1. Human Research and Ethics University of Melbourne

2. 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

3. Basic ethical principles Research merit and integrity Research merit and integrity using appropriate methods and based on the current study of literature using appropriate methods and based on the current study of literature Justice Justice recruitment is fair and reasonable whereby it doesn’t place an unfair burden on those participating 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 has a reasonable distribution of benefits and doesn’t exploit those who participate Beneficence Beneficence is the contribution of knowledge within the wider community is the contribution of knowledge within the wider community Respect Respect is abiding by the above three ethical principles and the right of the participant to say ‘no’ is abiding by the above three ethical principles and the right of the participant to say ‘no’

4. Which projects need approval? Current University and NHMRC policy states that “all research projects involving human participants must be reviewed by institutional ethics committees” 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. See both University and NHMRC policies at - http://www.research.unimelb.edu.au/humanethics/ aboutapproval/whyapproval. http://www.research.unimelb.edu.au/humanethics/ aboutapproval/whyapproval http://www.research.unimelb.edu.au/humanethics/ aboutapproval/whyapproval Some projects are exempt from ethical review. Some projects are exempt from ethical review.

5. Projects which are exempt #1 Use of data freely available in the public domain Use of data freely available in the public domain Research about a living individual using only public domain information Research about a living individual using only public domain information Pure observation studies of public behaviour Pure observation studies of public behaviour Pure observation studies in educational settings Pure observation studies in educational settings Quality assurance projects Quality assurance projects

6. Projects which are exempt #2 Testing within standard educational requirements, following standard practices Testing within standard educational requirements, following standard practices Student education and training exercises (but no testing of each other allowed) 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 Student coursework assignments and essays, where no data is collected from human participants University student evaluations of teaching University student evaluations of teaching Taste and food quality evaluations Taste and food quality evaluations

7. Why do I need ethics approval? To protect the rights and welfare of human participants 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 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 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 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) To meet the University’s obligations under the NHMRC’s National Statement on Ethical Conduct in Human Research (March 2007)

8. What do ethics committees look out for? Is there a risk of physical, psychological, spiritual or emotional harm? Is there a risk of physical, psychological, spiritual or emotional harm? Is there potential for infringement of privacy, confidentiality, or ownership? Is there potential for infringement of privacy, confidentiality, or ownership? Does the person’s involvement impose burdens that outweigh the benefit? Does the person’s involvement impose burdens that outweigh the benefit?

9. Issues for Ethics Committees Aim of research Aim of research Methodology: 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 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? Does what you are asking participants to do have the potential to yield the results you aim to find? Experience and training of researchers Experience and training of researchers Participants Participants who are they? who are they? how vulnerable are they? how vulnerable are they?

10. Issues for Ethics Committees Risks vs. Benefits Risks vs. Benefits Risk Management Risk Management immediate and later immediate and later unexpected outcomes unexpected outcomes Recruitment: how? by whom? Recruitment: how? by whom?

11. Issues for Ethics Committees Dependent relationships: pupil/teacher; student/lecturer; family members; doctor/patient Dependent relationships: pupil/teacher; student/lecturer; family members; doctor/patient Cross cultural research: cultural sensitivities, translating, interpreting Cross cultural research: cultural sensitivities, translating, interpreting Confidentiality Confidentiality legal limits legal limits small sample size small sample size data storage data storage

12. Issues for Ethics Committees Plain language statement and consent form Plain language statement and consent form tailor to suit participants tailor to suit participants Informed consent: Informed consent: clear full information clear full information voluntary choice to participate voluntary choice to participate Consent from whom: Consent from whom: parental consent for minors parental consent for minors legal guardians legal guardians community/organisations? community/organisations?

13. Issues for Ethics Committees Publication of results of research Publication of results of research To participants, funding bodies, conference or industry publications To participants, funding bodies, conference or industry publications Funding for research Funding for research Internal (University) or external (ARC, NHMRC, Donor etc) Internal (University) or external (ARC, NHMRC, Donor etc) Conflict of interest? Conflict of interest? e.g. affiliations or beneficiaries, such as did the school pay for this? e.g. affiliations or beneficiaries, such as did the school pay for this? Payment to participants: compensation vs. inducement Payment to participants: compensation vs. inducement Needs to be reasonable Needs to be reasonable

