19 - Role of Institutional Review Boards in Ensuring Ethical Oversight of Neuroimaging Research Using Emerging, Highly Portable MRI

Background:
Emerging portable neuroimaging technologies, notably low field MRI, are significantly transforming neuroscience research. They enable studies in novel and remote settings, which is particularly beneficial for underserved populations. Institutional Review Boards (IRBs) are tasked with broadening their understanding of the ethical issues these technologies bring to new communities. This expansion of scope is critical for the effective governance of both affiliated researchers and for providing guidance and resources to unaffiliated investigators who fall outside the scope of the Common Rule and FDA regulations. A key aspect of this transformation involves the democratization of bioethical governance, necessitating a redefinition of the roles of IRBs, researchers, and study participants. Fostering collaboration between academic IRBs and nonaffiliated researchers is essential to address existing mistrust and to jointly pursue ethical, high-quality portable MRI (pMRI) research.

Low field MRI technology, while varying in mobility, cost, safety, and image quality compared to traditional high field scanners, offers expanded imaging access at a lower cost. This has been recently recognized by the FDA's approval for use in diverse settings. Such expansion significantly enhances the potential for MRI research beyond traditional environments, opening up new possibilities and challenges in the field of neuroscience.
The affordability and portability of pMRI technologies have opened the door for a diverse range of investigators, including those from non-traditional backgrounds such as professors from various academic disciplines, citizen scientists, and patient advocacy groups. However, many of these new investigators may lack specific training in MRI research and access to institutional mechanisms for ethics and safety oversight.

Discussion:
The use of portable MRI systems in various settings, including traditional academic and new community environments, presents unique opportunities and challenges for neuroscience research. IRBs are required to adapt their oversight approaches to these changing contexts, accommodating the diverse range of investigators and research settings. This adaptation involves a deep understanding of the unique ethical and operational challenges posed by conducting portable MRI research in field settings and the development of tailored oversight strategies. IRBs are also positioned to pioneer innovative oversight models for community researchers who operate beyond the Common Rule and FDA's purview. Such models would involve collaboration with community boards and leveraging IRB expertise to ensure responsible and ethical research practices.
Limitations:
The technologies involved in highly portable MRI neuroimaging exhibit a range of strengths, limitations, and stages of development and commercialization. Further research is needed to understand the experiences and challenges in the oversight of these technologies. This abstract contributes significantly by highlighting the oversight issues and informing IRBs, safety committees, and other authorities about the emerging ethical challenges in this field.

Conclusion:
Research utilizing portable MRI technologies introduces novel challenges in ethical oversight. Conducting imaging outside traditional academic settings requires the implementation of new measures to minimize risks to research participants. These measures include addressing data security concerns and mitigating the potential for AI bias. Additionally, research conducted in community settings, particularly with marginalized and underserved populations, necessitates careful management to prevent negative outcomes such as helicopter research without community engagement, failure to confer local benefits, propagation of therapeutic misconceptions, and mismanagement of incidental findings. The accessibility of smaller, less costly imaging devices enables research by a broader range of investigators, including those who are less experienced, unaffiliated, or citizen scientists. These groups may conduct research beyond the reach of established regulations like the Common Rule and FDA, often with limited or no organizational oversight. In this rapidly evolving landscape, IRBs play a crucial role in developing guidance and coordinating policies to address the myriad challenges of MR safety, appropriate consent, AI bias, information security, responsible management of incidental findings, and robust community engagement. They are also key in formulating oversight strategies for research extending beyond traditional regulatory frameworks, and fostering collaborations with imaging research societies for safety training and quality assessment is vital to encourage best practices and dialogue among investigators, their organizations, community partners, and other oversight authorities.
*These two authors contributed equally to this work.