Abstract
This study aims to characterise Human Research Ethics Committee (HREC) members’ perceptions on five main themes associated with ethics reviews, namely, the nature of research, ethical/moral issues, assent, participants’ risk and HREC prerogatives issues. Three hundred and sixteen HREC members from over 200 HRECs throughout Australia responded to an online questionnaire survey. The results show that in general, HREC members’ beliefs are reasoned and align with sound principles of ethical reviews. There seems to be a disposition for living up to ethical/moral values, avoiding the issue of consent waivers and respecting participants’ welfare, as well as a sense of ambiguity about HREC prerogatives. Problematic areas were a tendency towards over-valuing quantitative research methods for their perceived validity and a neutral view on issuing consent waivers to participants with intellectual disability and, finally, the belief that research that limits disclosure, plans deception or actively conceals is morally unjustifiable. Implications for professional development and policy-making are discussed.
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Adeyeye, A. 2017. Bribery: Cost of doing business in Africa. Journal of Financial Crime 24 (1): 56–64. https://doi.org/10.1108/JFC-01-2016-0003.
Aman, M., and B. Handen. 2006. Reactions to ethical challenges and complexities of including people with intellectual disability as participants in research by Dr Teresa Iacono. Journal of Intellectual & Developmental Disability 31 (3): 180–180. https://doi.org/10.1080/13668250600876400.
Asai, A., and Y. Kadooka. 2013. Re-examination of the ethics of placebo use in clinical practice. Bioethics 27 (4): 186–193. https://doi.org/10.1111/j.1467-8519.2011.01943.x.
Athanassoulis, N., and J. Wilson. 2009. When is deception in research ethical? Clinical Ethics 4 (1): 44–49. https://doi.org/10.1258/ce.2008.008047.
Avins, A.L., D.C. Cherkin, K.J. Sherman, H. Goldberg, and A. Pressman. 2012. Should we reconsider the routine use of placebo controls in clinical research? Trials 13 (1): 44–44. https://doi.org/10.1186/1745-6215-13-44.
Benson, P.L., N. Leffert, P.C. Scales, and D.A. Blyth. 2012. Beyond the “village” rhetoric: Creating healthy communities for children and adolescents. Applied Developmental Science 16 (1): 3.
Breen, K.J. 2003. Misconduct in medical research: Whose responsibility? International Medicine Journal 33 (4): 186–191. https://doi.org/10.1046/j.1445-5994.2003.00373.x.
Brody, J.L., and H.B. Waldron. 2000. Ethical issues in research on the treatment of adolescent substance abuse disorders. Addictive Behaviors 25 (2): 217–228. https://doi.org/10.1016/S0306-4603(99)00041-6.
Buchanan, D.R., L. Gable, and C.B. Fisher. 2009. Best practices for responding to threats of violence in research ethically and legally. In Research with high-risk populations: Balancing science, ethics, and law, ed. D.R. Buchanan, C.B. Fisher, and L. Gable, 233–252. Washington, D.C: American Psychological Association.
Buchanan, D., K. Khoshnood, T. Stopka, S. Shaw, C. Santelices, and M. Singer. 2002. Ethical dilemmas created by the criminalization of status behaviors: Case examples from ethnographic field research with injection drug users. Health Education & Behavior 29 (1): 30–42. https://doi.org/10.1177/1090198102029001005.
Carpenter, D. (2008). Research ethics relating to cancer. In J. Gabriel (Ed.), The Biology of Cancer (pp. 153–165). West Sussex, England: John Wiley & Sons Ltd.
Chilengi, R. 2009. An ethics perspective on responsibilities of investigators, sponsors and research participants. Acta Tropica 112: S53–S62. https://doi.org/10.1016/j.actatropica.2009.08.004.
Daly, J., M. Bandyopadhyay, E. Riggs, and L. Williamson. 2008. Ethical review and the assessment of research proposals using qualitative research methods. Monash Bioethics Review 27 (3): 43–53.
Davies, D., and J. Dodd. 2002. Qualitative research and the question of rigor. Qualitative Health Research 12 (2): 79–89. https://doi.org/10.1177/104973202129119793.
De Smit, E., L.S. Kearns, L. Clarke, J. Dick, C.L. Hill, and A.W. Hewitt. 2016. Heterogeneity of human research ethics committees and research governance offices across Australia: An observational study. Australasian Medical Journal 9 (2): 33–39. https://doi.org/10.4066/AMJ.2015.2587.
Devdutt, N., and C. Vicky. 2014. Use of placebos poses ethical dilemma. Psychiatric Annals 44 (2): 89. https://doi.org/10.3928/00485713-20140205-07.
Dickson-Swift, V., E.L. James, and S. Kippen. 2005. Do university ethics committees adequately protect public health researchers? Australian and New Zealand Journal of Public Health 29 (6): 576–579. https://doi.org/10.1111/j.1467-842X.2005.tb00254.x.
Dickson-Swift, V., E.L. James, S. Kippen, and P. Liamputtong. 2008. Risk to researchers in qualitative research on sensitive topics: Issues and strategies. Qualitative Health Research 18 (1): 133–144. https://doi.org/10.1177/1049732307309007.
Feenan, D. 2002. Legal issues in acquiring information about illegal behaviour through criminological research. British Journal of Criminology 42 (4): 762–781. https://doi.org/10.1093/bjc/42.4.762.
Feilzer, M.Y. 2010. Doing mixed methods research pragmatically: Implications for the rediscovery of pragmatism as a research paradigm. Journal of Mixed Methods Research 4 (1): 6–16. https://doi.org/10.1177/1558689809349691.
Fisher, C.B., and S.J. Goodman. 2009. Goodness-of-fit ethics for nonintervention research involving dangerous and illegal behaviours. In Research with high-risk populations: Balancing science, ethics, and law, vol. 8, ed. D.R. Buchanan, C.B. Fisher, and L. Gable, 25–46. Washington, DC, US: American Psychological Association.
Fisher, C.B., A. Higgins-D’Alessandro, J.M. Rau, T.L. Kuther, and S. Belanger. 1996. Referring and reporting research participants at risk: Views from urban adolescents. Child Development 67 (5): 2086–2100. https://doi.org/10.2307/1131611.
Fry, C.L., W. Hall, A. Ritter, and R. Jenkinson. 2006. The ethics of paying drug users who participate in research: A review and practical recommendations. Journal of Empirical Research on Human Research Ethics: an International Journal 1 (4): 21–36. https://doi.org/10.1525/jer.2006.1.4.21.
Fry, C.L., A. Ritter, S. Baldwin, K.J. Bowen, P. Gardiner, T. Holt, R. Henkinson, and J. Johnston. 2005. Paying research participants: A study of current practices in Australia. Journal of Medical Ethics 31 (9): 542–547. https://doi.org/10.1136/jme.2004.009290.
Fry, C., and R. Dwyer. 2001. For love or money? An exploratory study of why injecting drug users participate in research. Addiction 96 (9): 1319–1325. https://doi.org/10.1080/09652140120070373.
Gaw, A. 2006. Beyond consent: The potential for atrocity. Journal of the Royal Society of Medicine 99 (4): 175–177.
Gillam, L. 2005. Protecting researchers is not the role of HRECs. Australian and New Zealand Journal of Public Health 29 (6): 580–581. https://doi.org/10.1111/j.1467-842X.2005.tb00255.x.
Green, L.A., J.C. Lowery, C.P. Kowalski, and L. Wyszewianski. 2006. Impact of institutional review board practice variation on observational health services research. Health Services Research 41 (1): 214–230. https://doi.org/10.1111/j.1475-6773.2005.00458.x.
Greenwood, J., C. Holmes, and J. Bidewell. 2001. Mission impossible? Developing best practice guidelines for institutional ethics committees (IECs) in Greater Sydney. Collegian 8 (1): 8.
Guillemin, M., L. Gillam, D. Rosenthal, and A. Bolitho. 2012. Human research ethics committees: Examining their roles and practices. Journal of Empirical Research on Human Research Ethics 7 (2): 38–49. https://doi.org/10.1525/jer.2012.7.3.38.
Haggerty, K.D. 2004. Ethics creep: Governing social science research in the name of ethics. Qualitative Sociology. 27 (4): 391–414.
Hall, B.M. 2006. Australia needs an office of academic integrity. The Medical Journal of Australia 185 (11–12): 619.
Hall, R. 2013. Mixed methods: In search of a paradigm. In Conducting research in a changing and challenging world, ed. T. Le and Q. Le, 71–78. New York: Nova Science Publishers.
