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Checklists

IRB members and staff use these checklists to consider and document regulatory items and enhance compliance with federal, state and local requirements.

Number Title Updated
401 Pre-Review (download) October 2022
402 Non-Committee Review (download) January 2019
410 Waiver or Alteration of Consent Process (download) October 2022
411 Waiver of Written Documentation of Consent (download) January 2019
412 Pregnant Women (download) November 2021
413 Non-Viable Neonates (download) November 2021
414 Neonates of Uncertain Viability (download) November 2021
415 Prisoners (download) November 2021
416 Children (download) October 2022
417 Adults with Impaired Decision-Making Capacity (download) March 2023
418 Non-Significant Risk Device (download) October 2022
419 Waiver of Consent Process for Emergency Research (download) October 2022
420 Scientific Review (download)
 August 2019
431 Minutes Quality Improvement Assessment (download) January 2021
441 HIPAA Waiver of Authorization (download) March 2022
740 Human Research Audit (download) December 2018
742 CMA Observation (download) December 2018
743 CMA Observation - Exempt (download) December 2018
840 Criteria for UMN IRB Serving as sIRB (download) March 2022
841 Criteria for Relying on an External IRB (download) March 2023

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

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