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Research Compliance Monitoring

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, even those determined to qualify for exempt status, are subject to audit. The majority of studies that are monitored are selected at random. However, emphasis may be placed on auditing studies with moderate to high risk to subjects, investigator originated studies, studies involving vulnerable populations and studies for which there is or may be a conflict of interest.

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.