Revision of CIOMS 2002 International Ethical Guidelines for Biomedical Research Involving Human SubjectsCIOMS

In 2010 the Executive Committee of CIOMS decided to revise the CIOMS Ethical Guidelines for Biomedical Research. The document was last revised in 2002. Since then, several developments have taken place, both in the field of biomedical research itself and in the field of research ethics. Among the latter developments is the recent revision of the Declaration of Helsinki in 2013.
The research and research ethics community, as well as the wider public, are now cordially invited to provide the Working Group of CIOMS with comments until 1 March 2016. The Working Group will then process the comments and suggestions, and submit the final document to the Executive Committee of CIOMS. This Committee will approve the document.

Status of the Current Draft

The current version of the CIOMS guidelines is a draft. Although guidelines address specific issues, such as choice of the control, individual informed consent, and research with children, the CIOMS guidelines should be read and understood as a whole. In the final version the Working Group will add introductory texts and appendices.

Literature and Guidance Documents

The draft guidelines have been based on the results of literature searches and ethical reflection within the Working Group. Certain papers and guidelines have been particularly valuable for the current draft guidelines, such as the Declaration of Helsinki of the WMA, the Ethical considerations in biomedical HIV prevention trials of UNAIDS and Standards and operational guidance for ethics review of health-related research with human participants of the WHO. All sources used will be acknowledged in the final document.

Major Changes

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 Working Group has also decided to merge the “Green Book” (the CIOMS Guidelines for Biomedical Research, 2002) with the “Blue Book” (the CIOMS Guidelines for Epidemiological Research, 2009) since the two guidelines substantially overlap each other. The scope of the guidelines has been broadened from biomedical research to health-related research with humans.

Providing Feedback

The proposal of the Working Group is now open for comments. Below each guideline there are two boxes: one for general comments and one for specific comments. Please provide us as much as possible with concrete, specific comments and text proposals. Since we expect to receive a great number of suggestions, we would like to caution that we will not be able to respond individually to each commentator.
Deadline for Comments: 1 March 2016

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Table of contents:
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