IRB staff and members use these documents as a reference when reviewing IRB submissions to enhance compliance with federal, state, and local requirements.
-
301Review Material January 2021
-
302Approval Intervals January 2025
-
303Communication of Review Results February 2024
-
304IRB Composition July 2022
-
305Quorum and Expertise February 2023
-
306Drugs and Biologics January 2025
-
307Devices January 2025
-
308Pre-Review January 2025
-
309Ancillary Review Matrix July 2024
-
310Human Research Determination January 2021
-
311Engagement Determination January 2025
-
312Exemption and Limited IRB Review July 2023
-
313Expedited Review January 2025
-
314Criteria for Approval January 2025
-
314aCriteria for Consent January 2025
-
314b
-
315Advertisements July 2021
-
316Payments February 2024
-
317Short Form of Consent Documentation January 2025
-
318Additional Federal Agency Criteria January 2025
-
320Scientific or Scholarly Review January 2025
-
321Review of Information Items July 2024
-
322Emergency Use September 2024
-
323Criteria for Approval for HUD January 2021
-
324Expanded Access to Drugs September 2023
-
325Compassionate Use of an Unapproved Medical Device September 2024
-
326Performance Evaluation for IRB Chairs August 2021
-
327Performance Evaluation for IRB Members August 2021
-
330HIPAA Authorization January 2022
-
331FERPA Compliance August 2024
-
332NIH GDS Institutional Certification February 2023
-
333Certificate of Confidentiality January 2025
-
334Vulnerable Populations January 2022
-
335Data and Safety Monitoring July 2024
-
336International Research July 2021
-
337
-
830Communication and Responsibilities July 2022
-
832Criteria for Relying on an External IRB February 2023
-
833Considerations for Serving as the sIRB July 2022
-
834Institutional Requirements for Ceded Studies February 2024
Share feedback or suggestions regarding how to improve these Toolkit documents, including the protocol and consent templates: HRPP Toolkit Feedback Form.