Handal, B., K. Watson, M. Fellman, M. Maher, and M. White. 2015. Unpacking the beliefs and attitudes of Australian HREC members: An examination of influences on reviewer decision-making. Research in Ethical Issues in Organizations 9 (13): 139–152. https://doi.org/10.1108/S1529-209620150000013009.
Handal, B., K. Watson, B. Brewer, M. Fellman, M. Maher, H. Ianniello, and M. White. 2017. Personal views of HREC members on contested issues: Possible influences on reviewer decision-making. Ethical Perspectives 24 (3): 405–439.
Handal, B., Lynch, S., Watson, K., Maher, M. & Hellyer, G. (2016). Teaching digital citizenship in higher education. In L.E. Dyson, W. Ng & J. Fergusson (Eds.), Mobile Learning Futures – Sustaining Quality Research Practice in Mobile Learning, 15th World Conference on Mobile and Contextual Learning mLearn (pp. 112–121). Sydney, Australia, October 24–26, 2016.
Hesse-Biber, S.N., and B. Johnson. 2013. Coming at things differently: Future directions of possible engagement with mixed methods research. Journal of Mixed Methods Research 7 (2): 103–109. https://doi.org/10.1177/1558689813483987.
Hirshon, J.M., S.D. Krugman, M.D. Witting, J.P. Furuno, M.R. Limcangco, A.R. Perisse, and E.K. Rasch. 2002. Variability in institutional review board assessment of minimal-risk research. Academic Emergency Medicine: Official Journal of the Society for Academic Emergency Medicine 9 (12): 1417–1420. https://doi.org/10.1111/j.1553-2712.2002.tb01612.x.
Hoffman, S. 2001. The use of placebos in clinical trials: Responsible research or unethical practice? Connecticut Law Review 33 (2): 449.
Iacono, T. 2006. Ethical challenges and complexities of including people with intellectual disability as participants in research. Journal of Intellectual & Developmental Disability 31 (3): 173–173. https://doi.org/10.1080/13668250600876392.
Johnson, R.B., A.J. Onwuegbuzie, C. de Waal, T. Stefurak, and D. Hildebrand. 2016. Unpacking pragmatism for mixed methods research. In The BERA/SAGE handbook of educational research, vol. 2, ed. D. Wyse, N. Selwyn, E. Smith, and L.E. Suter, 259–279. London: SAGE Publications.
Justman, S. 2013. Deceit and transparency in placebo research. The Yale Journal of Biology and Medicine 86 (3): 323–331.
Kottow, M. 2010. The improper use of research placebos. Journal of Evaluation in Clinical Practice 16 (6): 1041–1044. https://doi.org/10.1111/j.1365-2753.2009.01246.x.
Lai, R., D. Elliott, and H. Ouellette-Kuntz. 2006. Attitudes of research ethics committee members toward individuals with intellectual disabilities: The need for more research. Journal of Policy and Practice in Intellectual Disabilities 3 (2): 114–118. https://doi.org/10.1111/j.1741-1130.2006.00062.x.
Lakeman, R., and M. Fitzgerald. 2009. The ethics of suicide research. Crisis 30 (1): 13.
Lenk, C., K. Radenbach, M. Dahl, and C. Wiesemann. 2004. Non-therapeutic research with minors: How do chairpersons of German research ethics committees decide? Journal of Medical Ethics 30 (1): 85–87. https://doi.org/10.1136/jme.2003.005900.
Lothen-Kline, C., D.E. Howard, E.K. Hamburger, K.D. Worrell, and B.O. Boekeloo. 2003. Truth and consequences: Ethics, confidentiality, and disclosure in adolescent longitudinal prevention research. The Journal of Adolescent Health: Official Publication of the Society for Adolescent Medicine 33 (5): 385–394. https://doi.org/10.1016/S1054-139X(03)00184-8.
Ma, L., E. Phelps, J.V. Lerner, and R.M. Lerner. 2009. Longitudinal research in school bullying: Adolescents who bully and who are bullied. In Research with high-risk populations: Balancing science, ethics, and law, ed. D.R. Buchanan, C.B. Fisher, and L. Gable, 93–108. Washington, DC, US: American Psychological Association.
