Month: July 2024

Faster Together is a free online course designed to help researchers understand past research abuses and their influence on minority population participation in clinical trials. It also provides strategies and tools for improving recruitment methods to increase the diversity of trial participants.

The course has eight sessions which include content on:

• Understanding Why Increasing Minority Recruitment in Clinical Trials is Important
• Principles of Community Engagement
• How to Reach Out to Community Members
• Educating Potential Research Participants about Research
• Working with Community Healthcare Providers
• Developing Effective Screening, Education and Decision Support for People Who Live in Marginalized Communities
• Designing an Informed Consent Process that Improves Participant Understanding
• Understanding Why Completing a Clinical Research Study May be Difficult for Some Participants

Financial aid is available to learners who would like to purchase a certificate showing their successful completion of the course. The course is available in 21 languages.

Stage(s) of Research Process: 

• Study Planning – The course provides resources and tools for building partnerships with community leaders and community healthcare providers, and ways to educate potential research participants about clinical trial opportunities.
• Study Conduct – The course provides resources and tools for participant screening, culturally appropriate methods for informed consent, and strategies to improve participant retention during the clinical trial.

Who Might Benefit:  

• Researchers and Research Staff
  • Can take the course to understand the full history of minority participation in clinical research and learn techniques for making their recruitment strategies culturally appropriate.
  • Those who take the course can also learn the principles of community engagement and how to build equitable community partnerships.
• Communities and Patients, Caregivers and Patient Advocacy Groups
  • Can access all course material and may directly benefit from the content on principles of community engagement and ways to educate potential research participants about the research study. 
  • Can also use the Faster Together course as an educational tool when they work with researchers as collaborators or consultants on specific projects.

Key Takeaways and Examples in Practice:

• Videos of patients describing real life experiences are highly valued by learners.
• Quizzes are helpful learning tools. Questions with “What would you do?” scenarios were popular with learners.
• The self-paced learning available through the Coursera platform was viewed as a strength of the course and likely enhanced access and use of the information by a diverse audience.
• Some course participants found the material too general and would have liked more content on specific considerations for recruitment of individual racial/ethnic minority groups in localized community settings.

This work was done with the direct support by each of the following partners who advance this work:

• Vanderbilt Recruitment Innovation Center
• NCATS Trial Innovation Network

Keywords: Equitable Engagement, Methods of Engagement, Patients, Caregivers, and Patient Advocacy Groups; Researchers; Communities

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Links to Relevant Resources:

• Faster Together, Enhancing the Recruitment of Minorities in Clinical Trials – Coursera
• NCATS Trial Innovation Network
• Vanderbilt Recruitment Innovation Network – Provides Tailored Support to Research Teams
• Contact Faster Together

Definitions for each engagement objective can be found in the glossary.

The Recommendations for Community Engagement offer a step-by-step approach to developing and maintaining a Community Advisory Board (CAB), but many of the strategies can be applied to other types of community outreach. The Recommendations were developed together by community representatives and National Institute of Allergy and Infectious Diseases (NIAID) staff. The Recommendations help research staff and community representatives expand and deepen existing partnerships and start new ones.

The Recommendations define the roles and responsibilities of the community and research staff, consider the social and cultural context of the research, emphasize the importance of sustainable community engagement, and provide strategies for working with individuals who have been marginalized or underrepresented in research. The goal of the Recommendations is to increase community engagement in all stages of clinical research.

Stage(s) of Research Process:

• Study Planning: The Recommendations define the roles and responsibilities for community members and researchers. The Recommendations emphasize that community members should participate in the protocol development process, including review of study protocols, informed consent plans, and other related documents.
• Study Conduct: The Recommendations include an emphasis on consistent collaboration between researchers and community representatives throughout the study. This includes providing each other feedback and making sure that the study is being implemented as planned (e.g., in agreement with local and national regulatory and ethical standards). The Recommendations also suggest ongoing training for research staff on how to engage community members in the research process.
• Post-Study: CAB members play a critical role in ensuring that research findings reach all members of the community, particularly those who will be most directly affected. The Recommendations show how the CAB can play an active part in these communications by making sure messages are clear, and by providing advice on appropriate methods of communication. 

