sIRB - UNMC process
The UNMC sIRB Process is captured in the diagram below.
View diagram as text
Step One: Request Determination
- Lead Site submits sIRB request through RSS
- sIRB Team sets up initial consultation with Lead Site Study Team
- sIRB Request Determination based on study team and HRPP resources, IRB expertise
Step Two: Lead Site and Protocol Review
- Lead Site submits IRB application (protocol and lead site information) through RSS
- UNMC IRB, sIRB Team reviews the submission
- Lead Site Study Team works with the sIRB Team to resolve any outstanding items
- Protocol and lead site approved
Step Three: Participating Site Review
- Participating Sites sent invitations to complete participating site application through RSS.
- Applications reviewed by sIRB Team
- Reliance Agreement negotiation and determinaion
- Site approved as each site fulfills requirements
- Final activation contingent on meeting institutional requirements
Step Four: Study Maintenance
Activities during the course of the study include:
- Change Requests
- Continuing Review
- Single Subject Deviations
- Incident Reports
- Adverse Events
- Completion Reports
Contact sirb@unmc.edu with any UNMC sIRB process questions.