Worksheets

IRB staff and members use these documents as a reference when reviewing IRB submissions to enhance compliance with federal, state, and local requirements. 

NumberTitleUpdated
108Study-Specific Emergency-Disaster Risk Mitigation PlanningAugust 2024
301Review MaterialsMarch 2024
302Approval IntervalsMarch 2024
303CommunicationsMarch 2024
304IRB CompositionMarch 2024
305Quorum and ExpertiseMarch 2024
306DrugsJuly 2024
307DevicesAugust 2024
308Pre-ReviewJune 2024
309Ancillary Review MatrixAugust 2024
310Human Research DeterminationMarch 2024
311Engagement DeterminationMarch 2024
312Exemption DeterminationMarch 2024
313Expedited ReviewMarch 2024
314Criteria for ApprovalMarch 2024
315AdvertisementsAugust 2024
316PaymentsMarch 2024
317Short Form of Consent DocumentationMarch 2024
318Additional Federal Agency CriteriaJune 2024
321Review of Information ItemsMarch 2024
322Emergency UseMarch 2024
323Criteria for Approval HUDMarch 2024
324ContractsJuly 2024
325Device Compassionate UseMarch 2024
328Annual Performance Evaluation Criteria for IRB StaffAugust 2024
330HIPAA AuthorizationMarch 2024
331FERPA ComplianceMarch 2024
332NIH GDS Institutional CertificationMarch 2024
333Certificate of ConfidentialityMarch 2024
334Vulnerable PopulationsMarch 2024
335Data and Safety MonitoringMarch 2024
336International ResearchMarch 2024
337Database, Registry, RepositoryMarch 2024
338Indigenous ResearchMarch 2024
339Use of Artificial Intelligence ToolsAugust 2024
351Protocol Specific Emergency-Disaster Risk Mitigation Planning
(Flowchart: HRP-108: Study-Specific Emergency-Disaster Risk Mitigation Planning)
August 2024
352Additional Emergency-Disaster Review ConsiderationsAugust 2024
382IRB Member AdditionJune 2024
383IRB Member RemovalJune 2024
830Communication and ResponsibilitiesMarch 2024
831Local Context Review for Relying on an External IRBMarch 2024
832Individual Investigator Authorization AgreementsMarch 2024
1897Sponsor Investigator Policy ComplianceJuly 2024

 

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