Reassessing the Role of the Biomedical Research Ethics Committee
First Online: 07 October 2012 DOI:
10.1007/s10805-012-9171-6 Cite this article as: Ekberg, M. J Acad Ethics (2012) 10: 335. doi:10.1007/s10805-012-9171-6 Abstract
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.
Keywords Research ethics Research ethics committee Informed consent Quality assurance Social norms References
Allen, G. (2008). Getting beyond form filling: the role of institutional governance in human research ethics.
Journal of Academic Ethics, 6
Andanda, P. (2005). Module two: informed consent.
Developing World Bioethics, 5
Appelbaum, P. (2002). Clarifying the ethics of clinical research: a path towards avoiding the therapeutic misconception.
American Journal of Bioethics, 2, 22–23.
Beauchamp, T. (2011). Informed consent: its history, meaning and present challenges.
Cambridge Quarterly of Healthcare Ethics, 20
Beauchamp, T., & Childress. (2009).
Principles of biomedical ethics. Oxford: Oxford University Press.
Beck, U. (1992).
Risk society: Towards a new modernity. London: Sage.
Bentley, J., & Thacker, P. (2004). The influence of risk and monetary payment on the research participation decision making process.
Journal of Medical Ethics, 30
Cave, E., & Nichols, C. (2007). Clinical audit and reform of the UK research ethics review system.
Theoretical Medicine and Bioethics, 28
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.
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.
Cummins, D. (2002). The professional status of bioethics consultation.
Theoretical Medicine, 23
Curran, W. (1973). The Tuskegee syphilis study.
New England Journal of Medicine, 287
Department of Health (DH). (2001).
Governance arrangements for NHS Research Ethics Committees
. London: HMSO. (
Department of Health (DH). (2005).
Research Governance Framework. London: HMSO.
Edwards, S. (2005). Research participation and the right to withdraw.
Edwards, S., Ashcroft, R., & Kirchin, S. (2004a). Research ethics committees: differences and moral judgement.
Edwards, S., Kirchin, S., & Huxtable, R. (2004b). Research ethics committees and paternalism.
Journal of Medical Ethics, 30
European Forum of Good Clinical Practice. (2001)
European Guidelines for Auditing Ethics Committees.
Feyerabend, P. (1975).
Against method: Outline of an anarchistic theory of knowledge. Atlantic Highlands: Humanities Press.
HFEA. (1990; 2008). Human Fertilisation and Embryology Act. (
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.
International Committee of Medical Journal Editors (ICMJE). (2010). Uniform requirements for manuscripts submitted to biomedical journals. (
Jones, M., & Slater, B. (2003). The governance of human genetics: policy discourse and constructions of public trust.
New Genetics and Society, 22
Karunaratne, A., Myles, P., Ago, M., & Komesaroff, P. (2006). Communication deficiencies in research and monitoring by ethics committees.
Internal Medicine Journal, 36
Loff, B., & Black, J. (2004). Research ethics committees: what is their contribution?
Medical Journal of Australia, 181(8), 440–441.
Lowman, J., & Palys, T. (2000). Ethics and institutional conflicts of interest: the research controversy at Simon Fraser University.
Sociological Practice: A Journal of Clinical and Applied Sociology, 2
Macpherson, C. (1999). Research ethics committees: a regional approach.
Theoretical Medicine and Bioethics, 20
McDonald, M., & Cox, S. (2009). Moving towards evidence-based human participant protection.
Journal of Academic Ethics, 7
Montgomery, K., & Oliver, A. (2009). Shifts in guidelines for ethical scientific conduct: how public and private organisations create and change norms of research integrity.
Social Studies of Science, 39
Nuffield Council on Bioethics (NCB). (1999).
The ethics of clinical research in developing countries: a discussion paper. London.
Nuffield Council on Bioethics (NCB). (2002).
The ethics of research related to healthcare in developing countries. London.
Pence, G. (2004).
Classic cases in medical ethics (3rd ed.). New York: McGraw-Hill.
Petryna, A. (2007). Clinical trials offshored: on private sector science and public health.
Rothman, D., & Rothman, S. (1984).
The Willowbrook Wars. New York: Harper & Row.
Salter, B., & Salter, C. (2007). Bioethics in the global moral economy. The cultural politics of human embryonic stem cell science.
Science, Technology and Human Values, 32
Shaul, R. (2002). Reviewing the reviewers: the vague accountability of research ethics committees.
Critical Care, 6
Sutrop, M. (2011). Changing ethical frameworks: from individual rights to the common good?
Cambridge Quarterly of Healthcare Ethics, 20
Tinker, A., & Coomber, V. (2004).
University research ethics committees: Their role, remit and conduct. London: King’s College London.
UNESCO. (1997). Universal Declaration on the Human Genome and Human Rights. (
Bioethics Committees at work: Policies and Procedures.
van den Hoonaard, W. (2006). New angles and tangles in the ethics review of research.
Journal of Academic Ethics, 4
Wendler, D., & Grady, C. (2008). What should research participants understand to understand they are participants in research?
Whittaker, E. (2005). Adjudicating entitlements: the emerging discourses of research ethics boards.
Health, 9(4), 513–535.
World Medical Association. (WMA). (1964; 1975; 1983; 1989; 1996; 2000). Declaration of Helsinki. (
© Springer Science+Business Media Dordrecht 2012