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BMJ No 7102 Volume 315 Letters Saturday 26 July 1997 Informed consentResearch in pregnancy brings special considerationsEditor,The debate on informed consent stimulated by the BMJ must be welcomed by anyone interested in the ethics of medicine and research.(1) Subsequent correspondence has highlighted the differences between consent to treatment that benefits only the individual and consent to participation in research that aims to benefit other people.(2) For pregnant women, however, both treatment and research involve third parties, which might influence decision making. When treating pregnant women or offering them the chance to participate in research we must ensure that consent is truly informed and freely given. Women feel responsible for the fetus they carry to the extent that they often modify their habits and lifestyle during pregnancy. Pregnancy may affect their ability to make a free choice: they may feel bound to accept interventions that might benefit the fetus which they would rather decline, or they may refuse treatment for themselves in case it should harm the baby. If the risks and benefits to the fetus are not carefully explained they may not give their consent for research to which they feel a personal obligation or in which they are interested. Research in pregnancy brings special considerations. The 'two patient' model of pregnancy disallows the imposition of possible harm on one party for the sake of the other,(3) which is particularly important, for example, in studies on the mode of delivery. The father may have an opinion that will influence whether the mother participates. Previously independent women may be vulnerable and dependent on their doctor, whom they need to trust and whom they may want to please by entering research projects. If they are to forgo the 'good' of personal care they must trust that the trial truly is based on the null hypothesis-that there is no known difference between the proposed treatments or interventions. Some patients will prefer to assume that '[My] doctor knows best [about me and my baby]' and not be happy to enter into the discussion of uncertainty that a trial and the issue of informed consent will raise. These challenges sometimes lead to the exclusion of pregnant women from clinical trials. For work on drugs such as tocolytic agents, however, only pregnant women can help. Pregnancy does not remove a woman's competence to give informed consent, but it does bring extra considerations that researchers must bear in mind when trying to encourage these women to participate.
These views arose out of interviews with women who had been invited into research projects while pregnant; the work was supported by a grant of P5000 from the NHS Executive (West Midlands) research in primary care initiative. Kay Mohanna
42 Hazel Grove,
References 1 Smith R. Informed consent: the intricacies. BMJ 1997;314:1059-60. (12 April.) 2 Wilmshurst P. Informed consent in medical research. BMJ 1997;314:1481. (17 May.) 3 Tauer C. When pregnant women refuse interventions. AWHONN'S Clinical Issues 1993;4.4:596-604.
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