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Research Ethics & Compliance
Support
Human
Research Ethics
A structured approach
to ethical review of
human research at
UNSW Australia
Guidelines for HREC and HREAP
Members
Version 1.1, April 2014
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Contents
Introduction ........................................................................................................................... 4
Consistency in research ethics review .................................................................................. 4
The National Statement ........................................................................................................ 5
The principles ....................................................................................................................... 5
Converting principles to review questions ............................................................................. 6
Research Merits ................................................................................................................ 6
Research Integrity ............................................................................................................. 7
Beneficence ...................................................................................................................... 7
Respect ............................................................................................................................. 7
Justice ............................................................................................................................... 8
Decision making.................................................................................................................... 8
Review tools ......................................................................................................................... 9
References and resources .................................................................................................. 10
Appendix 1: Review Template............................................................................................. 11
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A structured approach to ethical
review of human research at
UNSW Australia
Guidelines for HREC and HREAP Members
Introduction
Australian institutions, including UNSW Australia and its centres and collaborating
institutions, that conduct research that involves human participants – human research –
have responsibilities to ensure that the research is ethically reviewed. This essential
responsibility is clearly stated in paragraph 5.1.1 of the National Statement on Ethical
Conduct in Human Research, 2007 (updated March 2014), NHMRC, ARC and UA.
(henceforth referred to as the National Statement).
The National Statement is designed to clarify the responsibilities of institutions, researchers
and review bodies (including low risk ethical review panels and human research ethics
committees) for the ethical design, conduct and review of human research. The principles
and processes contained in the National Statement apply to all Australian institutions that
seek eligibility to receive research funds from either the National Health and Medical
Research Council or the Australian Research Council.
A challenge for UNSW and particularly its Human Research Ethics Committees (HRECs)
and Human Research Ethics Advisory Panels (HREAPs) and their members is how to
determine with certainty, and apply with reliability, the criteria for the review of human
research that will meet the requirements of the National Statement. It is a challenge because
the National Statement is a comprehensive document that contains guidance at more than
one level of generality.
The purpose of this guide is to identify within the National Statement a clear set of ethical
review criteria that can provide clarity, reliability and consistency for the UNSW HRECs and
HREAPs and their members who conduct ethical review and guidance for researchers who
seek ethical clearance or approval of their projects.
Consistency in research ethics review
In most Australian universities, human research proposals that are submitted for ethical
review vary greatly in research discipline, methodology and participants so that the issues of
human research ethics and the outcome of their review will also vary widely. The same issue
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may arise in different proposals but the resolution of those issues may be different. However,
this variety should not excuse review bodies from functioning consistently.
Consistency in human research ethics does not mean consistency in review outcome. Nor
does it require that all members of review body think alike. It does mean consistency in
always applying the same criteria: asking the same questions. This consistency gives
assurance to researchers who can rely on all their proposals being subjected to the same
criteria. It gives confidence to reviewers that the criteria they use have an authoritative
source and it given reassurance to institutions that ethical review of their research meets
national standards.
The aim of this guide is to set out those criteria.
The National Statement
When a review body decides to approve a human research proposal the approval should
contain an explicit statement that the proposal meets the requirements of the National
Statement (National Statement, paragraph 5.2.22).
The National Statement requirements that need to be fulfilled if human research is to be
approved appear at three levels: values, principles and guidelines.
The values appear on pages 11 to 12 of the National Statement and are described in brief
general terms.
The guidelines appear throughout the chapters related to types of research in section 3 and
categories of participants in section 4. These are necessarily specific to particular research
or participant contexts.
The principles are the link between the values and the guidelines in that the principles reflect
the values and the guidelines are applications of the principles to specific research contexts.
Accordingly, the principles provide a practical statement of the requirements of the National
Statement that need to be satisfied for the approval of a proposal for human research.
The principles
These are contained in a set of paragraphs and sub-paragraphs on pages 11-12 of the
National Statement.
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Each of the four values, Research Merit and Integrity, Justice, Beneficence and Respect is
