We found a match
Your institution may have access to this item. Find your institution then sign in to continue.
- Title
MEDICAL RESEARCH INVOLVING INCAPACITATED ADULTS: IMPLICATIONS OF THE EU CLINICAL TRIALS DIRECTIVE 2001/20/EC.
- Authors
Kathleen Liddell; Julian Bion; Douglas Chamberlain; Christiane Druml; Erwin Kompanje; Francois Lemaire; David Menon; Bozidar Vrhovac; Wiedermann, Christian J.
- Abstract
The article focuses on the Article 5 of the European Union (EU) Clinical Trials Directive (CTD) which relates to research that involve incapacitated adults (IAs), and its implications for future regulation of medical research. It notes that the aim of the CTD is to harmonise the laws, regulations and administrative provisions of the Member States which relate to good clinical practice in the conduct of the clinical trials of drugs. The legal, ethical and practical difficulties nations could face after transposing Article 5 are analyzed.
- Publication
Medical Law Review, 2006, Vol 14, Issue 3, p367
- ISSN
0967-0742
- Publication type
Academic Journal
- DOI
10.1093/medlaw/fwl011