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Ethical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP)

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Abstract

A child has the full right of protection of his/her life by provision of optional medical care. There is a need in paediatrics for better evidence based practice founded on quality research into efficacy and safety of children’s medications. To protect the best interests of the child one must balance the ethical demand to do clinical studies with the necessity to avoid doing harm. To achieve this end good clinical practice in paediatric research demands that studies comply with the Declaration of Helsinki, ICH topic E11, EU Directives and other relevant international guidelines. Evident differences in physiology, pharmacology, pharmacokinetics and pharmacodynamics between children of differing ages and between children and adults demand properly constructed and conducted studies that respect the special somatic, emotional and mental needs of children. To justify any research project one must balance the benefit/risk ratio, provide experienced, competent personnel and infracture, obtain adequate informed consent/assent, and have the study evaluated and approved by an ethics committee containing expertise on the rights and needs of children.

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Further Reading

  • Chambers TL, Kurz R (1999) Ethical overview of paediatric research and practice in Europe from the Ethical Working Group of the Confederation of European Specialists in Paediatrics (CESP). Eur J Pediatr 158: 537–540

    Article  CAS  PubMed  Google Scholar 

  • Committee for Proprietary Medicinal Products/CPMP (1997) Note for guidance on clinical investigations of medicinal products in children (CPMP/EWP/462/95) London

  • Conroy S, Choonara I, Impiccatore P, Mohn A, Arnell H, Rane A, Knoeppel C, Seyberth H, Pandolfini C, Raffaelli MP, Rocchi F, Bonati M, Jong G, Hoog M de, van den Anker J (2000) Survey of unlicensed and off label drug use in paediatric wards in European countries. BMJ 320: 79–82

    CAS  PubMed  Google Scholar 

  • Council for International Organisations of Medical Sciences (CIOMS) in collaboration with the World Health Organisation (WHO) (1993) International ethical guidelines for biomedical research involving human subjects. Geneva

  • Director 2001/20/EC of the European Parliament and the Council on the approximation of the law, 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 (4 April 2001) Luxembourg http://www.eportc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf

  • Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP) (2003) Guidelines for informed consent in biomedical research involving paediatric populations as research participants. Eur J Pediatr 162: 455–458

    PubMed  Google Scholar 

  • Gill D, Kurz R (2002) Practical and ethical issues in paediatric clinical trials. Applied Clinical Trials 11: 60–63

    Google Scholar 

  • Gill D, Kurz R et al (2003) Guidelines for informed consent in biomedical research involving paediatric populations as research participants. Eur J Pediatr 162: 455–458

    PubMed  Google Scholar 

  • Hoet JJ (1998) Ethical aspects of clinical viewpoint. European Ethical Committee andEuropean Forum of Good Clinical Practice. Brussels

  • International Conference on Harmonisation of Technical Requirements for registration of Pharmaceuticals for Human Use (ICH) (2000) ICH Topic E11: note for guidance on clinical investigations of medicinal products in the paediatric population (CPMP/ICH 135/95). London (http://www.ich.org)

  • Kurz R (2002) Putting the child first: research as a part of paediatric care. Intern J Pharm Med 16: 11–13

    Article  Google Scholar 

  • Loewy EH (1996) Textbook of health care ethics. Plenum Press, New York, London

  • National Institute of Health (1998) NIH policy and guidelines on the inclusion of children as participants in research involving human subjects (http://grants.nih.gov/grants/guide/notice-files/not98–0244.html)

  • Royal College of Paediatrics and Child Health. Ethics Advisory Committee (2000) Guidelines for the ethical conduct of medical research involving children. Arch Dis Child 82: 177–182

    Article  PubMed  Google Scholar 

  • Sauer PJJ (2002) research in children: report on behalf of the Ethics Working Group of CESP. Eur J Pediatr 161: 1–5

    PubMed  Google Scholar 

  • Smyth RI, Weindling AM (1999) Research in children: ethical and scientific aspects. Paediatrics 354: 21–24

    Google Scholar 

  • Turner S, Nunn AJ, Freeding K, Choonara I (1999) Adverse drug reactions to unlicensed and off-label drugs on paediatric wards. A prospective study. Acta Paediatr 88: 965–968

    CAS  PubMed  Google Scholar 

  • United Nations Children’s Fund (1995) The Convention on the Rights of the Child. UK Committee for UNICEF, London (http://www.unicef.org/crc.htm)

  • WHO (2000) Operational guidelines for ethics committees that review medical research. WHO, Geneva (http://www.who.int/tdr/publications/publications/ethics.html)

  • World Medical Association (2000) Declaration of Helsinki. Recommendations guiding physicians in biomedical research involving human subjects. 52nd General Assembly: Edinburgh, Scotland, October 2000 (http://www.wma.net/e/policy/17-c e.html)

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Correspondence to Denis Gill.

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Members of the CESP Working Group are: Timothy L. Chambers (UK), Francis P. Cawley (Belgium), Denis Gill (Ireland), Milena LoGiudice (Italy), Stefan Grosek (Slovenia), Ronald Kurz (Austria), Staffan Mjones (Sweden), Pieter J. J. Sauer (The Netherlands), Martti Siimes (Finland).

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Gill, D. Ethical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP). Eur J Pediatr 163, 53–57 (2004). https://doi.org/10.1007/s00431-003-1378-5

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  • DOI: https://doi.org/10.1007/s00431-003-1378-5

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