The patient care costs budget category is to be used only for the cost of routine and ancillary medical services for patients enrolled in a clinical study that are performed in a hospital or clinical facility on an inpatient or outpatient basis.

If your research involves human subjects, the budget must propose reasonable costs for the clinical portion of the project. The National Institutes of Health (NIH) Grants Policy states that routine and ancillary research patient care costs provided by hospitals to individuals, including patients and volunteers, participating in research programs are allowable costs. “Routine services” include the regular room services, minor medical and surgical supplies, and the use of equipment and facilities for which a separate charge is not customarily made. “Ancillary services” are those special services for which charges customarily are made in addition to routine services, e.g., X-ray, operating room, laboratory, pharmacy, blood bank, and pathology.

Patient care costs should not include such costs as consulting physician fees or patient travel, parking, lodging, subsistence, or donor/volunteer fees. These costs may be requested under the "Other Expense" category.

The Center for Clinical Trials (CCT) Billing Analysis section reviews clinical study budgets for compliance with Medicare regulations and to ensure that the protocol and budget are harmonized.

Justification

Use the budget justification to itemize, in detail, the basis for estimating costs for research patient care, including the number of patient days, estimated cost per day, and cost per test or treatment. If inpatient and outpatient costs are requested, provide information for each separately.

If multiple sites are to be used, provide detailed information by site. List the names of the hospitals or clinics involved. Indicate whether these hospitals or clinics have a currently effective DHHS-negotiated patient care rate agreement and, if not, what basis will be used for calculating charges.

Also provide information about patient accrual, including variations anticipated among the project/budget years.

Include as part of the justification any anticipated use of the General Clinical Research Center (GCRC). Finally, specify any research patient care costs that are expected to be covered by other sources of support, such as a pharmaceutical company (including donated products) or other third parties.