Quality Assurance

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 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 subject compliance training and outreach.
• Recommending improvements and corrective action in the human research study and IRB process.

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