International Research Ethics
Posted Oct. 14, 2009, updated Oct. 15, 2012
Prepared by Mary Whisner for H590 International Research Ethics, Law and Policy.
Health & Medicine (lists guides, major databases)
- International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) (prepared in collaboration with the World Health Organization)
- International Ethical Guidelines for Epidemiological Studies (2009), RA652 .C68 2009 at Classified Stacks.
- Supersedes: International Ethical Guidelines for Review of Epidemiological Studies (1991).
- Not available free online.
- Declaration of Inuyama on Human Genome Mapping, Genetic Screening and Gene Therapy (1990)
- International Guiding Principles for Biomedical Research Involving Animals (1985)
- Principles of Medical Ethics Relevant to the Protection of Prisoners Against Torture (1983) (Resolution 37/194 (Principles of Medical Ethics) adopted by the United Nations General Assembly on 18 December 1982)
- Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (2005) (Oviedo Convention)
- European Group on Ethics in Science and New Technologies, Ethical Aspects of Clinical Research in Developing Countries (2003) (report to European Commission)
- Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Group includes regulators and industry representatives from the EU, the US, and Japan. Guidelines include:
- ICH Harmonised Tripartite Guideline for Good Clinical Practice E6(R1) (1996)
- Choice of Control Group and Related Issues in Clinical Trials E10 (2000)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
- The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, April 18, 1979
Nuffield Council on Bioethics (Oxford)
- The Ethics of Research Related to Healthcare in Developing Countries (2002 report with 2005 follow-up discussion paper)
- Information Sheet Guidances Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors (various dates)
- Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products (WHO Technical Report Series, No. 850, 1995, Annex 3)
- Operational Guidelines for Ethics Committees That Review Biomedical Research (2000)
- Handbook of WMA Policy
- Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects (adopted 1997; amended 2008)
- Ethics page
- Ethics, Trade, Human Rights and Health Law (ETH) department
- Special Programme for Research and Training in Tropical Diseases
Mahidol University (Thailand)
- The Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, Ethics of Research Involving Human Subjects
For other intergovernmental and nongovernmental organizations, see links here.