For Broad PCORI Funding Announcements (PFAs)
About PCORI | Who Can Apply | Research We Fund | Cost-Effectiveness Analysis | Engagement | Using PCORI Online | 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.
PCORI was authorized by the Patient Protection and Affordable Care Act of 2010 as a nonprofit, nongovernmental organization. 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 is eligible to apply for PCORI?
Applications may be submitted by:
- Any private-sector research organization, including any:
- Nonprofit organization
- For-profit organization
- Any public-sector research organization, including any:
- University or college
- Hospital or healthcare system
- Laboratory or manufacturer
- Unit of local, state, and federal government
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.
Do you have to be partnered with an academic institution to apply?
Individuals may not apply, but 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.
Does PCORI make special provisions for new investigators or early-stage investigators?
No. There are no special provisions for investigators who fall in these categories.
Does PCORI have mechanisms to support junior investigators—i.e., training and/or separate competition pool for funding?
At this time, PCORI does not have separate training funding mechanisms or separate set-asides for those early in their careers. The research team is a consideration during merit review; however, 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?
Are organizations eligible to apply to multiple funding announcements?
Yes, if the research questions are distinct. Organizations may submit more than one application to each PCORI Funding Announcement (PFA). However, organizations may not submit the same project to multiple PFAs in a given cycle.
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, they must ensure that the research topics/projects are not similar. LOIs that show scientific overlap or that appear to be duplicate submissions will be disqualified. PCORI will contact the PI and give them an opportunity to choose which PFA they 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.
Can I still submit an application to PCORI if I have 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 federal agency be submitted to PCORI?
Yes. You may submit an application to PCORI if you have submitted or intend to submit an application to another federal agency or foundation. However, if your application has been selected for funding by another organization or federal agency and you decide to accept that funding, please notify PCORI immediately and withdraw your application from the review cycle.
Can an application have multiple PIs?
PCORI requires that one individual be designated as a PI in the PCORI Online System. However, if your application has a co-investigator on the project, then you may note this in the Key Personnel section in PCORI Online, as well as the People and Places section of your application.
If I am invited to submit an application and fail to do so, will I be penalized or prevented from applying in a future funding cycle?
No, applicants will not be penalized or prevented from submitting an LOI during a future funding cycle.
What is PCORI’s resubmission policy?
An applicant may resubmit an application that was not funded. A proposal is considered a resubmission after it has completed PCORI’s merit review process (i.e., the applicant has received a summary statement). If an application was deemed nonresponsive and did not progress through the full review process, the applicant is required to submit a new LOI. When resubmitting an application, applicants are required to include the three-page resubmission letter. All applications are evaluated using the same review criteria. Responsiveness to previous reviewers’ concerns is not sufficient; the application must be patient-centered, methodologically rigorous, and programmatically responsive.
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 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 in 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.
Can I resubmit my 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 is my resubmission reviewed?
- Reviewers are notified which of their assigned applications are resubmissions.
- Reviewers will evaluate resubmissions as stand-alone applications, with a fresh perspective, using the 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 three-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 who were involved in the previous evaluation of a resubmission 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.
- For the current review cycle, 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.
Does Institutional Review Board (IRB) approval have 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. After a PI is notified of the award, he or she can then begin requesting IRB approval.
Do patient partners need IRB approval to participate? In some institutions, the IRB requires patients identified as “key research personnel” or “team members” to take training that can be daunting for potential patient partners.
The specific responsibilities of the patient research partner should dictate this determination. You must follow local IRB requirements. Although many of our project teams have not encountered difficulty with IRB requirements, PCORI recognizes your concerns, and we are working toward a solution to this issue.
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, an individual 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 the Administrative Official listed on the application.
What is the process for notifying PCORI that I will not be submitting an application?
Log in to PCORI Online and a list of Request Numbers will appear on the first page. Simply click the “Withdraw” button to the right of the Request Number if you wish to remove your application or LOI information from the system.
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 the features of patient-centered outcomes research (PCOR) that PCORI funds?
PCOR helps patients and their caregivers 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 patient-centered outcomes research (PCOR) relate to 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 comparative effectiveness research (CER). Some, but not all, CER is patient-centered. The type of CER PCORI funds is patient-centered CER. Not all CER will meet PCORI’s definition of patient-centered: addressing questions important to patients and other healthcare stakeholders, studying 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
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, however, based on content.
Where can I learn about research projects that PCORI has funded?
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 received. 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.
I have a question concerning the suitability of my proposed project. Can I speak with someone at PCORI? (I need help choosing the right PCORI Funding Announcement [PFA].)
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.
Can PCORI provide more information on what level of patient and stakeholder engagement is expected? Are there general guidelines or requirements for how often and through what methods patients and stakeholders need to be engaged?
