About PCORI | Who Can Apply | Research We Fund | Cost-Effectiveness Analysis | Engagement | Using the PCORI Online System | Letter of Intent | What to Include in the Application | Budgeting | Role of Administrative Official | Merit Review Process | Post Award | Rare Disease Research
Is PCORI a federal agency?
No. PCORI is an independent, nonprofit, nongovernmental organization, and it was authorized by Congress in 2010. Our purpose is to help patients, clinicians, purchasers, and policy makers make more informed health decisions by “advancing the quality and relevance of evidence about how to prevent, diagnose, treat, monitor, and manage diseases, disorders, and other health conditions.”
Why was PCORI created?
PCORI was established to help address the challenges clinicians and their patients experience in getting daily healthcare questions answered. We are dedicated to closing the gaps in the evidence that is needed to improve key health outcomes.
How does PCORI funding differ from other types of contracts or grants?
PCORI funds research through contracts rather than grant awards. The contracts are milestones- and deliverables-driven, and payment is strictly tied to expenses related to successful performance and achievement of contract milestones and deliverables.
What does a PCORI contract look like?
To review PCORI’s funded contract terms and conditions, see PCORI Contract for Funded Research.
Who Can Apply
Who is eligible to apply for PCORI funding?
Applications may be submitted by:
- Any private-sector research organization including:
- Nonprofit organizations
- For-profit organizations
- Laboratory or manufacturers
- Any public-sector research organization including:
- Universities or colleges
- Hospitals or healthcare systems
- Unit of local, state, and federal government
Individuals are not eligible to apply. All U.S. applicant organizations must be recognized by the Internal Revenue Service.
Are foreign organizations eligible for funding?
Yes. Foreign organizations and nondomestic components of organizations based in the United States (U.S.) may apply. However, their applications should clearly demonstrate the benefits of their research to the U.S. healthcare system and U.S. patient-centered research. 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.
Does PCORI make special provisions for new or early-stage investigators? For example, does PCORI have mechanisms to support junior investigators—i.e., training and/or separate competition pool for funding?
No. There are no special provisions for investigators who fall in these categories. At this time, PCORI does not provide separate training funding mechanisms or separate set-asides for those early in their careers. Although the research team is a consideration during merit review, PCORI has an interest in ensuring that new as well as established researchers participate in patient-centered outcomes research (PCOR).
Is there a minimum qualification for Principal Investigators (PIs)?
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 proposed work appropriate to the experience level of the PI?
- If the investigator does not have 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?
If an applicant receives a National Institutes of Health (NIH) K Award, is he or she still qualified to receive PCORI funding?
Yes. The level of effort stated in the K Award must remain consistent, but awardees are not restricted in the remaining effort or salary level. Also, PCORI is not a federal funding agency, and K awardees may supplement the NIH contribution to their salary based on the NIH salary scale (as long as the funds are not federal).
How many LOIs can a PI submit in one cycle?
A PI may submit multiple LOIs in a cycle. However, they can only submit one distinct LOI per PFA. If a PI submits an LOI to multiple PFAs, he or she must ensure that the research topics/projects are not similar. LOI submissions that show scientific overlap or appear to be duplicate in nature will be disqualification. If this were to occur, PCORI will contact the PI to determine which PFA he or she would like to apply to.
Can a PI submit more than one LOI to a PFA in one cycle?
No. However, an individual listed as a PI on one LOI may be listed and serve in another role, e.g., co-investigator, or co-PI on other LOIs within the same PFA during the same cycle.
Are PIs eligible to apply to multiple funding announcements?
Yes. PIs may submit more than one application to multiple funding announcements. However, the same project may not be submitted to multiple PCORI Funding Announcements (PFAs) in a given cycle.
Can a PI submit the same application to multiple PFAs in a single cycle?
No. We recognize that some research projects can be classified in more than one of the five research areas, but you will need to select the PFA that best fits your proposed research question. A PI may not submit the same project to multiple PFAs in a single cycle, but it may be submitted during another cycle.
Can a PI submit an application to PCORI if he or she has already been awarded a contract?
Yes. An individual may be a recipient of more than one PCORI award.
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 he or has submitted or intends 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.
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 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 an LOI during a future funding cycle.
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.
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 firstname.lastname@example.org with your request. For programmatic inquiries, please fill out the research inquiry form. Please note that PCORI is only authorized to discuss the application with the PI, PI designee, and Administrative Official listed on the application.
What is the process for notifying PCORI about withdrawing an application?
To withdraw an application, the PI must log in to PCORI Online and access a list of Request Numbers associated with his or her account which will appear on the first page. Simply click the “Withdraw” button to the right of the Application Number to remove an application or LOI information from the system.
PFA Resubmission Guidelines
What is PCORI’s resubmission policy?
A PI may resubmit an application that was not funded. An application is considered a resubmission after it has completed PCORI’s merit review process (i.e., the PI has received a summary statement). A previous submission in the form of an LOI only (without a full application) is not considered a resubmission. If an application was deemed nonresponsive and did not progress through the full review process, the PI is required to submit a new LOI. If invited to submit an application, PIs are required to include a one-page resubmission letter.
The resubmission letter provides an opportunity for applicants to provide an overview of how the application has been strengthened in its responsiveness to the current PFA. Simply responding to previous reviewers’ concerns is not sufficient; the application must be patient-centered, methodologically rigorous, and programmatically responsive. Merit reviewers will evaluate whether the application meets PFA requirements, addresses merit review criteria, and describes how it has improved overall.
If you submit the same application to a different program/PFA, it is considered a new submission. You may only resubmit to the same program/PFA, as different programs have different requirements. PCORI does not limit the number of times an applicant may resubmit.
What is PCORI’s Invitation to Resubmit?
Program staff may invite applicants from previous cycles to resubmit. If invited, applicants will bypass the LOI review stage. Instead of completing and uploading an LOI template, invited applicants are required to upload their letter of invitation during the LOI process. Invited applicants are still required to complete the LOI and application fields in PCORI Online by the submission deadlines. Unless the applicant has explicit and documented approval from the program staff to alter the originally submitted study aims of the application, the invited resubmissions should remain the same as in the original application.
An invitation to resubmit is not a guarantee that the application will be selected for funding. Invited applicants must adhere to the updated guidance in the PFA and compete with other invited and new applications.
If an application is rejected during a previous cycle, can it be resubmitted during a later cycle?
Yes. There is no limit to the number of resubmissions that can be submitted.
What is considered a resubmission?
An application is considered a resubmission if it completed the full review process and the applicant received a summary statement. If an application was deemed to be nonresponsive and removed from PCORI Merit Review, then it is not considered a resubmission in an upcoming cycle. In that case, the application should be submitted as a new application and should not include a resubmission letter. Resubmissions must be submitted for the same PFA as the original submission.
