Clinical Trial Budget Resources
Animal Research Considerations
Human Subjects Research Considerations
Environmental Health and Safety (EH&S) Considerations
A budget is a detailed statement outlining estimated project costs that support a sponsored project. It should include all Direct Costs as well as the calculated Facilities and Administrative (F&A) costs required to carry out the project objectives. The proposal budget should be derived directly from the project description and serves as the financial expression of the project.
Follow sponsor guidelines on requirements, allowability, and format. Plan for requirements in federal contracts that impact your budget.
Sponsor and UW budget categories sometimes don’t match. Review UW Budget categories and try to map them to the sponsor categories when preparing your budget.
The UW prefers to be paid in U.S. Dollars, not foreign currency. Exchange rates change all the time. If awarded in foreign currency, the value of sponsor payments can vary throughout the life of an award.
However, if the sponsor insists the proposal budget be expressed in foreign currency (and will pay in foreign currency), use an online currency converter to calculate the budget amounts on the eGC1 from U.S. dollars into the sponsor’s currency.
When sponsors make award payments in foreign currencies, the PI and department need to monitor spending and currency fluctuations more closely. Note: The PI and department are responsible for resolving deficits, including those that may arise from currency fluctuation.
Review more information and examples from Grant & Contract Accounting on Awards Paid in Foreign Currency.
When costs will benefit more than one project, they need to be allocated in proportion to how they will benefit each award. Document the allocation methodology used to budget the cost in your budget justification and in your award file. Make sure that methodology is consistently applied across like circumstances.
Acceptable Allocation Method Examples:
- Number of experiments, hours, clients or employees/FTE on the project
- Square footage
Costs that will only benefit one award should only be budgeted for that award.
Costs may not be allocated to more than one project based on budgetary convenience.
Direct costs are expenses specifically associated with a particular sponsored project or activity or that can be directly assigned to that project or activity with a high degree of accuracy (e.g. supplies allocation).
Personnel Salaries and Benefits are typically the largest category of expenses. Review UW Human Resources compensation information.
- Names and titles of personnel committing effort to this project.
- Effort each will devote to the sponsored activity, expressed as a percentage or calendar/academic months
- Institutional Base Salary (IBS)
Salary costs must be:
- Appropriate for effort expended
- Consistent with the appointment of the individual
- Supported by documentation of the expense
- Included in proposal and approved by the sponsor or within re-budgeting authority
Review examples of unallowable direct salary costs on a sponsored program
Compensation for teaching costs unless the sponsored program activity type is for Instruction or Research training, consultation or other non-University activity, excess compensation charges not included in Institutional Base Salary (IBS), and administrative or clerical salaries, unless justified and approved by the sponsor.
Some sponsors impose salary limitations, also sometimes known as salary caps e.g.: National Institutes of Health (NIH) salary caps.
Review guidance for Documenting Salary Caps on Proposal Budgets.
Faculty with 9 month appointments
- The UW limits Summer salary to 2.5 months
- When allowed by sponsors, summer salary should be budgeted as separate line items from academic year salary.
Approved supplements are available in the payroll system and reflected in Institutional Base Salary.
Anticipated Salary Increases
When allowed by sponsor, these increases should be included in the budget calculation. Increases must be reasonable and justified in the proposal.
- Cost of Living Allowances (COLA) are not set in UW policy. Some sponsors do not allow or impose a limits on COLA.
- Classified staff mandatory step increases according to HR compensation guidance.
- “To Be Determined” Staff: Budget for individuals not yet identified at the middle range for that job title.
Salaries of administrative and clerical staff are normally treated as F&A costs.
Administrative and clerical costs may be proposed as direct costs if all four of these criteria exist:
- Integral to the project or activity,
- Identified specifically with the project or activity,
- Explicitly included in budget or have prior written approval of Federal awarding agency and,
- Not also recovered as indirect costs.
If these costs are budgeted as direct costs, you must provide justification in the proposal.
