On 11/21/2020 the new IRB Two Year Check-In form will become available for your use in iRIS. This form has been combined with the Continuing Review (CR) form in iRIS. To complete a Two Year Check-In form, select “DUHS IRB Continuing Review/Two Year Check-In”. In the Study Information section, a new question has been added, asking users to select the type of form needed. New branching logic has been added to route users to the appropriate questions based on selection of either Continuing Review or Two Year Check-In.
Under the Revised Common Rule, which took effect on January 21, 2019, most minimal risk studies that received an initial expedited review on or after January 21, 2019 were given a Two Year Check-In requirement. (see Updated: Key Points for New Common Rule: Communication to Research Community) Additionally, minimal risk studies that were allowed to transition to the Revised Common Rule were given a Two Year Check-In requirement. If you have any question about which form (CR form or Two Year Check-In form) you need to complete to renew your IRB approval, please talk with the IRB Specialist assigned to your CRU/Department.
When it is time to submit a Two Year Check-In form on a study, between 60 to 45 days prior to the study’s expiration date, please complete and submit the Two Year Check-In form in iRIS. The IRB will review it and if the IRB does not have any outstanding concerns about the study, the study will then be released from all future continuing review or two year check-ins, and will be given an expiration date of 01/01/2100. If the IRB does have concerns and requires ongoing review, you will be notified in the approval notice.
· All changes to research and personnel must continue to be reported to the IRB via Amendment, for as long as your study remains open.
· All Safety Events must continue to be reported to the IRB according to IRB reporting criteria and timelines.
· Closure (Final Progress) Reports are also required as usual when studies close.
· All FDA regulated studies will still require annual Continuing Review (or more often than annual, if specified by the IRB).