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Human Research and Ethics

Human Research and Ethics

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Human Research and Ethics

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  1. Human Research and Ethics Dr Michèle de Courcy Chair, Faculty of Education HEAG University of Melbourne

  2. What’s ‘ethics’ about? • Integrity of researchers, which involves: • Commitment to • Contributing to knowledge • Pursuit & protection of truth • Reliance on appropriate research methods • Honesty

  3. Basic ethical principles • Respect for persons • Beneficence • Justice

  4. Which projects need approval? • Current University and NHMRC policy states that all research projects involving human participants as subjects are to be reviewed by institutional ethics committees.

  5. Is it “research”? Does it involve… • Interviews and focus groups • Surveys and questionnaires • Archived data which identifies individuals • Observation • Photography, audio/video taping • Experimental procedures

  6. Is it “research involving humans”? • Is the research about • Establishing facts, principles or knowledge? • Obtaining or confirming knowledge? • Does a person’s involvement have the potential to infringe one of the 3 basic principles?

  7. 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 with little benefit?

  8. 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 conducted and sponsored by it;

  9. Why? Continued … • 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 Research Involving Humans (June 1999)

  10. The University of Melbourne - Ethics Structure • One central Human Research Ethics Committee (HREC) – policy • Three Human Ethics Sub-Committees (HESC) – review projects • Health Sciences HESC • Behavioural & Social Sciences HESC • Humanities & Applied Sciences HESC

  11. Committee Composition of the HESCs • Chair • Layman and laywoman not associated with institution • Member with knowledge/current experience in research considered by HREC • Member knowledge/ current experience in professional care, counselling • Lawyer • Minister of religion • Other co-opted members as required

  12. Ethics Approval Process Application forms on Web - students to consult supervisors • Submit to Faculty Human Ethics Advisory Group (FHEAG) for review and recommendation to HESC • Some low risk projects can be approved by FHEAG, all must be reported to HESC • Review or noting by HESC at monthly meeting • Ethics office advises researchers re amendments or approval

  13. What is my supervisor’s role? • As a signatory of your application, your supervisor is responsible for: • Briefing you about the requirements of the HESC when you are planning your project • Guiding you in the completion of the application form • Guiding you in the ethical conduct of your research

  14. Ethics Approval Process • No work to commence until written approval received • Any amendments require approval • Any incidents or adverse effects to be reported to ethics committee • Annual report to be submitted for yearly renewal of approval • Approval granted for up to 5 years

  15. Issues for Ethics Committees • Aim of research • Methodology: good methodology = good ethics • Does what you say on the form match what you tell participants you are going to ask them to do? (in the PLS) • Experience and training of researchers

  16. Issues for Ethics Committees • Participants • who are they? • vulnerability (more care) • Risks vs. Benefits • Risk Management • immediate and later • unexpected outcomes

  17. Issues for Ethics Committees • Recruitment: how? by whom? • Dependent relationships: pupil/teacher; student/lecturer; family members; doctor/patient • Cross cultural research: cultural sensitivities, translating, interpreting • Confidentiality • legal limits • other limits e.g. small sample size • data storage

  18. Issues for Ethics Committees • Plain language statement & 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, as well as individuals?

  19. Issues for Ethics Committees • Publication of results of research • Funding for research • Conflict of interest? • Payment to participants:compensation vs. inducement

  20. 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/e35syn.htm • Research in Government Schools http://www.education.vic.gov.au/studentlearning/research/conductresearch.htm • Research in Catholic Schools http://web.ceo.melb.catholic.edu.au/?sectionid=48&sectionid=48&mode=print

  21. Internal sites and documents • Faculty of Education Human Ethics site • http://www.edfac.unimelb.edu.au/research/ethics/human_ethics.html • University of Melbourne Human Ethics site • http://www.unimelb.edu.au/research/ethics/human/#b • University of Melbourne Human Ethics “hints” page • http://www.unimelb.edu.au/research/ethics/human/hints.html

  22. Indigenous Research • Guidelines on Ethical Matters in Aboriginal and Torres Strait Islander Health Research (NHMRC, June 1991) under review • http://www.nhmrc.gov.au/issues/asti.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