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The scope of activities of the council was gradually broadened to include other forms of international collaboration in medical sciences in addition to the coordination of congresses. Consequently, '''in 1952''' the name of the council was changed to the Council for International Organizations of Medical Sciences (CIOMS) and its statutes were revised.
The scope of activities of the council was gradually broadened to include other forms of international collaboration in medical sciences in addition to the coordination of congresses. Consequently, '''in 1952''' the name of the council was changed to the Council for International Organizations of Medical Sciences (CIOMS) and its statutes were revised.


'''At the end of the 1950s''', CIOMS organized a meeting 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”. The meeting took place March 1959 in Vienna, under the chairmanship of Austin Bradford Hill, at that time director of the UK Medical Research Council's Statistical Research Unit. In spite of some hesitations the proceedings were published in English by Blackwell in 1960 under the title of Controlled Clinical Trials, and in French under the title Les essais thérapeutiques cliniques: méthode scientifique d’appréciation d’un traitement.
'''At the end of the 1950s''', CIOMS organized a meeting 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”. The meeting took place in March 1959 in Vienna, under the chairmanship of Austin Bradford Hill, at that time director of the UK Medical Research Council's Statistical Research Unit. In spite of some hesitations the proceedings were published in English by Blackwell in 1960 under the title of Controlled Clinical Trials, and in French under the title Les essais thérapeutiques cliniques: méthode scientifique d’appréciation d’un traitement.


'''Until 1966''', the activities of CIOMS were focused on the coordination of international medical congresses; grants and loans to member societies for the preparation of congresses and the publication of their proceedings; travel grants to young scientists, especially from developing countries to attend medical congresses; organization of symposia on medical subjects; and assistance to member organizations for the standardization of nomenclature in various medical disciplines.
'''Until 1966''', the activities of CIOMS were focused on the coordination of international medical congresses; grants and loans to member societies for the preparation of congresses and the publication of their proceedings; travel grants to young scientists, especially from developing countries to attend medical congresses; organization of symposia on medical subjects; and assistance to member organizations for the standardization of nomenclature in various medical disciplines.


'''After 1966''', various changes were made – some of which were dictated by the need for economy. Thus, the council was forced to discontinue its grants to young scientists and to curtail its financial assistance to member organizations. More significantly, it was felt that the holding of symposia on purely scientific medical subjects was an unnecessary duplication of the large number of scientific meetings already held.
'''After 1966''', various changes were made – some of which were dictated by the need for economy. Thus, the council was forced to discontinue its grants to young scientists and to curtail its financial assistance to member organizations. More significantly, it was felt that the holding of symposia on purely scientific medical subjects was an unnecessary duplication of the large number of scientific meetings already held.


However, the enormous progress in biology and medicine during the following twenty years, combined with the new world order that came into being as a result of the large number of newly independent countries led to new problems with important social and cultural implications. It was thus that the main activity of CIOMS became the convening of broadly based, multi-disciplinary, and internationally representative conferences concerned not only with the direct impact on society of progress in biomedical science, but also with its implications in such fields as bioethics, health policy, medical education and health services research. These working modalities changed again and gradually led to convening specialized international working groups with the aim of publishing solid balanced reports.
However, the enormous progress in biology and medicine during the following twenty years, combined with the new world order that came into being as a result of the large number of newly independent countries led to new problems with important social and cultural implications. It was thus that the main activity of CIOMS became the convening of broadly based, multi-disciplinary, and internationally representative conferences concerned not only with the direct impact on society of progress in biomedical science, but also with its implications in such fields as bioethics, health policy, medical education and health services research. These working modalities changed again and gradually led to convening specialized international working groups with the aim of publishing solid balanced reports.


'''In 2016''', CIOMS joined The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) as an observer. ICH is bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. ICH guidelines form part of official technical requirements for authorization of medicines. Historically several CIOMS pharmacovigilance guidelines served as the basis for ICH guidelines.
'''In 2016''', CIOMS joined The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) as an observer. ICH is bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. ICH guidelines form part of official technical requirements for authorization of medicines. Historically, several CIOMS pharmacovigilance guidelines served as the basis for ICH guidelines.


==Governance==
==Governance==

Revision as of 12:58, 14 February 2022

Abbreviation CIOMS
Formation 1949
Status International Scientific Association
Headquarters Geneva, Switzerland
Website www.cioms.ch
Head Since 2016, President, Prof Hervé LeLouët

and Secretary-General, Dr Lembit Rägo

The mission of the Council for International Organizations of Medical Sciences (CIOMS) is to advance public health through guidance on health research including ethics, medical product development and safety. CIOMS is an international nongovernmental organization established jointly by World Health Organization (WHO) and United Nations Educational, Scientific and Cultural Organization (UNESCO) in 1949. CIOMS represents a substantial proportion of the biomedical scientific community through its member organizations.

