Can changes of protocol be submitted for exemptions?

Frequently Asked Question

Exemption applications cannot be changed in ARROW once the determination has been finalized.  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.  If the tool gives you the determination of Not Research, you can use that certification for your records.

If you wish to make a change to a study that was determined to be exempt (Categories 1-6) from IRB review or was determined to be Not Human Subjects Research, please email the staff reviewer of the original application.The email should include the following:

  • a brief summary of the study procedures that were approved
  • a description of what you wish to change
  • any supporting documents, e.g. revised surveys or data collection sheets

The staff reviewer will review the change in relation to the original study and determine whether the change affects the exemption status. If it does not, you will be notified of this via reply email and must retain a copy of the email as documentation of the determination. If the change does affect the exempt status of your study, or is substantial enough that the staff reviewer determines that a new application is required.  See the Exemption Change Guidance Table for information about whether specific changes to exempt studies may require a new application.  Even if it looks like your change may require a new application, please email the staff reviewer about the change first.  If you are unsure after consulting the table, please email the staff reviewer.  Response can take 1-3 business days, depending on schedules and workloads for the IRB staff reviewer contacted.

Please note: changes of personnel (including POC) do not need to be reported to the IRB for exempt studies, unless the PI changes. If there is a change of PI for an exempt study, please submit a new exemption application via ARROW (or use the research decision tool for projects determined to be Not Research).

For contact information, see the below document.

See Also:

Keywords:FAQ, cp, exempt, personnel change exemption   Doc ID:21354
Owner:Stella K.Group:Health Sciences IRBs
Created:2011-11-21 13:45 CDTUpdated:2015-10-13 15:16 CDT
Sites:Health Sciences IRBs
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