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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
More
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 for Ethical Review
WRAIR Policy #24: Appendix A Submission Memo
WRAIR Policy #24: Appendix B Submission Requirements Human Subjects
WRAIR Policy #24: Appendix C

WRAIR Policy #25: Determinations that Research is involving Human Subjects

WRAIR Policy #26: Initial and Ongoing Human Subject Protection Education and Training Requirements

WRAIR Policy #27: Use of Human Cadavers for Research and Development
WRAIR Policy #27: Appendix A
WRAIR Policy #27: Appendix B
WRAIR Policy #27: Appendix C
WRAIR Policy #27: Appendix D
WRAIR Policy #27: Appendix E
WRAIR Policy #27: Appendix F
WRAIR Policy #27: Appendix G

WRAIR Policy #28: Compensation for Federal Personnel
WRAIR Policy #28: Appendix A
WRAIR Policy #28: Appendix B

WRAIR Policy #29: Assignment of PIs
WRAIR Policy #30: Human Subjects Research Protocol Closure
WRAIR Policy #31: Final Approval Authorization for Human Subjects Research
WRAIR Policy #31: Appendix A

WRAIR Policy #32: Use of Existing Human Biological Specimens
WRAIR Policy #32: Appendix A
WRAIR Policy #32: Appendix B

WRAIR Policy #33: Public Health Activity Determination
WRAIR Policy #33: Appendix A
WRAIR Policy #33: Appendix B
WRAIR Policy #34: Personnel and Family Participation in WRAIR Research Studies
WRAIR Policy #34: Appendix A

WRAIR Policy #35: Policy and Procedures for Addressing Allegations of Research Misconduct

WRAIR Policy #12-02: Records Management
DoDI 3200.20: Scientific and Engineering Integrity
DoDI 3210.7: Research Integrity and Misconduct

Guidance from the WRAIR HSPB for PI Changes
Guidance from the WRAIR IRB HSPB Appendix A
Guidance from the WRAIR IRB HSPB Appendix B
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
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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