Ethical, legal, and policy challenges in field-based neuroimaging research using emerging portable MRI technologies: guidance for investigators and for oversight

Abstract

Researchers are rapidly developing and deploying highly portable MRI technology to conduct field-based research. The new technology will widen access to include new investigators in remote and unconventional settings and will facilitate greater inclusion of rural, economically disadvantaged, and historically underrepresented populations. To address the ethical, legal, and societal issues raised by highly accessible and portable MRI, an interdisciplinary Working Group (WG) engaged in a multi-year structured process of analysis and consensus building, informed by empirical research on the perspectives of experts and the general public. This article presents the WG's consensus recommendations. These recommendations address technology quality control, design and oversight of research, including safety of research participants and others in the scanning environment, engagement of diverse participants, therapeutic misconception, use of artificial intelligence algorithms to acquire and analyze MRI data, data privacy and security, return of results and managing incidental findings, and research participant data access and control.

Keywords: neuroethics; neuroimaging; portable MRI; research ethics; rural and remote communities; vulnerable populations.

Figure 1

Illustration of how a portable MRI system might be deployed for field-based research in a school gymnasium. Image credit: Alexis Kocken.

Figure 2

Images of portable, accessible, and autonomous brain MRI scanners in use and in development. (1a) 64 mT scanner in ambulance. (1b) 64 mT scanner in research van. (1c) 1.5 T portable scanner. (1d) 80 mT table top scanner. (1e) 169.7 mT portable scanner prototype. (1f) 1.5 T scanner in portable cargo bin. These examples of portable, accessible, and AMRI technologies are illustrative, not exhaustive, of the new MRI technologies being developed. Reproduction of these images here is not meant to be an endorsement of any particular technology, but instead illustrates the range of devices being created. (1a) A research team is exploring the efficacy of using portable MRI in an ambulance. (1b) A research team has installed a portable MRI scanner in a cargo van that can arrive at a participant’s home and be ready for scanning in 5 min. (1c) An international research team has developed portable 1.5 Tesla MRI system technology with support from NIH BRAIN. (1d) A research team has developed a ‘prototype portable brain MRI scanner based on the Halbach permanent magnet described in Cooley et al. (2018) and configured for rotational encoding as in Cooley et al. (2015). The magnet weighs ~125 kg and achieves an 80 mT B0 field’. (1e) A research team has developed a portable, LF MRI head imager, with a permanent magnet array that generates strong magnetic fields inside the bore, but negligible magnetic fields outside the bore. This device uses an inward-outward ring array that supplies field in the axial direction. (1f) A research team has developed an accessible MRI system, including portable imaging suite, currently being developed to meet the WHO criteria for ‘accessibility’. Accessibility criteria will be met with a high temperature superconducting magnet and accompanying system incorporated into a standard shipping container.