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I. General Requirements for Engagement Awards

This section includes language that is specific to PCORI’s requirements for programmatic responsiveness under this funding announcement. Applicants should use this section as guidance when preparing their LOIs and full proposals. For information related to administrative and technical requirements for LOI and full proposal submission, please consult the Engagement Award Submission Instructions.

Engagement Award Priorities

The Engagement Award program supports PCORI’s Engagement Imperative—defined in our Strategic Plan—and provides a platform to increase engagement in research, that is, the meaningful involvement of patients, caregivers, clinicians, and other healthcare stakeholders throughout the research process. We expect projects selected for an Engagement Award to result in tools and resources that may be useful to other awardees for increasing patient and/or other stakeholder engagement in PCOR/CER, PCORI, and the broader PCOR community. We are committed to using and widely sharing this information. Please see the PCORI Engagement Tool and Resource Repository for examples of what this can look like.

Categories of Nonresponsiveness

Applications will be considered nonresponsive for an Engagement Award if they propose:

• Projects solely intended to increase patient engagement in healthcare or healthcare systems rather than healthcare research
• Projects to design or test healthcare interventions
• Activities that involve the use of a drug or medical device
• Development of clinical practice guidelines, care protocols, or decision support tools
• Development of coverage, payment, or policy recommendations or guidelines
• Projects related to quality measures, quality improvement, or engagement around quality measures
• Projects to recruit and enroll patients for clinical trials
• Projects that only involve patients as subjects (individuals enrolled into a study as participants)
• Research studies including randomized controlled trials, observational studies, and pragmatic clinical studies
• Development or maintenance of a registry, or recruitment to participate in a registry
• Projects designed solely to validate tools or instruments not created through a PCORI-funded project
• Writing research proposals or completing grant applications, grantmaking
• Projects focused solely on social determinants of health, with no focus on patient-centered outcomes research/comparative clinical effectiveness research (PCOR/CER)
• Planning for dissemination or dissemination initiatives without including PCORI-funded research or related products
• Implementation of PCORI findings in a clinical practice setting (PCORI funds dedicated implementation efforts through the Limited PCORI Funding Announcement: Implementation of PCORI-Funded Patient-Centered Outcomes Research Results.)
• Projects or meetings without a clear focus on patient-centered outcomes research/comparative clinical effectiveness research (PCOR/CER)
• Engaging in any activities that are for the purpose of directly or indirectly influencing any federal, state, or local laws, regulations, judicial decisions, or the like including, preparation or planning activities, research, and other background work related to or in contemplation of lobbying activities

Avoiding Redundancy

PCORI encourages potential applicants to review funded projects at pcori.org. We intend to balance our funded portfolio to achieve synergy and avoid redundancy where possible.

Required Education of Key Personnel on the Protection of Human Subject Participants

PCORI requires that all applicants adhere to the National Institutes of Health (NIH) policy on education in the protection of human subject participants. This applies to all individuals listed as key personnel in the application. The policy and frequently asked questions (FAQs) are available on the NIH website.

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II. Capacity Building

The Engagement Awards program is now accepting LOIs for the Engagement Award: Capacity Building, a research support funding opportunity, for projects up to two years in duration, and up to $250,000 in total costs. This program does not fund research studies.

• For the October 2021 Engagement Awards funding cycle, the contract start date should be planned for no earlier than June 1, 2022, and no later than November 1, 2022.

Funding Priorities

This funding announcement offers an opportunity for organizations and community groups to build capacity and skills for patient-centered outcomes research and comparative clinical effectiveness research (PCOR/CER). PCORI is receptive to applications to the Engagement Award: Capacity Building encompassing a wide range of research support project topics.

