1. Research Ethics Office for Research Gary Allen Chris Rose’Meyer Rhiannon Campbell Research Ethics Administrator ph: 3735 4855 fax: 07 3735 7994 email: r.campbell@griffith.edu.au r.campbell@griffith.edu.au Education Research Ethic Advisors Dr Leonie Rowan Dr Sue Whatman Dr Christine McDonald Photo: Australian HES 11/11/09 Office for Research - 2012

2. Overview 1.What is human research? 2.Why research ethics matters? 3.History of the governance of human research ethics – Response to international scandals 4.Governance in Australia 5.Using the National Statement (2007) 6.Griffith University Office for Research - 2012

3. What is Human Research? Examples of human research  Interviews  Surveys  Focus Groups  Observations  Chat rooms  Testing  Identified personal information not on the public record. Human research is conducted with or about people, or their data or their tissue. Persons Born Overseas (Percent) * Census Year 2001 Local Government Area ASGC Version http://maps.oesr.qld.gov.au/thematics/index.jsp?p_userty pe_id=2 Office for Research - 2012

4. Office for Research | g.allen@griffith.edu.au | © Griffith University 2012g.allen@griffith.edu.au Why research ethics matters? Responsibility to participants Reputation of the University Requirements of research funding bodies, state, federal and international Requirements of the University’s insurer – indemnification of researchers Future access to populations and sites Use of public funds carries with it obligations to the community Professional obligations Requirements of many journals

5. Office for Research - 2012 History of the governance of human research ethics Response to international scandals

6. Why Human Research Ethics? World War II  See Unit 731 (Japanese) for biological and chemical warfare  Mengele – 1500 sets of imprisoned twins  Luftwaffe – freezing experiments  Dachau – Malaria treatment  And many more well documented episodes of inhumanity. Following the Doctors’ Trials at Nuremberg the Tribunal delivered their opinion on medical experimentation on human beings – The Nuremberg Code (1947). History of Research Ethics 1.Nuremberg Code http://www.ushmm.org/research/doctors Office for Research - 2012

7. Nuremberg Code http://ohsr.od.nih.gov/guidelines/nuremberg.htm 1.The voluntary consent of the human subject is absolutely essential 2.The experiment should be such as to yield fruitful results for the good of society 3.The experiment should be so designed and based on the results of animal experimentation 4.The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury 5.No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; 6.The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. 7.Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. 8.The experiment should be conducted only by scientifically qualified persons 9.During the course of the experiment the human subject should be at liberty to bring the experiment to an end 10.During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage Office for Research - 2012

8. Nuremberg Code http://ohsr.od.nih.gov/guidelines/nuremberg.htm 1.The voluntary consent of the human subject is absolutely essential 2.The experiment should be such as to yield fruitful results for the good of society 3.The experiment should be so designed and based on the results of animal experimentation 4.The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury 5.No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; 6.The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. 7.Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. 8.The experiment should be conducted only by scientifically qualified persons 9.During the course of the experiment the human subject should be at liberty to bring the experiment to an end 10.During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage Office for Research - 2012 Beneficence Voluntary participation Informed Consent

9. Scandals – Deception / Consent Watch Queen  Observation of homosexual acts in public toilets.  Recorded car licence plates.  Learned of names and addresses from friendly policemen while pretending to be a market researcher.  As a public health surveyor interviewed men he had observed.  Most men married and secretive about homosexual activity. 3.Laud Humphreys – The Watch Queen in the Tea Room (1967) http://bioethics.net/ Office for Research - 2012

10. International research ethics frameworks for human research World Medical Association developed a set of ethical principles for the medical community regarding Human experimentation – Declaration of Helsinki 1966. http://www.wma.net/en/30publications/10policies/b 3/index.html 1.Self – determination 2.Informed Consent Ethical Principals and the Guidelines for the Protection of Human Subjects of Research – Belmont Report (1979) http://ohsr.od.nih.gov/guidelines/belmont.html 1.Respect for Persons 2.Beneficence 3.Justice 2.UN Declaration of Human Rights 3.Declaration of Helsinki (WMA) 4.Belmont Report http://www.mcmaster.ca/ors/ethics/ tutorial/define.htm Office for Research - 2012

