2016
New CIOMS Ethical Guidelines for Health-related research involving humans.
OUR MISSION
The Council for International Organizations of Medical Sciences (CIOMS) is an international, non-governmental, non-profit organization established jointly by WHO and UNESCO in 1949. CIOMS represents a substantial proportion of the biomedical scientific community through its member organizations, which include many of the biomedical disciplines, national academies of sciences and medical research councils. CIOMS mission is to advance public health through guidance on health research including ethics, medical product development and safety.
Interesting facts about CIOMS
×
book
1986 – The very 1st CIOMS Working Group report on Pharmacovigilance.
×
1986 – The very 1st CIOMS Working Group report on Pharmacovigilance.
CIOMS’ important work on pharmacovigilance originated from its programme on Drug Development and Use in the late 1980s. At that time it was called “The Monitoring and Terminology of Adverse Drug Reactions”. As a first step CIOMS convened a group of experts representing universities, regulatory agencies and drug manufacturers, and its report on "Monitoring and Assessment of Adverse Drug Effects" was published in 1986. This was followed by series of more than 12 CIOMS publications in the area of pharmacovigilance.
speaker_notes
The General Assembly of UN adopted CIOMS Principles of Medical Ethics Related to Prisoners in 1983.
×
The General Assembly of UN adopted CIOMS Principles of Medical Ethics Related to Prisoners in 1983.
In the 1970s and 80s CIOMS collaborated with the United Nations through its Centre of Human Rights and through the Committee on Crime Prevention and Control, of the Economic and Social Council (ECOSOC). The CIOMS Principles of Medical Ethics Related to Prisoners, which was drafted at the request of WHO, was adopted in 1982 by the General Assembly of the United Nations.
equalizer
The World Health Assembly adopted CIOMS Ethical Criteria for Medicinal Drug Promotion in 1994.
×
The World Health Assembly adopted CIOMS Ethical Criteria for Medicinal Drug Promotion in 1994.
In 1992, the World Health Organization’s 45th World Health Assembly (WHA) passed a resolution calling upon CIOMS to collaborate with WHO in convening a meeting of stakeholders to discuss possible approaches to advancing principles embodied in WHO’s Ethical Criteria for Medicinal Drug Promotion. The final report prepared by CIOMS was adopted with WHA resolution WHA47.11 in 1994, endorsing the report and requesting implementation of its principles. It is interesting to note that this WHA-approved document recommended to forbid direct-to-consumer advertising of prescription-only medicines to the general public. Although some countries like the USA have allowed direct-to-consumer advertising of prescription-only medicines since, WHA47.11 stands unchanged.
call_split
CIOMS - a pathfinder in International Nomenclature of Diseases.
×
CIOMS - a pathfinder in International Nomenclature of Diseases.
In 1975 CIOMS and WHO jointly undertook the International Nomenclature of Diseases (IND) project. Its principal objective was to define a single, internationally agreed recommended name for every for every morbid entity, in order to facilitate communication throughout the world. The main criteria for this name were that it should be specific, unambiguous, as self-descriptive as possible, as simple as possible, and based on cause where feasible. An additional objective of IND was that it should serve as a complement to the WHO International Classification of Diseases (ICD). The IND project drew on the services of 500 experts from many countries, and more than 20,000 synonymous terms were listed. However, due to lack of funds the project was suspended and no more volumes were issued after Volume VIII in 1992. The experience from the IND project was used in preparing the 10th Revision of the ICD.
question_answer
CIOMS pharmacovigilance guidelines have been the basis for respective ICH guidelines.
×
CIOMS pharmacovigilance guidelines have been the basis for respective ICH guidelines.
CIOMS Working Group (WG) guidelines have served as a basis for several ICH guidelines. For example:
- ICH-E2A (1994): Clinical Safety Data Management – Definitions and Standards for Expedited Reporting is based on the CIOMS I and II WG reports (1990 and 1992).
- ICH E2B is based on the report of CIOMS IA Working Group (1992).
- ICH-E2C (1996): Clinical Safety Data Management – Periodic Benefit-Risk Evaluation Reports (PBRER) is based on the work of CIOMS WGs II and III (1992, 1995).
