Medical studies with 'no material ethical issues' - an unhelpful, confusing and potentially unethical suggestion

Abstract

Both the recent 'Warner' review of the UK research ethics committee (REC) system and the subsequent consultation document produced by the Central Office for Research Ethics Committees (COREC) emphasize the need to distinguish 'research' from what might be termed 'non-research'. This is to be determined through a process of filtering or 'triage', the intention being that RECs will avoid considering proposals with 'no material ethical issues'. In this paper we argue that trying to distinguish 'true' research from other projects is counterproductive, misleading and potentially unethical. Our case is built around three assertions: (1) the distinction between research and non-research is imprecise; (2) both medical research and non-research can generate similar ethical issues; and (3) projects should be judged according to what they involve, not how they are labelled.