A Just Standard: The Ethical Management of Incidental Findings in Brain Imaging Research

Graham, M., Hallowell, N., & Savulescu, J. (2021). 

Journal of Law, Medicine & Ethics, 49(2), 269-281. 

doi:10.1017/jme.2021.38

Abstract

Neuroimaging research regularly yields “incidental findings”: observations of potential clinical significance in healthy volunteers or patients, but which are unrelated to the purpose or variables of the study.

From the Conclusion

Appealing to considerations of distributive justice provides an answer for these difficult cases. Data about a patient’s brain that may be generated by a neuroimaging scan in a research context is not something a healthy participant is entitled to as a matter of basic care. Accordingly, a researcher has no obligation to generate this information by performing additional scans (i.e., to “look” for incidental findings). Similarly, if a researcher discovers an incidental finding of unknown or uncertain clinical significance, they are not required to refer a participant for follow-up. Screening for brain abnormalities is not a requirement of basic care, and the burdens of follow-up on the health system (given the potential benefits) are inconsistent with distributive justice. This approach thus avoids the problem of trying to determine whether disclosure (is likely to) promote autonomy or benefit the patient. Rather, it requires researchers to ensure that participants are not deprived of anything to which they are entitled as a matter of distributive justice. This includes all of the protections to which participants in research are normally entitled, as well as the disclosure of clinically significant incidental findings.

The research is here.

‘Ethical responsibility’ or ‘a whole can of worms’

Differences in opinion on incidental finding review and disclosure in neuroimaging research from focus group discussions with participants, parents, IRB members, investigators, physicians and community members

Caitlin Cole, Linda E Petree, John P Phillips, Jody M Shoemaker, Mark Holdsworth, Deborah L Helitzer
J Med Ethics doi:10.1136/medethics-2014-102552

Abstract
Purpose 
To identify the specific needs, preferences and expectations of the stakeholders impacted by returning neuroimaging incidental findings to research participants.

Methods
Six key stakeholder groups were identified to participate in focus group discussions at our active neuroimaging research facility: Participants, Parents of child participants, Investigators, Institutional Review Board (IRB) Members, Physicians and Community Members. A total of 151 subjects attended these discussions. Transcripts were analysed using principles of Grounded Theory and group consensus coding.

Results 
A series of similar and divergent themes were identified across our subject groups. Similarities included beliefs that it is ethical for researchers to disclose incidental findings as it grants certain health and emotional benefits to participants. All stakeholders also recognised the potential psychological and financial risks to disclosure. Divergent perspectives elucidated consistent differences between our ‘Participant’ subjects (Participants, Parents, Community Members) and our ‘Professional’ subjects (IRB Members, Investigators and Physicians). Key differences included (1) what results should be reported, (2) participants’ autonomous right to research information and (3) the perception of the risk–benefit ratio in managing results.

Conclusions 
Understanding the perceived impact on all stakeholders involved in the process of disclosing incidental findings is necessary to determine appropriate research management policy. Our data further demonstrate the challenge of this task as different stakeholders evaluate the balance between risk and benefit related to their unique positions in this process. These findings offer some of the first qualitative insight into the expectations of the diverse stakeholders affected by incidental finding disclosure.

The entire article is here.