An Equity and Justice-Informed Ethical Framework to Guide Incidental Findings in Brain Imaging Research
2. Incidental Findings in Brain Imaging Research
3. Ethical Aspects concerning Incidental Findings in Neuroscience Research
4. Towards a Conceptual Ethical Framework for Handling Incidental Findings in Brain Imaging Research
- Researchers are obligated to look for and disclose IFs only within the remit of basic care that research participants are entitled to per distributive justice principles . It is not required for researchers to screen for brain abnormalities on brain imaging nor are they obligated to follow up as this is not considered basic care as per the ethical principle of distributive justice .
- Research studies should have a distinct IFs committee comprising 1–2 investigators involved in the research study (including the chief/principal investigator), bioethicists, community representatives, including those belonging to marginalized backgrounds, as well as a neurologist (or a general physician) and clinical neuroradiologist not directly involved in the research study.
- All cases, or matters thereof, of IFs should be referred to the above committee. The matter of disclosing IFs should be considered considering the following matters: (a) clinical significance of IFs (this should factor in the severity of IFs and health risks); IFs with low, uncertain, or unknown clinical significance are not disclosed. Clinically significant IFs should be disclosed to the participant through their respective healthcare provider or family physician (FP), unless the research subject has refused such IFs , who can assess the disclosure considering the clinical history of the patient, which is privy to the severity of IFs and associated health risks. The adjudication or discussion on the clinical significance of IFs should be based on the standards of care or current recommendations or indications at the time of review of the merit of the case by the IF committee. (b) DEI considerations: Should there be no FP or healthcare provider, which may be the case for members of vulnerable communities, the disclosure of clinically significant IFs should be made directly to the concerned research subject . Besides, the committee may also consider DEI issues as they may apply on a case-to-case basis. For example, a person without an FP can be linked to an FP in close vicinity so that the IFs disclosure can then be made through the FP.
- Above information or policy about handling IFs and disclosure should be incorporated into the informed consent forms and research information booklet. Research participants should have the known risks of IFs explained. Participants should also be asked if they want to be informed about IFs. The consent form may also include a clause indicating exemption for legal liabilities to consequences of incidental findings .
- Data on the prevalence and severity of IFs should be included in research publications. Furthermore, the institutional research ethics board should be informed about IFs.
- Standardized education toolkits for discovery, reporting, ethical aspects, and disclosure surrounding IFs in brain imaging research should be developed.
- All researchers involved in the study, and members of the IF committee, should be provided education and training on IFs and communication skills on various considerations that may apply to the disclosure of IFs .
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
|MRI||magnetic resonance imaging|
|EUSTICE||equity and justice|
|HIV||human immunodeficiency virus|
|DEI||diversity, equity, and inclusion|
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Bhaskar, S.M.M. An Equity and Justice-Informed Ethical Framework to Guide Incidental Findings in Brain Imaging Research. Clin. Pract. 2023, 13, 116-124. https://doi.org/10.3390/clinpract13010011
Bhaskar SMM. An Equity and Justice-Informed Ethical Framework to Guide Incidental Findings in Brain Imaging Research. Clinics and Practice. 2023; 13(1):116-124. https://doi.org/10.3390/clinpract13010011Chicago/Turabian Style
Bhaskar, Sonu M. M. 2023. "An Equity and Justice-Informed Ethical Framework to Guide Incidental Findings in Brain Imaging Research" Clinics and Practice 13, no. 1: 116-124. https://doi.org/10.3390/clinpract13010011