Building capacity in translational research ethics among early stage investigators: a pilot course on the ethics of the clinician-researcher dual-role

Purpose: Translational researchers often occupy dual roles as clinicians and investigators, creating ethical tensions that are inadequately addressed by traditional training in research ethics or clinical ethics.This study aimed to design, pilot, and evaluate a short course to improve early stage translational researchers' self-efficacy in conflicts between their roles as researchers and clinicians or community advocates.Methods: An inter-disciplinary team at University of Rochester developed an 8-module course aimed at improving self-efficacy in moral decision-making.Using Rest's Four Component Model, the eight course sessions focused on moral sensitivity, reasoning, motivation, and action with respect to dual-role ethical issues such as expanded trial access, ancillary obligations, and return of results.Thirteen early stage clinician-researchers participated in a pilot course delivered in person from March through May 2024.Evaluation included pre-and post-course surveys and focus groups.Results: Participants demonstrated significant improvements in self-efficacy for moral sensitivity (mean increase 0.79, p<.001), moral reasoning (mean increase 0.80, p=.001), and ability to take moral action (mean increase 0.67, p=.002).Participants' attitudes towards translational research were generally stable.Focus groups revealed that participants highly valued the course, but desired greater curricular cohesion and more guidance on implementation strategies. Conclusions:This pilot course successfully enhanced early-career translational researchers' self-efficacy for ethical decision-making in dual-role contexts.The findings suggest that ethics education tailored to translational researchers' unique challenges can meaningfully improve their capacity to navigate complex ethical tensions.