Who Might Benefit:

• Researchers
  • Can use these Recommendations to develop and maintain their own CAB.
  • Can also use these Recommendations to improve community members’ engagement in the research process through other methods.
  • Can use the Recommendations to better understand the importance of community engagement, how to build and maintain positive partnerships with community members, and how to increase the inclusion of community members’ perspective on all stages of research.

Key Takeaways and Examples in Practice:

• The Recommendations have been used successfully in HIV clinical trials for multiple years and can be adapted for other types of research.
• By using the Recommendations from the start of the research process, the Community Engagement team of the HIV Vaccine Trials network was able to quickly engage with new populations for the COVID-19 vaccine efficacy trials funded by the US government.
• By applying these community engagement recommendations, the COVID-19 vaccine efficacy trials enrolled diverse participants. 47% of participants enrolled in the COVID-19 vaccine trials were from Black, Indigenous, and People of Color communities, thanks to the use of these community engagement principles.

This work was done with the direct support by each of the following partners who advance this work:

• Division of AIDS at NIAID
• NIAID Office of HIV/AIDS Network Coordination:
• Community Partners

Keywords: Methods of Engagement; Collaborative Decision-Making; Sustainable Engagement & Capacity Building; Researchers

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Links to Relevant Resources:

• Recommendations for Community Engagement in HIV Research
• Resources for Inclusive Community Involvement (HIV/AIDS Network Coordination)
• Publication Summarizing Recruitment in COVID-19 Vaccine Efficacy Trials
• Division of AIDS at NIAID’s Community Engagement Website
• NIAID Office of HIV/AIDS Network Coordination Website
• Information about the Community Partners Working with the NIH HIV/AIDS Clinical Trials Network

Definitions for each engagement objective can be found in the glossary.

The National Institute of Neurological Disorders and Stroke (NINDS) incorporated in their 2021-2026 strategic plan to include the perspectives of people with lived experience (PWLE) with neurological disorders in selecting research priorities. NINDS remains committed to this goal by including PWLE in most workshops, roundtables, working groups, and committees as experts and people whose input directly impacts research priority setting.

To make sure PWLE are included in these efforts, NINDS created a new position called the Lived Experience Engagement Strategist. This person serves as a central point providing the overall strategy, maintaining momentum, and ensuring accountability for inclusion of PWLE across all NINDS work. NINDS also developed a community of practice, “LivedX,” that serves as a virtual collection of resources, tools, and best practices for PWLE engagement available to all NINDS staff.

Stage(s) of Research Process:

• Study Planning: PWLE and their expertise are included at the early stages of developing ideas and priorities for research. They work as respected members of committees, working groups, and panels. They are viewed as subject matter experts whose input is used to develop research priorities and create partnerships.

Who Might Benefit:

• Research Administrative Leaders
  • Can use the NINDS strategy for building an approach that allows for long-lasting engagement of PWLE in research priority setting.
  • Can consider the value of having dedicated staff who are responsible for making sure engagement with PWLE happens across the organization’s research programs.
  • Can consider the development of a collection of tools and best practices for PWLE engagement that can be accessed by all staff.
• Patients, Caregivers, and Patient Advocacy Groups
  • Can use NINDS efforts as an example of the staff support needed to maintain an organization-level commitment to PWLE inclusion.
  • Could use this example to help identify questions to ask organizations or researchers when considering a partnership. These questions can help patients, caregivers, and patient advocacy groups determine if the organization has the necessary resources in place for effective and long-lasting engagement.

