Background Immense volumes of personal health information are required to realize the anticipated benefits of artificial intelligence in clinical medicine. To maintain public trust in medical research, consent policies must evolve to reflect contemporary patient preferences. Methods Patients were invited to complete a 27-item survey focusing on: broad versus specific consent; opt-in versus opt-out approaches; comfort level sharing with different recipients; attitudes towards commercialization; and options to track PHI use and study results. Results 222 participants were included in the analysis; (...) 83% were comfortable sharing PHI with researchers at their own hospital, although younger patients were more uncomfortable than older patients. While 56% of patients preferred broad consent, 38% preferred specific consent; 6% preferred not sharing at all. The majority of patients preferred to be asked for permission before entry into a contact pool. Again, this trend was more pronounced for younger patients. Approximately half of patients were uncomfortable sharing PHI with commercial enterprises. Most patients preferred to track PHI usage, with the highest proportion once again reported by the youngest patients. A majority of patients also wished to be notified regarding study results. Conclusions While most patients were willing to share their PHI with researchers within their own institution, many preferred a transparent and reciprocal consent process. These data also suggest a generational shift, wherein younger patients preferred more specific consent options. Modernizing consent policies to reflect increased autonomy is crucial in fostering sustained public engagement with medical research. (shrink)

Background Rapid ethical access to personal health information to support research is extremely important during pandemics, yet little is known regarding patient preferences for consent during such crises. This follow-up study sought to ascertain whether there were differences in consent preferences between pre-pandemic times compared to during Wave 1 of the COVID-19 global pandemic, and to better understand the reasons behind these preferences. Methods A total of 183 patients in the pandemic cohort completed the survey via email, and responses were (...) compared to the distinct pre-pandemic cohort ; all were patients of a large Canadian cancer center. The survey covered broad versus study-specific consent; opt-in versus opt-out contact approach; levels of comfort sharing with different recipients; perceptions of commercialization; and options to track use of information and be notified of results. Four focus groups were subsequently conducted to elucidate reasons motivating dominant preferences. Results Patients in the pandemic cohort were significantly more comfortable with sharing all information and biological samples, sharing information with the health care institution, sharing information with researchers at other hospitals, sharing PHI provincially, nationally and internationally compared to the pre-pandemic cohort. Discomfort with sharing information with commercial companies remained unchanged between the two cohorts. Significantly more pandemic cohort patients expressed a wish to track use of PHI, and to be notified of results. Thematic analysis uncovered that transparency was strongly desired on outside PHI use, particularly when commercialization was involved. Conclusions In pandemic times, patients were more comfortable sharing information with all parties, except with commercial entities, where levels of discomfort remained unchanged. Focus groups identified that the ability to track and receive results of studies using one’s PHI is an important way to reduce discomfort and increase trust. These findings meaningfully inform wider discussions on the use of personal health information for research during global crises. (shrink)

Contexte : Dans les systèmes de santé universitaires complexes, les projets d’amélioration de la qualité (AQ) destinés à améliorer les soins et l’apprentissage prolifèrent, mais il existe des différences considérables quant à la manière dont ces projets sont supervisés sur le plan éthique, voire même s’ils le sont. À la suite d’un volume élevé de projets soumis à l’un de nos comités d’éthique de la recherche (CER), mais considérés comme n’étant pas de la recherche et donc non éligibles à un (...) examen, des questions ont commencé à se poser au sein de notre organisation sur la manière dont les dimensions éthiques des projets d’AQ pourraient être évaluées et sur les approbations institutionnelles qui pourraient être nécessaires pour garantir la conformité avec les normes émergentes. Méthodes : Une enquête environnementale à méthodes mixtes a conduit à une analyse quantitative rétrospective des projets d’AQ de notre organisation, associée à des consultations qualitatives approfondies avec le personnel, les médecins et les apprenants de l’ensemble de notre réseau de santé. Les exemptions de CER ont été analysées à l’aide de diagrammes d’exécution afin d’évaluer les volumes de base des projets d’AQ, et des analyses thématiques ont été menées sur les notes de terrain de 133 consultations avec les parties prenantes. Résultats : Au cours d’une période de 34 mois, 117 lettres d’exemption du CER ont été émises pour des projets d’AQ. Les consultations ont mis en évidence la nécessité d’un processus d’évaluation éthique clairement défini pour les projets d’AQ, de structures de gouvernance appropriées et de possibilités d’identifier et d’atténuer les risques. Les personnes interrogées ont également évoqué l’impératif éthique de mener des initiatives d’AQ. Le présent document explique comment ces thèmes ont contribué à l’élaboration et à la mise en place de notre comité d’examen de l’amélioration de la qualité (CEAQ). Conclusion : Depuis 2020, plus de 840 projets ont été examinés par notre CEAQ, dans le but d’atténuer les risques pour les patients, le personnel et les équipes de projet d’AQ dans l’ensemble de l’UHN. (shrink)