Ethics & Regulatory Knowledge Core

项目摘要：道德和监管知识核心 道德和监管核心(ERKC)的总体目标是 路易斯安那州临床和翻译科学中心(LA CATS)正在创建一种统一的系统方法来 在路易斯安那州进行临床和转化性研究。我们将在成功研究的基础上再接再厉 在第一个融资周期内建立基础设施，并将ERKC服务扩展到更广泛的 更多地点的研究人员。ERKC KCA建议实现以下目标：1)促进 审查所有洛杉矶CATS机构的流程。作为实现这一目标的一部分，ERKC将采取下一步 通过整合早期确定项目是否 适用于协助或放弃的审查。2)实施全州监管网络，将机构包括在内 不是洛杉矶猫的一部分。这一倡议将支持扩大便利审查，并将大大增强 全州努力支持旨在解决卫生问题的多机构和多学科项目 结果和差距。3)进一步加强洛杉矶CATS任务，以促进发起、实施和 通过调整ERKC活动完成试验，将其作为“转化医学”工作组的一部分 与健康知识核心、社区参与和外展核心以及临床协调 研究资源。我们的具体目标是改进监管过程并及早解决 研究项目在社区实施之前面临的伦理问题。目标1.整合 通过以下方式将简化的审评模型或完全依赖的审评模型纳入初始方案设计和审评流程 与1)调查人员和研究人员以及2)监管机构密切合作和协商 每个洛杉矶CATS机构的审查委员会(IRB或IACUC)。目标2.将道德和监管结合起来 资源用于1)洛杉矶所有CATS机构的调查人员培训和专业发展；2) 社区咨询委员会，将作为研究主题的宣传资源。目标3.促进 通过生物统计学和生物医学信息学的跨学科分析进行临床试验的伦理设计。 将特别注意建立同意程序和对以下人员的参与者保护 生物库和大型数据集。我们将通过以下方式实现这些目标：1)扩大培训范围，包括 负责任的研究行为和研究参与者倡导2)指导调查人员开发 信任与安全网患者和提供者的关系，以提高临床试验和 生物资源库；3)将我们的活动与其他洛杉矶猫的KCA相结合，以提供更全面和 协调调查人员培训，目标是简化监管流程和指导 与洛杉矶CATS生物信息学专家和其他KCA合作，开发透明和适当的 关于基因组学和生物银行的知情同意文件，这是洛杉矶猫的一项新倡议。

PROJECT SUMMARY: ETHICS AND REGULATORY KNOWLEDGE CORE The overarching goal of the Ethics and Regulatory Core (ERKC) Key Component Activity (KCA) 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 funding cycle and expand ERKC services to a wider variety of researchers in more sites. The ERKC KCA proposes to achieve the following goals: 1) Advance the facilitated review process among all LA CaTS institutions. As part of achieving this goal, the ERKC will take the next steps in improving the IRB process by integrating a procedure for early determination of whether a project is appropriate for facilitated or ceded review. 2) Implement a state-wide regulatory network to include institutions not part of LA CaTS. This initiative will support the expansion of facilitated 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 ERKC activities as part of a “Translational Medicine” working group in close coordination with the Health Literacy Core, Community Engagement and Outreach Core, and Clinical Research Resources. Our specific Aims are designed to improve the regulatory process and address early on the ethical issues research projects face before being implemented in the community. Aim 1. To integrate facilitated review models or full reliance review models into the initial protocol design and review process by working in close collaboration and consultation with 1) investigators and research staff and 2) the regulatory review committees (IRB or IACUC) at each LA CaTS institution. Aim 2. To incorporate ethics and regulatory resources into 1) training and professional development of investigators at all LA CaTS institutions and 2) community advisory boards, which will act as the research subject advocacy resource. Aim 3. To promote the ethical design of clinical trials through interdisciplinary analysis with biostatistics and biomedical informatics. Particular attention will be given to the creation of consent procedures and participant protection for biorepository and large data sets. We will accomplish these aims by: 1) expanding training to include responsible conduct of research and research participant advocacy 2) guiding investigators in developing trusting relationships with safety-net patients and providers to improve participation in clinical trials and biorepositories; 3) aligning our activities with the other LA CATS KCAs to provide more comprehensive and coordinated investigators training with a goal of streamlining the regulatory process and 4) guiding collaboration with LA CaTS bioinformatics experts and other KCAs to develop transparent and appropriate informed consent documents on genomics and bio banking, a new initiative for LA CaTS.