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BMJ No 7102 Volume 315 Letters Saturday 26 July 1997 Informed consentThe central problem is often poor design and conduct of trialsEditor,We are concerned about some aspects of the recent articles on consent.(1, 2) Len Doyal claims that informed consent may not be necessary for three most vulnerable groups: young children, patients with learning difficulties, and unconscious or semiconscious patients. Yet young children (unlike all adult groups) have the protection of their parents' consent, and this should always be respected.(3) The other two groups show the limitations of applying Kantian respect for autonomy, designed for property owning 18th century gentlemen, to vulnerable dependent patients. There is an urgent need to agree new ways of making research decisions with and for these minority groups.
As is usual in arguments against seeking informed consent, there is a tendency to concentrate on dramatic extremes: patients with severe mental impairment and patients receiving heroic cancer treatment. The development of principles from extremes is dangerous and should be discouraged. Difficulties with relatively small groups should not be used to excuse researchers from requesting the consent of the vast majority of the millions of people every year who help with research into mundane pharmaceutical trials of treatments of arthritis or everyday misery. A deeper problem with the articles is the assumption that consent is the central problem in research. We suggest that, more often, the central problem is the poor design and conduct of trials which alienate or distress people on whose practical support researchers depend. The solution here is not to tinker with consent but to clean up research. Health service users could help at every stage of clinical research: the selection of questions worth investigating; the design and conduct of trials, including the information materials; the interpretation and reporting of the evidence; dissemination; and working with practitioners to put findings into practice. Consumers for Ethics in Research has been working with health service users, researchers, and practitioners on these issues for the past eight years, partly through regular open meetings, during which many practical ideas have been advanced. Naomi Pfeffer
References 1 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.) 2 Tobias JS. BMJ's present policy (sometimes approving research in which patients have not given fully informed consent) is wholly correct. BMJ 1997;314:1111-4. (12 April.) 3 British Paediatric Association. Guidelines for the conduct of medical research with children. London: BPA, 1992.
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