Quality Assurance Activities

Quality Assurance Activities

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 (IRB) 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 investors 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. Not all studies will be selected. The majority of studies reviewed are selected with an emphasis on the following:

  • investigator-initiated studies
  • moderate to high risk to participants
  • vulnerable populations
  • high enrollment
  • studies for which there may be a conflict of interest
  • investigators who are new to research
  • monitoring does not already occur

Receiving notification that a study has been selected for a monitoring visit does not imply that wrongdoing is suspected in the conduct of the study. The principal investigator will be notified will be notified of study selection by phone and a letter will follow with the details of the scheduled visit. Visits offer an organized and efficient review that education on good research practices.

For additional information on Quality Assurance Activities, please contact:

Angela Braggs-Brown, RAC, CIP, MA, Director
Human Research Protection Program (HRPP)
Phone: 513-558-3005
Email: broag@uc.edu

Kareemah Mills, CIP, Assistant Director
Human Research Protection Program (HRPP)
Phone: 513-558-3576
Email: millsks@uc.edu