In the context of the Engagement Awards program, capacity building to support research refers to the following types of projects:

• Projects that support organizations with strong ties to patients, caregivers, clinicians, and/or other stakeholders who have a connection to, expertise in, or lived experience related to the focus area to equip them to engage as partners in PCOR/CER. These projects will focus on building the knowledge, competencies, and abilities of their community to be meaningful partners with researchers throughout the research process from topic selection through design and conduct of research to dissemination or implementation of results.
  • Activities might include, but are not limited to, educating and training patients and/or stakeholders on the fundamentals of PCOR/CER; establishing a sustainable collaborative or learning community; engaging patients and/or stakeholders to identify important patient-centered outcomes, prioritize PCOR/CER topics or themes, and/or develop a research agenda; capturing patient and/or stakeholder perspectives on emerging PCOR/CER needs and barriers/facilitators to patient-centered research.
  • Applicants may wish to consider utilizing PCORI’s Research Fundamentals, a free, on-demand, comprehensive training that offers different ways to learn about the health research process and be involved in patient-centered outcomes research.
• Projects that strengthen the skills of researchers to be better partners with patients and other stakeholders involved in PCOR/CER.
  • Applicants must clearly explain how the capacity that is developed through an award will be applied to existing or planned PCOR/CER partnership opportunities.
• Projects that support the adoption or expansion of existing engagement tools and resources whenever possible, rather than develop new products and tools. Projects may implement available tools, processes, or programs, alone or in combination, in a new population or geographic area—for example, a new network of clinicians, patient advocates, and academic researchers.
  • If this project is using a PCORI-funded engagement tool/resource, applicants should identify the existing engagement tool/resource that this project will be scaling or adopting by listing the: (a) Tool Name, (b) Project Title, (c) Project Lead Name, (d) URL to project page. Applicants will be required to secure a letter of support from the tool/resource originator should a full proposal be invited (see Submitting a Successful Application section for more information).
  • Applicants should identify and describe all tools/trainings/programs that will be used as part of the project, as well as share the evidence base for the resources that will be used.

We expect that projects selected for an Engagement Award will further PCORI’s goals of promoting the relevance of PCOR/CER to target audiences and the uptake of research results by end users. We are committed to using and sharing successful approaches.

The information and learnings generated by Engagement Award projects must be transferrable; they must be of interest or use not just to the applicant organizations but to others doing related work. The learnings and information will be made public so they can have a broader impact. Please see the PCORI Engagement Tool and Resource Repository for examples of what this can look like.

Related Opportunities

For applicants interested in projects focused on building capacity for disseminating and implementing PCORI-funded evidence, or actively disseminating PCORI-funded evidence, please see the Engagement Award: Dissemination Initiative funding opportunity.

For applicants interested primarily in multi-stakeholder convenings, meetings, and conferences that have a focus on, and commitment to, supporting collaboration around PCOR/CER, please see the Engagement Award: Stakeholder Convening Support funding opportunity.

To discuss the funding announcement that best fits your project idea, please email [email protected].

Special Area of Interest: Intellectual and Developmental Disabilities

Please Note: PCORI reminds prospective applicants that special areas of interest exist to encourage submissions on a topic, not to limit submissions to that topic only. PCORI welcomes Engagement Award: Capacity Building LOIs on all topics related to capacity building for PCOR/CER that fall within the guidelines of the program.

PCORI’s reauthorizing legislation in 2019 included two new research priority areas, one of which centers on intellectual and developmental disabilities. This priority area provides more focused support for engaging diverse stakeholders and facilitating patient-centered outcomes research and comparative clinical effectiveness research (PCOR/CER), which are critical for understanding and addressing the needs of those impacted by issues related to this topic. Because of our national priorities, LOIs focused on intellectual and developmental disabilities are of particular interest to PCORI.

For organizations considering applying for an Engagement Award focused on topics related to intellectual and developmental disabilities, please review the information available on the Engagement Awards Special Area of Interest: Intellectual and Developmental Disabilities webpage.

Special Area of Interest: Maternal Morbidity and Mortality

Please Note: PCORI reminds prospective applicants that special areas of interest exist to encourage submissions on a topic, not to limit submissions to that topic only. PCORI welcomes Engagement Award: Capacity Building LOIs on all topics related to capacity building for PCOR/CER that fall within the guidelines of the program.

PCORI’s reauthorizing legislation in 2019 included two new research priority areas, one of which centers on maternal mortality. This priority area provides more focused support for engaging diverse stakeholders and facilitating patient-centered outcomes research and comparative clinical effectiveness research (PCOR/CER), which are critical for understanding and addressing the needs of those impacted by issues related to this topic. Because of our national priorities, LOIs focused on maternal morbidity and mortality are of particular interest to PCORI.