Macintyre, M. 2014. Problems with ethics committees. The Australian Journal of Anthropology 25 (3): 381–383. https://doi.org/10.1111/taja.12109_4.
Mansbach, J., U. Acholonu, S. Clark, and C.A. Camargo. 2007. Variation in institutional review board responses to a standard, observational, pediatric research protocol. Academic Emergency Medicine 14 (4): 377–380. https://doi.org/10.1197/j.aem.2006.11.031.
McGuire, A.L., and W. Burke. 2008. An unwelcome side effect of direct-to-consumer personal genome testing: Raiding the medical commons. The Journal of the American Medical Association 300 (22): 2669–2671. https://doi.org/10.1001/jama.2008.803.
McGuire, A.L., and J.R. Lupinski. 2010. Personal genome research: what should the participant be told? Trends in Genetics: TIG 26 (5): 199–201. https://doi.org/10.1016/j.tig.2009.12.007.
McNeill, P. 1997. Paying people to participate in research: Why not? Bioethics 11 (5): 390–390. https://doi.org/10.1111/1467-8519.00079.
McWilliams, R., J. Hoover-Fong, A. Hamosh, S. Beck, T. Beaty, and G. Cutting. 2003. Problematic variation in local institutional review of a multicenter genetic epidemiology study. The Journal of the American Medical Association 290 (3): 360–366. https://doi.org/10.1001/jama.290.3.360.
Moolchan, E.T., and R. Mermelstein. 2002. Research on tobacco use among teenagers: ethical challenges. The Journal of Adolescent Health: Official Publication of the Society for Adolescent Medicine 30 (6): 409–417.
Mooney-Somers, J., and A. Olsen. 2016. Ethical review and qualitative research competence: Guidance for reviewers and applicants. Research Ethics. https://doi.org/10.1177/1747016116677636.
National Health and Medical Research Council (2007a). Australian code for the responsible conduct of research. Canberra. Retrieved from: https://www.nhmrc.gov.au/guidelines-publications/r39
National Health and Medical Research Centre, Australian Research Council. (2007b). National Statement on Ethical Conduct in Human Research. Available at https://www.nhmrc.gov.au.
Newcombe, J.P., and I.H. Kerridge. 2007. Assessment by human research ethics committees of potential conflicts of interest arising from pharmaceutical sponsorship of clinical research. Internal Medicine Journal 37 (1): 12–17. https://doi.org/10.1111/j.1445-5994.2006.01234.x.
Pieper, I., and C.J. Thomson. 2011. Contextualising merit and integrity within human research. Monash Bioethics Review 29 (4): 15–21. https://doi.org/10.1007/BF03351329.
Rabkin, J. & Small, E. (2001). Rights and responsibilities of research participants. Body Positive. Available at: http://www.thebody.com/content/art31134.html
Resnik, D.B., and E. Ness. 2012. Participants’ responsibilities in clinical research. Journal of Medical Ethics 38 (12): 746. https://doi.org/10.1136/medethics-2011-100319.
Richardson, S., and M. McMullan. 2007. Research ethics in the UK: What can sociology learn from health? Sociology 41 (6): 1115–1132. https://doi.org/10.1177/0038038507082318.
Ritter, A.J., C.L. Fry, and A. Swan. 2003. The ethics of reimbursing injecting drug users for public health research interviews: What price are we prepared to pay? International Journal of Drug Policy 14 (1): 1–3. https://doi.org/10.1016/S0955-3959(02)00094-4.
Shah, S., A. Whittle, B. Wilfond, G. Gensler, and D. Wendler. 2004. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA 291 (4): 476–482. https://doi.org/10.1001/jama.291.4.476.
Singer, M., G. Mirhej, D. Hodge, H. Saleheen, C.B. Fisher, and M. Mahadevan. 2008. Ethical issues in research with Hispanic drug users: Participant perspectives on risks and benefits. Journal of Drug Issues 38 (1): 351–372.
Smith, L.J. 2008. How ethical is ethical research? Recruiting marginalized, vulnerable groups into health services research. Journal of Advanced Nursing 62: 248–257. https://doi.org/10.1111/j.1365-2648.2007.04567.x.
Smith, R. 2006. Research misconduct: The poisoning of the well. Journal of the Royal Society of Medicine 99 (5): 232–237. https://doi.org/10.1258/jrsm.99.5.232.
