Safety First: Recognizing and Managing the Risks to Child Participants in Magnetic Resonance Imaging Research

Abstract

Specialized and up-to-date knowledge is required to identify and manage the risks associated with advanced biomedical research. Additional complexities need to be considered when the research involves infants or young children. In this article, we focus on recent information about the physical risks of pediatric magnetic resonance imaging research and highlight information gaps. With an eye to assisting institutional review boards and researchers, we consider strategies for the management of these risks and formulate key questions aimed at exposing hidden hazards. Institutional review boards should ask these questions, and researchers should bear them in mind as they develop research protocols.

Keywords:

• bioethics
• child
• ethics
• magnetic resonance imaging
• research
• safety
• safety management

Acknowledgments

The authors gratefully acknowledge the support of the Canadian Institutes for Health Research through a CIHR New Emerging Team Grant. The authors further wish to express their appreciation to Brad Abernethy, Matthew Kutcher, and members of the Neuroethics NET for helpful discussion and insightful comments.

Notes

¹While issues associated with the disclosure of risks to participants lie beyond the scope of this article, which focuses on risk identification and management, the questions listed at the end of each section could be used to guide the informed consent process between researchers and participants or their surrogate decision-makers.

²A search of ClinicalTrials.gov, using the search terms “neonate” and “MRI,” revealed 31 registered trials that are currently recruiting healthy and sick neonates (http://clinicaltrials. gov/ct2/search. Accessed April 8, 2009.)

³Many of these concerns apply also to critically ill older children who are patients in intensive care units.

⁴An MRI compatible device neither poses a physical hazard nor malfunctions in the MRI scanner.

⁵This study was conducted with involvement by manufacturers of the contrast agent.