BMJ 1997;314:1111 (12 April)

Education and debate

BMJ's present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct

Jeffrey S Tobias, clinical director a

a Directorate of Cancer Services, University College and Middlesex Hospitals, London W1N 8AA


right arrow   Introduction

Few if any issues engender such passionate–often acrimonious–disagreement among clinicians, ethicists, statisticians, and representatives of patient groups as does the continuing debate about informed consent and clinical research trials. In the blue corner: clinicians and biostatisticians keen to "move the field forward," so to speak, and answer as quickly as possible the research question currently under investigation. In the red corner ... just about everyone else. Anyone left in the centre? Only the hapless referee, in this case the somewhat perplexed journal, whose editorial board–constantly hectored from both sides–somehow has to give all parties a decent airing and ensure fair play.

Those arguing in favour of fully informed consent as an inviolable rule (except, perhaps, in very special circumstances) often point out the essential, non-negotiable nature of a patient's right to autonomy and self determination. Quite rightly they remind clinicians that patients now wish to participate . . . [Full text of this article]


right arrow   Concerns for patients' rights

right arrow   Practical difficulties with informed consent

right arrow   References

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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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  • Stenson, B J, Becher, J-C, McIntosh, N (2004). Neonatal research: the parental perspective. Arch. Dis. Child. Fetal Neonatal Ed. 89: F321-F324 [Abstract] [Full text]  
  • 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]  
  • Bauchner, H. (2002). Protecting Research Participants. Pediatrics 110: 402-404 [Full text]  
  • Truog, R. D., Robinson, W., Randolph, A., Morris, A. (1999). Is Informed Consent Always Necessary for Randomized, Controlled Trials?. NEJM 340: 804-807 [Full text]  
  • Doyal, L., Tobias, J S, Warnock, M., Power, L., Goodare, H. (1998). 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. BMJ 316: 1000-1005 [Full text]  
  • Pfeffer, N., Alderson, P., Campbell, H., Boyd, K. M, Surry, S. A M, Cullinan, T., Squire, S B, Hawley, R, Macfarlane, S, Agbaje, S, Beeching, N J, Wyatt, G B, Koning, K D., Gray, N, Hayward, C, Ali, A, Bianco, A E, Taylor, M, Brabin, B, Coulter, J B S, Daly, M d. B., Elbourne, D., Snowdon, C., Garcia, J., Epstein, K., Sloat, B., Mohanna, K., Woodcock, T., Norman, J., Sikorski, J., Watson, R., Wilson, P., House, A., Knapp, P., Williamson, C., Sutton, G. C, Garvican, L., Wilson, R., Malin, A., Lockwood, D., Mhlongo, S W P, Mdingi, G V, Ashcroft, R., Toth, B., Mant, J., Winner, S., Carter, J., Wade, D. T, Stott, D J, Langhorne, P, Rodgers, H, Rutter, D., Brewin, T., Barer, D. (1997). Informed consent. BMJ 315: 247-247 [Full text]  
  • Bratt, D. E, Soutter, P., Bland, M., Little, P., Williamson, I., Chanter, D. O, Stewart-Brown, S., Thornton, H., Holmes, W., Ana, J. N E, Morley, C., Paul, M., Hassiotis, A, Hulbert, M. F G, Counsell, C. E, Sandercock, P. A G, Wilmshurst, P., Baum, M., Montgomery, C., Lydon, A., Lloyd, K., Wiltshire, C., Frosh, A C, Hanif, J (1997). Informed consent in medical research. BMJ 314: 1477-1477 [Full text]  
  • Smith, R. (1997). Informed consent: the intricacies. BMJ 314: 1059-1059 [Full text]  



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