expanded into component principles. These provide a comprehensive set of criteria for
ethical review of any human research proposal.
In doing so, they form a basis on which researchers can demonstrate that their proposals
should be approved and on which review bodies and their members can justify and explain
their review decisions.
Converting principles to review questions
One risk of using the format and language of the principles on pages 11 and 12 of the
National Statement is that they can become a mere checklist.
An approach to the use by both researchers and review body members that takes the form
of substantive questions for review bodies to answer can avoid such a superficial checklist
approach.
As an example, the second principle within the value of Research Merit and Integrity is:
"(b) designed or developed using methods appropriate for achieving the aims of the
proposal;"
This can be expressed as a substantive question:
"Why are the methods appropriate to achieve the aims of the proposal?"
Constructed in this form, the criterion becomes a clear and essential question that a review
bodies need to ask and researchers need to answer in their applications.
The principles of the National Statement on one hand can lead to review questions on the
other hand. On the following pages, the principles are all converted into such substantive
questions.
Research Merits
i.
ii.
iii.
iv.
Justifiable by potential benefit can lead to the question ‘What is the benefit and why
does the benefit justify research?’
Uses appropriate methods to achieve aims can lead to the question ‘Why are
methods appropriate?’
Based on current knowledge in literature can lead to the question ‘What is current
knowledge?’
Respect for participants not compromised by aims, methods or results can lead to
the question ‘Why is respect not compromised?’
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v.
vi.
Conducted/supervised by those with appropriate experience, qualifications and
competence can lead to the question ‘Why are experience, qualifications, and
competence appropriate?’
Uses appropriate facilities and resources can lead to the question ‘Why are facilities
and resources appropriate?’
Research Integrity
i.
ii.
iii.
iv.
Searching for knowledge and understanding can lead to the question ‘What is the
knowledge and understanding that the researchers are seeking?’
Following recognized principles of research conduct can lead to the question ‘What
are the recognised principles of research conduct that the researchers will use?’
Conducting research honestly can lead to the question ‘How will the research be
conducted honestly?’
Disseminating/communicating results, to permit public scrutiny and add to public
knowledge/understanding can lead to the question ‘How will the results be
disseminated to permit scrutiny and contribute to public knowledge and
understanding?’
Beneficence
i.
ii.
iii.
iv.
Likely benefit, to participants or community, must justify risks of harm/discomfort to
participants can lead to the question ‘Why do likely benefits of the research justify
any risks of harm or discomfort to participants?’
To design research to minimize risks of harm/discomfort can lead to the question
‘How does the design minimize the risk of harm/discomfort?’
To clarify potential benefits and risks can lead to the question ‘How are potential
benefits and risks clarified for participants?’
For welfare of the participants can lead to the question ‘How will researchers fulfil
their responsibility for welfare of participants?’
Respect
i.
ii.
iii.
iv.
v.
Requires due regard for the welfare, beliefs, perceptions, customs and cultural
heritage, individual and collective can lead to the question ‘How does the research
give due respect for welfare, beliefs, perceptions, customs and cultural heritage of
participants?’
Respect for privacy, confidentiality and cultural sensitivities can lead to the question
‘How will researchers respect privacy, confidentiality and cultural sensitivities of
participants?’
Giving due scope to capacity of human beings to make own decisions can lead to the
question ‘How will the research give due scope to the capacity of participants to
make their own decisions?’
Where participants are unable to make own decisions/have diminished capacity,
respect involves empowering and providing protection can lead to the question
‘Where participants cannot make their own decisions, how will researchers empower
and protect them?’
Voluntary participation based on sufficient information about and adequate
understanding of purpose, methods, demands, risks and potential benefits of the
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research (National Statement paragraph 2.2.2) can lead to the questions ‘Why is
there sufficient information?’ and ‘Why will there be adequate understanding?’
Justice
i.
ii.
iii.
iv.
v.
vi.
vii.
Within the scope and objectives of research, selection, exclusion the inclusion of
research participants is fair and accurately described can lead to the questions ‘Why
are the selection, inclusion and exclusion criteria for the research fair?’ and ‘How will
the selection methods be accurately described in the results?’
Process of recruiting participants is fair can lead to the question ‘Why is the
recruitment process fair?’
No unfair burden of participation in research on groups can lead to the question ‘Why
is there no unfair burden of participation on particular groups?’
Fair distribution of benefits of participation in research can lead to the question ‘How
is the distribution of benefits of participation fair?’
No exploitation of participants can lead to the question ‘Why is there no exploitation
of participants?’
Fair access to the benefits of research can lead to the question ‘How is access to the
benefits of the research fair?’
Outcomes accessible to participants in timely and clear manner can lead to the
question ‘How will timely and clear access to the outcomes of the research be
provided to participants?’
Decision making
Both HRECs and HREAPs have members with different knowledge, expertise and
experience. The open exchange of differing opinions on whether a project meets the
National Statement criteria outlined above is most likely to reach shared decisions that are
ethically sound.
For more than low risk applications decisions need to be derived from an exchange of
opinions from at least each of the members who constitute the minimum membership
(National Statement paragraph 5.2.29).
The National Statement in paragraph 5.2.3 provides that members of review bodies,
including HRECs and HREAPs, are responsible to:


