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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 March 2017
302 Approval Intervals October 2016
304 IRB Composition October 2016
305 Quorum and Expertise June 2017
306 Drugs February 2017
307 Devices June 2018
308 Pre-Review February 2018
309 Ancillary Review Matrix May 2018
310 Human Research Determination February 2018
311 Engagement Determination November 2016
312 Exemption Determination November 2016
313 Expedited Review February 2018
314 Criteria for Approval March 2018
315 Advertisements October 2016
316 Payments October 2016
317 Short Form of Consent Documentation May 2018
318 Additional Federal Agency Criteria February 2018
321 Review of Information Items February 2018
322 Emergency Use February 2018
323 Criteria for Approval HUD February 2017
324 Contracts June 2017
325 Device Compassionate Use February 2017
330 HIPAA Authorization November 2016
331 FERPA Compliance November 2016
332 NIH GDS Institutional Certification November 2016
333 Vulnerable Populations April 2018
334 Certificate of Confidentiality March 2018
335 Data and Safety Monitoring Jan 2018
336 International Research May 2018
808 External IRB Pre-Review and Updates February 2018
814 Criteria for External IRB Reliance February 2018
831 Communication and Responsibilities June 2018

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