CIOMS Recommendations on Ethics in Medical Research The Eighth Global Forum on Bioethics in Research

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CIOMS Recommendations onEthics in Medical
Research The Eighth Global Forum on Bioethics
in ResearchGottfried KreutzDr. med.,
Dipl.-Chem. Director and ProfessorSecretary-Gene
ralCouncil for International Organizations of
Medical Sciences
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Outline - 1

• Council for International Organizations of
  Medical Sciences (CIOMS)
• - Founding
• - Status
• - Purpose and Objectives
• - Domains of Activities

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Outline - 2

• CIOMS MedDRA Working Group
• - Organization
• - Task
• - Composition of WG
• - Work process
• - Development steps

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Founding and Founding Organizations

• Year 1948 Consultation (UNESCO gt WHO)
• 1949 Conference and
• Agreement (Bruxelles)
• By United Nations (UN)
• World Health Organization (WHO)
• United Nations Education and Science Organization
  (UNESCO)

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Status of CIOMS

• Non-Governmental Organization with financial
  assistance from the two parent organizations
  (WHO, UNESCO)

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Purpose of CIOMS

• " 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 furnishing
  them with material aid where necessary. "
  (Introduction to current Statutes)

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Objectives of CIOMS (Article 3 of Statutes)

• To act as a co-ordination centre between the
  international associations and the national
  institutions adhering to the Council
• To facilitate and co-ordinate the activities of
  the international members of the Council
• To maintain collaborative relations with the
  United Nations and its specialized agencies, in
  particular with UNESCO and WHO

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Objectives of CIOMS (Article 3 of Statutes)

• To promote international activities in the field
  of medical sciences whenever the participation of
  several international associations and national
  institutions adhering to the Council is deemed
  necessary
• To serve the scientific interests of the
  international bio-medical community in general

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Domains of Activities of CIOMS

• Planning and timing of international medical
  congresses (until 1966)
• Medical nomenclature
• Medical research ethics
• Pharmacovigilance
• New therapeutic or diagnostic approaches

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International Ethical Guidelines for Biomedical
Research Involving Human Subjects

• Geneva 2002

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International Ethical Guidelines for Biomedical
Research Involving Human Subjects

• The Guidelines relate mainly to ethical
  justification and scientific validity of
  research ethical review informed consent
  vulnerability of individuals, groups,
  communities and populations women as research
  subjects equity regarding burdens and benefits
  choice of control in clinical trials
  confidentiality compensation for injury
  strengthening of national or local capacity for
  ethical review and obligations of sponsors to
  provide health-care services.
• (Versions 1982, 1993, 2002)

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CIOMS International Guidelines for Ethical Review
of Epidemiological Studies

• Published Geneva 1991
• Current working title, first revision
• International Ethical Guidelines for
  Epidemiological Studies

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Process for revision of the 1991GL on
epidemiological research

• The Core Group has met seven times since 2003 -
  latest Group meeting March 2007
• ? Draft document (currently on the CIOMS
  website for second external comment)
• First external consultation from summer 2006 to
  January 2007
• ? More than 500 comments from some 30
  institutions
• From 4 - 6 June 2007, as a pre-final step,
• Consultative Meeting for invited experts
  together with the Core Group
• ? Core Group to re-consider all comments
  received and to prepare the pre-final document
• The pre-final draft is planned to be presented
  again on the
• CIOMS website (expected by fall 2007) before
  final approval

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Drug Development Research in Resource-Limited
Countries

• Date of draft report December 2005
• Deadline for external comments on-going
• (the original deadline, April 2006, has been
  extended
• Composition of Joint CIOMS / WHO Working Group
• Regulatory Authorities from developing
  countries, senior scientists from pharmaceutical
  companies, WHO CIOMS officers

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Summary (CIOMS)

• CIOMS is the only institution worldwide who
  provides organizational structure and a forum for
  all organizations of medical sciences, for
  professional experts from all sectors (academic,
  private, regulatory), and for all domains
• CIOMS provides expertise in the organization and
  efficient communication of globally harmonized
  expert opinions
• CIOMS works as a Think-Tank

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Summary (Guidance in Research Ethics)

• CIOMS has published for almost three decades
  globally harmonized recommendations for research
  ethics
• CIOMS guidance document are reviewed and updated
  periodically
• Contributions to documents, draft or final, are
  welcomed and encouraged at any stage in the
  process

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Thank you for your attention !

• For further questions,
• please
• Ask now,
• Consult the CIOMS website www.cioms.ch,
• Write to kreutzg_at_who.int

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