Key Takeaways and Examples in Practice:

• Most tools, resources, and processes that support meaningful inclusion of PWLE can be utilized for many different efforts, and these resources should be kept in a central location that can be accessed by all staff.
• Examples in practice include guidelines for selecting PWLE to serve on working groups, codes of conduct for working groups that include PWLE, best practices for engaging PWLE as experts, and template forms to evaluate the inclusion of PWLE.
• Having a dedicated staff support lead for PWLE engagement sends a very visible and appreciated message to PWLE communities and patient advocacy organizations.
• PWLE have contributed meaningful input on multiple efforts, including the Research Roadmap for Myalgic encephalomyelitis/chronic fatigue syndrome, the NIH Amyotrophic Lateral Sclerosis (ALS) strategic planning working group, and ALS public-private partnership design phase efforts to speed up treatment development.
• PWLE have participated in multiple NINDS workshops, including the Non-Profit Forum, a hybrid workshop on Advances in Therapeutics Development for Parkinson’s Disease, the Traumatic Brain Injury (TBI) Classification and Nomenclature Workshop, and the HEAL Initiative workshop on advancing health equity in pain management.

This work was done with the direct support by each of the following partners who advance this work:

• People with Lived Experience of Neurological Disorders who volunteer their time and expertise to work with NINDS as partners
• NINDS leadership and staff
• Patient Advocacy Organization partners for helping NINDS connect with relevant PWLE partners

Keyword(s): Sustainable Engagement & Capacity Building; Collaborative Decision-Making; Methods of Engagement; Researchers; Patients, Caregivers, and Patient Advocacy Groups

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Links to Relevant Resources:

• Contact NINDS about PWLE efforts
• NINDS 2021-2026 strategic plan
• 2024 Research Roadmap for Myalgic encephalomyelitis / chronic fatigue syndrome (ME/CFS) report
• Priorities of the NIH Amyotrophic Lateral Sclerosis (ALS) Strategic Planning Working Group
• ALS Public-Private Partnership for Treatment Development
• Non-Profit Forum Information and Recordings
• Summary of Hybrid Workshop on Advances in Therapeutics Development for Parkinson’s Disease
• Recordings and Summaries of TBI Classification and Nomenclature Workshop

Definitions for each engagement objective can be found in the glossary.

The Community Engagement Alliance Consultative Resource (CEACR) offers personalized consultations for NIH-funded research teams on ways to work with the community impacted by their research. When participating in a CEACR consultation, research teams get the opportunity to speak directly with experts from the communities they hope to work with.

CEACR also holds a Speaker Series focused on inclusive participation and community engagement best practices in research. Some topics covered in the Speaker Series include community-centered research design, including community perspectives in the Institutional Review Board process, and ethical research with community-based organizations.

Stage(s) of Research Process:

• Study Planning: CEACR consultations about study planning discuss ways to start and maintain good partnerships with communities. Some examples of topics include ways to build relationships with community partners, and strategies for community outreach.
• Study Conduct: CEACR consultations about study conduct focus on making sure study methods are inclusive of groups that have been historically underrepresented in clinical research. Some examples of topics include creating recruitment materials that are culturally appropriate and editing recruitment materials to increase their appeal and usefulness (e.g., using terms more familiar to community members, using images that better represent the community or videos).

Who Might Benefit:

• Researchers Funded by NIH
  • Can request CEACR consultations to learn about strategies for improving community engagement.
  • Can have targeted conversations with expert panelists with experience working in diverse communities, including American Indians/Alaska Natives, Hispanics/Latinos, African Americans, rural communities, and pregnant women.
• Researchers and Community Members
  • Can access toolkits and fact sheets on growing and maintaining community partnerships on the CEACR website.
  • Can attend a Speaker Series that highlights ways to make sure all groups can participate in research relevant to them.

Key Takeaways and Examples in Practice:

• Research is more relevant and meaningful to communities when researchers value community members as equal partners of the team.
• Meaningfully engaging communities early and throughout the research process builds trust and sustains benefit and impact for communities.
• Acknowledging participants for their time and effort in clinical research studies is fundamental to the research process.
• When working with community partners to design and conduct research studies, community partners should receive equitable compensation that is included in the study budget from the beginning.