Can a PI resubmit an application to a different 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 broads, it will be considered a new submission. Resubmissions may be submitted to the same PFA only, as programs have different requirements.
How are resubmissions reviewed?
- Reviewers are notified which of their assigned applications are resubmissions.
- Reviewers will evaluate resubmissions as stand-alone applications, with a fresh perspective, Merit Review Criteria.
- 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 one-page resubmission statement submitted by the applicant.
- 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.
- 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.
- 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.
IRB Role in Submission
Does Institutional Review Board (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 he or she has not done so already to avoid delaying the research project.
What qualifications are required for patient partners to participate in the research project? Is 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.
Research We Fund
What research does PCORI fund?
PCORI funds patient-centered research to improve healthcare decision making by patients, clinicians, and caregivers. PCORI funds comparative clinical effectiveness research—determining which clinical options or approaches work best for patients and their caregivers given their particular concerns and characteristics.
PCORI funds patient-centered research that compares outcomes. More details can be found in Research We Support.
Research proposals submitted in response to PCORI Funding Announcements are evaluated against PCORI's Review Criteria. These criteria are consistent with patient-centeredness and are specifically designed to include a diverse set of perspectives in decision making.
What types of studies of interventions is PCORI interested in?
PCORI is interested in studies of interventions that may include:
- Specific drugs, devices, and procedures
- Other types of alternatives, such as medical and assistive devices and technologies
- Behavior change, including the use of behavioral or financial incentives (the latter for patients only)
- Organizational models and policies within and across healthcare systems (e.g., patient-centered medical homes, clinical protocols such as standing orders, clinical pathways)
- Communication and/or dissemination strategies
What are patient-centered outcomes research (PCOR) features that PCORI funds?
PCOR can be used by patients and their caregivers to communicate and make informed healthcare decisions, allowing their voices to be heard in assessing the value of healthcare options. This research:
- Assesses the benefits and harms of preventive, diagnostic, therapeutic, palliative, or health-delivery system features to inform decision making, highlighting the choices that matter to people
- Is inclusive of an individual’s preferences, autonomy, and needs, focusing on outcomes that people notice and care about, such as survival, functioning, symptoms, and health-related quality of life
- Incorporates a wide variety of settings and diversity of participants to address individual differences as well as barriers to implementation and dissemination
- Directly compares clinical interventions that are generally available in clinical settings
- Obtains the perspectives of stakeholders to address the burdens to individuals, availability of services, and requirements for technology and personnel
How does PCOR relate to comparative effectiveness research (CER) and does PCORI fund CER?
PCOR is a broad category of research with an emphasis on answering questions important to patients and other healthcare stakeholders. Some, but not all, PCOR is also CER. PCORI does fund patient-centered CER although not all CER is patient-centered. PCORI’s definition of patient-centered is research that addresses questions important to patients and other healthcare stakeholders, and studies outcomes meaningful to patients and other stakeholders.
What research does PCORI NOT fund?
Applications are considered nonresponsive and will be rejected if they propose to:
- Conduct a formal cost-effectiveness analysis
- Directly compare the costs of care between two or more alternative approaches to providing care
- Develop clinical practice guidelines
How does the research PCORI funds differ from Community Based Participatory Research (CBPR)?
The main difference is the focus of CBPR on social action, which is not a requirement for patient-centered CER funded by PCORI. Both are similar in the inclusion of end users in the production of evidence.
Does PCORI have funding quotas—geographic, by tax area, by population group, by institution?
PCORI tracks awardees by many variables, including geographic region, therapeutic area, and populations studied, but there are no specific quotas for the research PCORI funds. PCORI does seek to fund studies strategically based on content.
Does PCORI make available information on research projects it has funded?
Yes. To learn about research projects that PCORI has funded, please see PCORI Funding Awards. Funded projects can be searched by research priority area, state, or year funded.
Will PCORI review brief abstracts or concept papers to determine if proposed research is of interest?
PCORI will review programmatic questions from potential applicants. For questions about the nature of your research, please call us at (202) 627-1884 or complete our inquiry form to schedule a call with program staff. We ask that any emailed attachments be limited to no more than one page.
Does PCORI provide feedback on the suitability of a proposed project and guidance on determining the appropriate PFA to submit an application?
Yes. For questions about the nature of your research, please call us at 202-627-1884 or complete our inquiry form to schedule a call with program staff.
How are PCORI’s Methodology Standards incorporated into the application and review process?
All proposals must adhere to all relevant PCORI Methodology Standards. The standards were approved by our Board of Governors in November 2012, published in December 2012, and updated in November 2013. We recognize that a variety of study designs and analytic methods can produce valid new knowledge. Regardless of the particular methods employed, proposals are expected to use rigorous methodology.
What resources does PCORI make available for applicants to determine the level of patient and stakeholder engagement is required in an application? Are there general guidelines or requirements for frequency of engagement and through which methods patients and stakeholders need to be engaged?
Engagement can take on many forms, so we ask teams to come up with their own appropriate blueprints for partnerships. Due to many researchers not having experience engaging patients and other stakeholders in the planning, conduct, and dissemination of research, we provide information about engagement on our “What We Mean by Engagement” page, and the Engagement Rubric which outlines several options and examples of engagement in research.
Is “treatment” versus “usual care” considered an appropriate comparator?
Yes. PCORI funds research that compares at least two alternative approaches, both of which are viable alternatives. “Usual care” (or no specific intervention) may be an appropriate comparator if this is a realistic choice faced by patients and other stakeholders, but the clinical characteristics must be specified.
How does PCORI define “comparative” (placebo, usual care)? In behavioral health interventions and in prevention research, the concern is that studies comparing process variables may not meet PCORI’s definition of comparative.
PCORI considers placebo to be a reasonable comparator if active treatments/interventions/screenings are not available, or if there is a compelling reason why active treatments/interventions/screenings cannot be included in the study design. Usual care can also be a reasonable comparator, provided that rationale for its use as a comparator is persuasive.
Is there a specific disease or condition that is a priority for PCORI?
No. PCORI is concerned with patient outcomes, across a range of conditions and treatments. PCORI will periodically issue PFAs that focus on specific diseases or conditions within or across funding areas. Please check the PCORI website periodically for further information.
What populations of interest does PCORI want to address with its research?
