Emerging ethical issues raised by highly portable MRI research in remote and resource-limited international settings

Francis X. Shen, Susan M. Wolf, Supriya Bhavnani, Sean Deoni, Jed T. Elison, Damien Fair, Michael Garwood, Michael S. Gee, Sairam Geethanath, Kendrick Kay, Kelvin O. Lim, Georgia Lockwood Estrin, Monica Luciana, David Peloquin, Karen Rommelfanger, Nicoline Schiess, Khan Siddiqui, Efrain Torres, J. Thomas Vaughan

Research output: Contribution to journalArticlepeer-review

Abstract

Smaller, more affordable, and more portable MRI brain scanners offer exciting opportunities to address unmet research needs and long-standing health inequities in remote and resource-limited international settings. Field-based neuroimaging research in low- and middle-income countries (LMICs) can improve local capacity to conduct both structural and functional neuroscience studies, expand knowledge of brain injury and neuropsychiatric and neurodevelopmental disorders, and ultimately improve the timeliness and quality of clinical diagnosis and treatment around the globe. Facilitating MRI research in remote settings can also diversify reference databases in neuroscience, improve understanding of brain development and degeneration across the lifespan in diverse populations, and help to create reliable measurements of infant and child development. These deeper understandings can lead to new strategies for collaborating with communities to mitigate and hopefully overcome challenges that negatively impact brain development and quality of life. Despite the potential importance of research using highly portable MRI in remote and resource-limited settings, there is little analysis of the attendant ethical, legal, and social issues (ELSI). To begin addressing this gap, this paper presents findings from the first phase of an envisioned multi-staged and iterative approach for creating ethical and legal guidance in a complex global landscape. Section 1 provides a brief introduction to the emerging technology for field-based MRI research. Section 2 presents our methodology for generating plausible use cases for MRI research in remote and resource-limited settings and identifying associated ELSI issues. Section 3 analyzes core ELSI issues in designing and conducting field-based MRI research in remote, resource-limited settings and offers recommendations. We argue that a guiding principle for field-based MRI research in these contexts should be including local communities and research participants throughout the research process in order to create sustained local value. Section 4 presents a recommended path for the next phase of work that could further adapt these use cases, address ethical and legal issues, and co-develop guidance in partnership with local communities.

Original languageEnglish (US)
Article number118210
JournalNeuroImage
Volume238
DOIs
StatePublished - Sep 2021

Bibliographical note

Funding Information:
Research reported in this publication was supported by a Bioethics Supplement from the National Institute of Biomedical Imaging and Bioengineering (NIBIB) of the National Institutes of Health (NIH) under Award Number U01EB025153-03S1. The content is solely the responsibility of the authors and does not necessarily represent the official views of NIBIB or NIH. GLE is funded by a Sir Henry Wellcome Post-doc fellowship (Wellcome Trust grant number: 204706/Z/16/Z). The University of Minnesota Institutional Review Board determined that the workshop and survey research activity described in this article were not research involving human subjects as defined by DHHS and FDA regulations (STUDY00009902, May 15, 2020). Thank you to all participants in the project's virtual workshop on The Ethical, Legal, and Social Implications of Rapidly Expanding Global Access to MRI, held on April 6, 2020. For research assistance, we thank Warren Cormack, Jacob Hauschild, and Caroline Sell. For administrative and logistics support, we thank Audrey Boyle and the University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences. The authors are responsible for the views expressed in this article. Those views do not necessarily represent the views, decisions, or policies of the institutions with which they are affiliated. Institutions are listed for author identification only.

Funding Information:
FXS and SMW disclose NIH/NIMH grant RF1MH123698 on “Highly Portable and Cloud-Enabled Neuroimaging Research: Confronting Ethics in Field Research with New Populations” (Shen, Wolf, Lawrenz, PIs). SD receives grant support from Nestlé Nutrition. DF is a patent holder on the Framewise Integrated Real-Time Motion Monitoring (FIRMM) software. He is also a co-founder of Nous Imaging Inc. The nature of this financial interest and the design of the study have been reviewed by two committees at the University of Minnesota. They have put in place a plan to help ensure that this research study is not affected by the financial interest. KR discloses that she is funded by The Kavli Foundation. KS is an employee of Hyperfine Research, Inc.

Funding Information:
To advance work on these ELSI issues, we conducted a structured, year-long neuroethics analysis, embedded within a larger collaborative project funded by the U.S. National Institutes of Health (NIH) Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative (Imaging Human Brain Function with Minimal Mobility Restrictions, NIH 3U01EB025153-03S1). The primary focus of the ELSI analysis was on field-based MRI research in remote and resource-limited international settings, when that research is led, or involves significant participation from, research teams that are not based in the local community.

Funding Information:
Research reported in this publication was supported by a Bioethics Supplement from the National Institute of Biomedical Imaging and Bioengineering (NIBIB) of the National Institutes of Health (NIH) under Award Number U01EB025153-03S1. The content is solely the responsibility of the authors and does not necessarily represent the official views of NIBIB or NIH. GLE is funded by a Sir Henry Wellcome Post-doc fellowship (Wellcome Trust grant number: 204706/Z/16/Z).

Publisher Copyright:
© 2021

Keywords

  • International research
  • Low- and middle-income countries (LMICs)
  • Neuroethics
  • Neuroimaging
  • Portable MRI

PubMed: MeSH publication types

  • Journal Article
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

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