| 45 CFR 46 Protection of Human Subjects |
The HHS (OHRP) regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children. |
| 45 CFR 164 Disclosures for Public Health Activities |
The Privacy Rule, HIPAA. |
| 21 CFR 50 Protection of Human Subjects |
(FDA) 21 CFR 50 Include the regualtions for the protection of human research subjects. In many ways, identical to 45 CFR 46. |
| 21 CFR 56 Institutional Review Boards |
(FDA) 21 CFR 56 provides regulations describing the general standards for the composition, operation, and responsibility of an Institutional Review Board (IRB). |
| 21 CFR Part 312 Investigational New Drug Applications |
FDA regulations for the investigation of new drugs or the testing of drugs for a new indication. |
| 21 CFR Part 812 Investigational Device Exemptions |
FDA regulations for the investigation of devices. |
