstances, justify any burden,
discomfort or inconvenience to the Process to be followed
participants;
4.4.9 Consent should be sought from people
(b) the prospect of benefit from research highly dependent on medical care
participation is not exaggerated; wherever they are capable of giving
(c) the needs and wishes of participants consent and it is practicable to approach
to spend time as they choose, them.
particularly with family members, 4.4.10 Where it is not practicable to approach a
are respected; and person highly dependent on medical care,
(d) the entitlement of those receiving or the person is not capable of making
palliative care to participate is such a decision, consent should be
recognised. sought from the participant’s guardian, or
person or organisation authorised by law,
except under the circumstances described
Respect in paragraph 4.4.13.
4.4.5 People involved in research to 4.4.11 When consent is to be sought, either from
which this chapter applies may have the potential participant or another on his
impaired capacity for verbal or written or her behalf, steps should be taken to
communication. Provision should be made minimise the risk that:
for them to receive information, and to
express their wishes, in other ways. (a) stress or emotional factors may
impair the person’s understanding
4.4.6 In emergency care research, recruitment of the research or the decision to
into a research project often has to be participate; and
achieved rapidly. Where the research
involves emergency treatment and meets
the requirements of 4.4.1, consent for the
research may be waived provided the
conditions of paragraph 2.3.10 are satisfied.

(b) the dependency of potential 4.4.14 As soon as reasonably possible, the

participants and their relatives on participant and/or the participant’s
the medical personnel providing relatives and authorised representative
treatment may compromise the should be informed of the participant’s
freedom of a decision to participate. inclusion in the research and of the
option to withdraw from it without any
4.4.12 Where the researcher is also the
reduction in quality of care.
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
participant’s 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 and involves negligible risk, and may therefore be

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

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
justified by the potential benefits of the of a person with a cognitive impairment,
research. an intellectual disability, or a mental
illness to consent to the research. This
information should include:
Respect
(a) how the decision about the person’s
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 person’s guardian or any
person or organisation authorised by law. (d) the process for reviewing, during the
research, the participant’s 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 person’s capacity to give consent. a research project by a person with a
cognitive impairment, an intellectual
4.5.7 The process of seeking the person’s
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
participant’s 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
participant’s 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 must
information indicating future illegal activity. Such
be reviewed and approved by a Human Research
research may:
• be intended to study, and perhaps to the other processes of ethical review described
expose, illegal activity; in paragraphs 5.1.7 and 5.1.8, except where that
• be not specifically intended to discover
and involves negligible risk, and may therefore be
illegal activity, but likely to do so;
exempted from ethical review.
• discover illegal activity inadvertently and
unexpectedly.
In the first category there may be particular human research are set out in Sections 1 and
ethical questions about participants’ consent (see 2 of this National Statement.The guidelines
Chapter 2.2: General requirements for consent). and headings below show how those values,
In all three categories both ethical and legal principles and themes apply specifically in
questions for researchers and institutions might research that is the subject of this chapter.
arise from:
• what researchers might be obliged to
disclose; GUIDELINES
• the vulnerability of participants and
researchers because of discovery of Research merit and integrity
participants’ illegal activity (see paragraph
5.1.2(b)(ii)). 4.6.1 Research designed to expose illegal
activity should be approved only where
Legal implications may include: the illegal activity bears on the discharge
• a statutory obligation for a researcher of a public responsibility or the fitness to
to disclose information revealed or hold public office. Variation of consent
discovered; requirements for such research must
comply with either paragraph 2.3.3 or
• legal orders that compel disclosure of paragraph 2.3.7.
information obtained by a researcher.
4.6.2 Participants may be subject to risks
This chapter is not concerned with investigation because of their involvement in research
conducted as part of law enforcement. Nor does that discovers illegal activity. It should
it contain information or guidance about legal be clearly established that these risks are
obligations of researchers arising from their justified by the benefits of the research.
conduct of any research that discovers illegal Where the research is designed to expose
activity. Further, it is not the role of a Human illegal activity under paragraph 4.6.1,
Research Ethics Committee (HREC) or other that exposure may sometimes be benefit
enough.

CHAPTER 4.6 : PEOPLE WHO MAY BE INVOLVED IN ILLEGAL ACTIVITIES
Justice (b) the extent to which the researcher

will keep confidential any
4.6.3 Where research discovers information information about illegal activity
about illegal activity by participants or by participants or others, and the
others, researchers and institutions may response the researcher will make
become subject to orders to disclose to any legal obligation or order to
that information to government agencies disclose such information.
or courts. Decisions by researchers and
institutions about how to respond to 4.6.7 Researchers should be satisfied that
those orders should have regard to values participants who are subject to criminal
and principles set out in this National justice processes:
Statement and to scholarly values of (a) are aware that the research may
academic freedom and inquiry. discover illegal activity; and
(b) do not have unrealistic expectations
Beneficence of benefit from their participation.
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
Islander Peoples spans many methodologies also find the Ethical conduct in research with
and disciplines. There are wide variations in Aboriginal and Torres Strait Islander Peoples and
the ways in which Aboriginal and Torres Strait communities: Guidelines for researchers and
Islander individuals, communities or groups are stakeholders informative.
involved in or affected by research to which
The Ethical conduct in research with
this chapter applies. The variations depend on
Aboriginal and Torres Strait Islander Peoples
the scope of the project, the demographics of
and communities: Guidelines for researchers
participants, the illnesses or social phenomena
and stakeholders are based on six core values
under study, and their historical, social and
identified as being important to Aboriginal and
cultural context and connections.
Torres Strait Islander Peoples. The message
Researchers should address relevant issues of for researchers is that there is great diversity
research design, ethics, culture and language. across the many Aboriginal and Torres Strait
Depending on the field of study and complexity Islander cultures and societies. Application of
of the proposed research, these issues might be these core values, and of additional cultural and
addressed in numerous ways. A cornerstone of local-language protocols, should be determined
an ethical research relationship with Aboriginal by the Aboriginal and Torres Strait Islander
and Torres Strait Islander Peoples is respect for communities or groups involved in the research.
and valuing of cultural and language diversity. The six core values are:
For health research fitting the above description, • Reciprocity
researchers must consult Ethical conduct in
• Respect
research with Aboriginal and Torres Strait
Islander Peoples and communities: Guidelines • Equality
for researchers and stakeholders.
• Responsibility
Other documents that might provide useful
• Survival and protection
guidance for researchers are Keeping Research
on Track II and the Guidelines for Ethical • Spirit and integrity.4
Research in Australian Indigenous Studies
(Australian Institute of Aboriginal and Torres
Strait Islander Studies 2012).
Human Research Ethics Committees (HRECs)
are also required to apply the Ethical conduct
in research with Aboriginal and Torres 4
‘The six core principles in Ethical conduct in
Strait Islander Peoples and communities: research with Aboriginal and Torres Strait Islander
Guidelines for researchers and stakeholders Peoples and communities: Guidelines for researchers
as the basis for assessing proposals for health and stakeholders have been updated as follows:
research with Aboriginal and Torres Strait • Spirit and integrity
Islander participation. • Cultural continuity
• Equity
• Reciprocity
• Respect
• Responsibility

