Research Feasibility
The Miami CTSI supports two feasibility committees for the Miller School of Medicine research enterprise. The (1) Research Feasibility Committee reviews industry-sponsored clinical research studies while the (2) COVID-19 Feasibility Committee reviews COVID-19 related studies.
The purpose of these committees is to optimize the allocation of institutional resources and effort, reduce duplicative studies, and improve the overall performance of clinical research at the Miller School of Medicine.
For each study type, please review the steps to submitting a feasibility intake form.
Industry-Sponsored Clinical Research Studies
Beginning September 1, 2022, all new industry-sponsored clinical research studies, will be reviewed for feasibility by the Miller School of Medicine (MSOM) Research Feasibility Committee (RFC) prior to IRB submission.
What do I need to do?
Study teams will be required to complete the Feasibility Intake Form for all new, industry-sponsored clinical research studies, prior to IRB submission and ORA contracting.
Who do I contact with questions?
If you have any questions, please feel free to contact the Research Feasibility Committee at [email protected].
How long will it take?
Take a look at our Review Committee process and timeline.
Additional Resources
- Oneness Research Solution – Allows clinical research teams to query de-duplicated and de-identified UHealth and JHS patient data and generate aggregate counts, enabling preparatory-for-research activities, cohort discovery, and other clinical research activities.
- Epic Slicer Dicer User Guide – A basic SlicerDicer training video and related slide deck are available in our webinar platform. First time users will need to register for an account with your University of Miami email address. Once registered, follow the link and click “Enroll me” to view the video and materials.
Committee Members
| Carl Schulman, MD, PhD (Chair) | Surgery/Burn |
| Ivette Cejas, PhD (Co-Chair) | Otolaryngology |
| Barbara J. Coffey, MD | Psychiatry |
| Fernando Corrales-Medina, MD | Pediatrics – Hematology |
| Kamil Detyniecki, MD | Neurology – Epilepsy |
| Sakir Humayun Gultekin, MD | Pathology |
| Philip D. Harvey, MD | Psychiatry |
| Pasquale Patrizio, MD | Obstetrics and Gynecology |
| Richard Preston, MD | Medicine – Clinical Pharmacology |
| Sanoj Punnen, MD | Urology |
| David Reis, PhD | UHealth IT |
| Allan E. Rodriguez, MD | Medicine – Infectious Diseases |
COVID-19 Feasibility
What do I need to do?
All investigators interested in conducting a COVID-19 related study must complete the COVID-19 study intake form before submitting the study to the HSRO and ORA.
The Feasibility Committee is made up of scientific and clinical experts at the Miller School of Medicine. The committee’s charge is to assess which studies have the best chance of benefiting current and future patients with the goal of improving the quality of research and to ensure that there are not duplicative studies with the same participant population.
Investigators will be notified of the Committee’s decision and recommendation.
Who do I contact with questions?
If you have any questions regarding the new COVID-19 Feasibility Committee, please email [email protected].
Committee Members
| Maria Abreu, MD (Chair) | Medicine/Gastroenterology |
| Jose Castro, MD | Medicine/Infectious Diseases |
| Susanne Doblecki-Lewis, MD | Medicine/Infectious Diseases |
| Elizabeth Franzmann, MD | Otolaryngology/Head and Neck |
| Hayley Gershengorn, MD | Medicine/Pulmonary |
| Richard A. Preston, MD | Medicine/Clinical Pharmacology |
| Richard Silverman, MD | Anesthesiology/Critical Care Medicine |
| Adam Wanner, MD | Medicine/Pulmonary |