Article Text

Communication
Integrating participants as partners in research governance and operations: an approach from the All of Us Research Program Engagement Core
  1. Catherine Hammack-Aviran1,2,
  2. Alecia Malin Fair3,
  3. Melinda Aldrich4,
  4. Jennifer Richmond5,
  5. Selena McCoy Carpenter6,
  6. Karriem S Watson7,
  7. Elizabeth G Cohn8,
  8. Consuelo Hopkins Wilkins3,6
  1. 1Center for Biomedical Ethics and Society, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  2. 2Ethics, Education, Policy, and Society, Research Immersion Program at Vanderbilt University Medical Center, Nashville, Tennessee, USA
  3. 3Department of Medicine; Division of Geriatrics, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  4. 4Department of Medicine, Division of Genetic Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  5. 5Department of Social Sciences and Health Policy and Department of Implementation Science, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA
  6. 6Office of Health Equity, Vanderbilt University Medical Center, Nashville, Tennessee, USA
  7. 7All of Us Research Program, National Institutes of Health, Bethesda, Maryland, USA
  8. 8Zucker School of Medicine, Northwell Health Feinstein Institutes for Medical Research, Manhasset, New York, USA
  1. Correspondence to Professor Consuelo Hopkins Wilkins; consuelo.h.wilkins{at}vumc.org

Abstract

Objectives During the last two decades, researchers and funders increasingly recognised the value of engaging patients and communities in research. Despite progress, community engagement remains challenging. There are few examples of successful participant engagement in governance of large-scale research programmes. Here we describe efforts to engage participants as partners in new governance roles in the All of Us Research Program, a precision medicine research initiative which intends to enrol at least one million participants. Using intentional, participant-centric engagement strategies, the All of Us Engagement Core recruited and integrated a diverse group of participants into governance roles including Steering and Executive Committees. Evaluation measures included a survey to assess Consortium Members’ readiness for participant engagement.

Results Over a 3-year period, all items on the survey increased (higher readiness). Of the 291 respondents to the 2021 survey, respondents most frequently agreed that participant perspectives are essential (100%), participants understand enough to contribute meaningfully (94%) and participants should be involved in setting goals (96%). Respondents least frequently agreed that participants should have an equal voice in Working Groups (75%), Steering Committee (69%) and Executive Committee (63%).

Conclusion In conclusion, participants can be effectively integrated into large-scale research governance, which is associated with increased researcher readiness for engagement.

  • PUBLIC HEALTH
  • Clinical governance
  • Patient Participation
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Introduction

Engaging communities in research increases the quality, impact and relevance of health research and enhances public perception and receptiveness to research.1–3 Although community-engaged research has existed for more than 60 years, uptake of community and participant engagement in clinical research has been limited until recently.4 5 Policies requiring public involvement in health research were enacted in the UK in 2002.6 In the USA, the field of engagement research has rapidly evolved since the creation of the Patient-Centered Outcomes Research Institute in 20107 and the launch of the National Institutes of Health’s (NIH) Clinical and Translational Science Awards (CTSA) Program in 2006,8 which required community engagement. Subsequently, the value of engaging non-researchers in science has become widely accepted, and community advocates, patients and research participants are increasingly involved in biomedical research in a myriad of ways.9–11

Commitment to public and community engagement is now evident in large biomedical research programmes such as the All of Us Research Program, the centrepiece of NIH’s Precision Medicine Initiative12 All of Us, which will enrol at least one million participants from diverse backgrounds, has committed to actively engaging its ‘participants as partners’ in all aspects of the programme—from research design through governance.13 14 This type of engagement typically occurs in community-based participatory research, not large-scale genomics or precision medicine research; thus, implementation will require intentional, participant-centric strategies that amplify the voices of historically marginalised and excluded groups (see figure 1).2–5

Figure 1

All of Us Research Program Governance Structure. *Participant Partners serve on all groups except Consortium Training, Modules task force refers to activities leading into participant provided information.

Problem statement

Despite progress in the field of community engagement, successful integration of community members and patients in biomedical research remains challenging. Engagement is a complex process and barriers to meaningful engagement include differences in group norms, ineffective communication, divergent conceptualisations of priorities, lack of common language and power differentials15–18 Unfortunately, many researchers do not have the education, training or skills required to effectively integrate community members into research.15 19 20 Although programmes have emphasised the need to prepare community members for engagement, the lack of readiness among researchers is increasingly apparent. Engagement readiness is associated with researchers’ perceived value of engagement, ability to collaborate, knowledge of community, cultural humility, appreciation of community experience and effective communication skills.21

In this paper, we describe the structure of the All of Us participant Engagement Core, the approach to integrating participants in the governance structure, and assessment of researcher readiness for engagement. We offer insight into challenges, successes and lessons learnt to optimise participant engagement in biomedical research.

Methods

Description of the All of Us Consortium

The All of Us Consortium includes researchers, staff members, contractors, awardees and participants who serve in multiple roles in programme governance including as Participant Ambassadors and as members of the Steering Committee, Executive Committee and Advisory Panel (see table 1). Research participants serving in these roles are referred to as ‘Participant Partners’, and their integration into partner roles is facilitated and supported by an Engagement Core team comprising faculty and staff with expertise in community and patient engagement. The Engagement Core identifies participants, onboards them and helps prepare Participant Partners to actively engage in setting research priorities, enhancing the implementation of the programme, and participating in decision-making activities within governance groups. Evaluation data on the Participant Partners’ engagement experience are collected at emergent key points throughout the life of the programme and synthesised into existing engagement practices in real time.

Table 1

All of Us Research Program Governance Structure role description

Readiness to engage survey development

As part of our ongoing evaluation efforts, we designed the Readiness for Participant Engagement in Governance Survey to assess the readiness of the research teams and NIH program staff to effectively engage participants as partners in the programme. We drew on existing literature on researcher readiness for community-engaged dissemination and implementation research,22 and the nominal group technique as well as empirical evaluation measures for community engagement events and working meetings more generally.23–26 We used cognitive interview testing and stakeholder engagement in iterative rounds to revise the survey to align with our concept of readiness for engagement in governance defined as ‘Consortium Members’ prior experience with and perspectives on participant engagement’ to increase the facilitation of precise, informative data collection and interpretation.

The final Readiness for Participant Engagement in Governance Survey instrument was deployed in REDCap27 and included six primary domains (see table 2), 13 statements with a 6-point Likert scale of response options, along with free-text fields eliciting additional comments, caveats, nuances, explanations or other contextual information. The online survey was deployed to all Consortium Members and NIH staff involved in the All of Us Steering Committee, Executive Committee, Advisory Panel and Working Groups in May 2019, after Participant Partner integration, then again in March 2020 and October 2021 (see online supplemental appendix 1 for instrument). We used descriptive statistics to summarise participant responses to the survey. We also summarised respondent comments in the verbatim free-text fields and used these insights—combined with our experiences with Participant Partner integration in governance—to develop implications for practice and further study in the field.

Table 2

Primary domains of Readiness for Participant Integration in Governance Survey

Results

A total of 86 respondents completed the Readiness for Participant Engagement in Governance Survey in 2019, 76 in 2020 and 291 in 2021.

Respondent comments in the free-text survey field showcased the tension between researchers’, staff members and senior leaderships’ appreciation of participant engagement and failure of some Consortium Members to think participants should be in governance positions and to support capacity building (see table 3).

Table 3

Participant Partners’ integration into the research governance structure—quotes from the All of Us Research Program

Descriptive characteristics of survey respondents are presented in table 4.

Table 4

Descriptive characteristics of respondents to the 2019, 2020 and 2021 All of Us Readiness for Participant Engagement in Governance Surveys

While we can see overall consistency in support of the initiative over the 3 years, there is some variation in intensity from year to year. Given the larger sample size, the greater representation of principal investigators/researchers at 20% versus previous years (14% in 2019 and 16% in 2020) and the more balanced mix of respondents by role, we will focus on the 2021 results (see figure 2).

Figure 2

Responses to the 2019, 2020 and 2021 Readiness for Participant Engagement in Governance Surveys.

In 2021, we see positive support for the expanded role of participants as partners exceeding 80% in 9 of the 13 categories (combining somewhat agree, agree and strongly agree): that their perspectives are essential (100% agree), that they understand enough to contribute meaningfully (94%), that they should be involved in setting goals (96%) and in planning programming (87%).

The share of support is lower, but still a majority, for the participants to have an equal voice in Working Groups (75%), in the Steering Committee (69%) and in the Executive Committee (63%). Accordingly, there is a lesser intensity of strong agreement in these categories, not exceeding 16%. Another area of some concern is that a notable minority, 43%, agreed that the participants’ role as partners would lead to a slowdown in work.

Discussion

All of Us Research Program Consortium Members clearly indicated that participant engagement should not be tokenism but full authentic involvement that is informed, iterative and valued. Participants provide an essential perspective that impacts decision-making. Through seating the Participant Partners in governance positions, their voices are elevated from those traditionally excluded and under-represented in biomedical research. However, not everyone in the All of Us Consortium endorsed capacity building and inclusion of participants in governance, pointing to concerns regarding the learning curve for a participant in joining a governance body of the national scale/broad research scope of the project. Concerns were expressed that the participants’ involvement would hinder community responsiveness given the various regional and stakeholder affiliations.

Strengths and limitations

A key strength of this work is the integration of participants throughout All of Us. This meaningful engagement informs every part of All of Us and aims to increase integrity and credibility among populations that have historically been excluded from medical research. A key limitation is that this survey was cross-sectional and we cannot ensure the same respondents completed the survey from year to year to represent a change in individual views on readiness for participants in governance.

Lessons learnt and implications for further study in the field

An important learning for the Engagement Core is how to resolve disparate opinions regarding participants’ roles and influence in the governance structure. As an example, one can see from the quotes (table 3) and results (table 4, figure 2) that some Consortium Members feel participants should guide the research approach, while others believe that they should be less involved. Participant involvement may indeed ‘slow down the work’, but building consensus and considering viewpoints/ideas different from those of the science/researcher community should not be sacrificed for the sake of ‘speediness’.

Since 2018, we have continuously added to and refined a Manual of Operations to standardise our approach to Participant Partner recruitment, onboarding and evaluation of the experience. In our first year, we learnt to first share results with All of Us Engagement staff and leadership, next share with Participant Partners and lastly, share consortium-wide. This has become a best practice for our work. Sharing the readiness survey results consortium-wide allows everyone involved with All of Us (including Participant Partners) to see the impact of participants’ involvement, increases transparency of one another’s views, and allows everyone to see where views are congruent and where they diverge. Our team does not wish to hide the results—even the less positive ones—from anyone involved in All of Us. We believe the inherent tensions in this work allow for growth and understanding; examples include: participants can learn how they might more effectively participate in a governance group, the Engagement Core learns what is missing in our onboarding and leaders can learn how they can better engage participants in the work of committees and decision-making bodies.

A large complex research programme needs to be nimble, adapting and adjusting within a wide continuum to be more approachable, comprehensive and inclusive. Through this approach, research participants are empowered to change the discourse around health research strategies. Opportunities for participants to hold positions of leadership and meaningfully participate in decision-making, with processes in place to support these efforts are key. It is vital that participants in governance are involved throughout the entire life-cycle of the research programme like other members of the consortium. The learnings from this work may propel future programmes to meaningfully move the field forward to apply to their own governance structure set up where research participants play a significant leadership role.

Conclusions

Participants provide a meaningful view to many topics and offer opportunities to learn how the All of Us Research Program is being perceived by the public. The participant voice brings value to the development of participant-facing materials (surveys, communication, protocols, etc) on how to make them more culturally sensitive and relevant. Participants also know what is appealing to others in the study and can facilitate the development of trust among the scientific community. Incorporating the participant voice may influence these aspects of the programme in a way that makes the programme more participant-driven, or at the very least ensures that participants’ priorities do not get devalued by other potentially competing priorities of researchers.

The academic researcher may see the research as part of a larger process of scientific discovery whereas the Participant Partner may see it as the first step towards on-the-ground action to improve preventing and treating disease for their respective communities.

Ethics approval

Not applicable.

Acknowledgments

Survey data were collected and managed using REDCap electronic data capture tools hosted at Vanderbilt University Medical Center. The authors thank Kate Brelsford, MPH, PhD, for her contributions to the design and instrument development and Angelica Alton Johnson, MSW, for her contributions to the Readiness survey placement and messaging to the All of Us Research Study Consortium.

References

Supplementary materials

  • Supplementary Data

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Footnotes

  • Twitter @DrCHWilkins

  • Contributors CH-A: Conceptualisation, Methodology, Resources, Visualisation, Writing-Original Draft, Writing-Review and Editing; AMF: Writing-Review and Editing, Conceptualisation, Methodology, Visualisation, Writing-Original Draft, Supervision, Project administration; MA: Methodology, Resources, Writing-Original Draft, Formal analysis, Writing-Review and Editing; JR: Resources, Visualisation, Writing-Original Draft, Formal analysis, Writing-Review and Editing; SMcC: Writing-Review and Editing, Visualisation; KSW: Conceptualisation, Methodology, Resources; EGC: Conceptualisation, Methodology, Resources; CHW: Conceptualisation, Methodology, Resources, Investigation, Visualisation, Writing-Original Draft, Writing-Review and Editing, Supervision, Project administration, Funding acquisition, Guarantor.

  • Funding This work was supported by the National Institutes of Health (NIH) National Center for Advancing Translational Sciences (UL1TR002243); the National Institute on Minority Health and Health Disparities (U54MD010722); the National Institute of Health All of Us Data and Research Center NIH grant (1 OT2 OD35404); the All of Us Research Program Engagement Core NIH grant (1 OT2 OD035980); the Agency for Healthcare Research and Quality (T32HS026122); the National Cancer Institute (K99CA277366 and L60CA264691) and the West End Home Foundation (Award number N/A).

  • Disclaimer The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.