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Pediatric Magnetic Resonance Research and the Minimal-Risk Standard
While an accurate assessment of risk is always important, it is especially so in pediatric research. Recognizing the pivotal nature of the minimal-risk standard, we set out to determine under what circumstances pediatric magnetic resonance imaging research does or does not meet this standard. We found that while the physical and psychological risks that attend the MRI procedure do not exceed minimal risk, the sedation and contrast enhancement that are sometimes associated with MRI research do, as both exceed the level of risk encountered by typical, healthy children in their everyday experiences.

Key words/concepts: human subjects research, research ethics, pediatric research, vulnerable populations, magnetic resonance imaging (MRI) research, minimal-risk standard 

While an accurate assessment of risk is always important, it is especially so in pediatric research. Recognizing the pivotal nature of the minimal-risk standard, we set out to determine under what circumstances pediatric magnetic resonance imaging research does or does not meet this standard. We found that while the physical and psychological risks that attend the MRI procedure do not exceed minimal risk, the sedation and contrast enhancement that are sometimes associated with MRI research do, as both exceed the level of risk encountered by typical, healthy children in their everyday experiences.

Key words/concepts: human subjects research, research ethics, pediatric research, vulnerable populations, magnetic resonance imaging (MRI) research, minimal-risk standard 

Matthias H. Schmidt, Jennifer Marshall, Jocelyn Downie, and Michael R. Hadskis, "Pediatric Magnetic Resonance Research and the Minimal-Risk Standard," IRB: Ethics & Human Research 33, no. 5 (2011): 1-6.