IRB Policies and Guidance

Additional documentation on human research related issues are located at:

HRP-001 DefinitionsPolicy
HRP-002 AbbreviationsPolicy
HRP-004 Implementation of the 2018 Common RulePolicy
HRP-020 IRB Member Review ExpectationsPolicy
HRP-021 Legally Authorized RepresentativesPolicyLAR
HRP-022 Expiration Date of IRB ApprovalsPolicy
HRP-023 IRB RecordsPolicy
HRP-024 IRB RosterPolicy
HRP-080 IRB Member Review Expectations – HUDPolicyHDE
HRP-101 Pre-reviewPolicy
HRP-102 Executive ReviewersPolicyExpedited review
HRP-103 Non-Full Board Review PreparationPolicyExpedited review
HRP-104 Non-Full Board Review ConductPolicyExpedited review
HRP-105 Full Board Review PreparationPolicy
HRP-106 Full Board Review ConductPolicy
HRP-107 Full Board Review MonitoringPolicy
HRP-108 MinutesPolicy
HRP-109 Not Otherwise Approvable ResearchPolicy
HRP-110 ConsultationPolicy
HRP-111 Post Review ProceduresPolicy
HRP-112 Reportable EventsPolicynoncompliance, serious, continuing, unanticipated problems, risk, suspension, termination, UPR, expected, unexpected, , SAE, adverse event,
HRP-113 Unexpected IncarcerationPolicyprisoner
HRP-115 Subject Complaints and Allegation of Non-compliancePolicy
HRP-116 Voluntary SuspensionsPolicy
HRP-130 IRB FormationPolicy
HRP-132 IRB Member Addition and RemovalPolicy
HRP-134 Designated Exempt ReviewersPolicy
HRP-140 IRB Records RetentionPolicy
HRP-142 Quality Improvement EvaluationsPolicyQI
HRP-144 Meeting SchedulingPolicy
HRP-170 External IRB ScreeningPolicy
HRP-180 Emergency and Compassionate UsesPolicyemergent, expanded access, FDA
HRP-190 Discretionary PolicyPolicy
HRP-192 Quality AssurancePolicyQA
HRP-193 IRB-01 as the NF/SG VA Medical Center Affiliate IRBPolicyVAMC, VHS, Malcolm Randall
HRP-194 UF Single IRB (sIRB)Policy
HRP-300 Waiver of Consent – DHHSGuidance
HRP-301 Waiver of Consent – Emergency ResearchGuidance
HRP-302 Waiver of Consent – Leftover SpecimensGuidance
HRP-303 Waiver of Documentation of ConsentGuidance
HRP-305 Pregnant WomenGuidance
HRP-306 Neonates of Uncertain ViabilityGuidance
HRP-307 Nonviable NeonatesGuidance
HRP-308 PrisonersGuidance
HRP-309 Unexpected IncarcerationGuidance
HRP-310 ChildrenGuidance
HRP-311 Wards (Foster Children)Guidance
HRP-313 Non-significant Risk DeviceGuidance
HRP-400 Criteria for ApprovalGuidance
HRP-401 Scientific and Scholarly ReviewGuidance
HRP-402 AdvertisementsGuidance
HRP-403 PaymentsGuidance
HRP-404 Short FormGuidance
HRP-405 Department of Defense – Additional Criteria for ApprovalGuidance
HRP-406 Department of Justice – Additional Criteria for ApprovalGuidance
HRP-407 Department of Education – Additional Criteria for ApprovalGuidance
HRP-408 Environmental Protection Agency – Additional Criteria for ApprovalGuidance
HRP-410 International Research – Additional CriteriaGuidance
HRP-411 Reportable EventsGuidance
HRP-412 Financial Interest ManagementGuidance
HRP-413 Closure CriteriaGuidance
HRP-414 Decisionally Impaired AdultsGuidance
HRP-421 Human ResearchGuidance
HRP-422 EngagementGuidance
HRP-423 ExemptionsGuidance
HRP-424 Expedited ReviewGuidance
HRP-425 DrugsGuidance
HRP-426 DevicesGuidance
HRP-427 HIPAA AuthorizationGuidance
HRP-428 HIPAA Waiver of AuthorizationGuidance
HRP-430 IRB CompositionGuidance
HRP-431 QuorumGuidance
HRP-432 ContractsGuidance
HRP-450 Criteria for Approval HUDGuidance
HRP-451 Emergency Use Drugs and BiologicsGuidance
HRP-452 Emergency Use DevicesGuidance
HRP-453 Compassionate Use DevicesGuidance
HRP-470 External IRB ScreeningGuidance
HRP-480 FERPAGuidance