New European rules regarding the approval of clinical trials, the role of ethics committees and the protection of subjects

Archivum Immunologiae et Therapiae Experimentalis

Volumn 60, Issue 6, 2012, Pages 405-414

  Nys, Herman ^a  

^a UNIVERSITY OF LEUVEN   (Belgium)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CHILD CARE; CLINICAL TRIAL (TOPIC); COMPENSATION; EMERGENCY CARE; GOVERNMENT REGULATION; HEALTH INSURANCE; HUMAN; INFORMED CONSENT; MEDICAL ASSESSMENT; MEDICAL DECISION MAKING; MEDICAL ETHICS; MEDICAL RESEARCH; MENTAL DEFICIENCY; MENTAL HEALTH; PATIENT RIGHT; PATIENT SAFETY; RESEARCH SUBJECT; WELLBEING;

CLINICAL TRIALS AS TOPIC; CODES OF ETHICS; COMPENSATION AND REDRESS; EMERGENCIES; ETHICS COMMITTEES, RESEARCH; EUROPE; GOVERNMENT REGULATION; HEALTH POLICY; HUMANS; INFORMED CONSENT; LIABILITY, LEGAL; PRACTICE GUIDELINES AS TOPIC; RESEARCH SUBJECTS; THERAPEUTIC HUMAN EXPERIMENTATION;

EID: 84872100363     PISSN: 0004069X     EISSN: 16614917     Source Type: Journal    
DOI: 10.1007/s00005-012-0200-3     Document Type: Article

References (26)

1. Com (2008) 668 final.
2. ENTR/F/2/SF D (2009) 32674.
3. Com (2012) 369 final.
4. COM (2008) 668 final.
5. ENTR/F/2/SF D (2009) 32674.
6. According to article 249 §3 of the Treaty establishing the European Community.
7. Consultation Paper, p. 20-21.
8. Com (2012) 369 final.
9. Explanatory Memorandum to the Proposal, p. 2.
10. Explanatory Memorandum to the Proposal, p. 4-5.
11. See 'Whereas' (14) of the Proposal.
12. cf. T.K. Hervey and J.V. McHale, Health law and the European Union, Cambridge University Press, Cambridge, 2004, 254, commenting on the proposed Directive: 'The final drafting seems to suggest that non-therapeutic trials on medicinal products, concerning incompetent adults, will be unlawful when the Directive comes into force'.
13. See for a discussion of article 4 of the Directive; Pinxten W, Dierickx K, Nys H (2011) Diversified harmony: supranational and domestic regulation of paediatric clinical trials in the EU. J Cystic Fibrosis 10 (suppl. 2):S183-S198.
14. See Gevers JK (2008) Editorial. Medical research involving children. Eur J Health Law 15:103-108.
15. Pinxten W, Dierickx K, Nys H (2008) The implementation of Directive 2001/20/EC into Belgian law and the specific provisions on paediatric research. Eur J Health Law 15:155-156.
16. Among which Belgium.
17. Consultation Paper, p. 25.
18. e.g. Finland; see Halila R: Response to the Consultation Paper; available at http://ec.europa.eu/health/files/clinicaltrials/ctresp-2011-06/halila,- ritva.pdf.
19. Consultation Paper, p. 25.
20. Explanatory Memorandum, p. 9.
21. See 'Whereas' (47) of the proposed Regulation.
22. Explanatory Memorandum, p. 10.
23. Consultation Paper, p. 10.
24. See http://ec.europa.eu/justice/data-protection/document/review2012/com- 2012-11-en.pdf. See also Opinion No. 26 on Ethics of Information and Communication Technologies of the European Group on Ethics of Science and New Technologies to the European Commission of 22th February 2012.
25. Consultation Paper, p. 10.
26. Consultation Paper, p. 17.