Regulations
Main content start
Belmont report
California Law: Protection of Human Subjects in Medical Experimentation Act
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
- IRB Frequently Asked Questions
- Clinical Trials and Human Subject Protections - Guidance, resources, good clinical practices (GCPs)
- Human Tissue Intended for Transplantation
- Human Cells, Tissues, and Cellular and Tissue-Based Products
- FDA Tissue and Tissue Product Q&A
OHRP: Office of Human Research Protections
- Title 45 CFR 46: Protection of Human Subjects
- Policy guidance and documents
- Decision Charts - Human Subject Regulations
- Inclusion of Children - Policy Implementation (NIH)
- Certificates of Confidentiality
- International Compilation of Human Research Protections - listing laws, regulations, and guidelines on human subjects research in over 100 countries, and standards from international and regional organizations
- International Compilation of Social-Behavioral Human Research Protections – Similar to the “International Compilation of Human Research Protections” listed above, but including only standards for social-behavioral research.
- OHRP Frequently Asked Questions
VA: Department of Veterans Affairs
- 38 CFR Part 16
- Office of Research & Development (ORD) Programs
- VHA Publications website including:
- VHA Directive 1200.05 - Requirements for the Protection of Human Subjects in Research
- VHA Handbook 1058.01 - Research Compliance Reporting Requirements
- VHA Handbook 1108.04 - Investigational Drugs and Supplies
- VA Directive 6500 - Managing Information Security Risk: VA Information Security Program
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