Office of Extramural Research (OER) Web Site
Research Involving Vulnerable Populations
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Pregnant Women, Human Fetuses and Neonates
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. -
Prisoners
This page provides additional regulatory protections described in 45 CFR 46, Subpart C and applicable policies and guidance documents. -
Children
This page provides additional regulatory protections described in 45 CFR 46, Subpart D and applicable policies and guidance documents -
Persons at Risk for Suicidality
NIMH Issues to Consider in Intervention Research with Persons at High Risk for Suicidality -
Persons with Impaired Decisional Capacity
Research Involving Individuals with Questionable Capacity to Consent: Points to Consider
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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
Links