Federal regulations give special consideration to protecting the rights and welfare of vulnerable subjects. The regulations include additional provisions for research involving pregnant women, fetuses, and neonates (45 CFR 46 Subpart B); prisoners (45 CFR 46 Subpart C); and children (45 CFR 46 Subpart D) and (21 CFR 50 subpart D).
- Children (see Assent/Waiver of Assent)
- Decisionally Impaired Participants
- Pregnant Women, Fetuses and Neonates
Although these regulations are specific to these particularly vulnerable populations, investigators must consider other individuals or groups as vulnerable, such as those who are cognitively impaired, economically or educationally disadvantaged, minorities, the very sick, students, and others.
Before granting approval for research involving vulnerable populations, the Institutional Review Board (IRB) will evaluate the protocol to ensure safeguards are in place to protect the rights and welfare of the subjects. The nature and extent of these protections depends on the study population and the risks and likelihood of benefit involved in the research.