Members of a National Health Service, or other recognised Research Ethics Committee (REC), in deciding whether or not to withhold their assent for a clinical trial, must obey the law. If they do not do so, then they may become liable to pay personally negligence claims made by injured trials subjects. It could be no defence to say that members had consulted their own lower ethical standards; or merely that they had acted in good faith; or that they had followed (...) Department of Health (DH) guidelines, which do not have the force of law. The law requires that the rights, safety, and well-being of clinical trial subjects shall prevail over other interests. REC favourable opinion is a powerful endorsement of a trial, and prospective subjects are invited to rely upon it. REC members are legally bound to exercise their power to withhold assent to any clinical trial which does not give subjects the protection the law requires. (shrink)

The current rise in malpractice litigation has led to concern in the research community as to the prospect of litigation against researchers. Clearly as the responsibility for the day-to-day conduct of the research falls upon the researchers they will be potentially liable should there be negligence in the conduct of the research project itself. But to what extent can the research ethics committee and its members be held liable should harm result to the research subject? How far does the prospect (...) of the threat of litigation equate with the reality of the prospect of liability? Although the NHS research governance framework suggests that primary responsibility for the conduct of the trial is with the researcher this does not mean that REC members will be immune from actions in tort where research subjects suffer harm in the conduct of a research project approved by their NHS REC. This paper focuses upon the prospect for liability in the law of tort of NHS RECs and their members. While in practice the vast majority of such claims are unlikely to be successful members of RECs may incur resultant legal costs as a consequence of involvement in proposed litigation. It is submitted that the scope of indemnity provision provided to RECs and their members should be precisely determined, otherwise there is a real prospect that the risk of malpractice litigation may deter individuals from serving on such committees. (shrink)

This paper focuses on the REC and its political context to clarify the process of ethical review. The examples initially considered are taken from a Research Ethics Review editorial to develop the social explanation of the membership and function of a research ethics committee. It is suggested that the management and administration of medical matters are not always best understood solely in medical terms. The conclusion of the paper is that the larger political relationships determine the membership and function of (...) the research ethics committee. The REC is defined as the political mechanism for formally socializing medical research and its lay members as similarly socializing the REC. (shrink)

This paper seeks to clarify the process of ethical review primarily through a consideration of the lay member's role; it considers some of the conventional accounts of the role and portrays weaknesses in them. Its positive account places the ethical review service in a wide political context allowing the definition of lay member as a politically-positioned individual in the REC with the function of formally representing the public standards of morality in the medical research context.