Vulnerable Subjects
The Federal Regulations identify specific populations (special classes of subjects) as being especially vulnerable and requiring additional protections, including:
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Children.
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Prisoners.
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Individuals with impaired decision-making capacity.
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Economically or educationally disadvantaged persons.
When working with a vulnerable population, investigators should outline how they plan to create additional protections for the rights of these subjects. Some factors to consider are:
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Inclusion and exclusion criteria for selecting and recruiting participants.
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Informed consent and voluntarism.
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Coercion and undue influence.
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Confidentiality of data.
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Group characteristics such as economic, social, physical and environmental conditions, so that the research incorporates additional safeguards.
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Not overselecting or excluding certain groups based on perceived limitations or complexities associated with, or the easy availability of, those groups. (For example, it is not appropriate to target prisoners as research subjects merely because they are a readily available "captive" population.)
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Knowledge about applicable laws that bear on the decision-making abilities of potentially vulnerable populations.
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Having adequate procedures in place for assessing subjects' capacity, understanding and informed consent or assent.