14. The University of Melbourne - Ethics Structure One central Human Research Ethics Committee (HREC) – decides policy One central Human Research Ethics Committee (HREC) – decides policy Three Human Ethics Sub-Committees (HESC) – reviews and approves all standard projects Three Human Ethics Sub-Committees (HESC) – reviews and approves all standard projects Health Sciences HESC Health Sciences HESC Behavioural & Social Sciences HESC Behavioural & Social Sciences HESC Humanities & Applied Sciences HESC Humanities & Applied Sciences HESC Department HEAGs – reviews all projects and only approves minimal risk projects Department HEAGs – reviews all projects and only approves minimal risk projects Melbourne Graduate School of Education HEAG Melbourne Graduate School of Education HEAG

15. Process – Minimal Risk Begin by preparing an application online via THEMIS Begin by preparing an application online via THEMIS Complete, proof read and sign hard copy form Complete, proof read and sign hard copy form Submit to the Graduate School Human Ethics Advisory Group (HEAG) for review 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 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 After review, the researchers attend to the recommendations and re-lodge revisions with HEAG Low/minimal risk projects are approved by HEAG Low/minimal risk projects are approved by HEAG

16. Process - Standard Risk Same as for low risk applications, with the addition 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 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 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 NOTE: Sensitive topics, data collection overseas or with ATSI, disabled, disadvantaged and migrant communities is deemed to be standard risk research

17. What is the supervisor’s role? As a signatory of your application, the supervisor is responsible for: As a signatory of your application, the supervisor is responsible for: Briefing you about the ethics requirements when you are preparing your project Briefing you about the ethics requirements when you are preparing your project Guiding you in the completion of the application Guiding you in the completion of the application Guiding you in the ethical conduct of your research Guiding you in the ethical conduct of your research Monitoring your project Monitoring your project

18. Ethics Approval Process From submission to approval by the committee/s can take: From submission to approval by the committee/s can take: around four weeks for minimal risk applications; and around four weeks for minimal risk applications; and around six weeks for standard risk applications around six weeks for standard risk applications Important to know when the ethics deadlines are Important to know when the ethics deadlines are No work to commence until written approval received No work to commence until written approval received All amendments require approval All amendments require approval Any incidents or adverse effects are to be reported to the ethics committee via the annual report 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 Annual report needs to be submitted for yearly renewal of your ethics approval Approval can be renewed for up to 5 years Approval can be renewed for up to 5 years

19. External Documents American Psychological Association ethical principles of psychologists and code of conduct http://www.apa.org/ethics/code.html American Psychological Association ethical principles of psychologists and code of conduct http://www.apa.org/ethics/code.htmlhttp://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/ Children and Young Persons Act 1989 (in relation to Mandated Reporting Requirements) http://www.dms.dpc.vic.gov.au/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 Australian Association for Research in Education (AARE) Code of Ethics http://www.swin.edu.au/aare/ethcfull.htmhttp://www.swin.edu.au/aare/ethcfull.htm NHMRC statement on Human research ethics NHMRC statement on Human research ethics http://www.nhmrc.gov.au/publications/synopses/e35syn.htm http://www.nhmrc.gov.au/publications/synopses/e35syn.htm http://www.nhmrc.gov.au/publications/synopses/e35syn.htm Research in Government Schools http://www.education.vic.edu.au/scln/research.htm Research in Government Schools http://www.education.vic.edu.au/scln/research.htm http://www.education.vic.edu.au/scln/research.htm Research in Catholic Schools http://www.ceo.melb.catholic.edu.au/ Research in Catholic Schools http://www.ceo.melb.catholic.edu.au/http://www.ceo.melb.catholic.edu.au/

20. Internal sites and documents Graduate School of Education Human Ethics site Graduate School of Education Human Ethics site http://www.education.unimelb.edu.au/research/ethics/hu man_ethics.html http://www.education.unimelb.edu.au/research/ethics/hu man_ethics.html University of Melbourne Human Ethics site University of Melbourne Human Ethics site http://www.research.unimelb.edu.au/humanethics/ University of Melbourne Human Ethics “hints” page University of Melbourne Human Ethics “hints” page http://www.research.unimelb.edu.au/humanethics/external /hints/ http://www.research.unimelb.edu.au/humanethics/external /hints/

21. Indigenous Research Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Health Research (NHMRC, June 1991) under review 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 Guidelines for Ethical Research in Indigenous Studies (Australian Institute of Aboriginal and Torres Strait Islander Studies, 2000) 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

22. The end… Any questions?