Expedited IRB Review of Qualifying Single Patient IND Submissions

December 04, 2018

In 2017, the FDA announced that they have further streamlined the expanded access process by updating the Form 3926 to allow for a waiver of the requirement for review and approval at a convened IRB meeting.  As a result, OHRS is permitted to route qualifying Single Patient IND requests for expedited IRB review instead of requiring full board IRB review. 

In order to qualify for expedited IRB review, FDA Form 3926 must be used and the box indicating alternative IRB is permittable under part 10b must be checked and approved by the FDA.  A copy of FDA Form 3926 must be submitted to OHRS with your Single Patient IND request.

Please note that if FDA Form 1571 is used, review by a convened IRB will still be required.

OHRS has revised IS - Policy - Single Patient IND and Emergency Use of a Test Article and New Protocol Application: Single Patient IND and Emergency Use to allow for this new review process.

Please contact OHRS with questions regarding submission and review of Single Patient IND requests.