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 Quality Improvement program serves to keep investigators cognizant of rules, to correct procedural errors, and most importantly, to increase protections for subjects enrolled in research projects. Quality Improvement procedures include assessing investigator compliance with the IRB, monitoring the IRB review process, and inspecting study records and documentation.
- New Version of the online IRB Application – April 2012
- USC Flexibility Policy
- Continuous Quality Improvement (CQI) Efforts 2012
- 2012 Annual IRB Survey Results
- 2011 Annual IRB Survey Results
- 2010 Annual IRB Survey Results
- Human Subjects Protection Program Improvements (2011)
Quality Improvement Tools & Results
- Lessons Learned from CQI Assessments
- HSIRB Audit Checklist (Current Version)
- UPIRB Audit Checklist (Current Version)
- CQI Auditor Checklist (Previous Version)
Study Organization & Audit Resources
- What a Biomedical Study Binder Should Contain
- What a Soc Behavioral Study Binder Should Contain
- Sample Checklist for Documenting Subject Visits
- Problems Frequently Identified During an Audit/Assessment
- Protecting the Rights, Safety, and Welfare of Study Subjects – Supervisory Responsibilities of Investigators (FDA Guidance on investigators’ responsibilities concerning the rights, safety, and welfare of study subjects)
- “Monitoring with a Monitor’s Eye” (PDF)
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 Quality Improvement program seeks to fulfill its commitment to comply with federal regulations as declared in the Federalwide Assurance, and to protect human research subjects.