Hannah Davies

In 1798 Dr Edward Jenner published his famous account of “vaccination”. Some claim that a Research Ethics Committee, had it existed in the 1790s, might have rejected his work. I provide the historical context of his work and argue that it addressed a major risk to the health of the community, and, given the devastating nature of smallpox and the significant risk of variolation, the only alternative preventative measure, Jenner’s study had purpose, justification and a base in the practice of the day

Criticism of ethical review of research continues and research ethics committees (RECs) need to demonstrate that they are “fit for purpose” by meeting acknowledged standards of process, debate and outcome. This paper reports a workshop in Warsaw in April 2008, organised by the European Forum for Good Clinical Practice, on the problems of setting standards for RECs in the European Union. Representatives from 27 countries were invited; 16 were represented. Problems identified were the limited and variable resources, difficulties of setting standards for ethical debate and its outcomes and that REC members, as volunteers, may resent the imposition of standards. Other ways to set standards were discussed, including analysis of current multicentre review, collecting REC member reports for review, learning from appeals and feedback from applicants, and use of other regional and national meetings. The place of a central, national board or ethics committee was debated as was the need for collaborating with partners in other fields

Research ethics committees in the UK are under criticism for inconsistency in both process and opinion. As chairmen of a multicentre REC and a local REC, we felt that one possible reason was the lack of convenient, up to date guidance for chairmen, administrators, and members.We recognised that there is no shortage of material for REC members to read but it is time consuming to access and difficult to apply to questions raised by review of research projects. International bodies have produced guidance; political organisations and governments have laid down …