become familiar with this National Statement, and consult other guidelines relevant to the
review of specific research proposals; and
prepare for and attend scheduled meetings of the review body or, if unavailable, provide
opinions on the ethical acceptability of research proposals before meetings, subject to
institutional policies on absences.
HREC Chairs and HREAP Convenors should facilitate reviews in such a way that all
members have fair opportunities to contribute before a decision is reached. Chairs and
Convenors need to remain aware of prior policy determinations and be willing to decide
when expert advice is appropriate.
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Essential elements of most HREC decisions are the determination of:



to whom responses from investigators are to be referred;
who will decide on their adequacy; and
how a final approval decision will be reached.
Where there is less than full attendance of the minimum membership at a meeting, the
Chairs and Convenors have a specific responsibility to be satisfied, before a decision is
reached, that the views of those absent who belong to the minimum membership have been
received and considered (National Statement paragraph 5.2.30).
Review tools
There is value in adopting a structured approach to the conduct and/or the summary and
recording of HREC deliberation. Doing so makes it more likely that the HREC/Panel
addresses all the matters that need to be considered for the proposal under review.
Reviews can be structured by nominating one or more member/s to introduce the discussion
on a particular application and by using review guides and standard templates. Templates
can be incorporated, in an abbreviated form, into a concise review guide for members of
review bodies.
Such review guides can facilitate communication by being arranged in the same order as the
information is arranged in the application form that is used. An example of a guide is
attached in Appendix 1 which can potentially be adapted to fit a particular application form.
Participant information and consent forms (PICFs) often attract extensive discussion and
comment in most research applications and changes are frequently required. The processes
used to deal with changes to the PICF need to:



avoid using the meeting time for insubstantial matters;
achieve committee agreement on the substance of needed changes; and
satisfy members that (1) the substance of all agreed changes will be incorporated into
correspondence to investigators, and (2) in due time, that responses from investigators
were satisfactory.
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References and resources
National Statement on Ethical Conduct in Human Research, 2007, updated March 2014,
NHMRC, ARC, UA: https://www.nhmrc.gov.au/guidelines/publications/e72
Challenging Ethical Issues in Contemporary Research on Human Beings, 2007, NHRMC:
http://www.nhmrc.gov.au/guidelines/publications/e73
Information & Privacy Commission NSW:
http://www.ipc.nsw.gov.au/privacy/ipc_legislation.html
Keeping research on track: a guide for Aboriginal and Torres Strait Islander peoples about
health research ethics. 2006, NHMRC: http://www.nhmrc.gov.au/guidelines/publications/e65
Developing
Best
Practice
in
Human
Research
Ethics
Review:
http://docs.health.vic.gov.au/docs/doc/Developing-Best-Practice-in-Human-Research-EthicsReview
University of Wollongong, on-line tutorial:
http://www.uow.edu.au/research/rso/ethics/human/training/
Human Research Ethics information at UNSW can be found at:
https://research.unsw.edu.au/research-ethics-and-compliance-support-recs
For support and suggestions towards the content of this document please contact:
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Research Ethics & Compliance Support
Level 3, Rupert Myers Building South
UNSW Australia Kensington Campus
T: +61 2 9385 4235
E: humanethics@unsw.edu.au
W: https://research.unsw.edu.au/research-ethics-and-compliance-support-recs
Produced in Collaboration with
Appendix 1: Review Template
HREC/HREAP MEMBERS REVIEW GUIDE
Meeting Date:
Application
Number:
Application Title:
Chief Investigator:
Nature of
Research:
Section of
Application Form
Section 2.6: Sample
Size
Section 2.7:
Recruitment (and
Justice) (Participants)
Comments & questions
National Statement
Reference
Quantitative Research

