Special procedures apply to vulnerable populations. The procedures provide additional safeguards in research activities involving:
- pregnant women
- human fetuses
- incapacitated subjects
Investigators must complete and submit a Form for inclusion of pregnant women, fetuses, or neonates in research activities. Prisoners may be unduly influenced by their incarceration to participate in research, and, in order to ensure that their decision to participate is not coerced, the will adhere to Subpart C of 45 CFR 46. Investigators must complete and submit a Form E to request the inclusion of prisoners as research subjects. Children are another vulnerable population requiring special protection (see 45 CFR Part 46, Subpart D or 21 CFR Part 50, Subpart D). Investigators must complete and submit an Form #2D to request the inclusion of children as research subjects. Finally, research activities involving potential research subjects who, for a wide variety of reasons, are incapacitated to the extent that their decision-making capabilities are diminished or absent require additional protective measures. Impaired capacity is not limited to individuals with neurologic, psychiatric, or substance abuse problems. Conversely, researchers should not presume these individuals are cognitively impaired. Investigators must complete and submit an Form B to request the inclusion of subjects with impaired decision-making capacity.
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