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Veteran’s Affairs


As it pertains to a neonate, able to survive after delivery to the point of independently maintaining heartbeat and respiration. The Secretary may, from time to time, take in account medical advances and publish in the Federal Register guidelines to assist in determining whether a neonate is viable for purposes of 45 CFR 46. If a neonate is viable, then it may be included in research only to the extent permitted and in accordance with the requirements of 45 CFR 46.


Accidental or unintentional changes to or noncompliance with the IRB approved protocol that affects the subject's rights, safety, welfare, and/or the integrity of the data.


Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.

Vulnerable Subjects

Vulnerable populations can be defined as children, prisoners, pregnant women, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons. If vulnerable individuals are involved in clinical trials, IRBs must ensure that additional safeguards have been included to protect the vulnerable group. Safeguards may include the presence of interpreters or social workers to explain the research and ensure informed consent. IRBs have a specific obligation to protect those individuals who are particularly susceptible to coercion or undue influence (21 CFR 56.11). Studies involving vulnerable groups often pose difficult ethical questions. For example, vulnerable subjects may not be allowed to participate in research that involves more than minimal risk but conveys no benefits directly to the subjects. (21 CFR 56.11 and 45 CFR 46 Subparts B, C, D).