title: Informed consent for MRI and fMRI research: analysis of a sample of Canadian consent documents.
abstract: BACKGROUND
  Research ethics and the measures deployed to ensure ethical oversight of research (e.g., informed consent forms, ethics review) are vested with extremely important ethical and practical goals. Accordingly, these measures need to function effectively in real-world research and to follow high level standards.
  
  
  METHODS
  We examined approved consent forms for Magnetic Resonance Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) studies approved by Canadian research ethics boards (REBs).
  
  
  RESULTS
  We found evidence of variability in consent forms in matters of physical and psychological risk reporting. Approaches used to tackle the emerging issue of incidental findings exposed extensive variability between and within research sites.
  
  
  CONCLUSIONS
  The causes of variability in approved consent forms and studies need to be better understood. However, mounting evidence of administrative and practical hurdles within current ethics governance systems combined with potential sub-optimal provision of information to and protection of research subjects support other calls for more scrutiny of research ethics practices and applicable revisions.
authors.affiliation: Neuroethics Research Unit, Institut de recherches cliniques de Montréal, Canada.
authors.forename: Nicole
authors.initials: N
authors.lastname: Palmour
authors.forename: William
authors.initials: W
authors.lastname: Affleck
authors.forename: Emily
authors.initials: E
authors.lastname: Bell
authors.forename: Constance
authors.initials: C
authors.lastname: Deslauriers
authors.forename: Bruce
authors.initials: B
authors.lastname: Pike
authors.forename: Julien
authors.initials: J
authors.lastname: Doyon
authors.forename: Eric
authors.initials: E
authors.lastname: Racine
mesh_terms: D002170:Canada; D032882:Comprehension; D032962:Consent Forms / Q000941:ethics / Q000592:standards; D028744:Ethics Committees, Research; D006801:Humans; D033162:Incidental Findings; D007258:Informed Consent / Q000941:ethics*; D008279:Magnetic Resonance Imaging / Q000941:ethics; D033281:Nontherapeutic Human Experimentation / Q000941:ethics; D035842:Research Subjects; D012189:Retrospective Studies