Our PFAs have always noted the importance of including diverse populations in studies, with respect to age, gender, race, ethnicity, geography, or clinical status. We have developed the following, more detailed list of “hard-to-reach” or lesser-studied populations to guide our research and engagement efforts:
- Racial and ethnic minority groups
- Low-income groups
- Children (age 0–17 years)
- Older adults (65 years and older)
- Residents of rural areas
- Individuals with special healthcare needs, including individuals with disabilities
- Individuals with multiple chronic diseases
- Individuals with rare diseases
- Individuals whose genetic makeup affects their medical outcomes
- Patients with low health literacy, numeracy and/or limited English proficiency
- Lesbian, gay, bisexual, and transgender (LGBT) persons
- Veterans and members of the Armed Forces and their families
Does PCORI fund research focused on developing and validating an instrument to measure behavior change?
Maybe. PCORI will not fund research whose principal aim is to develop and validate an instrument, but will consider studies for which instrument development and/or validation is an ancillary benefit.
If an applicant proposes the establishment of a rare disease registry, would this meet requirements for PCORI funding and under which PFA would it be funded?
Maybe. PCORI might fund a rare disease registry if it is a component of a research study aimed to answer comparative research questions. In this case, the proposal would most likely fit under the Assessment of Prevention, Diagnosis, and Treatment Options PFA.
What is PCORI’s official policy on cost-effectiveness analysis?
Our founding legislation prohibits us from doing cost-effectiveness analysis. We don’t consider cost effectiveness to be an outcome of direct importance to patients. Applications will be considered nonresponsive if the proposed research:
- Conducts a formal cost-effectiveness analysis
- Directly compares the costs of care between two or more alternative approaches to providing care
Proposals that include studies of these issues may measure and report utilization of any or all health services, but may not employ direct measurements of costs of care. Specifically, our funding announcements state that “proposals that include studies of these issues without utilizing a formal cost-effectiveness analysis or directly measuring and comparing costs of care alternatives will be considered responsive and will be reviewed.”
PCORI does have an interest, however, in studies that address questions about conditions that lead to high costs to the individual or to society. This is included in our review criterion on impact of the condition on the health of individuals and populations. Thus, PCORI is interested in studies that:
- Examine the effect of costs on patients, such as patients’ out-of-pocket costs, hardship or lost opportunity, or costs as a determinant of or barrier to access to care.
- Address cost-related issues, such as the resources needed to replicate or disseminate a successful intervention.
- Evaluate interventions to reduce health system waste or increase health system efficiency.
What is the difference between cost-effectiveness analysis and cost analysis?
Cost-effectiveness analysis is a specific type of cost analysis. Cost analysis breaks down the costs of an operation and reports on each factor separately. According to the Centers for Disease Control, cost-effectiveness analysis, in the evaluation of health care, examines both the costs and health outcomes of alternative intervention strategies.
Will a proposal that includes a cost-effectiveness analysis as a secondary aim be deemed nonresponsive?
Yes. Proposals to conduct cost-effectiveness analysis in any capacity will be deemed nonresponsive. Secondary outcomes may, however, include changes in healthcare utilization, but not cost-effectiveness analysis.
Will a proposal that includes cost analysis as a secondary aim always be deemed nonresponsive?
No. Cost analysis of economic outcomes of interest to patients, such as out-of-pocket costs to patients, is acceptable as a secondary aim.
Will a proposal to measure cost effectiveness as any one of the specific aims and/or to include it as any outcome of the study be deemed nonresponsive, even if it measures other outcomes that are meaningful to patients and other stakeholders?
Yes. Proposals that conduct cost-effectiveness analysis in any capacity will be deemed nonresponsive.
Will a proposal that includes a cost-of-care analysis be deemed nonresponsive?
Yes. Cost-of-care analysis is not considered a patient-centered factor, although out-of-pocket costs to patients and changes in healthcare utilization are acceptable as secondary aims.
Will a proposal that includes the analysis of delivery cost of treatment options and budget impact from stakeholder perspectives be deemed nonresponsive?
Yes. Proposals must focus on outcomes that matter to patients and caregivers. However, secondary outcomes may include changes in healthcare utilization.
Will a proposal that includes a cost analysis to examine sustainability and dissemination of an intervention be deemed nonresponsive?
Yes. While some discussion of costs in the context of patient-centered outcomes and healthcare utilization are acceptable, they cannot be framed as cost-effectiveness analysis or total cost analysis.
Can applicants remove cost-effectiveness analysis from their proposal prior to Merit Review?
No. Applicants cannot make any edits to their proposal after it has been submitted.
Can an applicant resubmit a proposal for another cycle after removing the cost-effectiveness analysis? If so, should the Letter of Intent be resubmitted?
Yes. Applicants must resubmit a LOI in order to be considered for the next cycle. Be sure to check the Funding Opportunities prior to resubmission to see if any requirements have changed.
Given PCORI’s focus on patient-centered outcomes, should applicants avoid any research related to economic outcomes?
Not necessarily. Economic outcomes, such as out-of-pocket costs, that are meaningful to patients are acceptable as secondary aims.
What is the difference between patients and other stakeholders?
PCORI defines “patients” as persons with current or past experience of illness or injury, family members or other unpaid caregivers of patients, or members of advocacy organizations that represent patients or caregivers. Stakeholder partners may include members of constituencies based on professional, rather than personal, experience. For example, these constituencies can include: clinicians, purchasers, payers, industry, hospitals and health systems, policy makers and training institutions. Some individuals may fit into several categories. Find more information about how PCORI defines stakeholders here.
When proposing research focusing on prevention, who should applicants engage as patient partners?
PCORI research is intended to improve information available to aid with health decisions, and many of the end-users of such information will be people who may or may not have a defined health condition. PCORI uses the term patient broadly to include individuals for whom preventive and diagnostic information is of interest, such as persons at higher risk for the condition in question.
Should patients engaged in a proposed study have the exact condition being studied?
Applicants should aim to involve patients who represent the population of interest in the study. However, if that is not feasible, caregivers, family members, and patient advocacy organizations can also be helpful and may be used.
Does PCORI have a requirement for the number of patients involved to qualify for meaningful involvement?
PCORI does not provide guidance on the number of patients to be involved. Engagement approaches vary and should be crafted to best support the research study.
Should applicants involve actual patients as a partners in our project or would partnership with an advocacy group, not a specifically identified patient, be sufficient?
Patient advocacy organizations can play a valuable role in projects, as can individual patients. What is most important is to secure the viewpoint of patients from your population of interest and to ensure that the involvement of your patient or patient advocate partners is meaningful and authentic. See Engagement in Research.
Should patients be listed as co-investigators or consultants?
Patient partners should be described according to the roles they are performing on the research team. Beyond the titles of roles, it is important to lay out the tasks and purposes of each partner. PCORI does not have a preconceived notion of the roles which patients should play; meaningful patient engagement can occur in a myriad of ways with many different team compositions.
Do stakeholders, as well as patients, have to be included in the Engagement Plan?
