Strengthening Stakeholder Engagement in Human Research Protections.

项目摘要/摘要 伊利诺伊大学芝加哥分校临床与翻译科学中心(CCTS) 寻求促进地方和国家的翻译研究，作为国家网络的一部分，以 改善个人和人群健康。自从我们在2009年获得美国国立卫生研究院的第一笔资金以来， CCTS的总体目标和主要重点是改善人口健康，特别是 在少数族裔和未得到充分服务的人群中。我们高质量的多学科临床和 翻译研究，跨越翻译领域，包括社区优势 利益相关者的参与。以我们的组织基础和成功记录为基础， UIC CCTS处于有利地位，可以通过与其他枢纽合作做出实质性贡献， 支持国家CTSA活动，为社区参与做出独特贡献 对弱势和服务不足的人群进行研究。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融入到个人 研究项目，但它通常不是对研究的道德和监管监督的一部分。 这可能会导致对研究参与者的保护不足或过度。增强协作 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，但关于如何加强关系和努力，还有很多需要学习的地方 更好地协调以加强对人类研究的保护。这份建议的生命伦理学补充材料 UIC的临床和转译科学中心响应NIH的生命伦理呼吁 研究以开发可能为未来政策方向提供信息的证据基础，重点是 患者/参与者在研究监督和研究设计中的代表性。这样做的目的是 项目的目的是确定、确定优先顺序并传播战略和资源，以增加 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(HRPP)与制度的关系 社区参与活动。具体目标是：1)生成一个策略菜单 人力资源规划方案可以实施，以增加将利益攸关方的观点纳入研究 道德监督；和2)促进就人权伙伴关系优先战略达成共识，以增加 适当地将利益相关者的观点纳入研究伦理监督。

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.