By Luke Gelinas, IRB Chairperson
The United States regulations governing research with humans pay special attention to two ethical concepts that may not be familiar from everyday life: “coercion” and “undue influence.” These concepts appear in the section of the regulations that address informed consent, where investigators are instructed “to seek consent only under such circumstances…that minimize the possibility of coercion and undue influence” (21 CFR 50.20). These concepts also surface in IRB review of research involving vulnerable populations, where the regulations enjoin IRBs to apply additional safeguards for populations that “are likely to be vulnerable to coercion or undue influence” (21 CFR 56.111).
Despite the regulatory importance of these concepts, there is wide variation in how they are understood and applied by IRBs in practice. Coercion and undue influence in research can take many forms, and it is important not only to be clear about what these ideas mean in the abstract but to also have a sense of what does, and what does not, count as concrete cases of coercion or undue influence. This permits IRBs to identify situations involving heightened risks of coercion and undue influence and apply reasonable protections consistently.