Louis-Philippe Thibault1, Claude Julie Bourque2, Thuy Mai Luu3, Celine Huot4, Genevieve Cardinal5, Benoit Carriere6, Amelie Dupont-Thibodeau7, Ahmed Moussa8. 1. is a Student, Master's in Medical Education Program, Harvard Medical School, and a Pediatrician, Department of Pediatrics, CHU Sainte-Justine, Montreal, Quebec, Canada. 2. is an Assistant Professor and a Researcher, Department of Pediatrics, Centre for Applied Health Sciences Education, Faculty of Medicine, Université de Montréal, Quebec, Canada. 3. is an Associate Clinical Professor, Department of Pediatrics, and Clinician-Scientist, CHU Sainte-Justine Research Center, Faculty of Medicine, Université de Montréal. 4. is a Full Clinical Professor and Researcher, Department of Pediatrics and CHU Sainte-Justine Research Center, Faculty of Medicine, Université de Montréal. 5. is Chair of the Research Ethics Board and Manager, Research Ethics Office, CHU Sainte-Justine. 6. is an Associate Professor and the Director of Medical Education, CHU Sainte-Justine, Department of Pediatrics, Faculty of Medicine, Université de Montréal. 7. , is an Assistant Professor and a Researcher, Department of Pediatrics, CHU Sainte-Justine Research Center, Faculty of Medicine, Université de Montréal. 8. is an Associate Professor, Department of Pediatrics, a Clinician-Scientist, CHU Sainte-Justine Research Center, and Director, Center for Applied Health Sciences Education, Faculty of Medicine, Université de Montréal.
Abstract
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.
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.