Regulations
Belmont report [1]
California Law: Protection of Human Subjects in Medical Experimentation Act [2]
FDA: Food and Drug Administration [3]
- Informed Consent [4](guidance)
- 21 CFR Part 50 [5] - Protection of Human Subjects
- 21 CFR Part 56 [6] - Institutional Review Boards
- 21 CFR Part 312 [7] - Investigational New Drug Applications (INDs)
- 21 CFR Part 812 [8] - Investigational Device Exemptions (IDEs)
- Information Sheet Guidances [9] for IRBs, Investigators and Sponsors
- IRB Frequently Asked Questions [11]
- Clinical Trials and Human Subject Protections [12] - Guidance, resources, good clinical practices (GCPs)
- Human Tissue Intended for Transplantation [13]
- Human Cells, Tissues, and Cellular and Tissue-Based Products [14]
- FDA Tissue and Tissue Product Q&A [15]
OHRP: Office of Human Research Protections [16]
- Title 45 CFR 46: Protection of Human Subjects [17]
- Policy guidance and documents [18]
- Decision Charts - Human Subject Regulations [19]
- Inclusion of Children - Policy Implementation (NIH) [20]
- Certificates of Confidentiality [21]
- International Compilation of Human Research Protections [22] - 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 [23] – Similar to the “International Compilation of Human Research Protections” listed above, but including only standards for social-behavioral research.
- OHRP Frequently Asked Questions [24]
VA: Department of Veterans Affairs [25]
- 38 CFR Part 16 [26]
- Office of Research & Development (ORD) Programs [27]
- VHA Publications website including: [29]
- VHA Directive 1200.05 [30] - Requirements for the Protection of Human Subjects in Research
- VHA Handbook 1058.01 [31] - Research Compliance Reporting Requirements
- VHA Handbook 1108.04 [32] - Investigational Drugs and Supplies
- VA Directive 6500 - Managing Information Security Risk: VA Information Security Program [33]
International Research
- International Compilation of Human Research Protections [34] (OHRP) - listing laws, regulations, and guidelines on human subjects research in over 100 countries, and standards from international and regional organizations