In January 2005, the University of Cincinnati instituted the Human Subjects Research Post-Approval Monitoring Program which administers quality assurance/quality improvement monitoring. The purpose of this program is to ensure that scientific, ethical and regulatory requirements are followed in all Institutional Review Board approved protocols. The program is also designed to improve the quality of research by detecting errors and/or omissions that might occur when performing research activities. This will also give the investigators an opportunity to ask questions and receive information about regulations and issues regarding the protection of human subjects.

All studies, even those determined to qualify for exempt status, are subject to quality monitoring.  However, the emphasis of the monitoring program will be on studies with moderate to high risk to subjects, investigator initiated studies, studies involving vulnerable populations, studies for which there is or may be a conflict of interest and studies where monitoring does not already occur. 

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 wrong-doing is suspected in the conduct of the study.  The principal investigator will be notified of study selection by phone and a letter will follow with the details of the scheduled visit.

For additional information on the Post Approval Monitoring Program, please contact:

Daniel Woo, MD

Human Research Protection Monitoring Program

Phone: 513.558.2705 Fax: 513.558.4887 ML: MSB 0525

email: daniel.woo@uc.edu

Or

Joanne A. Lindwall, Director

Post Approval Monitoring Program

Phone: 513.558.3576 Fax: 513.558.4498 ML HPB 0661

email: joanne.lindwall@uc.edu