Manuals

• HRP-103–Manual–Investigator Manual
• HRP-103p–Manual–Investigator Manual–pSite

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Standard Operating Procedures

General SOPs

• HRP-001–SOP–Definitions
• HRP-012–SOP–Observation of Consent Process
• HRP-013–SOP–LARs, Children, and Guardians
• HRP-020–SOP–Incoming Items
• HRP-021–SOP–Pre-Review
• HRP-023–SOP–Emergency and Device Compassionate Use Review
• HRP-024–SOP–New Information
• HRP-025–SOP–Investigations
• HRP-026–SOP–Suspension or Termination Issued Outside of Convened IRB
• HRP-027–SOP–Emergency Use Compassionate Use Individual Patient Access Post-Review
• HRP-030–SOP–Designated Reviewers
• HRP-031–SOP–Non-Committee Review Preparation
• HRP-032–SOP–Non-Committee Review Conduct
• HRP-040–SOP–IRB Meeting Preparation
• HRP-041–SOP–IRB Meeting Conduct
• HRP-042–SOP–IRB Meeting Attendance Monitoring
• HRP-043–SOP–IRB Meeting Minutes
• HRP-044–SOP–Not Otherwise Approvable Research
• HRP-050–SOP–Conflicting Interests of IRB Members
• HRP-051–SOP–Consultation
• HRP-052–SOP–Post-Review
• HRP-055–SOP–Financial Conflicts of Interest
• HRP-060–SOP–Annual Evaluations of the HRPP
• HRP-061–SOP–Quarterly Evaluations of the HRPP
• HRP-063–SOP–Expiration of IRB Approval
• HRP-064–SOP–NIH GDS Institutional Certification
• HRP-065–SOP–Response Plan for Emergencies–Disasters Impacting the HRPP
• HRP-070–SOP–IRB Records
• HRP-071–SOP–Toolkit Management
• HRP-072–SOP–IRB Records Retention
• HRP-080–SOP–IRB Formation and Registration
• HRP-081–SOP–IRB Removal
• HRP-082–SOP–IRB Membership Addition
• HRP-083–SOP–IRB Membership Removal
• HRP-084–SOP–IRB Meeting Scheduling and Notification
• HRP-090–SOP–Informed Consent Process for Research
• HRP-091–SOP–Written Documentation of Consent

Single IRB Reliance-Specific SOPs

• HRP-801–SOP–Establishing Authorization Agreements
• HRP-802–SOP–Institutional Profile Management
• HRP-805–SOP–External IRB Updates
• HRP-806–SOP–Review Request to Cede Review

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General Documents

• HRP-104–Brochure–Should I Take Part in Research?
• HRP-105–Crosswalk–OHRP FDA Written Procedure Crosswalk
• HRP-108–Flowchart–Study-Specific Emergency–Disaster Risk Mitigation Planning
• HRP-109–Manual–IRB Member Manual

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Forms

• HRP-202–Form–IRB Member Information
• HRP-204–Form–IRB Committee Meeting Confidentiality Agreement (Kuali Build)
• HRP-206–Form–WVU Approved in Principle Request Form (Kuali Build)
• HRP-207–Form–QA/QI and Program Evaluation Self-Certification Tool (Kuali Build)
• HRP-208–Form–Emergency Use Concurrence Request (Kuali Build)
• HRP-817–Form–WVU IRB Reliance Request Form

