by Francis X. Shen, Susan M. Wolf, and Frances Lawrenz
The advent of highly portable MRI will transform brain research, but urgently requires ethical and legal guidance.
Rather than participants traveling to the MRI scanner, now the scanner can travel to them. This advance could enable research with remote and marginalized communities that have not previously been able to participate, and in doing so address the lack of representativeness and diversity in human neuroscience research.
The idea of a portable MRI (pMRI) scanner may sound like science fiction, but pMRI research has already been conducted outside a research participant’s home, in a moving ambulance, and at the bedside. There are also multiple efforts to develop open-source MRI machines “from the community to the community.” Last year one of us even conducted a community engagement education event in Boston featuring pMRI scanning just outside the doors of a community health center.
These remarkable developments pave the way for equally remarkable advances in treatments for brain disorders. But such promise will not be realized unless a number of unique pMRI ethical and legal challenges are addressed.
Working with an interdisciplinary expert Working Group supported by the NIH BRAIN Initiative Neuroethics program, our newly published article in the Journal of Law and the Biosciences (JLB) provides the first consensus guidance for addressing ethical, legal, and policy challenges in field-based neuroimaging research with highly portable MRI. We convened a national working group of experts spanning fields such as neuroscience, radiology, ethics, law, physics, and engineering. The Working Group met over the course of four years to address this question: what are the unique ethical and legal issues raised by pMRI research, and how can we most effectively address them? Our answers are presented in the new JLB article, Ethical, Legal, and Policy Challenges in Field-Based Neuroimaging Research Using Emerging Portable MRI Technologies: Guidance for Investigators and for Oversight.
Fig. 1. How a portable MRI system might be deployed for field-based research in a school gym.
Credit: Alexis Kocken
Fig 2. Examples of pMRI scanners, which range from 64mT to 1.5T. Left: 64mT MRI scanner installed in a “Scan Anywhere” van (Deoni et al. 2022) (image used with permission from Sean C.L. Deoni). Right: Portable 1.5T MRI system technology (image used with permission from Michael Garwood and Taylor Froelich).
Traditional MRI brain scanning has transformed neuroscience research. But because MRI scanners are expensive and require extensive infrastructure, they have mostly been housed in hospitals and large research institutions. As a result, access to MRI is limited and only researchers in select institutions can afford to conduct MRI research projects. Field-based pMRI research has the capacity to increase access and inclusivity in MRI research, by adding new researchers as well as new research participants.
pMRI can also help to enlarge and diversify the makeup of the MRI research community. MRI researchers have historically been trained in fields such as neuroscience, radiology, and neurology. We soon may see social scientists and even citizen scientists conduct pMRI studies. New investigators and new research locations hold great promise, but also raise new ethical issues. pMRI can also promote inclusive research recruitment by enabling rural, economically disadvantaged, and historically underrepresented populations to more readily participate by bringing the scanner to their communities.
We found that existing ethical guidance for MRI research is useful, but not sufficient, to cover pMRI research—especially pMRI research that takes place in the community. Additional gaps in research oversight may arise because portable MRI has the potential to empower citizen scientists and individuals engaged in do-it-yourself (DIY) research beyond the reach of the regulations requiring Institutional Review Board (IRB) oversight. Without conventional safeguards used in MRI brain research conducted in large research institutions, new strategies will be needed to ensure effective oversight of human subjects research, safety for those being scanned and bystanders, and training for investigators new to portable MRI research.
What can we do to usher in a new era of pMRI research that maximizes benefit while mitigates potential harms? Our Working Group arrived at 15 recommendations, including:
- High standards to become an MRI investigator: We require a license to drive, and similarly each member of the pMRI research team should have demonstrated competence to carry out their research role before they scan.
- Community engagement: Investigators should partner with the local communities in which pMRI research will occur prior to, during, and after the research study.
- Participant control over data: Participants should have agency over their pMRI data throughout the entire pipeline from data acquisition to data sharing.
- New guidelines: New pMRI safety guidelines and scanning protocols should be created by relevant professional bodies such as the American College of Radiology.
- Oversight in research beyond the reach of established IRBs: Where IRB review is not already required, researchers should establish a gatekeeping mechanism such as seeking private IRB review and/or equivalent community-based review.
- Informed consent: The informed consent process should address the potential for therapeutic misconception (participants mistaking research for clinical care) and clarify both what research results and what incidental findings will be offered to participants and how research findings differ from those produced in clinical care.
- Quality control: Companies manufacturing and marketing highly portable MRI have a responsibility to ensure ongoing Quality Control (QC).
- Incidental Findings: Researchers should plan pathways to timely care in the event of incidental findings or concerning research results, regardless of the challenges posed by the participant’s geographic location, insurance status, and ability to pay for care.
Working Group members are developing further guidance and commentary in a forthcoming symposium in the Journal of Law, Medicine & Ethics. Addressing these ELSI issues now, while pMRI is still emerging, is critical for the appropriate deployment of pMRI and achieving its potential to successfully diversify neuroscience research.
Central to our recommendations is the importance of community engagement. At a national conference on the ethics of pMRI hosted at the University of Minnesota last December, we heard from community leaders about the need to engage a broader public than has typically been invited to MRI research design. To achieve its potential, pMRI research will require contributions from investigators, professional bodies, manufacturers, communities, and regulators. Working together and following the road map we’ve developed in this project, a new era of equitable and inclusive pMRI research is within reach.
Francis X. Shen, JD, PhD is Professor of Law & Faculty Member in the Graduate Program in Neuroscience, University of Minnesota, Minneapolis, MN, Chief Innovation Officer, MGH Center for Law, Brain & Behavior, Boston, MA. fxshen@umn.edu
Susan M. Wolf, JD is Regents Professor and McKnight Presidential Professor of Law, Medicine & Public Policy; Faegre Drinker Professor of Law; Professor of Medicine, University of Minnesota, Minneapolis, MN 55455. Email: swolf@umn.edu
Frances Lawrenz, PhD is Emeritus Professor, University of Minnesota, Minneapolis, MN. Email: lawrenz@umn.edu
