Regulation and Guidance that Apply to Research Involving Human Subjects

NIH: Certificates of Confidentiality
ICH/GCP Regulations
Human Subject Regulations Decision Charts, (DHHS) (9/04)
Belmont Report
ICMJE Guidelines for clinical trial registration

FROM 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)

US 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
Clinical Trials and Insurance Coverage - A Resource Guide