Patient-Centered Outcomes Research InstituteApplicant FAQs
Applying to PCORI? Please review information in this section if you are submitting a letter of intent, full application, or if you have already applied for funding.
Broad Pragmatic Studies
- My research includes an evidence-based intervention that has demonstrated efficacy in a general population but lacks evidence for effectiveness in populations at risk for disparities. Can I tailor/test these types of interventions under my PCORI award?
- My BPS LOI was accepted and I was invited to submit my application under Category 1 (proposed budget less than or equal to $5 million); however, our proposed budget increased in preparing our application. Can I submit my full application under Category 2?
- Why did the Broad PFA and Pragmatic Clinical Studies (PCS) PFA merge into the Broad Pragmatic Studies (BPS) PFA?
- Will the BPS PFA be reissued in future funding cycles?
- What are the differences between “Category 1” and “Category 2” in the BPS PFA?
- Are there additional requirements for Category 2 LOIs/Applications?
About PCORI
Who Can Apply?
- What's the difference between a Co-PI and Dual PI?
- Can a Principal Investigator (PI) submit more than one Letter of Intent (LOI) per PCORI Funding Announcement (PFA)?
- Are foreign organizations allowed to be included as subcontractors for PCORI awards?
- Who is eligible to apply for PCORI funding?
- Are foreign organizations eligible for funding?
- Do you have to be partnered with an academic institution to apply?
Research We Fund
- What research does PCORI fund?
- What types of studies of interventions is PCORI interested in?
- What are patient-centered outcomes research (PCOR) features that PCORI funds?
- How does PCOR relate to comparative effectiveness research (CER) and does PCORI fund CER?
- What research does PCORI NOT fund?
- If an applicant receives a National Institutes of Health (NIH) K Award, is he or she still qualified to receive PCORI funding?
Cost and Cost-Effectiveness Analysis
- What is PCORI’s official policy on cost and cost-effectiveness analysis?
- What is the difference between cost-effectiveness analysis and cost analysis?
- 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?
- Will a proposal that includes a cost-effectiveness analysis as a secondary aim be deemed nonresponsive?
- Can an applicant resubmit a proposal for another cycle after removing the cost-effectiveness analysis? If so, should the Letter of Intent be resubmitted?
Engagement
- What is the difference between patients and other stakeholders?
- Can a patient advocacy organization provide patient perspectives?
- Can a person play more than one role on a team—for example, as both a stakeholder and a researcher?
- Can minors be involved as patient partners in health research?
- How many patient and stakeholder partners need to be involved in my study?
- Is there a particular work title and description for patient and stakeholder partners that we should use?
Letter of Intent
- Do I need to include the names of all key personnel in the LOI?
- Do you expect partnerships to be established by the time of LOI submission?
- Do I need to submit biosketches with my LOI?
- How will LOIs be evaluated?
- Is it possible to submit an application without submitting the LOI?
- How many pages is required for the Broad PFA LOI submission? Can a PI add additional information?
Using the PCORI Online System
- Is the PCORI contract system linked to eRA Commons?
- Whom can I contact for technical assistance when using PCORI Online?
- My PCORI Online account is locked. How do I get back in?
- PCORI Online displays that my login ID does not exist when I try to log in. What do I do?
- How do I access my LOI number?
- My organization is not listed as an option on the registration screen. What should I do?
What to Include in the Application
- What is PCORI’s stance on use of a single or central Institutional Review Board (IRB)?
- Does my application need to address information related to participant randomization, retention, or attrition?
- What information related to recruitment should I include in my research proposal?
- How is application information submitted using PCORI Online?
- 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?
- Are preliminary results or pilot studies required to have a successful application? To what extent is it acceptable to propose engagement and/or designs without any prior history?
Budgeting
- Does PCORI allow both a fixed-fee budget and a capitated budget?
- How do I calculate indirect costs?
- Can I use my PCORI award to pay for a work Visa?
- Can I use my PCORI award to pay for travel costs?
- Does PCORI pay for the cost of interventions being compared in the studies it funds?
- Can patient partners serve as DSMB members?
