Common rule update: continuing review Month 20XX Common rule update: continuing review UT IRB The University of Texas at Austin

Continuing Review Regulations Old Common Rule CR required at least annually for all research approved via expedited or full board review. New Common Rule CR is not required for: Expedited research Exempt research Research that is only conducting data analysis Research only accessing follow-up clinical data from standard of care procedures

Excluded Research Continuing review still required for: FDA regulated research Research supported or funded by the Department of Justice

UT IRB Implementation Research approved prior to January 21, 2019 Remains under Old Common Rule until conversion to new electronic system Continuing review will still be required

UT IRB Implementation Research approved January 21, 2019 and later If eligible, no CR required PI will receive a 1 question annual status update email asking if the study is still ongoing or eligible for closure If no response to the status update, the study will be closed 90 days after it’s anniversary date