Human subjects research at UConn is monitored by the HRPP Post Approval Monitoring Program. The goal of the Monitoring Program is to assess compliance of human subjects research with federal, state, and local law, and UConn-Storrs policies, to identify areas for improvement, and to provide recommendations based on best practices, current policies and the guidelines for the conduct of research as stated in the Belmont Report. Through our education efforts, we provide the most current information to investigators and students through education, training, and monitoring to help ensure all human subjects research is conducted in accordance with the IRB approved protocol. All studies, including those approved under the Exempt Category, are subject to audit. Categories of audits include routine, informed consent, for-cause and investigator-initiated. Except in cases where the safety of participants is a concern, or where the IRB specifically requests an unannounced audit, audits will be scheduled within two weeks of receiving notice. Immediately following the audit, the Education & Quality Assurance/Quality Improvement (QA/QI) Specialist will provide a brief summary of findings to the principal investigator and student researcher if applicable. The results of compliance reviews will be reported to the HRPP Director, IRB Program Director, the UConn-Storrs IRB (when the IRB of record), the investigator, and other UConn-Storrs leadership, as appropriate. A detailed report of the audit findings, any required follow up, and recommendations will be sent to the researchers. Additional details about the HRPP monitoring program and audit procedures are outlined in HRPP SOPs for UConn-Storrs (in process).docx.
If you have questions regarding the auditing process, or would like to schedule a time to meet with the Education & QA/QI Specialist for an individual or group education session, please contact:
Joan Levine, MPH, CIP
Education and QA/QI Specialist