IRB Review Updates

From: 
UMD IRB Team
Date: 
Thursday, October 14, 2021

Please review important updates below

 

Continuing Review Updates       
As of November 1st, Continuing Reviews/Progress Reports are no longer required for newly submitted Expedited protocols.  However, the IRB Member Reviewer may determine that a Continuing Review is needed based on the design of the project or the potential risk to participants. 

All protocols approved after November 1, 2021 will not have expiration dates unless the IRB Member Reviewer has indicated that a Continuing Review is required.  If a Continuing Review is required for your Expedited protocol, your IRB Approval Letter will include language about completing a Continuing Review prior to the expiration date of the protocol. If you are not required to complete a Continuing Review, your IRB Approval Letter will not have an expiration date or language referring to a Continuing Review submission.

Expedited protocols that are not required to submit a Continuing Review will be placed into an algorithm developed by the IRB Quality Assurance Program.  The algorithm will randomly select a sampling of Expedited protocols. The Quality Assurance Analyst will contact the PI for any study selected through this algorithm and will request a Progress Report be completed for the study. This is meant to act as a check-in on the progress of the Expedited protocol and compliance with the approved protocol.

Expedited protocols that have been approved prior to November 1, 2021 must submit their next scheduled annual Continuing Review/Progress Report in order for the IRB Member Reviewers to determine if an annual Continuing Review/Progress Report will be required moving forward.  If a Continuing Review is not required, the protocol information will be updated to remove the expiration date and the appropriate Expedited Approval Letter will be published.

Closure Reports Update
In order to maintain an accurate account of active studies on campus, PIs are strongly encouraged to complete a Closure Report once all human subject research activities have been completed for each study. Engagement in human subject research activities include any interaction/intervention with human subjects, or accessing storing identifiable, private data that can be linked back to individual subjects. Analysis of de-identified data can be conducted after a study has been closed.

The Closure Report template is available for download on the IRB Website and in IRBNet and should be submitted as a new package after it has been completed. Directions for completion of Closure Reports will be available on the homepage of the IRB website: https://research.umd.edu/irb

Please email irb@umd.edu with any questions!

 

Thanks!
The UMD IRB Team

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