Information about vulnerable populations
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Pregnant women, fetuses, and neonates are federally defined vulnerable populations under federal regulations which specifies additional protections f…
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Prisoners are a vulnerable population under federal regulations. Research involving prisoners must meet the additional requirements in 45 CFR 46 Subp…
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Children are considered a vulnerable population under federal regulations. Research involving children must meet additional requirements under 45 CFR…
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Adults who lack the capacity to provide informed consent — or who lose capacity during a study — cannot be enrolled unless the NIH IRB has approved t…
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NIH staff and immediate family members of the study team are not a defined vulnerable population under federal regulations. However, your research in…
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American Indian/Alaska Native Tribes are sovereign nations with distinct cultural norms, and as such additional considerations are warranted when con…
Policies
405 - Policy- Research Involving American Indian/Alaska Native Persons, Their Data and Biological Materials
This policy describes the requirements that apply when the NIH Institutional Review Board (IRB) is reviewing, or when an NIH Investigator seeks to co…
When research involves vulnerable populations, the investigator should describe additional protections they will apply in their study to ensure these populations are as safe and ethical as possible.
The Institutional Review Board (IRB) decides if the additional protections for these populations are sufficient to include them in the research. The IRB may also require additional protections or might not permit the population to participate in the research if the risks are not acceptable.