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 Guidance for IRBs, Investigators and Sponsors
- Significant Risk and Nonsignificant Risk Medical Device Studies
- FDA Guidance FAQs on Form 1572, Updated, May 2010
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 Consolidated Guidance (PDF)
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.
European Union General Data Protection (GDPR)