Abstract
BackgroundResearch 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.MethodsWe examined approved consent forms for Magnetic Resonance Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) studies approved by Canadian research ethics boards (REBs).ResultsWe 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.ConclusionThe 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.
Highlights
Research ethics and the measures deployed to ensure ethical oversight of research are vested with extremely important ethical and practical goals
Many have called for further evidence-based research ethics practices in the light of apparent knowledge gaps and disquieting practical problems of ethics review. [5,6] In this paper, we report an examination of consent forms approved by Canadian Research Ethics Boards (REBs)
We were interested in comparing consent forms and understanding how they met basic requirements of the established Canadian Tri-Council Policy Statement (TCPS) as well as how they dealt with emerging issues in neuroscience research
Summary
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 These measures need to function effectively in real-world research and to follow high level standards. As a result, research ethics oversight makes it possible for research to be carried on in contemporary social and political environments where the failure to comply with basic norms of ethics and individual rights can lead to severe backlash on researchers, academic institutions, research To fulfill these important goals, the measures put in place to deal with research ethics, issues such as informed consent forms and ethics review need to work effectively in real-world research and to follow high level standards. As part of a broader study, we focused on neuroimaging research because Magnetic Resonance Imaging (MRI) and functional Magnetic Resonance Imaging (fMRI) research techniques often fit minimal risk criteria [7] but have, sparked debates related to the discovery of incidental findings [8,9] in research as well as to the capabilities of neuroprediction of personality and behaviour. [10,11]
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