Changes to the UCSF IRB Continuing Review Process – No More Delays!

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Background

The IRB is allowed to issue expiration dates with the same anniversary when the Continuing Review is approved up to 30 days prior to the expiration date. The UCSF IRB has maintained the practice of postponing review until 30 days prior to expiration for all studies whenever possible so that study teams can keep the same anniversary date. We process more than 1,000 submissions each month and the staff processing continuing review applications routinely have more than 90 submissions assigned at any one time. Many of these assigned submissions are ready to review and approve but are simply being held until 30 days prior to expiration date to maintain the expiration date anniversary. This is inefficient and contributes to IRB review delays, approval lapses, and errors.
 
Since we started sending out a link to the UCSF IRB satisfaction survey upon approval of all submissions (adding modifications and continuing review forms, as well as initial review applications), we’ve received a steady stream of negative comments about the very long processing times for continuing reviews and the anxiety associated with being worried about a possible lapse in approval.
 
In response to this feedback, starting Monday, May 9th, the UCSF IRB will begin processing Continuing Reviews upon receipt. If you have a reason why you need to retain the same anniversary expiration date, you must specifically request that the anniversary date be retained via email to the UCSF IRB general email box. The new Continuing Review Form PI Signoff Sheet includes instructions for requesting an exception. This request must come from the PI. It may not always be possible to retain the same expiration anniversary, but we will try to honor these requests whenever possible.
 

What This Means for You

If your expedited review study is set to expire on 7/5/2016 and we receive your Continuing Review Form on 5/18/2016, it will be reviewed in the order received and will be assigned a new expiration date one year from the date of approval. For example, if it is approved on 6/3/2016, the new expiration date will be 6/2/2017.
 
For studies reviewed at an IRB meeting, the expiration date will be 1 year minus 1 day from the meeting date.
 

Tips for Hassle-Free Continuing Review

  • Upload ‘clean’ copies (i.e., without the IRB stamp) of consents as ‘Revisions’ of the currently approved stamped PDF version of the form
  • Use the document comparison tool to verify the new versions of consent forms EITHER do not have any changes OR that all changes have been identified and justified in the Continuing Review form
  • Use the form comparison tool to ensure you have listed and explained any changes to the form since the last approved version
  • Verify that all the study personnel have valid CITI Human Subjects Protection Training