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 represents a substantial proportion of the biomedical scientific community through its member organizations. The mission of CIOMS is to advance public health through guidance on health research including ethics, medical product development and safety.

Current membership (2018)

History

1949: The Council for Coordination of International Medical Congresses was formally constituted at a jointly-sponsored conference in Brussels. The Council’s original objective was to coordinate and support the work of international organizations of medical sciences through information exchange and financial assistance to organizers of congresses and to the individuals attending them. The scope of activities was gradually broadened to include other forms of international collaboration in medical sciences.

1952: The name of the Council was changed to Council for International Organisations of Medical Sciences (CIOMS), and its statutes were revised.

1959: CIOMS organised a meeting in Vienna under the joint auspices of UNESCO and WHO, “to discuss the principles, organization and scope of “controlled clinical trials”, which must be carried out if new methods or preparations used for the treatment of disease are to be accurately assessed clinically”. This meeting was a methodological landmark in clinical research.^[1]

1966: CIOMS reduced its financial assistance towards congresses on purely scientific medical subjects, as it was felt that this was an unnecessary duplication of the large number of scientific meetings being held.

In the years that followed, CIOMS changed its main activities to address some of the social and cultural implications resulting from the rapid progress in biomedical science and the emergence of a new world order with a large number of newly-independent countries. CIOMS started to convene multi-disciplinary international conferences concerned with bioethics, health policy, medical education and health services research. Over the next 20 years these working modalities evolved and gradually led to convening specialized international Working Groups with the aim of publishing well balanced reports on topics related to research ethics, drug development and safe use of medicines.

2016: CIOMS joined the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) as an observer.

CIOMS Working Groups

Guidelines for research on 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]. In 2016 new CIOMS ethical Guidelines titled "International ethical guidelines for health-related research involving humans" were published. These guidelines were prepared in collaboration with WHO and address additional topics. They stress the need for research that has scientific and social value, provide special guidance for health-related research in low-resource settings, detail the provisions for involving vulnerable groups in research, and describe under what conditions biological samples and health-related data can be used for research.^[3]

Guidelines on medicines safety

The first systematic international efforts to address medicines safety issues started after 1961, when thalidomide, a medication given to pregnant women to alleviate nausea, led to many thousands of infants being born with deformities. It is not an exaggeration to say that CIOMS guidelines have formed the basis of modern pharmacovigilance, and several CIOMS guidelines were the basis of creating respective ICH guidelines. Some examples:

ICH-E2A (1994): Clinical Safety Data Management – Definitions and Standards for Expedited Reporting was based on the reports of CIOMS Working Groups (WG) I and II for marketed medicinal products (published 1990 and 1992).

ICH-E2C (1996):’Clinical Safety Data Management – Periodic Benefit-Risk Evaluation Reports described the specifications for format and content of periodic safety update reports (PSURs) and was based on the reports of CIOMS WG II and III (published in 1992, 1995).

ICH-E2D (2003): Post-Approval Safety Management – Definitions and Standards for Expedited reporting formalized the application of relevant elements of ‘’ICH-E2A’’ in the post-authorization phase and was based on the reports of CIOMS WG V (2001).

ICH-E2F (2010): Development Safety Update Reports was based on the report of CIOMS WG VIII (published 2006) and describes the specifications for format and content of development safety update reports (DSURs).

More recently, the CIOMS Working Group on Vaccine Safety has completed published guidance on safety surveillance for new vaccines, especially those introduced early or exclusively to countries with limited pharmacovigilance experience and infrastructure, and on how to communicate information around vaccine safety issues to the public.

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

External links

• CIOMS home page