Date of Award
Restricted Internship Practicum Report
Master of Science
Field of Study
Clinical Research Management
Graduate School of Biomedical Sciences
Patricia A. Gwirtz
Caroline A. Rickards
Stephen O. Mathew
Introduction: As a collection of ethical principles and guidelines regarding biomedical research on humans, the Common Rule has remained largely unchanged since its inception while the clinical research landscape has grown dramatically in size and complexity. Now with the Common Rule being modernized, one of the proposed changes being executed is the requirement of a centralized Institutional Review Board (IRB) for multi-site research studies. This transition of a research site operating under a local IRB to a centralized IRB is expected to greatly improve collaborative studies.
Objective: The main goal of this practicum project is to assist in the implementation of a centralized IRB for multi-site research at Medical City of Fort Worth in order to comply with the changes to the Common Rule.
Methods/Results: To achieve the goal of this practicum project, the operational rules and regulatory processes at Medical City of Fort Worth were updated. This included revising the institutional IRB and FWA, adverse event and serious adverse event reporting, and audit policies, establishing a local database for active studies, converting study-related materials to an e-records system, and revising the institutional exemption status policy.
Conclusion: These activities led to the completion of the transition of Medical City of Fort Worth from a local IRB to a centralized IRB. Additionally, documentation of the process yielded a procedural guide for other institutions undergoing the same transition.
"Assisting the Implementation of a Centralized IRB in Multiple Categories of Research at Medical City of Fort Worth" Fort Worth, Tx: University of North Texas Health Science Center;