Reassessing the Role of the Biomedical Research Ethics Committee
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The role of the Research Ethics Committee (REC) in the design, conduct and dissemination of scientific research is still evolving and many important questions remain unanswered. Hence, the aim of this paper is to address some of the uncertainty that exists around the role and responsibilities of RECs and to discuss some of the controversy that exists over the criteria that RECs should follow when evaluating a research proposal. The discussion is organised around five of the major roles currently performed by RECs when assessing proposals in the biomedical sciences. It will be shown that these five roles need to be critically evaluated and reassessed. The five roles addressed are: assessing the legitimacy and validity of the informed consent process, second, conducting a comprehensive risk/benefit analysis, third, assessing the validity of a research proposal, fourth, ensuring that researchers observe the social norms, values, customs, traditions and laws that prevail in the community or jurisdiction in which the research will be conducted and finally, monitoring the research project as it unfolds and providing an ongoing advisory and consultancy service to both new and experienced researchers. In reassessing the role of the REC, this paper concludes with a set of general recommendations for RECs. These provide some guidance on the minimum criteria that should be followed when RECs evaluate proposals. These guidelines will be beneficial for new and experienced members of REC, and will help to make the process a more objective, efficient and standardised process. The guidelines will also be beneficial for researchers in the biomedical sciences who are preparing proposals for ethical review.
KeywordsResearch ethics Research ethics committee Informed consent Quality assurance Social norms
- Appelbaum, P. (2002). Clarifying the ethics of clinical research: a path towards avoiding the therapeutic misconception. American Journal of Bioethics, 2, 22–23.Google Scholar
- Beauchamp, T., & Childress. (2009). Principles of biomedical ethics. Oxford: Oxford University Press.Google Scholar
- Beck, U. (1992). Risk society: Towards a new modernity. London: Sage.Google Scholar
- Council for International Organizations of Medical Sciences (CIOMS). (1991). International guidelines for ethical review of epidemiological studies. In Z. Bankowski, J. Bryant, & J. Last (Eds.), Ethics and epidemiology: International guidelines. Geneva: CIOMS.Google Scholar
- Council for International Organizations of Medical Sciences (CIOMS). (1993). International ethical guidelines for biomedical research involving human subjects. In Z. Bankowski & R. Levine (Eds.), Ethics and research of human subjects: International guidelines. Geneva: CIOMS.Google Scholar
- Department of Health (DH). (2005). Research Governance Framework. London: HMSO.Google Scholar
- European Forum of Good Clinical Practice. (2001) European Guidelines for Auditing Ethics Committees. (http://www.efgcp.org/index.asp).
- Feyerabend, P. (1975). Against method: Outline of an anarchistic theory of knowledge. Atlantic Highlands: Humanities Press.Google Scholar
- HFEA. (1990; 2008). Human Fertilisation and Embryology Act. (http://www.hfea.gov.uk)
- Hirtle, M., Lemmens, T., & Sprumont, D. (2000). A comparative analysis of research ethics review mechanisms and the ICH Good clinical practice guideline. European Journal of Health Law, 7, 265–292.Google Scholar
- International Committee of Medical Journal Editors (ICMJE). (2010). Uniform requirements for manuscripts submitted to biomedical journals. (http://www.icmje.org/urm_full.pdf).
- Loff, B., & Black, J. (2004). Research ethics committees: what is their contribution? Medical Journal of Australia, 181(8), 440–441.Google Scholar
- Nuffield Council on Bioethics (NCB). (1999). The ethics of clinical research in developing countries: a discussion paper. London.Google Scholar
- Nuffield Council on Bioethics (NCB). (2002). The ethics of research related to healthcare in developing countries. London.Google Scholar
- Pence, G. (2004). Classic cases in medical ethics (3rd ed.). New York: McGraw-Hill.Google Scholar
- Rothman, D., & Rothman, S. (1984). The Willowbrook Wars. New York: Harper & Row.Google Scholar
- Tinker, A., & Coomber, V. (2004). University research ethics committees: Their role, remit and conduct. London: King’s College London.Google Scholar
- UNESCO. (1997). Universal Declaration on the Human Genome and Human Rights. (www.unesco.org).
- UNESCO. (2005). Bioethics Committees at work: Policies and Procedures. UNESCO. (www.unesco.org).
- Whittaker, E. (2005). Adjudicating entitlements: the emerging discourses of research ethics boards. Health, 9(4), 513–535.Google Scholar
- World Medical Association. (WMA). (1964; 1975; 1983; 1989; 1996; 2000). Declaration of Helsinki. (http://www.wma.net/en/30publications/10policies/b3/index.html).