level 1 trauma center

Tampa General Hospital (TGH)

Tampa General Hospital (TGH), a level 1 trauma center and Florida’s largest teaching hospital, provides not only caring services but also cutting-edge clinical research and trials. Yet, the facility understands the importance of ethics in scientific investigations, which has guided regulatory steps to comply with and protect human beings. The determination to promote clinical research excellence led to the establishment of the Office of Clinical Research (OCR), which provides administrative services such as resource mobilization and management, protocol review feasibility, investigation assistance, and biostatistical roles such as protocol design, sample size determination, developing data analysis plans, and methodical elements. Besides the OCR functions, TGH has a Center of Research Excellence that plays coordination roles. It is tasked with recruitment, enrollment of participants, screening, proposing study procedures, documentation, as well as protecting records. It also provides investigational drug services such as randomization, drug storage, lab processing, maintenance, as well as dispensation.

Independent Undertakings in Research

Besides the institutional role in research, TGH also encourages independent undertakings in research by its staff as well as partners. An underlying factor in recognizing private studies is the status of TGH as a Magnet hospital, an aspect that calls for the provision of opportunities and support for nursing research. However, studies by independent persons undergo a series of stringent evaluation procedures to ensure they do not only comply with the law but also observe ethical calls. The appraisal process starts with study submission, where relevant documents are presented to OCR and assigned to specific coordinators. Some of the forms that are fundamental to the approval process are access to a data form, IRB application and approval, study protocol, informed consent form, as well as résumé of the researchers. Besides the general documents, research information sheet, budget, as well as contract are attached to sponsored studies. Similarly, institutional approvals are provided for some studies as the case of FDA letters, EPIC Order Set for drug trials, and LCD letter for device investigations.

Institutional Measures to Uphold Ethical Research

The institutional measures of upholding ethical research work are complemented by a free virtual training, which focuses on means of protecting human subjects. TGH also assesses the credibility of individuals who access patients’ record for research work. Students and staff are credentialed by the OCR whereas Non-TGH employees by the human resource department. Similarly, TGH has also partnered with the University of South Florida for IRB services to complement the functions of the Feasibility Committee.