July 2023 IRB Bulletin: News from the IRB Office

As a part of the Northwestern University IRB Office’s initiative to share timely resources and information with the research community, the IRB Bulletin is released at the beginning of each month and contains relevant updates from the IRB office.  The IRB Bulletin is also posted monthly on the IRB News & Announcements webpage. Please keep reading for this month’s updates.    

Incident Assessment Tool (HRP-1207) 

We have made substantial clarifying changes to the Incident Assessment Tool (HRP-1207), in response to research community feedback. Edits include additional considerations such as short form and protocol deviations, clarifying information to align with recent edits to External IRBs SOP (HRP-092), and separating the Root Cause Analysis and Corrective and Preventive Action Plan into their own sections. We hope researchers find this to be a more comprehensive tool to use when unexpected events occur. Find the Incident Assessment Tool on the Reportable New Information Page. Contact IRBCompliance@northwestern.edu with questions or comments. 

Updated Documents 

The following updated protocol templates are now available on the Human Research Policies & Guidance Page 

• HRP-1919 - Guidance for Research Involving Deception or Incomplete Disclosure 

The following eIRB+ submission tutorials have been updated for clarity to better reflect submission expectations and updates to eIRB+. They are both available on the Northwestern Relying on an External IRB Page 

• HRP-1829 - eIRB+ Tutorial: New Study Submission – External IRB Requiring a Signed Reliance Agreement 
• HRP-1830 - eIRB+ Tutorial: New Study Submission – External IRB with a Master Reliance Agreement 

The following checklist was updated and is now available on the Checklists & Worksheets Page 

• HRP-1401 Post-Approval Monitoring of Recruitment Activities Checklist 

Please view the Events Page for details and registration information for upcoming Brown Bag informational sessions.  

Sincerely, 

Northwestern University IRB Office 

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