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Human Research and Ethics
University of Melbourne
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Outline of this session 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 Research merit and integrity
using appropriate methods and based on the current study of literature
Justice 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 is the contribution of knowledge within the wider
community Respect
is abiding by the above three ethical principles and the right of the participant to say ‘no’
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Which projects need approval?
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.
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Projects which are exempt #1
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
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Projects which are exempt #2
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
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Why do I need ethics approval?
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)
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What do ethics committees look out for?
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?
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Issues for Ethics Committees
Aim of research Methodology:
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
who are they? how vulnerable are they?
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Issues for Ethics Committees
Risks vs. Benefits
Risk Management immediate and later unexpected outcomes
Recruitment: how? by whom?
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Issues for Ethics Committees
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
Plain language statement and consent form tailor to suit participants
Informed consent: clear full information voluntary choice to participate
Consent from whom: parental consent for minors legal guardians community/organisations?
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Issues for Ethics Committees
Publication of results of research To participants, funding bodies, conference or
industry publications Funding for research
Internal (University) or external (ARC, NHMRC, Donor etc)
Conflict of interest? e.g. affiliations or beneficiaries, such as did the
school pay for this? Payment to participants: compensation vs.
inducement Needs to be reasonable
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The University of Melbourne - Ethics
Structure One central Human Research Ethics Committee (HREC) – decides policy
Three Human Ethics Sub-Committees (HESC) – reviews and approves all standard projects Health Sciences HESC Behavioural & Social Sciences HESC Humanities & Applied Sciences HESC
Department HEAGs – reviews all projects and only approves minimal risk projects Melbourne Graduate School of Education HEAG
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Process – Minimal Risk
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
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Process - Standard Risk
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
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What is the supervisor’s role?
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
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Ethics Approval Process From submission to approval by the
committee/s can take: 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
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External Documents 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/e35sy
n.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/
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Internal sites and documents
Graduate School of Education Human Ethics site
http://www.education.unimelb.edu.au/research/ethics/human_ethics.html
University of Melbourne Human Ethics site
http://www.research.unimelb.edu.au/humanethics/
University of Melbourne Human Ethics “hints” page
http://www.research.unimelb.edu.au/humanethics/external/hints/
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Indigenous Research
Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Health Research (NHMRC, June 1991) under reviewhttp://www.nhmrc.gov.au/issues/atsi.pdf
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
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The end…
Any questions?