This work was done with the direct support by each of the following partners who advance this work:

• Maliha Ilias, Ph.D., Scientific Program Lead, National Heart Lung and Blood Institute
• Al Richmond, M.S.W., Multiple Principal Investigator (MPI)
• Mylynda Massart , M.D., Ph.D., Multiple Principal Investigator (MPI)
• Elizabeth Miller, M.D., Ph.D., Co-Investigator
• Mary Goldberg, Ph.D., M.Ed., Co-Investigator

Keywords: Methods of Engagement; Collaborative Decision-Making; Equitable Engagement; Sustainable Engagement & Capacity Building; Return of Research Value; Researchers

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Links to Relevant Resources:

• The Community Engagement Alliance Consultative Resource
• The Community Engagement Alliance Consultative Resource, Fact Sheet
• CEACR Consult Request Form
• Publication Describing the Establishment of CEACR
• Fact Sheet on Growing and Sustaining Community Partnerships
• Full Playlist of CEACR Speaker Series Videos on YouTube
• CEACR Resources Including Fact Sheets, Toolkits, and Infographics

Definitions for each engagement objective can be found in the glossary.

The Toolkit for Patient-Focused Therapy Development website provides reliable information about the stages of therapy development and ways that rare disease patient group leaders can get involved. It was developed to provide engagement strategies for a broad range of patient advocacy groups, including smaller groups. The Toolkit was created by the National Center for Advancing Translational Sciences (NCATS) and members of patient advocacy groups.

The Toolkit includes:

• Easy-to-understand descriptions of the discovery phase, the early stage of identifying potential drugs that could be tested in future clinical trials
• Tips for preparing for and conducting clinical trials
• The Food and Drug Administration (FDA) review and approval process, and what occurs following FDA approval
• Definitions of common words used in research
• Links to helpful resources like online education and tips for working with the Centers for Medicare and Medicaid Services
• Tips for success

Stage(s) of Research Process: 

• Study Planning – The Toolkit provides recommendations for building relationships with key partners. In this section of the Toolkit, patient advocacy groups are given some strategies for identifying medical researchers and clinicians to serve on their scientific/medical advisory board.
• Study Conduct – Patient input on the clinical trial design is critical to ensuring that trial design is patient-friendly and inclusive. The Toolkit provides background information to assist patient advocacy groups in understanding key sections of a study protocol.
• Post-Study – After a research study is over, there are many ways to make sure the study’s results reach the right people. Patient advocacy groups can work with clinicians to develop screening programs that help identify people who can benefit from newly created treatments.

Who Might Benefit:

• Patients, Caregivers, and Patient advocacy groups can use the Toolkit to engage meaningfully with the therapy development process. The materials in the Toolkit were designed to be helpful for newly formed patient advocacy groups with limited resources and experience.
• Communities can benefit from the Toolkit if they serve on Institutional Review Boards or Data and Safety Monitoring Boards, participate in FDA Advisory Committee meetings, or want to play an active role in clinical research in other disease areas.
• Researchers can learn about how to partner with patient advocacy groups more effectively and how to accelerate translation of research observations into widely disseminated treatments by accessing information in the Toolkit.

Key Takeaways and Examples in Practice:

• Even newly formed patient advocacy groups can have an impactful voice in the therapy development process.
• The Toolkit utilizes five criteria when deciding to incorporate resources: generalizability (can be used by multiple patient groups), customizability (adaptable to different situations), actionability (has clear, concrete steps), uniqueness (fills a need not already met by other resources and content), and credibility (created by patient groups, created for patient groups, or already used by patient groups)
• Involving representatives of patient advocacy groups in the design and ongoing management of the Toolkit has enhanced its usability and informed the material contained in the Toolkit.
• Infrastructure provided by NCATS (website hosting, web-based process for toolkit feedback, management of the toolkit review group) has ensured long-term sustainability of the Toolkit.

