The University of Rochester's Clinical and Translational Science Institute

项目摘要 转译研究产生了跨越临床和研究之间的伦理问题 伦理道德。研究和临床伦理的标准框架没有提供足够的指导 研究人员和临床医生试图解决这些复杂的问题。该项目旨在建立 翻译伦理方面的能力。在目标1中，我们建立了一个独特的伦理的证据基础 翻译研究人员面临的挑战。使用结合了以下内容的混合方法 标准哲学研究与利益相关者访谈，我们希望找出关键的伦理挑战 在转化性研究中，应用标准临床和研究伦理的成功或困难 这些挑战的框架，以及临床和研究伦理之间的交叉点。我们将(1) 采访15名知名翻译研究人员，以确定常见的道德挑战和 培训中的差距，(2)对生物伦理文献进行系统审查，以确定和描述其特征 在翻译中采用标准临床或研究伦理框架的优势和差距 背景，以及(3)对一个这样的问题(即管理)进行深入的哲学案例研究 以及对罕见疾病患者的研究)，以勾勒出一个框架，以应对横跨 从基础科学到临床护理的转化管道。在目标2中，我们开发、试点和评估 行动中的翻译伦理模块(团队)，以提高 新兴的翻译研究人员。我们将设计一系列模块来发展生物伦理方面的能力 在下一代翻译研究人员中进行推理。这些模块将成为新的 罗切斯特大学为新兴研究人员开设的课程，专门专注于导航 卫生从业者和科学家的双重伦理角色。这包括翻译研究中出现的问题。 如正确判断均衡、治疗误区、患者的临床管理等 对于罕见疾病，使用临床数据进行二次研究的伦理，以及科学和技术之间的平衡 确定性和政策倡导。该项目将采用以设计为基础的研究方法来开发和 评估课程，使用定性访谈、迭代设计和2024年春季课程的试点。 该项目的成功完成将导致(I)独特的伦理挑战的证据基础 翻译研究人员面临的问题，(Ii)一套开放的培训资源正在出现 翻译生命伦理学的研究人员(III)有效性、可持续性和 这些资源的吸引力，以及(4)提高了一名 新兴的研究领军人物。我们预计，我们对翻译伦理的调查将提供 科学家和卫生从业者需要概念和教学工具，因为他们负责任地工作 产生有益于患者和社区的知识和干预措施。

Project Summary Translational research generates ethical questions that cross the boundary between clinical and research ethics. Standard frameworks in research and clinical ethics do not provide adequate guidance to researchers and clinicians attempting to navigate these complex questions. This project aims to build capacity in translational ethics. In Aim 1 we establish an evidence base of the unique ethical challenges faced by translational researchers. Using a mixed methods approach that incorporates standard philosophical research with stakeholder interviews, we hope to identify the key ethical challenges in translational research, the success or difficulty of applying standard clinical and research ethics frameworks to those challenges, and points of intersection between clinical and research ethics. We will (1) interview a cohort of 15 established translational researchers to identify common ethical challenges and gaps in their training, (2) conduct a systematic review of the bioethical literature to identify and characterize the strengths and gaps of adopting standard clinical or research ethics frameworks in the translational context, and (3) generate an in depth philosophical case study on one such problem (i.e. the management and study of patients with rare diseases) to sketch a framework for navigating ethical challenges that cross the translational pipeline from basic science to clinical care. In Aim 2, we develop, pilot and evaluate the Translational Ethics in Action Modules (TEAM) to improve capacity in bioethical reasoning amongst emerging translational researchers. We will design a series of modules to develop capacity in bioethical reasoning amongst the next generation of translational researchers. The modules will form part of a new course at the University of Rochester for emerging researchers that is specifically focused on navigating the dual ethical roles of health practitioner and scientist. This includes problems arising in translational research such as appropriately judging equipoise, the therapeutic misconception, the clinical management of patients with rare diseases, the ethics of secondary research using clinical data, and the balance between scientific certainty and policy advocacy. The project will adopt a design-based research approach to developing and evaluating the course, using qualitative interviews, iterative design and a pilot of the course in Spring 2024. Successful completion of this project will result in (i) an evidence base of the unique ethical challenges faced by translational researchers, (ii) a set of open-educational resources for training emerging researchers in translational bioethics (iii) an evidence base for the effectiveness, sustainability and attractiveness of those resources, and (iv) improved capacity in translational bioethics amongst a cadre of emerging research leaders. We anticipate that our investigation of translational ethics will provide the conceptual and pedagogical tools scientists and health practitioners need as they work to responsibly generate knowledge and interventions that benefit patients and communities.