Participation of children in clinical trials: UK, European and international legal perspectives on consent.

Research output: Contribution to journalArticle (Academic Journal)peer-review

5 Citations (Scopus)

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 the participation of children in medical research and compares the circumstances under which consent rules may be waived under each normative regime.
Original languageEnglish
Pages (from-to)1-24
Number of pages24
JournalMedical Law International
Volume5
Issue number1
Publication statusPublished - 2000

Keywords

  • Biomedical and Behavioral Research
  • European Convention on Human Rights and Biomedicine
  • International Conference on Harmonization
  • Legal Approach
  • Child
  • Clinical Trials as Topic
  • Emergency Treatment
  • Europe
  • Great Britain
  • Guidelines as Topic
  • Humans
  • Informed Consent
  • Internationality
  • Nontherapeutic Human Experimentation
  • Parental Consent
  • Randomized Controlled Trials as Topic
  • Therapeutic Human Experimentation

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