Yes. Other relevant stakeholders should be engaged as research partners. Applicants must explicitly identify each team member’s role in their proposal. If applicants intend to exclude certain stakeholders, they should be explicit on why their perspectives are not relevant. Find more information about how PCORI defines stakeholders here.
Can a person play more than one role on a team—for example, as both a stakeholder and a researcher?
It may be possible for a team member to play more than one role. For example, many researchers are practicing healthcare providers, such as physicians and nurses, and so they may also play a role as stakeholders. However, it is important to include patient representatives who serve only in that role. You must explicitly identify each person’s role in your proposal. If team members play more than one role, clearly specify which role they will play during each stage of the research.
When partners are involved with recruitment, how does an applicant work around their own Institutional Review Board (IRB) requirements, given that these partners are not employees of the institution but will have access to protected health information?
Local IRB requirements must be followed.
How can patient partners who are not institution employees in recruitment activities be engaged in research given that they will need to access protected health information?
Awardees must ensure compliance with their institutional privacy and security policies governing access, use, and disclosure of protected health information for research purposes. Please consult your institution’s IRB and/or legal counsel for any questions regarding compliance with the Health Insurance Portability and Accountability Act (HIPAA) regulations and other applicable laws.
How early in the research process should patient partners be engaged?
For Broad PFAs, patient partners will ideally be involved in drafting the proposal as well as the study design. We encourage patients and patient advocacy groups to carefully evaluate potential participation in a study. For example, potential partners should have concerns if a research team first approaches them just before a proposal submission is due and asks for “sign-off” on the plan but not for input.
For Targeted PFAs and Pragmatic Clinical Studies (PCS), applicants are not required to demonstrate that patents and other stakeholders are already engaged as research team members at the time an application is submitted. However, applicants should outline how patients and other stakeholders will participate as partners in various phases of the proposed research, once awarded. Applicants should describe their plan to form a Study Advisory Committee (SAC) or other appropriate engagement body, to ensure that a broad spectrum of patients and other stakeholders advise and assist the research team with refining the study questions, outcomes, and protocols.
What is a Study Advisory Committee (SAC)?
For Targeted PFAs and Pragmatic Clinical Studies (PCS), the SAC described in the PFA is to ensure that a broad spectrum of patients and other stakeholders advise and assist the research team with refining the study questions, outcomes, and protocols. These patients and other stakeholders must include national or regional organizations that represent, at a minimum, patients, caregivers, clinicians, policy makers, and other healthcare system stakeholders. Additional representation may be recommended in collaboration with PCORI, including individual patients with lived experience and other relevant stakeholders, such as scientific and methodological experts. However, PCORI understands that engagement structures and approaches vary widely. Other engagement approaches, such as forming stakeholder groups, panels, task forces, working groups, and other bodies, or involving individual patient and other stakeholder partners in various ways are also permissible to employ—either in addition to or instead of—the formation of the SAC. The SAC provision is not meant to require that a separate governance or advisory entity be established beyond the study governance and advisory structure the awardee has planned, if an applicant already has an approach for including the relevant and required patient and other stakeholder partners. For clarification in your application materials and merit review purposes, please indicate which body or structure is filling the SAC requirements, including the requirements for in-person meetings at least two times per year, and appropriate budgeting. Please note that formation of an SAC is not required in Broad PFAs.
How final should the research plan be at the outset of the award? Should awardees plan for modifications in the event that patient partners have input that prompts changes?
All proposals should be drafted to give merit reviewers the best picture of what is being proposed. Therefore, plan should be submitted with as much detail as possible.
For Broad PFAs, patient partners should ideally be involved early in the process, thereby minimizing the need for modifications.
For Targeted PFAs and Pragmatic Clinical Studies (PCS), it is expected that, once awarded, the Study Advisory Committee or other appropriate engagement body will assist the research team with refining the study questions, outcomes, and protocols.
How much compensation should be provided to patient partners? Can there be different levels of compensation?
PCORI does not specify compensation amounts for patient partners or other team members. For guidance on how to address compensation of patient partners, please review the Compensation Framework.
What kinds of incentives have been used for patient partners? What are some examples of alternatives to financial compensation?
Because each project is different, the most appropriate form or type of compensation will vary. If providing compensation is not possible, please articulate the reasons in your application. For guidance on how to address compensation of patient partners and accounting for other engagement costs, please see the Compensation Framework and Budgeting for Engagement.
When organizing the Engagement Plan content in the proposal, must the outline of the Engagement Rubric be followed exactly? For a proposal, it may be more logical to for an applicant to arrange the information by patient partner or other stakeholder groups.
Applicants should follow the format outlined in the Engagement Rubric. The rubric provides a standardized format for organizing engagement information for the Merit Reviewers to use during the evaluation process. Failure to follow the format could lead to difficulties for the Merit Reviewers assessing the application.
Why must applicants provide the names of our patient and stakeholder partners?
Many members of the patient and other stakeholder community have requested that PCORI make the names of partnering individuals and organizations available, along with other research project information such as the name of the PI(s), the name of the awardee institution, and public abstract, in order to credit the contributions of the full research team adequately. We have high regard for patient, researcher, and other stakeholder contributions and strive to give appropriate recognition to all research team members.
Can patient or stakeholder partners remain anonymous if requested?
Applicants should provide PCORI only those names of patient or other stakeholder partners for whom you have obtained appropriate permission to disclose their identity to PCORI and for PCORI to use their names in public communications relating to the award. Examples of communications include posting on the PCORI website along with the public abstract, in press releases and in responses to third-party requests. If a patient or other stakeholder partner has a concern about being publicly named, you can contact PCORI staff at (202) 370-9312 or at email@example.com for guidance on how to recognize appropriately partners who wish to remain anonymous.
Why are the engagement requirements different in Pragmatic Clinical Studies (PCS) and Targeted PFAs than in Broad PFAs?
PCORI believes that meaningful patient and other stakeholder engagement is a critical component of patient-centered outcomes research and comparative effectiveness research. The primary difference between the engagement requirements in the Broad PFAs and those in the PCS and Targeted PFAs is the timing and scale of the engagement. The topics around which the PCS and Targeted PFAs are drafted were identified through a lengthy, multi-stakeholder process, underscoring the importance and relevance of these topics to the patient and stakeholder community. Applicants applying to the PCS and Targeted announcements must demonstrate how, upon receiving a contract for funding, they will engage their relevant patient and stakeholder partners as described in the PFAs found in the Funding Center. Conversely, the Broad PFAs are not oriented around a previously-prioritized and identified topic and therefore applicants must demonstrate active patient and other stakeholder partnership and support for the topic idea, research gap, and decisional dilemma at the time of proposal submission.