Stanford University, Department of Psychology. (2011). Paid participants' rights and responsibilities. Retrieved from https://psychology.stanford.edu/paidparticipantrights
Stein, C.M., and W.A. Ray. 2010. The ethics of placebo in studies with fracture end points in osteoporosis. The New England Journal of Medicine 363 (14): 1367–1370. https://doi.org/10.1056/NEJMsb1006120.
Thomas, E., and J.K. Magilvy. 2011. Qualitative rigor or research validity in qualitative research. Journal for Specialists in Pediatric Nursing 16 (2): 151–155. https://doi.org/10.1111/j.1744-6155.2011.00283.x.
Toumbourou, J.W., T. Evans-Whipp, J. Clements, B.J. McMorris, M. Mathers, and R.F. Catalano. 2004. Ethical guidelines for the payment of research participants should be clarified: Reflections from cross-national research. Australian and New Zealand Journal of Public Health 28 (6): 584–585. https://doi.org/10.1111/j.1467-842X.2004.tb00052.x.
University of Texas. (2011). Subject responsibilities. Retrieved 28th March, 2014, from http://www.utexas.edu/research/rsc/humansubjects/participants/subject_responsibilities.html
Van Der Weyden, M.B. 2006. Preventing and processing research misconduct: A new Australian code for responsible research. The Medical Journal of Australia 184 (9): 430.
Van Essen, G.L., D.A. Story, S.J. Poustie, M.M.J. Griffiths, and C.L. Marwood. 2004. Natural justice and human research ethics committees: An Australia-wide survey. The Medical Journal of Australia 180 (2): 63–66.
Vanlommel, K., J. Vanhoof, and P. van Petegem. 2016. Data use by teachers: The impact of motivation, decision-making style, supportive relationships and reflective capacity. Educational Studies 42 (1): 36–53.
Van Luijn, H.E.M., A.W. Musschenga, R.B. Keus, W.M. Robinson, and N.K. Aaronson. 2002. Assessment of the risk/benefit ratio of phase II cancer clinical trials by Institutional Review Board (IRB) members. Annals of Oncology: Official Journal of the European Society for Medical Oncology / ESMO 13 (8): 1307–1313. https://doi.org/10.1093/annonc/mdf209.
Van Luijn, H.E.M., N.K. Aaronson, R.B. Keus, and A.W. Musschenga. 2006. The evaluation of the risks and benefits of phase II cancer clinical trials by institutional review board (IRB) members: a case study. Journal of Medical Ethics 32 (3): 170–176.
Viens, A.M. 2001. Socio-economic status and inducement to participate. American Journal of Bioethics 1 (2): 1–2f. https://doi.org/10.1162/152651601300169202.
Wendler, D. 1996. Deception in medical and behavioral research: Is it ever acceptable? The Milbank Quarterly 74 (1): 87–114.
Wendler, D., and C. Grady. 2008. What should research participants understand to understand they are participants in research? Bioethics 22 (4): 203–208. https://doi.org/10.1111/j.1467-8519.2008.00632.x.
White, V.M., H. Bibby, M. Green, A. Anazodo, W. Nicholls, R. Pinkerton, M. Phillips, R. Harrup, M. Osborn, L.M. Orme, R. Conyers, K. Thompson, and M. Coory. 2016. Inconsistencies and time delays in site-specific research approvals hinder collaborative clinical research in Australia. Internal Medicine Journal 46 (9): 1023–1029. https://doi.org/10.1111/imj.13191.
Wiggins, B.J. 2011. Confronting the dilemma of mixed methods. Journal of Theoretical and Philosophical Psychology 31 (1): 44–60. https://doi.org/10.1037/a0022612.
Wilkinson, M., and A. Moore. 1997. Inducement in research. Bioethics 11 (5): 373–373. https://doi.org/10.1111/1467-8519.00078.
Wolff-Michael, R. 2005. Ethics a social practice: Introducing the debate on qualitative research and ethics. Forum Qualitative Social Research 6 (1): 25–30.
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Handal, B., Campbell, C., Watson, K. et al. Human research ethics committees members: ethical review personal perceptions. Monash Bioeth. Rev. 39, 94–114 (2021). https://doi.org/10.1007/s40592-021-00130-8
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DOI: https://doi.org/10.1007/s40592-021-00130-8