Recent policy in relation to clinical research proposals in the UK has distinguished between two types of review: scientific and ethical. This distinction has been formally enshrined in the recent changes to research ethics committee (REC) structure and operating procedures, introduced as the UK response to the EU Directive on clinical trials. Recent reviews and recommendations have confirmed the place of the distinction and the separate review processes. However, serious reservations can be mounted about the science/ethics distinction and the policy of separate review that has been built upon it. We argue here that, first, the science/ethics distinction is incoherent, and, second, that RECs should not only be permitted to consider a study’s science, but that they have anobligation do so.
- Science/ethics distinction
- research ethics committees
- review of proposals
- obligations of research ethics committees
- harms and benefits
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Competing interests: We declare that the answer to the questions on the BMJ competing interest form [http://bmj.com/cgi/content/full/317/7154/291/DC1] are all no and therefore have nothing to declare except for the following: Angus Dawson is a lay member of the Shropshire Local Research Ethics Committee and Steve Yentis is Chairman of the Riverside Research Ethics Committee. The views expressed in this article do not represent the views of either committee. Angus Dawson has been involved in training the members of research ethics committees and individuals with responsibility for research ethics and research governance in higher education as part of his employment at Keele University.
Ethical approval: not required.