Core 09: Ethics and Regulatory Knowledge Core

核心 09：道德和监管知识核心

• 批准号: 10677689
• 负责人: Leigh Lamonica
• 金额: $ 8.93万
• 依托单位: LSU PENNINGTON BIOMEDICAL RESEARCH CTR
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-15 至 2027-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10677689
• 关键词: Address; Advocacy; Area; Biometry; COVID-19 pandemic; Center for Translational Science Activities; Chronic Disease; Clinical Research; Clinical Sciences; Clinical Trials Design; Collaborations; Communities; Community Outreach; Community Participation; Consultations; Data Analyses; Development; Disease; Disparity; Economics; Ethical Issues; Ethics; Excision; Feedback; Felis catus; Funding; Goals; Health; Human; IACUC; Institution; Institutional Review Boards; Interest Group; Knowledge; Learning; Louisiana; Mission; Modeling; Monitor; Outcome; Participant; Procedures; Process; Protocols documentation; Research; Research Infrastructure; Research Personnel; Research Project Grants; Research Subjects; Resources; Review Committee; Services; Site; Structure; Subgroup; Surveys; Training; Translational Research; Trust; animal safety; biomedical informatics; burden of illness; community engagement; design; early screening; improved; informal learning; interdisciplinary collaboration; meetings; multidisciplinary; responsible research conduct; social; sound; success; tool; working group

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.

项目摘要：道德和监管知识核心 路易斯安那州临床和实验室伦理与监管知识（ERK）核心的总体目标 转化科学中心（LA CaTS）是创建一个统一的系统方法来进行临床和 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设施的基础上， 在第一和第二个资助周期，通过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LA之间的依赖审查过程 CATS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改善IRB 通过整合一个程序来早期确定数据分析项目是否合适 监管依赖。2)继续与合作机构的监管/IRB办公室联系， 实施全州范围的监管网络，包括不属于LA CaTS的机构。该倡议将支持 扩大监管依赖审查，并将大大加强整个国家的努力，以支持多， 旨在解决健康成果和差距的机构和多学科项目。3)进一步 通过调整ERK核心，增强LA CaTS的使命，以促进试验的启动、实施和完成 作为疾病重点兴趣小组的一部分，与社区参与密切协调， 外展核心我们的具体目标旨在改善监管程序，并及早筛查任何 在社区实施研究项目之前，应考虑与研究项目相关的潜在伦理问题。 目标1。继续通过核心领导人磋商和机构联络提供监管支持 1）研究者和研究人员，2）各LA的监管审查委员会（IRB和IACUC） CaTS机构。目标二。继续将道德和监管资源纳入培训， 所有LA CaTS机构的研究者专业发展，重点是培训新的研究者 和我们的路线图学者对道德和负责任的研究和研究诚信行为。目标3。 建立和维护研究参与者倡导委员会，ERK核心工作组的一个分组， 它将作为潜在研究参与者的探测板， 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，以创建伦理和监管专家网络， 利用研究策略中概述的依赖机制; 2）提供正式和非正式的指导， 科学研究的完整性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广泛社区参与的重要性 通过一个新的咨询委员会来进行尊重社区关切的研究。