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sIRB - UNMC process

The UNMC sIRB Process is captured in the diagram below.

sirb_process.png

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.