Undergraduate medical students. Simulation-based activity to conduct the informed consent process for health research studies

Abstract Introduction Training through medical simulation allows for continuous learning under controlled conditions. Simulation-based training activities can be used simultaneously with other educational strategies to strengthen the attitudinal skills needed to develop an informed consent process in the context of health research. Objective To facilitate learning in undergraduate medicine students, and to evaluate their competences to carry out an informed consent process in a scenario that resembles reality. Materials and methods In this semi-longitudinal study, a simulation-based activity was conducted with 136 medical students of the fourth (Group A) and fifth year (Group B) of the Marist University of Merida, in southern Mexico. Results The mean score for both groups was 72.48 ± 1.05 (95% CI = 70.4–74.5); 86.2 ± 0.96 (95% CI = 84.2–88.0); and 77.7 ± 0.72 (95% CI = 76.3–79.1), in the pre-test, the simulation and the post-test, respectively. The students of group A self-evaluated their performance with 3.93/5.00, and those of Group B, 4.04/5.00. Discussion This study showed that Group A students did not score lower on simulation-based activity when compared to students in Group B, suggesting that before the fifth year of undergraduate medical education, students could properly develop an informed consent-process for health research if they receive early education about medical ethics and research bioethics. Issues related to bioethics in human health research can be included as soon as medical students initiate research methodology courses.