Strengthening Stakeholder Engagement in Human Research Protections.

项目总结/文摘

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.