Publications include 'Clinical Research in Resource - Limited Settings' (2021) and 'International Ethical Guidelines for Health-related Research Involving Humans ' (2016).

History

In 1948, United Nations Educational, Scientific and Cultural Organization (UNESCO) consulted World Health Organization (WHO) about the possibility of establishing an organization for facilitating more coordination in the planning and timing of international medical congresses. An agreement between UNESCO and WHO was made for the establishment of a permanent Council for Coordination of International Medical Congresses. The council was formally constituted at a jointly sponsored conference in Brussels in 1949 as a non-governmental organization, with financial assistance from the two parent organizations, UNESCO and WHO.

The purpose of the council was described as being to facilitate the exchange of views and scientific information in the medical sciences by securing continuity and coordination between international organizations of medical sciences, by making their work known, and by providing them with material aid where necessary. This was to be achieved through the exchange of information and by the provision of material and financial assistance to congresses and to the individuals attending them.

The scope of activities of the council was gradually broadened to include other forms of international collaboration in medical sciences in addition to the coordination of congresses. Consequently, in 1952 the name of the council was changed to the Council for International Organizations of Medical Sciences (CIOMS) and its statutes were revised.

At the end of the 1950s, CIOMS organized a meeting 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”. The meeting took place in March 1959 in Vienna, under the chairmanship of Austin Bradford Hill, at that time director of the UK Medical Research Council's Statistical Research Unit. In spite of some hesitations the proceedings were published in English by Blackwell in 1960 under the title of Controlled Clinical Trials, and in French under the title Les essais thérapeutiques cliniques: méthode scientifique d’appréciation d’un traitement.

Until 1966, the activities of CIOMS were focused on the coordination of international medical congresses; grants and loans to member societies for the preparation of congresses and the publication of their proceedings; travel grants to young scientists, especially from developing countries to attend medical congresses; organization of symposia on medical subjects; and assistance to member organizations for the standardization of nomenclature in various medical disciplines.

After 1966, various changes were made – some of which were dictated by the need for economy. Thus, the council was forced to discontinue its grants to young scientists and to curtail its financial assistance to member organizations. More significantly, it was felt that the holding of symposia on purely scientific medical subjects was an unnecessary duplication of the large number of scientific meetings already held.

However, the enormous progress in biology and medicine during the following twenty years, combined with the new world order that came into being as a result of the large number of newly independent countries led to new problems with important social and cultural implications. It was thus that the main activity of CIOMS became the convening of broadly based, multi-disciplinary, and internationally representative conferences concerned not only with the direct impact on society of progress in biomedical science, but also with its implications in such fields as bioethics, health policy, medical education and health services research. These working modalities changed again and gradually led to convening specialized international working groups with the aim of publishing solid balanced reports.

In 2016, CIOMS joined The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) as an observer. ICH is bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. ICH guidelines form part of official technical requirements for authorization of medicines. Historically, several CIOMS pharmacovigilance guidelines served as the basis for ICH guidelines.

Governance

Secretariat

The day-to-day management of CIOMS is carried out by the Secretariat in conformity with the directions of the Executive Committee. It consists of the Secretary-General and his/her team and is based in Geneva, Switzerland.

Executive committee

The Executive Committee consists of up to twelve representatives chosen from among the International and National members.

General Assembly

The General Assembly consists of all CIOMS members and meets in ordinary session every two years and the alternate years by teleconference. It can also be convened by the Executive Committee in special sessions.

Working Groups

A broad range of topics are covered by CIOMS via working groups. Senior scientists from regulatory authorities, pharmaceutical industry and academia join together in order to develop consensus guidelines within areas such as international reporting of adverse drug reactions (ADRs), for example via the CIOMS I reporting form (later its structure was embedded in ICH E2B guideline and its revisions). Other areas include: periodic drug safety update summaries and development safety update report, core clinical safety information on drugs, terminology of ADRs, standardised MedDRA queries and pharmacogenetics.

There have also been joint working groups together with WHO covering drug development research and pharmacovigilance in resource-limited countries and vaccine pharmacovigilance.

One particularly noteworthy publication from earlier days includes the Principles of Medical Ethics relevant to the Protection of Prisoners Against Torture; and some of the most frequently requested current publications include:

Below is more information on the recent Working Groups and their respective publications.

