In this brief paper I intend to make some distinctions between the activities that research ethics committees are required to undertake as part of their role in protecting research participants. These functions are, identifying ethical issues and risks within research projects, providing advice on how to resolve these issues and risks without compromising the validity of the research and finally, when this cannot be achieved, deciding whether the research should still be allowed to go ahead. Distinguishing these distinct functions allows us to determine what an appropriate membership of a Research Ethics Committee is. I will sketch out the implications of these functions for the appropriate membership of NHS and university based ethics committees in the UK.
References
1.
There is some controversy about which of these if either is more fundamental. For further discussion see EdwardsSKirchinSHuxtableR. Research ethics committees and paternalism. J Med Ethics2004; 30:88–91 & Garrard E, Dawson A. What is the role of the research ethics committee? Paternalism, inducements and harm in research ethics. J Med Ethics 2005; 31:419–423.
For example students if a university based REC, patients if an NHS committee.
5.
A lay member in this context refers to someone who has no organizational affiliation with the relevant group. So in the case of universities, someone who is not employed by the university may be a lay member, and in the case of the NHS RECs someone who is not employed by the NHS.
6.
While this risks the ethics committee making scientific comment rather than ethical comment, this is rightfully an ethical issue, since it affects whether a project is ethically permissible or not. For further discussion of the science/ethics distinction see: Dawson A, Yentis S. Contesting the Science/Ethics Distinction in the Review of Clinical Research. Journal of Medical Ethics, accepted for publication.
7.
Interestingly this is required by the Economic and Social Research Council (ESRC) guidelines for social science research funded by the ESRC but not by the NHS standard operating procedures for research ethics committees. Economic and Social Research Council. ESRC Research Ethics Framework, op cit & Standard Operating Procedures for Research Ethics Committees, Central Office for Research Ethics Committees; version 3.0, June 2005. http://www.corec.org.uk/recs/guidance/docs/SOPs.doc#Section2 (Accessed 03/05/06).
8.
Implementing the recommendations of the Report of the Ad Hoc Advisory Group on the Operation of NHS Research Ethics Committees: a consultation. Central Office for Research Ethics Committees, January 2006. http://www.corec.org.uk/consultation/ImplementationPlanConsultation.pdf (Accessed 03/05/2006).
9.
This is discussed in detail in HunterD. Proportional ethical review and the identification of ethical issues. Journal of Medical Ethics, accepted for publication.
10.
The set up of University Research Ethics Committees is discussed in Hunter D. An alternative university-wide model for the ethical review of human subject research. Res Ethics Rev2006; 2(2): 47–50.
11.
About two thirds according to TinkerACoomberV. University research ethics committees: Their role, remit and conduct. London: King's College London & the Nuffield Foundation; September2004. http://www.kcl.ac.uk/depsta/ppro/reports/URECreport.pdf (Accessed 03/05/06).
12.
Whilst a set of guidelines like COREC's Standard Operating Procedures goes some way to deal there is a presupposition that members of the committee are familiar with this guidance. COREC, Standard Operating Procedures for Research Ethics Committees, 2005. Op cit.
