Glossary Term

45 CFR 46 Subpart B

Regulatory

Also known as: Subpart B, pregnant women research protections, fetal research protections

Additional protections for pregnant women, human fetuses, and neonates involved in research.

Subpart B sets criteria the IRB must apply before approving research involving these populations, including assessment of risk to the woman versus the fetus, prospect of direct benefit, and consent requirements (e.g., both parents in certain circumstances).

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