Engaging Diverse Stakeholders in Genomic/Precision Medicine Research: The All of Us Research Program Engagement Core

让不同的利益相关者参与基因组/精准医学研究：我们所有人研究计划的参与核心

• 批准号: 10789515
• 负责人: CONSUELO HOPKINS WILKINS
• 金额: $ 207.61万
• 依托单位: VANDERBILT UNIVERSITY MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10789515
• 关键词: All of Us Research Program; Area; Child; Childhood; Communities; Data; Enrollment; Evaluation; Exclusion; Feedback; Future; Genomics; Infrastructure; Mental Health; Minority; Minority Groups; Parents; Participant; Personal Satisfaction; Phase; Research; Research Personnel; Resources; Role; Science; Seminal; Surveys; Time; Voice; Work; aged; data access; design; evidence based guidelines; interest; marginalized population; member; patient engagement; precision medicine; programs; recruit; tool; young adult

In this Research Opportunity Announcement for Area of Interest 4, we describe the seminal work of establishing an infrastructure that operationalizes engagement of diverse research participants, distinct from recruitment/enrollment, and building on the foundational work of integrating research participants within the governance of research programs. Our approach and best practices are embedded into the Engagement Core’s five aims 1)Serve as the central hub for participant engagement – providing resources, expertise, and tools – to the All of Us Consortium for engaging participants as partners in the governance, priority setting, implementation, and evaluation of All of Us; 2) Effectively integrate participants, who reflect the broad diversity of All of Us, as partners in the governance, oversight, and evaluation of All of Us; 3) Capture and integrate the voices of diverse participants to enhance the design, implementation, and use of All of Us data, resources, and results; 4) Continuously assess the impact of participant engagement on all aspects and phases of All of Us including governance, design, implementation, and evaluation; and 5) Advance the science of engagement with an emphasis on engaging historically marginalized and minoritized groups. To date, our Engagement Core has established the infrastructure for participant engagement, by successfully integrating 81 participants (including 58 [72%] from minoritized and historically excluded communities into various All of Us governance roles including 12 members on the steering committee and 6 on the executive committee. Our Engagement Core has responded to 55 requests for engagement reflecting a range of activities including review of a mental health and well-being PPI survey and generating potential solutions to safely extend data access to non-traditional researchers in the All of Us Researcher Workbench. In the next phase, we will continue the multi-faceted strategies above and will expand our approaches to include voices currently missing from existing engagement such as young adults, and parents of children aged 18 and younger (critical given upcoming pediatric enrollment). We will also create new mechanisms such as a rapid feedback panels - a diverse group of participants who will provide time-sensitive feedback in critical areas. Ultimately, we will document successful strategies to contribute evidence-based recommendations for future large-scale studies with a substantial participant engagement component.

在本研究机会公告感兴趣的领域4中，我们描述了建立一个基础设施的开创性工作，该基础设施使不同研究参与者的参与变得可操作，与招募/注册不同，并建立在将研究参与者整合到研究项目治理中的基础工作之上。我们的方法和最佳实践嵌入到参与核心的五个目标中1）作为参与者参与的中心枢纽-为我们所有人联盟提供资源，专业知识和工具，使参与者成为我们所有人的治理，优先事项设定，实施和评估的合作伙伴; 2）有效地整合参与者，他们反映了我们所有人的广泛多样性，作为我们所有人治理，监督和评估的合作伙伴; 3）捕捉和整合不同参与者的声音，以加强设计、实施和使用All of Us数据、资源和成果; 4）持续评估参与者参与对All of Us各个方面和阶段的影响，包括治理、设计、实施和评估; 5）推进参与科学，重点关注历史上被边缘化和少数群体的参与。迄今为止，我们的参与核心已经建立了参与者参与的基础设施，成功地将81名参与者（包括58名[72%]来自少数民族和历史上被排斥的社区）整合到各种All of Us治理角色中，包括指导委员会的12名成员和执行委员会的6名成员。我们的参与核心已经回应了55个参与请求，反映了一系列活动，包括审查心理健康和福祉PPI调查，并生成潜在的解决方案，以安全地将数据访问扩展到All of Us Researcher中的非传统研究人员。在下一阶段，我们将继续上述多方面的战略，并将扩大我们的方法，以包括目前在现有参与中缺失的声音，如年轻人和18岁及以下儿童的父母（鉴于即将到来的儿科入组，这一点至关重要）。我们还将建立新的机制，如快速反馈小组-一个由各种参与者组成的小组，他们将在关键领域提供及时的反馈。最终，我们将记录成功的策略，为未来的大规模研究提供基于证据的建议，其中包括大量的参与者参与。