CIOMS Recommendations on Ethics in Medical Research The Eighth Global Forum on Bioethics in Research Gottfried Kreutz Dr. med., Dipl.-Chem.; Director and Professor Secretary-General Council for International Organizations of Medical Sciences - PowerPoint PPT Presentation

Loading...

PPT – CIOMS Recommendations on Ethics in Medical Research The Eighth Global Forum on Bioethics in Research Gottfried Kreutz Dr. med., Dipl.-Chem.; Director and Professor Secretary-General Council for International Organizations of Medical Sciences PowerPoint presentation | free to download - id: 497fd-ZDc1Z



Loading


The Adobe Flash plugin is needed to view this content

Get the plugin now

View by Category
About This Presentation
Title:

CIOMS Recommendations on Ethics in Medical Research The Eighth Global Forum on Bioethics in Research Gottfried Kreutz Dr. med., Dipl.-Chem.; Director and Professor Secretary-General Council for International Organizations of Medical Sciences

Description:

... Medical Research. The Eighth Global Forum on Bioethics in Research ... Medical research ethics. Pharmacovigilance. New therapeutic or diagnostic approaches ... – PowerPoint PPT presentation

Number of Views:338
Avg rating:3.0/5.0
Slides: 22
Provided by: owd3
Learn more at: http://gfbronline.com
Category:

less

Write a Comment
User Comments (0)
Transcript and Presenter's Notes

Title: CIOMS Recommendations on Ethics in Medical Research The Eighth Global Forum on Bioethics in Research Gottfried Kreutz Dr. med., Dipl.-Chem.; Director and Professor Secretary-General Council for International Organizations of Medical Sciences


1
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
2
Outline - 1
  • Council for International Organizations of
    Medical Sciences (CIOMS)
  • - Founding
  • - Status
  • - Purpose and Objectives
  • - Domains of Activities

3
Outline - 2
  • CIOMS MedDRA Working Group
  • - Organization
  • - Task
  • - Composition of WG
  • - Work process
  • - Development steps

4
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)

5
Status of CIOMS
  • Non-Governmental Organization with financial
    assistance from the two parent organizations
    (WHO, UNESCO)

6
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)

7
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

8
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

9
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

10
International Ethical Guidelines for Biomedical
Research Involving Human Subjects
  • Geneva 2002

11
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)

12
CIOMS International Guidelines for Ethical Review
of Epidemiological Studies
  • Published Geneva 1991
  • Current working title, first revision
  • International Ethical Guidelines for
    Epidemiological Studies

13
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

14
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

15
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

16
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

17
Thank you for your attention !
  • For further questions,
  • please
  • Ask now,
  • Consult the CIOMS website www.cioms.ch,
  • Write to kreutzg_at_who.int

18
(No Transcript)
19
(No Transcript)
20
(No Transcript)
21
About PowerShow.com