Can changes of protocol be submitted for exemptions?

Exemption applications can be changed in ARROW once the determination has been finalized. Because the new exemption categories under the revised Common Rule are more nuanced and complex, study teams will need to submit changes of protocols to their exemptions under certain circumstances in order for the IRB to confirm that the exemption status remains unchanged. In general, in order for the IRB to confirm that the conditions under which the research was determined to be exempt have not changed, any updates to the study that meets the following criteria should be submitted for review if they could:

  • Increase risks of participation and place them at risk for criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation
  • Adversely alter the risk:benefit ratio of the study
  • Affect research participants’ willingness to participate in a study

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 staff reviewer.

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 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 application and determine whether the change affects its 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. The staff reviewer may request a new application if the change affects the IRB’s determination related to the project or of such a substantial nature to warrant a new application is required. Even if it looks like your change may require a new application, please email the staff reviewer about the change first. Responses can take 1-3 business days, depending on schedules and workloads for the IRB staff reviewer contacted.

See Also:

Keywords:FAQ, cp, exempt, personnel change exemption, change, NHSR, decision tree, Exemption Change Guidance Table   Doc ID:21354
Owner:Monica E.Group:Health Sciences IRBs
Created:2011-11-21 13:45 CDTUpdated:2018-12-12 10:17 CDT
Sites:Health Sciences IRBs
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