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. 

NUMBERTITLEUPDATED
001DefinitionsMarch 2024
012Observation of Consent ProcessMarch 2024
013Legally Authorized Representatives, Children and GuardiansMarch 2024
020Incoming ItemsMarch 2024
021Pre-ReviewMarch 2024
022Review AssignmentMarch 2017
023Emergency and Device Compassionate Use ReviewMarch 2024
024New InformationMarch 2023
026Suspension or TerminationMarch 2024
027Emergency and Device Compassionate Use Post-ReviewMarch 2024
030Designated ReviewersMarch 2024
031Non-Committee Review PreparationMarch 2024
032Non-Committee Review ConductMarch 2024
040IRB Meeting PreparationMarch 2024
041IRB Meeting ConductMarch 2024
042IRB Meeting Attendance MonitoringMarch 2024
043IRB Meeting MinutesMarch 2024
044Not Otherwise Approvable ResearchMarch 2024
050Conflicting Interests of IRB MembersMarch 2024
051ConsultationMarch 2024
052Post-ReviewOctober 2022
054Review of Financial Conflicts of InterestMarch 2024
060Annual HRPP EvaluationsMarch 2024
062Daily or Frequent TasksMarch 2024
063Expiration of IRB ApprovalMarch 2024
064NIH GDS Institutional CertificationMarch 2024
065QA IRB Performance AuditAugust 2019
066Education and TrainingDecember 2023
070IRB RecordsMarch 2024
071HRPP Toolkit ManagementMarch 2024
072IRB Records RetentionMarch 2024
073Requests to Transfer IRB Authority to UMNAugust 2019
080IRB FormationMarch 2024
081Inactivating an IRBMarch 2024
082IRB Membership AdditionMarch 2024
083IRB Membership RemovalMarch 2024
084IRB Meeting Scheduling and NotificationMarch 2024
090Informed Consent Process for ResearchMarch 2024
091Written Documentation of ConsentMarch 2024
700Human Research AuditAugust 2019
701QA ReportingAugust 2019
703Complaints Questions ConcernsMarch 2021
801Authorization AgreementsMarch 2024
802Institutional Profile ManagementMarch 2024
804Site Pre-ReviewMarch 2024
805External IRB UpdatesOctober 2023
806Review Request to Rely on External IRBMarch 2024

 

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