Code Of Federal Regulations Flashcards
45 CFR Part 46
HHS Regulation for the protection of human subjects in research. Includes 5 subparts.
45 CFR 46 Subpart B
Additional protections for pregnant women, human fetuses and neonates involved in research.
45 CFR 46 Subpart C
Additional protections pertaining to biomedical and behavioral research involving prisoners as subjects.
45 CFR 46 Subpart D
Additional protections for children involved as subjects in research.
21 CFR Part 11
Regulations for electronic records, electronic signatures, and handwritten signatures executed to electronic records.
21 CFR Part 50
Protection of human subjects in all clinical investigations regulated by the FDA.
21 CFR Part 56
General standards for IRBs that review clinical investigations regulated by the FDA.
21 CFR Part 312
Procedures and requirements governing the use of investigational new drugs (INDs).
INVESTIGATIONAL NEW DRUGS
21 CFR Part 812
Provides procedures for the conduct of clinical investigations of devices.
INVESTIGATIONAL DEVICES
What two forms provide regulations that govern IRBs?
45 CFR 46 & 21 CFR 56
What form regulates the informed consent process of human subjects?
21 CFR 50