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A Comprehensive Analysis of MRI Research Risks: In Support of Full Disclosure

Published online by Cambridge University Press:  02 December 2014

Jennifer Marshall
Affiliation:
Health Law Institute, Dalhousie University, Halifax, NS
Toby Martin
Affiliation:
St. Amant, Centre, Winnipeg, MB
Jocelyn Downie
Affiliation:
Health Law Institute, Dalhousie University, Halifax, NS
Krisztina Malisza
Affiliation:
Institute for Biodiagnostics, National Research Council, Winnipeg, MB, Canada
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Abstract

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Magnetic resonance imaging (MRI) procedures have been used for over 20 years. This modality is considered relatively safe and holds great promise. Yet, MRI has a number of risks. In order for MRI research to meet the Canadian standard of disclosure, the investigator must communicate and make note of all risks in their research protocols and consent forms. Those creating and reviewing research protocols and consent forms must take notice of the different circumstances under which MRI poses a risk. First, this paper will describe the current standard of disclosure in Canada for research participants. Second, the paper will provide a comprehensive synthesis of the known physical and psychological risks associated with MRI. Third, the paper will provide recommendations concerning areas for further investigation and risk reduction strategies. This information will thus equip researchers and research ethics boards (REBs) with the criteria needed for the composition of research protocols that meet the Canadian disclosure standard.

Résumé:

RÉSUMÉ:

L'imagerie par résonance magnétique (IRM) est utilisée en clinique depuis plus de 20 ans. Elle est considérée relativement sût très prometteuse. Cependant l'IRM comporte certains risques. L'investigateur doit noter tous les risques dans ses protocoles de recherche et les indiquer dans les formulaires de consentement, afin que la recherche en IRM rencontre les standards canadiens sur la divulgation. Ceux qui élaborent les protocoles de recherche et les formulaires de consentement ainsi que ceux qui les révisent doivent signaler dans quelles conditions l'IMR comporte des risques. Cet article décrit d'abord les standards canadiens actuels de divulgation aux sujets de recherche, puis présente une synthèse extensive des risques physiques et psychologiques connus associés à l'IRM et enfin formule des recommandations, dans le corps de l'article et sous forme de table sommaire, concernant les aspects qui doivent être investigués davantage et les stratégies de réduction des risques. Cette information fournira aux chercheurs et aux comités d'éthique de la recherche les critères nécessaires à la rédaction de formulaires de consentement et de protocoles de recherche qui rencontrent les standards canadiens de divulgation.

Type
Review Article
Copyright
Copyright © The Canadian Journal of Neurological 2007

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