Who is eligible to apply for PCORI funding?

Research Project Applications

In general, applications for the conduct of research and management of funding may be submitted by appropriate academic research, private sector research or study-conducting entities. This may include, among others, agencies and instrumentalities of the federal government, nonprofit and for-profit research organizations and colleges and universities.

Per PCORI’s authorizing statute, every applicant must demonstrate capability to comply with the following conditions:

  • Abide by the transparency and conflicts of interest requirements that apply to PCORI with respect to the research managed or conducted under contract.
  • Comply with the PCORI methodological standards adopted by the Board of Governors.
  • Consult, as appropriate, with the expert advisory panels for clinical trials and rare disease.
  • Deposit de-identified data from the original research into a PCORI-designated repository to facilitate data sharing, as appropriate.
  • Have appropriate processes in place to manage data privacy and meet ethical standards for the research.
  • Comply with the requirements of PCORI for making the information available to the public.
  • Comply with other terms and conditions determined necessary by PCORI to carry out the research project.

Potential applicants are strongly encouraged to review the standard research contract prior to application. 

Individuals are not permitted to apply. 

Foreign organizations and nondomestic components of U.S. organizations must provide a thorough and thoughtful justification for the research's ability to benefit the U.S. healthcare system and that the engagement plans include U.S. patients and stakeholders and are relevant to the U.S. healthcare system. 

What qualifications are required for patient partners to participate in the research project? Is institutional review board (IRB) approval of patient partners required? 

Patient partners and their role on the research project, either as key personnel or as other team members, should be identified in the protocol submitted to the IRB. Awardees must comply with any applicable IRB requirements.

Are foreign organizations allowed to be included as subcontractors for PCORI awards? 

Yes. Foreign organizations and nondomestic components of organizations based in the United States may be included as subcontractors for PCORI awards. Note that, in general, PCORI’s assessment of the inclusion of foreign organization subcontractors will follow similar requirements and considerations as laid out in the framework assessing foreign organizations’ eligibility as prime contractors for PCORI funding. Applicants should provide a thorough and thoughtful justification.

For more information, please see our What and Who We Fund page.

Are foreign organizations eligible for funding? 

Yes. Foreign organizations and nondomestic components of organizations based in the United States may apply. However, PCORI’s general preference is that prime awards be made to a U.S.-based organization. A prime award contract to a non-U.S.-based organization should be carefully justified and preferably include a key U.S.-based organization and co-principal investigator as a subcontractor. 

In assessing whether a research award can be made to a non-U.S. organization as a prime contractor and/or the research can be conducted outside of the United States, PCORI will carefully review and consider the following factors: 

  1. The research funded by PCORI must result in findings that are relevant and useful to U.S. patients and healthcare decision makers.
  2. The proposed project must demonstrate that essential scientific needs will be met by conducting the study outside the United States or having the study conducted by non-U.S. research organizations—e.g., (a) timely accrual of research participants needed for the specific research study that requires a broad recruitment pool can only be achieved by conducting the study outside the United States or by non-U.S. organizations; or (b) significant scientific advantages can be gained by research conducted mainly outside of the United States or by non-U.S. organizations, such as broader diversity in the study population or settings, better deployment of methodological expertise, etc.
  3. The proposed study must demonstrate meaningful effort and involvement of U.S. organizations and investigators with pertinent expertise and experience to contribute to the project. The engagement plan for the proposed study should also adequately and sufficiently include U.S. patients and stakeholders and have clear relevance to the U.S. healthcare system.

Can a principal investigator (PI) resubmit an application to a different PCORI Funding Announcement (PFA) than the original submission? 

No. If an applicant submits the same application to a different PFA, whether from a targeted to a broad PFA or between broad PFAs, it will be considered a new submission. Resubmissions may be submitted to the same PFA only, as programs have different requirements.

Please be sure to read the Submission Instructions for your PFA for related requirements.

Can an application have multiple PIs?

Depending on the nature of the proposed study, a collaborative and multidisciplinary team may be required. PCORI permits applicants to name a maximum of two PIs within an application. The PIs may be from the same or different institutions. Each PI is accountable and responsible for the conduct of the award and ensuring all awarded milestones, deliverables and reports are completed in accordance with the award terms and conditions.

