What are exemption renewals?

FAQ

Although studies found to be exempt do not require yearly continuing reviews, they may need to be renewed at some point during their time as a research project.

How will I know my exemption is up for renewal?
ARROW will send five year extension email notifications to study teams for exempt projects that have been open for five years (with the exception of projects that have been certified as Not Research or Not Human Subjects Research).

Email notifications will be sent 90, 60 and 30 days prior to the expiration date.

What should I do if I want to keep my project open?
If you wish to extend an exempt project, please complete the ‘Extend Exemption’ activity in the exempt project workspace prior to the expiration date. This activity is not reviewed by the IRB office and no replacement application is required. Completing the activity simply indicates in ARROW that the project is not yet complete.

What should I do if I want to close my project?
If you wish to close an exempt project, please complete the ‘Submit Study Completion Report’ activity in the exempt project workspace (please see How to Close Studies for help). The study completion report will be reviewed by the IRB office as with any other study completion report.

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

What do I need to do if I want to make changes?
If you wish to make a change to a study that was determined to be exempt (Categories 1-6) or was determined to be Not Human Subjects Research, please see the instructions in the Exemption Change FAQ (Can changes of protocol be submitted for exemptions? ), as exemption applications cannot be changed in ARROW.
  • If the change affects the exempt status of your study, a new application is required.
  • If the change does not affect the exemption status, you will be notified of this via reply email and must retain a copy of the email as documentation of the determination.
If you wish to make a change to a project that was determined to be Not Research (QI/QA or Program Evaluation), please use the Research Decision Tool to determine if your project still qualifies as Not Research.



Keywords:extension, exempt   Doc ID:53954
Owner:Faye L.Group:Health Sciences IRBs
Created:2015-07-15 14:03 CDTUpdated:2015-10-13 15:16 CDT
Sites:Health Sciences IRBs
Feedback:  0   0