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
  • Significant Risk and Nonsignificant Risk Medical Device Studies [10]
• 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]
  • Human Research Policies and Guidance [28]
• 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