Contesting the science/ethics distinction in the review of clinical research.
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 an obligation do so.
Dawson
Angus J
AJ
Centre for Professional Ethics, Keele Hall, Keele University, Staffs, ST5 5BG. UK. a.j.dawson@keele.ac.uk
Yentis
Steve M
SM
D001690:Biological Science Disciplines / Q000941:ethics; D035843:Biomedical Research / Q000941:ethics*; D026724:Ethical Review; D006801:Humans; D010380:Peer Review / Q000941:ethics*; D012107:Research Design; D006113:United Kingdom