Research Study Budget Design + Analysis
To properly negotiate budgets for research studies it is important to assess protocol feasibility and identify the costs to conduct the study. A study should not be pursued if it does not cover the costs to conduct it unless there are additional financial resources identified.
The first step to create a comprehensive budget is to develop an internal budget. Internal budgets are used for sites to identify all of their costs to conduct a study and can be used as a tool to negotiate the sponsor budget. It is critical to have a thorough understanding of the study documents to develop a comprehensive budget. This entails reviewing the protocol, contract, consent, and case report forms to identify each procedure, visit, participant contact, supplies, and patient care costs that are needed to conduct the study. It is recommended to identify the work that is required per participant. All of the identified items should be listed in the internal budget.
Once all items are identified to conduct the study, a determination needs to be made if the service is considered Standard of Care (SOC) or Research Only. Standard of Care services are those that are typically performed in the participant population for the disease being studied and will be billed to the patient/insurance. Research Services are those that are performed for research purposes only. Research services are NOT billed to the patient/insurance. See the Clinical Research Billing Guide for information regarding how to make this determination. Mark the SOC and Research determinations in the internal budget. The Research services will be the costs to conduct the study.
It is important to note that one size does not fit all when it comes to budgeting. There are many different types of studies and sponsors who all have different budgeting needs. There are, however, common core components to developing any study budget. Core budget components include administrative costs, travel, staff costs, supplies, equipment, patient care costs, etc. There may also be a need for cost sharing or subcontracts.
- RBO Key Considerations for Internal Budgets for Industry Sponsored Clinical Trials
- RBO Industry Sponsored Internal Budget Template
- RBO Billing Decision Tree
- RBO Clinical Research Billing Guide
Administrative and Start up Costs
Administrative costs may include pharmacy fees; IRB fees, Institutional review fees, courier expenses, photocopying, secretarial supplies, parking fees, subject meals, phone lines, long distance charges, and storage expenses. Facilities and Administrative (F&A) or Overhead costs also need to be considered. F&A costs are those costs associated with providing and maintaining the infrastructure that supports the research enterprise (buildings and their maintenance, etc…) and which cannot easily be identified with a specific project.
It is recommended that sites request one time, up front, non-refundable fees to cover the cost to prepare a study to start. The idea is to get paid for work completed, even if the study does not start. Sites must also remember to include one-time fees for the Institutional Review Boards, Hospital Research Offices, Pharmacies, etc...
If a study requires travel to investigator meetings or training meetings those costs should be included in the budget. Include costs for transportation, accommodations and per diem, registration, and all other allowable expenses.
When preparing the budget, it is important to identify the types of personnel involved in the study such as; faculty, research coordinators/nurses, research assistants, graduate associates, undergraduate associates, consultants etc… Staff percentage of time on the project needs to be identified along with their fringe benefit rates. A Release Time Form must be completed for all faculty and staff for a research sponsored project.
Staffing costs may include the time it takes to attend the start-up meeting, prepare regulatory documents, prepare the budget, screen/recruit participants, obtain informed consent, schedule visits, complete CRFs, complete AE/SAEs forms, manage events, attend mandatory educational classes/training, attend monitoring visits, correct CRFs, answer queries, track lost to follow-up/no-shows, on-call time, and study close out.
Supplies and Equipment
Common supplies include paper, pens, folders, binders, labels, laboratory tubes, venipuncture supplies, shipping materials, etc. Equipment such as -70 Freezers or special imaging scanners may also be needed for certain studies.
Patient Care Costs
Patient care costs include tests and procedures that are required only because the patient is participating in a research project - they are not a part of routine medical care. The cost of such tests, performed at OSU University Hospitals Health System and OSU Physician Practices and billed by these entities, are patient care costs. Professional fees or costs collected by private billing agencies are not considered patient care costs.
Procedure costs should be easily identified by the study procedure outline. Typical costs include lab tests, radiology procedures, ECGs, supplies for study treatment, and space or bed charges. T
If the study involves services that may be billed to Medicare or third-party payers, Investigators are required to complete a Coverage Analysis form. The purpose of a coverage analysis is to ensure that the costs for items and services that are included as part of the study plan are billed to the appropriate payer and in compliance with applicable Medicare regulations for research billing.
A coverage analysis can be performed many ways. There is no “right” way to perform a coverage analysis. There are, however, key steps to be completed during the process. These steps are outlined in the Clinical Research Billing Guide.
- RBO Coverage Analysis Frequently Asked Questions
- RBO Coverage Analysis Form
- RBO Research Billing Guide
A subcontract may be required if part of the research effort under a grant or contract is to be performed by another organization. If the subcontract is part of a proposal to a federal sponsor or from federal funds, please work with the Office of Sponsored Programs sponsored program officer to determine how to set up the sub-contract and how to budget.
Cost sharing means charging part of the costs of a sponsored project to a source other than the sponsor. If cost sharing is included in a proposal to a federal sponsor and the proposal is funded, the promised cost share becomes a requirement of the award whether or not that requirement is specified in the award document. All cost sharing must be documented as having been provided. Some costs, such as supplies, do not lend themselves readily to documentation and audit, so using these items as cost share should be avoided if at all possible. If Cost Sharing is part of a proposal please work with the Office of Sponsored Programs sponsored program officer to determine how to set up the Cost Sharing arrangements and how to budget.
Negotiating the Budget
Compare the internal budget to the sponsor proposed budget. If the sponsor budget does not cover the site’s costs to conduct the study propose changes to the budget. Some sponsors will state that the budget is non-negotiable but it is always worth trying to negotiate to cover costs. Sponsors tend to become more willing to negotiate once a site has developed a proven track record of conducting quality studies.
Some studies may be worth subsidizing for scientific merit or for other reasons. Departments or other providers may agree to subsidize studies. It is recommended that the investigator gets written approval from the appropriate person for subsidizing an agreement to cover any outstanding costs to conduct the study.