Research to which this chapter applies must be (b) suitable information about the
reviewed and approved by a Human Research research;
(c) notification of participants’ consent
and of research progress; and
in paragraphs 5.1.7 and 5.1.8.The HREC process
must have included assessment by or advice (d) final reporting.
from:
4.7.4 The researcher should seek to identify
• people who have networks with any potential negative consequences
Aboriginal and Torres Strait Islander of the proposed research, to design
Peoples and/or knowledge of research processes to monitor them, and to advise
with Aboriginal and Torres Strait Islander steps for minimising them.
Peoples; and
• people familiar with the culture and Justice
practices of the Aboriginal and Torres Strait 4.7.5 The research methods and processes
Islander people with whom participation should provide opportunities to develop
in the research will be discussed. trust and a sense of equal research
Values, principles and themes that must inform partnerships.
the design, ethical review and conduct of all 4.7.6 Where:
2 of this National Statement.The guidelines (a) the geographic location of the
and headings below show how those values, research is such that a significant
principles and themes apply specifically in number of the population are likely
research that is the subject of this chapter. to be Aboriginal and Torres Strait
Islander, and/or
(b) the research is focused on a topic
GUIDELINES or disease/health burden identified
as being of specific concern to
Aboriginal and Torres Strait Islander
Research merit and integrity Peoples and the population base
4.7.1 The researcher should ensure that has a significant proportion of
research methods are respectful and Aboriginal and Torres Strait Islander
acknowledge the cultural distinctiveness people, the research should provide
of discrete Aboriginal and Torres fair opportunity for involvement of
Strait Islander communities or groups Aboriginal and Torres Strait Islander
participating in the research – including Peoples, and the guidelines in this
national or multi-centre research. chapter apply to those participants.
4.7.2 There should be evidence of support

for the research project from relevant Beneficence
Aboriginal and Torres Strait Islander 4.7.7 The benefits from research should include
communities or groups and the research the enhancement or establishment of
methodology should engage with their capabilities, opportunities or research
social and cultural practices. outcomes that advance the interests of
4.7.3 The researcher should ensure that Aboriginal and Torres Strait Islander
research methods provide for mutually Peoples.
agreed mechanisms for such matters as: 4.7.8 The described benefits from research
(a) appropriate recruitment techniques; should have been discussed with and
agreed to by the Aboriginal or Torres
Strait Islander research stakeholders.
4.7.9 The realisable benefits for Aboriginal and

Torres Strait Islander participants from the
research processes, outcomes and outputs
should be distributed in a way that is
agreed to and considered fair by these
participants.
Respect
4.7.10 The research proposal should
demonstrate evidence of respectful
engagement with Aboriginal and Torres
Strait Islander Peoples. Depending on
the circumstances, this might require
letters of support from Aboriginal and/ or
Torres Strait Islander community Councils
or other organisations accepted 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 should reflect continuing consultation
country, additional ethical considerations may with the local participant population and
arise. In some situations, regard for the beliefs, the communities to which they belong
customs and cultural heritage of participants will (paragraph 4.8.19).
require recognition of values other than those
4.8.4 Researchers should inform ethical review
of this National Statement. Sometimes these
bodies in Australia:
values will be in tension with one or more of
the ethical values of this National Statement. (a) whether, in the country in which
Sometimes the legal, regulatory or ethical review they intend to do research, there
processes of another country may also demand are ethics approval processes that
conduct that is in tension with the ethical values are relevant to that research, and
of this National Statement. The guidelines in whether any such processes are
this 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, body’s approval.
principles and themes apply specifically in
4.8.5 Where there are no ethics approval
research that is the subject of this chapter.
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 co- account. Researchers should inform
researchers will carry out the research in review bodies about these likely burdens
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
This Section sets out the processes by which
the Australian code for the responsible conduct
institutions establish, conduct and oversee those
of research.
CHAPTER 5.1: INSTITUTIONAL RESPONSIBILITIES
Guidelines (ii) understand the need to assess

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

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
data under these chapters satisfies review procedures
the conditions for exemption from 5.1.10 Institutions that set up levels of
review – see paragraphs 5.1.22 ethical review other than HREC, as
and 5.1.23): described in paragraphs 5.1.18 to 5.1.23,
• Chapter 4.1: Women who are must establish criteria for allocating
pregnant and the human fetus research to these different levels of review
(including exemption from review),
• Chapter 4.4: People highly taking into account Chapter 2.1: Risk and
dependent on medical care who benefit. These criteria must be readily
may be unable to give consent accessible to all those involved in the
• Chapter 4.5: People with a conduct and review of research.
cognitive impairment, an 5.1.11 The ethical values and principles in this
intellectual disability, or a National Statement should be the basis
mental illness on which institutions establish different
• Chapter 4.7: Aboriginal and levels of ethical review, allocate different
Torres Strait Islander Peoples kinds of research to them, and review
those allocations.
and some categories of research
falling under 5.1.12 Institutions must monitor any processes
of ethical review of low risk research
• Chapter 4.6: People who may to ensure those processes continue
be involved in illegal activities to provide sufficient protection
(see first bolded paragraph for participants.
for details).
5.1.13 Institutions should regularly assess all
5.1.7 For research that carries only low risk their ethical review processes, including
(see paragraph 2.1.6) and does not the criteria for allocating research to
fall under any of the chapters listed in different levels of review, to ensure that
paragraph 5.1.6, institutions may choose those processes continue to enable the
to establish other levels of ethical review. institution to meet its responsibilities
These levels are described in paragraphs under this National Statement.
5.1.18 to 5.1.21.
5.1.14 Where possible this assessment should
5.1.8 Research that carries only negligible be informed by the documented
risk (see paragraph 2.1.7) and meets experience of research participants and/
the requirements of paragraphs 5.1.22 or by involving participants or the wider
and 5.1.23 may be exempted from community in the assessment.
ethical review.
5.1.15 Institutions should also remain alert to
emerging ethical issues in any area of
human research that may warrant changing
the level of ethical review required.
5.1.16 To enable assessment of their ethical 5.1.20 The levels of ethical review referred to in
review processes, institutions should paragraph 5.1.18 may include, but need
prepare and make readily accessible not be limited to:
regular reports on all of those processes.
(a) review or assessment at
5.1.17 Institutions should have in place an departmental level by the head
auditing process to confirm that: of department;
(a) research in their institution is being (b) review or assessment by a
reviewed at the levels of review their departmental committee of peers
criteria require; (with or without external or
independent members);
(b) research is being exempted from
review only in accordance with the (c) delegated review with reporting to
criteria set out in paragraphs 5.1.22 an HREC; or
and 5.1.23.
(d) review by a subcommittee of
an HREC.
Research involving no more than
5.1.21 Those reviewing research at a non-HREC
low risk level must refer to an HREC any research
5.1.18 Institutions that establish any non‑HREC they identify as involving more than
levels of ethical review for low risk low risk.
research must have the resources and
capacity to carry out such review Research that can be exempted
competently and professionally.
from review
5.1.19 Where institutions establish such
5.1.22 Institutions may choose to exempt from
non‑HREC levels of ethical review for low
ethical review research that:
risk research, that review must:
(a) is negligible risk research (as defined
(a) be carried out by people who are
in paragraph 2.1.7); and
familiar with this National Statement
and have an understanding of the (b) involves the use of existing
ethical issues that can arise in the collections of data or records that
research under review; contain only non-identifiable data
about human beings.
(b) be informed by Section 1:
Values and Principles of Ethical 5.1.23 Institutions must recognise that in
Conduct, Section 3: Ethical deciding to exempt research from
Considerations in the Design, ethical review, they are determining that
Development, Review and the research meets the requirements
Conduct of Research and Section of this National Statement and is
4: Ethical Considerations Specific ethically acceptable.
to Participants;
(c) take account of researchers’ HRECs: research involving more than
judgements as to whether their low risk
research is suitable for review by a
non-HREC process; 5.1.24 Each institution that conducts human
research involving more than low risk must
(d) have due regard to relevant ensure that this research is reviewed and
privacy regulation. approved by an HREC that is constituted
and functioning in accordance with this
National Statement, whether or not that
HREC is established by the institution.