This work was done with the direct support by each of the following partners who advance this work:

• FDA
• Global Genes
• National Organization for Rare Disorders
• Rare Diseases Clinical Research Network

Keywords: Methods of Engagement; Collaborative Decision-Making; Equitable Engagement; Sustainable Engagement & Capacity Building; Return of Research Value; Researchers; Communities; Patients, Caregivers, and Patient Advocacy Groups

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Links to Relevant Resources:

• The Toolkit for Patient-Focused Therapy Development website
• About NCATS Toolkit
• Contact the NCATS Toolkit

Definitions for each engagement objective can be found in the glossary.

The Toolkit for Clinical Trial Participants and Community Members provides information on clinical trials to help individuals decide if they would like to take part in a clinical trial. The information is delivered using short videos, infographics, interactive quizzes, and short articles. Some of the Toolkit topics include a description of a clinical trial, reasons for participating in a clinical trial, the process of informed consent, and the risks and benefits of participation.

The Toolkit also provides additional health information in short, easy to understand formats that can assist individuals in their health journey. Some of the topics included in this section of the Toolkit include navigating a hospital stay, stroke reduction strategies, how to communicate with a doctor, and preventing hospital billing and insurance problems.

Stage(s) of Research Process:

• Study Conduct: This Toolkit is designed to help individuals decide if participating in a clinical trial is right for them. Therefore, this Toolkit is meant to be used during study recruitment to improve the informed consent process by providing additional, easy-to-understand information about clinical trial participation.

Who Might Benefit:

• Patients, Caregivers, or Individuals
  • That are thinking about participating in a clinical trial can use the Toolkit to better understand what a clinical trial is and why their participation matters.
  • That might participate in a clinical trial can use the Toolkit to understand how a clinical trial may impact their life.
  • May find the information about general health care concerns useful when navigating hospital stays, health insurance issues, or communications with their doctor.
• Researchers
  • Can use this Toolkit during participant recruitment by providing links to the Toolkit online or printing out the relevant infographics for participants.
  • Interested in equitably recruiting female and racial and ethnic minority populations may find this Toolkit useful as it was designed to improve the representation of these groups on clinical trials.

Key Takeaways and Examples in Practice:

• Providing individuals with information on how their participation in a clinical trial can improve medicine, give back to their community, or help others in the future can increase recruitment.
• The Toolkit provides easy-to-understand materials that help patients, caregivers, and individuals become equal partners in the research process.
• There is no one-size-fits-all approach to providing information to individuals about clinical trials. Using a variety of communication techniques, like infographics and videos, increase the number of people who can understand the information.

This work was done with the direct support by each of the following partners who advance this work:

• National Institute of Neurological Disorders and Stroke provided support through Grant #U24MD006961
• Washington Heights and Inwood Council on Aging
• StrokeNet
• Latino Health Access

Keywords: Equitable Engagement; Patients, Caregivers, and Patient Advocacy Groups; Researchers

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Links to Relevant Resources:

• Toolkit for Clinical Trial Participants and Community Members
• Contact the Toolkit Managers

Definitions for each engagement objective can be found in the glossary.

The Pathways to Health for All report recommends community engagement as one way to improve the health equity and health disparities research programs at the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The report recommends that researchers build and sustain partnerships with community members and community organizations. It also recommends developing resources to help community-based organizations meaningfully engage in research.

The report was developed with patients, caregivers, and others living with or at risk for diabetes, digestive, or kidney diseases. These individuals were equal members of the Working Group, and their perspectives and priorities are included in the final recommendations.

Stage(s) of Research Process: 

• Study Planning: The report provides recommendations for talking with patients and community members to identify their top concerns and develop research ideas.
• Study Conduct: The report provides suggestions for ways to educate community members and community-based organizations on the importance of research, and ways to learn from community members to improve the study.
• Post-Study: The report describes opportunities for making research data accessible to the community, sustaining relationships beyond the end of individual studies, and building long-term research capacity among community partners.

