This Administrative Supplement for Research on Bioethical Issues, SU01EB025153-03S1, extended the integration of senior bioethics personnel into the parent grant’s (1U01EB025153-01, Garwood, parent grant PI) development of a highly portable magnetic resonance imaging (MRI) device.
This supplement was part of a trajectory of work, starting with a previous Neuroethics Administrative Supplement (3U01EB025153-02S2) for the same U01. In the earlier supplement, we focused on the ethical, legal, and social implications (ELSI) of field-based neuroimaging research in the United States. This second supplement, on which we report now, allowed us to expand our scope to consider international ELSI issues.
It is estimated that 90% of the world’s population, especially those in low- and middle-income countries (LMICs) and low-resource communities, does not have access to MRI. This “diagnostic divide” is driven by the high cost of setting up bulky MRI machines in rural, low-resource communities. The highly portable MRI technology being developed by the parent grant offers the promise of addressing these brain imaging inequities. But to fulfill this promise, robust analysis of the pertinent ethical, legal, and societal implications (ELSI) of the field-based neuroimaging is needed. We will pursue two Aims based on seven key issues identified through our analysis in the first neuroethics supplement: (i) autonomy and informed consent; (ii) privacy; (iii) establishing local capacity to administer and interpret MRIs in LMICs, (iv) potential bias of interpretive algorithms in diverse populations; (v) return of individual-specific research results (IRRs) and incidental (or secondary) findings (IFs) to research participants; (vi) responding to participant requests for access to their data; and (vii) post-trial obligations of researchers.
Aim #1: What gaps exist in current ethical and regulatory frameworks applicable to the international use of highly mobile MRI in research and clinical settings in low-resource settings? We used a scoping review method to address this question, and conducted comparative legal and policy analysis of laws / regulations applicable to portable MRI in international contexts.
Aim #2: Based on the analysis conducted in Aim #1, we hosted a structured consultative workshop of multidisciplinary stakeholders to identify the likely use cases for highly mobile neuroimaging in international contexts, and provide a conceptual roadmap of the attendant ELSI issues. Aim #2 produced the first publication in this emerging field to specifically provide guidance on ELSI issues in highly portable neuroimaging in international research and clinical applications: Emerging Ethical Issues Raised by Highly Portable MRI Research in Remote and Resource-Limited International Settings. NeuroImage 2021;238:118210, doi:10.1016/j.neuroimage.2021.118210.