Regulation and Guidance that Apply to Research Involving Human Subjects
ICH/GCP Regulations
Belmont Report
FDA
FDA Guidance
21 CFR 50 - Protection
21 CFR 56 - Institutional Review Boards, (FDA)
21 CFR 312 - Investigational New Drug Applications, (FDA)
21 CFR 812 - Investigational Device Exemptions, (FDA)
DEPARTMENT OF HEALTH AND HUMAN SERVICES
45 CFR 46 - Federal Policy for the Protection of Human Subjects. The Common Rule (DHHS)
US HHS Office for Human Research Protections (OHRP)
US HHS Office for Human Research Protections (OHRP) - Frequently asked Questions