The University of Rochester's Clinical and Translational Science Institute

罗切斯特大学临床与转化科学研究所

• 批准号: 10791573
• 负责人: Martin S Zand
• 金额: $ 30.78万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-08-15 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10791573
• 关键词: Adopted; Advocacy; Awareness; Basic Science; Bioethics; Case Study; Clinical; Clinical Data; Clinical Ethics; Clinical Management; Clinical Sciences; Clinical Trials; Communities; Competence; Complex; Consent; Dentistry; Effectiveness; Equilibrium; Equipoise; Ethical Issues; Ethics; Faculty; Goals; Health; Intervention; Interview; Knowledge; Learning Module; Literature; Measurement; Methods; Participant; Patient advocacy; Patients; Philosophy; Physicians; Policies; Postdoctoral Fellow; Rare Diseases; Recording of previous events; Research; Research Ethics; Research Personnel; Research Project Grants; Resources; Role; Sampling Biases; School Nursing; Science; Scientist; Series; Training; Translating; Translational Research; Universities; Work; clinical care; cohort; design; education resources; evidence base; improved; iterative design; medical schools; next generation; population health; skills; success; systematic review; therapeutic misconception; tool; translational pipeline; translational scientist; welfare

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.

项目摘要 转化研究产生了跨越临床和研究边界的伦理问题 伦理研究和临床伦理学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 翻译伦理能力。在目标1中，我们建立了一个独特的伦理证据库， 翻译研究者面临的挑战。采用混合方法， 标准的哲学研究与利益相关者访谈，我们希望确定关键的道德挑战 在转化研究中，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。我们会（1） 采访一组15名知名翻译研究人员，以确定共同的伦理挑战， （2）对生物伦理学文献进行系统的审查， 在转化过程中采用标准临床或研究伦理框架的优势和差距 背景下，（3）产生一个深入的哲学案例研究对这样一个问题（即管理 和罕见疾病患者的研究），以勾勒出一个框架， 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 行动中的转化伦理模块（TEAM），以提高生物伦理推理的能力， 新兴的翻译研究者。我们将设计一系列模块，以发展生物伦理方面的能力。 下一代翻译研究人员的推理。这些模块将构成新的 罗切斯特大学为新兴研究人员开设的课程，专门侧重于导航 健康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 如平衡的正确判断、治疗误区、病人的临床处理等 罕见疾病，使用临床数据进行二次研究的伦理学，以及科学 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， 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）独特的道德挑战的证据基础 翻译研究者面临的问题，（ii）一套开放式的培训资源正在出现 （iii）为有效性、可持续性和可持续性提供证据基础， 这些资源的吸引力，以及（iv）提高了 新兴的研究领导者。我们期望我们对翻译伦理学的研究将提供 科学家和卫生从业人员需要的概念和教学工具， 产生有益于患者和社区的知识和干预措施。

项目成果

Risk of Diabetes Mellitus Among Medicaid Beneficiaries in Hawaii.

• DOI: 10.5888/pcd14.170095
• 发表时间: 2017-11-22
• 期刊: Preventing chronic disease
• 影响因子: 5.5
• 作者: Li D;Chinn CC;Fernandes R;Wang CMB;Smith MD;Ozaki RR
• 通讯作者: Ozaki RR

The ecology of patient and caregiver participation in consultations involving advanced cancer.

• DOI: 10.1002/pon.4710
• 发表时间: 2018-06
• 期刊: Psycho-oncology
• 影响因子: 3.6
• 作者: Freytag J;Street RL Jr;Xing G;Duberstein PR;Fiscella K;Tancredi DJ;Fenton JJ;Kravitz RL;Epstein RM
• 通讯作者: Epstein RM

Lung cellular senescence is independent of aging in a mouse model of COPD/emphysema.

• DOI: 10.1038/s41598-018-27209-3
• 发表时间: 2018-06-13
• 期刊: Scientific reports
• 影响因子: 4.6
• 作者: Rashid K;Sundar IK;Gerloff J;Li D;Rahman I
• 通讯作者: Rahman I

Serotonin system genes contribute to the susceptibility to obesity in Black adolescents.

• DOI: 10.1002/osp4.511
• 发表时间: 2021-08
• 期刊: Obesity science & practice
• 影响因子: 2.2
• 作者: Meng Y;Groth SW;Hodgkinson CA;Mariani TJ
• 通讯作者: Mariani TJ

Airway gene-expression classifiers for respiratory syncytial virus (RSV) disease severity in infants.

• DOI: 10.1186/s12920-021-00913-2
• 发表时间: 2021-02-25
• 期刊: BMC medical genomics
• 影响因子: 2.7
• 作者: Wang L;Chu CY;McCall MN;Slaunwhite C;Holden-Wiltse J;Corbett A;Falsey AR;Topham DJ;Caserta MT;Mariani TJ;Walsh EE;Qiu X
• 通讯作者: Qiu X