The other key distinction between these funding announcements is the scope and scale of the awards, with the PCS and Targeted PFAs being significantly larger in size and dollar amount. The engagement costs are thus much greater for the PCS and Targeted PFAs than for the Broad PFAs. We heard from applicants that the cost of engaging patients and stakeholders on a national or regional scale prior to award was cost-prohibitive and the revised engagement requirements allow for the cost of engagement to be covered fully by the contract. Additionally, it prevents attempts to form partnerships for applications that may not be funded and, thus, result in financially unsustainable engagement activities.
To support our Broad PFA applicant community, we have the Pipeline to Proposal Awards program, a competitive funding opportunity that provides three tiers of engagement funding for patients, researchers, and other stakeholders interested in potentially submitting a PCORI research proposal. More information about that program can be found here.
Using the PCORI Online System
How does an applicant register to submit an application?
To apply for PCORI funding, an applicant (PI or PI designee) must register in PCORI Online. A name, an email address, a password, and a security question and answer are required to register. Once signed in, you will be directed to the home screen. Click on the Research Awards tile to apply for funding. PCORI strongly recommends that only the PI create the LOI/application record, because whoever creates the record will have permanent access to it in PCORI Online.
Are there any requirements prior to registering for PCORI Online?
Yes. In order to submit an application or register your organization in our system, you will need a Data Universal Numbering System (DUNS) number and an Employer Identification Number (EIN). If necessary, you can apply for a DUNS and/or an EIN.
If you are not a U.S.-based organization and therefore do not have an EIN or DUNS, please contact PCORI at firstname.lastname@example.org for instructions on how to register and apply.
Is the PCORI contract system linked to eRA Commons?
No. We are not affiliated with the National Institutes of Health (NIH), and do not use its online grants system. We use our own online system, PCORI Online.
Whom can I contact for technical assistance when using PCORI Online?
Request technical assistance by contacting us at email@example.com or call the Contracts Helpline at: (202) 627-1885.
My PCORI Online account is locked. How do I get back in?
On the PCORI Online login page, click the “Reset or create password” link. You will be prompted to enter your account information to reset your password. Please contact us at firstname.lastname@example.org if you continue to have issues.
PCORI Online displays that my login ID does not exist when I try to log in. What do I do?
Please note that changing your contact email address in PCORI Online will not automatically update your login ID. We strongly encourage you to use your contact email as your login ID, as it simplifies any potential login issues. Please contact us at email@example.com if you continue to have issues.
How do I access my LOI number?
An LOI number is automatically generated when the applicant saves the LOI to PCORI Online. Upon selecting the “Save & Review” button, the new LOI number will be visible at the top of the webpage in PCORI Online.
My organization is not listed as an option on the registration screen. What should I do?
Please email firstname.lastname@example.org with your organization’s DUNS number and contact information (name, address, and email). Please indicate if your organization has multiple accounts.
An individual from my organization is not visible in the PI and Contact Information dropdown menus. When I try to add them, it says the email is already taken.
The individual’s profile is not linked with the organization under which the application will be submitted. Please email email@example.com and provide the name of the individual and the name of the organization to which they should be linked.
Letter of Intent
LOI Content Requirements
What information does a Principal Investigator (PI) need to submit for the LOI portion of the application process?
An LOI is required for new and resubmitted applications:
- New applicants can submit an LOI by logging into PCORI Online, completing the required LOI fields for the PFA, and uploading the completed PFA-specific LOI template into the system.
- Submitting an LOI is a requirement of resubmissions unless the applicant has received an Invitation to Resubmit. Applicants who are resubmitting must complete the LOI fields for the PFA and upload a completed LOI Template to PCORI Online. Invited applicants are required to upload their Invitation to Resubmit letter and complete the LOI questions in PCORI Online but do not need to upload the LOI template.
Where do I find the correct LOI Template?
Download the PFA-specific LOI Template from the PCORI Funding Opportunities. The following four Broad PFAs use the same LOI Template: Addressing Disparities, Assessment of Prevention, Diagnosis and Treatment Options, Communication and Dissemination Research and Improving Healthcare Systems. All other PFAs have their own PFA-specific LOI Template.
How many pages is required for the Broad PFA LOI submission? Can a PI add additional information?
The LOI submission length is two pages, excluding references, and no additional information should be submitted. PIs should follow the instructions on the LOI template carefully to understand what information is required and how to best provide information required in the pages allotted. Please view the Application Guidelines for your PFA.
What format is preferred when using the LOI template provided by PCORI?
All LOIs are required to use Calibri font size 11 and single spacing. Replace the italicized gray and any instructional text in the template with your response. You must retain the bold headings and question numbers in the template and write your response directly after the bold heading. Applicants are also required to use half-inch margins (the header may fall within the top margin, but the body text should not begin closer than a half-inch from the edge of the page). You do not have to provide spaces between questions. The LOI sample template for your PFA is available for formatting purposes.
Can the research proposed in an application differ from the research initially described in the LOI?
PIs should not make any major changes–such as research question(s), study design, specific aims, comparators, institution or Principal Investigator– to their application. LOIs go through a competitive process and PIs are invited to apply based on the information provided. If you need to change any of this information or have any questions, email firstname.lastname@example.org.
Can the PI listed in the final application differ from the PI listed in the LOI?
No, if the PI changes between the LOI phase and the application phase, applicants must speak with a Program Officer before the deadline to obtain approval. Failure to obtain approval prior to the deadline may result in the application being rejected.
What budget information is required for the LOI? How detailed does it need to be?
Only a budget estimate is required to complete the LOI. A full budget with a justification will need to be provided at the application stage.
LOI Submission Process
How are applicants notified after a Letter of Intent (LOI) is submitted?
PCORI staff screens LOIs for programmatic fit and administrative noncompliance. Approximately five weeks after the LOI deadline, PCORI will notify applicants via email whether or not they have been invited to submit an application. PCORI encourages prospective applicants to contact us if they have any questions prior to the deadline.
Additionally, one-time funding announcements may have special guidelines regarding LOI submission and screening. Applicants should carefully read the related PCORI Funding Announcement (PFA) to learn about and follow all guidelines.
Is it possible to submit an application without submitting the LOI?
No, only applicants who are invited to submit applications can do so.
Can the PI submit the LOI via his or her account in PCORI Online, or does the LOI need to be submitted by the institutional Administrative Official?
The PI should submit the LOI for the project, as the PI will be serving as our main point of contact. However, a PI Designee may also submit the LOI. An Administrative Official is required to submit the full application.
Can multiple individuals from an applying organization access the LOI?
Yes. The PI may assign up to two PI Designees to access and edit the LOI. Only one person may work on the application in PCORI Online at a time.