Who Might Benefit:

• Researchers
  • Seeking to conduct community-engaged research can use the recommendations to inform their efforts.
  • Can learn how to build relationships with community organizations to set priorities, develop research ideas, and sustain relationships beyond the end of a single study.
• Patients, Caregivers, Patient Advocacy Groups, and Communities working with research teams could benefit from the partnerships that will result from the use of these recommendations. The report can also help them set expectations for researchers.

Key Takeaways and Examples in Practice:

• Community engaged research is needed to improve health equity and reduce health disparities.
• NIDDK now encourages community engaged research practices in more funding announcements.
• Inviting patients and community members to speak at scientific workshops can improve community engagement in research.
• The priorities of patients, caregivers, and others living with or at risk for diabetes, digestive, or kidney diseases are featured in call-out boxes throughout the report. This format makes it easy for readers to understand the values of those who will most benefit from the research.

This work was done with the direct support by each of the following partners who advance this work:

• The NIDDK Advisory Council’s Health Disparities and Health Equity Research Working Group (See Appendix D of the Report for Individual Members)

Keywords: Equitable Engagement; Collaborative Decision-Making; Sustainable Engagement & Capacity Building; Researchers

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Links to Relevant Resources:

• Pathways to Health for All – Report on NIDDK Website
• Pathways to Health for All – PDF Version of Report
• Contact NIDDK for Questions

Definitions for each engagement objective can be found in the glossary.

Good Participatory Practice (GPP) guidelines provide a blueprint for engaging patients, caregivers, and community members in research. The GPP guidelines were originally developed for HIV prevention clinical trials but are now used across multiple disease areas.

Following GPP is one way to conduct research that is important to the community, and they give researchers an opportunity to better align their ideas with community values. GPP guidelines also provide a framework for navigating questions and concerns if they occur during a research study.

Stage(s) of Research Process:

• Study Planning: The GPP guidelines include examples of how to understand the ideas and customs of communities, identify ways to communicate with the community, and how to work with community members to make research decisions.
• Study Conduct: The GPP guidelines help researchers plan for managing any obstacles experienced during the research study. Some of these recommendations include identifying a community member who can advise on solutions, keeping clear records of the study, and tracking the team’s responses to any problems.
• Post-Study: The GPP guidelines provide suggestions for advertising the trial and for sharing the results after the trial is finished. Some of these recommendations include identifying community members who can help communicate study results, determining the preferred ways community members want to learn about the study, and planning for post-study communication at the beginning of the research project.

Who Might Benefit:

• Researchers
  • Can use the GPP guidelines to better understand how to engage communities in research that is important to them and to determine if their approach was successful.
  • Can use the online course available on the GPP website to learn about the guidelines and how to use them in their research.
• Patients, Caregivers, Patient Advocacy Groups, and Communities may use the guidelines to hold researchers and research institutions accountable for good community engagement or implement parts of the guidelines directly.

Key Takeaways and Examples in Practice:

• GPP describes a process for building trust between research teams and communities. This increased trust improves trial design, understanding of trial results, and how they are applied.
• One example of how the GPP improves research is seen in work done by the CAPRISA research center in South Africa. The CAPRISA research center provides ongoing support to the community including local schools, and this support has increased trust by the community who then provide honest feedback on what community members think about research and if they will participate.

• A second example of the GPP improving research is seen in a clinical trial to test a new drug from Gilead to prevent HIV infection. The study team created new ways for community members to provide input on the trial, and the study protocol was modified to accommodate their recommendations.
• A third example of GPP in research is seen in the NIAID Microbicide Trials Network’s study of a rectal microbicide. Through a collaborative consultation process that built trust within communities, they saw improved study participation, adherence, and results.