11. Personal responsibility: Reflective practice John Hopkins Hospital Baltimore  Office of Human Research Protection suspended supported medical research projects involving humans. » 2400 federally funded human experiments » 15 000 patients and volunteers » $419M for research ($277 in experiments involving humans)  Death of volunteer at university’s asthma and allergy centre.  Use of unapproved drug (hexamethonium) without informing IRB  Lack of reflective practice as earlier volunteers were also incapacitated – this should have been reported as an adverse event. The lesson of John Hopkins (2001) http://www.hopkinsmedicine.org/ Office for Research - 2012

12. Governance in Australia Implementation of international standards and expansion beyond clinical work

13. Australian national framework Office for Research - 2012 NHMRC Statement on Human Experimentation and Supplementary Notes (First published 1966, multiple revisions, last revised 1992) National Statement on Ethical Conduct in Research Involving Humans (1999) National Statement on Ethical Conduct in Human Research (2007) Australian Code for the Responsible Conduct of Research (2007) – Research Integrity not research ethics, but an important document for your research

14. National Statement on Ethical Conduct in Human Research (2007) Office for Research - 2012 Authority and scope Content and role in ethical review Principles - Research integrity, Respect for persons, Beneficence and Justice Specific content – Research involving Aboriginal or Torres Strait Islander people, Research conducted overseas, Young people, Research in the workplace, Mental impairment, Illegal activity, Data banking, and more

15. Office for Research | g.allen@griffith.edu.au | © Griffith University 2012g.allen@griffith.edu.au Principles of ethical conduct Merit and integrity o Genuine search for knowledge o Based on literature, prior research and / or established problem o Sufficient expertise and resources o Any conflicts of interest addressed Respect for persons o Intrinsic value of humans, rather than resources o Welfare, beliefs, perceptions, customs and cultural heritage o Privacy, confidentiality and cultural sensitivities o Honour assurances provided o Respect the capacity for self determination

16. Office for Research | g.allen@griffith.edu.au | © Griffith University 2012g.allen@griffith.edu.au Principles of ethical conduct Beneficence o Responsibility to minimise harms o Not non-maleficence o Not overstating the benefits o Benefits must justify the risks o Fair flow of benefits versus burdens o Genuinely informed consent Justice o Fair selection and inclusion o Distributive justice o No unfair burden o Fair flow of / access to benefits o No exploitation o Impact on prejudice and discrimination

17. In the National Statement (2007)  Different research methods and disciplines: » Qualitative research » Human tissues » Clinical trials » Databanks  Different types of participants » Children » Overseas » Aboriginal and Torres Strait Island people  Ethical review » Membership and role of HRECs » Low risk and negligible risk » Duplication of review  Researcher responsibilities  Institutional responsibilities Since the 1999’s first edition explicitly expanded the scope beyond clinical to all human research. Office for Research - 2012

18. Using the National Statement (2007) Research ethics in practice

19. Office for Research | g.allen@griffith.edu.au | © Griffith University 2012g.allen@griffith.edu.au Risks in human research A common mistake researchers make is to describe a project as involving no risks When what they actually mean is that there are strategies in place to negate or minimise the risks

20. Risks in Human Research  What are some of the risks of Human Research. » Physical (Injury, illness, harm) » Psychological (significant distress) » Social (impact on social networks, access to services and support) » Economic (loss of income, earnings and cost to participants) » Legal (exposure to civil or criminal proceedings) » Humiliation (devaluation of worth) » Environment (see Code not NS)  Recognition of burden on participants. Another common mistake is to assume that risks only refers to physical or perhaps also significant psychological harms. Office for Research - 2012

21. Risks in Human Research Assessing Risks  To whom do the risks apply? » Participants, potential participants, third parties, environment, and / or researchers.  Addressing risks » Are there alternatives? » Can risks be negated or minimised? » Can risks be managed?  Can the risks be justified?  Disclosure to potential participants Yet another common mistake is to focus only on the risks to the participants. Office for Research - 2012

