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

301Review Materials (download)March 2024
302Approval Intervals (download)March 2024
303Communications (download)March 2024
304IRB Composition (download)March 2024
305Quorum and Expertise (download)March 2024
306Drugs (download)November 2021
307Devices (download)March 2021
308Pre-Review (download)March 2023
309Ancillary Review Matrix (download)March 2024
310Human Research Determination (download)March 2024
311Engagement Determination (download)March 2024
312Exemption Determination (download)March 2024
313Expedited Review (download)March 2024
314Criteria for Approval (download)March 2024
315Advertisements (download)March 2024
316Payments (download)March 2024
317Short Form of Consent Documentation (download)March 2024
318Additional Federal Agency Criteria (download)November 2021
321Review of Information Items (download)March 2024
322Emergency Use (download)March 2024
323Criteria for Approval HUD (download)March 2024
324Contracts (download)February 2018
325Device Compassionate Use (download)March 2024
330HIPAA Authorization (download)March 2024
331FERPA Compliance (download)March 2024
332NIH GDS Institutional Certification (download)March 2024
333Certificate of Confidentiality (download)March 2024
334Vulnerable Populations (download)March 2024
335Data and Safety Monitoring (download)March 2024
336International Research (download)March 2024
337Database, Registry, Repository (download)March 2024
338Indigenous Research (download)March 2024
382IRB Member Addition (download)January 2019
383IRB Member Removal (download)March 2021
830Communication and Responsibilities (download) March 2024
831Local Context Review for Relying on an External IRB (download)March 2024
832Individual Investigator Authorization Agreements (download)March 2024
1897Sponsor Investigator Policy ComplianceJuly 2023


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