For organizations considering applying for an Engagement Award focused on topics related to maternal morbidity and mortality, please review the information available on the Engagement Awards Special Area of Interest: Maternal Morbidity and Mortality webpage.

Submitting a Successful Application

Applicants must consider the following guidance:

• At this time, PCORI strongly discourages all in-person convening activities and encourages applicants to consider alternative plans for any in-person convening activities within applications for future awards. When submitting a full proposal, the Workplan and Budget Justification applicant templates must include a detailed contingency plan for activities and costs related to travel and in-person meeting should the COVID-19 pandemic interfere with travel-related activities. PCORI expects all applicants to implement the most stringent safety protocols as determined by all applicable public health authorities and state and local guidelines.
  • Please consult PCORI’s Applicant and Awardee FAQs Related to COVID-19 to ensure your proposed project adheres to PCORI’s guidance related to applicant pre-award concerns.
  • PCORI is aware that there is an evolving context around the COVID-19 pandemic. We are committed to working with awardees to adapt projects and processes to the evolving context during this time so that deliverables are implemented fully as per the executed contract.
• If using or adopting a PCORI-funded engagement tool or resource:
  • Include a description of the engagement tool(s) or resource(s) selected and justification for its continued and expanded use. Provide information about prior use or implementation of the tool(s) or resource(s), including any data on its effectiveness to build capacity for patient and stakeholder engagement in PCOR/CER.
  • Secure and provide approval to use and, if applicable, adopt tool(s) and resource(s) from the relevant copyright or other intellectual property rights owner of the tool(s) and/or resource(s) in the form of a written letter of support with the full proposal submission. This will typically be from the awardee institution of the original PCORI award (it is up to the applicant to determine from whom to receive such support). The relevant owner must grant the applicant rights to the engagement tool(s)/resource(s) sufficient to carry out the project.
    • The purpose of this letter to ensure that (1) an applicant will be able to fulfill the proposed project and avoid any roadblocks that may prevent fulfillment, and (2) past PCORI awardees are made aware that their tool/resource is being used in another PCORI project.
    • If an applicant is unable to secure such a letter of support or otherwise receive a preliminary license to the intellectual property, the applicant shall notify PCORI prior to the full proposal submission deadline with a determination as to whether (1) the proposed project must be modified to work without such rights, or (2) the proposed project must be abandoned.
    • All letters of support must be attached to the full proposal and submitted no later than the stated full proposal submission deadline.
    • Any revisions to the proposed project due to failure to secure a letter of support must be completed prior to the stated full proposal submission deadline.
• To ensure a thorough and competitive review process, PCORI strictly enforces the formatting and administrative compliance guidelines outlined in the PFAs, FAQs, and Submission Instructions. Applicants that fail to submit the required documents or comply with formatting and administrative compliance guidelines may be rejected from the review process. All rejection decisions are final.

To be considered responsive, applications must include:

• Rationale that there is a need for additional patient and/or stakeholder capacity to participate in PCOR/CER.
• Demonstration of a clear and direct link to future opportunities for participation in PCOR/CER.
• Intended impact of the proposed project.
• Organization’s relationship to the population and pertinent context of the relationship.
• Organization’s track record in engagement.
• Commitment from the patient and/or stakeholder communities to be involved in the project, and clear patient and/or stakeholder involvement/leadership in all stages of the project from LOI development to dissemination of project results. Letters of support from patient and/or stakeholder communities are strongly encouraged.
• A budget that reflects the time and contributions of all partners, including patients and stakeholders. Fair financial compensation demonstrates that patients, caregivers, and patient/caregiver organizations’ contributions to the project, including related commitments of time and effort, are valuable and valued. (See our Financial Compensation of Partners Framework and Budgeting for Engagement Activities for more information. Though these documents discuss compensation in research, the concepts are relevant for Engagement Award projects.) Budgets should account for all costs associated with proposed activities and note any in-kind support or external funding. Applicants should keep personnel costs (applicant organization/institution staff) below 50 percent of the total project budget. However, higher personnel costs may be considered with strong justification included in application documents.
• Evaluation metrics for assessing the success of engagement strategies.
• Plans for sustainability and next steps after the project period has ended. Future funding from PCORI should not be assumed. If the project does not lend itself to sustained activities after the project period concludes, provide justification.

