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.
What Are Clinical Research Billing Compliance (RBC) 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?
The OCR performs RBC Reviews on any UF Human Subjects Research projects with patient-based study activities performed in a
- 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
- IRB Informed Consents
What Training is Available for Managing RBC Risks?
- Mandatory RBC810 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 Research Billing Compliance certification on a biennial basis (once every two years).
- Research Billing Compliance Training Series
To learn more about Clinical Research Billing Compliance, visit the OCR Clinical Research Support Dashboard (gatorlink login required).