Description of the Research
As the detail and quality of neuroimaging scans improves the issue of IFs in neuroimaging research is increasingly recognized in ethics literature. IFs are defined as findings of potential medical significance discovered outside the purpose of a research scan. In order to create feasible and adoptable policies for managing IFs, institutions must gather more empirical stakeholder information to consider the needs of all those impacted by disclosure.
Research Question/Thesis
Identify the specific needs, preferences, and expectations of the stakeholders impacted by returning neuroimaging IFs to research participants, specifically within the context of an active imaging center that conducts a formal review of all research magnetic resonance imaging scans by a trained radiologist and all findings, regardless of medical significance, are returned to participants.
Methods
Six key stakeholder groups were identified to participate in focus group: participants, parents of child participants, investigators, IRB members, physicians, and community members. A total of 151 subjects attended these discussions. Transcripts were analyzed 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 IFs as it grants certain health and emotional benefits to participants. All stakeholders also recognized 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 IFs 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 IF disclosure.
Next Steps
Overall this data supports the ethical demand for investigators to manage IFs, but the downstream impact on the research institution and the healthcare system remain unclear. Further empirical data is still needed on the actual impact of this full disclosure model, as well as greater investigation of all current models of IF management.