IRB Administrative Review

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Office for Research Protections     |     Institutional Review Board

“Administrative Review” describes the annual review process for studies that do not require a regulatory Continuing Review as determined by the IRB as a result of the Common Rule changes that went into effect beginning January 21, 2019. Studies subject to the revised (2018) Common Rule requirements will be assigned an Administrative Review instead of a Continuing Review when applicable. The Administrative Review form in CATS IRB is more abbreviated than the Continuing Review form. In particular, the Administrative Review form does not include the collection of information like subject enrollment numbers and study detail updates. The Administrative Review form does ask researchers to verify that all modifications and new information has been submitted to the IRB as these requirements have not changed. In addition, the criteria for study closure remain, and an investigator must complete and submit the Administrative Review form in CATS IRB on an annual basis to keep the study active until the study meets the IRB’s criteria for closure.

Investigators will receive reminders regarding the need to submit an administrative review form beginning 90 days prior to its due date.  

At this time, Exempt studies do not require Administrative or Continuing Reviews. Approval letters indicate the review level of a study and include information about Administrative or Continuing Review when required. 

For additional guidance, refer to the "Administrative Review" section found on page 52 in the Investigator Manual (HRP-103).