Modern human research ethics draws on Hippocratic literature that directs doctors to use their knowledge and power to benefit the sick, heal and not harm, preserve life and maintain the confidentiality of the physician-patient relationship.
Modern human research ethics draws on Hippocratic literature that directs doctors to use their knowledge and power to benefit the sick, heal and not harm, preserve life and maintain the confidentiality of the physician-patient relationship.
After World War II it became clear that traditional medical ethics required revision to meet contemporary challenges. The primary focus was to protect human research subjects in the wake of the Nazi experiments conducted on prisoners (the Nuremberg Code [1] and the Declaration of Helsinki [2]). In the beginning, self-regulation was left to professional scientists’ discretion, but more recently, self-regulation has been replaced by external regulation through institutional governance protocols[3].
Australian Human Research Ethics Committees (HRECs) are guided by the principles of respect for autonomy, non-maleficence, beneficence and justice[4] as well as the guidelines outlined in the National Statement on Ethical Conduct in Human Research guidelines[5], in combination with legislative regulations and institutional protocols.
HRECs members combine these responsibilities and contribute their time, knowledge and experience, largely on a voluntary basis. Overall, the HREC system seems to work quite effectively, according to feedback from researchers.
Like other Universities, Curtin HREC reviews a diverse range of human research applications that involve a range of research fields such as anthropology, performing arts, marketing, ethnography, psychology, physical activity and epidemiology.
University HRECs are usually constituted as advisory committees with primary responsibilities to review, approve (or not) research involving human participants and to determine whether they are ethically acceptable in accordance with relevant standards and guidelines.
Governance
Three different approaches have evolved for research governance: the technocratic style, which focusses primarily on risk and risk assessment; ethical and scientific review to promote research integrity; and community participation in HREC deliberations to demonstrate public accountability[6,7].
These themes arose from community pressure for research, and science in general, to be more overtly regulated, to incorporate risk assessment for participants and researchers and to recognise the role of public opinion in framing the research agenda.
Research governance involves multiple processes, including review of local, reciprocal and multi-institutional human research ethics applications (HREA); risk assessment; project monitoring; waiver of consent processes; material transfer agreements and budgetary review.
Research projects conducted across institutions are best managed by reciprocal agreements between HRECs that minimise duplication of application and review activities. In our experience at Curtin University, the average processing time from submission to approval for Low Risk applications is 20 days and 50 days for Non-Low Risk applications. In a recent study, the average total time that ethics applications spent in review in New South Wales was 77 days[8].
Further harmonisation of HREC processes occurs through meetings of University Ethics Officers and HREC Chairs to strengthen communications and provide training for HREC members. In addition, Curtin University hosts an annual public lecture to promote awareness of human research ethics.
Accountability
Almost all institutions require formal peer review by an external agency (e.g. NHMRC) or alternatively, by internal specialist advisory committees to complement ethics review. Many institutions have deployed online management systems to facilitate application processes and link to reporting and review of research progress. Annual and final reporting of research outcomes is mandatory and forms one of the requirements for institutional certification by NHMRC.
During 2016-17, Curtin HREC approved approximately 7% of applications without amendment, 83% with minor amendments, 10% with major amendments and 2% submissions were not approved; no major problems have arisen from any of the research studies approved during this period.
Ethical review and monitoring aims to promote good ethical practice and reduce adverse outcomes. Frequently, the HREC will require researchers to compile an adverse event protocol before approval is granted. All HRECs attempt to guide researchers in the protection of participants’ welfare and privacy, with particular attention given to vulnerable groups (minors, elderly and cognitively or physically impaired).
However, despite all the governance protocols, reviews, monitoring and research integrity guidelines, human research approvals still rely on risk minimisation and therefore individual researchers are responsibile for a degree of self-regulation.
If we all start from the point of view that “a good scientific question is based on sound ethics” then the potential risks will be reduced and transparency and accountability will be enhanced.
References
- Shuster, E., Fifty Years Later: The Significance of the Nuremberg Code. N Engl J Med, 1997. 337: p. 1436-40.
- World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects. JAMA, 2013. 10(20): p. 2191-4.
- OECD, Guidelines on the Protection of Privacy and Transborder Flows of Personal Data: Explanatory Memorandum, OECD, Paris http://www.oecd.org/document/18/0,3343,en_2649_34255_1815186_1_1_1_1,00.html. 1980 (Accessed May 2017).
- Beauchamp, T.L., Childress JF, Principles of Biomedical Ethics 2013 (Seventh Edition): Oxford University Press.
- NHMRC, National Statement on Ethical Conduct in Human Research (Updated May 2015). www.nhmrc.gov.au/guidelines/publications/e72 (accessed May 2017).
- Landeweerd, L., Townend D, Mesman J, Van Hoyweghen I, Reflections on different governance styles in regulating science: a contribution to ‘Responsible Research and Innovation’. Life Sci Soc Policy, 2015. 11(8).
- NHMRC, Statement on Consumer and Community involvement in Health and Medical Research, National Health and Medical Research Council (2016), Consumers Health Forum of Australia. September 2016. . www.nhmrc.gov.au/guidelines/publications/s01 (accessed June 2017).
- Hunter, D., Is research ethics regulation really killing people? Med J Aust, 2015. 202(6): p. 338-9.
By Dr Peter O’Leary, Chair Human Research Ethics Committee, Curtin University