Post-approval monitoring and/or for-cause audits provide internal oversight on compliance issues relating to the conduct of human subject research on behalf of the University of Tennessee at Chattanooga Institutional Review Board (IRB). All active human subject research studies under the purview of UTC IRB can be chosen for review.
Post-approval monitoring is a routine compliance review of the study documents and/or the observation of the consent process. Studies are selected for monitoring according, but not limited to, the following criteria:
- Risk level of the study.
- Studies enrolling vulnerable populations.
- Studies reviewed under Full-Board Review or Classroom Exemption processes.
- Randomly selected from active studies.
For-cause audits are not a routine compliance review and are usually triggered by the following events:
- Participant Complaint
- Employee Complaint
- IRB request due to new information that might affect the rights and welfare of research participants
Overview of the Review Process
The IRB will contact the Investigator and Faculty Advisor (if applicable) via e-mail and ask for the following: availability of the PI and an allocation of resources, such as files, space, and/or access to electronic records. On the day of the review, the study file(s) will be reviewed and interviews may be conducted with study staff.
Preparing For A Monitoring Or Audit Visit
Complete the Self-Assessment Tool and submit it to ORI at least one day prior to site visit.
Locate and be prepared to show ORI representative project files and/or data.
Contact the IRB office with any questions and communicate concerns regularly about the visit.
Upon completion of the review, a final report is submitted to the PI. If there are findings that need to be reported, then that report along with a response is submitted to the UTC IRB for review and consideration.