5.1.25 Institutions5 that establish HRECs are 5.1.28 Where an institution has established an
responsible for ensuring that those HRECs HREC, the institution is responsible for
are established and continue to operate in ensuring that:
accordance with this National Statement.
(a) members have relevant experience
and/or expertise;
Establishment of HRECs
(b) members undertake:
5.1.26 Institutions that individually or jointly
establish HRECs should adequately (i) appropriate induction, which
resource and maintain them. Resourcing could include mentoring by a
should be sufficient to enable HRECs: current HREC member, and
(a) to satisfy the requirements (ii) continuing education;

for sound ethical review (c) review of research proposals
(see paragraph 5.1.37); is thorough;
(b) to communicate well with (d) review processes and procedures are
researchers (see paragraphs 5.2.14 expeditious;
to 5.2.16);
(e) decisions are transparent, consistent,
(c) not to charge fees where doing and promptly communicated;
so would discourage research
the institution has an obligation (f) actual and potential conflicts of
to support. interest that may affect research
and its review are identified and
5.1.27 When establishing an HREC, an institution managed (see Chapter 5.4: Conflicts
should set out and publicise its terms of of interest);
reference, including:
(g) membership of the HREC is made
(a) the scope of its responsibilities for public in annual reports or by other
ethical review; routine processes, and is available
(b) its relationship to other processes to researchers submitting research
of research review; proposals to that HREC;
(c) its relationship to non-affiliated (h) good communication between

researchers; the institution/s, the HREC and
researchers is promoted;
(d) its institutional accountability;
(i) the workload of the HREC does
(e) its mechanisms of reporting; not compromise the quality and
timeliness of ethical review; and
(f) categories of minimum
membership; and (j) any institution using the HREC
can be assured the HREC is
(g) remuneration, if any, for members.
operating in accordance with this
National Statement.
5 Where the context is the establishment and maintenance of an HREC, ‘institutions’ also includes any entity or
agency that establishes an HREC but does not conduct human research.
Composition of HRECs These members may attend meetings

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

(f) presentation of applications for

ethical review;
(g) timely consideration and review of
applications;
(h) managing conflicts of interest
(see paragraphs 5.4.1 to 5.4.6);
(i) communicating with researchers,
including face to face, by telephone
and in writing (including email)
(j) reporting on its activities to
the institution;
(k) methods of decision making;
(l) prompt notification of decisions;
(m) record keeping (see paragraphs
5.2.25 to 5.2.29);
(n) monitoring of approved research
(o) reporting and handling of
adverse events;
(p) receiving and handling of complaints
(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 5.2.20) at meetings;
(s) fees, if any, to be charged; and
(t) appropriate confidentiality of the
content of applications and the
deliberations of review bodies.
Insurance
5.1.38 Institutions must be satisfied that
sponsors of clinical trials have
indemnity, insurance and compensation
arrangements in accordance with
applicable regulatory requirements.
5.1.39 Institutions must also have arrangements
to compensate participants for harm
resulting from negligence in research.
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 5.2.4 Members of a review body should

disclose to it any actual or potential
conflict of interest, including any financial
Review body procedures or other interest or affiliation, that bears
5.2.1 Institutions that set up non-HREC levels on any research coming before the review
of ethical review should ensure that body (see paragraph 5.4.5).
they have good working procedures
for those levels. These should include Researcher responsibilities
the procedures from paragraph 5.1.37
5.2.5 In each research proposal, the
and paragraphs 5.2.26 to 5.2.29 that are
researcher/s should demonstrate that the
necessary for sound review at each of
research has merit and reflects the ethical
those levels.
values of justice, beneficence and respect
for humans (see paragraph 1.1).
Review body member responsibilities
5.2.6 For relevant health research, researchers
5.2.2 Each member of an ethical review body should show that the research meets
is responsible for deciding whether, in his the requirements of the CPMP/ICH
or her judgement, a proposal submitted to Note for Guidance on Good Clinical
the review body meets the requirements Practice (CPMP/ICH-135/95), ISO 14155
of this National Statement and is Clinical Investigation of Medical
ethically acceptable. Devices, the World Health Organization
5.2.3 To fulfil that responsibility, each member International Clinical Trials Registry
of a review body should: Platform and the TGA.
(a) become familiar with this National 5.2.7 Research proposals should be clear
Statement, and consult other and comprehensive, and written in
guidelines relevant to the review of lay language.
specific research proposals; 5.2.8 A researcher should disclose to the review
(b) prepare for and attend scheduled body the amount and sources or potential
meetings of the review body or, sources of funding for the research.
if unavailable, provide opinions 5.2.9 A researcher developing or designing a
on the ethical acceptability of research proposal involving two or more
research proposals before meetings, institutions should inform them all at an
subject to institutional policies on early stage in this process.
absences; and
5.2.10 A researcher should keep an auditable
(c) attend continuing education or record of any research he or she is
training programs in research ethics undertaking that is exempted from ethical
at least every three years. review in accordance with paragraphs
5.1.22 and 5.1.23.

5.2.11 A researcher should disclose to the review 5.2.16 Open communication of these kinds
body any actual or potential conflicts of has implications for the resourcing of
interest, including any financial or other review bodies (see paragraphs 5.1.18,
interest or affiliation, that bears on the and 5.1.26).
research (see Chapter 5.4: Conflicts of
interest). Where applicable, this disclosure
Participants’ interests
should specify:
5.2.17 Information about research should be
(a) any business, financial or other
presented to participants in ways that
similar association between a
help them to make good choices about
researcher and the supplier of a
their participation, and support them in
drug or surgical or other device to
that participation. These ways must take
be used in the research; and
into account:
(b) any restrictions on publication or
(a) whether the information is best
dissemination of research findings.
communicated through speech,
5.2.12 When reporting the research, writing, some other way, or a
a researcher should again disclose any combination of these;
actual or potential conflicts of interest,
(b) the need for accurate and reliable
including any financial or other interest or
translation (written and/or oral)
affiliation, that bears on the research.
into a participant’s first language
5.2.13 For researcher responsibilities in or dialect;
relation to monitoring, see Chapter 5.5:
(c) culture and its effects on how
Monitoring approved research.
language (English or other)
is understood;
Good communication between review
(d) educational background and level;
bodies and researchers
(e) age;
5.2.14 Good ethical review requires open
communication between review (f) visual, hearing or communication
bodies and researchers, and a shared impairment.
commitment to the review process.
5.2.18 In any clinical research, a review
The process should not be adversarial.
body should be satisfied that research
Institutions should encourage this shared
participants are adequately informed of
commitment by promoting:
the funding arrangements of the research
(a) awareness of this National Statement (see also 3.1.29).
among researchers; and
5.2.19 A review body should consider consulting
(b) ready accessibility of review bodies a participant advocate to help it assess
and their staff to researchers. whether a proposal under consideration
adequately provides for participants’
5.2.15 Misunderstandings can often arise when decision making and understanding.
only written communication is used.
From the outset review bodies should
encourage informal communication Researchers or experts at review
with researchers, and should consider body meetings
face-to-face meetings to resolve
5.2.20 A review body may invite researcher/s,
issues about research proposals that
and researchers may request, to be
have not been resolved by written or
present for discussion of their
telephone communication.
proposed research..
5.2.21 A review body may seek advice from Documents and records
experts to help in considering a research
proposal (e.g. as in paragraph 5.1.33). 5.2.25 All documents and other material used in
Such experts should be bound by the recruiting potential research participants,
same confidentiality requirements as the including advertisements, letters of
review body members. Any conflicts invitation, information sheets and consent
of interest they may have should be forms, should be approved by the
disclosed and managed (see paragraphs review body.
5.4.1 to 5.4.6). 5.2.26 A review body should maintain a record
5.2.22 Communication between a research of all research proposals received and
sponsor and a review body should reviewed, including at least the:
be avoided where it may, or may be (a) name/s of the institution/s to which
perceived to, influence the ethical review the research approval is provided;
and approval of the project.
(b) project identification number/s;
Making and communicating decisions (c) name/s of principal researcher/s;
5.2.23 A review body may approve, request (d) title of the project;
amendment of, or reject a research (e) correspondence between the review
proposal on ethical grounds. body and the researcher about
5.2.24 The review body must clearly the review;
communicate its decision to the (f) acceptance or rejection of any
researcher/s: changes to the proposal;
(a) Where a proposal is approved, (g) proposed date of completion of
communication must be in writing the proposal;
(which may include email)
and should include an explicit (h) formal advice of final ethical
statement that the proposal approval or non-approval, with date;
meets the requirements of this (i) terms and conditions, if any,
National Statement. of approval of any proposal;
(b) Where amendments are (j) duration of the approval;
requested, communication may
be written or, where appropriate, (k) name of any other review body
informal (see paragraph 5.2.15). whose opinion was considered;
Reasons should be given for the (l) mechanisms to be used to monitor
requested amendments. the conduct of the research; and
(c) Where a proposal is rejected, (m) relevance, if any, of the
communication of the rejection must Commonwealth, State or Territory
be in writing (which may include legislation or guidelines relating
email) and should include reasons to privacy of personal or
linked to this National Statement. health information.
5.2.27 In addition, a review body should
retain on file a copy of each research
proposal and application for ethical
approval, including any information
sheets, consent forms or relevant
correspondence, in the form in which
they were approved.

