Human Research and
Ethics
University of Melbourne
Outline of this session
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This is a mandatory component of ‘why we have
Human Research Ethics’. I will quickly outline:
Basic ethics principles
 Which projects need approval
 Current project exemptions
 Why you need ethics approval
 What ethics committees look out for
 University of Melbourne Human Ethics Structure
 Supervisor’s Role
 Approval Process
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Basic ethical principles
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Research merit and integrity
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Justice
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recruitment is fair and reasonable whereby it doesn’t place an unfair
burden on those participating
has a reasonable distribution of benefits and doesn’t exploit those
who participate
Beneficence
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using appropriate methods and based on the current study of
literature
is the contribution of knowledge within the wider community
Respect
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is abiding by the above three ethical principles and the right of the
participant to say ‘no’
Which projects need approval?
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Current University and NHMRC policy states that
“all research projects involving human participants
must be reviewed by institutional ethics committees”
See both University and NHMRC policies at http://www.research.unimelb.edu.au/humanethics/
aboutapproval/whyapproval.
Some projects are exempt from ethical review.
Projects which are exempt #1
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Use of data freely available in the public domain
Research about a living individual using only public
domain information
Pure observation studies of public behaviour
Pure observation studies in educational settings
Quality assurance projects
Projects which are exempt #2
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Testing within standard educational requirements,
following standard practices
Student education and training exercises (but no
testing of each other allowed)
Student coursework assignments and essays, where
no data is collected from human participants
University student evaluations of teaching
Taste and food quality evaluations
Why do I need ethics approval?
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To protect the rights and welfare of human participants
To ensure that any risk of discomfort or harm to
participants is minimal, and justified by the potential benefits
of the research
To protect the University’s reputation for research that it
conducts and/or sponsors
To minimise the potential for claims of negligence made
against researchers and the University
To meet the University’s obligations under the NHMRC’s
National Statement on Ethical Conduct in Human
Research (March 2007)
What do ethics committees look out
for?
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Is there a risk of physical, psychological, spiritual or
emotional harm?
Is there potential for infringement of privacy,
confidentiality, or ownership?
Does the person’s involvement impose burdens that
outweigh the benefit?
Issues for Ethics Committees
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Aim of research
Methodology:
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Does what you say on the form match what you tell participants
you are going to ask them to do? (in the Plain Language Statement)
Does what you are asking participants to do have the potential to
yield the results you aim to find?
Experience and training of researchers
Participants
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who are they?
how vulnerable are they?
Issues for Ethics Committees
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Risks vs. Benefits
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Risk Management
immediate and later
 unexpected outcomes
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Recruitment: how? by whom?
Issues for Ethics Committees
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Dependent relationships: pupil/teacher;
student/lecturer; family members; doctor/patient
Cross cultural research: cultural sensitivities,
translating, interpreting
Confidentiality
legal limits
 small sample size
 data storage
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Issues for Ethics Committees
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Plain language statement and consent form
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tailor to suit participants
Informed consent:
clear full information
 voluntary choice to participate
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Consent from whom:
parental consent for minors
 legal guardians
 community/organisations?
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Issues for Ethics Committees
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Publication of results of research
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Funding for research
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Internal (University) or external (ARC, NHMRC, Donor etc)
Conflict of interest?
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To participants, funding bodies, conference or industry
publications
e.g. affiliations or beneficiaries, such as did the school pay for this?
Payment to participants: compensation vs. inducement
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Needs to be reasonable
The University of Melbourne Ethics Structure
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One central Human Research Ethics Committee (HREC) –
decides policy
Three Human Ethics Sub-Committees (HESC) – reviews
and approves all standard projects
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Health Sciences HESC
Behavioural & Social Sciences HESC
Humanities & Applied Sciences HESC
Department HEAGs – reviews all projects and only
approves minimal risk projects
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Melbourne Graduate School of Education HEAG
Process – Minimal Risk
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Begin by preparing an application online via THEMIS
Complete, proof read and sign hard copy form
Submit to the Graduate School Human Ethics Advisory
Group (HEAG) for review
If doing research in schools, don’t forget to obtain
permission from relevant authority and lodge to HEAG
After review, the researchers attend to the
recommendations and re-lodge revisions with HEAG
Low/minimal risk projects are approved by HEAG
Process - Standard Risk
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Same as for low risk applications, with the addition
Standard risk projects are forwarded and undergo a
subsequent review by the HESC at their monthly
meeting
HESC then advises researchers regarding further
amendments or grant approval
NOTE: Sensitive topics, data collection overseas or
with ATSI, disabled, disadvantaged and migrant
communities is deemed to be standard risk research
What is the supervisor’s role?
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As a signatory of your application, the
supervisor is responsible for:
 Briefing
you about the ethics requirements when
you are preparing your project
 Guiding you in the completion of the application
 Guiding you in the ethical conduct of your
research
 Monitoring your project
Ethics Approval Process
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From submission to approval by the committee/s can take:
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around four weeks for minimal risk applications; and
around six weeks for standard risk applications
Important to know when the ethics deadlines are
No work to commence until written approval received
All amendments require approval
Any incidents or adverse effects are to be reported to the
ethics committee via the annual report
Annual report needs to be submitted for yearly renewal of
your ethics approval
Approval can be renewed for up to 5 years
External Documents
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American Psychological Association ethical principles of psychologists
and code of conduct http://www.apa.org/ethics/code.html
Children and Young Persons Act 1989 (in relation to Mandated
Reporting Requirements) http://www.dms.dpc.vic.gov.au/
Australian Association for Research in Education (AARE) Code of
Ethics http://www.swin.edu.au/aare/ethcfull.htm
NHMRC statement on Human research ethics
http://www.nhmrc.gov.au/publications/synopses/e35syn.htm
Research in Government Schools
http://www.education.vic.edu.au/scln/research.htm
Research in Catholic Schools http://www.ceo.melb.catholic.edu.au/
Internal sites and documents
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Graduate School of Education Human Ethics site
http://www.education.unimelb.edu.au/research/ethics/hu
man_ethics.html
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University of Melbourne Human Ethics site
http://www.research.unimelb.edu.au/humanethics/
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University of Melbourne Human Ethics “hints” page
http://www.research.unimelb.edu.au/humanethics/external
/hints/
Indigenous Research
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Guidelines on Ethical Matters in Aboriginal and Torres Strait
Islander Health Research (NHMRC, June 1991) under review
http://www.nhmrc.gov.au/issues/atsi.pdf
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Guidelines for Ethical Research in Indigenous Studies
(Australian Institute of Aboriginal and Torres Strait Islander
Studies, 2000)
http://www.aiatsis.gov.au/corp/docs/EthicsGuideA4.pdf
The end…
Any questions?