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

April 1, 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.    

There is no Brown Bag this month and you are encouraged to review past Brown Bag informational sessions.  

New FAIR Survey 

The IRB Office’s DEI&J group, FAIR, is launching a survey to collect your feedback about how to best provide resources to study teams concerning Diversity, Equity, Inclusion, and Justice. We will be raffling off 5 NU-themed prizes for those who participate! Please complete the survey here. 

Updated Documents 

New Privacy Statement from the Office for Research 

  • The Office for Research has finalized and posted two new Privacy Statements on their website. One of these privacy statements is related to the “Personal Information Protection Law of the People’s Republic of China” or PIPL. This statement is available on the OR website’s Research Policies and Guidance page under Privacy: https://research.northwestern.edu/policies-and-guidance/index.html 
  • The PIPL statement is also linked on the IRB Policies & Guidance Page under “Personal Information Protection Law of the People’s Republic of China (PIPL)”. 

Updated External IRB SOP – 092  

  • The IRB Office updated its SOP on External IRBs this month. Sections 5.2 “Continuing Review and Modifications” and 5.3 “Reportable New Information” had substantial updates, including the following expectations: 
    • When initial acknowledgment from the Northwestern IRB is obtained, many ongoing study updates may be implemented once External IRB approval of the update is secured. The Principal Investigator is still expected to submit External IRB approved documents and approval letters in eIRB+ within two weeks of receipt. 
    • The Principal Investigator is required to submit Reportable New Information (RNI) to the External IRB per the External IRB’s reporting criteria. The Principal Investigator is required to perform this reporting to the External IRB in parallel with an RNI submission in eIRB+. 
    • The Northwestern IRB Office considers study closure a change in status. Therefore, the Principal Investigator is required to submit the External IRB approval of closure documentation to Northwestern University via eIRB+ within two weeks of receipt. 

The following updated SOPs are now available on the SOPs Page 

  • Non-Committee Review Preparation – 031 
  • Lapse (Expiration) of IRB Approval (Continuation of Current Participants) – 063 
  • Annual HRPP Evaluations – 060  

 

Sincerely, 

Northwestern University IRB Office 

 

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