Can a PI remove an already started LOI from the “my task” section in PCORI Online or change the funding announcement for the LOI if the wrong PFA was initially selected?
There is no way to delete a previously started or submitted LOI from your account. However, you may withdraw the LOI from consideration by simply clicking the “Withdraw” button located to the right of the Request Number displayed on the screen when you log in to PCORI Online. Incomplete LOIs will not affect your application. However, we request that you withdraw the incorrect LOI for our internal tracking purposes.
What to Include in the Application
Can the information proposed in an application differ from the research initially described in the Letter of Intent (LOI)?
Yes. However, PIs are invited to submit an application based on the information provided in the LOI. Any changes to the following require PCORI's written approval prior to submission:
- Principal Investigator
- Study design
- Research question(s)
- Specific aims
Please email email@example.com regarding information you would like to change or if you have any questions. Due to the volume of requests PCORI received, applicants should submit the request early during the application process.
Can an application list a different PI than originally listed in the LOI?
Changes in the PI or institution between the LOI and application phase require prior approval from PCORI’s Program staff prior to submitting the full application. Submit the request to firstname.lastname@example.org and include a rational for the change, letter of support from the intended PI, and a CV or biosketch for the replacement PI.
How is application information submitted using PCORI Online, PCORI’s web-based application system?
Complete an application using PCORI Online by: 1) entering information into fields provided on the screens and 2) completing and uploading templates provided by PCORI or documents created by applicants. Please follow the page-formatting requirements below.
What are the page-formatting requirements for submitting an application?
The Application Guidelines and PCORI templates note additional instructions including page or length restrictions, when applicable. Documents uploaded (excluding letters of support) to PCORI Online must be formatted as follows:
- Header: Include the Principal Investigator’s (PI’s) full name in the top left corner of the page header on every page.
- Margins: Use at least half-inch margins. The header may fall within the top margin, but the body text should not begin closer than one half-inch from the edge of the page.
- Font: Use size 11 Calibri for the main body of the text. Figures and captions may have smaller type. Figures, tables and captions may be size 8 font.
- Page Numbering: Each page must be numbered consecutively for each PDF upload. Each section of an uploaded document must begin with page 1.
- Spacing: Use single spacing.
- Document Format: Upload all attachments in PDF format.
- Page limit: This varies based on document. * File name format: refer to Application Checklist.
- References: PCORI suggests including all references as in-text citations using American Medical Association (AMA) citation style, but other citation styles are accepted.
What if I plan on using a research network infrastructure (such as PCORnet) and/or related data resource (such as EMR in health care delivery systems or claims data) in my application?
Applicants intending to use an existing research network and/or data resource should detail in the appropriate sections of the research plan (e.g., study design or approach, study population and setting, or analytical plan as appropriate) the following, as appropriate:
- Identify all participating research network entities (e.g., in the case of PCORnet, the names of the participating CDRNs, PPRNs, PCORnet Collaborative Research Groups, Health Plans) collaborating on the project and the affiliated study performance sites.
- If applicable, describe how data will be managed across study sites within the research network, and whether any dedicated data coordinating functions or facility will be utilized.
- All applicants utilizing an existing research network and/or data resource should substantiate in the applications familiarity with the network governance policies or data use restrictions and provide documentation supporting the proposed utilization of the research networks and/or data resources.
How does the Technical Abstract differ from the Public Abstract?
Both abstracts should be descriptive of the study being proposed. The Technical Abstract should be written for a scientific audience and can include more technical language. The Public Abstract, however, is meant to be published on the PCORI website when awards are announced. This information regarding proposals are intended for the general public and it should describe the study in layman’s terms.
What is the difference between the Engagement Plan and the Dissemination and Implementation Assessment section?
The Engagement Plan is designed to capture how applicants plan to involve patients and stakeholders in the research project, while the Dissemination and Implementation section of your research plan should map how research results will be shared.
What do I need to include in the Dissemination and Implementation Potential section?
Develop a plan that maps how your research results will be shared in other settings, as well as the potential barriers to dissemination and implementation.
Who should write the letters of support and to whom should they be addressed?
Each person listed as key personnel should write a letter of support; any group or individual willing to speak for or recommend the research project is also encouraged to complete a letter. Letters of support should be addressed to the PI, consolidated into a single PDF, and uploaded into the PCORI Online System.
If an application has 45 subcontract sites, should each PI from each site submit a Letter of Support? Are there any limits to the number of letters that should be included?
Yes, the PI from each site should write a Letter of Support. No, there is no limit to the number of letters submitted.
PCORI provides templates for certain portions of the application. Are PI’s required to use these templates or can applicants create their own templates?
PCORI requires applicants to use the templates provided for the current funding cycle. Templates are available to download from the individual PCORI Funding Announcement (PFA) page located in the Funding Opportunities. Please be sure to use the templates for the specific PFA and cycle you are applying to, as templates may vary from PFA to PFA and cycle to cycle. Additional information can be found in the Application Guidelines.
What can be deleted from the Research Plan Template?
Applicants may delete any instructional text and/or sub-bullets below each section header. For example, applicants must keep A. Background, B. Significance, etc., but you may remove “Describe the impact of the condition…”
Can I rearrange the order of questions in each section of the Research Strategy Template?
Yes. Applicants may reorder each sub-bullet within each section of the Research Strategy Template, but you must keep the sections in the same order as they are listed in the Research Strategy Template.
How should applicants include the methodology standards in the research strategy?
In the Research Strategy section of the Research Plan Template, applicants should describe in detail the research strategy and plan, and should demonstrate how the proposed study is responsive to the PFA. Include the relevant PCORI Methodology Standard citations (e.g., “PC-3”) as identified in the Methodology Report; applicants should refer to this report for an explanation on each standard. Applicants do not need to list every standard, only standards that are relevant to your proposal.
What should be included for milestones in the Milestones tab within PCORI Online?
Milestones described within the Milestones tab should include project objectives and deliverables that will be accomplished at specific times during the proposed project.
What is required in the Project/Performance Site(s) and Resources sections of the People and Places Template?
The Project/Performance Sites section should contain a list of addresses for all the places where the work described in the Research Plan will be conducted. This list must include the organizational name, full physical address, city, county, state, zip code, and congressional district. Be sure to list the primary research site first and follow with additional research sites as needed. Demonstrate that the proposed facilities have the appropriate resources required to conduct the project to plan, within budget, on time, and successfully.
What Research Team and Environment information is required in the Research Strategy section of the Research Plan Template?
For the Team information, describe how the members of the team contribute to the probability of success because of their skills, expertise, connections, etc. This should not duplicate biosketch information. Use this section to describe how this group of individuals will succeed as a team.
