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

June 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.    

 

New Post-Approval Monitoring Activity – Study Status Assessment (for Studies Without an Expiration Date) 

  • The Compliance Team is introducing a new checklist that researchers may use to perform study status assessments on non-exempt studies that do not have an IRB approval expiration date, and thus do not require an annual continuing review. The Compliance Team recommends that researchers independently perform a study status assessment annually or every 2 to 3 years in lieu of a continuing review. 
  • All approved human research without an expiration date, including those where the Northwestern University IRB ceded IRB review to an external IRB, are subject to routine monitoring, except those determined to qualify for exempt status. Completion of a Study Status Assessment is only required when the Compliance Team selects a study for routine monitoring. 
  • The new checklist, HRP-433 Studies Without an Expiration Date, can be found on the IRB’s Checklists & Worksheets page. Further information about post-approval monitoring can be found here.  

 

ClinicalTrials.gov language added to IRB Outcome Letters 

To support institutional compliance with the ClinicalTrials.gov registration and results information submission requirements, the IRB updated the outcome letters to add clinicaltrials.gov language. See more information on the Clinical Trial Requirements Page. 

 

Upcoming IRB Brown Bag 

“Keeping Up with Compliance: A Peek into Post-Approval Monitoring Assessments”  

Please join the IRB Office Compliance and Education Team as they provide best practices in keeping up with human research compliance in the post-approval world. Kim Rowan, Brittanē Foy, Jennie Thai, and Yasmeen Khan will begin with an introduction to the team, why research needs and benefits from compliance and education, and who dictates rules pertaining to human research at Northwestern University. Our guest speakers will then guide us through Post-Approval Monitoring (PAM) and IRB Office tools designed to keep investigators in compliance and prepared for randomly- selected and self-conducted monitoring assessments. We are also promised an overview of IRB Office PAM observations and metrics as well as an introduction to the new Study Status Assessment tool and a Tips and Tricks primer specially curated for event attendees. This is a Brown Bag you and your human research colleagues will not want to miss! 

Please click here for details and registration information for upcoming Brown Bag informational sessions.  

 

Updated Webpage 

  • The Modifications page was updated to add a section on "Changes involving the Investigational Product". Research protocols involving investigational drugs at NMHC must utilize the Investigational Drug Services (IDS) Pharmacy for the storage, dispensing, and control of the investigational drug, whether for inpatient or outpatient use. If you are submitting changes to your protocol that affect the investigational product (dosing, preparation, administration, storage, shipping, etc.) please email the IDS Pharmacy at nminvestigationaldrugservice@nm.org. See the Modifications page for details. 

 

Updated Documents 

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

  • HRP-442 - Genetic Biobanking Studies Checklist 
  • HRP- 830 - Communication and Responsibilities Worksheet 

 

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

  • SOP - Principal Investigator (PI) Permissions; HRP-096 
  • HRP-023 - SOP - Emergency Use;  
  • HRP-080 - SOP - IRB Formation; 
  • HRP-083 - SOP - IRB Membership Removal 
  • HRP-033 - SOP - Determining and Processing When Continuing Review is Required 
  • HRP-041 - SOP - IRB Meeting Conduct 

 

Staff Announcements 

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

  • We are happy to announce the promotion of Laura Loeb, PhD, CIP to Senior IRB Analyst, Social Behavioral Research Team. Laura joined the NU IRB Office on December 5, 2022, as an analyst with the Social and Behavioral Research IRB Team.  Laura has proven herself as a valuable member of the IRB team, with exceptional knowledge of social and behavioral research.  Laura is an enthusiastic colleague who takes great pride in her work and enjoys supporting the SBR community.   Laura was previously a Compliance Specialist at Loyola University Chicago, and prior to that, she was a Research Compliance Manager at the University of Virginia SBS IRB.  Before UVA, Laura was on the other side of the process as a social behavioral researcher at UCLA.   

 

Sincerely, 

Northwestern University IRB Office 

 

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