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111.8 Organization Policy on Research Involving Vulnerable Populations

April 2016

Research conducted at the Organization may involve inclusion of populations that are mentioned in federal regulations DHHS 45 CFR 46 and FDA 21 CFR 56 as possible “vulnerable populations.”   Both sets of regulations state an “IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.” FDA regulations also include in the list “handicapped” persons.  The IRBs are authorized by the Organization to review and approve research to be conducted in any of the mentioned possible vulnerable populations.  Federal regulations do not outline specific criteria to be applied by an IRB when a project will enroll adult mentally disabled persons, or adult economically or educationally disadvantaged persons, or handicapped persons.  The Organization authorizes the IRBs to review and make case-by-case determinations on when a proposed population may constitute a vulnerable population.  The IRBs’ decisions regarding a vulnerable population will take into account the specific mental illness diagnosis, handicap, educational and/or economic disadvantage, the specific recruitment setting, and the nature of the research study proposed when making this determination. Additionally, when the IRB regularly reviews research that involves vulnerable participants, the IRB membership will include one or more members who are knowledgeable about or experienced in working with such participants.