For the Environment information provide more in-depth detail about the capabilities of these sites. Applicants should:
- Provide a description of the facilities, including their capacities, capabilities, relative proximity, and extent of availability to the project.
- Describe how the research environment contributes to the probability of success (e.g., institutional support, physical resources, and patient engagement).
- Discuss ways in which the proposed study will benefit from the unique features of the research environment or community involvement.
If neither of these criteria applies, explain how the study will employ useful collaborative arrangements in these environments. Finally, describe institutional and community investment in the success of the research. This can include the availability of organized peer groups, logistical support (administrative management and oversight and best practices training), financial support (protected time for research with salary support), and access to and support of patient groups.
If a research team member has a National Institutes of Health (NIH) Biosketch, can he or she use this as his or her PCORI Professional Profile?
Yes, applicants may use a current NIH Biosketch as a professional profile instead of the PCORI Professional Profile, but it must not exceed five pages.
What information should be included in the Profile/Biosketch?
A Profile/Biosketch (limit five pages each) must include the person’s name, title, degrees, and the following information, where relevant:
- Personal statement
- Education and training
- Employment and positions held
- Selected peer-reviewed publications and other publications
- Public speaking or presentations
- Research support
Who needs to have a Profile/Biosketch?
Any individual contributing to the project in any substantive way is expected to have a complete Professional Profile/Biosketch. The profiles/biosketches must include patients and stakeholders involved as well. PCORI recognizes that not all sections of a Professional Profile/Biosketch will be applicable to patient and stakeholder members of the research team; therefore, applicants are encouraged to fill out the PCORI Patient/Partner Biosketch instead.
Are Biosketches required for patient and other stakeholder partners?
Biosketches are required for all key personnel, whether they are researchers, patients, or other stakeholders. Patient partners have a wealth of experience and wisdom, and we would like them to have an opportunity to provide that background, just as researchers or other stakeholders do. Please use the PCORI Biosketch template developed specifically for patient and stakeholder partners.
Pilot Study Information
Are preliminary results or pilot studies required?
No. PCORI will consider funding applicants who have not conducted preliminary research or pilot studies. However, it is recommended that applicants who do not include pilot or preliminary data in their applications clearly explain the reason(s) for not including such data. Please see the “Guidance for Proposing Research” and “Research Priorities” sections in the PFA for more information.
What pilot data are required in order to have a successful application? To what extent is it acceptable to propose proposing engagement and/or proposing designs without any prior history? Do we need to show a track record with patient or community partners?
There are no explicit requirements regarding pilot data in order to be eligible for PCORI funding. As with any research application, feasibility of key aspects of the research is important to demonstrate, and for some projects, pilot data may be an appropriate way to communicate feasibility of the proposed research plan. A history of engagement with the proposed research partners is not required; however, it is encouraged if applicable to the particular study. Prior work with research partners should be noted because these learnings should inform the application. For some studies, demonstrated commitment of patients or other stakeholders may be appropriate; for other studies, a plan for engaging end-users may be appropriate.
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.
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 NIH 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 to total costs.
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.
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.
If travel is required for a 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.
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.
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 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.
Can I include cost-of-living adjustments in my budget?
Yes. Applicants may include adjustments for inflation in your detailed budget.
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.
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.
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 PCORI require a Data and Safety Monitoring Plan (DSMP) for all of its funded research projects?
Yes. PCORI requires a DSMP for all of its funded research projects involving human subjects. The minimal requirements for a DSMP are outlined in the PCORI Policy on Data and Safety Monitoring Plans for PCORI-Funded Research. The applicable IRB must approve the DSMP.
Does PCORI require a Data and Safety Monitoring Board (DSMB) for all of its funded research projects?
PCORI requires awardees to ensure that there is a DSMP, 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 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.
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.
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.
Can patient partners serve as 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.
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 2 percent of the projects 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 2 percent of the total direct costs. Applicants should send requests for approval to email@example.com.
Role of Administrative Official
What are the responsibilities of the Administrative Official (AO)?
The AO is the individual within the recipient organization who is responsible for the proper administration of the contract, including, but not limited to, overseeing the submission of the contract activation, contract renewals, and additional materials required by PCORI’s policies and procedures.
Can a Principal Investigator (PI) serve as the AO?
No. The AO is the designated representative of the grantee organization in matters related to the award and administration of the contract.
The AO certifies that the applicant organization will: (1) comply with all applicable assurances and certifications referenced in the application; (2) be accountable for the appropriate use of funds awarded; and (3) oversee the performance of the grant-supported project or activities resulting from the application.
How do I add an AO to my application?
Under the “Contact Information” tab of the LOI in PCORI Online, use the magnifying glass to select the name of your AO. Only Project Personnel with active PCORI Online accounts will appear in the magnifying glass search results. If the name does not appear in the magnifying glass search results, the AO must create a user name and password by within PCORI Online. After the AO creates a username and password, their name will appear in the magnifying glass search results.
How is the AO notified that the submission is ready to be sent to PCORI? Does the AO log in under the PI’s ID and submit, or does he or she create a separate account?
When the PI clicks “Submit,” the AO will receive an email from PCORI notifying him or her to log in, accept the terms and conditions, and authorize the application. Once the AO logs in to the system, they will click on the icon under AO Approve/Withdraw to Approve, Reject, or Withdraw the submitted application. After the AO submits the application, the application is moved into the “Under Review” phase and no further edits can be made.
To what terms and conditions must the AO agree before approving the application?
The terms and conditions are as follows:
- Administrative Official (AO) acknowledges PCORI’s contractual mechanism to be a contract and not a grant, and affirms that Applicant Institution is able to accept the contract terms and conditions without alteration.
- I hereby certify that, to the best of my knowledge, the information in this PCORI application is true and accurate.
- I understand that the discovery of false or fictitious information included in the application may result in rejection from the review process or termination of an award.
- I certify that the funds applied for will be used as outlined in the proposed budget, and in accordance with the contract terms and conditions.
- To the best of my knowledge, none of the Key Personnel and/or collaborating institutions is or are currently banned from receiving federal funds due to debarment or engagement in research misconduct.
- By submitting this application, I attest that I am recognized by my institution as an official authorized to enter into contractual agreements and commit institution resources.
Can the application be sent back to the PI if the AO identifies a problem?
Yes. If changes to the application are required, the AO may release the application back to the PI. In order to do so, the AO must click the “Reject” button. The AO will need to notify the PI that an action is required on their part.
Merit Review Process
Who is involved in the merit review process?
As part of “research done differently,” PCORI includes patients, caregivers, and other healthcare stakeholders in reviewing funding applications. In merit review panels, each reviewer’s score weighs equally to ensure that patients’ and other stakeholders’ perspectives are heard. See Become a Merit Reviewer for more information.