Role of the Administrative Official
- What are the responsibilities of the Administrative Official (AO)?
- Can a Principal Investigator (PI) serve as the AO?
- How do I add an AO to my application?
- 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?
- To what terms and conditions must the AO agree before approving the application?
- Can the application be sent back to the PI if the AO identifies a problem?
Merit Review Process
- Whom should I contact if I have questions or concerns regarding information provided in my summary statement?
- How was the scoring quartile for my application calculated?
- What information is included in my summary statement?
- When will I receive my summary statement?
- How was the average overall score for my application calculated?
- Will I receive a score if my application was discussed?
Post-Award Process
- How are award announcements made?
- When are recipients of PCORI funding able to start incurring costs for their project?
- Are there any guidelines about when a project can start?
- Can an award be transferred from one organization to another?
- Is an awardee receiving PCORI funding subject to federal audit requirements in relation to that particular PCORI award?
- How are award announcements made?
Fast-Track Resubmission Process
- What is the Fast Track Resubmission pilot and how are applications selected to participate?
- If an application is selected to participate in the Fast-Track Resubmission pilot, is it still under consideration for funding for the original funding cycle to which it was submitted?
- If an application is invited to be submitted through the Fast-Track Resubmission pilot, is it required to be re-submitted?
- Can Fast-Track Resubmission offers be deferred to another cycle?
- If the Fast-Track Resubmission invitation is accepted, does the investigator upload the same application materials again to PCORI Online?
- If a Fast-Track Resubmission invitation is received, when is it possible to speak with a Program Officer about the summary statement for the original application?
Brief Interventions for Adolescent Alcohol Use - Cycle 1 2022
- Which intervention settings are allowable under this funding announcement?
- What does it mean to be a multisite study?
- Do applicants need to confirm all study sites by the time of Letter of Intent (LOI) submission, including sites in a multisite study?
- Who should be eligible for my proposed study?
- Which populations are being targeted by this funding announcement?
- Which interventions are eligible?
Prevention, Early Identification & Treatment of Delirium - Cycle 1 2022
- What intervention settings are allowable under this funding announcement?
- What does it mean to be multisite?
- Do applicants need to confirm all study sites by the time of Letter of Intent (LOI) submission?
- Must all sites in a multisite study be identified by the time of application submission, or can they be identified later in the study?
- Which populations are being targeted in this funding announcement?
- Are adults with intellectual, developmental, or other related disabilities an eligible population?
Comparative Effectiveness of Interventions Targeting Mental Health Conditions in Individuals with Intellectual and Developmental Disabilities PFA Specific FAQs - Cycle 1 2022
- If the proposed study involves IDD populations who cannot self-report, such as individuals with limited communication, will PCORI accept outcome measures that parents and/or legal guardians have identified as important?
- Is PCORI Seeking to fund observational studies for this tPFA?
- How does a request for PCORI coverage of patient care costs affect review of Letters of Intent for this tPFA?
- Are there any limits to the amount of patient care costs that can be proposed for coverage under the this tPFA?
- What study intervention costs can be proposed for PCORI funding support?
- Will exceptions be considered for proposed studies longer than the 3-year study duration?
Improving Methods for Conducting Patient-Centered Outcomes Research
- How should applicants indicate how and where the Research Plan adheres to each of the Methodology Standards?
- How should applicants complete the Engagement Plan in the Research Plan?
- What is the Methods program general policy with regard to engagement in proposals?
- Does the Methods PFA require applicants to complete the Engagement Template?
- What is the Methods PFA's general policy about funding disease-specific proposals for instrument development or validation?
- Are applications submitted in response to the Methods PFA required to include a comparative component?
Implementation: Limited Competition PCORI Funding Announcement
- Who is eligible to apply for implementation funding?
- When will applicants be eligible to apply for D&I funding?
- Does the Principal Investigator (PI) of the original PCORI research study have to be the PI of the implementation project?
- Is there a minimum qualification for a Principal Investigator?
- Can I submit an application to implement results that are not from a PCORI funded award?
- Can I submit an application in collaboration with another investigator at another institution?
