Critical analysis of the Council for International Organizations of Medical Sciences 2016 International Guidelines for health-related research involving humans.

This paper presents a preliminary discussion of the Council for International Organizations of Medical Sciences (CIOMS), recently issued “International Ethical Guidelines for Health-related Research Involving Humans” (2016) that acknowledges the document’s declared concern of the protection of human subjects and awareness of their needs and interests in “low-resource settings”. Nevertheless, guideline recommendations present exceptional situations –vulnerability, mental incompetence- wherein voluntary and consented participation may be reduced or omitted under three concurrent conditions: compelling scientific value, the need to include persons that will not benefit directly from participation, exposure to minimal or slight risks. CIOMS 2016 extends the range of issues than need deliberation and regulation, but it does not clarify controversial issues in research ethics. The indetermination of special situations that would allow incomplete or absent informed disclosure weakens rigorous ethical norms and opens up to slippery slopes of permissiveness that may be harmful to host-nations and participants of biomedical studies.