5.2.28 A review body should record decisions

about approval, amendment or rejection
of proposals in written or electronic form,
with reasons for those decisions, linking
those reasons to this National Statement.
5.2.29 Where more than one review body has
reviewed a research proposal, each such
review body should record, as far as
possible (see paragraph 5.3.3):
(a) details of other review body/ies
involved;
(b) the decision/s of each other review
body; and
(c) details of any amendments required
by each other review body.
HREC meetings
5.2.30 As far as possible, each HREC meeting
should be arranged to enable at least
one member in each category to attend
(see paragraphs 5.1.29 to 5.1.32).
Meeting papers should be provided
enough in advance to enable members to
be fully informed.
5.2.31 Decisions by an HREC about whether a
research proposal meets the requirements
of this National Statement must be
informed by an exchange of opinions
from each of those who constitute the
minimum membership (see paragraph
5.1.30). This exchange should, ideally,
take place at a meeting with all those
members present.
5.2.32 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.
5.2.33 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 5.4.2 An institution with a conflict of interest

bearing on research should inform
A conflict of interest in the context of research relevant ethical review bodies about
exists where: the conflict.
• a person’s individual interests or 5.4.3 Ethical review bodies should see that
responsibilities have the potential to measures are adopted to manage
influence the carrying out of his or conflicts of interest involving researchers
her institutional role or professional (see paragraph 5.2.10). These measures
obligations in research; or may include requiring that:
• an institution’s interests or responsibilities (a) the information be disclosed to
have the potential to influence the research participants;
carrying out of its research obligations.
(b) a person other than the researcher
While a conflict may relate to financial interests, make the initial approach to
it can also relate to other private, professional or participants;
institutional benefits or advantages that depend
(c) the information be disclosed in any
significantly on the research outcomes.
report of the research;
A conflict of interest may compromise the
(d) the research be conducted by
research process itself and/or the institutional
another researcher; or
processes governing research, and may lead
researchers or institutions to base decisions (e) the research not be conducted.
about the research on factors outside the
5.4.4 Where an ethical review body becomes
research requirements.
aware that there may be a conflict of
A perception that a conflict of interest exists interest involving the institution, the
can be as serious as an actual conflict, review body should notify the institution.
raising concerns about an individual’s integrity
5.4.5 An ethical review body should require
or an institution’s management practices.
its members, and also any experts whose
advice it seeks, to disclose any actual or
potential conflict of interest in research to
GUIDELINES be reviewed, including any:
5.4.1 Institutions should establish transparent (a) personal involvement or

processes to identify and manage participation in the research;
actual and potential conflicts of (b) financial or other interest or
interest involving: affiliation; or
(a) the institution itself; (c) involvement in competing research.
(b) researchers; or The review body should adopt measures
(c) ethical review bodies, their members to manage such conflicts. In the case of
or advisors. members these measures may include
exclusion from a meeting, or from some
or all of the body’s deliberations, or in the
case of expert advisors, requesting only
written advice from them.
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 person’s 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 or review body in carrying out their

safety monitoring responsibilities.
Monitoring of research here refers to the Researchers should refer to other
process of verifying that the conduct of published NHMRC guidance addressing
research conforms to the approved proposal. these matters.
Responsibility for ensuring that research is
5.5.4 Researchers are responsible for notifying
reliably monitored lies with the institution under
the review body that mechanisms for
which the research is conducted.
monitoring are in place, and for satisfying
Mechanisms for monitoring can include: the review body that the mechanisms are
appropriate to the research.
(a) reports from researchers;
5.5.5 At regular periods – reflecting the degree
(b) reports from independent agencies
of risk, and at least annually and at the
(such as a data and safety
completion of the project – researchers
monitoring board);
should provide reports to the relevant
(c) review of adverse event reports; review body/ies and institution/s,
including information on:
(d) random inspections of research sites,
data, or consent documentation; and (a) progress to date, or outcome in the
case of completed research;
(e) interviews with research participants
or other forms of feedback from them. (b) maintenance and security of records;
(c) compliance with the approved
proposal; and
GUIDELINES (d) compliance with any conditions
of approval.
Monitoring approved research 5.5.6 The granting and extension of ethical
5.5.1 Each institution has ultimate responsibility approval for a research project must be
for ensuring, via its research governance on the condition that the researchers:
arrangements, that all its approved (a) conduct the research in compliance
research is monitored. with the approved protocol or
5.5.2 Monitoring arrangements should be project description;
commensurate with the risk, size and (b) provide reports of the progress
complexity of the research. of the trial and any safety reports
5.5.3 For each clinical trial, institutions and or monitoring requirements as
review bodies should ensure that indicated in NHMRC guidance and
there are appropriate mechanisms in accordance with the manner and
for safety monitoring and reporting, form specified by the review body;
including standard safety reporting and (c) submit for approval any amendments
the use of a Data and Safety Monitoring to the project, including but not
Board (DSMB) or (an) identified person/s limited to amendments that:
or committee with suitable expertise
to assist and advise the institution and/
CHAPTER 5.5 : MONITORING APPROVED RESEARCH
(i) are proposed or undertaken in 5.5.9 It may be unethical for a researcher to

order to eliminate immediate continue a clinical trial if:
risks to participants;
(a) there are or have been substantial
(ii) may increase the risks to deviations from the trial protocol;
participants; or
(b) adverse-effects of unexpected
(iii) significantly affect the conduct type, severity, or frequency are
of the research; encountered; or
(d) inform the review body as soon (c) as the trial progresses, the
as possible of any new safety continuation of the trial would
information from other published disadvantage some of the participants
or unpublished research that may as determined by the researchers or
have an impact on the continued others monitoring the trial.
ethical acceptability of the research
5.5.10 Where ethical approval for a research
or that may indicate the need for
project is withdrawn:
modification of the project;
(a) the researcher, the institution/s and,
(i) for clinical trials with
where possible, the participants
implantable medical devices,
should be informed of
confirm the existence of, or
the withdrawal;
establish, a system for enabling
the tracking of the participant, (b) the institution must see that the
with consent, for the lifetime of researcher promptly suspends the
the device. research and makes arrangements to
meet the needs of participants; and
Discontinuation or suspension (c) the research may not be resumed
of research unless either
5.5.7 Researchers should inform the (i) the researcher subsequently
relevant institution/s, the review establishes that continuance will
body/ies that approved the research not compromise participants’
and, wherever possible, the research welfare; or
participants, if the research project is to
(ii) the research is modified to
be discontinued before the expected date
provide sufficient protection for
of completion, and why. For research at
participants, the modification
more than one site, or research where
is ethically reviewed, and the
there has been multiple ethical review,
modified research is approved.
it must be clearly established, before the
research begins, how this information will 5.5.11 If an institution or review body considers
be communicated. that urgent suspension of research is
necessary before the process described in
5.5.8 Where a review body finds reason to
paragraphs 5.5.7 and 5.5.8 is undertaken,
believe that continuance of a research
the instruction to stop should come via
project will compromise participants’
the management of the institution.
welfare, it should immediately seek
to establish whether ethical approval 5.5.12 In the light of reports received under
for the project should be withdrawn. paragraph 5.5.3 and paragraph 5.5.5, review
This process should ensure that bodies may require researchers to amend
researchers and others involved in the research procedures to protect participants.
project are treated fairly and with respect. 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
researchers or the conduct of research, or the responsible conduct of research,
about the conduct of a Human Research Ethics they should be handled in accordance
Committee (HREC) or other ethical review with the ‘research misconduct’ processes
body. Complaints may be made by participants, specified in that document.
researchers, staff of institutions, or others.
5.6.3 Where complaints about researchers
All complaints should be handled promptly
allege serious misconduct that falls
and 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 with bullying.
under those processes. Where complaints about
5.6.4 Institutions should also establish
researchers are serious and fall outside that
procedures for receiving, handling and
description of research misconduct, they should
seeking to resolve complaints about the
be handled under institutional processes for
conduct of review bodies in reviewing
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
as to whether a research proposal meets
the complainant and the review body
the requirements of this National Statement.
that is the subject of the complaint,
For this reason, while this chapter provides for
complainants should have access to a
complaints about the process of review, it does
person external to that review body to
not provide for appeals by researchers against a
handle the complaint.
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
GUIDELINES has not been resolved by the processes
5.6.1 To handle complaints about referred to in paragraphs 5.6.1 to 5.6.5.
researchers or the conduct of research, 5.6.7 Institutions should publicise their
institutions should: complaints-handling procedures.
(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 approved clinical research. Researchers

also have responsibilities under the
Responsibility for the ethical design, review Australian code for the responsible
and conduct of human research is exercised conduct of research.
at different levels, from the detail of research
5.7.2 Review bodies have responsibilities
conduct to the more general oversight of review
for the ethical review of research.
and funding. Accordingly, responsibility is
The measures of accountability by which
exercised at the different levels by:
review bodies demonstrate to institutions
• researchers (and where relevant their their fulfilment of those responsibilities
supervisors); appear in Chapter 5.2: Responsibilities
of HRECs, other ethical review bodies,
• Human Research Ethics Committees
and researchers.
(HRECs) and other ethical review bodies;
5.7.3 Institutions have responsibilities:
• institutions whose employees, resources
or facilities are involved; (a) to ensure that ethical review
of research occurs. These
• funding organisations;
responsibilities are set out in Chapter
• agencies that set standards; and 5.1: Institutional responsibilities; and
• governments. (b) for the conduct of research.
These responsibilities are set out in
The line of accountability for these
the Australian code for the responsible
responsibilities runs:
conduct of research. They include
• from researchers to review bodies and ensuring that research is both
institutions; sound and lawful, and is conducted
or supervised by educated and
• from review bodies and institutions to experienced researchers.
funders and other agencies;
5.7.4 In addition to providing information
• from agencies to government; and annually, institutions shall, on reasonable
• from government to the Australian public. request, provide other information
about their ethical review processes to
Typically, this accountability involves reporting the NHMRC.
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
conduct of research.
GLOSSARY
GLOSSARY
accountability confidentiality
The measures by which researchers, The obligation of people not to use
review bodies and institutions can private information – whether private
demonstrate that their responsibilities because of its content or the context of its
have been, or are being, fulfilled. communication – for any purpose other
Typical accountability measures involve than that for which it was given to them.
reporting from one level of the hierarchy
conflict of interest
to a higher (or more general) level.
In the research context: where a person’s
beneficence individual interests or responsibilities
Doing good to others: here also includes have the potential to influence the
‘non-maleficence’, avoiding doing harm. carrying out of his or her institutional role
or professional obligations in research;
benefit
or where an institution’s interests or
That which positively affects the interests
responsibilities have the potential to
or welfare of an individual or group.
influence the carrying out of its
cell line research obligations.
A term used by scientists to describe cells
consent
grown in the laboratory over an extended
A person’s or group’s agreement,
period. Cell lines can be created from
based on adequate knowledge and
many different types of tissues and
understanding of relevant material,
include those that will only grow for a
to participate in research.
limited period of time as well as those
that may become ‘immortal’ through co-researcher
alteration of their genomes either through One or more participants (or a particular
mutations arising naturally or induced sub-group of participants) who make/s
artificially. Cell lines usually comprise a a significant contribution to the planning,
stable population of cells, although some design, implementation or outputs
heterogeneity is generally present and of a research project, including the
changes in the characteristics of the cells collection, analysis or interpretation
may occur over time. of data. Examples of co-researcher
contributions include where participants
child
contribute expertise, such as their
Subject to law in the relevant jurisdiction,
cultural knowledge of mores and local
a minor who lacks the maturity to make a
practices, or their personal insights
decision whether or not to participate in
into local conditions, special interests
research. See also young person.
(e.g., gaming), or social identities or
clinical trial contexts (e.g. young people living in
A form of research designed to find out out-of-home care, community activists
the effects of an intervention, including a or people who identify as LGBTIQ).
treatment or diagnostic procedure. (See Chapters 3.1 and 4.8.)
community
A collection of individuals, which may
extend from the whole population to a
smaller grouping associated by cultural,
ethnic, geographical, social or political
factors or some other commonality.
GLOSSARY
data harm
Data refers to bits of information in their That which adversely affects the
raw form. Data can refer to raw data, interests or welfare of an individual or
cleaned data, transformed data, summary a group. Harm includes physical harm,
data and metadata (data about data). anxiety, pain, psychological disturbance,
It can also refer to research outputs and devaluation of personal worth and social
outcomes. (See Chapter 3.1, Element disadvantage.
4). Note: Information generally refers to
HREC
data that have been interpreted, analysed
Human Research Ethics Committee.
or contextualized.
human tissue
databank
The substance, structure, and texture
A systematic collection of data.
of human organs or body parts when
deception separated from human beings; includes
Where relevant material is withheld from blood, blood components and waste
research participants and/or they are products. (See also the definition for
intentionally misled about procedures ‘human biospecimens’ in Chapter 3.2)
and/or purposes of research.
identifier
discomfort Details attached to data, such as name
A negative accompaniment or effect of and/or contact information, that identify
research, less serious than harm. an individual. It may remain possible
to identify an individual even after all
ethical / unethical
identifiers have been removed, if a code
Right or morally acceptable / wrong or
number has been assigned and there
morally unacceptable.
is access to the code, or if the data or
ethics review tissue can be cross-linked to other data or
Review of research by an HREC or tissue banks.
other body.
inconvenience
ethics review body A minor negative accompaniment or
Body set up to carry out ethics review of effect of research, less serious than
human research. discomfort.
genomic data index case
Raw data, processed data or information The original patient or participant
that has been subject to a process of in genomic research who stimulates
critical analysis and/or interpretation investigation of other members of
to assign meaning in the context of the family. This person is also referred to
genomic research. as the ‘proband’.
genomic research innovation
Research with the potential for hereditary In the research context, the introduction
implications which may range from of one or more novel elements of an
single gene genetic research to whole intervention that represent/s a substantive
genome sequencing and any other ‘omic’ departure from the spectrum of standard
research (e.g. exomic, proteomic, etc) care or service delivery. An innovation
with potential hereditary implications. may apply modalities or strategies used
Genomic research includes the full scope and tested in one domain to a novel
of ‘genetic’ research.. application. An innovation may or may
not be therapeutic in intent or effect and
may or may not be considered to be
experimental; however, a condition of
GLOSSARY
research involving an innovation is that mutations

the safety, efficacy, or effectiveness of Genetic changes that can be investigated
the innovation in the context in which or discovered in the form of
it is used is not known at the onset of
• Germ line mutations, which involve
the research.
inherited or de novo variations or
integrity mutations that occur in germ cells
Honesty and probity as qualities of implicating one or more genes
character and behaviour. known to cause or predispose a
person to disease (e.g. BRCA1)
intervention
An intentional change in the • Somatic mutations, which involve
circumstances of research participants. acquired variations or mutations in
The aim of interventional research is one or more genes within tissues
to evaluate the impact of that change (e.g. tumours with BRAFV600E).
on one or more outcome measures.
negligible risk
The intervention can be a health-related
Research in which there is no foreseeable
procedure or process or a behavioural,
risk of harm or discomfort, and any
educational or social modification. It can
foreseeable risk is of inconvenience only.
involve a policy change, a therapeutic
strategy, a change in service provision or opt-out approach
an approach to provision of information A method used in the recruitment
that is introduced and manipulated, of participants into research where
controlled or directed by the researcher. information is provided to the potential
participant regarding the research and
justice
their involvement and where their
Regard for the human sameness
participation is presumed unless they take
shared by all human beings, expressed
action to decline to participate.
in a concern for fairness or equity.
Includes three aspects of justice: participant (in research)
procedural justice, involving fair methods Anyone who is the subject of research in
of making decisions and settling any of the ways set out in Purpose,
disputes; distributive justice, involving scope and limits of this document.
fair distribution of the benefits and
burdens of society; and corrective justice, personal information
involving correcting wrongs and harms Information or an opinion about an
through compensation or retribution. identified individual, or an individual who
is reasonably identifiable:
limited disclosure
Not disclosing to research participants (a) whether the information or opinion
all of the aims and/or methods of is true or not; and
the research. (b) whether the information or opinion
low risk (research) is recorded in a material form or not.
Research in which the only foreseeable placebo (in research)
risk is one of discomfort. A substance not containing an active
monitoring (of research) agent under study, administered to
The process of verifying that the some participants to compare the effects
conduct of research conforms to the of the active agent administered to
approved proposal. other participants.
privacy
A domain within which individuals and
groups are entitled to be free from the
scrutiny of others.
GLOSSARY
protocol research misconduct

