- Applies to: UF Human Subjects Clinical Research
- Effective date: Ongoing
Clinical research studies that involve interventions with human subjects often have procedures that are considered “standard of care” or “routine”, as well as procedures that are strictly performed for research purposes only.
Additionally, the sponsor may pay for part of or all of these costs (even costs that are considered “standard of care”). These differences must be clearly understood and delineated in the billing plan and approved prior to implementation.
In determining what might be “routine care” or “standard of care”, Principal Investigators should consider the following:
- Are the tests, procedures, etc. within a reasonably defined standard of routine and usual care for a particular condition as defined by established best practices or well supported in peer-reviewed medical literature?
- Do you order the same tests, procedures, etc. and in the same frequency for similar patients not participating in a study?
- Will the medical records of your patients (with the same conditions) who are not enrolled in a study support this pattern of treatment?
Please note: Medicare or other third-party payers may not consider costs reimbursable even if considered by the individual physician as clinically necessary or routine care. Some examples of this include non-covered services, an unidentified diagnosis code or disagreement with the frequency of the approved procedure.