Abstract
BackgroundBrain imaging studies using magnetic resonance imaging (MRI) sometimes reveal incidental findings (IFs) that might be relevant to some of the health issues in research participants. Although professional communities have discussed how to manage these IFs, there is no global consensus on the concrete handling procedures including how to inform participants of IFs.MethodsFirst, this study reviewed previous studies for the number of IFs discovered in brain imaging studies using MEDLINE. Second, a multi‐institutional study determined the number of IF discoveries and evaluated the method of informing participants at multiple institutions, which participated in a national brain science project in Japan.ResultsBoth the review and multi‐institutional study showed that IFs with a high urgency level were discovered in 0–2.0% of participants, including healthy volunteers, and that the rate of IF discovery in general was higher in studies conducted in elderly population. Moreover, multi‐institutional study suggested the criteria used to judge whether or not to inform participants of IFs may differ by institution.ConclusionsOur results suggest that in order to ensure informing the participants of high urgency IFs, physicians who are capable of interpreting brain images clinically should review all brain images, and the establishment of a support system is required for brain imaging studies at nonmedical institutions. Since the method of informing participants of IFs might affect their understanding and acceptance of IFs, which are related to managing risks of false “clean bill of health” or psychological impacts of informing IFs, further research focusing on communication of IFs is needed.
Highlights
Brain science studies have recently achieved great advances with the use of brain imaging technologies such as magnetic resonance imaging (MRI)
While referring to a systematic-review of incidental findings (IFs) in MRI by Morris et al (2009), we focus on only the research setting and cover the follow-up study data after IF finding
This present study provides support for the basic data that should be provided in the informed consents (ICs) process for future brain imaging studies, including the fact that highly urgent findings might be discovered in approximately 2% of research participants at maximum, including healthy volunteers
Summary
Brain science studies have recently achieved great advances with the use of brain imaging technologies such as magnetic resonance imaging (MRI). There has been little research that compared the number of IFs discovered at different institutions or examined the feasibility of employing a standardized IF handling procedure, despite the fact that many studies are conducted at multiple institutions as large-scale collaborative projects. Given this situation, we set two objectives for this study; first, to review already published empirical studies for the number of IFs discovered during brain MRI and analyze their characteristics, and second, to find out the number of IFs, and the status and method of informing participants of their IFs among multiple institutions. While referring to a systematic-review of IFs in MRI by Morris et al (2009), we focus on only the research setting and cover the follow-up study data after IF finding
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