Background: Few physicians view informed consent as a critical component of the physician-patient relationship or as a way to improve individual and population health. We hypothesized that formal education about informed consent would affect first-year pediatrics residents' knowledge and attitudes. Method: Twenty-seven first-year pediatrics residents participated in a randomized controlled trial with a wait-list control group. The one-hour interactive intervention consisted of a lecture, video, and small-group discussion. Outcomes were measured after randomization at baseline and after the intervention group received the intervention. Data were analyzed using multivariate analysis and between and within group t tests. Qualitative data were obtained after the wait-list control group's exposure to the intervention. Results: The quantitative analyses demonstrated that the intervention yielded statistically significant improvements in the measured outcomes. The qualitative analyses confirm the quantitative findings. Conclusion: A formal session on informed consent in the pediatrics residency educational program positively affects residents' knowledge and attitudes about informed consent.
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