This work was done with the direct support by each of the following partners who advance this work:

• AVAC
• UNAIDS

Keywords: Collaborative Decision-Making; Methods of Engagement; Return of Research Value; Researchers, Patients, Caregivers, and Patient Advocacy Groups; Communities

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Links to Relevant Resources:

• Good Participatory Practice Website
• Good Participatory Practice: Guidelines for Biomedical HIV Prevention Trials (English)
• Good Participatory Practice Guidelines on UNAIDS Website
• Online Course Introducing Good Participatory Practice
• Good Participatory Practice: Evidence of Success

Definitions for each engagement objective can be found in the glossary.

The All of Us Participant Ambassador and Governance Model is one way to include participants’ ideas in the direction of a large research network. In this model, a participant is defined as someone who is enrolled in the research program. There are four different roles that a participant could fill. Each participant fills their role for three years and is paid for their time (between $4,200 and $8,000 per year).

Participants’ responsibilities vary based on their role but include assisting with choosing the direction for research projects, making sure that All of Us meets its mission, and providing feedback on All of Us activities.

Making this model work required careful action. The model was developed by the Engagement Core under an OTA award to Vanderbilt University Medical Center. To use this model effectively, the All of Us engagement core identified a national group of participant partners, provided clear expectations and many resources for participant partners to use, delivered adequate training to set participant partners up for success, and utilized supportive environments for ongoing engagement. This work is done in collaboration with the All of Us Division of Engagement and Outreach (DEO).

Stage(s) of Research Process

• Study Planning: Participant partners assist with study planning activities such as choosing research questions, identifying priority populations, providing feedback on research methods, and choosing study outcomes.
• Study Conduct: Participant partners assist with creating enrollment and consent processes that work best for diverse populations, identifying the best ways to recruit future participants, providing alternative ideas about what the research results may mean, and bringing attention to factors that may not have been examined during the research study.
• Post-Study: Participant partners assist with creating materials to help with explaining research results (e.g., videos), and providing input on the best way to deliver research results to participants.

Who Might Benefit:

• Researchers can use the All of Us model for integrating participants’ opinions throughout research network and project decision-making. The model provides ideas for how to select, pay, and engage participants in research.
• Patients, Caregivers, and Patient Advocacy groups and Communities can use the All of Us model as an example of good community engagement and support this approach when asked to work with researchers to create research studies and research networks.

Key Takeaways and Examples in Practice:

• The All of Us team found that sharing research results to All of Us staff and leadership first, then with Participant Partners, and lastly sharing them consortium-wide was a best practice.
• Transparency of all views is important. By sharing all results, including the less positive ones, researchers and participant partners can identify where they can improve.
• Participant partners should be involved in decision-making throughout the entire research program, just like other members of the team.
• True participant and community engagement must have some element of demonstrated change in behavior, practice, or culture on behalf of the researchers, the research process, or the research institution.

This work was done with the direct support by each of the following partners who advance this work:

• Consuelo H. Wilkins, MD, MSCI (Principal Investigator), Selena McCoy Carpenter, Alecia Malin Fair, and Kayla Somerville (project team) – all from Vanderbilt University Medical Center
• Elizabeth G Cohn, RN, PhD, FAAN (Co-I) – from Northwell Health Feinstein Institute for Medical Research
• Melody S. Goodman, PhD (Co-I) – from New York University

Keywords: Collaborative Decision-Making; Equitable Engagement; Return on Research Value; Methods of Engagement; Researchers; Communities

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Links to Relevant Resources:

• Publication Describing the All of Us Participant Ambassador Model
• Publication Describing How to Engage Stakeholders in Genomic Research
• Publication Describing How to Integrate Participants into Research Operations
• Publication Describing All of Us Participant Perspectives on the Return of Value in Research
• All of Us Annual Engagement and Outreach Report
• Contact the NIH All of Us Research Program Division of Engagement and Outreach at [email protected]

Definitions for each engagement objective can be found in the glossary.