Implementation of Effective Shared Decision Making Approaches in Practice Settings PFA
- Who is eligible to apply for the Implementation of Effective Shared Decision Making Approaches in Practice Settings funding announcement?
- When will applicants be eligible to apply for SDM funding?
- Does the PI of the original PCORI-funded research study have to be the PI of the implementation project?
- Are there minimum qualifications for a PI and the study team?
- Can I submit an application to implement results that are not from a PCORI-funded award?
- Is there a list of PCORI-funded research projects that have submitted their DFRRs to PCORI?
Implementation of Findings from PCORI’s Major Research Investments PFA
- Who is eligible to apply for the Implementation of Findings from PCORI’s Major Research Investments (IMRI) PFA?
- Is there a minimum qualification for a PI?
- Can I submit an application to implement results that are not from a PCORI-funded award?
- If I submit an LOI and fail to submit an application, will I be penalized or prevented from applying in a future funding cycle?
- Is Institutional Review Board (IRB) approval necessary before applicants are notified if the project has been funded?
- What types of implementation projects is PCORI interested in for the Implementation of Findings from PCORI’s Major Research Investment PFA?
Comparative Effectiveness of Novel Pharmacologic and Evidence-based Nonpharmacologic Treatments for Migraine Prevention PFA - Cycle 3 2021
- Are comparators aimed at preventing associated symptoms of migraines (such as recurrent gastrointestinal disturbance, benign paroxysmal vertigo, and benign paroxysmal torticollis) considered appropriate and responsive to this funding opportunity?
- Are supplements and nutraceuticals "novel" pharmacological interventions?
- Does PCORI consider cannabis a "novel" pharmacologic intervention?
- May I propose a pharmacological intervention that is not FDA approved, such as off-label drug use in pediatric population?
- Will this funding opportunity accept proposals aiming to develop phone apps, instruments, etc., for the prevention of migraines?
- Is the Migraine funding opportunity only interested in CGRP comparisons?
Healthy Aging: Optimizing Physical and Mental Functioning Across the Aging Continuum - Cycle 3 2021
- Can studies include non-clinical outcomes, such as self-efficacy and patient activation, as primary outcomes?
- What is the maximum research project duration and the maximum project budget?
- What is the required length of the LOI for this PFA?
- Does PCORI provide support in finding patient advocates or groups?
- Will PCORI be open to covering any intervention costs in the budget?
- Do the interventions to be compared need to be currently reimbursable?
Comparative Effectiveness of Multimodal Intervention to Prevent Osteoporotic Fractures FAQs - Cycle 3 2021
- Would a comparison of multi-component intervention to a single component intervention be acceptable?
- What aspects of the study should include stakeholder input?
- Should applicants involve actual patients as partners in our project or would partnership with an advocacy group, not a specifically identified patient, be sufficient?
- What stakeholders should our team engage as we plan and conduct our study?
- Is an Engagement Plan required for this PFA?
- What outcomes should be included?
Phased Large Awards for Comparative Effectiveness Research PFA - Cycle 3 2021
- What if some projected research costs for my PLACER submission are not covered by PCORI or they exceed the PLACER funding cap?
- Is a feasibility phase required for PLACER awards?
- I have questions about the suitability of my research project for this PFA. May I speak with a PCORI staff person?
- Under one PLACER award, are multiple RCTs allowed, similar to the program project/center grants used by NIH to establish large, multi-project efforts including a diverse array of research studies?
- How many co-PIs are acceptable? Could there be three, including two co-PIs who are running the clinical trial plus one co-PI who represents the DCC?
- Can a Stakeholder serve as a Dual-PI for awards under the PLACER PFA?
Expedited COVID-19 Targeted PFA - Cycle 2 2021
- What is the due date for the application?
- Will there be a due date extension?
- When will we be notified if we are invited to the application consultation phase?
- Are there specific requirements for the length of the project?
- Is there a budget limit?
- Will PCORI consider submissions on a smaller scale?
Improving Postpartum Maternal Outcomes for Populations Experiencing Disparities PFA-specific FAQs - Cycle 2 2021
- Does PCORI cover intervention costs?
