Glossary Term

Common Rule (45 CFR 46)

The federal policy for the protection of human subjects, codified at 45 CFR 46 and adopted by most federal departments and agencies.

The Common Rule, formally 45 CFR 46 Subpart A, was first issued in 1991 and revised in 2018. It establishes IRB requirements, informed consent standards, and protections for human subjects in federally supported research.

Subparts

**Subpart A**: Basic policy (Common Rule)
**Subpart B**: Pregnant women, fetuses, neonates
**Subpart C**: Prisoners
**Subpart D**: Children
**Subpart E**: IRB registration

The 2018 revisions introduced new exempt categories, the key-information section in consent, and single-IRB requirements for federally funded multi-site studies.

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