The Declaration of Helsinki was, until recently, the leading international code on the conduct of clinical trials on human subjects. The Council of Europe's Convention on Human Rights and Biomedicine (1997) and the ICH guidelines for Good Clinical Practice (1996) represent a significant step towards increased harmonization of standards in the conduct of medical experiments on human subjects. But in spite of emerging areas of consensus, there remain important areas of unclarity and divergence. Medical practitioners involved in paediatric research in the UK are concerned about the lack of certainty in the law, particularly on the application of consent rules to emergency research. This paper examines UK, European and International norms on participation of children in medical research and compares the circumstances under which consent rules may be waived under each normative regime.
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Clinical researchers seeking public NIH funding in the USA are now required to include children in all research involving human subjects unless there are scientific or ethical reasons not to include them (NIH Policy and Guidelines on the inclusion of Children as Participants in Research Involving Human Subjects, March 6, 1998) following a workshop held in 1996 by the National Institute of Child Health and Human Development (NICHD) and the American Academy of Paediatrics which sought to address the inclusion of children in clinical research. The scientific evidence presented at the workshop showed that the majority of marketed drugs in the USA are not labelled for use in children and carry little or no information for use in children. The conclusion of the workshop was that there is a need to increase the inclusion of children in clinical research, and that the need reaches across a wide spectrum “including studies on pharmaceutical and therapeutic agents, behavioural, developmental and life cycle issues including childhood antecedents of adult disease, and prevention and health services research.” (NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects, March 6 1998).
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By contrast to the absence of legal rules, there is a plethora of extra-legal norms, in the form of administrative guidelines issued by the Department of Health to Research Ethics Committees (RECS) and Multi-Centre Research Ethics Committees, in addition to rules issued by the Medical Research Council. Professional rules are issued separately by the Royal Colleges. For an overview of the bewildering array of ethical research guidelines in the UK, see: SmithTrevorEthics in Medical Research: A Handbook of Good Practice, Cambridge: CUP, 1999.
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Researchers also have professional obligations to comply with the rules issued by the relevant professional body of which they are a member (e.g.. the Royal College of Physicians, the British Paediatric Association, the Royal College of Psychiatrists, etc…). If the research is conducted in the NHS, then it has to be approved by a Research Ethics Committee (REC guidelines are issued by the DoH). Researchers seeking funding from the Medical Research Council also have to comply with the MRC rules.
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The Department of Health has issued guidelines on Good Clinical Practice and Clinical Trials in the NHS (December 1999) which endorse the 1996 ICH guidelines and are purported to be consistent with the Guidelines for Good Clinical Practice in Clinical Trials 1998) issued by the Medical Research Council. The Department of Health describes the guidelines as “intended to be of relevance to any prospective study involving human participants and the administration of a treatment or type of management, including diagnosis, prevention and the provrsion of lifestyle”. (Guidance on Good Clinical Practice and Clinical Trials in the NHS, December 1999, p. 1).
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