International Research Ethics
Posted Oct. 14, 2009.
Prepared by Mary Whisner for H590 International Research Ethics, Law and Policy.
Selected Ethical Standards
Council for International Organizations of Medical Sciences (CIOMS)
- International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002) (prepared in collaboration with the World Health Organization)
Council of Europe
- Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research (2005) (Oviedo Convention)
European Union
- 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)
UNAIDS and WHO
United States Food and Drug Administration
- 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)
World Medical Association
- Handbook of WMA Policy
- Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects (adopted 1997; amended 2008)
Other Selected Sites
United Nations
Joint United Nations Programme on HIV/AIDS
- Ethics page
- Ethics, Trade, Human Rights and Health Law (ETH) department
- Special Programme for Research and Training in Tropical Diseases
Other Organizations
Mahidol University (Thailand)
- The Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, Ethics of Research Involving Human Subjects
Nuffield Department of Clinical Medicine -- Tropical Medicine (Oxford)
For other intergovernmental and nongovernmental organizations, see links here.