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 meet the following criteria should be submitted for review if they could:
- Increase risks of participation and place participants at risk for criminal or civil liability or be damaging to the participants’ 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 assigned staff reviewer.
The staff reviewer will review the change in relation to the original application and determine whether the change affects its exemption status. The staff reviewer will request a new application if the change affects the IRB’s determination related to the project or if it is of such a substantial nature to warrant a new application is required. If it looks like your change may require a new application, please email the staff reviewer about the change first.