Research Compliance Monitoring

The Research Compliance Monitors (RCM) are charged with implementing the Quality Monitoring Program (Word doc). 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.

All studies, even those determined to qualify for exempt status, are subject to the quality monitoring program. However, the emphasis of the quality monitoring program will be on 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. Conflicts of interests must be disclosed at the time of initial application to the Institutional Review Board (IRB). The monitoring program will ensure that the study is being conducted in accordance with any conflict of interest management plan required by the Conflict of Interest Committee.

The majority of studies that are monitored are selected at random. 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. The principal investigator will be notified of study selection by letter and the RCM will follow through with scheduling the visit. Findings from the visit will be conveyed to the principal investigator by a letter from the Director of the Human Subjects Protection Office. The Research Compliance Monitor may however discuss findings with the principal investigator at the conclusion of the visit.

The activities and conduct of the IRB are also monitored in conjunction with each study that is monitored. The Chair of the IRB panel that approved the study will receive a copy of the letter that is sent to the principal investigator from the Director of the Human Subjects Protection Office.