A document that provides the Includes fabrication, falsification,
background, rationale and objectives of plagiarism or deception in proposing,
the research and describes its design, carrying out or reporting the results of
methodology, organisation and the research, and failure to declare or manage
conditions under which it is to be a serious conflict of interest. Also includes
performed and managed. failure to follow research proposals
approved by a research ethics committee,
qualitative research
particularly where this failure may result
Research involving the studied use
in unreasonable risk or harm to humans,
of empirical materials such as case
other animals or the environment.
studies, personal experience, life
Also includes the wilful concealment
stories, interviews, observations,
or facilitation of research misconduct
and cultural texts.
by others. See also Australian code for the
relatives responsible conduct of research, 2018.
Persons related by blood to the index
respect for human beings
case, as distinguished from family
Recognition that each human being has
members who are persons who may or
value in himself or herself.
may not be related by blood, but who
may be affected by information with risk
hereditary implications. The function of the magnitude of a harm
and the probability that it will occur.
research
Includes at least investigation undertaken sponsor
to gain knowledge and understanding or An individual, company, institution or
to train researchers. organisation that takes responsibility
for the initiation, management, and/or
research findings
financing of research.
Information that becomes known as a
result of the research. Research findings validity
may take the form of In the context of genomic research
findings or individual test results, a
• Findings related to primary aims of
judgement about the likely accuracy
the research (including individual
of the findings or results, as measured
test results)
by National Association of Testing
• Findings related to secondary Authorities (NATA) accredited testing or
aims of the research or that its equivalent. Validity may refer to the
are unintended, unanticipated, pathology processes establishing the
inadvertent or incidental to the aims analytic validity and clinical validity of
of the research. a testing method and/or the use of an
accredited test to confirm the presence of
a variant found in the research.
voluntary participation
Participation that is free of coercion
and pressure.
young person
In the context of this National Statement,
a minor who (subject to the law in
the relevant jurisdiction) may have the
maturity to make a decision whether or
not to participate in research.
See also child.
INDEX
INDEX
Aboriginal participants: Chapter 4.7 core principle: Section 1 (Introduction),
1.6–1.9
accountability: Chapter 5.7
dependent or unequal relationships:
action research: Chapter 3.1 (Introduction) 4.3.6–4.3.7
administrative records as data: Chapter 3.1 illegal activities: participants involved in: 4.6.4
(Element 4)
Indigenous participants: 4.7.7–4.7.9
animal use in research: Chapter 3.4
(Introduction) medically dependent participants: 4.4.3–4.4.4
animal-to-human xenotransplantation: overseas research: 4.8.14–4.8.18
Chapter 3.4
paediatric research: 4.2.5
application of values and principles: Section 1
researcher responsibilities: 5.2.5
appointment of HREC members: 5.1.34–5.1.36
benefits of research: Chapter 2.1
approval withdrawn after review: 5.5.7–5.5.12
best interests of the child: 4.2.13–4.2.14
archival research: Chapter 3.1 (Introduction)
biospecimens see human biospecimens
ART guidelines: Chapter 3.2 (Introduction)
assessment of risk: Chapter 2.1
Australian code for the care and use of animals cessation of research: 5.5.7–5.5.12
for scientific purposes: Chapter 3.4 children: Chapter 4.2; see also fetal involvement
(Introduction) in research
Australian code for the responsible conduct neonates: 4.1.21, 4.4.3
of research, 2018: ‘Preamble’ (Research
governance), Chapter 2.1 (Introduction), chimeric embryos: Chapter 3.4 (Introduction)
5.1.1, 5.6.2–5.6.3, 5.7.1, 5.7.3, 5.7.6
clinical trials: Chapter 3.1 (Introduction)
Australian Health Ethics Committee: ‘Preamble’
(Authors of this National Statement) discontinuation: 5.5.9
Australian Privacy Principles Guidelines: funding information: 5.2.18

Chapter 2.3 (Introduction) insurance requirements: 5.1.38
Australian Research Council Act monitoring: 5.5.3–5.5.6
2001: ‘Preamble’ (Authors of this
National Statement) registration and description: 3.1.7–3.1.9, 5.2.6
autonomy, value of: Section 1 (Introduction) see also interventions
coercion of consent: 2.2.9
cognitively impaired participants: Chapter 4.5
banked data: Chapter 3.1 (Element 4)
commercial tissue or biospecimen use
beneficence: Chapter 3.1 (Element 5,
Element 6) consent: 3.2.12, 3.3.10
cognitively impaired participants: 4.5.4 fetal tissue: 4.1.20

financial benefit to participants and waiver of
consent: 2.3.10
communicating decisions (review bodies):
5.2.23–5.2.24
INDEX
communication between review bodies and strategies: Chapter 3.1 (Element 3)

researchers: 5.2.14–5.2.16
withdrawal: 2.2.19–2.2.20, 3.2.12
communication of findings
xenotransplantation: 3.4.7–3.4.8
dissemination of project outcomes:
Chapter 3.1 (Element 6) see also respect
genomic research: Chapter 3.3 (Element 5) cross-border research: Chapter 4.8
human biospecimen-based research: custodians of data: 3.1.44, 3.1.55–3.1.57

Chapter 3.2 (Element 5)
to participants: Chapter 3.1 (Element 5),
3.2.15, 3.3.26–3.3.35 Data and Safety Monitoring Boards: 5.5.3
to third parties: 3.1.66–3.1.68 data collection, use and management:
Chapter 3.1 (Element 4)
complaint handling: Chapter 5.6
after the project: Chapter 3.1 (Element 7)
composition of HRECs: 5.1.29–5.1.33
consent to future use of data: 2.2.14–2.2.18
confidentiality: 1.11, 2.2.6, 2.3.10–2.3.11, 4.3.10
data and information (defined): Chapter 3.1
agreements: 3.1.45, 3.1.57 (Element 4)
of applications and deliberations of review data management arrangements: 3.1.44–3.1.50
bodies: 5.1.37(t), 5.2.21
data of cultural or historical significance:
of data: 2.3.10(f), 2.3.11(c), 3.1.73 3.1.74
in research using biospecimens: 3.2.12(b) genomic research: 3.3.18–3.3.25
see also privacy use of data: 2.2.14–2.2.18, Chapter 3.1
conflicts of interest: Chapter 5.4 (Element 4)
conscientious objection: 5.1.2 sharing data or information: 3.1.55–3.1.62
to research using human embryos or fetal see also record-keeping
tissue: Chapter 3.2 (Introduction), 4.1.14 death
to xenotransplantation research: Chapter 3.4 human biospecimens obtained after: 3.2.5
(Introduction)
deception or concealment in research: 2.3.4
consent
decision making by review bodies: 5.2.23–
banked data: 3.1.31–3.1.39 5.2.24
declining consent: 2.2.19–2.2.20 decision tree for management of findings in
genomic research: 3.3.10–3.3.17, 3.3.47–3.3.57 genomic research: after 3.3.35
human biospecimen collection: 3.2.1, declining consent: 2.2.19–2.2.20
3.2.11–3.2.14 de-identification of data: Chapter 3.1
human biospecimen exportation: 3.2.9 (Element 4)
human biospecimens obtained after death: dependent relationships: Chapter 4.3
3.2.5 devaluation of personal worth: Chapter 2.1
medically dependent participants: 4.4.9–4.4.14 (Introduction)
participant inability to give consent: Chapter disclosure
4.4 data management: 3.1.45, 3.1.53, 3.1.59
qualifying or waiving: Chapter 2.3, 3.2.6 limiting: 2.3.1–2.3.4
requirements for: Chapter 2.2 that research has ceased: 5.5.7–5.5.11
standing parental consent: 4.2.10–4.2.12 to third parties: 3.1.66–3.1.68
see also communication of findings
INDEX
discomfort from research: Chapter 2.1 focus groups as sources of data: Chapter 3.1
(Introduction) (Element 4)
discontinuation of research: 5.5.7–5.5.12 future use of data or tissue: 2.2.14–2.2.18
dissemination of findings see communication
of findings
distributive justice: Section 1; see also justice gamete research: Chapter 3.2 (Introduction),
Chapter 3.4 (Introduction)
documentation by review bodies: 5.2.23–
5.2.29 see also data collection, use and gauging risk: Chapter 2.1 (Introduction)
management Gene Technology Act 2000: Chapter 3.4
DSMBs: 5.5.3 (Introduction)
duplication of review, minimising: Chapter 5.3 genetic information, privacy issues: 3.3.58–
3.3.61
genetically modified animals: 3.4.4, Chapter 3.4
(Introduction)
economic harms: Chapter 2.1 (Introduction)
genomic research: Chapter 3.3
embryos: Chapter 3.2 (Introduction),
Chapter 4.1 governance see research governance
hybrid or chimeric: Chapter 3.4 (Introduction) Guidelines for Ethical Research in Australian
Indigenous Studies: Chapter 3.1
see also fetal involvement in research (Introduction), Chapter 4.7 (Introduction)
emergency care research: 4.4.6
establishment of HRECs: 5.1.24–5.1.28
ethical conduct handling complaints: Chapter 5.6
background to: ‘Preamble’ Helsinki Declaration: ‘Preamble’
values and principles: Section 1 hereditary implications of research
Ethical conduct in research with Aboriginal consent processes: 3.1.39

