Children and medical research

Medicine and Law

Volumn 24, Issue 3, 2005, Pages 505-513

  Halila, Ritva ^a   Lötjönen, Salla ^a  

^a National Advisory Board on Research Ethics   (Finland)

Author keywords

Children; Clinical trials; Clinical trials directive; Self determination

Indexed keywords

ADOLESCENT; AGE; ARTICLE; AWARENESS; BODY WATER; CHILD; CHILD HEALTH CARE; CLINICAL RESEARCH; CLINICAL STUDY; DECISION MAKING; DEVELOPMENTAL STAGE; DRUG INDUSTRY; HUMAN; HUMAN RIGHTS; INFORMED CONSENT; MANDATORY PROGRAM; MEDICAL RESEARCH; PARENT; REFUSAL TO PARTICIPATE; RISK BENEFIT ANALYSIS; TRAINING; WATER CONTENT;

EID: 25844516520     PISSN: 07231393     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (11)

1. World Medical Association: Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects, http://www.wma.net/e/policy/b3.htm
2. Guideline for good clinical practice: ICH Harmonised Tripartite Guidelines. http://www.emea.eu.int/pdfs/human/ich/013595en.pdf
3. International Ethical Guidelines for Biomedical Research Involving Human Subjects. http//www.cioms.ch/frameguidelines nov 2002.htm
4. Medical Research Act (488/1999) http://www.finlex.fi/english/index.html
5. Directive 2001/20/EC of the European Parliament and of the Council 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 Journal of the European Communities 1 May 2001 L121/34-44.
6. Commission consultation on a draft proposal for a European Parliament and Council Regulation (EC) on medicinal products for paediatric use, http://pharmacos.eudra.org/F2/pharmacos/new.htm (8.3.2004).
7. Commission consultation on a draft proposal for a European Parliament and Council: Regulation (EC) on medicinal products for paediatric use (see footnote 6).
8. In 29th September 2004, the European Commission adopted a final proposal to the Parliament and the Council for a Regulation on medicinal products for paediatric use (COM (2004) 599 final 2004/0217 (COD), http://pharmacos.eudra.org/F2/Paediatrics/index.htm, accessed 24.1.2005). The proposal follows fundamentally the same lines to the earlier consultation document.
9. Perspectives on Medical Research Conducted on Children. http://www.etene.org/e/documents.shtml
10. Dr. Ritva Halila was the secretary and Dr. Salla Lötjönen chaired the working group.
11. United Nations Convention on the Rights of the Child (20th November 1989) http://www.unicef.org/crc/crc.htm (accessed 24.1.2005)