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BMJ No 7102 Volume 315 Letters Saturday 26 July 1997 Informed consentRespect for autonomy may conflict with principle of beneficenceEditor,The argument of Len Doyal(1) and Sheila McLean (in her commentary(2)), that respect for patients' autonomy demands that they should be informed about possible alternative treatments, should be applied not just to clinical trials but to any situation in which there is uncertainty about which treatment is best. As Martin Dennis and colleagues' trial evaluating the introduction of a stroke family care worker shows, any new treatment or care service, no matter how apparently benign, has the potential to do harm, yet many are introduced without formal evaluation.(2) For example, when coronary care units were introduced few people would have questioned their intrinsic benefits in promoting better monitoring and early treatment of complications, yet how many deaths may have been caused by overenthusiastic use of prophylactic antiarrhythmic drugs?(3) We therefore have a duty to evaluate rigorously not just new practices but many of those that have already come into widespread use. If uncertainty still exists about the value of coronary care units or about the patients most likely to benefit, should we respect the autonomy of patients with acute chest pain (regardless of age or other commonly applied eligibility criteria) by explaining all the potential advantages and disadvantages of specialised coronary care? Alternatively, should we conduct a randomised trial and explain to patients allocated to care in a general ward exactly what special facilities will not be made available to them? The bias in expectations introduced by such an approach would not only weaken the conclusions of the study, as Dennis points outs in his commentary,(2) but could lead to the wrong conclusions, possibly misleading clinicians for years to come. Rigid insistence on full disclosure risks undermining the confidence of patients that they are getting the best possible treatment. We know that this can have a substantial adverse effect, so respect for autonomy may thus conflict with the principle of beneficence. Why should one ethical principle take precedence over another, and why should different standards be applied to `normal' clinical practice and research? Could it be because the informed consent procedure is easier to audit, particularly in a clinical trial, and is therefore more susceptible to legal challenge? If we submit to such thinly veiled legalistic threats then not only will reliable scientific evaluation of health care services be impossible (as Dennis and colleagues have shown) but we will no longer be able to deal with the inevitable uncertainties of clinical practice in a way that protects patients from serious potential harm. David Barer
References 1 Doyal L. Informed consent in medical research. BMJ 1997;314:1107-11. (12 April.)
2 Dennis M, O'Rourke S, Slattery J, Staniforth T, Warlow C.
Evaluation of a stroke family care worker: results of a r 3 Cardiac Arrhythmia Suppression Trial (CAST) Investigators. Effect of encainide and flecainide on mortality in a randomised trial of arrhythmia suppression after myocardial infarction. N Engl J Med 1989;321:406-12.
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