Partnership with communities and diverse patient representation are critical to earning and maintaining trust in the research and health care enterprises. Furthermore, diverse patient representation in research – where both research partners and study participants reflect the population being studied – is an essential ingredient for enhancing study conduct and ensuring not only study validity, but equitable uptake of and access to novel practices and therapies. This post outlines strategies for the engagement of diverse patients and caregivers in research governance, defined as “the processes, structures, and traditions that determine how power is exercised, how stakeholders have their say, how decisions are taken, and how decision-makers are held to account.” A previous blog post explored creating mutual benefit for researchers and research participants as a complementary mechanism to help achieve more inclusive patient representation in research.

Patients help shape the research process and hold the research enterprise (i.e., researchers, life sciences industry, policymakers, and other stakeholders) accountable for serving and protecting the interests of affected communities through their participation in governance bodies and activities. Diverse and inclusive governance structures can help center equity, align research priorities and aims, improve feasibility of conducting studies, identify relevant outcomes, and enhance uptake of findings. In order to be inclusive and representative, research governance should reflect the diversity of those affected by the condition or practice under study, with attention to race, ethnicity, gender identity, age, socioeconomic status, and disability. 

This post presents a comprehensive framework of strategies to enhance the diversity of patient representatives in research governance. It includes illustrations of how strategies are implemented in the real world by patient/participant-driven research communities (PDRCs), play an increasingly impactful role across the clinical research ecosystem. A PDRC is a group of individuals or organizations that is led or governed by people with lived experience and for which a primary purpose is to enable research that is a priority to their communities.

How to Make Research Governance More Equitable and Inclusive

An effective governance plan must address as many of the various reasons people choose to engage in research as possible. A brief scan of publicly available resources found in the peer-reviewed and gray literature revealed that strategies and practices for building more diverse, equitable, and inclusive patient participation in research governance generally fell into the following six categories. Examples are outlined in exhibit 2:

  • Structures: strategies that pertain to the arrangement of and relations between the individuals, groups, institutions, or entities providing the scaffolding for research governance, such as advisory or leadership councils.
  • Policies: sets of plans, principles, or definite courses of action that are used as the basis for decision-making.
  • Community-Centered Practices: approaches that intentionally account for the social and local needs of engaged partners.
  • Cultural Humility: strategies that enable and promote positive and effective interaction with diverse cultures.
  • Education/Training: strategies that focus on providing partners with the content and process knowledge needed to enable their full and robust engagement in research governance activities.
  • Supportive Resources: strategies that involve the provision of facilitating tools, devices, platforms, or materials that support full engagement in governance activities.

Exhibit 2: Strategies for Improving Representativeness of Patients in Research Governance.

PDRCs are on the frontlines of developing multi-layered strategies for diversifying research governance. These entities themselves are patient-/participant-governed, and they place a strong emphasis on the important role of governance that ensures patients have an empowered voice in the decisions driving the research process.

The Patient-Centered Outcomes Research Institute convened eight PDRCs into the PDRC Learning Network to build capacity and promote sustainability of PDRCs. One of the Learning Network activities was a work group dedicated to exploring how PDRCs are implementing strategies to diversify patient participation in research governance in the real world. Below are examples from two PDRCs outlining how their work falls into the identified strategy categories.

Codifying Diversity in Governance Body Member Recruitment

One PDRC, IBD Partners, codified diversity in their recruitment process for their Patient Governance Committee (PGC) with amendments to PGC’s bylaws and application processes with the explicit intention of seeking underrepresented voices in their recruitment channels and ensuring applicants’ abilities to reflect on and leverage their own unique experiences. In 2018, the bylaws were amended to formalize the consideration of diversity criteria when selecting new candidates. The criteria include age, gender, level of education, geographic location, occupation, and disease type. In response, the PDRC made intentional changes to outreach and opportunity marketing, applications, and candidate selection processes.

Specifically, the network sought to recruit new PGC members through channels with reach to underrepresented populations such as advocacy channels, social network channels, and peer-to-peer channels. By working closely with advocacy and existing social network groups, IBD Partners was able to ally with trusted pillars of the IBD community and engage with patients in environments/contexts that are familiar to them, lending greater legitimacy to their effort and increasing the likelihood of attracting well-qualified applicants.

