BMJ 1998;316:1000-1005 ( 28 March )

Education and debate

Ethical debate
    Informed consent in medical research
    Informed consent---a response to recent correspondence
    Changing the BMJ's position on informed consent would be counterproductive
    Informed consent---a publisher's duty
    Trial subjects must be fully involved in design and approval of trials
    Studies that do not have informed consent from participants should not be published

Informed consent in medical research

The first 150 words of the full text of this article appear below.

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


Editorial by Smith and Personal views pp 1026-7

Len Doyal, professor of medical ethics

St Bartholomew's and The Royal London Hospital School of Medicine and Dentistry, London E1 2AD

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.1-4 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.

Table Removed (Available Only in the Full Text)

Many correspondents either explicitly or implicitly endorse the hard line that I take in my paper . . . [Full text of this article]


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Relevant Articles

Informed consent
Michael Baum, I G Kestin, S E Josse, David H Brewster, Marion R S Bain, James W T Chalmers, Ann Gould, John A Dewar, W David George, John Nottingham, Andrew J Winter, David Mullis, Keith W Radcliffe, D T Wilcox, F Wilcock, L Spitz, and A Pierro
BMJ 1998 317: 947. [Extract] [Full Text]

Mistakes
George Dunea
BMJ 1998 316: 1026. [Full Text] [PDF]

Informed consent: edging forwards (and backwards)
Richard Smith
BMJ 1998 316: 949-951. [Extract] [Full Text] [PDF]

This article has been cited by other articles:

  • Rogers, W A, Draper, H (2003). Confidentiality and the ethics of medical ethics. J. Med. Ethics 29: 220-224 [Abstract] [Full text]  
  • Boter, H., van Delden, J. J M, de Haan, R. J, Rinkel, G. J E (2003). Modified informed consent procedure: consent to postponed information. BMJ 327: 284-285 [Full text]  
  • Rees, E., Hardy, J. (2003). Novel consent process for research in dying patients unable to give consent. BMJ 327: 198- [Abstract] [Full text]  
  • Lawlor, D. A, Stone, T. (2001). Public health and data protection: an inevitable collision or potential for a meeting of minds?. Int J Epidemiol 30: 1221-1225 [Full text]  
  • Bellin, E., Dubler, N. N. (2001). The Quality Improvement-Research Divide and the Need for External Oversight. AJPH 91: 1512-1517 [Abstract] [Full text]  
  • Jackson, E. (2000). Abortion, Autonomy and Prenatal Diagnosis. Social Legal Studies 9: 467-494 [Abstract]  
  • Strobl, J., Cave, E., Walley, T. (2000). Data protection legislation: interpretation and barriers to research. BMJ 321: 890-892 [Full text]  
  • Clement, S. (1999). Full information about trials might be given retrospectively to participants. BMJ 318: 736a-736 [Full text]  
  • Baum, M., Kestin, I G, Josse, S E, Brewster, D. H, Bain, M. R S, Chalmers, J. W T, Gould, A., Dewar, J. A, George, W D., Nottingham, J., Winter, A. J, Mullis, D., Radcliffe, K. W, Wilcox, D T, Wilcock, F, Spitz, L, Pierro, A (1998). Informed consent. BMJ 317: 947a-947 [Full text]  

Rapid Responses:

Read all Rapid Responses

Informed Consent - The Role of Research Ethics Committees
Terence W Wiseman
bmj.com, 14 Sep 1998 [Full text]
Informed consent, neonatal research and audiotaping of conversations.
T H H G Koh
bmj.com, 30 Oct 1998 [Full text]
Re: Informed consent, neonatal research and audiotaping of conversations.
Brian Morgan
bmj.com, 2 Nov 1998 [Full text]
Implications of Dutch law on clinical trials in Intensive Care medicine
Jozef Kesecioglu, et al.
bmj.com, 11 Jul 2004 [Full text]



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