Engagement can take many forms, so we ask teams to come up with their own appropriate blueprints for partnership. Because many researchers have not had 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 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 funding announcements have always noted the importance of including in studies diverse populations with respect to age, gender, race, ethnicity, geography, or clinical status. We have developed a 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 persons
- Veterans and Members of the Armed Forces and their families
I would like to develop and validate an instrument to measure behavior change. Will PCORI fund this research?
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.
We would like to set up 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, your proposal would most likely fit under the Assessment of Prevention, Diagnosis, and Treatment Options PFA.
I have received a National Institutes of Health (NIH) K Award. Am I still eligible to apply for PCORI funding?
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). All applicants are strongly advised to consult with the awarding sponsor to ensure eligibility with their Career Development Award.
What is PCORI’s official policy on cost-effectiveness analysis?
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.
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.
Addressing this issue specifically, our funding announcements say 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."
Why does PCORI have a specific 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.
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 to measure cost effectiveness as any one of the specific aims and/or 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-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 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.
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.
Can we remove cost-effectiveness analysis from our proposal prior to Merit Review?
No. Applicants cannot make any edits to their proposal after it has been submitted.
We plan to resubmit our proposal without the cost-effectiveness analysis. Should we resubmit our Letter of Intent?
Yes. Applicants must resubmit a LOI in order to be considered for the next cycle. Be sure to check the Funding Center 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 on how PCORI defines stakeholders here.
What does PCORI mean by patient? What about research that focuses on prevention—we do not have patients to engage, so what should we do? Do “people” meet the definition?
PCORI research is intended to improve information available to aid with health decisions, and many of the end-users of the 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. PCORI does require stakeholder engagement in the research it funds, and the appropriate stakeholders are expected to vary by research question. Guidance on how best to identify stakeholders to engage centers on the intended end-users can be found on our Engagement in Research page.
Do patients need to 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.
How many patients are required for meaningful involvement? Must we have an actual patient as a partner in our project or would partnership with an advocacy group, not a specifically identified patient, be sufficient?
PCORI does not provide guidance on the number of patients to be involved. Nor do we have a preconceived notion of what engagement should look like in a given project. See Engagement in Research. 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.
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 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.
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 do we work around our 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 early in the research process should we bring in patient partners?
Ideally, patient partners will be involved in drafting the proposal as well as in the study design. We encourage patients and patient groups to evaluate potential participation in a study carefully. 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.
How firm should the research plan be at the outset? Should we leave some “wiggle room” in case patient partners have input that prompts changes?
The proposal should be drafted to give merit reviewers the best picture of what is being proposed. Therefore, describe your plan with as much detail as possible. Ideally, patient partners should be involved early in the process, thereby minimizing the need for “wiggle room.”
How much compensation should we provide patient partners? Can there be different levels of compensation?
PCORI does not specify the compensation for patient partners or other team members. According to the Engagement Rubric, “Time and contributions of patient partners are valued and demonstrated in fair financial compensation, as well as reasonable and thoughtful time-commitment requests.” PCORI recently published a Compensation Framework to help applicants determine appropriate compensation levels for patient partners.
What kinds of incentives have been used for patient partners? What are some examples of alternatives to financial compensation?
Generally, patient partners are compensated financially, although other incentives have also been used, such as providing parking, childcare, or other facilitators of participation in events. Because each project is different, the most appropriate form of compensation will vary.
How can I designate an individual as Co-PI?
A Co-PI should be listed in the Key Personnel section of PCORI Online. The “Co-Principal Investigator” option may be selected from the Project Role drop-down menu.
When organizing the Engagement Plan content in the proposal, must I follow the outline of the Engagement Rubric exactly? For my proposal, it may be more logical to arrange the information by patient partner/stakeholder groups.
You should follow the format outlined in the Engagement Rubric. The rubric provides a standardized format for organizing your 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.
Why must we provide the names of our patient and stakeholder partners?
Many members of the patient and 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.
What do I do if my patient or stakeholder partners wish to remain anonymous?
You should provide PCORI only those names of patient or 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, such as by posting on the PCORI website along with the public abstract, in press releases and in responses to third-party requests. If a patient or 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 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 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.
Are there any requirements prior to registering in the PCORI Online System?
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?
If you run into technical difficulties using the PCORI Online System, please contact 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 login page, click the link that says “Reset or create password,” and you will be prompted to enter your account information to continue with the process of resetting your password. Please contact us at firstname.lastname@example.org if you continue to have issues.
PCORI Online is telling me that my login ID does not exist. What do I do?
Please note that if you change your contact email address in PCORI Online, it will not change 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 find my request ID number?
