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Worksheets

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

Number Title Updated
301 Review Materials January 2019
302 Approval Intervals October 2016
303 Communications August 2019
304 IRB Composition January 2019
305 Quorum and Expertise January 2019
306 Drugs February 2017
307 Devices March 2021
308 Pre-Review June 2021
309 Ancillary Review Matrix January 2021
310 Human Research Determination March 2021
311 Engagement Determination January 2019
312 Exemption Determination March 2021
313 Expedited Review April 2019
314 Criteria for Approval June 2021
315 Advertisements October 2016
316 Payments March 2021
317 Short Form of Consent Documentation January 2019
318 Additional Federal Agency Criteria January 2019
321 Review of Information Items March 2019
322 Emergency Use January 2019
323 Criteria for Approval HUD January 2019
324 Contracts June 2017
325 Device Compassionate Use January 2019
330 HIPAA Authorization November 2016
331 FERPA Compliance January 2019
332 NIH GDS Institutional Certification November 2016
333 Vulnerable Populations August 2019
334 Certificate of Confidentiality March 2018
335 Data and Safety Monitoring August 2019
336 International Research July 2018
337 Database, Registry, Repository August 2019
382 IRB Member Addition January 2019
383 IRB Member Removal March 2021
830 Local Context Review for Relying on an External IRB (download) June 2021
832 Individual Investigator Authorization Agreements June 2021

Share feedback or suggestions regarding how to improve these Toolkit documents, including the protocol and consent templates: HRPP Toolkit Feedback Form.