The Research Compliance Monitor is charged with auditing IRB approved studies. The purpose of this program is to provide a systematic, internal process that will increase compliance with federal, state and institutional requirements, and also ensure that research is conducted in accordance with the approved protocol and the ethical principles set forth in the Belmont Report. The policy and procedures related to the audit program are set forth in policy 2009-005.0 titled Monitoring of IRB Approved Studies.
All studies, including those determined to qualify for exempt status and those for which IRB oversight has been deferred, are subject to audit. Studies may be randomly selected or selected for other reasons as described in the monitoring policy.
Receiving notification that a study has been selected for a monitoring visit does not imply that there is anything wrong with the conduct of the study. For studies reviewed by the local IRB, the activities and conduct of the IRB are also monitored in conjunction with each study that is monitored.