Core 09: Ethics and Regulatory Knowledge Core

项目总结：伦理与监管知识核心 路易斯安那州临床和医疗中心伦理和监管知识(ERK)核心的首要目标 翻译科学中心(LA CATS)是创建一个统一的系统的方法来进行临床和 路易斯安那州的翻译研究。我们将在已建立的成功研究基础上再接再厉 在第一个和第二个资助周期内，将核心服务扩展到更多地点的更广泛的研究人员。 ERK核心建议实现以下目标：1)推进所有法律界的依赖审查进程 猫咪机构。作为实现这一目标的一部分，ERK核心将采取下一步措施来改进IRB 通过集成用于早期确定数据分析项目是否合适的过程来处理 对于监管的依赖。2)继续与伙伴机构的监管/内部审查机构办公室保持联系，以 实施全州范围的监管网络，将不属于洛杉矶CATS的机构包括在内。这一倡议将支持 监管依赖审查的扩大，将极大地加强全州支持多 旨在解决健康结果和差距的体制性和多学科项目。3)进一步 加强洛杉矶CATS任务，通过调整ERK核心来促进启动、进行和完成试验 作为关注疾病的兴趣小组的一部分，与社区参与密切协调的活动 和外展核心。我们的具体目标是改进监管流程，及早筛查任何 在研究项目进入社区实施之前，可能存在与研究项目相关的伦理问题。 目标1.继续通过核心领导人的协商和机构联络提供监管支助 至1)调查人员和研究人员；2)每个LA的监管审查委员会(IRB和IACUC) 猫咪机构。目标2.继续将道德和监管资源纳入培训和 洛杉矶所有CATS机构调查员的专业发展，重点是培训新的调查员 和我们的路线图学者关于道德和负责任的研究行为和研究诚信。目标3. 建立和维持一个研究参与者宣传委员会，这是ERK核心工作组的一个小组， 它将作为人类研究参与者，为潜在的研究参与者提供意见 宣传资源。我们将通过以下方式实现这些目标：1)进一步加强 机构IRB(和其他监管)办公室，以创建道德和监管专家网络，并 利用研究战略中概述的依赖机制；2)在以下方面提供正式和非正式指导 科学研究诚信和负责任的研究行为；以及3)解决社会和经济问题 参与研究工作的障碍和促进社区广泛参与重要性的障碍 在尊重社区关切的研究中，通过一个新的顾问委员会。

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.