Remember, NICE reviews aren’t “audits”
The New Investigation Consult and Education (NICE) reviews provided by the ACH and UAMS research compliance staff are wonderful tools. They can help a newly approved study get off to a good start by identifying and fixing any problems before subject enrollment begins.
Keep this important tip in mind when following up on NICE review findings. If you need to submit a modification to the IRB to correct something found in a NICE review, please check the “NO” option in response to the modification form questions asking if this modification request is “in response to an audit by the UAMS Office of Research Compliance or ACH/ACHRI Corporate Compliance.”
Checking the “yes” response to this question treats the modification like a full-blown compliance audit response. That means the CLARA form will lead you through audit-related questions, and route the modification through the regular audit review process. Instead, this type of change should be handled like a routine modification, and checking “no” ensures that it will be routed correctly.
And the most compelling reason to click “no” is — if you click “yes” and submit the modification as an audit response, there’s no way to go back and un-audit-fy it. You’ll be left with no choice but to cancel that modification and start all over, with the all the attendant risks of ensuing crankiness.
So remember, it’s a big NO to the audit question when submitting modifications in response to NICE reviews!