Regulations

FDA: Food and Drug Administration

Informed Consent (guidance)
21 CFR Part 50 - Protection of Human Subjects
21 CFR Part 56 - Institutional Review Boards
21 CFR Part 312 - Investigational New Drug Applications (INDs)
21 CFR Part 812 - Investigational Device Exemptions (IDEs)
Information Sheet Guidances for IRBs, Investigators and Sponsors

Summary of Investigator Responsibilities IRB Frequently Asked Questions
Clinical Trials and Human Subject Protections - Guidance, resources, good clinical practices (GCPs)
Good Clinical Practice (ICH) - Summary of Investigator Responsibilities (PDF)
Good Clinical Practice - International Conference on Harmonisation (ICH): Consolidated Guidance (pdf file)

OHRP: Office of Human Research Protections

Title 45 CFR 46: Protection of Human Subjects
Policy guidance and documents
Inclusion of Children - Policy Implementation (NIH)
Certificates of Confidentiality
OHRP Frequently Asked Questions

International Research

International Compilation of Human Research Protections (OHRP) - listing laws, regulations, and guidelines on human subjects research in over 100 countries, and standards from international and regional organizations.