The University of Rochester's Clinical and Translational Science Institute

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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.