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III. Project Evaluation

Applicants must include a completed Evaluation Reporting Tool as a deliverable at the end of the project period. The Evaluation Reporting Tool provides a template to collect information about Engagement Awards that can help with evaluation of our portfolio, as well as evaluation of individual projects. This reporting tool should be taken into consideration during proposal development and uploaded at the end of the project period as a final deliverable. Awardees may use a different evaluation framework if there is one that is more aligned with their project proposal, subject to PCORI approval. Applicants adopting such an approach must identify the proposed alternate evaluation framework in their application.

The goal of this reporting tool is to ensure a standard set of reported information for Engagement Awards. Given the difficulty in applying metrics and a standard set of indicators around engagement best practices, this tool provides a baseline of outcomes to report on in Engagement Award projects.

At a minimum, evaluation plans should document the reach (in absolute numbers) of the engagement effort among the targeted end users and settings.

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IV. Review Process

Letters of Intent (LOI) must be submitted by the stated deadline. LOIs will be screened for responsiveness to the call for applications and fit to program goals. PCORI will review LOIs within 60 calendar days of submission.

Full proposal submissions are by invitation only, after review and approval of the LOI, and must be submitted by the stated deadline. PCORI may request additional information from the applicant after the initial review of the full proposal. PCORI aims to provide a final programmatic approval decision on the full proposal, via email, within 90 calendar days of the submission deadline. If the full proposal is programmatically approved, a PCORI staff member will coordinate arrangements to begin budgetary review and contracting negotiations. Typically, contract negotiations take about six-to-eight weeks.

To select high-quality patient-centered projects, PCORI’s Engagement and Contract Management and Administration teams, and internal and external subject-matter experts (as necessary) will review all LOIs and full proposals.

Review Criteria:

1. Program Fit
2. Project Plan and Timeline
3. Qualifications of the Project Lead, Personnel, and Organizational Capabilities
4. Patient and Stakeholder Engagement Plan and Collaborators
5. Past Performance
6. Budget/Cost Proposal

For additional details on the review process, click here.

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V. How to Apply

1. Read the full funding announcement.
2. Follow the process outlined in the Submission Instructions
3. Submit a Letter of Intent.
4. Submit a Full Proposal (if invited)

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VI. Applicant Resources

October 2021 Cycle Resources

• Applicant Webinar: Thursday, August 19, 2021 (Recorded, no registration necessary)
• Applicant Office Hours Session 1: Monday, August 23, 2021, 1-1:30 pm (ET)
• Applicant Office Hours Session 2: Wednesday, September 15, 2021, 1-1:30 pm (ET)
• Submission Instructions

Preparing Your LOI

• Capacity Building PFA (PDF)
• Submission Instructions
• Submission Checklist
• Capacity Building LOI Question Guide
• Applicant FAQs
• PCORI Online: Pre-Award User Guides
• PCORI Online: Pre-Award Cheat Sheet – LOI Submission
• Review Process

Preparing Your Full Proposal

• Capacity Building PFA (PDF)
• Submission Instructions
• Submission Checklist
• Applicant FAQs
• PCORI Online: Pre-Award User Guides
• PCORI Online: Pre-Award Cheat Sheet – Application Submission
• Review Process

Required Full Proposal Templates

• Biosketch Template
• Budget Template (Two-Year Project)
• Budget Justification Template (Two-Year Project)
• Milestone/Deliverable Table Template (Two-Year Project)
• Project Workplan and Timeline (Capacity Building)
• Board of Directors Template

Additional Applicant Resources

• Evaluation Reporting Tool Template (For Awarded Projects)
• Cost Principles: Description of Allowable Direct Costs under a PCORI Award
• Standard Contracts for Engagement Award Projects
• Funded Projects Portfolio: Engagement in Research
• Engagement Tool and Resource Repository
• Research Fundamentals
• Building Effective Multi-Stakeholder Research Teams
• Engagement in Health Research Literature Explorer
• Glossary

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VII. Questions?

If you have any additional questions or would like to schedule a program fit call, please contact PCORI at [email protected] or (202) 370-9312. PCORI will respond within three business days.

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