If proposing a dual-PI application, you must designate one as the contact PI. The contact PI must be employed by the applicant institution and listed first within the application. Although PCORI will recognize both PIs, the Contact PI is responsible for submitting the application and for communications between the PIs and PCORI, including coordinating meetings with PCORI staff.

Please be sure to read the Submission Instructions for your PFA for other requirements related to dual-PI applications.

Can an application that is currently under review at another organization and/or a federal agency be submitted to PCORI?

Yes. A PI may submit an application to PCORI if they have submitted or intend to submit an application to a federal agency or foundation. However, if the application has been selected for funding by another organization or a federal agency and the PI decides to accept that funding instead, please notify PCORI immediately and withdraw the application from the review cycle.

Do you have to be partnered with an academic institution to apply?

No, you do not have to be partnered with an academic institution to apply; however, individuals may not apply.

Any private-sector research organization, including nonprofit and for-profit organizations; any public-sector research organizations, universities, colleges, hospitals, laboratories and healthcare systems; and units of state, local and federal governments may submit an application to PCORI. All U.S. applicant organizations must be recognized by the Internal Revenue Service. Foreign organizations and nondomestic components of organizations based in the U.S. may also apply; their application should clearly demonstrate the benefits of their research to the U.S. healthcare system and U.S. patient-centered research.

For more information, please see our What and Who We Fund page.

Does IRB approval need to be obtained before applicants are notified whether the project has been funded?

No. IRB approval does not need to be obtained prior to submitting an application. However, IRB documentation, if applicable, will be required as one of the first post-award milestones. Accordingly, after the Awardee Institution is notified of the award, the PI should seek IRB approval if they have not done so already to avoid delaying the research project.

How are resubmissions reviewed?

  1. Reviewers are notified which of their assigned applications are resubmissions. 
  2. Reviewers will evaluate resubmissions as stand-alone applications, with a fresh perspective, using the Merit Review Criteria
  3. Resubmissions are distinct in that reviewers are provided with the following documents: 
    • Summary statement from the previous application review, inclusive of reviewers’ critiques and notes from the in-person discussion (if the application was discussed). 
    • A resubmission statement submitted by the applicant. 
  4. While the extent to which specific reviewer comments were addressed is not part of the scoring, awareness of the previous critiques, notes from the in-person discussion and subsequent application revisions may provide the reviewer with helpful context for evaluating the current application. 
  5. Reviewers will be instructed to follow the guidance above and review resubmissions based on the current information presented and its current merits; at no point should a rediscussion of the previous review be initiated, as the goal is to provide a fair and thorough review of the application as is. 
  6. If an applicant has submitted an application to a targeted PFA and did not receive an award, any subsequent application they submit to a different PFA will not be considered a resubmission. 

How should I contact PCORI about the status of my application or if I want to make any changes to the application?

You may contact PCORI by emailing [email protected] with your request. For programmatic inquiries, please contact [email protected]. Please note that PCORI is only authorized to discuss the application with the PI and institutional administrative official (AO) listed on the application.

I was invited to submit a full application but cannot make the deadline. Can I defer my application to a future round?

Applicants with an accepted Letter of Intent (LOI) are eligible to defer submission of their application to the next available cycle.

All such deferral requests must be submitted by the PI to [email protected] before the specified submission deadline, cc’ing the AO listed on the application. The PI is asked to include a brief explanation (1-2 sentences) detailing their primary reason for requesting the deferral in relation to submitting their strongest application. Please note, this explanation will be utilized by PCORI to better understand the needs of its applicants as a whole and will not be considered when granting/rejecting a deferral request. For a request to be granted, the deferral request must be submitted before the application deadline, and the AO must be included in the request email.

If an applicant wishes to defer their application more than once, the deferral request must be submitted again. More than one deferral will require programmatic approval and may be denied.

While applicants may be approved for a deferral, PCORI's funding cycles may change in relation to specific areas of interest or emphasis and the applicant needs to ensure their project is still responsive to the PFA.

