Which populations are protected by Subparts B, C, and D of 45 CFR 46?

Which populations are protected by Subparts B, C, and D of 45 CFR 46?

• A. Subpart B protects pregnant women, fetuses, and neonates; Subpart C protects prisoners; Subpart D protects children.
• B. Subpart B protects animals; Subpart C protects minors; Subpart D protects elderly.
• C. Subpart B protects healthy adults; Subpart C protects employees; Subpart D protects none.
• D. Subpart B protects minors; Subpart C protects veterans; Subpart D protects prisoners.

Answer: (A)

The main idea is that certain groups require extra protections under the Common Rule. Subpart B adds safeguards for pregnant women, fetuses, and neonates; Subpart C adds safeguards for prisoners; and Subparts D adds safeguards for children. Together, these subparts specify who needs heightened protections beyond the general rules. So, surgeries for pregnant women, fetuses, and newborns have additional protections to address risks and consent issues; prisoners have safeguards because of potential coercion in correctional settings; and children have protections because they cannot give legally independent consent. This aligns with the populations listed under each subpart, which is why those groups are covered by Subparts B, C, and D of 45 CFR 46.

The main idea is that certain groups require extra protections under the Common Rule. Subpart B adds safeguards for pregnant women, fetuses, and neonates; Subpart C adds safeguards for prisoners; and Subparts D adds safeguards for children. Together, these subparts specify who needs heightened protections beyond the general rules.

So, surgeries for pregnant women, fetuses, and newborns have additional protections to address risks and consent issues; prisoners have safeguards because of potential coercion in correctional settings; and children have protections because they cannot give legally independent consent. This aligns with the populations listed under each subpart, which is why those groups are covered by Subparts B, C, and D of 45 CFR 46.