and Torres Strait Islander Peoples and human biospecimens: Chapter 3.2 see also
communities: Guidelines for researchers genomic research
and stakeholders: Section 1 (Introduction),
Chapter 3.1 (Introduction), Chapter 4.7 human research: ‘Preamble’; ‘Purpose, scope
(Introduction) and limits of this document’ see also
research
Ethical guidelines on the use of assisted
reproductive technology in clinical Human Research Ethics Committees
practice and research (ART guidelines): appointment of members: 5.1.34–5.1.36
Chapter 3.2 (Introduction), Chapter 4.1
(Introduction) composition of: 5.1.29–5.1.33
exempted research: 5.1.22–5.1.23 establishment: 5.1.24–5.1.28
experts at review body meetings: 5.2.20–5.2.22 meetings: 5.2.30–5.2.33
export of human biospecimens: 3.2.9 Human Research Ethics Committees’ role
extended consent: 2.2.14–2.2.18 communicating decisions: 5.2.23–5.2.24
human biospecimen collection: 3.2.1
Human Research Ethics Committees’ role
families see relatives
human biospecimen research findings
fetal tissue research: Chapter 3.2 (Introduction) communication: 3.2.15, 3.3.37
fetal involvement in research: Chapter 4.1 human embryo and fetal tissue research:
findings see communication of findings Chapter 3.2 (Introduction), Chapter 4.1
(Introduction)
INDEX
opt-out approach approval: Chapter 2.3 intellectual property: 3.1.31, 3.1.44, Chapter 3.1
(Introduction), 2.3.6–2.3.8 (Element 7)
procedures: 5.1.37 intellectually disabled participants: Chapter 4.5
processes of research governance and review: intensive care research: 4.4.7
Chapter 5.1
International Clinical Trials Registry Platform:
proposals involving Aboriginal and Torres 3.1.7, 5.2.6
Strait Islander participation: Chapter 4.7
(introduction) international research: Chapter 4.8
record-keeping: 5.2.25–5.2.29 interventions: Section 3 (Introduction),

3.1.4–3.1.7
research involving cognitively impaired
participants: Chapter 4.5 (Introduction), paediatric research: Chapter 4.2 (Introduction)
4.5.10 people highly dependent on medical care ():
research involving concealment or deception: Chapter 4.4 (Introduction)
2.3.4 see also clinical trials
research participant inability to give consent: interviews
Chapter 4.4 (Introduction), 4.4.13
in monitoring approved research: Chapter 5.5
research studying or likely to expose illegal (Introduction)
activity: Chapter 4.6 (introduction)
as sources of data: Chapter 3.1 (Element 4)
responsibilities: ‘Preamble’, Chapter 5.2
waiver of consent: 2.3.9–2.3.12, 3.2.14, 3.3.14,
3.3.24
justice
xenotransplantation: Chapter 3.4
hybrid embryos: Chapter 3.4 (Introduction)
core principle: Section 1 (Introduction),
1.4–1.5, Chapter 3.1 (Element 4)
dependent or unequal relationships:
identifiability of information: Chapter 3.1 4.3.4–4.3.5
(Element 4)
illegal activities, participants involved in: 4.6.3
illegal activities, participants involved in:
Chapter 4.6 inclusion/exclusion criteria for participants:
3.1.15
imported human biospecimens: 3.2.7–3.2.10
inconvenience from research: Chapter 2.1
(Introduction) medically dependent participants: 4.4.2
Indigenous participants: Chapter 4.7 overseas research: 4.8.11–4.8.13
infants see children paediatric research: 4.2.4
information and data: Chapter 3.1 (Element 4)
information sharing: 3.1.55–3.1.62 see also
communication of findings Keeping research on track II: Chapter 3.1
(Introduction), Chapter 4.7 (Introduction)
innovative clinical practice: Section 3
(Introduction)
institutional responsibilities: Chapter 5.1 legal issues
insurance requirements: 5.1.38–5.1.39 harm from research, Chapter 2.1 (Introduction)
integrity in research see research governance; legal obligations: ‘Purpose, scope and limits of
research merit and integrity this document’, 3.1.47, 3.1.49, 3.1.73
concerning illegal activities: Chapter 4.6
(Introduction), 4.6.6
INDEX
disclosure to third parties: 3.1.66–3.1.68 oversight of ethical review procedures:

5.1.10–5.1.17 see also monitoring
of other countries: Chapter 4.8 (Introduction) approved research
legal protection for ethical review team: 5.1.9
limited disclosure: Chapter 2.3
limits of National Statement: ‘Purpose, scope paediatric research: Chapter 4.2
and limits of this document’ participants in research
low risk research: ‘Purpose, scope and limits of children and young people: Chapter 4.2
this document’, Chapter 2.1 (Introduction),
defined: Chapter 2.1 (Introduction), 2.1.6
communication of findings to: Chapter 3.1
ethical review processes: 5.1.12, 5.1.18–5.1.20 (Element 5), 3.2.15
exempt from review: 5.1.21–5.1.22 defined: ‘Purpose, scope and limits of
use of shared or banked data: 3.1.62 this document’
ethical issues for: Section 4
Indigenous participants: Section 3
medical care, patients dependent on: (Introduction), Chapter 4.7
Chapter 4.4 interests of: 5.2.17–5.2.19
meetings of HRECs: 5.2.30–5.2.33 medically dependent participants: Chapter 4.4
mentally ill participants: Chapter 4.5 in other countries: Chapter 4.8
merit of research see research merit and payment of: 2.2.10–2.2.11
integrity
people in dependent or unequal relationships:
minimising duplication of review: Chapter 5.3 Chapter 4.3
minimising risk: Chapter 2.1 (Introduction) people who may be involved in illegal
monitoring approved research: Chapter 5.5 activities: Chapter 4.6
see also research governance pregnant women: Chapter 4.1
recruitment: Chapter 3.1 (Element 2)
National Health and Medical Research Council patients dependent on medical care:
Act 1992: ‘Preamble’ Chapter 4.4
negligible risk research: Chapter 2.1 payment for participants: 2.2.10–2.2.11
(Introduction)
personal histories as data: Chapter 3.1
neonatal intensive care research: 4.4.3 (Element 4)
cognitively impaired participants: 4.5.1–4.5.2 physical harm: Chapter 2.1 (Introduction)
non-identifiable data: Chapter 3.1 (Element 4), placebos: 3.1.5
5.1.22(b)
post-mortem specimens: 3.2.5
non-participants, risks to: Chapter 2.1
(Introduction); see also third parties pregnant women: Chapter 4.1
Nuremberg Code: ‘Preamble’ pressure to consent: 2.2.9
principles of ethical conduct: Section 1
privacy
observational studies as sources of data:
Chapter 3.1 (Element 4) conflicts of interest: 5.4.6
opt-out approach: Chapter 2.3 in data collection and management:
Chapter 3.1 (Element 4), 3.1.53, 3.3.22
overseas research: Chapter 4.8
genomic research: 3.3.7, 3.3.22, 3.3.58–3.3.61
INDEX
guidelines: Chapter 2.3 (Introduction), 5.2.26 merit and integrity: Section 1; see also research
governance
human biospecimen research: 3.2.12
risks and benefits: Chapter 2.1
issues specific to genetic information:
3.3.58–3.3.61 scope see research scope, aims, themes, and
methods
see also confidentiality
see also participants in research; researchers
Prohibition of Human Cloning for
Reproduction Act 2002: Chapter 3.4 Research Code: ‘Preamble’
(Introduction)
research governance: ‘Preamble’, ‘Purpose,
psychological harm: Chapter 2.1 scope and limits of this document’
purpose of National Statement: ‘Purpose scope accountability: Chapter 5.7
and limits of this document’
complaint handling: Chapter 5.6
conflicts of interest: Chapter 5.4
qualifying consent: Chapter 2.3 institutional responsibilities: Chapter 5.1
minimising duplication of review: Chapter 5.3
monitoring approved research: Chapter 5.5
record-keeping: 3.1.48, 3.1.74, 5.2.25–5.2.29 see
also data collection, use and management review body responsibilities: Chapter 5.2
recruitment: Chapter 3.1 (Element 2) Research Involving Human Embryos Act 2002:
Chapter 3.2 (Introduction), Chapter 3.4
genomic research: 3.3.4–3.3.9 (Introduction)
human biospecimen research: Chapter 3.2 research merit and integrity
(Element 2)
cognitively impaired participants: 4.5.1–4.5.2
xenotransplantation: 3.4.6
core principle: Section 1 (Introduction),
see also participants in research 1.1–1.3
re-identification of data: Chapter 3.1 dependent or unequal relationships: 4.3.1–
(Element 4) 4.3.3
reimbursement of participants: 2.2.10–2.2.11 illegal activities, participants involved in:
4.6.1–4.6.2
relatives
communication of findings to: 3.3.33
medically dependent participants: 4.4.1
ethical issues concerning: 3.1.64–3.1.65, 3.2.2,
3.2.12(d), 3.2.12(f), 3.2.15, Chapter 3.3 overseas research: 4.8.1–4.8.10
(Introduction)
paediatric research: 4.2.1–4.2.3
recruitment: 3.3.4
research results see communication of findings
return of finding to participants and
consideration of research scope, aims, themes, and methods
implications for relatives, 3.3.36–3.3.47 genomic research: 3.3.1–3.3.3
standing parental consent: 4.2.10–4.2.12 human biospecimen research: 3.2.1
research xenotransplantation: 3.4.1–3.4.5
defined: ‘Purpose, scope and limits of this researchers

document’ accountability: Chapter 5.7
elements of: Chapter 3.1 communication with review bodies: 5.2.14–
harm from: Chapter 2.1 (Introduction) 5.2.16
conflicts of interest: Chapter 5.4
INDEX
responsibilities: Chapter 3.1 (Element 7),

5.2.5–5.2.13
terminal care research: 4.4.4
at review body meetings: 5.2.20–5.2.22
termination of pregnancy: 4.1.11–4.1.23
respect
third parties: Chapter 2.1 (Introduction), 2.2.12–
cognitively impaired participants: 4.5.5–4.5.11 2.2.13, 3.1.66–3.1.68; see also relatives;
core principle: Section 1 (Introduction), non-participants, risks to
1.10–1.13 tissue
dependent or unequal relationships: 4.3.8– fetal: Chapter 4.1
4.3.10
future use of: 2.2.14–2.2.18
illegal activities, participants involved in:
4.6.5–4.6.7 human biospecimens: Chapter 3.2
Indigenous participants: 4.7.10–4.7.12 Torres Strait Islander participants: Chapter 4.7
medically dependent participants: 4.4.5–4.4.8 transition provisions for existing biospecimens:
3.2.10
overseas research: 4.8.19–4.8.21
paediatric research: 4.2.6–4.2.9
results see communication of findings unconscious people, research with: 4.4.8
review body procedures and responsibilities: unequal relationships: Chapter 4.3
Chapter 5.2
Universities Australia (UA): ‘Preamble’
risk management: ‘Preamble’, Chapter 2.1 (Authors of this National Statement)
illegal activities, participants involved in: 4.6.2 unspecified consent: 2.2.14–2.2.18
medically dependent participants: 4.4.1, 4.4.3,
4.4.13
paediatric research: Chapter 4.2 (Introduction), values and principles of ethical conduct:
4.2.7, 4.4.3 Section 1
pregnant women and fetus: 4.1.3, 4.1.10
researchers: 4.8.18, 5.1.2
waiving consent: 2.3.9–2.3.12, 3.2.6, 3.2.14,
in xenotransplantation: Chapter 3.4 3.3.14, 3.3.24
see also low risk research; monitoring withdrawal of approval: 5.5.7–5.5.12
approved research
withdrawal of consent: 2.2.19–2.2.20, 3.2.12
World Health Organization, International
Clinical Trials Registry Platform: 3.1.7,
scope of National Statement: ‘Purpose, scope 5.2.6
and limits of this document’
social harms: Chapter 2.1
specific consent: 2.2.14 (a) xenotransplantation: Chapter 3.4
standing parental consent: 4.2.10–4.2.12
stored human biospecimens: 3.2.2–3.2.3,
3.2.13–3.2.14 young people: Chapter 4.2
suspension of research: 5.5.7–5.5.12

Australian National Statement in Ethical Conduct 2018

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Australian National Statement in Ethical Conduct 2018

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National Statement on Ethical

Conduct in Human Research

2007 (Updated 2018)

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 in the design, development,

Section 4 Ethical considerations specific to participants 61

Section 5 Processes of research governance and ethical review 83

THE NATIONAL STATEMENT:

NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED 2018) | 1

This National Statement does not exhaust the

2 | NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED 2018)

ETHICAL BACKGROUND Since earliest times, human societies have

NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED 2018) | 3

R esearch governance Authors of this National Statement

4 | NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED 2018)

The Australian Research Council Act 2001

NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED 2018) | 5

PURPOSE, SCOPE AND LIMITS OF THIS

PURPOSE What is research?

The National Statement is therefore designed ‘Research’… includes work of direct

6 | NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED 2018)

artefacts…where these lead to new or In addition, the conduct of human research

NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED 2018) | 7

Some human research is subject to specific

8 | NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED 2018)

SECTION 1: VALUES AND PRINCIPLES

INTRODUCTION Reference to these values throughout the

NATIONAL STATEMENT ON ETHICAL CONDUCT IN HUMAN RESEARCH, 2007 (UPDATED 2018) | 9

GUIDELINES 1.3 Research that is conducted with integrity

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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

Where a person’s reactions exceed discomfort

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For those gauging the severity of the harm, Managing risks

Do the benefits justify the risks?

2.1.4 In determining the existence, likelihood

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CHAPTER 2.2: GENERAL REQUIREMENTS

2.2.6 Information on the following matters Renegotiating consent

(c) provision of services to participants

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CHAPTER 2.3: QUALIFYING OR WAIVING

INTRODUCTION The opt-out approach is a method used in

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

c) the research involves no more a) involves active concealment or

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f) there is an adequate plan to protect

SECTION 3: ETHICAL CONSIDERATIONS

INTRODUCTION The guidance in Chapter 3.1 is broadly

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CHAPTER 3.1: THE ELEMENTS OF RESEARCH

INTRODUCTION Researchers may have an impact on research

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This chapter discusses the manner in which the GUIDELINES

• Element 7: After the Project • How will the planned methods

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3.1.6 In health research involving an Element 2: Recruitment

3.1.12 Research proposals should clearly 3.1.18 In developing and implementing

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 4 Ethical considerations specific to participants 61

Section 5 Processes of research governance and ethical review 83