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Human Subjects Research


Policies

HRP-001 POLICY - Definitions

HRP-002 POLICY - Abbreviations

HRP-003 POLICY - Designations

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-072 POLICY - Electronic Signatures and Electronic Records in IRBManager Software

 

SOPS

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-116 SOP - Subject Compliants

HRP-120 SOP - Management of 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-142 SOP - Monthly Tasks

HRP-170 SOP - External IRB Screening

HRP-180 SOP - Emergency and Compassionate Uses

HRP-191 SOP - Evaluation of allegation of noncompliance

 

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

 

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-412 WORKSHEET - Financial Interest Management

HRP-413 WORKSHEET - Closure Criteria

HRP-414 WORKSHEET - Adults Lacking Capacity

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-450 WORKSHEET - Criteria for Approval of 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

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