Research Feasibility
The Miami CTSI supports the feasibility committee for the Miller School of Medicine research enterprise. The Research Feasibility Committee reviews industry-sponsored clinical research studies and new investigator-initiated trials and studies (excluding those federally funded).
The purpose of this committee 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.
Beginning October 1, 2026, all new investigator-initiated clinical research trials/studies, regardless of sponsor type or funding source (excluding federally funded projects), must be reviewed for feasibility by the Miller School of Medicine’s (MSOM) Research Feasibility Committee (RFC) prior to IRB submission and ORA contracting.
What do I need to do prior to RFC submission?
- Obtain department approval from internal research committee and/or division/department/unit head. Download sample approval letter
- Obtain Biostatistics Collaboration and Consulting Core (BCCC) review and approval of the protocol. This is required prior to RFC submission, documented via a BCCC determination letter. For RFC purposes, BCCC review requires a completed protocol draft, including study design and sample size justification. BCCC will endeavor to complete this review within two weeks of submission.
- An initial consultation with the BCCC is available through CTSI support. Continued or ongoing statistical support beyond this initial consultation may require additional funding.
The BCCC can provide valuable consultation on:
- Study design considerations relevant to statistical validity (e.g. randomization, control conditions, outcome definitions)
- Sample size and power calculations including consistency with protocol’s stated enrollment plan
- Statistical analysis plans
Click here to submit your BCCC Consultation Request
Once both approvals are received, study teams must complete the MSOM Research Feasibility Intake Form and upload both approval letters.
Effective 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 and ORA contracting.
Research Feasibility Process
Study teams will be required to complete the Research Feasibility Intake Form for all new, industry-sponsored clinical research studies and new investigator-initiated trials and studies (excluding those funded federally), 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 Resource
- 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 |