IRB Bulletin: News from the IRB Office (May 2023) 

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.    

Upcoming IRB Brown Bag 

“Where Human Research Meets Integrity: What You Need to Know” 

Please join Northwestern University's IRB Office as we approach human research protections through the unique lens of research integrity. Our guest speaker, Senior Compliance Specialist with the Office for Research Integrity (ORI), Michelle Stalilonis, will walk us through how ORI approaches investigations into research misconduct and partners to support the important work of protecting human research participants. Michelle will also summarize Responsible Conduct of Research requirements and Northwestern’s Introduction to Research Administration Training, both of which are designed to support Northwestern researchers and staff involved in research administration. Please view the Events Page for details and registration information for upcoming Brown Bag informational sessions.  

New International Research Requirements 

The IRB Office has identified additional guidance language for investigators conducting international research. These updated materials will assist investigators in maintaining regulatory compliance and meeting institutional requirements. The IRB Review of International Research webpage and following documents were updated to include information on Export Control regulations and policies:  

• Biomedical Protocol Template 
• SBS Protocol Template 

• Investigator Manual       

New eIRB+ Feature 

Previously if a modification to a study involved only minor changes to the study team, it was automatically approved. These modifications required all Study Team Members to have current CITI training. This was live for standard modifications and external IRB modifications. In an effort to streamline IRB processes, modifications to study team AND Co-Investigators are now automatically approved. This is live for standard modifications, and we will announce in a future IRB Bulletin when this is live for external IRB modifications. 

Updated Web VPN 

For individuals that utilize a web-based VPN to access eIRB+, please review the updated Off-Campus Access (web VPN) webpage. To comply with University security policies, the VPN requires Multi-Factor Authentication (MFA).    

Updated Documents 

The following updated protocol templates are now available on the Protocol Templates Page 

• Local Protocol Addendum (HRP-508) 
• Biomedical Protocol Template (HRP-593) 
• SBS Protocol Template (HRP-583) 
• Data and Specimen Analysis Protocol (HRP-1704) 

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

• Non-Significant Risk Device - GENERAL – 418 
• HRP-411 Waiver of Written Documentation of Consent 
• HRP-308 - Pre-Review Worksheet 

The following SOP was updated and is now available on the SOPs Page 

• HRP-061 Ongoing HRPP Evaluations 

The following guidance was updated and is now available on the Human Research Policies & Guidance page 

• Human Research Protection Program Plan - HRP-101 

Sincerely, 

Northwestern University IRB Office 

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