Do patients and stakeholders participate in the review process?
Yes. PCORI’s Merit Review process includes patient, stakeholder, and scientific reviewers, with the exception of pure analytic applications as a part of the Improving Methods PCORI Funding Announcement (PFA).
In what format do reviewers view the application?
Reviewers view the entire application in PDF format.
What do the numbers on the scoring scale mean?
During the preliminary review and the in-person panel review, reviewers use a nine-point scale to assign criterion scores, initial overall scores, and final overall scores (see the table below for more details). LOIs are not scored.
What are PCORI’s Merit Review criteria?
The criteria are outlined here.
Will I receive a score if my application was reviewed?
If your application was reviewed but not discussed during the in-person phase, you will not receive an average overall score.
Will I receive a score if my application was discussed?
If your application was discussed at the in-person review, you will receive an average overall score and discussion notes from the panel discussion by the day of award announcements.
When will I receive my summary statement?
Summary statements will be released to applicants approximately two weeks before the Board of Governors announcement of awards.
What information is included in my summary statement?
- Statements for undiscussed applications include:
- Evaluations written by assigned reviewers during the preliminary phase
- Statements for discussed applications include:
- Evaluations written by assigned reviewers during the preliminary phase
- Final average overall score from the in-person panel
- Discussion notes from the full panel discussion
- Scoring quartile
Quartiles are provided to inform an applicant’s relative position to other applications in the PFA to which they applied, but do not inform funding decisions, as programs do not consider quartile information. Quartiles are also more informative for applicants than raw percentiles, as PCORI does not use a “pay line” or “funding line.”
How was the scoring quartile for my application calculated?
The quartiles are based on the calculated percentiles and calculated to the hundredth of a score point:
- Percentile = (100*application rank/number of applications discussed for the PFA)
- Quartile 1 (1-24%); Quartile 2 (25-49%); Quartile 3 (50-74%); Quartile 4 (75-100%)
Quartile 1 includes the better scoring applications (lower numeric score), and Quartile 4 includes the applications that received higher numeric scores.
How was the average overall score for my application calculated?
The average overall score is the final average score the application received if your application moved forward to the in-person discussion. The assigned reviewers (along with all other panel members) score applications using the scoring scale of 1 (best score) through 9 (poorest score). The full panel’s final overall scores are averaged then multiplied by 10, resulting in the score included on your summary statement. The top score is a 10 and the lowest is a 90. We do not currently release any information about how other discussed applications fared.
Whom should I contact if I have questions or concerns regarding information provided in my summary statement?
Email firstname.lastname@example.org or call PCORI at 202-627-1884 to schedule time to discuss review questions or concerns with a Program Officer.
How are award announcements made?
After the merit review process concludes, PCORI will email applicants inviting them to listen to the Board of Governors webinar, during which the Board announces awards for each of the funding announcements in the most recent cycle. This email includes the date, time, and registration details. One day prior to the Board of Governors webinar, those who have been recommended for funding will receive an email notification. After the webinar, PCORI will notify all applicants via email if they have been funded.
Is an awardee receiving PCORI funding subject to federal audit requirements in relation to that particular PCORI award?
No. The awardee, at their own discretion, may choose to include a PCORI award in A-133 or other audit testing. PCORI is subject to oversight by the U.S. Government Accountability Office (GAO). The GAO and PCORI may choose to audit a recipient on a random basis or because of a concern, and commission a third-party audit of a recipient. If so, the recipient must provide access to all contract and financial records, documents, files, and other materials related to the funded research project. Awardees are also required to make project staff and subcontract staff available for interviews or discussions, and allow the facilities and PCORI-funded equipment to be inspected within a reasonable time and no later than 30 days following a request by PCORI or the GAO.
Can an award be transferred from one organization to another?
Yes. All transfers must be approved by PCORI. A Principal Investigator who desires to transfer a contract/post-award must, at minimum, provide notice and receive written approval from the original organization.
Are there any guidelines about when a project can start?
Generally, the start date for a project should be no later than three months after the contract is executed.
When are recipients of PCORI funding able to start incurring costs for their project?
For cost-reimbursable contracts, costs may be incurred up to 90 days prior to the start date of the contract, but no earlier than the date the award was announced by PCORI’s Board of Governors.
Rare Disease Research
What type of rare disease research will PCORI fund?
PCORI funds research comparing two or more interventions with proven efficacy that are currently being used in clinical practice to treat patients with a given medical condition. PCORI research seeks to address questions or concerns that are important to patients and other stakeholders. This type of research is referred to as patient-centered comparative effectiveness research (CER).
Investigators applying for PCORI funding must make the case that the study addresses a clinical choice and decisional dilemma faced by patients and healthcare providers. As part of the justification for the importance of the study, investigators should describe how the interventions being studied are currently used in clinical practice for the diagnosis, treatment, or management of the condition, both in terms of how widely they are used and any particular clinical and population considerations.
Additionally, PCORI encourages investigators to use validated outcome measures, including patient-reported outcomes, and provide preliminary data that support the proposed measures.
Will PCORI consider funding a rare disease study that includes a usual care group?
PCORI prefers studies comparing at least two active interventions. If usual care is included as the comparator in the control group of the study, applicants should describe what usual care entails and this will be measured over the course of the study in each patient, and in multiple settings, if applicable. Specifically, the investigator is required to: (1) justify why usual care is the appropriate comparison; (2) describe usual care in the context of broader clinical settings (i.e., whether significant variables exist); and (3) describe how usual care will be measured over the course of the study in each patient.
Does PCORI have different criteria against which rare disease applications are evaluated?
PCORI generally applies the same evaluation criteria to review all research applications. However, we understand that existing evidence regarding interventions for rare diseases is often limited. In articulating the clinical decision dilemma, investigators must describe the existing evidence on the proposed interventions, even if the data are limited. If the data have not been published, investigators should describe why they are not, as well as any plans for the public release of the data. In some instances, PCORI may consider applications that involve interventions with limited evidence if the application compares two or more interventions that are currently being used in medical practice to treat patients with a given rare disease. Please note that applicants will need to document and address the limitations and risks of using minimal efficacy data.
Will PCORI consider rare disease CER studies where one of the interventions being compared is a drug being used off-label in clinical practices?
In some instances, particularly with respect to research in rare diseases, it may be the case that off-label use of drugs is a realistic choice and represents appropriately a potential alternative therapy in need of evaluation. In these instances, a specific rationale to support the inclusion of an off-label therapy should be clearly documented in the application. As part of the justification for the importance of the study, investigators should describe how often the interventions being compared are currently used in clinical practice for treatment of the condition being studied.
Posted: September 2013; Updated: May 17, 2017