Ethical Guidelines for Human Research Revised

Regulatory NewsRegulatory News | 06 December 2016 |  By 

The Council for International Organizations of Medical Sciences (CIOMS) last week finalized the latest revision to its ethical guidelines for health research involving human participants.

According to CIOMS, the revision aims to address challenges and shortcomings with the previous revision from 2002, especially related to value and fairness of research involving human subjects.

In 1982, CIOMS released its first set of guidelines aimed at creating a set of internationally recognized ethical principles for biomedical research that addresses research conducted in low-resource settings. In the intervening years, CIOMS updated its guidelines twice more in response to global health questions that challenged previous standards, once in 1993 and again in 2002.


In this latest revision, CIOMS attempts to address new developments and questions that have arisen over the past decade and a half.

"Since 2002, several developments had taken place including: a heightened emphasis on the importance of translational research, a felt need to clarify what counts as fair research in low-resource settings, more emphasis on community engagement in research, the awareness that exclusion of potentially vulnerable groups in many cases has resulted in a poor evidence base, and the increase of big data research."

The 2016 version also significantly broadens the scope of the research covered by the 25 guidelines—from biomedical research to "health-related research." According to CIOMS, "the Working Group considered biomedical research too narrow, since that term would not cover research with health-related data, for example."

In an article appearing in JAMA on Tuesday, CIOMS President and professor of medical ethics Dr. Johannes JM van Delden and Dr. Rieke van der Graaf, who headed the working group tasked with revising the CIOMS guidelines, lay out the major changes from the previous version.

According to the van Delden and van der Graaf, the revised CIOMS guidelines begin by placing greater importance on the scientific and social value of research.

"Researchers and sponsors must ensure that research addresses important and unsolved questions to improve health and increase the reliability of scientific information, promote efficient translation, and reduce research waste, even when research investigation poses few or only minor risks to study participants," they write.

The revised guidelines also significantly alter the concept of vulnerable populations with the aim of including patients previously considered vulnerable, such as children or individuals incapable of giving informed consent.

Additionally, the revised guidelines attempt to tackle the inadequacies of traditional informed consent for studies involving biological materials and health data rather than human participants. Instead, the new guidelines include discussions on the concept of broad informed consent and informed opt-out procedures for such studies.

"Broad informed consent in essence is consent for governance. Adequate governance systems substitute for the loss of an individual's control over her or his data and biological materials. These governance systems should specify—among other items—to which legal entity the material is entrusted, how authorization from the donor is obtained, and what procedure determines whether unsolicited findings should be disclosed," they write.




© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy