Pediatric Magnetic Resonance Research and the Minimal Risk Standard
Health Law and Policy, Magnetic resonance imaging (MRI), electronic technology, privileged glimpses into the human body
Magnetic resonance imaging (MRI) research combines powerful electromagnetic forces and sophisticated electronic technology to provide privileged glimpses into the human body. These features make the field a proving ground for ethical debate on research risks. They also create practical challenges for research ethics boards (REBs) engaged in the review of protocols and charged with the task of ensuring the safety and well-being of participants. Determining the level of risk associated with any given protocol can be one of the most difficult tasks. Thus, it is not surprising that REBs’ risk assessment involving MRI studies has been inconsistent, ranging from minimal to high risk.1
While an accurate assessment of risk is always important, it is especially so in pediatric research. We have previously examined the risks associated with pediatric magnetic resonance neuroimaging research.2Recognizing the pivotal nature of the minimal-risk standard, we now set out to determine under what circumstances pediatric magnetic resonance imaging research does or does not meet this standard. We did not address the issue of whether the physical, psychological, and other risks associated with incidental findings3in MRI research exceed the minimal-risk standard. The complexity of this issue warrants thorough treatment in a separate paper.
Michael Hadskis et al, “Pediatric Magnetic Resonance Research and the Minimal Risk Standard” (2011) 33:5 IRBEHR 1.