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Guidelines for informed consent in biomedical research involving paediatric populations as research participants

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Abstract

To promote and protect the best interests of children involved in biomedical research, paediatricians have to ensure that participating minors and their parents/legal representatives have understood and assented/consented to the research. Therefore guidelines providing child-specific guidance that are compatible with other international guidelines on informed consent are laid down. Special regard is paid to the willingness to participate and the social and cultural background of the patients, the legal conditions of the countries, the capacity of the child to understand and give his/her informed assent, the adequate communication with the child and the parents, the respect of the will of the patient, the understandable written informed consent of legal representatives and to the evaluation of the informed consent/assent process by competent ethics committees.

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Further reading

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

  2. 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

  3. DeLourdes-Levy M, Larcher V (2003) Informed consent/assent in children. Statement of the Ethics Working Group at the Confederation of European Specialists in Paediatrics (CESP) Eur J Pediatr (in print)

  4. Directive 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.eortc.be/Services/Doc/clinical-EU-directive-04-April-01.pdf

  5. Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP) (2002) Ethical principles and operational guidelines for good clinical practice in paediatric research. Recommendations of the Ethics Working Group of CESP. The EFGCP Annual Conference 24–25 January 2002, Conference Documents, Brüssels, http://www.efgcp.org

  6. 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, hppt://www.ich.org

  7. Ondrusek N, Abramoovitch R, Pencharz P, Koren G (1998) Empirical examination of the ability of children to consent to clinical research. J Med Ethics 24: 158–165

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

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

  10. 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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Authors and Affiliations

  1. The Children's Hospital, IRL Dublin I, Temple Street, Ireland

    Dennis Gill

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  1. Dennis Gill
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Consortia

Ethics Working Group of the Confederation of European Specialists in Paediatrics: Francis P. Crawley (Belgium), Milena LoGiudice (Italy), Stefan Grosek (Slovenia), Ronald Kurz (Austria), Maria de Lourdes-Levy (Portugal), Staffan Mjönes (Sweden), Demetre Nicolopoulos (Greece), Armido Rubino (Italy), Pieter J.J. Sauer (Netherlands), Martti Siimes (Finland), Michael Weinding (UK), Maximilian Zach (Austria), Timothy L. Chambers (UK)

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Correspondence to Dennis Gill.

Additional information

Ronald Kurz has authored these guidelines on behalf of the Ethics Working Group of the CESP

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Gill, D., Ethics Working Group of the Confederation of European Specialists in Paediatrics: Francis P. Crawley (Belgium), Milena LoGiudice (Italy), Stefan Grosek (Slovenia), Ronald Kurz (Austria), Maria de Lourdes-Levy (Portugal), Staffan Mjönes (Sweden), Demetre Nicolopoulos (Greece), Armido Rubino (Italy), Pieter J.J. Sauer (Netherlands), Martti Siimes (Finland), Michael Weinding (UK), Maximilian Zach (Austria), Timothy L. Chambers (UK). Guidelines for informed consent in biomedical research involving paediatric populations as research participants. Eur J Pediatr 162, 455–458 (2003). https://doi.org/10.1007/s00431-003-1192-0

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  • DOI: https://doi.org/10.1007/s00431-003-1192-0

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