Unless noted all IRB policies and procedures are in pdf or docx format.
Policies
- HRP-010 POLICY - Human Research Protection Program
- HRP-020 POLICY - IRB Member Review Expectations
- HRP-021 POLICY - Legally Authorized Representatives Children and Guardians
- HRP-022 POLICY - End Approval Dates
- HRP-023 POLICY - IRB Records
- HRP-024 POLICY - IRB Roster
- HRP-050 POLICY - States and Transitions
- HRP-070 POLICY - Investigator Obligations
- HRP-071 POLICY - Prompt Reporting Requirements
- HRP-001 POLICY - Definitions
- HRP-002 POLICY - Abbreviations
- HRP-003 POLICY - Designations
Standard Operating Procedures
- HRP-101 SOP - Regulatory Review
- HRP-102 SOP - Designated Reviewers
- HRP-103 SOP - Non-Committee Review Preparation
- HRP-104 SOP - Non-Committee Review Conduct
- HRP-105 SOP - Committee Review Preparation
- HRP-106 SOP - Committee Review Conduct
- HRP-107 SOP - Committee Review Monitoring
- HRP-108 SOP - Minutes
- HRP-109 SOP - Not Otherwise Approvable Research
- HRP-110 SOP - Consultation
- HRP-111 SOP - Post Review
- HRP-112 SOP - New Information
- HRP-113 SOP - Unexpected Incarceration
- HRP-114 SOP - Suspension and Termination by the Organization
- HRP-115 SOP - Subject Complaints
- HRP-120 SOP - Management and Financial Interests
- HRP-121 SOP - Organizational Financial Interests
- HRP-122 SOP - Undue Influence of the HRPP
- HRP-130 SOP - IRB Formation
- HRP-131 SOP - IRB Deactivation
- HRP-132 SOP - IRB Member Addition
- HRP-133 SOP - IRB Member Removal
- HRP-134 SOP - Designated Exempt Reviewers
- HRP-135 SOP - Designated Exempt Review Conduct
- HRP-140 SOP - IRB Records Retention
- HRP-141 SOP - Annual Tasks
- HRP-143 SOP - Daily Tasks
- HRP-144 SOP - Meeting Scheduling
- HRP-145 SOP - Post Approval Monitoring
- HRP-170 SOP - External IRB Screening
- HRP-180 SOP - Emergency and Compassionate Uses
Investigator Manual & Guidance
- HRP-910 - Investigator Manual (docx)
- HRP-802 INVESTIGATOR GUIDANCE - Informed Consent
- HRP-803 INVESTIGATOR GUIDANCE - Document of Informed Consent
- HRP-810 INVESTIGATOR GUIDANCE - Additional DOD Obligations
- HRP-811 INVESTIGATOR GUIDANCE - Additional DOE Obligations
- HRP-812 INVESTIGATOR GUIDANCE - Additional DOJ Obligations
- HRP-813 INVESTIGATOR GUIDANCE - Additional EP Obligations
- HRP-814 INVESTIGATOR GUIDANCE - Additional EPA Obligations
- HRP-815 INVESTIGATOR GUIDANCE - Additional FDA Obligations
- HRP-816 INVESTIGATOR GUIDANCE - Additional ICH-GCP Obligations
- HRP-817 INVESTIGATOR GUIDANCE - Additional ISO 14155 Obligations
Worksheets
- HRP-400 WORKSHEET - Criteria for Approval
- HRP-405 WORKSHEET - Additional Criteria DOD
- HRP-406 WORKSHEET - Additional Criteria DOJ
- HRP-407 WORKSHEET - Additional Criteria ED
- HRP-408 WORKSHEET - Additional Criteria EPA
- HRP-409 WORKSHEET - Additional Criteria DOE
- HRP-410 WORKSHEET - Additional Criteria International
- HRP-411 WORKSHEET - New Information
- HRP-413 WORKSHEET - Closure Criteria
- HRP-414 WORKSHEET - Adults Lacking Capacity
- HRP-415 WORKSHEET - Consent Disclosures
- HRP-420 WORKSHEET - Regulatory Review
- HRP-421 WORKSHEET - Human Research
- HRP-422 WORKSHEET - Engagement
- HRP-423 WORKSHEET - Exemptions
- HRP-424 WORKSHEET - Expedited Review
- HRP-425 WORKSHEET - Drugs
- HRP-428 WORKSHEET - HIPAA Waiver of Authorization
- HRP-430 WORKSHEET - IRB Composition
- HRP-431 WORKSHEET- Quorum
- HRP-432 WORKSHEET- Contracts
- HRP-440 WORKSHEET - Additional Criteria New Jersey
- HRP-441 WORKSHEET - Additional Criteria California
- HRP-450 WORKSHEET - Criteria for Approval HUD
- HRP-451 WORKSHEET - Emergency Use Drugs and Biologics
- HRP-452 WORKSHEET - Emergency Use Devices
- HRP-453 WORKSHEET - Compassionate Use Devices
- HRP-454 WORKSHEET - Expanded Access Drugs and Biologics
- HRP-470 WORKSHEET - External IRB Screening
- HRP-480 WORKSHEET - FERPA
- HRP-481 WORKSHEET - PPRA
Checklists
- HRP-300 CHECKLIST - Waiver of Consent
- HRP-303 CHECKLIST - Waiver of Documentation of Consent
- HRP-305 CHECKLIST - Pregnant Women
- HRP-306 CHECKLIST - Neonates of Uncertain Viability
- HRP-307 CHECKLIST - Nonviable Neonates
- HRP-308 CHECKLIST - Prisoners
- HRP-309 CHECKLIST - Unexpected Incarceration
- HRP-310 CHECKLIST - Children
- HRP-326 CHECKLIST - Devices