The Human Subject QA/QI Program is housed within the Research Compliance and Integrity Unit (RCI). The Program, which is independent of the IRB, currently has one auditor/review who reports to the Director of RCI.
The QA/QI auditor conducts routine reviews of active IRB studies and also performs “for cause” audits at the request of the IRB. There are multiple purposes and objectives of the the QA/QI program, including:
- Evaluating human subject studies for possible non-compliance with the IRB Protocol and/or regulatory requirements.
- Promoting a culture of compliance among the human subject research community.
- Assisting with human subhect compliance training and outreach.
- Recommending improvements and corrective action in the human research study and IRB process.
For Questions Contact Research Compliance & Integrity