In 2011, the CIOMS Executive Committee decided to set up a Working Group to revise the CIOMS guidelines. Since then the Working Group and CIOMS staff have worked hard to revise and update CIOMS 2002 guidelines with an additional aim to merge it with CIOMS 2009 International Ethical Guidelines for Epidemiological Studies. 

The new CIOMS International Ethical Guidelines for Health-related Research Involving Humans  are now available in PDF format.  Printed copies will be available for purchase from 1 February 2017.

Download the PDF version here

 

CIOMS International Ethical Guidelines

CIOMS, in association with WHO, started its work on ethics in biomedical research in the late 1970s. The World Medical Association had issued the initial Declaration of Helsinki in 1964 and an expanded version in 1975. The outcome of the CIOMS/WHO collaboration was entitled Proposed International Ethical Guidelines for Biomedical Research Involving Human Subject (1982). The period that followed saw the outbreak of the HIV/AIDS pandemic and proposals for large-scale trials of prevention and treatment for the disease. These developments, including research involving vulnerable populations, progress in product development and biotechnology, raised new ethical issues that had not been considered in former guidelines.

The Declaration of Helsinki was revised twice in the 1980s – in 1983 and 1989. It was timely to revise and update the CIOMS 1982 guidelines. Working with partners such as WHO and its Global Programme on AIDS resulted in two sets of guidelines: International Guidelines for Ethical Review of Epidemiological Studies in 1991, and International Ethical Guidelines for Biomedical Research Involving Human Subjects in 1993. After several years, ethical issues emerged for which the 1993 CIOMS Guidelines had no specific provisions. They related mainly to externally sponsored clinical trials carried out in low-resource settings. The revision process was started and CIOMS organized a consultation meeting with eight commissioned papers. The revision process finished with the third version of the CIOMS guidelines issued in 2002.  Changes in the environment also triggered the revisiting of the 1991 guidelines of epidemiological studies. In 2009, the new CIOMS International Ethical Guidelines for Epidemiological Studies was published.  

During its annual meeting in 2009 the Executive Committee of CIOMS considered the desirability of a revision of the CIOMS Ethical Guidelines for Biomedical Research Involving Human Subjects. Since 2002, several new developments had again taken place including the revision of the Declaration of Helsinki in 2008. In 2011, the CIOMS Executive Committee decided to set up a Working Group to revise the CIOMS 2002 and 2009 guidelines. The Working Group decided to broaden the scope of the 2002 guidelines from “biomedical research” to “health-related research”. The Working Group considered biomedical research too narrow since that term would not cover research with health-related data, for example.

The Working Group also acknowledged that there is no clear distinction between the ethics of social science research, behavioural studies, public health surveillance and the ethics of other research activities. The current scope is confined to the classic activities that fall under health-related research with humans, such as observational research, clinical trials, biobanking and epidemiological studies. 

This group has met several times since September 2012.  In September 2015 the Working Group also opened its draft for public comments.

More information about the revision process can be found here.

The Council for International Organizations of Medical Sciences (CIOMS) is happy to web post the text of the new CIOMS International Ethical Guidelines for Health-related Research involving Humans. This web posted final text was approved by the CIOMS Executive Committee during the XXII General Assembly of CIOMS on 29 November 2016. 

Press event agenda

Watch the press event

CIOMS Guidelines and WMA Declaration of Helsinki

Revision of CIOMS Guidelines Overview

New Meetings

1st Working Group on DILI Meeting, Geneva, Switzerland, 27-28 April 2017

11th Working Group on MedDRA IWG Meeting, Geneva, Switzerland, 22-23 March 2017

CIOMS 84th Executive Committee Meeting, Geneva, Switzerland, 28 November 2017

 

Recent Meetings

83rd CIOMS Executive Committee/General Assembly Meeting, Geneva, Switzerland, 29 November 2016

10th Working Group on MedDRA IWG Meeting, Geneva, Switzerland, 6-7 September 2016

10th Working Group Meeting on Revision of CIOMS International Ethical Guidelines, Utrecht, Netherlands, 1-3 June 2016

8th CIOMS Working Group Meeting on Vaccine Safety, Accra, Ghana, 22-23 March 2016

9th Working Group on MedDRA IWG Meeting, Geneva, Switzerland, 15-16 March 2016

82nd CIOMS Executive Committee Meeting, Geneva, Switzerland, 8 December 2015

ISoP meeting, Prague, Czech Republic, 27-30 October 2015

8th Working Group on MedDRA IWG Meeting, Geneva, Switzerland, 24-25 September 2015

7th CIOMS Working Group meeting on Vaccine Safety, near Philadelphia, PA, USA, 21-22 September 2015

8th Working Group X on Meta-analysis, New Brunswick, NJ, USA, 1-2 July 2015

9th Working Group on Revision of CIOMS International Ethical Guidelines, Paris, France, 14-16 June 2015

th Working Group on MedDRA IWG, Chavannes-de-Bogis, Switzerland, 19-20 May 2015

8th Working Group on Revision of CIOMS International Ethical Guidelines, Vilnius, Lithuania, 22-24 March 2015

6th Vaccine Safety Working Group, Lyon, France, 18-19 March 2015 

ISoP Meeting, Mysore, India, 12-14 January 2015

 

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