Protocol Budgets and Funding

** Note ** Prior to application submission, you must meet with Dilcia Grenald, Assistant Administrative Manager (x63484 or email: dgrenald@med.cornell.edu), to discuss the particular aspects of your budget. This will prevent any unnecessary delays in the review process.

Funding Categories

The extent to which the CTSC funds the costs for hospitalization and ancillary tests performed on research subjects depends upon the type of research being performed and the available patient care funds awarded through the CTSC grant.

The CTSC defines inpatient and outpatient research subjects as follows:

• Category A: Inpatient admissions or outpatient visits, solely for research purposes where hospitalization would otherwise unnecessary and no health advantages are expected to accrue as a result of the hospitalization or visit.  The CTSC pays for hospitalization (bed costs), and/or outpatient visits and research costs itemized on the approved version of the protocol budget.  This also applies to protocols that are investigator-initiated, even if industry has agreed to provide funding (documentation required).
  
  
• Category B: Patients in the hospital for treatment of a disease or disorder may also be part of a research study.  Costs for diagnosis and treatment according to established standards of care are billed to the patient or third-party coverage. Ancillary costs related to research are covered by the CTSC.
  
  

• Category D: Industry-initiated research. All charges are paid directly by industry through the responsible investigator. The investigator should contact the Assistant Administrative Manager, Dilcia Grenald at 212-746-3484 for current charges. 
  
  
• Mixed A and B: Patients under standard care may have "study category A days" devoted primarily to research. The CTSC grant pays for the routine hospitalization costs for those days, in addition to other specific ancillary charges agreed upon during the review process.
  
  

• Scatter-bed: Occasionally research costs for scatter-beds (non-CTSC beds) may be charged to the CTSC grant when special facilities (e.g., intensive care unit or other services requiring unique resources not available on the CTSC), are required to accommodate a research patient.  Scatter-bed requirements are determined on an individual project basis.
  
  

• Offsite Research Visit (ORV): When required, subjects may be seen in facilities that are neither JCAHO-accredited nor Medicare- or Medicaid- certified (e.g., school, church, clinic). Please contact the CTSC for more information if your study will have these types of visits.

The grant covers the costs of the research on category "A" and "B" patients. It also covers the cost of hospitalization for category "A" subjects. It does not cover the cost of non-research tests, which may be performed coincidentally or as a convenience to the subject. The grant also does not cover the cost of the hospital room and medical care for type "B" or "D" patients.

Research and Hospitalization Costs

It is the responsibility of the principal investigator to explain to subjects the hospitalization costs of their participation in the study and the assumption of the responsibility for those costs by either the CTSC, the investigator's own funds, third-party payors, or the individual study subject. It is the investigator's responsibility to make certain that participants understand that only the research costs for time spent on the CTSC may be paid by the center, and that the CTSC is not responsible for charges that apply for any other purpose or period of their hospitalization.

Ancillary Tests and Procedures

The CTSC offers many services at minimal or no charge for protocols that are investigator initiated (e.g. patient meals, nursing services, specialized core lab assays, biostatistics and informatics support).

In addition to these services, the CTSC has a limited amount of funding to assist investigators in conducting their studies. These ancillary funds may be used to pay for additional items detailed on the protocol budget approved by the Translational Research Advisory Committee. Ancillary services are defined as services routinely available through the hospital departments for all patients in the hospital (e.g., blood tests, x-rays, medications). This definition may apply even when these services are purchased from sources outside the hospital for reasons of economy or efficiency. The CTSC, however, cannot assume the responsibility for high cost ancillary services such as CT scans, MRIs, etc., unless approved in advance by the Advisory Committee. For a list of available labs and costs, refer to the NYPH Lab Fee Schedule.

Other Requirements

• All industry-initiated or industry-sponsored protocols must include a copy of the signed and approved contract in ePAR.
• Protocols with external funding (NIH, foundation, or institutional) must also submit a copy of the budget submitted with the grant proposal.