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Applicant 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.
Supplemental Funding for Existing PCORI-funded Comparative Clinical Effectiveness Research to Improve Understanding of Patient-Centered Economic Outcomes
- What does "awardees are encouraged to think about analysis that explores these factors in some depth, while avoiding aggregating or comparing total costs of care" mean?
- What is meant by "analyses that focus on a cost comparison to determine (or that could be interpreted as determining) a preferred intervention?"
- What are "total cost comparisons, cost-effectiveness analysis (CEA) or related types of economic evaluation?"
- What "social risk factors and/or social determinants of health on costs and other economic burdens incurred by patients, caregivers and other stakeholders" are acceptable?
- What is meant by “perspectives” in "Analysis should synthesize findings of costs and other economic burdens from the perspectives of the different stakeholders for whom such data are proposed to be collected as part of the supplement?"
- I do not have the ability to measure costs incurred by stakeholders besides patients or caregivers. Do I qualify?
Supplemental Funding for Existing PCORI-funded Comparative Clinical Effectiveness Research to Increase Diversity and/or Advance Health Equity
- Does diversity only include race and ethnicity?
- Does the supplement require that my study be powered for heterogeneity of treatment effects (HTE)?
- Can I add a new site to assist with increasing the diversity of the sample?
- May supplement funds be used to hire additional investigators or staff?
- May supplement funds be used for incentives or bonuses for sites that meet their diversity enrollment targets?
- May supplement funds be used to create and distribute additional promotional materials or for translation purposes?
Brief Interventions for Adolescent Alcohol Use - Cycle 1 2023
- 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?
Broad Pragmatic Studies - 2023
- What are the National Priorities for Health?
- What is the difference between the 2012 National Priorities for Research versus the 2021 National Priorities for Health?
- How do I determine to which National Priority for Health my research best aligns?
- What is the difference between PCORI’s National Priority Areas for Health, eight topic themes, and the four ongoing key topics identified within the BPS PFA?
- My proposed research does not align with one of the eight topic themes. Can I still apply to the 2023 BPS PFA?
- What is a Key Topic? If my proposed research does not align with one of the four Key Topics, can I still apply to the 2023 BPS PFA?
Prevention, Early Identification & Treatment of Delirium - Cycle 1 2023
- What Is PCORI’s Policy for Data Management and Data Sharing and How Does It Apply to This PFA?
- 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?
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?
Open Competition PFA: Implementation of Findings from PCORI's Research Investments
- Who is eligible to apply for the Open Competition PCORI Funding Announcement: Implementation of Findings from PCORI's Research Investments?
- 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?
- What is the resubmission policy for the Open Competition: Implementation of Findings from PCORI’s Research Investments PFA?
- Is Institutional Review Board (IRB) approval necessary before applicants are notified if the project has been funded?
Implementation: Limited Competition PCORI Funding Announcement
- Can I apply for a Dissemination Award and Implementation Award at the same time?
- 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?
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?
Partnering Research and Community Organizations for Novel Health Equity Research: Addressing Health Systems Factors and Social Determinants of Maternal Health - 2023 Cycle 1
- 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?
- Would a pediatric health intervention be considered to meet the setting requirement?
- Is it acceptable to include health systems in one state? The health systems span the state, and the patient populations are heterogenous.
- Which patient populations are eligible for studies/being targeted by this funding announcement?
Science of Engagement
- Is it required for Science of Engagement research projects to conduct comparative clinical effectiveness research (CER) or can they propose to study appropriate practices and measurements of research engagement?
- What is the range of measures PCORI is interested in receiving?
- Do you have LOI and proposal templates available for this funding announcement? Should I use templates from other funding announcements to prepare?
- Is PCORI planning to award one applicant up to $4.5 million or will all funded SoE projects this cycle total up to $4.5 million, splitting the amount by the number of projects that are funded?
- Can an Science of Engagement project be embedded within an existing funded project (e.g., NIH or PCORI)?
- If we have already developed a tool with only preliminary data collected thus far, can we apply to validate this tool in partnership with community partners?
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?
Collecting Data on Costs and Economic Burdens
- 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?
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 the difference between a protocol and the PCORI Research Plan?
- 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?
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
- 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?
Healthy Aging: Optimizing Physical and Mental Functioning Across the Aging Continuum – 2022 Cycle 3
- What intervention settings are allowable under this funding announcement?
- What is meant by an institutional setting?
- What do you mean by multisite?
- Are foreign institutions eligible to directly apply for funding?
- 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?
Comparative Effectiveness of Multimodal Interventions to Prevent Osteoporotic Fractures – 2022 Cycle 3
- 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 should be included?
- Is an Engagement Plan required for this PFA?
Telehealth to Optimize Management of Multiple Chronic Conditions among Vulnerable Populations in Primary Care - 2022 Cycle 3
- May I Contact Someone At PCORI About The Suitability Of My Proposed Project?
- What Are The Differences Between “Category 1” And “Category 2”?
- Are There Additional Requirements For Category 2 LOIs and Applications?
- My 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?
- 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?
- Will PCORI Allow Potential Funding Support of Patient Care Costs For this PFA?
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?
Health System Strategies for Hypertension Control and Management - Cycle 2 2022
- 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?
- Do treatments and interventions need to be FDA approved?
Brief Interventions for Adolescent Alcohol Use - Cycle 1 2022
- Does PCORI have guidance on stakeholder engagement with minors?
- Will studies that include a community health worker and/or patient navigator be considered unresponsive?
- Do interventions in school settings need to be delivered by school nurses?
- What is considered a “brief” intervention?
- Which intervention settings are allowable under this funding announcement?
- What does it mean to be a multisite study?
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?
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
- What intervention settings are allowable under this funding announcement?
- What does it mean to be multisite?
- Are foreign institutions eligible to directly apply for funding?
- 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 this funding announcement targeting?
Comparative Effectiveness of Multimodal Intervention to Prevent Osteoporotic Fractures FAQs - Cycle 3 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 should be included?
- Is an Engagement Plan required for this PFA?
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?
Improving Postpartum Maternal Outcomes for Populations Experiencing Disparities PFA-specific FAQs - Cycle 2 2021
- What is considered a resubmission?
- Should interventions focus only on the postpartum period?
- Can interventions focus on mental and behavioral health?
- Budgets can be up to $5M for small studies, and up to $15M for large studies. What is considered a small study?
- Is PCORI interested in studies that address questions about conditions that lead to high costs to individuals or society?
- Does PCORI cover intervention costs?
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
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?
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?