The UF Office of Clinical Research (OCR) is responsible for ensuring that all UF clinical research studies have patient-care billing plans that are compliant with rules and regulations regarding who will be paying the costs of all patient-based items, services, and activities required by the clinical protocol.
OCR is also responsible for teaching Research Billing Compliance (RBC) regulations, principles, and workflows to UF study staff who work on Human Subjects Clinical Research studies that generate protocol-required patient-care costs.
What are Clinical Research Billing Compliance Risks?
There are two areas of Clinical Research Billing Compliance concern for studies involving human subjects and patient-based billable services:
- “Billing Out” False Claims – This occurs when study participants or their insurance companies (third party payers) are billed for study services that should NOT be billed to participants or their insurance.
- Fiscal Language Conflicts in Contracts & Consents – This occurs when the study informed consent has “costs” or “subject injury” language that conflicts with information in the study protocol, budget, award, contract, or agreement.
What Studies Need RBC Review?
OCR performs RBC Reviews on any UF Human Subjects Clinical Research project with patient-based study activities performed in a:
- Clinic
- Hospital
- Research Space
- UF Clinical Research Center
How Do I Manage RBC Risks?
To provide a compliant framework for clinical research billing, UF and UF Health have worked together to create RBC workflows in the following areas:
- Epic (UF Health Electronic Medical Record and Billing System)
- OnCore (UF Clinical Research Management System)
- Clinical Research Agreements
- Financial Language Assessment (FLA) for UF IRB Informed Consents
What Training is Available for Managing RBC Risks?
- Mandatory Certification Training on Human Subjects Clinical Research Billing Risks – All UF personnel who work on Human Subjects Research and Clinical Trials that involve protocol-required patient-based services must complete certification on a biennial basis (once every two years).
- The OCR Training Series
Questions?
- Email: OCR-QA@ahc.ufl.edu
- Team Lead: Mary Ellen Toombs (352) 294-5297
- Individual team members: See OCR Staff