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

Author:

Gill Dennis,

Publisher

Springer Science and Business Media LLC

Subject

Pediatrics, Perinatology, and Child Health

Reference10 articles.

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

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