Should research ethics triumph over clinical ethics?

Abstract

Evidence-based medicine (EBM) and its main strategy, randomized clinical trials, have had less impact on medical practice than might be expected. Of the various reasons that make practitioners wary of applying research results, this paper explores some consequences of scientists' and research sponsors' adamant insistence that reliable science can only be achieved if protocols adhere exclusively to the ethics of investigation basically reduced to obtaining informed consent and avoiding risks as far as possible. This means, and has been explicitly contended, that neither patients nor doctors should fall prey to the therapeutic fallacy which leads them to expect that research will also take care of patient-subjects' medical welfare. Doctors would betray their profession if they allowed clinical research to disregard their therapeutic obligations in favour of strict scientific methodology, as is bound to happen when using placebos in spite of existing therapy, disregarding equipoise, disallowing benefit claims, emphasizing the distinction between research ethics and clinical ethics but denying any difference between therapeutic and non-therapeutic trials. That scientists and practitioners should not agree on needs and priorities in the medical context, constitutes an additional factor in the less than optimal reception of EBM by the health care professions.