Examples of potentially allowable direct charged administrative and clerical staff costs:
- Organizing a conference as a component of a larger project
- Managing travel for a large number of participants
- Organizing large datasets
- Managing complex projects with multiple sites, especially if there are multiple subawards.
If questioned, PI must justify expenses to the sponsor and auditors, and will be responsible for paying back any unallowable expenses, if required.
Requirements to Direct Bill F&A Costs from the Post Award Fiscal Compliance Office
Faculty with Veteran Affairs (VA) Appointments
For faculty who have a VA appointment (up to 40 hours or “8/8th”) and up to a full time appointment with the UW, use the UW IBS to calculate effort and salary compensation.
Dr. Y has with a full time salary rate of $100,000 has a 50% UW appointment and is requesting 10% salary support. The commitment on the proposal represents 10% of the 50% appointment.
- Salary: 10% of the 50% salary, $5,000 ($100,000 x 50% x 10%)
- Person Months: 10% of 50% time = 0.6 person months.
- Percent Effort: 10% of 50% time, or 5%
Graduate student appointments (GSA) are considered full-time at 50% FTE during academic year and 100% during summer. When including Graduate assistants, budget for salaries, fringe benefits and tuition remission.
GSA: definition, limitations, budgeting and re-budgeting from Post Award Fiscal Compliance
UW Graduate School Teaching Assistant(TA)/ Research Assistant (RA) Salaries
Use the average first year postdoc compensation level in the respective school/college, or in the absence of a policy, consult the UW Academic Resources salary rates and minimums schedule. Budget for full actual costs.
NIH Awards: maximum amount awarded by NIH for graduate students supported on research grants or cooperative agreements is tied to the zero level National Research Service Award (NRSA) postdoctoral stipend in effect at the time the grant award is issued.
Employee Benefits (i.e., fringe) are a direct cost charged as a percentage of salary. The rates are reviewed and approved by the federal government and apply to all sponsored projects.
Use the active rates for the applicable time period, and use the preliminary/proposed rates (if available) for all future years.
Applied Physics Laboratory (APL) Costs
Before including APL personnel or locations in your budget, contact the appropriate APL department administrator. They will help ensure all applicable APL Prorated Direct Costs, APL Fixed Fee and budget justifications are included in your proposal budget.
APL’s sole purpose is research, and their operating expenses are an allowable direct cost (2 CFR Part §200.413) on projects where APL personnel or locations are involved. APL operating expenses are recovered through the application of the APL Prorated Direct Costs (PDC) rate.
Individual people or entities participating in a sponsored program as a non-employee.
- Participation of persons as research subjects
- Implementation of computer systems
- Contracts to conduct and provide survey results, environmental studies and assessments
- POD training
- Professional consultants
Review a full list of UW personal service categories.
Consult sponsor guidance for including consultants in your budget, requirements vary.
Independent contractors, who are:
- Typically experts in the field
- Not UW employees and,
- Don’t have a faculty appointment (e.g. VA, Children’s etc.)
Include a letter of collaboration with dates of service, rate of pay, other miscellaneous expenses and deliverables.
Collaborators at other higher education institutions who plan to use institutional resources are considered subrecipients and will need a formal subaward set up.
Review guidance for determining Subrecipient, Vendor, or Consultant?
Participant Support Costs
Direct costs for stipends or subsistence allowances, travel allowances, and registration fees paid to or on behalf of participants or trainees (but not employees) in connection with conferences or training projects.
Participant support costs are allowable if the project includes an education or outreach component, the costs are separately budgeted, and the agency approves the cost. Include the following in budget justification: “The inclusion of the participant support costs in the budget and the subsequent award by agency will be considered prior agency approval.”
More information from Post Award Fiscal Compliance on Participant Support .
Other Contractual Services
Vendors or Suppliers who provide routine services for a fee, (e.g. Consultant Travel, Advertising, Shipping, Rent, Inpatient and outpatient hospital charges, Laboratory Fees).
