Study SubmissionTo submit a research study, please email all appropriate documents to email@example.com.
The required documents are:
- 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 firstname.lastname@example.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 email@example.com before the study is activated. For your convenience, the submission form can be found here.
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.
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
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
Quality improvement is a cyclic process to improve internal processes and practices within an organization. QI is a continuous process that benchmarks practices against established indicators. Data is obtained internally and IRB oversight is typically not indicated unless results are presented outside of the organization.
Evidence-based practice is the conscientious use and integration of the best available evidence with consideration of one’s own clinical expertise and patient values and preferences to improve outcomes for individuals, groups, communities, and systems. EBP involves identification of a focused clinical question and critical appraisal of the strength of evidence that may include research, reports of QI, and expert opinion. IRB oversight is not indicated unless the project is presented outside of the organization.
STUDIES & PUBLICATIONS
- Patients Perceptions of Fall Prevention in an Acute Care Hospital; PI Mary Kutash PhD, ARNP
- Early enteral feeding in mechanically ventilated patients who have undergone cardiothoracic surgery Vicki Figlewski BSN, RN
- Nurses Cultural Competence and Patient Satisfaction; PI Jaqueline Ketchman MSN, RN, CCRN
- Post-operative pain management following thoracic outlet decompression with first rib resection; PI Dana Reed MSN, ARNP
- Resilience among Burn Nurses; PI Joann Green MSN, RN, CNS
- Providing Heart Failure Education in a Smartphone Application to Improve Health Literacy, Laureen mack DNP, RN
- Examining Factors that Influence Nurses Perceptions of Evidence Based Practice at a Magnet© Designated Teaching Hospital Marjorie Escobio MSN, RN
- Compassion fatigue among diverse healthcare providers in an urban teaching hospital using structural equation modeling; PI Linda Lowe BS, RN
- Night shift and its health effects: PI Anne Gilot MSN RN
- Keeping nurses in the workforce and at the bedside: Influential experiences in the nursing work environment; PI Patti Keppel PhD, RN
- Multicultural Competence: PI Jaqueline Ketchman MSN, RN, CCRN
- The relationship between nurse's emotional intelligence and patient outcomes; PI Mary Kutash PhD, ARNP
- Tick Tock Yawn, the Effects of Sleep Deprivation on Night Shift Nurses; PI Julie Bruno MSN RN
- The Impact of a Discharge Coordinator on Length of Stay and Patient Satisfaction Scores on a Medical Unit; PI Carole Sligh MSN, RN
- Extracorporeal Membrane Oxygenation in Adult Patients in a Large Urban Teaching Hospital: A Descriptive Study; PI Patricia Roccio MA, RN, CCRN
- Video versus direct patient monitoring: An evaluative research; PI Janet Davis DNP, RN, NE-BC, CPHQ
- Malabsorption anemia in RYGB patients; PI Frances Sahebzamani PhD (USF)
- Dissemination and Implementation of Evidence-based Methods to Measure and Improve Pain Outcomes; PI Deana Leach ARNP, MSN
- The Lived Experience of Surrogate/Proxy Decision Making in Consideration of Discontinuance of Life; PI Cindy Brown ARNP,MSN
- Fugate, K., Hernandez, I., Ashmeade, T., Miladinovic, B., Spatz, D. L. (2015). Improving human milk and breastfeeding practices in the NICU. JOGNN, 44, 426-438. DOI: 10.1111/1552-6909.12563
- Ashmeade, T. L., Haubner, L., Collins, S., Miladinovic, B., Fugate, K. (2014, September 5) Outcomes of neonatal golden hour implementation project. American Journal Of Medical Quality: The Official Journal Of The American College Of Medical Quality. Retrieved from http://ajm.sagepub.com/content/early/2014/09/05/1062860614548888
- Leach D., Spaulding J., Thomas J., Conn C., Kutash M. (2013).The Effect of Caffeine on Postoperative Urinary Retention After Joint Replacement Surgery. Orthopedic Nursing, 32, (5), 282-285.
- Curry K., Kutash M., Chambers T., Evans A., Holt M., Purcell S. (2012)A Prospective, Descriptive Study of Characteristics Associated with Skin Failure in Critically Ill Adults. Ostomy Wound Management, 58, (5), 36-43.
- Cobb,S., Russo,T., Kutash,M., Kellems,R.(2012). Medical Flight Crew Perceived Work-Related Musculoskeletal Symptoms and Related Characteristics. Air Medical Journal, 31,(1),36-41.
S., Kutash,M., & Cobb,S. (2011). The relationship between nurses’ stress and nurse staffing factors in a hospital setting. Journal of Nursing Management, 19,(6),714-720.
- Cobb,S, & Kutash,M. (2011). A Study to Describe Perceptions of ARNP Roles in an Acute Care Setting. Journal for Nurse Practitioners,7,(5), 378-384.
- Kutash M, Short M, Shea J, Martinez M. 2009The Lift Team is an Important Part of a Safe Patient Handling Program. JONA. 39(4),170-175.
- Curry K, Cobb S, Kutash M, Diggs C. 2008 Characteristics of Patients that Self Extubate in a Surgical Trauma ICU. American Journal of Critical Care.17 (1). 45-51.
- Kutash M, Northrop L.2007. Family Members Experiences of the Intensive Care Unit Waiting Room. Journal of Advanced Nursing.60 (4).384-388.