Strengthening Stakeholder Engagement in Human Research Protections.

加强利益相关者对人类研究保护的参与。

• 批准号: 10363791
• 负责人: Robin J. Mermelstein
• 金额: $ 15.99万
• 依托单位: UNIVERSITY OF ILLINOIS AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-15 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10363791
• 关键词: Adoption; Attitude; Automobile Driving; Award; Bioethics; Chicago; Clinical; Clinical Research; Clinical Sciences; Collaborations; Communication; Communities; Consensus; Consent; Delphi Study; Empirical Research; Ensure; Ethical Issues; Ethical Review; Ethics; Fostering; Foundations; Funding; Future; Goals; Guidelines; Health; Human; Illinois; Individual; Institution; Institutional Review Boards; Interview; Journals; Lead; Learning; Methods; Minority Groups; Participant; Patients; Peer Review; Phase; Policies; Positioning Attribute; Process; Publications; Regulation; Research; Research Design; Research Ethics; Research Project Grants; Resources; Social Values; Structure; Translational Research; Underserved Population; United States National Institutes of Health; Universities; Ursidae Family; Voice; Vulnerable Populations; career networking; clinical center; community engaged research; community engagement; design; evidence base; improved; member; multidisciplinary; population health; prevent; programs; stakeholder perspectives; success; symposium; translational pipeline

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.

项目概要/摘要 伊利诺伊大学芝加哥分校 (UIC) 临床与转化科学中心 (CCTS) 寻求促进地方和国家的转化研究，作为国家网络的一部分 改善个人和人口健康。自 2009 年 NIH 首次资助我们以来， CCTS 的总体目标和驱动重点是改善人口健康，特别是 少数民族和服务不足的人群。我们高质量的多学科临床和 转化研究，跨越转化范围并包括社区的优势 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，可以通过与其他中心合作做出重大贡献， 支持国家 CTSA 活动，并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。跨学术研究机构， 社区和患者利益相关者的参与现在越来越多地融入个人 研究项目，但它通常不是研究伦理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 参与活动可以让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，还有很多东西需要学习 更好地协调以加强人类研究保护。本提议的生物伦理学补充 UIC 临床和转化科学中心响应 NIH 对生物伦理​​学的呼吁 研究开发可以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。本次活动的目标 项目的目的是确定、优先考虑并传播战略和资源，以增加 利益相关者参与研究伦理监督，重点是加强 人类研究保护计划（HRPP）与机构之间的关系 社区参与活动。具体目标是： 1）生成策略菜单 HRPP 可以实施以增加利益相关者观点在研究中的纳入 道德监督； 2) 就 HRPP 的优先战略达成共识，以增加 在研究伦理监督中适当纳入利益相关者的观点。