the size and profile of
the sample is adequate
to answer the research
question 3.3.3
Qualitative Research

is the sampling
appropriate to the
objectives and
theoretical basis of the
research 3.1.6

Selection, exclusion,
inclusion fair 1.4 (a)
No unfair burden 1.4 (c)
Fair distribution of
benefits of participation
1.4 (d)
No exploitation 1.4 (e)
Recruitment fair 1.4 (b)




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
Section 2.8: Project
Description




Sections 2.9 & 3.0
(Privacy)
Justifiable by potential
benefit 1.1 (a)
Methods appropriate to
achieve aims 1.1 (b)
Based on current
literature/prior studies
1.1 (c)
Prior peer review?? 1.2
Design ensures respect
1.1 (d)
See privacy addendum


Section 3.4 Risks and
Benefits to Participants
(Risks and Benefits)






Recruitment Materials




PICFs




Study Tools

Potential benefits 1.6
Adequate disclosure
1.7
Fair access 1.4 (f)
Results available 1.5
Risks of participation
1.7 (b), 2.1.3, 2.1.4
Risks managed and
disclosed 1.7 (b), 2.1.3
Likely benefits justify
risks 1.6, 2.1.5
Respect capacity to
decide 1.12
Gives voluntary choice
2.2.1
Provide sufficient
information 2.2.2
Relies on adequate
understanding 2.2.2
Respect capacity to
decide 1.12
Gives voluntary choice
2.2.1
Provide sufficient
information 2.2.2
Relies on adequate
understanding 2.2.2
Are appropriate tools to
answer the research
question
The tools are
appropriate for the
target population
Privacy Addendum (Section 2.9 & 3.0)
Privacy
Questions to consider
1. Collection – relates to
the collection of health
information



How does the study
comply?
Will the researchers collect information
that they won’t use in this study, but
plan to use in future studies?
Does the consent form accurately
reflect all health information they are
collecting and what it will be used for?
Have the participants been informed
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2. Use & Disclosure of
health information – “Use”
refers to the information
being used internally
within the research group.
“Disclosure” refers to your
research group giving the
information to a separate
body or organisation

3. Ensuring data quality –
require health information
to be accurate, complete,
up to date & relevant to
your study

4. Requirements for the
security and retention of
data

5. Transparency by
documenting policies on
the management of
information and to make
these policies available to
the research participants






they have the right to review their
information?
Is there a possibility anybody outside
the research group will use the
information they have collect without
the person’s knowledge or consent?
Does the research ask to disclose
someone’s information to another
research team/external body either
within NSW, interstate or overseas?
What processes are in place to ensure
all information recorded is accurate
and up to date?
In what situations would this
information be important?
How are all types of study data
stored?
What processes are in place to ensure
study data is not misused, lost or
modified?
How long is study data stored for?
How will study data be destroyed?
If a participant requests what
information the research team holds
about them can the research team tell
them how to access it and what it has
been used for?
6. Relates to access and
correction of information

7. Limits on the
assignment of identifiers
that are intended to
uniquely identify the
participants in relation to
their health information

8. Anonymity

Is it possible for participants to remain
anonymous in the study? Why/Why
not?
9. Transborder dataflows

Does the study involve sending
information or samples outside of
NSW?
Does the PICF form clearly state any
transborder data flow?
Do the research team send any
identifying information across
borders?



If a participant establishes that the
information the researchers hold about
them is inaccurate, incomplete,
misleading or not up to date, how
does the researcher go about
correcting it?
Does the research team assign study
numbers to participants?
What are the
advantages/disadvantages of
assigning a study number?
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