Abstracts
Abstract
Large scale, multisite clinical research trials have been increasing in frequency. As it stands currently, a research project performed at multiple institutions requires ethics review at each institution. While local (institutional) review may be necessary in some instances, repetitive reviews may require unnecessary changes and not serve to further protect participants. Multiple ethics reviews of a single study have been shown to delay research and require, in some cases, significant resources in order to fulfill the requests of individual ethics boards. This literature review discusses the conceptual issues and outlines empirical research surrounding multisite ethics review from different jurisdictions, as well as alternative methods to streamline the ethics review process including reciprocal review, centralized review, and a proposed modification to the centralized review process.
Keywords:
- multisite research,
- human subject research,
- research ethics board,
- institutional review board,
- reciprocal review,
- centralized review,
- multisite ethics review
Résumé
Les essais cliniques multicentriques à grande échelle ont augmenté en fréquence. À l’heure actuelle, un projet de recherche réalisé dans plusieurs institutions nécessite une évaluation éthique pour chaque établissement. Bien que l’évaluation (institutionnelle) locale peut être nécessaire dans certains cas, les évaluations répétitives peuvent nécessiter des changements inutiles et ne servent pas à protéger davantage les participants. Il a été démontré que le fait d’avoir plusieurs évaluations éthiques d’une seule étude retarde la recherche et exige, dans certains cas, des ressources importantes afin de satisfaire aux demandes des différents comités d’éthique. Cette revue de la littérature aborde les questions conceptuelles et présente les recherches empiriques entourant l’évaluation éthique multicentrique de différentes juridictions. Elle aborde également les méthodes alternatives pour rationaliser le processus d’évaluation éthique, y compris l’évaluation réciproque et l’évaluation centralisée, ainsi qu'une proposition de modification du processus d’évaluation centralisé.
Mots-clés :
- recherche multicentrique,
- recherche sur des sujets humains,
- comité d’éthique de la recherche,
- comité d’évaluation institutionnel,
- évaluation réciproque,
- évaluation centralisée,
- avis éthique multicentrique
Appendices
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