The Research Patient Care Costs budget category covers the costs of routine and ancillary medical services provided to patients enrolled in a clinical study. These services are performed in a hospital or clinical facility, either inpatient or outpatient, as part of the research project.
Allowable Costs
According to NIH Grants Policy, routine and ancillary patient care costs are allowable for research participants, including patients and volunteers.
Routine services may include:
- Regular room services
- Minor medical and surgical supplies
- Use of equipment and facilities for which separate charges are not customarily made
Ancillary services are special services for which charges are normally made, such as:
- X-ray or imaging
- Operating room
- Laboratory tests
- Pharmacy
- Blood bank
- Pathology
Costs that do NOT belong in this category:
- Consulting physician fees
- Patient travel, parking, lodging, or subsistence
- Donor or volunteer fees
These excluded costs can be requested under the Other Expenses category.
Budget Justification
A clear, detailed budget justification is required to support research patient care costs. Include:
- Basis for estimating costs: Number of patient days, estimated cost per day, and cost per test or treatment
- Separate breakdown: Inpatient and outpatient costs
- Multi-site projects: List each hospital or clinic, indicate if they have a current DHHS-negotiated patient care rate, and explain how charges are calculated if no rate exists
- Patient accrual: Include expected variations across project/budget years
- Use of facilities: Note any anticipated use of the General Clinical Research Center (GCRC)
- Other funding sources: Specify any costs expected to be covered by external support (e.g., pharmaceutical companies, donated products, or other third parties)
Compliance Review
The Center for Clinical Trials (CCT) Billing Analysis reviews clinical study budgets to ensure:
- Compliance with Medicare regulations
- Alignment between the study protocol and the budget
Accurate justification and documentation are essential to meet sponsor and regulatory requirements and to support audit readiness.