Strengthening Stakeholder Engagement in Human Research Protections.

项目总结/摘要 伊利诺伊大学芝加哥分校（UIC）临床和转化科学中心（CCTS） 寻求催化转化研究，地方和国家，作为国家网络的一部分， 改善个人和人口健康。自2009年NIH首次资助以来， CCTS的总体目标和驱动重点是改善人口健康，特别是 在少数民族和服务不足的人群中。我们的高质量多学科临床和 翻译研究，跨越翻译范围，包括社区的优势 利益攸关方的参与。在我们的组织基础和成功记录的基础上， UIC CCTS处于有利地位，可以通过与其他中心合作， 支持国家CTSA活动，并为社区参与做出独特贡献 对弱势群体和得不到充分服务的人群进行研究。在学术研究机构中， 社区和患者利益相关者的参与现在越来越多地纳入个人 研究项目，但它通常不是研究的道德和监管监督的一部分。 这可能导致对研究参与者的保护不足或过度。加强协作 人类研究保护计划（HRPP）和机构级社区之间的关系 参与活动可以使利益相关者的观点对研究伦理产生影响 监督，但在如何加强关系和努力方面还有很多东西要学。 更好地协调以加强对人类研究的保护。这份拟议的生物伦理学补充文件 UIC的临床和转化科学中心响应NIH的生物伦理学呼吁 开展研究，以建立可为今后政策方向提供信息的证据基础，重点是 研究监督和研究设计中的患者/参与者代表。这个的目标 项目的目的是确定、优先考虑和传播战略和资源， 利益攸关方参与研究伦理监督，重点是加强 人类研究保护计划（HRPPs）和机构之间的关系 社区参与活动。具体目标是：（1）制定一系列战略 HRPP可以实施，以增加利益相关者的观点纳入研究 道德监督; 2）就人权方案伙伴关系的优先战略达成共识， 在研究伦理监督中适当纳入利益相关者的观点。

Project Summary/Abstract The University of Illinois at Chicago (UIC) Center for Clinical and Translational Science (CCTS) seeks to catalyze translational research, locally and nationally, as part of a national network to improve individual and population health. Since our initial funding by the NIH in 2009, the overarching goal—and driving focus—of the CCTS is to improve population health, particularly among minorities and underserved populations. Our high-quality multidisciplinary clinical and translational research, spans the translational spectrum and includes strengths in community stakeholder engagement. Building on our organizational foundation and record of success, the UIC CCTS is well-positioned to make substantial contributions by collaborating with other hubs, supporting national CTSA activities, and making unique contributions to community-engaged research with vulnerable and underserved populations. Across academic research institutions, community and patient stakeholder engagement is now increasingly incorporated into individual research projects, yet it is not typically a part of ethical and regulatory oversight of research. This may lead to under- or over-protection of research participants. Increased collaboration between human research protections programs (HRPPs) and institution-level community engagement activities could bring stakeholder perspectives to bear on research ethics oversight, but there is much to learn about how relationships could be strengthened and efforts better coordinated to enhance human research protections. This proposed bioethics supplement to UIC’s Center for Clinical and Translational Science responds to NIH’s call for bioethics research to develop an evidence base that may inform future policy directions, focusing on patient/participant representation in research oversight and study design. The goals of this project are to identify, prioritize, and disseminate strategies and resources for increasing stakeholder engagement in research ethics oversight with a focus on strengthening relationships between human research protections programs (HRPPs) and institutional community engagement activities. The specific aims are to: 1) Generate a menu of strategies that HRPPs could implement to increase the inclusion of stakeholder perspectives in research ethics oversight; and 2) Foster consensus regarding priority strategies for HRPPs to increase appropriate inclusion of stakeholder perspectives in research ethics oversight.