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. 2012 Jun;17(6):313-6.

Ethics application protocols for multicentre clinical studies in Canada: A paediatric rheumatology experience

Loren A Matheson  1 , Adam M Huber, Aleasha Warner, Alan M Rosenberg
Affiliations

Ethics application protocols for multicentre clinical studies in Canada: A paediatric rheumatology experience

Loren A Matheson et al. Paediatr Child Health. 2012 Jun.

Abstract
in English, French

Introduction: Individual institutions govern research ethics applications and each must administer and regulate their own protocols. Variations in ethics review procedures and expectations among centres impose impediments to efficiently conducting multicentre studies.

Methods: Observations relating to preparing multisite ethics documents for a study conducted by Canadian paediatric rheumatology investigators are described. Research ethics applications from the 12 participating centres were compared.

Results: Although the applications were similar in their content, they differed in their formatting. All applications shared a commitment to ensuring that the study conformed to exemplary ethical standards.

Conclusions: There is wide variation in the multicentre clinical study ethics application process at the institutional level. Considering the common fundamental elements required by all ethics review boards, the present study conceptualized introducing a discipline-specific uniform ethics application process acceptable to all Canadian research ethics boards. This may be a more efficient strategy that could help lessen the burden of collaborative research.

Introduction: Chaque établissement régit des applications éthiques en recherche, et doit administrer et réglementer ses propres protocoles. Des variations dans les méthodes d’analyse éthique et les attentes entre les centres imposent des entraves à la tenue d’études multicentriques.

Méthodologie: Les auteurs décrivent les observations relatives à la préparation de documents éthiques multisites dans le cadre d’une étude menée par des chercheurs canadiens en rhumatologie pédiatrique. Ils ont comparé les applications éthiques de recherche utilisées dans les 12 centres participants.

Résultats: Même si le contenu des applications était similaire, leur mise en forme était différente. Dans tous les documents, on s’engageait à s’assurer que l’étude respectait des normes éthiques exemplaires.

Conclusions: On constate une importante variation dans le processus d’applications éthiques des études cliniques multicentriques des établissements. Étant donné les éléments fondamentaux communs exigés de tous les comités d’analyse éthique, la présente étude a conceptualisé l’adoption d’un processus d’applications éthiques uniforme propre à chaque discipline et acceptable au sein de tous les comités canadiens d’éthique de la recherche. Ce pourrait être une stratégie plus efficace qui pourrait rendre les recherches coopératives moins fastidieuses.

Keywords: Ethics; Multicentre studies; Paediatrics; Rheumatology.

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References

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