Education and debate

Informed consent in medical research: Journals should not publish research to which patients have not given fully informed consent–with three exceptions

^a St Bartholomew's and The Royal London School of Medicine and Dentistry, Queen Mary and Westfield College, University of London, London E1 2AD

Is the demand for informed consent absolute? In the first of this pair of articles a professor of medical ethics argues that the principle of informed consent to participate in medical research is fundamental if patients are competent volunteers. Consent is not needed when patients are incompetent to give it (young children, unconscious patients, etc); when research uses only medical records; and when stored human tissue is used. Before publishing the results of such research, however, journals must ensure that certain minimal conditions are complied with. In the second article an oncologist argues that journals should be free sometimes to publish research in which patients have not given fully informed consent. He points to the practical difficulties of obtaining fully informed consent from all patients and, because of this, poor recruitment into trials. He suggests that a helpful approach would be to obtain "blanket" approval at the outset of treatment for inclusion in studies that might be in progress during the patient's illness–accepting that the doctor would always act in good faith and be prepared to explain treatments at any time.

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Relevant Article

Informed consent in medical research

David E Bratt, Pat Soutter, Martin Bland, Paul Little, Ian Williamson, Dennis O Chanter, Sarah Stewart-Brown, Hazel Thornton, Wendy Holmes, Joseph N E Ana, Colin Morley, Moli Paul, A Hassiotis, Mark F G Hulbert, Carl E Counsell, Peter A G Sandercock, Peter Wilmshurst, Michael Baum, Charles Montgomery, Anna Lydon, Keith Lloyd, Christopher Wiltshire, A C Frosh, and J Hanif
BMJ 1997 314: 1477. [Extract] [Full Text]

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Rapid Responses:

Read all Rapid Responses

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