1. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Professor Peter O’Leary, Chair, Human Research Ethics Committee What you need to know about ethics

2. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Outline  Research integrity training (iPerform)  Human research ethics at Curtin http://research.curtin.edu.au/research-integrity-ethics/human-research-ethics/ http://research.curtin.edu.au/research-integrity-ethics/human-research-ethics/  Peer review  Role of Curtin HREC  The review process  Common problems Research method, questionnaires Recruitment Data security Consent

3. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Human Research Ethics at Curtin  Research involving humans as subjects must be approved by HREC;  The NHMRC Act (1992) requires all research involving humans to be subject to ethical review; Curtin must have a Human Research Ethics Committee to be eligible for public research money;  This Committee must comply with the guidelines in the National Statement on Ethical Conduct in Human Research (2013);  http://www.nhmrc.gov.au/guidelines-publications/e72 (NHMRC) http://www.nhmrc.gov.au/guidelines-publications/e72  http://www.nhmrc.gov.au/guidelines-publications/r39 (ARC) http://www.nhmrc.gov.au/guidelines-publications/r39  HREC Role: Protect participants Protect researchers Ensure research merit & integrity Monitor research (governance)

4. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J National Statement on Ethical Conduct in Human Research (2007) http://www.nhmrc.gov.au/guidelines-publications/e72 http://www.nhmrc.gov.au/guidelines-publications/e72  Beneficence (doing good) This aids assessment of risk and benefit  Justice This is mainly distributive justice, ensuring that the burden of research does not fall unfairly on any individual or class of person  Respect for autonomy Respecting the decision-making capacities of autonomous persons The need for informed consent  Non-maleficence (avoiding harm) It was not enough to try to do good, it was also necessary to actively avoid doing harm

5. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Australian Code for the Responsible Conduct of Research: http://www.nhmrc.gov.au/guidelines-publications/r39 http://www.nhmrc.gov.au/guidelines-publications/r39 Guiding principles Management of research data and primary materials Supervision of trainees Publication and dissemination of research findings Authorship Peer review Conflicts of interest Collaborative research across institutions Breaches

6. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J

7. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Non low-risk research (National Statement)  Interventions and therapies (Ch 3.3) Clinical and non-clinical trials  Human genetics (Ch 3.5)  Women who are pregnant and the human fetus (Ch 4.1)  Children and young people (Ch 4.2)  People in dependent or unequal relationship (Ch 4.3)  People who are highly dependent on medical care (Ch 4.4)  People with cognitive impairment, intellectual disability or mental illness (Ch 4.5)  People who may be involved in illegal activities (Ch 4.6)  Aboriginal and Torres Straight Islander peoples (Ch 4.7)

8. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Application Form Download from Ethics website Researcher Head of School Signoff Ethics Support Officer Triage Application Low risk Non Low Risk Reviewers Scientific Advisory Committee Responses Approve Researcher amends application HREC Review Researcher amends application Approve Research approved by candidacy or external scientific review eg ARC, NHMRC, etc Researcher amends application Research application Process for human research ethics review

9. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Ethics in human research  The key task of the HREC is  To ensure research is conducted according to high ethical standards so the welfare of participants is protected. To ensure participants’ welfare, the committee reviews proposals in terms of Research design, Consent Clarity and information for participants Risk to participants and Curtin Compliance with National Statement

10. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Harm  The potential for infringing basic ethical principles arises where human involvement could cause harm damage physical psychological, spiritual or emotional well-being, exploit cultural knowledge, infringe privacy or confidentiality, or impose burdens with little benefit.  Ethical responsibility “ Research participants may enter into a relationship with researchers whom they may not know, but need to trust.”  Research ethics & altruism “Participants contribute their time and involvement for the common good – altruistically- deserve protection’.

11. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Peer review  Peer review before conducting research makes better research, protects all involved  Avoids abuses of research  Tuskegee syphilis study.  Nazi science  Willowbrook State School  Thalidomide to scopolamine  The Alder Hay affair  The Stanford Prison Experiment (1971)  The 'Tearoom Trade' Study  Adverse outcomes

12. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J What constraints are there?  Community attitudes Imagine your decision being on the front page of the daily newspaper. Would it be a good story? Would your friends, family, neighbours be proud?  Law: primary and secondary Legislation, common law, regulations, contracts  International agreements, covenants Human rights, rights of the child etc.

13. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Judgements on risk  Deciding what constitutes minimal risk or unacceptable risk involves professional judgments  Seek advice from experienced members in your discipline  Put a case, share the thinking, agree, disagree  Amend or defend your thinking where necessary  This is core business for professionals. It is your responsibility to come to a shared understanding of acceptable risk in your area of research.  Get an ethics team together in your area.  Talk and listen.

14. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Core principles in human research ethics The core principles come from the Belmont Report (1979) which was commissioned after the Tuskegee syphilis expt.  Research merit and integrity The research has to be likely to do what it sets out to do. If you have doubts on method, you have an obligation to raise those doubts formally.  Justice Look to see if the burden is too great. Is there burden without benefit?  Beneficence Likely benefit must justify risks or harms. Benefit can mitigate burden.  Respect Humans have an a priori claim to respect. Respect recognises intrinsic value and requires regard for culture, welfare, beliefs etc  Non-maleficence An obligation to not inflict harm intentionally

15. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Adverse events  Researchers should include an adverse events protocol that identifies the sorts of events that might be classed as adverse.  What is an adverse event? Depends on research Examples Complaints from participants or public Injury or other harm to participant, or researcher Loss of data Laboratory accident

16. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Common problems  Language: jargon, acronyms or complex phrasing  Research method  Recruitment of participants – methods not clear  Participants’ rights and welfare – participants not informed sufficiently and in clear, plain language  Consent forms and information sheets – not brief, clear and unambiguous.

17. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J More common problems  Research involving minors  consent particularly; e.g. mature minors.  Assent needed from child participants  Research involving indigenous participants  Especially community involvement  Data security  Must be transported safely & stored on campus securely  Confidentiality of data  Approvals needed from other HRECs  reciprocal process

18. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Recruitment  How are people recruited ? Get very clear information.  Is the participant information sheet very clear and able to be understood by the participants?  Who is recruiting? Is there any possibility of conflict of interest through e.g. power relations, researcher is also the clinician?  Avoid research with colleagues or students as participants.

19. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Data security  Data must be stored in a secure location on a Curtin campus  Follow the guidelines for Western Australian universities  Do not allow storage only in researcher’s home.  Backups at Curtin required for field data. Ensure there is a process for securing data (e.g. encrypted hard drive; CDs posted to supervisor; secure web site)  Ensure sensitive data cannot be intercepted

20. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J WAUSDA Guidelines

21. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Clinical trials  There are strong rules governing clinical trials.  Any testing on humans of a therapeutic good or practice is a clinical trial.  Clinical trials must be registered with the ANZCTR.  Good clinical practice guidelines must be followed: use the Notes for Guidance on Good Clinical Practice http://www.tga.gov.au/sites/default/files/ich13595an.pdf  The sponsor of a clinical trial must have agreed in writing to indemnify the trial, or there needs to be clear indemnity from other sources. If in doubt, ask for information.

22. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Consent  Consent must be INFORMED CONSENT  Informed consent only possible if the participants fully understand all that will happen and the likely risks.  Consent need not be written, but the process needs to be clear  Consent should take account of cultural issues (e.g. clan agreement; elder agreement). Individual/personal consent may not always be either sufficient or appropriate

23. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Relevant considerations  Incentives  Are financial or other rewards to be given to participants?  Are these of such a size and value that they may unduly influence the freedom of participants to withdraw or otherwise protect themselves from risk?

24. Curtin University is a trademark of Curtin University of Technology CRICOS Provider Code 00301J Good practice  Present a clear explanation to the HREC on why you want to do what you plan.  Refer to the National Statement; cite relevant paragraphs  Work with participants, not on them  Discuss ethical issues with colleagues and supervisors  Ask who will benefit and who will bear the burden. Is the research needed?  Ask: would you participate in this research on the basis of the information provided to participants?