SOPs

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Standard Operating Procedures

Protocol Life-Cycle Actions
UWZ-002.01 Scientific Review of Human Subjects Research Protocols
UWS-HP-603.02 Conducting Initial Review of Human Subjects Research
UWS-HP-603.02 Appendix A1 PEF
UWS-HP-603.02 Appendix A2 Abbreviated PEF
UWS-HP-603.02 Appendix A3 WRAIR IRB Protocol Checklist
UWS-HP-603.02 Appendix A4a WRAIR IRB Consent From Template
UWS-HP-603.02 Appendix A4b Informed Consent Form Template
UWS-HP-603.02 Appendix A5 Qualifications Summary
UWS-HP-603.02 Appendix A6 Limited IRB Review
UWS-HP-603.02 Appendix A7 Data Security Form

UWS-HP-615 03 Amendments to HSR

UWS-HP-618.03 Continuing Review and Continuation SOP
UWS-HP-618.03 Appendix 1 – Continuing Review 90 Day Notifications
UWS-HP-618.03 Appendix 2a – Continuing Review (CR) Application
UWS-HP-618.03 Appendix 2b – Abbreviated Continuing Review (CR) Application
UWS-HP-618.03 Appendix 3 – HSPB and WRAIR IRB Member Continuing Review Worksheet

UWZ-623.01 Submission of Protocols Involving Human Subjects, Human Biological Materials, and/or Human Data for Scientific and Ethical Review
IRB Processes & Procedures
UWS-HP-605.02 Humanitarian Use Devices
UWS-HP-606.03 SOP Non-Compliance W
UWS-HP-606.03 A Intake Form
UWS-HP-606.03 B Non-Compliance Report
UWS-HP-606.03 C Non-Compliance Process Checklist
UWS-HP-609.04 Conflicts of Interest Appendix A
UWS-HP-609.04 Conflicts of Interest Appendix B
UWS-HP-610 04 IRB Non Disclosure Form
UWS-C-612.04 Appeal of IRB Decisions
UWS-C-613.04 Expedited Human Subjects Research Protocol Review
UWS-HP-613.04 - Appendix A Expedited Review Categories
UWS-HP-613.04 - Appendix B Expedited Review Checklist
UWS-HP-617.02 Waiver or Alteration of Informed Consent for Minimal Risk Research
UWS-C-619.03 Safety Reporting for Clinical Trials
UWS-C-621.03 Deviations and Unanticipated Problem Reporting
UWS-C-621.03 Appendix A Deviation Form
UWS-C-621.03 Appendix B
UWS-C-621.03 Appendix C
UWS-C-621.03 Appendix D
UWS-C-628.02 Review of Human Subjects Research by the Fully Convened WRAIR IRB
UWS-C-628.02 Appendix A
UWS-C-628.02 Appendix B
UWS-C-628.02 Appendix C
UWS-C-628.02 Appendix D
UWS-C-628.02 Appendix E
UWS-C-628.02 Appendix F
UWS-HP-638.00 Progress Reports and Continuation Determination
Review and to HRPO
WRAIR IRB - Fully Constituted Ethics Board with DOD and HHS Assurances
Compliance Monitoring
UWZ-C-633.01 Routine Monitoring for Human Subjects Research Program Compliance
UWS-H-633.02 Post Approval Compliance Monitoring for Human Subjects Research
UWZ-C-634.01 Directed (For Cause) Monitoring of Human Subjects Research
Recruitment & Consent Process
UWS-HP-608.02 Waiver of IC in GTMR Emergency Research
UWZ-C-617.02 Waiver or Alteration of Informed Consent for Minimal Risk Research
UWZ-C-627.01 Review of Recruitment Processes and Materials

More
Specific Types of Research
UWZ-C-604.02 Expanded Use of Investigational Drugs for Treatment Use
UWZ-C-607.02 Emergency Use Notification and Reporting Procedures
Additional Considerations
UWZ-C-624.01 Working with Other Institutions Engaged in Research (Assurances, IAAs, & Deferrals)
WRAIR Policy Letters
Implementation-Redacted 03012021
WRAIR Policy 12-02: Records Management
WRAIR Policy 26: DoD Human Research Protection Program (HRPP) Summary of Education - Redacted
WRAIR Policy 26: Enclosure 1
WRAIR Policy 26: Enclosure 2
WRAIR Policy 26: Enclosure 3
WRAIR Policy 28: Compensation for Federal Employment when They Participate in Research as Human Subjects-Redacted 03032021
WRAIR Policy 28: Appendix A
WRAIR Policy 28: Appendix B
WRAIR Policy 29: Assignment of Principle Investigators (002) - Redacted 02282021
WRAIR Policy 30: Human Subjects Research Protocol Closure (002)-Redacted 03012021
WRAIR Policy 31: Final Approval Authorization for Human Subjects Research Protocol

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