- ICH-E2D (2003): Post-Approval Safety Management – Definitions and Standards for Expedited Reporting is based on the work of CIOMS WG V (2001)
- ICH-E2F (2010): Development Safety Update Reports is based on the report of CIOMS WG VIII (2006).
- ICH-E2A (1994): Clinical Safety Data Management – Definitions and Standards for Expedited Reporting is based on the CIOMS I and II WG reports (1990 and 1992).
- ICH E2B is based on the report of CIOMS IA Working Group (1992).
- ICH-E2C (1996): Clinical Safety Data Management – Periodic Benefit-Risk Evaluation Reports (PBRER) is based on the work of CIOMS WGs II and III (1992, 1995).
- ICH-E2D (2003): Post-Approval Safety Management – Definitions and Standards for Expedited Reporting is based on the work of CIOMS WG V (2001)
- ICH-E2F (2010): Development Safety Update Reports is based on the report of CIOMS WG VIII (2006).
work
The longest running CIOMS Working Group – since 2002 – is dedicated to Standardized MedDRA Queries (SMQs).
×
The longest running CIOMS Working Group – since 2002 – is dedicated to Standardized MedDRA Queries (SMQs).
The MedDRA Working Group (WG) on Standardised Medical Queries (SMQs) based on MedDRA terminology is, for the time being, CIOMS’ “oldest” Working Group having started back in 2003. It was subsequently modified to a core group in 2008 before becoming an Implementation Working Group (IWG) in 2011. This IWG has produced the “Red Books” on the Development and Rational Use of Standardised MedDRA Queries (SMQs). The latest update was published in 2016.
Our history
1993
Start of CIOMS focus on pharmacovigilance and reporting adverse drug reactions.
1982
Adoption by UN of CIOMS Medical Ethics for prisoners.
1977
Launch of Ethics of Research involving humans.
1959
Vienna meeting on controlled clinical trials.
1952
Present name CIOMS adopted.
1949
Council formally constituted in Brussels by WHO and UNESCO.
Read more about CIOMS history
In 1948
UNESCO consulted The 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 WHO and UNESCO 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, WHO and UNESCO.
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 Organisations of Medical Sciences (CIOMS) and its statutes were revised.
At the end of the 1950s,
CIOMS organised a meeting under the joint auspices of the UN Educational, Scientific and Cultural Organisation (UNESCO) and the World Health Organization (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.
The 1959 meeting was a methodological landmark. Read more about it here.
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 being 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 well balanced reports.
One of the major aims of CIOMS within the area of drug development and safety
has been to contribute to harmonised views of international systems and terminologies used for the safety surveillance of medicinal products and vaccines between stakeholders. It has therefore been crucial to invite all stakeholders; the independent status of CIOMS has permitted it to coordinate the contributions and expertise of senior scientists from research-based biopharmaceutical companies, national drug regulatory authorities, academia, and representative bodies of medical specialties to this harmonizing and strengthening of drug-safety surveillance measures. Scientists are invited based on their recognized specific expertise and, if required, in consultation with their background institution. Members and consulted experts and their affiliations are listed in the publications. The consensus reports and documents are discuss and recommend general principles without focusing on individual medicinal products. Areas covered include international reporting of adverse drug reactions (CIOMS I reporting form), management of safety data from clinical trials, periodic drug safety updates in the pre-and post-approval phases, core clinical safety information on drugs in development and also those available to patients and prescribers, Adverse Drug Reaction terminology, Standardized MedDRA® Queries (SMQs), drug development research issues, pharmacogenetics, pharmacovigilance in resource-limited countries and safety signal detection and management.
The International Council for Harmonisation (until 2015 International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use) or just “ICH”, is a unique arrangement bringing together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration. Since its inception in 1990 it has developed into most influential arrangement of producing regulatory guidelines, mostly for quality, safety and efficacy, which are implemented in the EU, Canada, Japan, Switzerland and United States.
As the CIOMS working groups have no legal jurisdiction or mandate to make binding decisions, reliance is placed on other bodies to incorporate the CIOMS recommendations, guidelines or good practices into a regulatory or legislative framework. ICH serves here a good example. Finally, it is important to notice that from June 2016, CIOMS is an official ICH observer.
History of CIOMS, its activities and members
More