The group's main goal is advancing public health by publishing guidelines on ethics, product development, and safety in medical research, such as the 2016 International Ethical Guidelines for Health-Related Research Involving Humans.[3]
The General Assembly of all CIOMS member organizations meets every year, alternating between in-person and teleconference formats, to elect the Executive Committee and its voting President. The Executive Committee of twelve representatives from national and international member groups meets at least one a year, appointing and guiding the Secretariat, consisting of the Secretary-General and their team in Geneva, Switzerland. The Executive Committee can invite non-voting ad hoc observers and technical experts.[4]
After its 1948 founding by UNESCO and the WHO as the Council for Coordination of International Medical Congresses, these UN specialized agencies funded its first conference in Brussels, Belgium. In 1952, the group was renamed as the Council for International Organizations of Medical Sciences (CIOMS) to reflect a focus on guiding member organizations that internally organize field-specific conferences. From 1967 to 1997, it organized annual round tables on medical science topics, offering a standardized conference format:[5]
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
In 1990, CIOMS shifted to a format of assembling working groups of scientists from regulatory bodies, industry, and academia to meet for 2–4 years to reach consensus with other stakeholders and publish recommended guidelines.[6] When the working groups are composed solely of CIOMS members, they are assigned a sequential identifier, whereas partnerships with outside groups are known by their specific topic:
Working Group I (founded 1990): International Reporting of Adverse Drug Reactions
Working Group II (founded 1992): International Reporting of Periodic Drug-Safety Update Summaries
Working Group III (founded 1995): Guidelines for Preparing Core Clinical-Safety Information on Drugs
Working Group IV (founded 1998): Benefit-Risk Balance for Marketed Drugs: Evaluation of Safety Signals
Standardized Medical Dictionary for Regulatory Activities (MedDRA) Queries (founded 2002)
Vaccine Pharmacovigilance (founded November 2005)
Working Group VIII (founded September 2006): Signal Detection
Working Group IX (founded April 2010): Risk Minimization
Working Group X (founded September 2010): Meta-Analysis
Bioethics (founded 2011)
Vaccine Safety (founded 2013)
Drug-Induced Liver Injury (founded April 2017)
Clinical Research in Resource-Limited Settings (founded November 2017)
Working Group XI (founded April 2018): Patient Involvement in the Development, Regulation and Safe Use of Medicines
Expert Working Group on MedDRA Labeling Groupings (founded April 2019)
Working Group XII (founded September 2019): Benefit-Risk Balance for Medicinal Products*
Working Group XIII (founded March 2020): Real-World Data and Real-World Evidence in Regulatory Decision Making*
International Guidelines on Good Governance Practice for Research Institutions (founded July 2021)
Working Group XIV (founded May 2022): Artificial Intelligence in Pharmacovigilance*
All reports are available from https://cioms.ch/publications/; Titles marked with * are not yet published (still work in progress)
In March 1959, Austin Bradford Hill, then director of the UK Medical Research Council's Statistical Research Unit, chaired a Vienna-based CIOMS conference on controlled clinical trials. The proceedings, published in 1960, commented on research ethics, experimental design, and statistical analysis. Hill would later outline "Bradford Hill criteria" for establishing causal relationships between statistically correlated phenomena.[7]
This publication laid the groundwork for CIOMS' 1982, 1993, 2002, 2009, and 2016 versions of International Ethical Guidelines for Health-Related Research Involving Humans.[3] These guidelines have been praised for including diverse stakeholders from low- and middle-income countries, compared to the Declaration of Helsinki written by physicians of the World Medical Association. While neither of these documents are legally binding like the Council of Europe's Oviedo Convention, their role as recommended guidelines avoids ethical imperialism.[8]