- Is PCORI interested in studies that address questions about conditions that lead to high costs to individuals or society?
- Budgets can be up to $5M for small studies, and up to $15M for large studies. What is considered a small study?
- Can interventions focus on mental and behavioral health?
- Should interventions focus only on the postpartum period?
Nonsurgical Options for Women with Urinary Incontinence PFA-specific FAQs - Cycle 2 2021
- What types of research designs are applicable for this PCORI Funding Announcement (PFA)?
- If an observational study is proposed, can the proposed analysis plan use both retrospective data and prospective data?
- What interventions are eligible?
- Will PCORI pay for the cost of delivering interventions if they are not currently covered by insurance?
- What outcomes will we be required to add to our study if funded?
- Is an Engagement Plan required for this PFA?
PCORnet, The National Patient-Centered Clinical Research Network – Phase 3 - Cycle 2 2021
PCORnet Phase 3 PFA - Cycle 1 2021
Suicide Prevention: Brief Interventions for Youth - 2020 Cycle 3
COVID-19 Targeted PFA - Cycle 2 2020
- Is there a Letter of Intent (LOI) requirement for this PFA?
- What are the required application templates?
- How do you partner with PCORnet?
- Can the trial partner be a federal agency?
- Are patients from other countries allowed to participate in the study?
- Can an organization submit more than one application for the COVID-19 PFA?
Observational Analyses of Second-Line Pharmacological Agents in Type 2 Diabetes - Cycle 2 2020
- How should I handle elements of the Research Plan Template (e.g. the Recruitment Plan for Prospective Studies) that are not applicable to my proposed study design?
- What aspects of the study should include stakeholder input?
- Should applicants involve actual patients as partners in our project or would partnership with an advocacy group, not a specifically identified patient, be sufficient?
- What stakeholders should our team engage as we plan and conduct our study?
- Is an Engagement Plan required for this PFA?
- Can additional primary outcomes beyond 3-point MACE be included in studies funded through this announcement?
Limited Competition: Conducting Rare Disease Research Using PCORnet - Cycle 2 2020
- Can an institution that is not a network partner within PCORnet serve as the prime contractor for this award?
- Can an institution that is not a network partner in PCORnet serve as a subcontracting site for the conduct of the study?
- How can individuals/organizations interested in rare disease research find network partners within PCORnet to collaborate with for this award?
- Can a Clinical Research Network, Health Plan Research Network, or PCORnet network partner submit more than one LOI?
- How does PCORI define Rare Disease?
- Will PCORI consider applications that address a rare disease population already included in the PCORI research portfolio?
Rare Disease Research
- How does PCORI define rare disease?
- What type of rare disease research will PCORI fund?
- Does PCORI have a special interest in any rare disease subcategories (e.g., acquired adult diseases or inherited pediatric diseases)?
- Does PCORI offer funding opportunities to support a pre-existing rare disease registry, or the development of a rare disease registry?
- Does PCORI only fund projects that have a broad impact? Would PCORI consider research in a rare disease to have a broad impact?
- Will PCORI consider funding a rare disease study that includes a usual care group?
Treatment Options for Age-Related Hearing Loss PFA
- Does PCORI fund the cost of interventions including hearing devices?
- Can investigators include the cost of reimbursing patients for their participation in the study?
- Can a clinical partner delivering clinical services in the study be reimbursed for other roles in the study?
- Will PCORI allow investigators to propose the use of newly approved devices such as hearing aids?
- Can an investigator serve as Principal Investigator for an LOI and participate as key personnel (e.g., co-Investigator or subcontractor) on a second LOI for this PFA?
- Can foreign organizations submit an LOI in response to this PFA?
Partnerships to Conduct Research within PCORnet (PaCR) - Cycle 1 2019
- Can an institution within a CRN or HPRN that is NOT the Prime, be the Prime for this Award?
- Can a CRN or HPRN submit only one LOI, or is there a possibility to submit more than one LOI?
- Can you explain the dual PI role?
- Does the PI need to be one of the current PIs of the existing CRN or HPRN?
- Are you considering the contribution from other funders as part of the $2M in direct costs?
