Welcome to the Research Regulatory Office. Our office:
administrates and supports the Queen's Health Systems Institutional Review Board (QHS IRB). The department is charged with upholding regulatory policies and procedures related to the protection of human subjects in research.
Services
IRB review and approval of human subjects research (initial, modification, and renewal).
Determination of non-human subjects research projects (e.g., quality improvement, process improvement).
Reporting of adverse events and/or deviations from protocol.
Coordinating review with external IRBs.
Coordinates and provides Medicare Coverage Analysis/Coverage Analysis (MCA/CA) and calendar builds within the clinical trial management system, Clinical Conductor, for all clinical research studies. The CA is a systematic review of the clinical trial documents to determine whether the study is a qualifying clinical trial and which items/services/procedures are billable to insurance or study-paid.
Conducts institutional quality assurance/compliance Monitoring to ensure applicable research policies and procedures are followed.