Assisting the Implementation of a Centralized IRB in Multiple Categories of Research at Medical City of Fort Worth

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dc.contributor.advisorPatricia A. Gwirtz
dc.contributor.committeeMemberCaroline A. Rickards
dc.contributor.committeeMemberStephen O. Mathew
dc.creatorRandhawa, Pawanpreet
dc.date.accessioned2019-08-22T21:05:23Z
dc.date.available2019-08-22T21:05:23Z
dc.date.issued2017-05-01
dc.date.submitted2017-05-12T08:54:07-07:00
dc.description.abstractIntroduction: 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.
dc.format.mimetypeapplication/pdf
dc.identifier.urihttps://hdl.handle.net/20.500.12503/29059
dc.language.isoen
dc.provenance.legacyDownloads6
dc.subjectHealth Services Administration
dc.subjectIRB
dc.subjectInstitutional Review Board
dc.subjectCentral IRB
dc.subjectLocal IRB
dc.titleAssisting the Implementation of a Centralized IRB in Multiple Categories of Research at Medical City of Fort Worth
dc.typeInternship Practicum Report
dc.type.materialtext
thesis.degree.departmentGraduate School of Biomedical Sciences
thesis.degree.disciplineClinical Research Management
thesis.degree.grantorUniversity of North Texas Health Science Center at Fort Worth
thesis.degree.nameMaster of Science

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