- How binding is the LOI budget given the short timeline? Are we going to be held to the budgets, and the justification in the LOI, or is that going to be a bit fluid for the full application?
Medication-Assisted Treatment (MAT) Delivery for Pregnant Women with Opioid Use Disorders (OUD) PFA
- Is there a minimum amount on the awards that will be issued? Does PCORI support focused projects that request a lower amount of funding?
- What is PCORI's definition of a healthcare system in relation to this funding announcement?
- Is this a one-time only funding announcement?
- Where should the study take place?
- What is the minimum recommended sample size for this PFA?
- Does this PFA support cost-effectiveness analysis?
Psychosocial Interventions with Office-Based Opioid Treatment for Opioid Use Disorder PFA
Symptom Management for Patients with Advanced Illness PFA
- Are complementary therapies considered acceptable for this PFA?
- Does PCORI provide salary support for patients/stakeholders who are part of the study team?
- Does the funding cover costs for interventions and associated patient care costs?
- Does the $2 million include PCORI's indirect cost rate?
- Are insurers or payers considered acceptable partners?
- How are engagement efforts best described in an application?
Pragmatic Clinical Studies to Evaluate Patient Centered Outcomes
- Will the PCS PFA be issued again during Cycle 3 2021?
- Will PCORI allow potential funding support of patient care costs for future cycles of the Pragmatic Clinical Studies Funding Opportunity or for its other funding opportunities?
- How does a request for PCORI coverage of patient care costs affect review of Letters of Intent for the Cycle 1 2021 PCS PFA?
- Are there any limits to the amount of patient care costs that can be proposed for coverage under the Cycle 1 2021 PCS PFA?
- What study intervention costs can be proposed for PCORI funding support?
- I submitted a prior PCS application. Would my Cycle 1 2021 submission be considered a resubmission?
Patient-Powered Research Network (PPRN) Research Demonstration Project
Treatment of Multiple Sclerosis PFA - Cycle 3 2015
- May I contact someone at PCORI about the suitability of my proposed project?
- What types of costs will PCORI cover?
- What are PCORI’s guidelines for treatment cost/coverage?
- How should the proposal address patient and stakeholder engagement?
- Should I include references in my LOI?
- How will LOIs be evaluated?
Clinical Strategies for Managing and Reducing Long-Term Opioid Use for Chronic Pain
- What should I do to complete an LOI, and where can I find it?
- We have received a number of questions about the Study Advisory Committee (SAC) requirement in the targeted and pragmatic PFAs for Cycle 3 2015, and how this requirement should be managed. See below for more information.
- What do you mean by “powering the study for subgroups of interest”?
- Although Letters of Support are not required at the LOI stage, do applicants need to confirm all study sites, especially if one is choosing between a few but needs to be more time regarding visibility and buy-in?
- Medical side effects of treatment are listed as a potential key outcome. Does this mean side effects of the comparators being evaluated or does it mean side effects of opioid therapy?
- What types of observation studies PCORI would be interested in for this PFA?
Management Strategies for Treatment-Resistant Depression - Cycle 3 2015
- Is this a one-time solicitation?
- We have received a number of questions about the Study Advisory Committee (SAC) requirement in the targeted and pragmatic PFAs for Cycle 3 2015, and how this requirement should be managed. See below for more information.
- Can an organization submit more than one LOI for this PFA?
- Is PCORI interested in only the specific subgroups listed within this PFA?
- Is it a requirement that the treatment arms compare augmentation to switching?
- How is “adequate course of antidepressant treatment” defined?
New Oral Anticoagulants (NOACs) in the Extended Treatment of Venous Thromboembolic Disease - Cycle 3 2015
- We have received a number of questions about the Study Advisory Committee (SAC) requirement in the targeted and pragmatic PFAs for Cycle 3 2015, and how this requirement should be managed. See below for more information.
- Can an organization submit more than one LOI for this NOACs PFA?
- For a study comparing health system–level interventions where the primary analyses are patient-centered outcomes, can funding be used to conduct secondary analyses of economic impacts?
- What do you mean by “powering the study for subgroups of interest”?
