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IRB Concerns: Vulnerable Participants

The concept of vulnerability means something different in an IRB context that it does in common usage of the term: a vulnerable participant is someone who, due to personal limitations or a situation they are in, might not be completely free to refuse to participate in a research study because they have reduced capacity to make decisions for themselves. 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 to participate either. We may talk of vulnerable individuals or vulnerable populations, but in either case the vulnerability is often due to one of the following conditions/situations, as described by the University of Virginia:

1) Cognitive or communicative (e.g., 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). Children are discussed on a separate subpage.

2) Institutional (a student participating in a professor's research or an employee in an employer's; in this instance, the researcher has power over the potential participant and could theoretically use that power in retribution if the potential participant elected not to participate; a similar reasoning is used in describing prisoners and other institutionalized people such as the elderly (in some cases) as vulnerable)

3) Deferential (the researcher is a doctor and the potential participant is a patient, or the researcher is a senior family member; in these circumstances the researcher is generally treated with special respect and deference and it is presumed that they will get their wishes)

4) 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). The issue of incentives is discussed on a separate subpage.

5) Economic (the potential participant is poor, homeless, or otherwise economically disadvantaged and the incentives to participate (free resources) would make such a difference in the person's life or well-being as to have a coercive effect). The issue of incentives is discussed on a separate subpage.

6) 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)

Prisoners in particular require special review on the part of the IRB including the presence of a prisoner representative during the Full Board review of the research. Prisoner representatives can include a former prisoner, a social worker, or an advocate of another generally accepted type. Students are discouraged from pursuing research involving prisoners and faculty and staff are advised that such projects will call for a slow review process compared to our traditionally efficient turnaround.

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 and have not been coerced.

Look for some changes to the above related to IRB legal modifications in the near future.