22. Justifying the risks in Human Research Assessing Benefits  What are the benefits?  To whom do the benefits flow? » Directly to participants and/or participant community (people like the participants) » Other stakeholders / wider society » Sponsors / Griffith University » Researchers  Recognising uncertainty in research  Justifying research with minimal benefit  Describing benefits to potential participants As we know, there are known knowns. There are things we know we know. We also know there are known unknowns. That is to say we know there are some things we do not know. But there are also unknown unknowns, the ones we don't know we don't know. Donald Rumsfeld http://www.wisdomquotes.com/003 223.html Office for Research - 2012

23. Have you “Done” ethics yet?  Research ethics is first and foremost a personal responsibility  It is a design, conduct and quality issue  Researchers should engage with the ethical principles and review process  See the process as a continuing professional responsibility until the research is completed  Not form filling – someone else’s problem  Objective is to help you improve design and quality of the research This is not an expression we like to hear because… Office for Research - 2012

24. Limitations Clinical Research  Precedents and scandals relate primarily to medical research.  More easily quantifiable risks Quantitative Assumptions  Sample size  Consent (verbal) Western Liberal – Democratic expectations  Consent  Attitudes towards personal burdens vs collective benefits  Standard of care It is important to recognise that the National Statement has its limitations Office for Research - 2012

25. Human research ethics at Griffith University Proportional, transparent and collegiate

26. Office for Research | g.allen@griffith.edu.au | © Griffith University 2012g.allen@griffith.edu.au Sources of guidance, information and resources Research Ethics Manual Office for Research – Process and system questions Office for Research – Responding to ethical review feedback Psychology REA(s) HDR Supervisor Office for Research – Application of ethical principles to your work and / or policy questions

27. Griffith University – Levels of Ethical review Full Review More than low risk Allow approximately 40 days for the initial review Full Review More than low risk Allow approximately 40 days for the initial review Expedited Review 2 Low Risk + Significant ethical issues Allow approximately 15 days for the initial review Expedited Review 2 Low Risk + Significant ethical issues Allow approximately 15 days for the initial review Expedited Review 1 Low Risk + Minimal ethical issues Allow approximately 7 days for the initial review Expedited Review 1 Low Risk + Minimal ethical issues Allow approximately 7 days for the initial review Expedited Review 1 (NR) Negligible Risk Allow approximately 5 days for the initial review Expedited Review 1 (NR) Negligible Risk Allow approximately 5 days for the initial review Office for Research - 2012

28. How to Apply Office for Research - 2012 Portal Research My Ethics New Application Submit Online

29. Recruitment – see also Booklet 21 The fair share of burden and benefit, identification of potential participants, first contact method, recruitment materials, perceived benefits, and risk Office for Research - 2012

30. Impacts on Recruitment Conflicts of interest - Perceived conflicts, and the researcher’s own communities Confidentiality issues – Internal identification and risk Regulatory privacy issues. Relevant informed consent – Not legalistic or formula-based, but research, participant and context specific, reconfirmed / renegotiated consent, not ending responsibilities, and anticipating future use Power relationships – Role of researcher, duality of role, impact of sponsor and what this means for voluntary participation / consent and risk Office for Research - 2012

31. Steps to Success Application Ethics Manual REA / HDR Advisor Supervisor Office for Research - 2012

32. General Tips Consider earlyDiscuss with your (supervisor and) REAConsult the Manual for adviceApply for the right level of reviewShare your own decision makingKnow the standards and justify the approachConsider the perspective of a potential participantTreat the review process as a discourseEthical issues doesn’t mean the research is not permissibleFully complete the form & include your attachments Office for Research - 2012

33. Other issues to be considered Use of third party services – The continued ethical responsibility of the research team, and conflicts in standard Observation – How to handle consent, risks, illegal / sensitive activities, risks to the researchers, and ethical review Deception – When is it ethical, consent, ethical reviewReimbursement, incentives and coercion – Meaningful application of the NS Realities of practice – Ethical responsibility and recognition of flexibility, implications of emergent possibilities Feedback – The sharing of overall results with participants, and participant communities Office for Research - 2012

34. Contacts Office for Research - 2012 Chris Rose’Meyer x 27227 Gary Allen (x 27226)