A request ID number will be automatically generated once the LOI has been saved. Upon selecting the “Save and Review” button, the new request ID number will be visible at the top of the webpage in PCORI Online.
My organization is not listed as an option. What should I do?
The organization is not in the PCORI Online system. Please email firstname.lastname@example.org with the DUNS number and the organization contact information (name, address, and email). Additionally, if your organization has multiple accounts, please email email@example.com.
An individual 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 firstname.lastname@example.org and provide the name of the individual and the name of the organization to which they should be linked.
I did not receive an email notification and I am the PI/AO.
There is likely a delay in notifications being sent out. It is the PI’s responsibility to notify the AO after they have released the application to them.
What is the notification process 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.
My research question could fall under two PFAs. Can I submit the same project to multiple PFAs?
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 Principal Investigator (PI) may not submit the same project to multiple PFAs in a single cycle, but it may be submitted during another cycle.
How much can the research proposed in my application differ from that initially described in my LOI?
Applicants 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 are invited to apply based on the information provided. If you need to change any of this information or have any questions, email email@example.com.
Can I list a different PI in the final application than was 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.
If I do not submit an LOI, can I still submit an application? (I missed the deadline to submit an LOI. Can I still submit an application?)
No, only applicants who are invited to submit applications can do so.
Can the PI submit the LOI via his or her account, 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. An Administrative Official is required to submit the application.
Can multiple people access the LOI?
Yes. The PI may assign a “PI Designee” to access and edit the LOI. Only one person may work on the application in PCORI Online at a time.
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.
I am currently in the process of filling out my LOI, but I chose the wrong PFA. Is there a way to remove it from my tasks or change the funding announcement?
There is no way to delete a previously started or submitted LOI. However, you may withdraw it. When you log in to PCORI Online a list of Request Numbers will appear on the first page. Simply click the “Withdraw” button to the right of the Request Number.
Incomplete LOIs will not affect your application. However, we request that you go in to the system and withdraw the incorrect LOI for our internal tracking purposes.
How soon after I submit my LOI can I begin my application?
Applicants who are invited to submit an application can begin the application process immediately.
How should I format my LOI using the template PCORI provides?
All LOIs are required to use Calibri font size 11 and single spacing. Replace the italicized gray and any instructional text with your response. You must retain the bold headings and question numbers 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. Please view the LOI sample template, located in the Applicant Resources of the Funding Center.
Can I change information from my LOI to application?
Yes. However, you 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
If you need to change any of this information or have any questions, email firstname.lastname@example.org. Due to the volume of requests PCORI received, applicants should submit the request early.
PCORI provides templates for certain portions of the application. Do I have to use these templates or may I create my own templates?
PCORI requires applicants to use the templates provided for the current funding cycle. Templates are available in the Funding Center. Please be sure to use the templates for the specific PCORI Funding Announcement (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 are the page-formatting requirements that I should follow when submitting an application?
To complete an application, information is submitted by: entering information into fields within the PCORI Online System, completing and uploading templates provided by PCORI, or creating and uploading documents. Please follow the page-formatting requirements below:
Documents that are uploaded (excluding letters of support) must be formatted as follows:
- Header: Include the Principal Investigator’s (PI’s) full name in the top left corner of the page header.
- 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.
- Page Numbering: Consecutively number each section, starting with page 1 (e.g., Research Strategy 1–20).
- Spacing: Use single spacing.
- Document Format: Upload all attachments in PDF format.
The Application Guidelines and PCORI templates note additional instructions including page or length restrictions, when applicable.
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 our website when awards are announced. This is how information about your proposal will be understood by the general public, and it should describe your study in layman’s terms.
What can be deleted from the Research Strategy Template?
You may delete any instructional text and/or sub-bullets below each section header. For example, you must keep A. Background, B. Significance, etc., but you may remove “Describe the impact of the condition…”
What can be removed from the PCORI templates?
You may delete instructional text boxes, but you must keep each section header.
Can I rearrange the order of questions in each section of the Research Strategy Template?
Yes. You 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 I include the methodology standards in my research strategy?
In the Research Strategy section of the Research Plan Template, you should describe in detail your research strategy and plan, and you should demonstrate how your proposed study is responsive to the PFA. Include the relevant PCORI Methodology Standard citations (e.g., “PC-3”) as identified in the Methodology Report; you should refer to this report for an explanation on each standard. You do not need to list every standard, only standards that are relevant to your proposal.
What should be included for milestones in the Milestones/Deliverables Template?
Milestones described within the Milestones/Deliverables Template should include project objectives and deliverables that will be accomplished at specific times during the proposed project.
What format should be used for milestones on the Milestone Template?
You may fill in the table on the template describing each milestone and its projected completion date; or insert a Gantt chart which shows your project milestones and projected completion dates.
