The revised Common Rule’s changing definition of vulnerable populations is the focus of Public Responsibility in Medicine and Research (PRIM&R) director Eliza Hurley’s most recent PRIM&R blog post. Dr. Hurley has some interesting comments about the removal of pregnant women as a vulnerable population, a change she describes as “welcome and long overdue.” She also addresses the IRB’s role in considering vulnerability. In her words, the Notice of Proposed Rulemaking suggested “the only vulnerability that needs to be considered [by and IRB] is vulnerability to coercion or undue influence.” However, she sees other types of vulnerabilities as relevant to IRB review — vulnerability to be exploited during the research process, to taking on excessive risk, or to being excluded from participating in research for convenience reasons. She notes that OHRP advisor Ivor Pritchard reminds us that the approval criterion of ensuring that subject selection is equitable gives IRBs the latitude to consider other types of vulnerability. However, Dr. Hurley notes that the criterion in the revised rule reads, “Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted. The IRB should be particularly cognizant of the special problems of research that involves a category of subjects who are vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons,” again specifically noting the issues of coercion and undue influence. “An explicit call to pay special attention to those who are vulnerable to coercion or undue influence risks the possibility that IRBs will take this as permission to ignore other types of vulnerability,” Dr. Hurley writes.
Please read her blog post at the link above. In addition to addressing issues important to IRB reviewers, it also contains links to some other useful resources and discussions.