Discovery and informing research participants of incidental findings detected in brain magnetic resonance imaging studies: Review and multi‐institutional study

Abstract Background Brain imaging studies using magnetic resonance imaging ( MRI ) sometimes reveal incidental findings ( IF s) that might be relevant to some of the health issues in research participants. Although professional communities have discussed how to manage these IF s, there is no global consensus on the concrete handling procedures including how to inform participants of IF s. Methods First, this study reviewed previous studies for the number of IF s 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. Results Both the review and multi‐institutional study showed that IF s 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 IF s may differ by institution. Conclusions Our results suggest that in order to ensure informing the participants of high urgency IF s, 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 IF s might affect their understanding and acceptance of IF s, which are related to managing risks of false “clean bill of health” or psychological impacts of informing IF s, further research focusing on communication of IF s is needed.