Applicants should also note that the PFA to which they originally applied may not be released again during the next or future cycles, making them ineligible for a deferral.

If a PI is invited to submit an application and fails to do so, will that PI be penalized or prevented from applying in a future funding cycle?

No, PIs will not be penalized or prevented from submitting a LOI during a future funding cycle.

Is there a minimum qualification for a PI?

PCORI does not have minimum qualifications for the PI. However, please keep in mind the following factors when determining whether your research team has the right experience and capabilities:

  • Are the investigators appropriately trained and suited to carry out the planned studies? 
  • Is the work proposed appropriate to the experience level of the PI? 
  • If the investigator does not have patient-centered outcomes research (PCOR) experience, are there appropriate collaborative arrangements with experts in PCOR? 
  • Does the study team have complementary and integrated expertise? 
  • Are the team’s leadership approach, governance and organizational structure appropriate for the project? 
  • Do the PI and other research team members have a sufficiently high level to achieve the study aims as described? 

We encourage our applicants to look at the Merit Review Criteria for more information on the specific criteria against which their application will be reviewed.

What is PCORI's resubmissions policy for research awards?

An applicant may resubmit an application that was not funded but completed PCORI’s merit review process (i.e., the applicant received a summary statement). For research awards, PCORI does not limit the number of times an applicant may resubmit.

If a full application was deemed nonresponsive and did not progress through the full merit review process, it is considered a new submission and requires submission of an LOI. Submitting the same application to a different program’s PFA is also considered a new submission. Each program’s PFA has different requirements; therefore, applicants should carefully review the program-specific PFA to which they are applying. Submitting an LOI is also a requirement.

Please be sure to review the Submission Instructions for your PFA for other requirements related to Resubmissions.

What's the difference between a Co-PI and Dual PI?

Co-PI: An individual recognized by the prime institution and the PI as someone who shares scientific and administrative leadership responsibilities for a project with the PI. The Co-PI is an individual who the PI relies on to contribute substantively to the scientific development and direction of the project in addition to the execution of the project. The Co-PI shares responsibility with the PI for ensuring that milestones are achieved and contracted deliverables are completed on time. The Co-PI is considered “key personnel” and may be employed by or formally affiliated (through a written agreement) with the prime institution or a collaborating institution. The patient and/or stakeholder partner may be listed as a Co-PI. The designation of a Co-PI does not affect the PI’s roles and responsibilities, nor does it imply a Dual PI Award.

Dual PI: An award in which the prime institution has designated two individuals as PIs who share equally the authority and responsibility for leading and directing the project, intellectually and logistically. The presence of two PIs on an application or award diminishes neither the responsibility nor the accountability of any individual PI. A formal Leadership Plan is required for a Dual PI role.

For more information on PCORI terms, please see the PCORI Glossary.

What is the process for notifying PCORI about withdrawing an application? 

To withdraw an application, the PI should email a request to [email protected] with the application’s AO copied.

If an application is rejected during a previous cycle, can it be resubmitted during a later cycle? 

For PCORI's Research Awards, yes, there is no limit to the number of resubmissions that can be submitted.

Please be sure to read the Submission Instructions for your PFA for related requirements.

Are PIs eligible to apply to multiple funding announcements during the same cycle?

Yes, a PI may submit multiple LOIs in a cycle. However, the same project may not be submitted to multiple PCORI Funding Announcements (PFAs) in a given cycle. If a PI submits an LOI to multiple PFAs, they must ensure that the research topics/projects are not similar and there is no scientific overlap. LOI submissions that show scientific overlap or appear to be duplicate in nature will be disqualified. If this were to occur, PCORI will contact the PI to determine to which PFA they would like to apply.

Can a PI submit an application if they have already been awarded a contract by PCORI?

Yes. A PI may be a recipient of more than one PCORI award.

Can I apply to be a reviewer if I also plan to submit an application for PCORI funding?

Yes. PCORI works with reviewers to manage conflicts of interest actively and invites all professionals who are interested in PCORI to submit applications to participate as a reviewer. However, a PI cannot serve as a reviewer for the same PFA in the same cycle in which his or her application is being reviewed.

Posted: September 1, 2023; Updated: November 29, 2023

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