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

项目摘要/摘要：人类主体和监管(伦理)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 支持对人类受试者进行以公平为重点的实施研究。实施科学 与社区参与的、以股票为重点的研究的目标高度一致。这项研究的设计和 然而，实施科学中使用的方法挑战了目前对调查人员和IRB的培训 委员会。为了应对以公平为中心的实施科学所面临的独特伦理挑战， 伦理学核心将协助项目负责人、先导研究和其他调查人员了解和满足 与其具体实施项目相关的道德和法规要求。 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KUMC的其他实施人员进行道德咨询 研究人员：a)在其协议中确定与伦理和设计相关的挑战；b)鼓励项目领导 与首席执行官核心合作，以获得利益相关者对研究设计和实施的意见；以及c)制定 实施科学和人类受试者的公平性为每项研究制定计划，以解决以下方面的研究 涉及弱势群体和新颖的研究设计。核心也将确立伦理导航 服务。道德导航员具有监管实践和要求方面的专业知识，将协助项目 Leads和其他调查人员进行实施研究以制定协议/同意，与 IRB，提交方案，修改方案，并保持关于所有与人类受试者相关的培训和 最后期限。 目标2.策划和提供培训，以支持执行科学和公平方面的伦理研究。 道德操守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 恰如其分。它还将加强KUMC现有的负责任的研究和良好临床行为 实践培训，包括执行情况和差异研究的实例；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，以建立适当审查的机构能力。 目标3.与行政核心合作，评估道德绩效。 道德操守核心将收集行政核心所需的持续数据，以评价核心服务。在……里面 此外，道德核心将进行详细的内部评估，以解决优势、劣势和 核心服务需要改进的领域。

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.