Standard Operating Procedures (SOPs)
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.
- HRP-001 – SOP – Definitions
- HRP-012 – SOP – Observation of Consent Process
- HRP-013 – SOP – LARs, Children, and Guardians
- HRP-020 – SOP – Incoming Items
- HRP-021 – SOP – Pre-Review
- HRP-023 – SOP – Emerg and Device Comp Use Review
- HRP-024 – SOP – New Information
- HRP-025 – SOP – Investigations
- HRP-026 – SOP- Susp or Term Issued Outside of Conv IRB
- HRP-027 – SOP – Emerg Use Comp Use Indiv Pt Access Post Rev
- HRP-030 – SOP – Designated Reviewers
- HRP-031 – SOP – Non-Committee Review Preparation
- HRP-032 – SOP – Non-Committee Review Conduct
- HRP-040 – SOP – IRB Meeting Preparation
- HRP-041 – SOP – IRB Meeting Conduct
- HRP-042 – SOP – IRB Meeting Attendance Monitoring
- HRP-043 – SOP – IRB Meeting Minutes
- HRP-044 – SOP – Not Otherwise Approvable Research
- HRP-050 – SOP – Conflicting Interests of IRB Members
- HRP-051 – SOP – Consultation
- HRP-052 – SOP – Post-Review
- HRP-060 – SOP – Annual Evaluations of the HRPP
- HRP-061 – SOP – Quarterly Evaluations of the HRPP
- HRP-062 – SOP – Daily Tasks
- HRP-063 – SOP – Expiration of IRB Approval
- HRP-064 – SOP – NIH GDS Institutional Certification
- HRP-065 – SOP – Response Plan for Emergencies-Disasters Impacting the HRPP
- HRP-070 – SOP – IRB Records
- HRP-071 – SOP – Toolkit Management
- HRP-072 – SOP – IRB Records Retention
- HRP-080 – SOP – IRB Formation and Registration
- HRP-081 – SOP – IRB Removal
- HRP-082 – SOP – IRB Membership Addition
- HRP-083 – SOP – IRB Membership Removal
- HRP-084 – SOP – IRB Meeting Scheduling and Notification
- HRP-090 – SOP – Informed Consent Process for Research
- HRP-091 – SOP – Written Documentation of Consent
- HRP-801 – SOP – Establishing Authorization Agreements
- HRP-802 – SOP – Institutional Profile Management
- HRP-804 – SOP – External IRB Post-Review
- HRP-805 – SOP – External IRB Updates
- HRP-806 – SOP – Review Request to Rely on External IRB