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1. MEDICAL RESEARCH INVOLVING INCAPACITATED ADULTS: IMPLICATIONS OF THE EU CLINICAL TRIALS DIRECTIVE 2001/20/EC.

Author

Kathleen Liddell, Julian Bion, Douglas Chamberlain, Christiane Druml, Erwin Kompanje, Francois Lemaire, David Menon, Bozidar Vrhovac, and Wiedermann, Christian J.

Subjects
*CLINICAL trials, *MEDICAL research, *PEOPLE with disabilities, *CLINICAL drug trials
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.

Published
2006
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