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 should be requested under the "Other Expense" category. 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 both inpatient and outpatient costs are requested, provide information for each separately. If multiple sites are to be used, provide detailed information by site. 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. While the budget is being developed, Principal Investigators are encouraged to review proposed patient care costs with a Clinical Trial Analyst in the Center for Clinical Trials. The Analyst will "walk" through the protocol to ensure that all potential costs have been considered, and in particular, all costs that are research study costs are included in the proposed budget. For more information, go to Clinical Trial Budgets and Budget Review |
