Implementation Science and Equity: Human Subjects & Regulatory (ETHICS) Core

项目概要/摘要：人类受试者和监管（伦理学）核心 道德核心的目的是为COBRE成员和更广泛的KUMC社区提供有针对性的 支持开展以人类为对象的以公平为重点的实施研究。实施科学 与社区参与，以公平为重点的研究目标高度一致。研究设计和 然而，实施科学中使用的方法对研究人员和IRB的当前培训提出了挑战 委员会。为了应对进行公平意识的实施科学的独特道德挑战， 伦理核心将协助项目负责人、试点研究和其他研究者了解和满足 与其具体实施项目有关的道德和监管要求。 目标1.建立实施研究伦理咨询服务。 核心领导层将与项目负责人和其他KUMC实施人员进行伦理咨询 研究人员：a）在其方案中确定伦理和设计相关的挑战; B）鼓励项目负责人 与首席执行官核心合作，就研究设计和实施征求利益相关者的意见;以及c）制定 人类受试者中的科学与公平实施每项研究的计划，以解决研究的各个方面， 涉及弱势群体和新颖的研究设计。核心还将建立道德导航 的服务.道德操守导航员具有监管实践和要求方面的专业知识，将协助项目 负责人和其他研究人员进行实施研究，以制定方案/知情同意书，与 IRB，提交方案，修订方案，并保持所有人类受试者相关培训的最新信息， 最后期限 目标2.策划和提供培训，以支持实施科学和公平的道德研究。 伦理核心将确定相关的内部和外部培训，并将研究人员与培训联系起来， 适当它还将加强KUMC现有的负责任的研究行为和良好的临床试验， 实践培训包括实施和差异研究的例子;纳入证据 关于结构性歧视，以及与隐性偏见有关的综合练习。核心将提供IRB 对成员进行这些研究方法方面的培训，以建立进行适当审查的机构能力。 目标3。与行政核心合作，评估道德操守绩效。 伦理核心将收集管理核心所需的持续数据，以评估核心服务。在 此外，道德操守核心将进行详细的内部评估，以解决优势，劣势， 核心服务的改进领域。

PROJECT SUMMARY/ABSTRACT: HUMAN SUBJECTS & REGULATORY (ETHICS) CORE The purpose of the ETHICS Core is to provide COBRE members, and the broader KUMC community, targeted support for conducting equity-focused implementation research with human subjects. Implementation science is highly consistent with the goals of community-engaged, equity-focused research. The study designs and methods used in implementation science, however, challenge the current training of investigators and IRB committees. To meet the unique ethical challenges of conducting equity-minded implementation science, the ETHICS core will assist Project Leads, pilot study, and other investigators with understanding and meeting the ethical and regulatory requirements related to their specific implementation projects. Aim 1. Establish the Implementation Research Ethics Consultation Service. Core leadership will conduct Ethics Consultations with Project Leads and other KUMC implementation researchers to: a) identify ethical and design-related challenges in their protocols; b) encourage Project Leads to work with the CEO Core to get stakeholder input on research design and implementation; and c) develop an Implementation Science and Equity in Human Subjects Plan for each study to address aspects of research that involve vulnerable populations and novel research design. The Core will also establish the Ethics Navigation service. The ETHICS Navigator, with expertise in regulatory practices and requirements, will assist Project Leads and other investigators conducting implementation research to develop protocols/consent, interact with the IRB, submit protocols, revise protocols, and remain up to date on all human subjects-related trainings and deadlines. Aim 2. Curate and provide trainings to support ethical research in Implementation Science and Equity. The ETHICS Core will identify relevant internal and external trainings and link researchers with trainings as appropriate. It also will enhance KUMC’s existing Responsible Conduct of Research and Good Clinical Practice trainings to include examples of implementation and disparities research; incorporate evidence regarding structural discrimination, and integrated exercises related to implicit bias. The Core will provide IRB member training in these research approaches to build institutional capacity for appropriate review. Aim 3. Collaborate with the Administrative Core to evaluate ETHICS performance. The ETHICS Core will collect ongoing data required by the Administrative Core to evaluate Core services. In addition, the ETHICS Core will conduct a detailed internal evaluation to address strengths, weaknesses, and areas for improvement for Core services.