Browsing by Subject "IRB"
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Item Assisting the Implementation of a Centralized IRB in Multiple Categories of Research at Medical City of Fort Worth(2017-05-01) Randhawa, Pawanpreet; Patricia A. Gwirtz; Caroline A. Rickards; Stephen O. MathewIntroduction: 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.Item Evaluation of the Systematic Clinical Trials Protocol Approval Process at a Matrix Cancer Center(2007-11-01) Bloomer, Tyler; Patricia Gwirtz; Rusty Reeves; Lynn BakerThe National Cancer Institute (NCI) estimates that approximately 555,550 people die of cancer each year in the United States. This is an average of a little more than 1,500 people per days and ranks cancer as the second leading cause of death behind heart disease. In 2007, an astonishing 1,444,920 new cancer cases are anticipated to be diagnosed. It is through scientific research and the necessary employment of clinical trials that advanced are made to fight this dreadful disease. A breakthrough or advancement made in the treatment of cancer begins with basic research of cells and tissues in the laboratory. Once a particular treatment or technique is developed, and proven to be successful in animal models, it can then be evaluated in people through clinical trials. Clinical trials follow a rigorous scientific process to answer specific questions relating to the new newly developed therapy or technique. A clinical trial is the only mechanism to determine the true effectiveness of a promising new therapeutic being investigated. Thus, any unnecessary delays in approving a clinical trial protocol increases the time before that trial can begin enrolling patients and therefore gain approval for new treatment options. The International Conference of Harmonization Good Clinical Practice (ICH GCP) guidance document defines a protocol as “a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial.” The ICH GCP further goes on to describe that the protocol gives the rationale and background for a trial. The World Health Organization’s (WHO) Handbook for Good Clinical Research Practice states that “the study protocol is the core document communicating trial requirements to all parties who have responsibility to all parties who have responsibility for approval, conduct, oversight, and analysis of the research.” Thus, before any trial can begin accruing patients, its protocol, along with a study’s informed consent, must be thoroughly reviewed and approved by a network of entities to ensure that a study’s protocol outlines a trial that is safe and effective. A recent study conducted at the Vanderbilt-Ingram Cancer Center (VICC) and at a VICC Affiliate Network (VICCAN) sites indicated that two particular processes took longer than all others involved in their clinical trial protocol approval process. These two particular processes were the Scientific Review Committee review process and the Contracts and Grants approval process. This was contrary to what the authors expected, in that, they believed the IRB review and approval process would take the longest. Many of the challenges reported by the authors of the study at the VICC parallel those encountered in the protocol approval process at UT Southwestern. A closer examination of these parameters is needed. The Harold C. Simmons Comprehensive Cancer Center (SCCC) at UT Southwestern Medical Center is a matrix cancer center and relies upon the interactions between other institutions and departments to conduct all phases of its cancer research. Thus, the process involved in approving a clinical trial protocol also rely upon the interactions between other institutions and departments. This is where many challenges and various institutional administrative barriers arise. Therefore, it is the goal of this practicum report to formally evaluate and document the protocol approval process at the SCCC at UT Southwestern. The report will also identify unwarranted time delays in the process and provide feasible resolutions to expediting the overall clinical trial protocol approval process without compromising patient safety or research integrity. At the cessation of this report, a further analysis may be conducted using its findings to determine whether or not these time delays in the process and provide feasible resolutions to expediting the overall clinical trial protocol approval process without compromising patient safety or research integrity. At the cessation of this report, a further analysis may be conducted using its findings to determine whether or not these time delays in approving a study protocol are consistent with approval processes encountered at other institutions and academic health center settings like the Vanderbilt-Ingram Cancer Center and the Simmons Comprehensive Cancer Center.Item Submission to the IRB: Will Modified Training Improve the Probability of Successful Submission of IRB Protocols?(2016-12-01) Chou, Yuhung H.; Gatch, Michael B.The ability to design, conduct, and oversee of a research project has becoming essential for the pharmacy residents to become pharmacists. Each year, pharmacy students undergo training on the specialized institutional review board (IRB) program at Baylor Scott and White Research (BSWRI) and how to submit their research application to the IRB. It is crucial for the pharmacy residents to undergo the IRB training since they typically struggle to submit their research applications due to lack of research background during undergraduate years. This year’s training was modified to test whether the change will improve the submission process compared to the training in 2014 by implementing memory aids such as skeleton outlines and emphasis on important materials by the presenter. The effectiveness of the training was measured by the average number of times that the residents submitted to the IRB, as tallied by the iRIS database. The residents in 2016 performed the same compared to the residents in 2014. Further investigation needed to improve submission numbers.Item The State of IRB Staff in America(2009-12-01) Oglesby, Amanda E.; Dr. Patricia GwirtzPurpose: To conduct a descriptive examination of Institutional Review Board (IRB) staff members across the United States. Objective: To determine a pattern or “type” of individual who is most drawn to working with IRBs and to develop a deeper understanding of the backgrounds and experiences of the IRB staff. Design: An IRB staff survey was distributed, via e-mail, to medical school IRBs which were grouped according to NIH funding in 2008. Results: The IRB staff pursued an IRB career because of motivational reasons, and they were able to obtain the job due to their background and skills. Conclusion: Results suggest there is a difference between amount of NIH funding and highest degree obtained, number of protocols reviewed, and number of full-time employees.