Imaging Human Brain Function with Minimal Mobility Restrictions: Administrative Supplement for Research on Bioethical Issues

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.

Project outcomes 

Aim 1 (literature reviews) was accomplished through the production of 12 internal memos reviewing international research guidelines and scholarly publications, and the compilation and synthesis of these reviews into a briefing book for participants at a virtual Working Group meeting held on April 6, 2020. The literature review included a comprehensive review of applicable ethical guidance for research in low- and middle-income countries (LMICs).

Aim 2 (interdisciplinary consultative workshop and publication) was also accomplished as planned. A 25-person Working Group met for a 5-hour virtual workshop by Zoom on April 6, 2020.

The Working Group included 10 scientists with experience conducting neuroscience research in remote or resource-poor communities, mostly outside the U.S., that had limited access to nearby scientific and medical expertise. Many of these research projects have taken place in remote field settings far from a major health center.

The workshop had three goals: (1) identify gaps and unresolved issues posed by field-based neuroimaging research in remote and resource-limited international contexts; (2) develop a conceptual roadmap of the highest-priority ELSI issues; and (3) identify next steps. The workshop sessions explored: current and likely uses cases, capabilities, and limitations of portable MRI technology, including the associated utilization of cloud-based platforms, machine learning, and AI; applicable law and regulation for international MRI research; informed consent protocols in the context of brain imaging in remote and resource-limited international contexts; and ELSI implications of the data flow, analysis, storage, and cloud-based data sharing methods to be utilized by field-based MRI. The meeting discussion addressed issues including the return of individual-specific research results and incidental findings to research participants.

After the meeting, a survey instrument was used to ascertain Working Group views on the technological feasibility and ethical, legal, and social issues (ELSI) posed by field-based MRI research in remote and resource-limited international contexts. The survey results served as the basis for two follow-up online meetings of the Working Group.

The workshop and follow-up meetings led to a co-authored (19 co-authors) publication of a peer-reviewed article in NeuroImage:

Title: Emerging ethical issues raised by highly portable MRI research in remote and resource-limited international settings
Co-authors: Francis X. Shen, JD, PhD; Susan M. Wolf, JD;* Supriya Bhavnani, PhD; Sean Deoni, PhD; Jed T. Elison, PhD; Damien Fair, PA-C, PhD; Michael Garwood, PhD; Michael Gee, MD, PhD; Sairam Geethanath, PhD; Kendrick Kay, PhD; Kelvin Lim, MD; Georgia Lockwood-Estrin, PhD; Monica Luciana, PhD; David Peloquin, JD; Karen Rommelfanger, PhD; Nicoline Schiess, MD, MPH; Khan Siddiqui, MD; Efraín Torres; J. Thomas Vaughan, PhD
Citation: NeuroImage, 238, 118210. https://doi.org/10.1016/j.neuroimage.2021.118210

The results of this project were presented at the 2021 BRAIN Initiative Investigators Meeting, at a panel (organized by Supplement PI, Francis Shen) entitled, Symposium: Achieving Diversity, Equity and Inclusion in Neuroscience Research in Under-Served, Under-Resourced and Remote Settings (June 16, 2021).

Summary (from meeting web site): NIH BRAIN will generate new opportunities for neuroimaging research in under-served, under-resourced, and remote settings. This can reach participants in urban and rural populations and low- and middle-income countries to better reflect racial, ethnic, and socioeconomic diversity. As neuroimaging moves into these field settings, this symposium will explore the importance of community engagement. The panel will  consider how to ensure that local communities are ongoing partners; how research can produce local value; and how NIH BRAIN can facilitate bi-directional learning.

The results were also presented by a poster at the 2021 BRAIN Initiative Investigators Meeting, entitled, The Need for ELSI Guidance on Mobile Neuroimaging Technologies: Stakeholder Perspectives of Scientists Developing the Technologies (Francis X. Shen, Frances Lawrenz, Susan M. Wolf, Michael Garwood).