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The CIOMS (Council for International Organizations of Medical Sciences) guidelines on human research were originally developed to indicate how the ethical principles as set out in the Declaration of Helsinki could be effectively applied in low and middle income settings. First published in 1982, the guidelines were revised in 1993 and 2002. A CIOMS Working Group has been revising the guidelines since 2012, and the current draft text is now open for comment. The research and research ethics community, as well as the wider public, are now cordially invited to provide comments.
Further details: http://www.cioms.ch/index.php/guidelines-test
Deadline for comments: 1 March 2016.
Differences between the 2002 Guidelines and 2015 draft guidelines
The 2015 draft merges the CIOMS Guidelines for Biomedical Research (2002) with the CIOMS Guidelines for Epidemiological Research (2009) since the two guidelines substantially overlap each other. The scope of the current draft guidelines has accordingly been broadened from biomedical research to health-related research with humans.
Most guidelines have been substantially revised. Guidelines have also been merged where possible. At the same time, new guidelines have been added to address new, pressing issues that require ethical guidance (such as disaster research or implementation research). The revised table of contents, with links to the text, is below:
- Guideline 1 – Social value
- Guideline 2 – Research conducted in low-resource settings
- Guideline 3 – Equitable distribution of benefits and burdens in the selection of groups of participants in research
- Guideline 4 – Potential benefits and risks of research
- Guideline 5 – Choice of control in clinical trials
- Guideline 6 – Caring for participants’ health needs
- Guideline 7 – Community engagement
- Guideline 8 – Collaborative partnership and capacity building for research and review
- Guideline 9 – Individual informed consent
- Guideline 10 – Modifications and waivers of informed consent
- Guideline 11 – Use of stored biological materials and related data
- Guideline 12 – Use of health-related data in research
- Guideline 13 – Reimbursement and compensation for research participants
- Guideline 14 – Treatment and compensation for research-related harms
- Guideline 15 – Research involving vulnerable persons
- Guideline 16 – Research involving individuals who are not capable of giving informed consent
- Guideline 17 – Research involving children and adolescents
- Guideline 18 – Women as research participants
- Guideline 19 – Pregnant women and lactating women as research participants
- Guideline 20 – Research in disaster situations
- Guideline 21 – Implementation research
- Guideline 22 – Use of online information
- Guideline 23 – Research ethics committees and review
- Guideline 24 – Public accountability
- Guideline 25 – Conflicts of interest
Please visit the CIOMS website and the text of the specific Guidelines to provide feedback. The Working Group asks that as much as possible, concrete, specific comments and text proposals be provided and apologises that it will not be able to respond individually to each commentator.
The Council for International Organizations of Medical Sciences (CIOMS) is an associate partner of UNESCO, and is in official relations with WHO.
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