At its 78th Executive Committee Meeting in November 2011, CIOMS decided to initiate a review procedure of its Guidelines on Ethics in Biomedical Research published in 2002. The Guidelines are globally distributed and widely used.
Considering changes in the field of research and developments within research ethics and in order to provide proper guidance to the users of the CIOMS guidelines, they should be up to date and reflect the current state of the art in research ethics.
Many new points taken on board in the epidemiological guidelines of CIOMs published 2009 need also to be included in revised CIOMS guidelines. These include: (1) conflict of interest; (2) research using the Internet; and (3) epidemiological research close to or overlapping with "biomedical".
In addition, the revision of the Declaration of Helsinki together with the changes in other relevant documents do constitute a compelling reason for a revision.
The report is an updated and extended version of a recent publication in Basic and Clinical Ph...
4th Vaccine Safety Working Group, UMC, Uppsala, Sweden, 20-21 May 2014
6th Working Group on Revision of CIOMS International Ethical Guidelines, Geneva, Switzerland, 21-23 May 2014
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5th Working Group on MedDRA, ICH, Geneva, Switzerland, 9-10 April 2014
5th Working Group on Revision of CIOMS International Ethical Guidelines, Utrecht, Netherlands, 26-28 February 2014
7th Working Group X on Meta-analysis, Durham, North Carolina, USA, 25-26 February 2014
3rd Vaccine Safety Working Group, CDC, Atlanta, GA, USA, 5-6 February 2014
CIOMS 80th Executive Committee Meeting, XXI General Assembly & Workshop, 20 November 2013, WHO Headquarters, Geneva, Switzerland
CIOMS 4th Working Group on Revision of CIOMS International Ethical Guidelines, 17-19 November 2013, WHO Headquarters, Geneva, SwitzerlandCIOMS Working Group on Vaccine Safety 17-18 September 2013 , WHO Headquarters, Geneva, Switzerland
CIOMS WG X on Considerations for applying good meta-analysis practices to clinical safety data within the biopharmaceutical regulatory process, 12-13 September 2013, Singapore
CIOMS Working Group on the Review of 2002 International Ethical Guidelines, 26-28 June 2013, UMC, Utrecht, The Netherlands
CIOMS WG on Vaccine Safety, 29-30 May 2013 , EMA, London, UK
CIOMS Working Group on the Review of 2002 International Ethical Guidelines, 11-12 February 2013, Geneva, Switzerland
CIOMS Working Group X, 14-15 March 2013, MEB, Utrecht, The Netherlands
CIOMS Working Group IX, 18-19 March 2013, NDA, Stockholm, Sweden
MedDRA 3rd IWG Meeting, 9-10 April 2013, IFPMA/CIOMS, Geneva, Switzerland
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