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IRB Bulletin: News from the IRB Office (March 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  

Please join us for a special conversation between the Sponsored Research and IRB Offices on the seamless management of sponsored human research projects. Associate Director of IRB Operations, Lisa Linn, will walk us through how to link funding information to eIRB+ applications, and Senior Director of Sponsored Research Business Systems & Operations, Kim Griffin, will help make sense of the process and downstream effects of doing so. Kim will also let us know what to expect with Northwestern’s shift from InfoEd to the new enterprise sponsored research management system, Central Electronic Research System (CERES), which to rolls out next month, in April 2023.    

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

  

Updated “Guidance Regarding Requirements for Federal Grants” Webpage  

To better support researchers with federally sponsored research, the IRB Office updated its Guidance Regarding Requirements for Federal Grants webpage. These updates clarify expectations for IRB submissions associated with federal grants and address frequently asked questions like “When should Just-In-Time funded projects be submitted to the IRB for review?”.  

  

Documents  

The following guidance was updated and is now available on the Policies and Guidance Page:  

  •   Guidance on Use of Investigational Medical Devices in Human Subjects Research HRP-1918

The following short form consent form is now available on the Short Form Consent Page:

  • Lithuanian Short Form & Certificate of Translation

The following guidance is now available on the Checklists & Worksheets Page:  

  • GDPR Compliance Data Protection HRP-335

Staff Announcements  
We are pleased to share the following IRB Office staff announcements:   

Khrystyna Helner has joined the Northwestern University IRB Office as a Senior IRB Biomedical Analyst. Khrystyna comes to us from Ann and Robert H. Lurie Children’s Hospital where she served as Research Compliance Coordinator. There she conducted reviews of new protocol submissions and amendments, developed and maintained policies for regulatory review, and participated in site monitoring visits. Khrystyna also has experience as a licensed professional therapist. Khrystyna obtained a bachelor’s degree in Psychology and Children Studies from Illinois State University and a master’s in Counseling Psychology from The Chicago School of Professional Psychology. As a member of the IRB Biomedical team, Khrystyna will support our HRPP in conducting the review of all types of submissions, including greater than minimal risk research, will serve as a regulatory and policy guide to the research community, and will help support our IRB Biomedical panels.  

 

Sincerely, 

Northwestern University IRB Office 

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