Does PCORI allow both a fixed-fee budget and a capitated budget? 

PCORI does allow for both fixed-fee as well as capitated budgets, but they must be clearly delineated and well justified in your budget justification. Proposed costs and responsibilities cannot be duplicated in the two categories, and applicants should be mindful to ensure that any per-patient costs are not duplicated across other spending categories. PCORI encourages applicants to ensure that costs are clearly delineated and justified in terms of what specific costs are allocated toward fixed costs, and what costs are associated to a capitated budget. 

For example, if there is a capitated per-patient cost that includes recruitment costs, then they cannot also include recruitment responsibilities in the personnel costs for that site. Or, if there is a site principal investigator (PI) who is being paid separately from the per-patient costs, then those responsibilities as site PI should be clearly delineated and different from the capitation charges – tasks that are very specifically not activities captured in the capitation such as writing manuscripts or providing guidance to the project’s strategy. 

How do I calculate indirect costs? 

PCORI has a 40 percent indirect cost cap. Indirect costs are calculated by using PCORI Allowable Direct Costs. This direct cost excludes equipment costs, patient-related costs and any subcontractor costs over $25,000 of total costs (indirect and direct) for each subcontract. For example, if a prime contractor pays each of three subcontractors $100,000, for a total of $300,000, then the prime can only apply indirect costs to $75,000. 

Can I use my PCORI award to pay for a work visa? 

All fees and costs associated with the submission, review and approval of all types of work visas are unallowable. 

Can I use my PCORI award to pay for travel costs? 

PCORI follows the Uniform Guidance travel costs regulation (2 CFR 200.474). Travel costs are allowable as a direct cost where such travel will directly benefit the project and is reasonable and consistent with the awardee institution’s existing travel reimbursement policy in accordance with 2 CFR 200.474. 

Does PCORI pay for the cost of interventions being compared in the studies it funds? 

In general, PCORI does not fund intervention costs, including, but not limited to, salary and time compensation for personnel that are delivering the intervention, or playing a key role in it, as well as equipment and other material costs associated with delivery of the intervention. These are considered direct patient care costs, and PCORI expects these costs to be covered by the healthcare delivery system or other interested payer. 

PCORI encourages all applicants to find support from sites, payers, stakeholders, etc., in the payment or cost sharing of the interventions. Only under special circumstances will PCORI consider coverage of patient care intervention costs. If you are proposing the use of PCORI funds for any portion of these costs, your application must include a justification, in the budget justification template, outlining the clear importance of the request in the overall success of the project, as well as future sustainability and implementation plans once the project is completed (for example, how these costs will be covered in the future, post-PCORI funding, for implementation in other communities and healthcare settings). Providing justification, however, does not guarantee that the costs will be approved. 

Can patient partners serve as Data and Safety Monitoring Board (DSMB) members? 

Yes. PCORI recommends the inclusion of a patient or family representative who is independent of the research study to serve on the DSMB. 

We would like to appoint a DSMB for our research project. Will PCORI establish a DSMB for us? 

No. Establishing the DSMB is the Awardee Institution’s responsibility. The DSMB is an advisory body to the sponsor of the research project, which is typically the Awardee Institution for PCORI-funded research projects. As the funder of the research, PCORI does not convene DSMBs nor will PCORI staff serve as DSMB members. Please see the PCORI Policy on Data and Safety Monitoring Plans for PCORI-Funded Research for additional guidance on PCORI’s principles for structuring a DSMB. 

How do I request DSMB funds for my project? 

Applicants may request funds to cover the expenses associated with a DSMB. The funds requested, and awarded, may not exceed two percent of the project’s total direct costs. These are allowable direct costs, which should be included in the “Other” budget category. Applicants must get approval from PCORI’s Director of Contracts Management and Administration if they are requesting DSMB funds in excess of two percent of the total direct costs. Applicants should send requests for approval to [email protected]

What do I do if there is not enough room to include all of the necessary individuals in the key personnel section of the budget detail form? 

You may insert as many additional rows as necessary. 

If an institution does not have a federally negotiated rate or independently audited rate, can it still request indirect costs? 

Yes. Applicants may request indirect costs but may only request up to 10 percent. Applicants must note this indirect cost rate in the Budget Justification. 

We would like to set up a DSMB for our clinical trial. Will PCORI establish a DSMB for the study? 

PCORI will not convene a DSMB on behalf of the study. 

Does PCORI require a DSMB for all of its funded Research Projects? 

