Empowering the Participant Voice: Collaborative Infrastructure and Validated Tools for Collecting Participant Feedback to Improve the Clinical Research Enterprise

摘要/摘要 与研究参与者合作，以了解和改进他们的研究经验 参与是研究人员、机构及其联邦赞助商的高度优先事项。然而， 研究人员通常缺乏工具、专业知识和技术来轻松收集参与者的反馈 需要以参与者响应的方式量身定做研究。一个简短、高质量的收集工具 参与者体验数据已经可用，越来越多的调查人员想要使用它。这个 研究参与者感知调查(RPPS)是在许多参与者的参与下开发的， 其他利益相关者。在数千名研究参与者中进行了测试，RPPS包含了高度可靠的 研究经验的一套可操作的衡量标准，包括沟通、同意、信任和 其他。该项目的目标是创建创新的协作基础设施来进行调查 任何调查人员或机构都可以轻松使用。这一创新项目将形成一项协作努力 在六个临床翻译科学奖(CTSA)机构和其他利益攸关方中，谁将 结合他们的优势开发新的简化基础架构，以实现常规收集 研究参与者对其研究经验的反馈。合作者和利益相关者 我将开发一个框架，其中包括一套通用标准，以确保结果数据 不同机构之间的可比性，针对用例的建议，以说明数据如何 有价值，并将结果返回给利益相关者、用户指南和可视化结果的工具 一个仪表盘，并进行关键分析。每个协作站点将调查一个或多个 改进基础设施的方法和共享反馈，并展示他们如何参与的示例 反馈可用于评估和改进研究实践。新的基础设施将共享 通过RedCap共享库广泛地吸引了CTSA和其他RedCap用户，其中所有 组件可以免费下载。使用案例的基础架构和结果将是 通过演示文稿和出版物传播。新的基础设施将具有高度的可持续性， 因为全球所有CTSA和3500多家机构都在使用RedCap。共享调查数据的能力 保密将允许创建基准，以比较内部和跨 机构。RPPS调查、基础设施和基准用户的学习协作将 使其能够利用跨网络的数据的力量来确定改进的优先事项 研究和协作测试创新的Impact。能够随时收集所需数据 以参与者和社区响应的方式定制实践，有可能改善 研究参与者体验，改进同意流程，改进代表招聘，以及 加快研究完成，推进人类健康发现。

Summary/Abstract Partnering with research participants in order to understand and improve their experiences in research participation is a high priority for research investigators, institutions and their federal sponsors. However, researchers often lack the tools, expertise, and technology to easily collect the participant feedback needed to tailor studies in participant-responsive ways. A short, high quality validated tool for collecting participant experience data is already available, and increasingly investigators want to use it. The Research Participant Perception Survey (RPPS) was developed with the input of many participants and other stakeholders. Tested in thousands of research participants, the RPPS contains a highly reliable set of actionable measures of the research experience, including communication, consent, trust, and others. The goal of this project is to create innovative collaborative infrastructure to make the survey easy for any investigator or institution to use. This innovative project will form a collaboration effort among six Clinical Translational Science Awardee (CTSA) institutions and other stakeholders, who will combine their strengths to develop new streamlined infrastructure to enable routine collection of research participants’ feedback about their research experiences. The collaborators and stakeholders will develop a framework including a common set of standards to make sure the result data are comparable across institutions, recommendations for use cases to illustrate how the data can be valuable, and for returning results to stakeholders, user guides, and the tools to visualize the results on a dashboard and to conduct key analyses. Each collaborating site will survey participants in one or more ways and share feedback to refine the infrastructure and to showcase their examples of how participant feedback can be used to evaluate and improve research practices. The new infrastructure will be shared widely with the CTSAs and other REDCap users through the REDCap Shared Library, where all the components can be downloaded without charge. The infrastructure and results of use cases will be disseminated through presentations and publications. The new infrastructure will be highly sustainable, as REDCap is used by all CTSAs and over 3500 institutions worldwide. The ability to share survey data confidentially will allow the creation of benchmarks for comparison of practices within and across institutions. A learning collaborative of users of the RPPS surveys, infrastructure, and benchmarks, will make it possible to leverage the power of data across networks to identify priorities for improving research and collaborate on testing innovations for impact. The ability to readily collect the data needed to tailor practices in participant- and community-responsive ways, has the potential to improve the research participant experience, improve the consent process, improve representative recruitment, and accelerate study completion, to advance discoveries in human health.