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BMJ No 7102 Volume 315 Letters Saturday 26 July 1997 Informed consent Journals should require routine reporting of consent rates Editor, We wish to contribute to the debate on informed consent.(1) Two of us (HC, SAMS) have recently conducted a review of randomised control trials published in the Archives of Diseases in Childhood from 1982 to 1996. We found that 112 (45%) of 249 trials did not report whether informed consent had been obtained. Of the trials that did note that informed consent had been obtained, 111 (81%) of 137 quoted consent rates of 100%. This proportion varied by study setting and paediatric subspecialty and was particularly high in trials in inpatients (90%) and trials in neonates (96%). Two of the trials that reported 100% consent rates included over 500 children. Some of the trials may have considered obtaining patients' consent to be part of the inclusion criteria for participation. We are concerned, however, that investigators may have been following the letter of the law but not the spirit of the law. The process of obtaining consent should include the elements not only of information, comprehension, and consent but also of voluntariness-which includes absence of persuasion. It is important that investigators understand that patients' dependency can lead to absence of participation and choice, and that non-verbal behaviour and the setting can exert considerable influence.(2) Beyond our immediate concern about the legitimacy of consent rates of 100% in large trials, we believe that a perceived lack of care in obtaining consent may lead to the imposition of a legalistic approach to gaining consent in paediatric research. Concern exists in several quarters that parental consent may not be sufficient to justify research with children. It could be argued that the individual circumstances of each specific study should be assessed by investigators and local research ethics committees. In law, however, research with children remains a grey area, and a shift towards greater emphasis on individual autonomy could restrict research much more than at present. Such a shift is made more likely if the process of obtaining consent is perceived to be less than fully empowering to the subjects concerned. In this context, local research ethics committees and editors of medical journals should be alert to the possibility of informed consent that is not freely obtained, should require routine reporting of consent rates, and should challenge investigators to explain or comment on extremely high consent rates. Even more importantly, however, investigators should be encouraged to regard the process of obtaining informed consent not as an irritating chore but as an opportunity to use their clinical skills to secure the subject's wholehearted cooperation in an important task. Harry Campbell Senior lecturer in epidemiology Kenneth M Boyd Senior lecturer in medical ethics University of Edinburgh, Edinburgh EH8 9AG Susan A M Surry Medical student University of Western Ontario, London, Ontario, Canada References 1 Smith R. Informed consent: the intricacies. BMJ 1997;314:1059-60. (12 April.) 2 English DC. Bioethics: a clinical guide for medical students. London: W W Norton, 1994. Home | Current issue | Past issues | Classified ads | Career Focus | Feedback Collections | About this site | About the BMJ | BMA | Medline