The Raison d'Être of Mutual Recognition: An Analysis of the 2015 Reform to Research Ethics Review Policies, Processes and Problems in Québec
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Abstract
Ethics review is a pre-requisite to conducting research involving humans in Canada, and indeed in most international jurisdictions. The Tri-Council Policy Statement on Ethical Conduct for Research Involving Humans (TCPS2) serves as the national policy framework for research ethics review in Canada, and outlines three potential oversight models: independent, delegated and reciprocal. While the independent model preserves institutional oversight of research, it contributes to a duplicative system that can unduly delay research and impose barriers to research collaboration. This analysis centres on a 2015 reform to the policy model of research ethics review for collaborative, multi-site studies in the province of Québec. Informal interviews with key informants supplemented a document analysis of provincial research ethics policies using the comparative framework proposed by Lavis and colleagues. Consolidating bureaucratic structures and preserving locally-relevant review studies that span multiple sites remain among the most pressing challenges to transitioning from an independent model, and could provide reference for other provinces that have, or are currently in the process of such a transition.
L'évaluation éthique est un passage obligé de toute recherche sur sujets humains au Canada, ainsi que dans la plupart des pays. L'énoncé de politique des trois conseils sur l'éthique de la recherche avec des êtres humains (EPTC2) joue le rôle de cadre national de réglementation de l'évaluation éthique de recherche au Canada, et identifie trois modes de régulations potentiels : indépendant, délégué, et réciproque. Alors que le modèle indépendant garantit la régulation de la recherche par l'institution, il contribue aussi à un système de duplication pouvant indûment retarder la recherche et pose des obstacles à la collaboration inter-centrique. La présente analyse porte sur une réforme du modèle de politique d'évaluation éthique des études collaboratives multi-sites menée en 2015 au Québec. Des entretiens informels avec des informateurs clés ont complété une analyse de documents sur les politiques provinciales d'éthique de la recherche suivant le cadre comparatif proposé par Lavis et collègues. Créer des structures administratives consolidées tout en préservant des évaluations éthiques pertinentes au plan local pour des recherches multi-centriques reste le défi le plus pressant pour sortir du modèle indépendant, mais pourrait fournir un cadre de référence pour d'autres provinces ayant accompli ou entamé ce processus de transition.
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