We have combined a growing body of evidence from the peer-reviewed literature with open dialogue among a wide range of professionals from different specialties to analyze different approaches for handling incidental findings in brain imaging. In considering the various scenarios for our analyses, we remain mindful of the distinction between research subjects who volunteer after recruitment and are compensated, and neurologic patients who have a therapeutic relationship with a caregiver. Strict standards for handling incidental findings are not appropriate given the present state of knowledge about them. Investigators must be guided by their IRBs, be clear about the approaches they choose, and work closely with the medical community, as appropriate, to achieve a beneficial result. We conclude, therefore, with the points summarized in , which provide practical guidelines for achieving these goals.
Practical guidelines for researchers and clinicians conducting brain imaging research
Substantial work remains to be done toward fully understanding the challenges of incidental findings and the details of responding to them. We did not, for example, consider studies involving secondary uses of clinical or research scans in which previously undetected findings are uncovered. These will require separate and thoughtful consideration given the time lapse and likelihood that scans may be obtained for such a project under a waiver of consent.
The development of a database of incidental findings and an atlas of different types of incidental findings would be a valuable medical resource in advancing our knowledge of incidental findings. Given the non-invasiveness of many neuro-imaging methods, it is now possible to scan the same subjects repeatedly. However, this possibility represents a source of consideration for future work on incidental findings, as it may lead to an underestimation of the occurrence of incidental findings if people with normal scans are enrolled in multiple studies while others with findings only enter one study. Taking into consideration the logistics and complexities of confidentiality, a mechanism for tracking repeat vs single-time volunteers is needed to ensure that further data on neurologic incidental findings accurately reflect their occurrence.
Protecting human subjects and patients in research is of paramount importance, and key to the discussion of incidental findings are trust and reciprocity in a scientific process that has made important advances in furthering the understanding of mind and behavior and in realizing immeasurable benefits in the diagnosis and treatment of neurologic and psychiatric disease. To preserve this trust, researchers and physicians involved in brain research have an ethical duty to consider the psychological, social, and medical contexts subjects bring to the research setting. It is imperative that the design of brain imaging research and other applications accommodate these extended dimensions of brain research.