Review guidance for preparing proposals with subawards and the UW policy for Sponsored Program Subaward Administration. Each subaward should be listed separately, using the UW sub-object code 03-62 (subcontract). Calculate F&A on subawards following GIM 13 guidelines.
Review guidance for determining Subrecipient, Vendor, or Consultant?
What if subrecipient doesn’t have a negotiated rate?
If a prime sponsor has a published F&A rate policy, the subrecipient should propose its F&A in accordance with this policy.
For example: the NIH limits F&A on Grants to Foreign and International Organizations to 8% with a few exceptions.
If the originating sponsor is silent on F&A, the F&A rate subrecipient should use is 10% Modified Total Direct Costs (MTDC).
- itemized transportation costs (e.g. airfare, ground transportation etc.),
- number of days per diem,
- number and estimated cost of trips
- number of individuals on each trip
- on federal awards, justify how each person’s travel is necessary to the award.
- destination of each trip
- If exact location is not known, include the general location.
Most sponsors require that you justify and retain documentation for travel expenses including how they benefit the project.
- Global Operations Support Essential information for travel planning and risk awareness
- Global Travel Information for UW travelers
- Global Research Single Points of Contact
- Review Export Compliance Measures
- Global Support: Student International Travel Policy
Supplies and Materials
List supplies by major type, (e.g., publication costs, glassware, chemicals). Include estimated cost of each type and how estimates were calculated, e.g. publications costs: list number of pages and cost per page.
Describe allocation rationale for supplies and materials between different proposals/awards in your budget justification.
Prior year accounting records or other documentation may be used to support estimates. Retain documentation in your award file.
Considerations for Supplies and Materials
- Food, meals and refreshments: Awards must specify and allow food purchases if they are included in the budget. Review UW food purchase guidance
- Office Supplies: generally unallowable as a direct cost under federal awards.
- Salaries of administrative and clerical staff are normally treated as F&A costs.
- Avoid “Miscellaneous” and “Contingency” categories.
- Sponsor supplies and materials budget requirements e.g. NIH Genomic assays are supplies but the F&A calculations are different.
- Genomic Assays (GA) are budgeted as supply costs, however NIH only pays F&A on the first $50,000 of GA costs each year.
- NIH Policy Statement – F&A Costs
Review your sponsor guidelines on equipment fabrication, rental or purchases. Review Equipment Inventory Office guidance on Government Furnished Equipment.
The UW Equipment capitalization threshold is $5000. Equipment is excluded from F&A.
- List each item by type, model number and manufacturer.
- If equipment needs are not definite, probable choices may be listed on a separate sheet and an estimated total shown on budget page.
- Include related costs like shipping and insurance in the equipment costs if allowed by your sponsor.
- Sales Tax Exemption – Equipment purchased may qualify for the Machinery and Equipment Tax Exemption or “M&E Exemption”.
Review more information from the Equipment Inventory Office on Acquisitions.
Describe the equipment that will be fabricated along with a list of items that go into fabrication (e.g. materials, cost center services, salary, etc.). Review Equipment Inventory Office information on Fabrication. F&A is not applied on costs involved in fabricating equipment unless the equipment will be transferred to the sponsor or external entity for use at the end of the project.
Each piece of rented equipment should be listed by type, model number, and manufacturer along with the current rental rate of each item. Equipment rental is considered a “service” charge and F&A should be calculated.
Include associated tuition charges for graduate students employed in a 50% FTE appointment for full payroll quarters. Review Quarterly Tuition and Fees from Office of Planning and Budgeting. Tuition costs are exempt from F&A.
F&A costs are expenses that cannot be specifically identified with a particular project or activity. Also known as “indirect costs” or “overhead,” these costs are for buildings, utilities, services of administrative offices such as purchasing, accounting, payroll, and personnel offices, and other expenses necessary for operations of the institution. Review GIM 13 for more information.
