Core 09: Ethics and Regulatory Knowledge Core

项目总结：伦理与监管知识核心

Project Summary: Ethics and Regulatory Knowledge Core The overarching goal of the Ethics and Regulatory Knowledge (ERK) Core of the Louisiana Clinical and Translational Science Center (LA CaTS) is to create a unified systematic approach to the conduct of clinical and translational research across Louisiana. We will build on the successful research infrastructure established during the 1st and 2nd funding cycles by expanding Core services to a wider variety of researchers at more sites. The ERK Core proposes to achieve the following goals: 1) Advance the reliance review process among all LA CaTS institutions. As part of achieving this goal, the ERK Core will take the next steps in improving IRB processes by integrating a procedure for early determination of whether a data analysis project is appropriate for regulatory reliance. 2) Continue to make contacts with Regulatory/IRB offices at partner institutions to implement a state-wide regulatory network to include institutions not part of LA CaTS. This initiative will support the expansion of regulatory reliance review and will greatly enhance efforts across the state to support multi- institutional and multi-disciplinary projects designed to address health outcomes and disparities. 3) Further enhance the LA CaTS mission to facilitate initiation, conduct, and completion of trials by aligning the ERK Core activities as part of a Disease Focused Interest Group in close coordination with the Community Engagement and Outreach Core. Our Specific Aims are designed to improve the regulatory process and screen early for any potential ethical issues related to the research projects before they go into implementation in the community. Aim 1. Continue to provide regulatory support through consultations by the Core leaders and institutional liaisons to 1) investigators and research staff and 2) the regulatory Review Committees (IRB and IACUC) at each LA CaTS institution. Aim 2. Continue to incorporate ethics and regulatory resources into the training and professional development of investigators at all LA CaTS institutions with a focus on training new investigators and our Roadmap Scholars on the ethical and responsible conduct of research and research integrity. Aim 3. To establish and maintain a research participant advocacy board, a subgroup of the ERK Core Working Group, which will act as a sounding board for potential research participants by serving as a human research participant advocacy resource. We will accomplish these aims by: 1) further strengthening the connections among institutional IRB (and other regulatory) offices in order to create a network of ethics and regulatory experts and utilize the reliance mechanism outlined in the research strategy; 2) providing formal and informal instruction in scientific research integrity and the responsible conduct of research; and 3) addressing social and economic barriers to participation in the research effort and promotion of the importance of broad community participation in research that is respectful of community concerns through a new advisory board.