- Will an interaction test be less powerful than subgroup-specific tests? If you can demonstrate that an intervention can work in a variety of subgroups, is it required to demonstrate how those effects differ between subgroups?
- Would financial incentives to patients to increase medication adherence be an appropriate comparison intervention?
Partnerships to Conduct Research (PaCR) within PCORnet PFA - Cycle 2 2017
- One of the key requirements for the PFA is partner funding. I did not see a place in the LOI to discuss partner funding outside of "proposed partnerships".
- Are you flexible about the period of performance?
- What is the review criteria for the LOIs?
- For the LOI review process, will reviewers be familiar with PCORnet?
- What is the format for submission of the LOI and the full application?
- What if the co-funders were interested in long-term outcomes, and were prepared to pay for this study to extend beyond the PCORI-funded period which might provide the ability to get short-term outcomes?
Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain – Cycle 1 2017 PFA
- The PFA states that applications will be considered nonresponsive if the proposed research evaluates new or existing decision-support tools. Is it permissible to include such tools as part of an intervention package?
- Please distinguish between "sequence of care" and "stepped care.” Does PCORI view these as synonymous?
- The PFA specifies that multidisciplinary interventions must include “two or more disciplines who deliver care in a coordinated fashion.” Are any specific disciplines required for inclusion in each multidisciplinary intervention (e.g., physicians)?
- How is “sequenced intervention” being defined?
- This PFA allows for comparison of sequenced or combination multidisciplinary interventions. Is there a preference for either type over the other?
- Will nonrandomized controlled trials be considered if a strong rationale and alternative model for comparison are submitted?
Strategies to Prevent Unsafe Opioid Prescribing in Primary Care among Patients with Acute or Chronic Noncancer Pain – Cycle 2 2017
- What do you mean by “powering the study for subgroups of interest”?
- Although Letters of Support are not required at the LOI stage, do applicants need to confirm all study sites, especially if one is choosing between a few but needs to have more time regarding visibility and buy-in?
- Medical side effects of treatment are listed as a potential key outcome. Does this mean side effects of the comparators being evaluated, or does it mean side effects of opioid therapy?
- What types of observational studies would PCORI be interested in for this PFA?
- If the strategy we are evaluating includes multiple components (e.g., profiling and educational interventions and expansion of services), is it responsive to the first research question if it also includes an element of shared decision making?
- What is considered to be in "widespread use"?
Multidisciplinary Treatments Low Back Pain PFA - Cycle 1 2017
- The PFA states that applications will be considered nonresponsive if the proposed research evaluates new or existing decision-support tools. Is it permissible to include such tools as part of an intervention package?
- Please distinguish between "sequence of care" and "stepped care.” Does PCORI view these as synonymous?
- The PFA specifies that multidisciplinary interventions must include “two or more disciplines who deliver care in a coordinated fashion.” Are any specific disciplines required for inclusion in each multidisciplinary intervention (e.g., physicians)?
- How is “sequenced intervention” being defined?
- This PFA allows for comparison of sequenced or combination multidisciplinary interventions. Is there a preference for either type over the other?
- Will nonrandomized controlled trials be considered if a strong rationale and alternative model for comparison are submitted?
Comparison of Surgical and Nonsurgical Options for Management of Chronic Nonspecific Low Back Pain - Cycle 1 2017
- How much variation in the non-surgical care is acceptable? Can different study sites use different approaches to non-surgical care? How should applicants approach the issue of fidelity and intensity of the non-surgical care?
- Does PCORI expect the study to have individual randomization of each participant, or could a cluster randomization design be used?
- Should participants be randomized to “lumbar fusion surgery” or to “referral for surgery?”
- Why doesn't this PFA allow comparison of two different surgical interventions? Why doesn’t this PFA allow comparison of two different nonsurgical interventions? Will other PFAs related to this topic be released?
- Lumbar fusion is not recommended for "nonspecific" low back pain—why is this one of the required treatment arms?
- What is meant by “a defined period of standard protocol-driven rehabilitation care before randomization” as discussed in the PFA? How is this different from the comparator arm of the study featuring a multidisciplinary nonsurgical intervention?