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 the others 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 is required in the Research Team and Environment section of the Research Strategy section of the Research Plan Template?
Describe how the members of your 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.
The Environment section should provide more in-depth detail about the capabilities of these sites. You 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.
What is the difference between the Engagement Plan and the Dissemination and Implementation Assessment section?
The Engagement Plan is designed to capture how you plan to involve patients and stakeholders in your research project, while the Dissemination and Implementation section of your research plan should map how your research results will be shared.
What do I need to include in the Replication and Reproducibility of Research Plan and Data Sharing?
Develop a plan to reproduce potentially important findings from this project in other data sets and populations.
What do I need to include in the Dissemination and Implementation Potential?
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.
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 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.
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, you may use a current NIH Biosketch as a professional profile instead of the PCORI Professional Profile, but it must not exceed five pages.
Can I list a different PI in the application than was listed in the Letter of Intent (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 sciencequestions@pcori org and include a rational for the change, letter of support from the intended PI, and a CV or biosketch for the replacement PI.
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 someone 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.
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 Total Direct Costs section of the PFA. To view a PFA, visit the Funding Center.
Can you provide additional information on the indirect costs and their implications for subcontractors?
A prime applicant may assess its indirect costs on the first $25,000 of total costs (indirect and direct) for all consortiums combined. This is different from the way in which Modified Total Direct Costs are calculated for consortiums. For example, if an applicant has a 40% indirect cost rate and has 10 consortiums totaling $100,000, the maximum indirect cost rate that can be charged to PCORI is $10,000 ($25,000 * 40% = $10,000).
Consortiums may assess their indirect costs on their allowable direct costs in keeping with PCORI budget policies. Each consortium must use their 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 the NIH practice.
My organization or subcontractor has a higher indirect cost rate than PCORI allows. Can I use our rate?
No. If your indirect cost rate is higher than PCORI’s indirect cost rate limit, you must use the 40 percent indirect cost rate. Additionally, if your organization has a federally negotiated or independently audited rate below 40 percent, your organization must use the federally negotiated rate.
If my institution does not have a federally negotiated rate or independently audited rate, can I still request indirect costs?
Yes. You may request indirect costs, but you may only request up to 10 percent. You must note this indirect cost rate in your Budget Justification.
What do I do if there is not enough room to include all of the necessary individuals in the Key Personnel section of the Budget Detail form?
You may insert as many additional rows as necessary.
If travel is required for my 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 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. I make $250,000, so can I charge $200,000 to the contract at 80 percent of my time?
No. You must use no more than the maximum allowed salary amount as the base for calculating the amount of your salary request. For example, if your base salary is $250,000 and you will work on the project 80 percent of the year, then you may only charge $160,000 to the PCORI project.
Is there a cap on the allowable fringe rate?
No. There is no cap on the allowable fringe rate. You should use your organization’s fringe rate policy, and you must include this policy document with your other budget documents.
Can I include cost-of-living adjustments in my budget?
Yes. You may include adjustments for inflation in your Detailed Budget.
Can tuition costs be included in the budget?
No. Please do not include tuition costs in your budget; however, a student hired by the institution may have his or her salary/wage paid through the PCORI contract.
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 your budget and provide justification. If your 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 Institutional Review Board approval?
Yes. PCORI will allow this expense as an indirect cost, not as a direct cost to the program.
Does PCORI require a Data Safety Monitoring Board (DSMB) for their projects?
PCORI will review this on a case-by-case basis. If you feel that a DSMB should be provided for your project, please include this in your proposed budget and, if meritorious, PCORI will work with you once the project is awarded to set up a DSMB.
We would like to set up a DSMB for our clinical trial. Will PCORI establish a DSMB for the study?
PCORI does not require establishing a DSMB and will not convene one on behalf of the study.
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 “PI and Contact Information” section of the application in PCORI Online, select the name of your AO from the “Administrative Official” dropdown menu. If the name does not appear in the dropdown, click “Add New” and fill out the appropriate information. A login will be created for this individual and they will be sent a notification that an account has been created. If you receive an error message stating that the AO is already in PCORI Online but you do not see their name, please contact email@example.com and provide the AO’s name and email address.
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 to AO,” 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 and clicks “Submit,” a notification that the application has been submitted to PCORI is sent to the PI and the AO. After the AO submits the application, the application is moved into the programmatic 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 “Send Back to PI” button. The AO will need to notify the PI that an action is required on their part.
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 Review Funding Applications 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 not discussed during the in-person phase, you will not receive an 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 overall score and discussion notes from the panel discussion on 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 overall score for my application calculated?
The overall score is the final average score the application received if your application moved forward to the in-person discussion. The four 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.
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: November 12, 2015