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
- 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