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

实施科学与公平：人类受试者

• 批准号: 10557513
• 负责人: Jason Edwin Glenn
• 金额: $ 11.99万
• 依托单位: UNIVERSITY OF KANSAS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-11 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10557513
• 关键词: Address; Appropriateness Review; Area; Awareness; Categories; Centers of Research Excellence; Clinical; Collaborations; Communities; Competence; Complex; Consent; Consult; Consultations; Data; Discrimination; Disparity; Effectiveness; Equity; Ethics; Ethics Consultation; Evaluation; Exercise; Gender; Geography; Goals; Good Clinical Practice; Health; Health system; Human; Individual; Inequity; Institution; Institutional Review Boards; Lead; Leadership; Link; Medical; Mentors; Methods; Mind; Performance; Pharmaceutical Preparations; Pilot Projects; Protocols documentation; Race; Regulation; Research; Research Design; Research Methodology; Research Personnel; Schedule; Services; Structure; Training; Translating; Universities; Vulnerable Populations; Work; care delivery; community engaged research; community engagement; design; experience; falls; follow-up; health care delivery; health care quality; health equity; health inequalities; human subject; human subject protection; implementation research; implementation science; implicit bias; improved; innovation; institutional capacity; investigator training; meetings; member; novel; research to practice; responsible research conduct; social determinants; structural health determinants; vulnerable community

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.

项目摘要/摘要：人类受试者与监管（伦理）核心 道德核心的目的是为 COBRE 成员以及更广泛的 KUMC 社区提供有针对性的 支持以人类为对象进行以公平为中心的实施研究。 与社区参与、注重公平的研究目标高度一致。 然而，科学中使用的方法对研究人员和 IRB 目前的培训提出了挑战 为了应对进行具有公平意识的实施科学的独特道德挑战， 道德核心将协助项目负责人、试点研究和其他研究人员了解并满足 与其具体实施项目相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 实施进行道德咨询 研究人员： a) 确定其方案中与道德和设计相关的挑战 b) 鼓励项目负责人； 与首席执行官核心合作，获取利益相关者对研究设计和实施的意见；以及 c) 制定 在人类受试者中实施科学和公平 为每项研究制定计划，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。 道德导航员拥有监管实践和要求方面的专业知识，将为项目提供协助。 领导者和其他研究人员进行研究实施以制定协议/同意书，与 IRB，提交方案、修改方案并及时了解所有与人类受试者相关的培训和 最后期限。 目标 2. 策划并提供培训以支持实施科学和公平方面的伦理研究。 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： 它还将增强 KUMC 现有的负责任的研究行为和良好的临床。 实践培训包括实施示例和差异研究； 关于结构性歧视，以及与隐性偏见相关的综合练习，核心将提供 IRB。 对成员进行这些研究方法的培训，以建设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。 道德核心将收集管理核心所需的持续数据来评估核心服务。 此外，道德核心将进行详细的内部评估，以解决优势、劣势和问题 核心服务有待改进的领域。