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Editorial

Clinical trials: consent in children

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Pages 1-3 | Published online: 09 Jan 2014

References

  • Directive 2001/20/EC of the European Parliament and of the Council of 4th April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official J. Eur. Comm. L 121/34–121/44 (2001).
  • Koren G. Healthy children as subjects in pharmaceutical research. Theories Med. Bioethics24(2), 149–159 (2003).
  • World Medical Association. Declaration of Helsinki Ethical Principles for medical research involving human subjects. World Medical Association, October (2000).
  • Abramovitch R, Freedman JL, Thoden K, Nikolich C. Children’s capacity to consent to participation in psychological research: empirical findings. Child Dev.62, 1100–1109 (1991).
  • Hurley JC, Underwood MK. Children’s understanding of their research rights before and after debriefing: informed assent, confidentiality and stopping participation. Child Dev.73(1), 132–143 (2002).
  • Kennedy I, Grubb A. Medical Law Text and Materials. Butterworth, London, UK (1989).
  • Royal College Of Paediatrics And Child Health: Ethics Advisory Committee. Guidelines for the ethical conduct of medical research involving children. Arch. Dis. Child.82, 177–182 (2000).
  • Ondrusek N, Abramovitch R, Pencharz P, Koren G. Empirical examination of the ability of children to consent to clinical research. J. Med. Ethics24, 158–165 (1998).

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