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)January 2019
302Approval Intervals (download)March 2023
303Communications (download)October 2022
304IRB Composition (download)January 2019
305Quorum and Expertise (download)November 2021
306Drugs (download)November 2021
307Devices (download)March 2021
308Pre-Review (download)March 2023
309Ancillary Review Matrix (download)March 2023
310Human Research Determination (download)November 2021
311Engagement Determination (download)October 2022
312Exemption Determination (download)March 2023
313Expedited Review (download)October 2022
314Criteria for Approval (download)June 2022
315Advertisements (download)October 2016
316Payments (download)November 2021
317Short Form of Consent Documentation (download)January 2019
318Additional Federal Agency Criteria (download)November 2021
321Review of Information Items (download)March 2019
322Emergency Use (download)January 2019
323Criteria for Approval HUD (download)January 2019
324Contracts (download)February 2018
325Device Compassionate Use (download)November 2021
330HIPAA Authorization (download)November 2016
331FERPA Compliance (download)November 2021
332NIH GDS Institutional Certification (download)November 2021
333Vulnerable Populations (download)November 2021
334Certificate of Confidentiality (download)November 2021
335Data and Safety Monitoring (download)August 2019
336International Research (download)July 2018
337Database, Registry, Repository (download)August 2019
382IRB Member Addition (download)January 2019
383IRB Member Removal (download)March 2021
830Communication and Responsibilities (download) October 2023
831Local Context Review for Relying on an External IRB (download)October 2023
832Individual Investigator Authorization Agreements (download)June 2021
1897Sponsor Investigator Policy ComplianceJune 2023


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