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Abstract
Unknown harms are by their nature difficult to communicate. While magnetic resonance imaging (MRI) has known risks (e.g., metal projectiles, dislodgement of medical implants), this imaging modality also has potential unknown long-term negative health effects associated with its static magnetic fields. We carried out a research ethics board (REB) file review of previously approved MRI research studies and found that unknown risks were either left undisclosed or were inadequately disclosed to research participants and REBs. This article outlines issues raised by our REB file review and suggests steps that should be taken in order to satisfactorily communicate information about potential unknown harms of MRI.
ACKNOWLEDGMENTS
The author is grateful to the Institute of Neurosciences, Mental Health and Addiction (INMHA) of the Canadian Institutes of Health Research (CIHR) for their generous financial support through the Neuroethics New Emerging Team (NET) grant. The author would also like to thank NET members for their thoughtful comments on earlier versions of this article.
Notes
1. Tesla is a unit measurement that refers to the magnetic field strength of the magnet. (1 Tesla is about 20,000 times greater than the Earth's naturally occurring magnetic field.)
2. Significant risk is defined in this guidance document as the “potential for serious risk to the health, safety, or welfare of a subject.” Nonsignificant risk is vaguely defined as “not meeting the definition of significant risk.”
CFR: Title 45 Code of Federal Regulations, Part 46.