What if researchers have an Initial Review application for a non-COVID-19 study currently under review?

Last updated: 4.14.20

As of April 14, 2020, all face-to-face study visits must be temporarily halted until at least June 30, 2020. Exceptions to this hiatus are therapeutic studies involving drugs or devices, or other research activities that are critical to the health/safety of patients or study participants. These studies may continue using face-to-face interactions. Therefore, if a researcher has a therapeutic study currently under review, no revisions should be necessary in order to proceed with plans for face-to-face study visits, however, there may be limitations on study activation based on resources available in the CRU, the Pharmaceutical Research Center (PRC), and other hospital resources.

If the study is non-therapeutic and currently includes face-to-face study visits, researchers will need to choose one of the of the following options:

  • Unless the face-to-face interactions are approved by the Dean, confirm that face-to-face activities will not begin until the restrictions on these visits have been lifted. In this case, the ARROW application materials outlining in-person visits do not need to be revised. However, no face-to-face study activities with subjects can begin until campus lifts the current restrictions. Researchers should inform the IRB staff reviewer who has been assigned to review the study of this determination so the IRB can document it appropriately.
  • Revise any face-to-face study visits to remote visits. Researchers should contact the IRB staff reviewer who has been assigned to review their study to and let the staff reviewer know that revisions need to be made to incorporate remote visits into the study design. The staff reviewer will work with the researcher to coordinate these revisions as needed.




Keywords:coronavirus, COVID-19, submission   Doc ID:99330
Owner:Monica E.Group:Health Sciences IRBs
Created:2020-03-24 08:29 CDTUpdated:2020-04-14 10:51 CDT
Sites:Health Sciences IRBs
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