Study Submission

• OCR Submission Form
• Study Protocol
• Study Budget
• IRB Application
• Informed Consent Forms
• Data Collection Forms
• Contractual Agreements
• FDA Approval Letter (Investigational Drug and Device Studies)
• Investigator Brochure (Investigational Drug Studies)
• TGH Drug Research Information Sheet (Investigational Drug Studies)
• Instructions for Use (Investigational Device Studies)
• Device Manual (Investigational Device Studies)
• TGH Device Research Information Sheet (Investigational Device Studies)
• Additional Documents as Appropriate

The OCR will review the study documents and may contact you to ask questions about how you plan to operationalize the study. There are supplementary forms for studies impacting TGH departments/units or using any TGH services. These forms are not required for initial submission; however, the OCR recommends submission of the appropriate supplementary forms to expedite turnaround for study approval. If you are uncertain, please contact us at research@tgh.org. The supplementary TGH feasibility forms are:

• TGH Unit Operational Review of Proposed Research
• TGH Imaging Operational Review of Proposed Research
• Technology Operational Review of Proposed Research
  

Note: An abbreviated form is available for retrospective chart review studies with no informed consent, budget, contract, and/or Tampa General Hospital billable procedures or services. Additionally, these types of studies must be submitted to research@tgh.org before the study is activated. For your convenience, the submission form can be found here.

Credentialing
Researchers must be credentialed by the Office of Clinical Research to do research. You may submit your study for approval while completing the credentialing process. For more information, refer to the Credentialing section

As a Magnet hospital, Tampa General Hospital recognizes the importance of nursing research and encourages the conduct and utilization of research in all areas of nursing. Nurses have the opportunity to participate in any aspect of nursing research from data collection to serving as a principal investigator. In addition to our dedicated Nurse Specialist for Nursing Research we have strong collaborative relationships with nursing faculty from various universities and our Office of Clinical Research. Research conducted by our nursing staff has been recognized at the local, national and international levels through presentations and publications.

SUBMISSION PROCESS

The submission process is outlined on the "Study Submission" page

TGH Protocol Template: Biomedical
TGH Protocol Template: Social Behavior
TGH Protocol Template: Chart Reviews
TGH Informed Consent Template: General
TGH Informed Consent Template: Compassionate Use
TGH Informed Consent Template: Survey Research

APPROVAL PROCESS FOR RESEARCH

All research conducted at TGH, regardless of the investigator, must meet the same criteria for approval. (1) IRB approval (2) TGH OCR approval. TGH recognizes several IRB’s; however, our local IRB is the University of South Florida. Individuals who are not using one of the IRB’s that we recognize will need to submit an application to USF IRB. If the study is being conducted to meet educational requirements, the student’s school may require approval by their IRB as well as USF.

As part of the approval process, all members of the research team are required to be credentialed for research. A TGH application will also need to completed as well as an updated CV(first page needs to be signed and dated) for the PI. Refer to the "Credentialing Page”  for further instructions.

ADVANCED NURSE SPECIALIST RESEARCH

The Nurse Research Specialist helps nurses to engage in research and evidence-based practice endeavors for the advancement of quality of care. Nurses at all levels and all specialties are encouraged to be actively involved. Assistance provided by the Nurse Research Specialist can range from identification of a topic or question, assistance with study design, protocol development, IRB approval, and dissemination of findings up to and including publication. The Nurse Research Specialist is also available to help with identification of external grants for nursing research as well as the grant application process.

For information about research and evidence based practice, please contact:

Mary Kutash PhD, ARNP
Advanced Nurse Specialist Research
Magnet® Program
813-844-7040 (office)
813-844-7128 (fax)
mkutash@tgh.org

Through the Friends of Nursing, the TGH Foundation also supports nursing research through the small grant program Nursing Research Projects. This internal grant program provides up to $2,000 to nurses who have been employed at TGH for at least one year, are permanent team members, and work a minimum of 20 hours per week.  All applicants are reviewed by the Research Council.  Interested staff should contact Mary Kutash, PhD, ARNP, for more information

FREQUENTLY ASKED QUESTIONS

STUDIES & PUBLICATIONS