What you need to know to select the correct F&A rate:
- How to Determine the Correct Rate
- Policy Circumstances
- Activity Types
- Activity Locations
- Multiple Locations
- List each anticipated outgoing subaward separately
- Each subaward budget should include its direct and F&A costs
- Indicate each subawards in the UW budget using the sub-object code 03-62
- Calculate UW F&A on the first $25,000 of each subawards total costs
In limited situations, the Director of Sponsored Programs may waive F&A. To request a waiver, include the completed F&A waiver form, signed by the PI with Dean and Chair concurrence, in the eGC1 with your proposal materials to the Office of Sponsored Programs (OSP).
The University does not waive F&A for for-profit entities.
Budget Justifications are an important part of the review process (internally and externally) and details how the sponsor’s funds will be spent. Justify budget costs in detail according to the sponsor instructions. Sponsor scientific reviewers may do a preliminary cost analysis using the budget justification to determine if the science justifies the budgeted cost.
Review the budget justification primer for examples.
Explain estimates or unusual circumstances in your budget justification. Retain supporting documentation, rationales and sources for estimates, allocation or unusual circumstances along with vendor catalogs or written quotes as support documentation in your local award file.
Example estimation tools, methods and resources include:
- SAGE Budget Module
- Payroll system
- Anticipated merit increase
- Cost of living increase
- Travel per diems and other travel cost information
- State, federal and international tax information
- Vendor and supplier purchasing
- Relevant University policy information such as: GIM 13- F&A Rate Agreement or GIM 35 – Institutional Based Salary etc.
- Approved & preliminary fringe benefit rates
- Sponsor policy
- Federal guidelines
If a sponsor does not allow certain costs as a direct cost, they may not be included in the budget.
For example, administrative/clerical costs are not allowed as a direct cost on a federal grant. If you believe your program qualifies for an exception, you must describe how the four criteria for direct charging administrative/clerical costs are met.
OSP’s approval of the eGC1 or the sponsor making an award based on your proposal where the criteria for direct charging administrative/clerical costs were met, does not mean those costs cannot be questioned later.
The System to Administer Grants Electronically (SAGE) is the UW approval routing system for sponsored program proposals. Associated departments review and approve the entire proposal including related budgets.
Cost share is the costs of a sponsored project that the sponsor does NOT pay for.
A sponsor can require cost share and must state this requirement in the funding opportunity. A cost share commitment also occurs when a proposal includes allowable expenses or quantifiable contributions that will not be charged to the sponsor (e.g. effort level of personnel listed with no commensurate request for salary).
Cost share is not expected by federal sponsors if the agency does not include a cost share requirement in the funding opportunity. When not mandatory, the inclusion of a cost share commitment may not be used as a factor in merit review. Voluntary cost share, therefore, should not be presented in the proposal.
Cost sharing is discouraged and leads to:
- higher Facilities and Administrative (F&A) rates,
- increased administrative burden,
- redirection of University resources from other University activities.
When cost share is submitted in a proposal and accepted by the sponsor it becomes a binding commitment. The department/PI is required to provide, monitor and report on the committed resources during the project.
Sponsor approval is required to claim waived F&A as cost share. When direct costs are contributed as cost share, the associated F&A is also considered cost share.
Approvals from other UW units contributing cost share must be on the eGC1 or otherwise documented.
Costs and budget issues to consider include:
- Animal housing costs (per diems)
- Special lab equipment, specialized housing arrangements, or specialized services
- Timing considerations: approvals prior to animal acquisition, quarantine, training requirements
The following services are covered under F&A costs:
- Training in animal use and handling
- Protocol review
- Grant/protocol congruence review
- Protocol development assistance
- Standard veterinary care
- Standard animal husbandry
Costs and budget issues to consider include:
Consider whether you will need to hire staff, or contract with UW’s Institute for Translational Health Services (ITHS) for staff. Decide whether you will need a staff person to serve as an Institutional Review Board (IRB) liaison because the UW will be the lead for collaborative or multi-site research that is being reviewed by a single IRB.
Subject payment or reimbursement
Include any subject payments, or reimbursement of subjects’ expenses. If subjects’ health insurance will be charged for research-related clinical items and services; consider whether the grant will pay for co-pays and deductibles.
