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
001DefinitionsOctober 2025
012Observation of Consent ProcessMarch 2024
013Legally Authorized Representatives, Children and GuardiansMarch 2024
020Incoming ItemsMarch 2024
021Pre-ReviewOctober 2025
023Emergency and Device Compassionate Use ReviewMarch 2024
024New InformationOctober 2025
026Suspension or TerminationOctober 2025
027Emergency and Device Compassionate Use Post-ReviewMarch 2024
030Designated ReviewersMarch 2024
031Non-Committee Review PreparationOctober 2025
032Non-Committee Review ConductOctober 2025
040IRB Meeting PreparationMarch 2024
041IRB Meeting ConductMarch 2024
042IRB Meeting Attendance MonitoringMarch 2024
043IRB Meeting MinutesOctober 2025
044Not Otherwise Approvable ResearchMarch 2024
050Conflicting Interests of IRB MembersMarch 2024
051ConsultationMarch 2024
052Post-ReviewOctober 2025
054Review of Financial Conflicts of InterestAugust 2024
060Annual HRPP EvaluationsMarch 2024
061Quarterly Evaluations of the HRPPAugust 2024
062Daily or Frequent TasksOctober 2025
063Expiration of IRB ApprovalMarch 2024
064NIH GDS Institutional CertificationOctober 2025
065Response Plan for Emergencies-Disasters Impacting the HRPPAugust 2024
066Education and TrainingJuly 2024
070IRB RecordsMarch 2024
071HRPP Toolkit ManagementMarch 2024
072IRB Records RetentionMarch 2024
073Requests to Transfer IRB Authority to UMNJuly 2024
080IRB FormationOctober 2025
081IRB RemovalMarch 2024
082IRB Membership AdditionOctober 2025
083IRB Membership RemovalMarch 2024
084IRB Meeting Scheduling and NotificationOctober 2025
090Informed Consent Process for ResearchMarch 2024
091Written Documentation of ConsentMarch 2024
099Reporting by HRPPJuly 2024
700Human Research AuditJuly 2024
701QA IRB Performance AuditAugust 2024
703Complaints Questions ConcernsJuly 2024
801Authorization AgreementsOctober 2025
802Institutional Profile ManagementMarch 2024
804External IRB Post-ReviewMarch 2024
805External IRB UpdatesMarch 2024
806Review Request to Rely on External IRBOctober 2025

 

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