Standards for research ethics committees: purpose, problems and the possibilities of other approaches.
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.
Davies
H
H
H Davies, National Research Ethics Service, 4-8 Maple Street, London W1T 5HD, UK. Hugh.davies@nres.npsa.nhs.uk
Wells
F
F
Czarkowski
M
M
D002985:Clinical Protocols / Q000592:standards*; D026724:Ethical Review / Q000592:standards*; D028744:Ethics Committees, Research / Q000592:standards* / Q000639:trends; D005062:European Union; D006801:Humans; D011044:Poland