To maintain excellence in the protection of human subjects and to meet federal and Association for the Accreditation of Human Research Protection Programs (AAHRPP) requirements, a successful monitoring program is essential. At USC, the CQI program serves to keep investigators cognizant of rules, to correct procedural errors, and most importantly, to increase protections for subjects enrolled in research projects. CQI procedures include assessing investigator compliance with the IRB, assessing the IRB review process, and inspecting study records and documentation.

A system of regular, not for cause, objectively chosen monitoring visits is an indicator of quality or lack thereof, a communication tool, and a process that raises standards. Information leading to a for-cause audit may be received from a sponsor, the FDA, a whistleblower, self disclosure from an investigator, or a subject complaint. Audits may also be initiated in response to protocol amendments, continuing reviews, or reviewer questions and concerns. The Office for the Protection of Research Subjects (OPRS), delegated HSPP staff member(s) or paid consultant(s) may conduct the audits. Observations and reports are submitted to the investigator and researchers. The IRB is not notified of findings unless noncompliance issues put subjects at an increased level of risk.

Under federal regulations, the IRB has the right to monitor adherence to IRB approved research protocols, thus the IRB/OPRS is creating an oversight process that does not end with approval of a research protocol. The USC CQI program seeks to fulfill its commitment to comply with federal regulations as declared in the Federal Wide Assurance, and to protect human research subjects.

CQI Auditor Checklist
Continuous Quality Improvement (CQI) Efforts for the Human Subjects Protection Program (HSPP)