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

401Pre-Review (download)March 2024
402Non-Committee Review (download)March 2024
410Waiver or Alteration of Consent Process (download)March 2024
411Waiver of Written Documentation of Consent (download)March 2024
412Pregnant Women (download)March 2024
413Non-Viable Neonates (download)March 2024
414Neonates of Uncertain Viability (download)March 2024
415Prisoners (download)March 2024
416Children (download)March 2024
417Adults with Impaired Decision-Making CapacityMarch 2024
418Non-Significant Risk Device (download)March 2024
419Waiver of Consent Process for Emergency Research (download)March 2024
420Scientific Review (download)August 2019
431Minutes Quality Improvement Assessment (download)March 2024
441HIPAA Waiver of Authorization (download)March 2024
740Human Research Audit (download)December 2018
742CMA Observation (download)December 2018
743CMA Observation - Exempt (download)December 2018
840Criteria for UMN IRB Serving as sIRB (download)March 2024
841Criteria for Relying on an External IRB (download)March 2024


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