Reforming research ethics committees (Editorial)
For the first 25 years of their existence in the United Kingdom research ethics committees were left more or less in peace by the Department of Health. Since the publication of the "red book" in 1991, 1 however, they have undergone a continual process of radical change, from the introduction of multicentre research ethics committees in 1997, through research governance, to various legislative reforms of research practice including the clinical trials regulations of 2004. 2–4 Ethical review has been extended to more and more kinds and locations of research. At the same time, ethics committees have been subject to continuous criticism from researchers and public and private sector sponsors of research. Criticism from patients and the public has been less audible. Some of the criticism of research ethics committees has focused on issues for which they can bear no responsibility, such as the interpretation of the Data Protection Act 1998 or the operation of trusts' research governance procedures. Ethics committees have been the lightning rod for the frustration researchers have felt about the bureaucratisation of research. Yet much of this frustration is reasonably directed at ethics committees. They can be slow, idiosyncratic, and poorly informed about research methods or guidelines on the ethics of research. And researchers can reasonably feel that many of the reforms since 1991, while intended to simplify ethics review of research, have actually made matters worse. This criticism appears to be common across Europe, with wide variations in approval times and required amendments being reported by many researchers. 56 Late last year Lord Warner, then a junior health minister, commissioned an ad hoc advisory group to review the operation of NHS research ethics committees in the health and social care sector. The group's findings were published in June. 7 The group's principal conclusions are that independent ethical review of research is important but that it needs to be efficient and timely and to concentrate on ...