Referential texts

International and European Reference Texts on Human and Animal Experimentation

 The Nuremberg Code (1947) in BMJ 1996; 313:1448

 World Medical Association Declaration of Helsinki Ethical Principles for Medical Research Involving Human Subjects Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, and amended by The 29th WMA General Assembly, Tokyo, Japan, October 1975, 35th WMA General Assembly, Venice, Italy, October 1983, 41st WMA General Assembly, Hong Kong, September 1989, 48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996, and the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000 Note of Clarification on Paragraph 29 added by the WMA General Assembly, Washington 2002 Note of Clarification on Paragraph 30 added by the WMA General Assembly, Tokyo 2004

 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use – ICH Harmonised Tripartite Guideline, Guideline for Good Clinical Practice E6 Recommended for adoption at step 4 of the ICH process on 1 May 1996 by the ICH steering committee (including the post step 4 corrections agreed by the steering committee on 10 June 1996) ICH Global Cooperation, Group c/o ICH Secretariat IFPMA, 30 rue de Saint Jean, P.O. Box 758, 1211 Geneva 13 , Switzerland - Tel : +41 (22) 338 32 00 -Fax : +41 (22) 338 32 30 – e-mail: admin@ich.org - www.ich.org

 Convention on Human Rights and Biomedicine, Council of Europe: Oviedo, Spain, April 4, 1997.

 The European Directive 2001/20/CE and its transposition into national legislation

 Directive 95/46/EC on the protection of individuals with regard to the processing of personal data and on the free movement of such data

 2000/520/EC: Commission Decision of 26 July 2000 pursuant to Directive 95/46/EC of the European Parliament and of the Council (Safe harbor principle)