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In an IRB context, a vulnerable participant is someone who, because of personal limitations, group membership, or situational constraints, may lack the freedom or capacity to refuse participation; vulnerability therefore undermines voluntariness and meaningful informed consent. [Belmont Report; 45 CFR part 46]. Vulnerability in this sense is important because if a person is not completely free to refuse to participate in research, in a sense they cannot give meaningful consent or assent to participate either. Vulnerability is thus tied to the "voluntariness" aspect of consent.

Because of this, federal regulations limit or prohibit the use of "Exempt" status for certain groups

Prisoners  [45 CFR 46.104(b)(2)]

Exemptions generally do not apply if prisoners are the target population. An exemption may only be used if the research is aimed at a broader population and only incidentally includes prisoners. Any study targeting prisoners requires Full Board review with a prisoner representative present. Students may only pursue research involving prisoners as part of a project for which a faculty or staff member is the principal investigator. Faculty and staff are advised that such projects will call for a slow review process compared to our traditionally efficient turnaround.

Children [45 CFR 46.104(b)(3)]

Exemptions apply for some categories of research. For example, the Interaction Exemption can only be used for educational tests or public observation where the researcher does not participate in the activities. Additionally, if limited IRB review is required, children cannot be included. The Educational Exemption and Secondary Research Exemptions can apply when their conditions are met. The Benign Behavioral Intervention exemption cannot be used for research including children. See the subpage on research with children for more information.

Pregnant Women, Fetuses, and Neonates [45 CFR 46.104(b)(1)]

All exemption categories may be applied if the specific conditions of the exemption are met. 

Non-exempt research: Particularly in the case of biomedical research, pregnant women and fetuses are federally defined as vulnerable but this situation of vulnerability is not discussed in depth here because Ä¢¹½ÊÓƵ researchers do not currently carry out biomedical research involving pregnant women or fetuses. IRB review of these projects focuses on (A) preliminary evidence, (B) whether the research prospectively offers direct benefit (to woman and/or fetus), (C) the level of risk to fetus/neonate, and (D) proper parental consent when required. 

Other Vulnerabilities (e.g., Cognitive, Economic, Institutional) [45 CFR 46.111(a)(7)]

Even if a population is not "federally defined" (like students, employees, or the medically ill), their vulnerability affects the voluntariness and comprehension of consent. Examples include:

• Cognitive or communicative: For example, a mental or language barrier; someone who does not speak English or is educationally disadvantaged, or is a child and thus not mature enough to understand the nature of the research, or is a developmentally delayed or mentally ill adult and thus in the same circumstance. Someone without cognitive or communicative barriers, but who is in an emotional state where they are not able to think clearly about or advocate for their own interests, could also fall into this category. Someone may also fall into this category if the voluntariness and comprehension conditions are met but the person is unable to express their choice about participating effectively for some reason.
• Institutional/Deferential: Students, employees, or patients may feel pressured to participate in a superior's research. This can be because they are subject to formal authority (institutional vulnerability) or informal power relationships (deferential vulnerability).
• Medical: the potential participant has a serious or terminal illness and thus has a medical need that they can only get met by participating in the research; alternately, a person who is depressed or otherwise emotionally upset as a result of their medical situation may not have the capacity to act in their own best interests
• Economic: Large incentives may have a coercive effect on disadvantaged participants. The issue of incentives is discussed on a separate subpage.
• Social: a person is a member of a social group that faces real or perceived discrimination and thus is unusually vulnerable to coercion in a research context. Undocumented immigrants, for example, may face a legal threat if they refuse to participate in research. 

None of the above points should be taken to mean that someone with one of the above identities or in one of the above situations can never participate in research, only that they are to receive special protections to make sure that they do in fact consent, have not been coerced, and understand clearly what participation in the research entails. The IRB will expect safeguards (independent consent procedures, reduced incentives, independent recruiters, translators, etc.) to be in place.