International regulations and recommendations
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine. Convention on Human Rights and Biomedicine. Council of Europe. European Treaty Series 164 (1997)
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (CETS no. 195)
International Ethical Guidelines for Biomedical Research Involving Human Subjects (Council for International Organization of Medical Sciences)
Declaration of Helsinki (WMA)
WHO: Operational Guidelines for Ethics Committees That Review Biomedical Research (2000), TDR/PRD/ETHICS/2000.1
Recommendation No. R (90) 3 of the Committee of Ministers to Member States concerning Medical Research on Human Beings (pdf, 290 kB)
Guideline for Good Clinical Practice, CPMP/ICH/135/95