Education And Debate Ethical debate

Informed consent in medical researchInformed consent—a response to recent correspondenceChanging the BMJ's position on informed consent would be counterproductiveInformed consent—a publisher's dutyTrial subjects must be fully involved in design and approval of trialsStudies that do not have informed consent from participants should not be published

BMJ 1998; 316 doi: http://dx.doi.org/10.1136/bmj.316.7136.1000 (Published 28 March 1998) Cite this as: BMJ 1998;316:1000

Informed consent in medical research

In the issue of 12 April 1997 the BMJ invited comment on the acceptable limits of informed consent in medical studies. In view of the large correspondence this generated, we invited the two original commentators, Len Doyal and Jeffrey Tobias, to revisit the subject. We also invited comments from three people who are not doctors, researchers, or medical ethicists: two of them represent the views of patients and potential patients

Informed consent—a response to recent correspondence

  1. Len Doyal, professor of medical ethics
  1. St Bartholomew's and The Royal London Hospital School of Medicine and Dentistry, London E1 2AD
  2. Meyerstein Institute of Oncology, Middlesex Hospital, London W1N 8AA
  3. Great Bedwyn, Marlborough SN8 3PE
  4. Terrence Higgins Trust, London WC1X 8JU
  5. Horsham, West Sussex RH13 6DF

    Editorial by Smith and Personal views pp 1026-7

    The publication of the debate between myself and Jeffrey Tobias about the acceptable limits of informed consent in medical research has generated an immense and varied number of letters to the BMJ.14 This in itself is gratifying, whether or not correspondents agree with my arguments. It provides ample evidence of widespread and serious deliberation about the moral boundaries of the rights of participants in research.

    Previous articles and comment on informed consent are available on our website (see Collections)

    Many correspondents either explicitly or implicitly endorse the hard line that I take in my paper on the right of competent people to an acceptable level of information before agreeing to participate in medical research. Other contributions confirm my emphasis on the moral importance of the principle of informed consent but, in light of the highly specific circumstances where I argue that the principle must be qualified, question the degree or clarity of my own commitment to it. What is important here is our shared belief in the moral imperative of respecting human autonomy in almost all circumstances.

    I still disagree with those authors who argue that it is not necessary to obtain informed consent if this will lead to the methodological compromise, or possible cancellation, of potentially beneficial studies involving clinical interventions that carry minimal risks. What these …

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