Editor's Choice | This Week in BMJ | Press releases
BMJ No 7102 Volume 315 Letters Saturday 26 July 1997 Informed consentLack of respect for patients in medical research may reflect wider disrespect in clinical practiceEditor,I do not think that the BMJ should continue to publish papers that do not include informed consent.(1) Martin Dennis and colleagues, who studied the effect of contact with a stroke family care worker, did not ask patients to consent to randomisation.(1) As Sheila McLean points out in her commentary on Dennis and colleagues' study, none of the considerations that the authors faced were unique.(1) I suggest that they are in fact faced by many trialists. Certainly none of them were of such importance as to override fundamental ethical principles. In Dennis and colleagues' study it would have been possible, by using multivariate analysis, to determine whether initial preference (assessed, for example, by a question posed before randomisation) had a significant impact on satisfaction or other variables. This is an approach that colleagues and I used in a randomised controlled trial.(2) I sympathise with the desire to remove as much bias as possible, but we would do well to heed the philosopher Xenophanes (6th century bc), who said: 'Through seeking we may learn and know things better, but as for certain truth no man hath known it, for all is but a woven web of guesses.' The situation faced by Satish Bhagwanjee and colleagues was certainly more complex.(3) Nevertheless, Len Doyal rightly suggests that 'assent' from relatives of incompetent patients should be sought.(4) Bhagwanjee and colleagues' concern to maintain confidentiality posthumously might have been satisfied by their making clear to the assenting relatives that the result would be destroyed and not disclosed to them if the patient died. I wonder whether a lack of respect for patients in medical research reflects a wider, subtle, disrespect in clinical practice: how many general practitioners, midwives, or obstetricians, for example, can honestly say that they seek the informed consent of all women for antenatal screening for syphilis? The draft revision of the Hippocratic oath recently circulated by the BMA states: 'I will ensure patients receive the information and support they want to make decisions about disease prevention and improvement of their health.'(5) Our duty as medical researchers is clear. Jim Sikorski
Department of General Practice,
References 1 Dennis M, O'Rourke S, Slattery J, Staniforth T, Warlow C. Evaluation of a stroke family care worker: results of a randomised controlled trial. [With commentaries by S McLean and M Dennis.] BMJ 1997;314:1071-7. (12 April.) 2 Clement S, Sikorski J, Wilson J, Das S, Smeeton N. Women's satisfaction with traditional and reduced antenatal visit schedules. Midwifery 1996;12:120-8. 3 Bhagwanjee S, Muckert D J J, Jeena P M, Moodley P. Does HIV status influence the outcome of patients admitted to a surgical intensive care unit? A prospective, double blind study. [With commentaries by R Kale, S Bhagwanjee et al, and Y K Seedat.] BMJ 1997; 314:1077-84. (12 April.) 4 Doyal L. Journals should not publish research to which patients have not given fully informed consent-with three exceptions. BMJ 1997;314:1107-11. (12 April.) 5 BMA. Draft revision of the Hippocratic oath. BMA annual report of council 1996-97. London: BMA, 1997.
Home | Current issue | Past issues | Classified ads | Career Focus | Feedback Collections | About this site | About the BMJ | BMA | Medline
|