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Standard Operating Procedures

Standard operating procedures (SOPs) describe policies and procedures related to IRB review, management, or function.

IRB members and staff use SOPs to enhance compliance with federal, state, and local requirements. 

NUMBER TITLE UPDATED
001 Definitions October 2022
013 Legally Authorized Representatives, Children and Guardians November 2021
020 Incoming Items December 2018
021 Pre-Review October 2022
022 Review Assignment March 2017
023 Emergency and Device Compassionate Use Review January 2019
024 New Information March 2023
026 Suspension or Termination November 2021
027 Emergency and Device Compassionate Use Post-Review January 2019
030 Designated Reviewers August 2019
031 Non-Committee Review Preparation August 2019
032 Non-Committee Review Conduct October 2022
040 IRB Meeting Preparation September 2020
041 IRB Meeting Conduct March 2021
042 IRB Meeting Attendance Monitoring March 2018
043 IRB Meeting Minutes March 2022
044 Not Otherwise Approvable Research January 2019
050 Conflicting Interests of IRB Members June 2017
051 Consultation March 2021
052 Post-Review October 2022
054 Review of Financial Conflicts of Interest May 2020
060 Annual HRPP Evaluations October 2022
062 Daily or Frequent Tasks August 2019
063 Expiration of IRB Approval March 2017
064 NIH GDS Institutional Certification November 2021
065 QA IRB Performance Audit
 August 2019
066 Education and Training October 2022
070 IRB Records August 2019
071 HRPP Toolkit Management December 2018
072 IRB Records Retention February 2018
073 Requests to Transfer IRB Authority to UMN August 2019
080 IRB Formation March 2021
081 Inactivating an IRB January 2019
082 IRB Membership Addition January 2019
083 IRB Membership Removal January 2019
084 IRB Meeting Scheduling and Notification March 2017
090 Informed Consent Process for Research March 2023
091 Written Documentation of Consent March 2023
700 Human Research Audit August 2019
701 QA Reporting August 2019
703 Complaints Questions Concerns March 2021
801 Authorization Agreements March 2023
802 Institutional Profile Management March 2023
804 Site Pre-Review June 2021
805 Site Updates June 2021
806 Request to UMN as sIRB March 2023
807 Request to Rely on External IRB June 2021
809 pSite Review June 2021

 

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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