Post-Approval Monitoring


Purpose

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

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:

  1. Risk level of the study.
  2. Studies enrolling vulnerable populations.
  3. Studies reviewed under Full-Board Review or Classroom Exemption processes.
  4. Randomly selected from active studies.

For-Cause Audits

For-cause audits are not a routine compliance review and are usually triggered by the following events:

  1. Participant Complaint
  2. Employee Complaint
  3. Whistleblower
  4. 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.