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5 Med. L. Int'l 1 (2000-2002)

handle is hein.journals/medclint5 and id is 1 raw text is: Medical Law International, 2000, Vol. 5, pp. 1-24 0968-5332/00 $10 © 2000 A B Academic Publishers-Printed in Great Britain PARTICIPATION OF CHILDREN IN CLINICAL TRIALS: UK, EUROPEAN AND INTERNATIONAL LEGAL PERSPECTIVES ON CONSENT AURORA PLOMER University of Leeds, UK ABSTRACT 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. INTRODUCTION The regulation of clinical trials on human subjects has become the focus of renewed European and international efforts in recent years. A Clinical Trials Directive (OJC 306, 08.10.97, p. 9) has been under consideration since 1997. Its final amended version was adopted by the Commission in April 1999 (OJC 161, 08.06.99, p. 5) and is pending adoption by the Council. The Directive seeks to give legal force to principles and guidelines of good clinical practice (GCP) in the conduct of clinical trials. GCP guidelines were annexed in 1990 to Directive 75/ 31 8/EEC but are not currently mandatory. The Clinical Trials Directive expressly endorses the principles contained in the current revision of the Declaration of Helsinki and the new Council of Europe Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine (Convention on Human Rights and Biomedicine, Oviedo, 1997) which contains several articles for the protection of human subjects in scientific research. Separate moves towards harmonization of standards in the pharmaceutical industry have also been under way since 1990, under the aegis of the International

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