Changes
While not all exemption changes require IRB review, study teams need to submit changes under certain circumstances in order for the IRB to confirm that the exemption status remains unchanged. Examples of exempt changes that require IRB review: adding questions to an instrument, new procedures, or new study materials; the addition of external data sharing; the addition of a new study population.

See the Exemption Change Guidance Table for information about whether specific revisions or updates to exempt studies may require a change of protocol in ARROW. If you are unsure after consulting the table, please email the IRB analyst that reviewed the application.

If you wish to make a change to a study that was determined to be Not Human Subjects Research, please email the IRB analyst of the original application. The analyst will review the change in relation to the original application and determine whether the change affects its status, requiring a new application.

Renewals
Study teams should expect to receive renewal email notifications for exempt studies that have been open for three years (except for projects certified as Not Human Research). Reminders are sent 90, 60 and 30 days prior to the set expiration date. If the exempt project is on-going, the study team should complete the Renew Exemption activity in the study workspace prior to the expiration date.

If you wish to close an exempt project, please complete the Submit Study Completion Report activity in the study workspace (see How to Close Studies for help).

If no action is taken, the project will automatically be closed in ARROW on the expiration date.