In addition, the PGC application was updated and now includes questions related to demographics, diagnosis, experience as a member of the IBD community, prior experience with IBD Partners, unique skills the applicant brings, and why patient-centered research is important to the applicant. All PGC members receive compensation for their participation.

This is an example of strategies in the structure and policy categories. By formalizing the consideration of key diversity dimensions for membership and establishing clear practices for how this should be operationalized, the committee has established strong structural mechanisms for the engagement of diverse patient voices in the network’s governance. Anecdotal assessments from membership indicate this has strengthened the PGC and its work and has motivated the committee to maintain its commitment to identifying and filling representation gaps in future cycles.

Keeping the Community at the Center

The PDRC ArthritisPower established a Patient Engagement Advisory Panel (PEAP) to provide guidance and oversight for strategies to increase network diversity by assessing the network’s current state and resources. The PEAP is a separate and distinct body within the broader governance structure, which allows the group independence as they review and enhance the ArthritisPower™ mobile application, identify and test potential community outreach strategies, and develop  their Peer Navigator program.

In June 2020, ArthritisPower sought to recruit a diverse set of members with a mix of prior research-related experience and knowledge. The PEAP is comprised of nine patient members, and includes diversity in gender, primary language, race/ethnicity and experience with research. The panel includes three “patient leaders” who are also engaged in the network and research activities beyond the PEAP. The remaining six panel members are only involved with ArthritisPower through the PEAP and have limited prior exposure to research.

Panel members were identified primarily through peer recruitment and personal referrals from clinicians and advocacy organization staff, utilizing community-centered channels that allowed them to leverage prior trusted relationships. PEAP candidates’ applications were evaluated based on criteria such as prior experience related to advocacy and research, commitment to fostering diversity, collaborative workstyle, commitment/passion, and dependability/responsiveness. All PEAP members receive an annual honorarium for participation.

To ensure members were set up for success, the PEAP launched with a kick-off meeting followed by a series of four trainings. The kick-off meeting served to review the purpose and scope of the panel as well as member roles and expectations. Three of the trainings were focused on the basics of research—data collection, understanding results, etc. The final training was centered on the use of social media to disseminate research. Trainings were conducted separately in English and Spanish to accommodate all member needs. This ensured all members began work with the same foundation while also providing an opportunity for members to meet each other and establish rapport prior to direct collaboration.

Strategies employed here represent two categories found in the scan: community-centered practices and supportive resources. The PEAP proactively brainstorms and tests new types of community outreach strategies to ensure work is community-centered and informed by community leaders. As for supportive resources, PEAP members are compensated for their time and expertise.

Conclusion

If the clinical and health services research enterprise is to address the challenge of underrepresentation in research governance, it will require dismantling traditional hierarchies and norms for governing multi-stakeholder research and recruiting members to participate in those governance structures. Adopting intentional and participant-centered approaches to improve representativeness in governance practices will require attention to structures, policies, community-centered practices, cultural humility, education/training, and supportive resources. Increased attention to patient and participant representation will no doubt create new demands on the research enterprise, requiring new skills, time, and resource allocations from research teams. Emerging entities, such as the PDRCs noted in the examples above, are beginning to prioritize these approaches. As more organizations and research teams implement these approaches, the clinical research enterprise’s collective experience with effective recruitment and retention practices will grow and mature.

More about this work can be found here. Read about it in Health Affairs here.

The views presented in this article are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors, or its Methodology Committee.  

Staff

Elizabeth Cope, Ph.D., M.P.H.

Senior Director, Public and Population Health - AcademyHealth

Elizabeth Cope is Senior Director of Public and Population Health at AcademyHealth, bringing experience in the... Read Bio

Prashila Dullabh
Author

Prashila Dullabh, M.D.

Vice President and Senior Fellow - NORC at the University of Chicago

Prashila Dullabh is a a vice president and senior fellow in Health Sciences group and the director of the Heal... Read Bio

Member

Michelle Johnston-Fleece, M.P.H.

Senior Program Officer - Patient-Centered Outcomes Research Institute

Michelle Johnston-Fleece, M.P.H., is senior program officer at the Patient-Centered Outcomes Research Institut... Read Bio

Member

Claudia Grossmann, Ph.D.

Senior Program Officer - Patient-Centered Outcomes Research Institute

Claudia Grossmann, Ph.D., is a senior program officer with the research infrastructure team at the Patient-Cen... Read Bio

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