Council for International Organizations of Medical Sciences
The Council for International Organizations of Medical Sciences (CIOMS) is an international nongovernmental organization established jointly by WHO and UNESCO in 1949.
CIOMS serves the scientific interests of the international biomedical community in general and has been active in promulgating guidelines for the ethical conduct of research, among other activities. CIOMS promulgated guidelines in 1993 entitled International Ethical Guidelines for Biomedical Research Involving Human Subjects. These 15 guidelines address issues including informed consent, standards for external review, recruitment of participants, and more. The Guidelines are general instructions and principles of ethical biomedical research.[1]
CIOMS working groups
- CIOMS I: International Reporting of Adverse Drug Reactions (1990)
- CIOMS II: International Reporting of Periodic Drug-Safety Update Summaries (1992)
- CIOMS III: Guidelines for Preparing Core Clinical-Safety Information on Drugs (1999)
- CIOMS IV: Benefit-Risk Balance for Marketed Drugs:Evaluating Safety Signals (1998)
- CIOMS V: Current Challenges in Pharmacovigilance: Pragmatic Approaches (2001)
- CIOMS VI: Management of Safety Information from Clinical Trials (2005)
- CIOMS VII: Development Safety Update Report (DSUR) (2006)
- CIOMS VIII: CIOMS Working Group on Signal Detection (2006)
- CIOMS IX: Practical Approaches to Risk Minimisation for Medicinal Products (2010)
Guidelines for human subjects
The International Ethical Guidelines for Biomedical Research Involving Human Subjects, sometimes informally referred to as CIOMS Guidelines, is a set of ethical principles regarding human experimentation created in 1993 by CIOMS and updated in 2002. These 21 guidelines (15 in the original report) address issues including Informed consent, standards for external review, recruitment of participants, and more. The Guidelines are general instructions and principles of ethical biomedical research.[2]
Guidelines for animal testing
The Council has also issued International Guiding Principles for Biomedical Research Involving Animals.[2]
See also
- Clinical trial
- Animal testing
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- Regulation of therapeutic goods
- Uppsala Monitoring Centre
- World Medical Association
References
- ↑ Marymount University, Loyola. "Reports, Declarations, Codes & Guidelines". LMU.
- 1 2 International Ethical Guidelines for Biomedical Research Involving Human Subjects (3rd ed.). Geneva: CIOMS in collaboration with WHO. ISBN 9290360755. Retrieved 1 December 2014.
- U.S. National Institutes of Health - "CIOMS Guidelines", Human Participant Protections Education for Research Teams