PCORI requires awardees to ensure that there is a data safety and monitoring plan, which may include the need to appoint a DSMB for some research projects, as provided in the PCORI Policy on Data and Safety Monitoring Plans for PCORI-Funded Research. An Awardee Institution should appoint a DSMB if required by the institutional review board (IRB) or a regulatory agency (e.g., Food and Drug Administration), or if it determines it is appropriate after considering factors such as potential risks; target study subject population, nature and size; and the research project’s scope and complexity. 

Where a DSMB is established/appointed for a research project, all DSMB members must be independent of the research study, with no vested interest in a specific treatment or therapy being studied and must not include the study investigators or other members of the research study, including patient research partners. 

If my project is awarded, does PCORI pay for the costs of obtaining IRB approval? 

Yes. PCORI will allow this expense as a direct cost with adequate explanation provided in the Budget Justification. 

Does a single piece of equipment that costs over $5,000 need to be approved by PCORI prior to submitting an application? 

No. Please include this item in the budget and provide justification. If the application is chosen for funding, PCORI will assess this cost during the budget review. All items in a proposed budget are subject to review by PCORI. 

Can tuition and/or stipend costs be included in the budget? 

No. Please do not include tuition costs in the budget. However, a student hired by the institution may have his or her salary/wage paid through the PCORI contract. Payments to students through stipends are not allowable. 

Can I include cost-of-living adjustments in my budget? 

Yes. Applicants may include adjustments for inflation in your detailed budget. 

Is there a cap on the allowable fringe rate? 

No. There is no cap on the allowable fringe rate. Applicants should use their organization’s fringe rate policy and must include this policy document with your other budget documents. 

PCORI has a limit on the amount of salary a person can collect under a contract. If an individual’s salary is $250,000, can the applicant charge $200,000 to the contract at 80 percent of the individual’s time? 

No. Applicants must use no more than the maximum allowed salary amount as the base for calculating the amount of the salary request. For example, if the base salary is $250,000 and an individual will work on the project 80 percent of the year, then the applicant may only charge $160,000 to the PCORI project ($200,000 *80% = $160,000). 

Is the personal salary cap per individual or per application? Is it annual or total? 

The personal salary cap is per individual. The $200,000 cap relates to the annual institutional base salary for each person and does not include fringe benefits. 

If travel is required for my PCORI Funding Announcement (PFA), how is this reflected in the budget? 

If travel to a PCORI conference is required, it will be stated in the PFA. Please refer to the PFA for instructions on how to include this element in your budget. 

There is not enough room for all of the individuals I need to include in the budget detail section. What do I do? 

Insert as many additional rows as necessary.  

If an institution or subcontractor has a higher indirect cost rate than PCORI allows, can the applicant use their rate? 

No. If an applicant’s indirect cost rate is higher than PCORI’s indirect cost rate limit, the applicant must use the 40 percent indirect cost rate. Additionally, if the institution has a federally negotiated or independently audited rate below 40 percent, the institution must use the lower rate. 

Can applicants provide additional information on the indirect costs and their implications for subcontractors? 

For applications submitted with Cycle 3 2016, or for future cycles, a prime applicant may assess its indirect costs on the first $25,000 of total costs (indirect and direct) on each subcontract. Consortiums may assess their indirect costs on their allowable direct costs in keeping with PCORI budget policies. Each consortium must use their federally negotiated, independently audited or negotiated indirect cost rate not to exceed 40% of the allowable direct cost base. The same budget requirements that apply to the prime also apply to subcontracts. 

While consortium indirect costs must be noted in the prime applicant’s direct cost budget, consortium indirect costs are not included in the applicant’s direct cost budget cap, similar to National Institutes of Health practice. 

Note: For “total cost” awards, consortium indirect costs are included in the total cost of the project. Refer to the PFA to determine if the budget cap is based on total direct costs or total costs. 

What are the total direct costs over the life of the project that can be requested? 

The maximum amount of funding that can be requested for one project depends on the PFA. This information can be found in the Budget and Project Duration section of the PFA. To view PFA information, visit the PCORI Funding Opportunities

What is the difference between direct cost and total direct cost included in the PFA?  

Direct Costs are the Prime plus all Subcontractor(s)’ direct cost. Total Direct Costs from the applicant perspective are the Prime plus all subcontract direct costs plus indirect costs = total direct costs. Please refer to the PFA to determine if the budget cap is based on total direct costs. 

The total budget for our application is $5 million over five years. Does PCORI cap the budget at $1 million per year or is it just 5 million spent over a period of five years?

Most PCORI projects are funded for multiple years. The approved total budgets cover the full project period of performance.

Posted: September 1, 2023; Updated: November 9, 2023

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