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Walter Reed Army Institute of Research (WRAIR)
Walter Reed Army Institute of Research (WRAIR)
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About Us
Leadership
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Command Sergeant Major
History
Mission
Biomedical Research
Center for Infectious Disease Research
Bacterial Diseases
Diagnostics and Countermeasures
Emerging Infectious Diseases
Entomology
Experimental Therapeutics
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Biologics Research & Development
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Viral Diseases
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Multidrug-Resistant Organism Repository and Surveillance Network
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Human Subjects Protection
Regulations
Regulations
Other Regulations & Guidance
10 USC 980
HIPAA Privacy Act
International Conference on Harmonization (ICH) E6 (R2) Guidelines for Good Clinical Practice
National Academy of Sciences: Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age
The Belmont Report
The Nuremberg Code
USAMRMC Policy 2018-75: Administrative Oversight Review and Approval
World Medical Association Declaration of Helsinki
Title 21
21 CFR 11 - Electronic Records; Electronic Signatures
21 CFR 312 - Investigational New Drug Application
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 812 - Investigational Device Exemptions
More
Office of Secretary of Defense
32 CFR 219 - Protection of Human Subjects
Title 45
45 CFR 46 - Protection of Human Subjects
Army Regulations
Army Regulation 70-25 - Use of Volunteers as Subjects of Research
Army Regulation 40-68 - Clinical Quality Management
Additional Considerations
Click to learn how the Revised Common Rule will be implemented at WRAIR.
DoD Directives
DODI 3216.02 - Protection of Human Subjects and Adherence to Ethical Standards …
WRAIR IRB Policies & Appendices
WRAIR Policy #01: Submission of Protocols for Ethical Review
WRAIR Policy #01: Submission of Protocols for Ethical Review - Appendix A
WRAIR Policy #01: Submission of Protocols for Ethical Review - Appendix B
WRAIR Policy #01: Submission of Protocols for Ethical Review - Appendix C
WRAIR Policy #02: Determinations
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
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