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BMJ No 7102 Volume 315 Letters Saturday 26 July 1997 Informed consentSubjects may not understand concept of clinical trialsEditor,We agree with Richard Smith that the issue of informed consent is not simple.(1) Even when a paper clearly states that information was given and consent obtained, readers cannot assume that the information given was 'full' or that the consent was 'fully informed.' We recently conducted a qualitative interview study with the parents of 21 babies enrolled in the United Kingdom collaborative trial of extracorporeal membrane oxygenation.(2, 3) The trial compared two methods of life support in critically ill newborn babies: conventional management (ventilatory support) and oxygenation of the blood through an external circuit. In the qualitative study the parents were asked about their reactions to the offer to participate in the trial and to randomisation. The findings showed that they often had difficulty with the idea of randomisation and the rationale for its use. An example of a difficulty in explaining the scientific method is the use of the word 'trial.' The concept of a clinical trial was unfamiliar to most parents and the term did not necessarily convey the crucial information that two treatments (allocated on a random basis) were being compared. The trial was seen by some parents more as 'a trial period.' There were other areas of difficulty for the parents. For example, where parents did not know that medical uncertainty was the basis for the trial they sought other means to explain the use of randomisation (perhaps as a way for doctors to circumvent a difficult choice between treatments, or to decide between babies competing for scarce beds). We generated three hypotheses from the data: (a) that parents were given accurate information but did not retain the details; (b) that parents were given partial information at the discretion of the caregiver, so that if they were perceived to be under too much stress the caregiver withheld or softened certain details; and (c) that parents were given inaccurate information, which reflected the caregivers' own beliefs about the trial. These hypotheses are not mutually exclusive. We are continuing our research in other trials to try to develop strategies to support caregivers and to ease the process of obtaining and giving informed consent. We would be interested to hear from others working in this or related fields. Diana Elbourne
Medical Statistics Unit, Claire Snowdon
Jo Garcia
National Perinatal Epidemiology Unit,
References 1 Smith R. Informed consent: the intricacies. BMJ 1997;314:1059-60. (12 April.) 2 Snowdon C, Garcia J, Elbourne D. Understanding randomisation: parental responses to the allocation of alternative treatments in a clinical trial involving their critically ill newborn babies. Soc Sci Med (in press). 3 UK Collaborative ECMO Trial Group. UK collaborative randomised controlled trial of neonatal extracorporeal membrane oxygenation. Lancet 1996;348:75-82.
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