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Regulations

Title 21
21 CFR 11 - Electronic Records; Electronic Signatures
21 CFR 50 - Protection of Human Subjects
21 CFR 54 - Financial Disclosure by Clinical Investigators
21 CFR 56 - Institutional Review Boards
21 CFR 600 - Biological Products: General
21 CFR 312 - Investigational New Drug Application
21 CFR 812 - Investigational Device Exemptions
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Title 45
45 CFR 46 - Protection of Human Subjects
Office of Secretary of Defense
32 CFR 219 - Protection of Human Subjects
WRAIR IRB Policies & Appendices
WRAIR Policy #24: Submission of Protocols Involving Human Subjects, Human Information or Biospecimens, for Scientific and Ethical Review
WRAIR Policy #24: Appendix A
WRAIR Policy #24: Submission Cover Memo - Appendix B
WRAIR Policy #24: Appendix C
WRAIR Policy #25: Determination that an Activity is Research Involving Human Subjects
WRAIR Policy #26: DoD Human Research Protection Program (HRPP) Summary of Education
WRAIR Policy #04: Cadaver Use
WRAIR Policy #04: Cadaver Use - Appendix D
WRAIR Policy #09: Use of Existing Human Biological Specimens and Information
WRAIR Policy #09: Use of Existing Specimens - Appendix A
WRAIR Policy #09: Use of Existing Specimens - Appendix B
WRAIR Policy #10: Public Health Activity Determination
WRAIR Policy #10: Public Health Activity Determination - Appendix A
WRAIR Policy #10: Public Health Activity Determination - Appendix B
WRAIR Policy #30: Human Subjects Research Protocol Closure
WRAIR Policy #31: Final Approval Authorization for Human Subjects Research Protocol Implementation
WRAIR Policy #32: Use of Existing Human Biological Specimens and Human Data
Army Regulations
Army Regulation 70-25 - Use of Volunteers as Subjects of Research
Army Regulation 40-68 - Clinical Quality Management
DoD Directives
DODI 3216.02 - Protection of Human Subjects and Adherence to Ethical Standards …
DODD 6000.08
10 USC 980
Other Regulations & Guidance
USAMRMC Policy 2018-75: Administrative Oversight Review and Approval
The Nuremberg Code
The Belmont Report
World Medical Association Declaration of Helsinki
HIPAA Privacy Act
NIH Guidelines on Recombinant DNA and Gene Transfer
International Conference on Harmonization (ICH) E6 (R2) Guidelines for Good Clinical Practice
2015 Edition of the International Compilation of Human Research Standards
National Academy of Sciences: Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age
Additional Considerations
Click to learn how the Revised Common Rule will be implemented at WRAIR.

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