What is the difference between patients and other stakeholders? 

PCORI defines “patients” as a) persons with a current or past illness or injury diagnosis, or at high risk for a condition (for studies focused on prevention); b) family members or people who provide support as unpaid caregivers; or c) members of advocacy organizations representing patients or caregivers. These are the stakeholders who bring lived experience to the research table. PCORI uses the terms patients, patient stakeholders and patient partners interchangeably. Other stakeholder partners are professional representatives of the health ecosystem. They include clinicians/clinical staff, purchasers, payers, industry, hospitals and health systems, policy makers and training institutions, as well as other organizations or sectors appropriate for a particular topic and/or population. Learn more here.

Can a patient advocacy organization provide patient perspectives?

Yes. Patient advocacy organizations often play a valuable role as partners and can bring a broader range of patient perspectives to the study. If individual patients or caregivers aren’t included and an organization is the sole representative partner, this should be explained in your application. Many studies involve patients, caregivers and patient advocacy organizations.

Can a person play more than one role on a team — for example, as both a stakeholder and a researcher?

Yes. PCORI recognizes that people often identify with more than one role based on a combination of personal and professional experiences. For example, a researcher might also be a practicing medical professional, so they may serve as a clinical advisor on the study in addition to their investigative role. Similarly, someone with lived experience of the condition under study might also work in health care or research and can bring these different perspectives. Documentation of roles and responsibilities for stakeholder and patient partners can help designate what perspective they are adding to the study team; if the partner has dual roles, their primary role should be noted. Keep in mind that perspectives are products of one’s experience and environment, so it is important to include patient partners who work outside of the healthcare and research system. 

Can minors be involved as patient partners in health research? 

Yes. If children or youth are the study population, you should seek ways to involve them along with their parents or guardians. You may also include young adults who experienced the condition as a minor. The proposed engagement activity should be appropriate for their age and condition. For ideas on how to involve children and youth, you may search the PCORI Engagement in Health Research Literature Explorer and PCORI Engagement Tool and Resource Repository

How many patient and stakeholder partners need to be involved in my study? 

The needs of your study and the overall engagement strategy should help you determine the number of partners to invite as well as the type of partners. Consider the size and geographic scope of the study, the setting(s), the study’s target population(s) and the diversity of patients you seek to enroll in the study. 

Is there a particular work title and description for patient and stakeholder partners that we should use? 

No. Meaningful patient engagement occurs in a myriad of ways and along a continuum from input to shared leadership, so partners should be described according to their role and level of involvement. If they have a highly active role in carrying out the work of the study, they might be listed and compensated as co-investigators. If they are serving in an advisory capacity, they might be listed and compensated as consultants. Beyond titles, it is also important to describe the tasks and responsibilities of each partner. To learn more about the engagement continuum and how partner input can influence studies through engagement activities, please see this resource: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2018.05067 

If patient partners are not institution employees, can we involve them in recruitment activities requiring access to protected health information? 

Awardees must comply with their institutional privacy and security policies governing access, use and disclosure of protected health information for research purposes. Please consult your institution’s institutional review board (IRB) and/or legal counsel for any questions regarding compliance with the Health Insurance Portability and Accountability Act (HIPAA) regulations and other applicable laws. 

How should we approach compensation for patient and stakeholder partners? 

PCORI expects partners to be compensated for their work on a study; however, we do not specify the amount or form of compensation. PCORI encourages careful consideration of equitable compensation across stakeholders and sites. Applicants should be thoughtful about what is being asked of each partner as well as the expenses for participating. Compensation rates (e.g., hourly, honorarium); variances between stakeholder compensation rates; and any additional support should be explained in the Budget Justification section of the application. In the rare circumstance that a partner waives compensation, this should be noted in their Letter of Support. For guidance, please review the Compensation Framework and Budgeting for Engagement.  

Do I need to involve patients and stakeholders in drafting the application? 

Ideally, patient and stakeholder partners will be involved in developing the proposal, shaping the research question, selecting outcome measures and conceptualizing the study design. However, PCORI recognizes that some applicants may not have partnerships in place at the time of submission. If this is the case, applicants should describe what efforts were made to ensure the proposed study is patient-centered. PCORI strongly discourages applicants from merely approaching potential partners and advocacy organizations for endorsement without also seeking input. Please refer to the appropriate PCORI Funding Announcement (PFA) for specific engagement requirements. 

I’m still identifying patient and stakeholder partners for my proposed study. How do I address this in the application? 

In this situation, applicants should explain how patient and stakeholder partners will be identified, the rationale for their selection and their role over the course of the study. It is helpful to list the types of stakeholders you intend to invite along with a brief description of their proposed role. If you have the general support of an organization, but the representative won’t be named until a notice of award, it is helpful to provide letters of support describing the organization’s role. Please refer to the PFA for specific guidance about engagement requirements. 

Do engagement requirements vary by PFA? 

While all PCORI funding requires meaningful patient and stakeholder engagement as a component of the study or project, the requirements might vary based on the funding announcement. Applicants should thoroughly read the specific PFA for requirements and guidance and are encouraged to attend the funding announcement or view the recorded funding announcement Town Hall webinar. During these PFA-specific webinars, PCORI staff will explain the expectations for successful proposals, including engagement requirements, and are available to answer questions. 

Is there a separate section in the application for describing the proposed engagement activity? 

No. Applicants should follow the instructions in the PFA and provide the requested detail within the research plan template. 

We are concerned about patient privacy. How will patient and stakeholder names be used by PCORI? 

PCORI recognizes that many partners wish to be credited as contributing members of the research team while others prefer to remain anonymous. It is incumbent upon applicants to obtain appropriate permissions for disclosing the names of partners to PCORI and for use on public-facing materials. When a patient partner requests anonymity, you can use descriptors within your application. For example: Linda, mother of 9-year-old child with diagnosis, or M.C., 45-year-old man with history of opioid use disorder. 

PCORI isn’t a common funder at my institution. Does PCORI have any resources that can help me explain patient-centered comparative clinical effectiveness research (CER) and the benefit of engagement to research decision makers and other faculty members? 

Yes. One of the slide decks available in the Building Effective Multi-Stakeholder Research Teams resources is designed for this purpose. You may use this slide deck in its entirety or select content based on your presentation needs. You can find this content here

Does PCORI provide resources to help applicants and awardees successfully execute their engagement strategy? 

Yes. PCORI has developed several resources for the research community. Engagement resources can be found on PCORI's website. These include: 

When will the 'Foundational Expectations for Partnership' impact PFAs and PCORI investigators?

PCORI's “Engagement in Research: Foundational Expectations for Partnerships,” which are an update to the PCORI Engagement Rubric as well as an online guidance and resource, are already available online. Applicants can expect to find additional information on how to address these expectations in specific funding announcements starting in Cycle 2, 2024.

Posted: September 1, 2023; Updated: February 26, 2024

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