PCORI is excited to announce several updates to our funding processes which we believe will streamline the application process and enhance the funding opportunities that we offer.

One of the most noteworthy changes, which was also featured in a Leadership Perspective last month, is the merging of the Pragmatic Clinical Studies (PCS) and Broad funding opportunities into the renamed Broad Pragmatic Studies funding opportunity. This update is intended to streamline the submission process for applicants interested in applying for PCORI funding and optimize the merit review process across the spectrum of pragmatic study designs submitted to PCORI.

Applicants to the Broad Pragmatic Studies opportunity can submit proposals in two categories: (1) projects lasting up to five years with up to $5 million in direct costs, and (2) those lasting up to five years with up to $10 million in direct costs. Total funding available for this new opportunity will remain at $162 million. [More]

In addition to Broad Pragmatic Studies, PCORI released seven additional funding opportunities for Cycle 1 2022. For details on each, visit Funding Opportunities.

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High-Priority Research Topics for Future Funding Opportunities

This year, PCORI will also continue to release Targeted PFAs every funding cycle and will include Special Areas of Emphasis (SAEs) in its Broad Pragmatic Studies funding opportunity each cycle as well. SAEs encourage submissions for specific research topics (see box on right) without limiting applications solely to these topics. SAEs are posted publicly prior to the Letter of Intent (LOI) deadline for any given cycle.

For a complete listing, view this PCORI April 2021 press release: More than a dozen high-priority research topics approved for future PCORI funding opportunities.

Policy and Process Updates

PCORI Cost Principles

The PCORI Cost Principles, which identify expenses that are considered allowable under a PCORI award/contract, have been updated for all PFAs issued after January 11, 2022 (beginning with Cycle 1 2022). All PCORI awardees are obligated to use the funds in accordance with the award terms and conditions specified in the PCORI award contract, including, but not limited to the PCORI-approved project plan, budget, and PCORI cost principles. Major updates include:

• Compensation Cost to Study Participants or Patient Partners. This cost was formerly known as Incentives. PCORI added language regarding project participants who contribute time and/or effort.
• Gift Cards. Gift cards are now an allowable cost and should be distributed promptly following purchase. Awardees must maintain a gift card log to track the distribution of gift cards and have a documented gift card policy.
• Indirect Costs. This cost is new to the cost principles and outlines PCORI’s limit for total indirect costs. If available, prime applicants must submit their federally negotiated rate agreement.
• Peer Review.  Peer review costs are now allowable costs to ensure scientific integrity and make study findings widely available.
• Travel. Travel costs have been updated to include the Federal Travel Regulations and are now consistent with the other resource documents that PCORI provides to stakeholders.

A comprehensive description of allowable costs under a PCORI award can be found in the Funding Opportunities section of our website

Early Release of Summary Statements

To further improve the efficiency of the application process for applicants, PCORI will begin releasing summary statements for applications not discussed at merit review panel meetings based on the initial review feedback received during the online portion of the merit review process. In these cases, applicants will receive summary statements approximately two months earlier than our current process for those applicants whose applications did not move forward to the discussion.

2022 Pilot Initiatives for Select Funding Opportunities

Fast-Track Resubmission

Review of application data reveals that resubmitted applications are 30 percent more likely to be awarded funding upon resubmission. As a result, PCORI is piloting a new initiative—Fast-Track Resubmission—to expedite the application resubmission process.

This pilot will enable certain applicants to the Broad Pragmatic Studies and Methods PFAs the opportunity to revise and resubmit their application without needing to submit a new Letter of Intent, thereby enabling resubmission one cycle earlier than our traditional funding process timelines. Eligible applicants are selected at PCORI’s discretion and must meet the following criteria:

• Application scored better than 50 at the In-Person Merit Review panel meeting
• Application addresses a Special Area of Emphasis or a priority area in our research portfolio

The goal of this pilot is to identify strategies to streamline PCORI funding application pathways and ultimately increase efficiency in funding high-quality awards. For more information, please review the Fast-Track Resubmission FAQs in our Help Center.   

Coverage of Intervention Costs

Historically, PCORI has not covered the costs for study interventions, including the procedures, treatments, interventions, or other standard clinical care (patient care) being proposed for comparison in the research project (patient care costs). In  2021, PCORI piloted a process in selected funding opportunities to consider funding support for applications that provided well-supported and justified requests to cover direct patient care costs. Due to early indications of the success of this pilot, the ability to request coverage of patient care costs will be available to all applicants applying to the Broad Pragmatic Studies PFA in 2022.  Additional PFAs issued during 2022 may also be included within this pilot, so please review future PCORI PFAs for additional information.

The coverage of patient care costs pilot is intended to allow applicants greater time to secure evidence of commitment from key stakeholders to support the uptake of the study results, as expressed via letters of support, supplementary funding, or contribution of other resources. Successful applications will need to justify proposed patient care costs according to criteria outlined in the PFA.  If an application is approved for an award, the proposed coverage of patient care costs will be subject to review and negotiation as part of PCORI contract negotiation and execution activities. For additional information see Broad Pragmatic Studies FAQs in our Help Center.

Application Deferral to Subsequent Funding Cycles

Another pilot program that will be continued from 2021, is the ability for applicants with accepted Letters of Intent to defer application submission to the next PCORI funding cycle. This pilot program is available to applicants invited to submit an application for the Broad Pragmatic Studies and Methods PFAs. Applicants may make this request up to two times, and those requests may cross cycle years (e.g., an applicant invited to submit an application for Cycle 2 may defer submission to Cycle 3, and then may potentially again request a deferral to Cycle 1 2023). For more information, click here.