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Ethical concerns regarding guidelines for the conduct of clinical research on children

S D Edwards1, M J McNamee

  • 1Centre for Philosophy, Humanities and Law in Healthcare, School of Health Science, University of Wales Swansea, Swansea SA2 8PP, UK. s.d.edwards@swansea.ac.uk

Journal of Medical Ethics
|June 1, 2005
PubMed

Insights

This study examines ethical guidelines for involving children in clinical research who cannot provide informed consent. It highlights tensions between major international and UK-based ethical frameworks, calling for clearer guidance.

Area of Science:

  • Medical Ethics
  • Clinical Research Ethics

Background:

  • Ethical considerations for children in clinical research are complex, particularly for those unable to provide informed consent.
  • Existing guidelines present tensions that require clarification by official bodies.

Purpose of the Study:

  • To examine ethical aspects of involving children incapable of informed consent in clinical research.
  • To identify and address tensions within current ethical guidelines from various organizations.

Main Methods:

  • Comparative analysis of ethical guidelines.
  • Focus on discrepancies between the World Medical Association Declaration of Helsinki and UK-based guidelines.

Main Results:

  • Identified specific tensions between the World Medical Association Declaration of Helsinki and guidance from the British Medical Association, Royal College of Paediatrics and Child Health, and CIOMS.
  • Current guidelines lack explicit clarity regarding the ethical involvement of children unable to consent.

Conclusions:

  • Official bodies must make their guidance more explicit regarding the ethical involvement of children in clinical research.
  • Recommendations for aligning guidance with the World Medical Association Declaration of Helsinki are proposed.

Keywords:
Biomedical and Behavioral Research

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