IRB review fees
The UW IRBs do not charge review fees. However, if the research will be reviewed by a non-UW (external) IRB, the external IRB may charge fees. You may need to include IRB review fees in the budget in the following situations:
- The UW is the lead site for collaborative or multi-site research and a single IRB will be used for all sites or institutions involved in the research. For NIH grants, see this NIH Guidance. HSD can also provide guidance about how to identify and estimate costs.
- The study is industry-initiated and industry-funded and the sponsor will not pay the fees directly.
Human Subjects Division (HSD) administrative fee
If your research is industry-initiated and industry-funded, you must send the study to and independent IRB (for example: WIRB or Advarra) for IRB approval instead of the UW IRB. The industry sponsor will pay the IRB review fees charged by the independent IRB, but they are also required to pay HSD an administrative fee of $1500. This administrative fee should be included in your budget. See HSD’s webpage on Industry Research for more information.
Emergency medicine research
Emergency medicine research that requires the special Exception to Informed Consent must conduct community consultation before beginning the study, which requires funds. Consult with HSD for guidance about appropriate activities, based on the nature of the research intervention and the study population. It almost always involves more than public service announcements, news releases and bus placards.
Interpretation and translation
Federal non-discrimination laws require clinical trials to allow interested and eligible subjects to participate even if they do not speak English. This means that researchers should develop a plan for how translation and interpretation will be provided for interested and eligible subjects. For studies that may have small numbers of these subjects, this may best be handled by including in the budget the cost of retaining an interpretation and translation service that can be called upon as needed.
If your project includes hazardous materials review the following considerations.
Take into account costing allocation of materials. Review GIM 23-Distribution of Costs Across Two or More Sponsored Programs and guidance from Post Award Fiscal Compliance on cost allocation.
- Use the Laboratory PPE Assessment Guide to determine the type of personal protective equipment (PPE) needed.
- Use the Job Hazard Analysis tool to determine required controls to mitigate risk
- Estimate cost of ordering PPE and first aid kit through UW Procurement.
- Determine need for chemical spill kit or mercury spill kit.
- Use the Occupational Health Recommendation provided by the EH&S Employee Health Clinic to determine costs for vaccinations and medical surveillance.
- Work with Environmental Health and Safety to accurately calculate and plan for cost of disposal of hazardous and radioactive waste.
Environmental Health and Safety (EH&S) Services covered under F&A costs
- Training (except First Aid)
- Chemical waste collection and disposal
- Health and safety surveys and monitoring
- Assistance meeting health and safety requirements of grant proposals
- Radiation use authorizations
- Radiation dosimetry and bioassay
- Fire prevention services
- Fume hood testing
- Central SDS library and inventory system
- Respiratory fit-testing
- Hazardous material spill management advice and consultation
Forms, Tools, and Resources
- F&A Waiver Request
- Documenting Salary Cap on Proposal Budgets to External Sponsors
- GUIDE: SAGE Budget
- Institutional Facts & Rates
- Budget Justification Primer
- PAFC: Proposal Costs
- Subrecipient, Contractor/Vendor, or Consultant?
- GCA: Cost Share
- PAFC: Cost Allocation
- PAFC: Requirements to Direct Bill F&A Costs
- Cost of Single IRB Review
- NSF: Sections of an NSF Proposal, The Budget: Part 1
Policy, Regulation, and Guidance
- GIM 35 – Effort Reporting Policy for Sponsored Agreements
- GIM 23 – Sponsored Program Costing Policy
- GIM 21 – Cost Share on Sponsored Programs
- GIM 13 – Facilities and Administrative (F&A) Rates
- GIM 03 – Fringe Benefit Rates and Sponsored Projects
- Guidelines for Collaborative Research Sharing RCR
- Best Practices for Coordination and Set-up of Cost-Shares for Collaborative…
- Travel Office: Travel Policies and Procedures
- National Research Service Award (NRSA) Postdoctoral Stipend