In this article, the author contends that the current indemnity provided to REC members is unfair and is so badly drafted that it cannot be described as an indemnity at all. He contends that the Appointing Authorities should give guidance to clarify the scope of the indemnity or replace it. The author discusses potential legal claims by REC members against their Appointing Authority if this is not provided. The legal liability of REC members for negligence and other claims is also (...) discussed. The author provides a solution in a simpler form of indemnity framed by reference to actual claims that can be made against a REC member. (shrink)

Members of a National Health Service, or other recognised Research Ethics Committee, 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 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)