The implementation of directive 2001/20/EC into Belgian law and the specific provisions on pediatric research

European Journal of Health Law

Volumn 15, Issue 2, 2008, Pages 153-161

  Pinxten, Wim ^a   Dierickx, Kris ^a   Nys, Herman ^a  

^a UNIVERSITY OF LEUVEN   (Belgium)

Author keywords

Consent; Ethic committee; European directive; LEH; Minors; Pediatric research

Indexed keywords

EXPERT SYSTEM; FINANCIAL MANAGEMENT; HEALTH CARE PERSONNEL; HEALTH MAINTENANCE ORGANIZATION; INFORMED CONSENT; LAW; MEDICAL ETHICS; ORGANIZATION AND MANAGEMENT; PEDIATRICS; PROFESSIONAL STANDARD; REVIEW;

ADOLESCENT; BELGIUM; BIOMEDICAL RESEARCH; CHILD; CHILD WELFARE; ETHICS COMMITTEES, RESEARCH; ETHICS, RESEARCH; HUMANS; INFORMED CONSENT; MINORS; PUBLIC POLICY;

EID: 53549088329     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/157180908X322996     Document Type: Review

References (11)

1. For an unauthorized translation of the LEH, see: C. Trouet, M. Gobert, M. Podoor, "Clinical Trials in Belgium. The Belgian implementation of the European Clinical Trials Directives. An Operational Guidance," Intersentia, 2007.
2. Royal Decree of 30 June 2004 providing for implementation measures of the Law of 7 May 2004 concerning experiments on the human person with regard to clinical trials with medicinal products for human use, modified by the Royal Decree of 18 May 2006. (MB/BS 26 May 2006) Royal Decree of 15 July 2004 establishing the retributions to be paid in the context of an application for a clinical trial or an experiment. (MB/BS 16 July 2004) Royal Decree of 27 April 2007 providing the fees to be paid in the context of Article 30, §6 of the LEH. (MB/BS 22 May 2007) Royal Decree of 15 July 2004 establishing the retributions to be paid in the context of an application for a clinical trial or an experiment. (MB/BS 16 July 2004).
3. H. Nys, "La Directive 2001/20/C.E. concernant les bonnes pratiques cliniques dans la conduite d'essais cliniques de médicaments à usage humain", Journal des Tribunaux, 2002, 6054, p. 353-366.
4. Belgian State Gazette, 11 July 2007.
5. P. SCHOTSMANS, "Commissies voor Medische Ethiek: Een actuele stand van zaken", Acta Hospitalia, 2007, p. 65-67.
6. Ethics Committees that did not assess any research protocols in 2006 were not taken into account.
7. P. SCHOTSMANS, "Commissies voor Medische Ethiek: Een actuele stand van zaken", Acta Hospitalia, 2007, p. 65-67.
8. In case of gene therapy or somatic cell therapy, an extension of the time limit with 30 days (+90 days) is possible. In case of xenogenetic cell therapy, no time limits are applicable. (European Directive art. 6,7).
9. J. P. Karlberg, "West to East Drift in European Sponsored Clinical Trials", Clinical Trial Magnifier, 2008, 1, p. 5 (http://www.cticon.org/ download.aspx?id=cf6d29e9-8464-4949-8d1d-c35b1c3cf 576; Accessed: 1 June 2008).
10. Art 373 of the Belgian Civil Code.
11. If individuals are unable to write because of physical reasons, oral consent is valid if given in the presence of at least one witness of legal age who is independent from the sponsor and the investigator.