Name of Working Group (year of establishment) Titles of publications (year of publishing)
CIOMS VIII: CIOMS Working Group on Signal Detection (2006) Practical Aspects of Signal Detection in Pharmacovigilance (2010); Translation: Chinese.
CIOMS IX: CIOMS Working Group on Practical Considerations for Development and Application of a Toolkit for Medicinal Product Risk Management (2010) Practical Approaches to Risk Minimisation for Medicinal Products (2014).
CIOMS Working Group to Revise CIOMS Ethical Guidelines for Biomedical Research (2011) International Ethical Guidelines for Health-Related Research Involving Humans (2016); Translations: Chinese, French, Japanese, Portuguese, Russian (with the support of WHO European Regional Office), Spanish (in cooperation with the Pan American Health Organization), and Ukrainian; to follow: Arabic.
CIOMS X: CIOMS Working Group on Considerations for applying good meta-analysis practices to clinical data within the biopharmaceutical regulatory process (2011) Evidence Synthesis and Meta-Analysis for Drug Safety (2016)
CIOMS Implementation Working Group on MedDRA (2012) Development and Rational Use of Standardised MedDRA Queries (SMQs): Retrieving Adverse Drug Reactions with MedDRA (2016), Translation: Japanese.
CIOMS Working Group on Vaccine Safety (2013) CIOMS Guide to Active Vaccine Safety Surveillance (2017); CIOMS Guide to Vaccine Safety Communication (2018).
CIOMS Working Group on Drug Induced Liver Injury (2017) Drug-induced Liver Injury: Current status and future directions for drug development and the post-market setting (2020)
CIOMS Working Group on Clinical Research in Resource-limited Settings (2017) Work in progress
CIOMS Working Group XI: Patient Involvement in the Development and Safe Use of Medicines (2018) Work in progress
CIOMS Working Group MedDRA Labelling Groupings (2019) Work in progress
CIOMS Working Group XII: Benefit-Risk Balance for Medicinal Products (2019) Work in progress
CIOMS Working Group XIII: Real-World Data and Real-World Evidence in Regulatory Decision Making (2020) Work in progress

Membership

International Members

National Members

Associate Members

Round table conferences

CIOMS has organized Round Table Conferences on the following topics:

  • I. Biomedical Science and the Dilemma of Human Experimentation Paris, France, 1967
  • II. Heart Transplantation Geneva, Switzerland, 1968
  • III. Evaluation of Drugs: Whose Responsibility? Liège, Belgium, 1968
  • IV. Medical Research: Priorities and Responsibilities, Geneva, Switzerland, 1969
  • V. Training of Research Workers in Medical Sciences, Geneva, Switzerland, 1970
  • VI. Drug Abuse: Non-Medical Use of Dependence-Producing Drugs, Geneva, Switzerland, 1971
  • VII. Recent Progress in Biology and Medicine: Its Social and Ethical Implications, Paris, France, 1972
  • VIII. Protection of Human Rights in the Light of Scientific and Technological Progress in Biology and Medicine, Geneva, Switzerland, 1973
  • IX. Medical Care and Society, Rio de Janeiro, Brazil, 1974
  • X. Health Needs of Society: A Challenge for Medical Education Ulm, Germany, 1976
  • XI. Trends and Prospects in Drug Research and Development, Geneva, Switzerland, 1977
  • XII. Medical Ethics and the Protection of Human Rights Cascais, Portugal, 1978
  • XIII. Economics and Health Policy, Geneva, Switzerland, 1979
  • XIV. Medical Ethics and Medical Education, Mexico, 1980
  • XV. Human Experimentation and Medical Ethics, Manila, Philippines, 1981
  • XVI. Health for All –a Challenge to Research in Health Manpower Development, Ibadan, Nigeria, 1982
  • XVII. Biomedical Research Involving Animals –Proposed International Guiding Principles, Geneva, Switzerland, 1983
  • XVIII. Health Policy Ethics and Human Values: An International Dialogue, Athens, Greece

1984

  • XIV. Battered Children and Child Abuse, Berne, Switzerland, 1985
  • XX. Health Manpower out of Balance. Conflicts and Prospects, Acapulco, Mexico 1986
  • XXI. Health Policy, Ethics and Human Values: European and North American Perspectives, Noordwijk, the Netherlands, 1987
  • XXII. Ethics and Human Values in Family Planning, Bangkok, Thailand, 1988
  • XXIII. Health Technology Transfer: Whose Responsibility? Geneva, Switzerland, 1989
  • XXIV. Genetics, Ethics and Human Values: Human Genome Mapping, Genetic Screening and Gene Therapy, Tokyo and Inuyama City, Japan, 1990
  • XXV. Ethics and Epidemiology: International Guidelines, Geneva, Switzerland, 1990
  • XXVI. Ethics and Research on Human Subjects. International Guidelines, Geneva, Switzerland, 1992
  • XXVII. Drug Surveillance: International Cooperation –Past, Present and Future, Geneva, Switzerland, 1993
  • XXVIII. Poverty, Vulnerability, the Value of Human Life and the Emergence of Bioethics, Ixtapa, Mexico, 1994
  • The Declaration of Inuyama, a follow-up to the 1990 Conference, Inuyama and Nagayo, 1995
  • XXIX. Ethics, Equity and Health for All, Geneva, Switzerland, 1997

See also

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