Because research may pose additional and/or unknown risks to pregnant women, human fetuses and neonates, the regulations require additional safeguards for the protection of pregnant women, human fetuses and neonates in research. These safeguards are found in 45 CFR 46, Subpart B.
This page provides additional regulatory protections described in 45 CFR 46, Subpart C and applicable policies and guidance documents.
Definitions Specific to Subpart C
Roles and Responsibilities of NIH Staff in Reviewing and Funding Research Involving Prisoners
Roles and Responsibilities of the Office for Human Research Protections (OHRP)
Roles and Responsibilities of Awardee Institutions in the Protection of Prisoner-Subjects