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Worksheets

General Worksheets

• HRP-301–Worksheet–Review Materials
• HRP-302–Worksheet–Approval Intervals
• HRP-303–Worksheet–Communication of Review Results
• HRP-304–Worksheet–IRB Composition
• HRP-305–Worksheet–Quorum and Expertise
• HRP-306–Worksheet–Drugs and Biologics
• HRP-307–Worksheet–Devices
• HRP-308–Worksheet–Pre-Review
• HRP-309–Worksheet–Ancillary Review Matrix
• HRP-310–Worksheet–Human Research Determination
• HRP-311–Worksheet–Engagement Determination
• HRP-312–Worksheet–Exemption Determination
• HRP-313–Worksheet–Expedited Review
• HRP-314–Worksheet–Criteria for Approval
• HRP-314a–Worksheet–Criteria for Consent
• HRP-315–Worksheet–Advertisements
• HRP-316–Worksheet–Payments
• HRP-317–Worksheet–Short Form of Consent Documentation
• HRP-318–Worksheet–Additional Federal Agency Criteria
• HRP-320–Worksheet–Scientific or Scholarly Review
• HRP-321–Worksheet–Review of Information Items
• HRP-322–Worksheet–Emergency Use
• HRP-323–Worksheet–Criteria for Approval HUD
• HRP-325–Worksheet–Device Compassionate Use
• HRP-326–Worksheet–Performance Evaluation for IRB Chairs
• HRP-327–Worksheet–Performance Evaluation for IRB Members
• HRP-328–Worksheet–Performance Evaluation for IRB Staff
• HRP-330–Worksheet–HIPAA Authorization
• HRP-331–Worksheet–FERPA Compliance
• HRP-332–Worksheet–NIH GDS Institutional Certification
• HRP-333–Worksheet–Certificate of Confidentiality
• HRP-351–Worksheet–Protocol-Specific Emergency–Disaster Risk Mitigation Planning
• HRP-352–Worksheet–Additional Emergency–Disaster Review Considerations

Single IRB Reliance-Specific Worksheets

• HRP-830–Worksheet–Communication and Responsibilities
• HRP-832–Worksheet–Criteria for Ceding IRB Review
• HRP-833–Worksheet–Criteria for Serving as sIRB

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Checklists

• HRP-410–Checklist–Waiver or Alteration of Consent Process
• HRP-411–Checklist–Waiver of Written Documentation of Consent
• HRP-412–Checklist–Pregnant Women
• HRP-413–Checklist–Non-Viable Neonates
• HRP-414–Checklist–Neonates of Uncertain Viability
• HRP-415–Checklist–Prisoners
• HRP-416–Checklist–Children
• HRP-417–Checklist–Adults with Impaired Decision-Making Capacity
• HRP-418–Checklist–Non-Significant Risk Device
• HRP-419–Checklist–Waiver of Consent Process for Emergency Research
• HRP-430–Checklist–Investigator Quality Improvement
• HRP-431–Checklist–Minutes Quality Improvement
• HRP-441–Checklist–HIPAA Waiver of Authorization

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Templates

General Templates

• HRP-502–Template–Adult Medical Consent Document
• HRP-502a–Template–Adult Non-Medical Consent
• HRP-502b–Template–Parent Guardian Consent
• HRP-502c–Template–Child Assent Form
• HRP-502d–Template–Combined Parent Guardian and Child Consent
• HRP-502e–Template–Cover Letter
• HRP-502f–Template–Supplemental Consent Language for Studies Involving Digital Health Technology
• HRP-502g–Template–Stand-Alone HIPAA Authorization
• HRP-506–Template–Consent Document–Expanded Access
• HRP-507–Template–Consent Document–Short Form

Protocol Templates

• HRP-503–Template–Protocol
• HRP-503a–Template–SBS Protocol
• HRP-503b–Template–NHSR Protocol
• HRP-503c–Template–Secondary Research Protocol
• HRP-503d–Template–Humanitarian Use Device Protocol
• HRP-503e–Template–Exemption Determination Protocol
• HRP-508–Template–Site Supplement

Other Templates

• HRP-504–Template–Letter–School Permission to Conduct Research

Single IRB Reliance-Specific Templates

• HRP-818–Template–WVU Required Institutional Consent Language
• HRP-818a–Template–WVU Required Consent Language for Advarra IRB
• HRP-819b–Template–WVU-Required Consent Language for WCG IRB

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Human Research Protection Program Plan

• HRP-101–Plan–Human Research Protection Program Plan

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