Residents as Research Subjects: Balancing Resident Education and Contribution to Advancing Educational Innovations.

Background: Research in education advances knowledge and improves learning, but the literature does not define how to protect residents' rights as subjects in studies or how to limit the impact of their participation on their clinical training. Objective: We aimed to develop a consensual framework on how to include residents as participants in education research, with the dual goal of protecting their rights and promoting their contributions to research. Methods: A nominal group technique approach was used to structure 3 iterative meetings held with the pre-existing residency training program committee and 7 invited experts between September 2018 and April 2019. Thematic text analysis was conducted to prepare a final report, including recommendations. Results: Five themes, each with recommendations, were identified: (1) Freedom of participation: participation, non-participation, or withdrawal from a study should not interfere with teacher-learner relationship (recommendation: improve recruitment and consent forms); (2) Avoidance of over-solicitation (recommendation: limit the number of ongoing studies); (3) Management of time dedicated to participation in research (recommendations: schedule and proportion of time for study participation); (4) Emotional safety (recommendation: requirement for debriefing and confidential counseling); and (5) Educational safety: data collected during a study should not influence clinical assessment of the resident (recommendation: principal investigator should not be involved in the evaluation process of learners in clinical rotation). Conclusions: Our nominal group technique approach resulted in raising 5 specific issues about freedom of participation of residents in research in medical education, over-solicitation, time dedicated to research, emotional safety, and educational safety.