Portable MRI for neuroimaging research in remote field settings can reach populations previously excluded from research, including communities underrepresented in current brain neuroscience databases and marginalized in health care. However, research conducted far from a medical institution and potentially in populations facing barriers to health care access raises the question of how to manage incidental findings (IFs) that may warrant clinical workup. Researchers should not withhold information about IFs from historically excluded and underserved population when members consent to receive it, and instead should facilitate access to information and a pathway to clinical care.

In this article, we examine the relationship between the World Health Organization International Health Regulations (IHR) and human rights and its implications for IHR reform, considering the evolution of human rights in the 2005 IHR, the role of human rights in IHR reforms and the implications of these reforms in key domains including equity and solidarity, medical countermeasures, core capacities, travel restrictions, vaccine certificates, social measures, accountability, and financing.

This article explores two questions: (1) whether portable MRI research might escape regulatory oversight altogether under existing U.S. privacy and research ethical frameworks, leaving research participants without adequate protections, and (2) whether existing regulatory frameworks, when they do apply, can guard society’s broader interest in ensuring that portable MRI research pursues socially beneficial, ethically sound aims that minimize the potential for externalities affecting nonparticipating individuals and groups, who might be stigmatized or otherwise harmed even if they decline participation in the research.

In a new era of regulatory oversight, the US Supreme Court upended traditional Chevron deference to agency interpretations of ambiguous Congressional provisions in Loper in June 2024. Federal courts were instructed to make their own assessments of statutory authorities amid an onslaught of public health agency challenges surfacing nationally. Even so, SCOTUS may be eyeing further limits on agency powers despite clear and substantial repercussions for the health of the nation.

The introduction of portable MRI (pMRI) has the potential to directly impact dementia research and ultimately clinical care. In this paper, we explore two ethical challenges facing the introduction of pMRI in dementia research. The first is the need to ensure that pMRI enhances rather than undermines efforts aimed at improving ethnoracial representation in dementia research. The second is the need to implement pMRI in dementia research in a dementia-friendly way that attends to the social context and lived experience of people with dementia.

This pilot study is the first formal exploration of the concept of “Organizational Professionalism” (OP) among health system leaders in high-performing healthcare organizations. Semi-structured key informant interviews with 23 leaders from 8 healthcare organizations that were recipients of the Malcolm Baldrige National Quality Award (MBNQA) or Baldrige-based state quality award programs explored conceptualization, operationalization, and measurement of OP. Further exploration and understanding of OP in healthcare organizations has the potential to establish and sustain professional and ethical organizational cultures that bolster trust through the sound implementation of laws, policies, and procedures to support the delivery of high-quality patient care.

The paucity of existing baseline data for understanding neurologic health and the effects of injury on people from Indigenous populations is causally related to the limited representation of communities in neuroimaging research to date. In this paper, we explore ways to change this trend in the context of portable MRI, where portability has opened up imaging to communities that have been neglected or inaccessible in the past. We discuss pathways to engage local leadership, foster the participation of communities for this unprecedented opportunity, and empower field-based researchers to bring the holistic worldview embraced by Indigenous communities to neuroimaging research.

This article delves into the legal developments, bioethical nuances, and societal perspectives surrounding posthumous sperm use, particularly in the context of soldiers falling during their service. It analyzes the Israeli example during The Swords of Iron War, where the bioethical dilemma is decided based on national solidarity, beyond the “clean” bioethical-legal discussion.

Portable MRI (pMRI) technology, which promises to transform brain imaging research by facilitating scanning in new geographic areas and the participation of new, diverse populations, raises many ethical, legal, and societal issues (ELSI). To understand this emerging pMRI ELSI landscape, we surveyed expert stakeholder views on ELSI challenges and solutions associated with pMRI research.

A proposed state administrative rule would have required medical ethicists to approve certain aspects of gender-affirming care. The authors argue the proposed rule lacked appropriate justification compared to other instances of state-mandated ethics oversight and would undermine trust, raise practical challenges, and send harmful messages to society, patients, and providers.

To help academic and non-profit investigators interested in drug repurposing navigate regulatory approval processes, we compared pathways for repurposed drugs to obtain approval at EMA, UK MHRA, and the US FDA. Though we found no pathways specifically for repurposed drugs, pathways to market are available in all repurposing scenarios.

The emergence of innovative neuroimaging technologies, particularly highly portable magnetic resonance imaging (pMRI), has the potential to spawn a transformative era in neuroscience research. Resourced academic institutional review boards (IRBs) with experience overseeing traditional MRI have a special role to play in ethical governance of pMRI research and should facilitate the collaborative development of nuanced and culturally sensitive guidelines and educational resources for pMRI protocols. This paper explores the ethical challenges of pMRI in neuroscience research and the dynamic leadership role that IRBs should play to promote ethical oversight of emerging pMRI research.

Highly portable and accessible MRI technology will allow researchers to conduct field-based MRI research in community settings. Previous guidance for researchers working with fixed MRI does not address the novel ethical, legal, and societal issues (ELSI) of portable MRI (pMRI). Our interdisciplinary Working Group (WG) previously identified 15 core ELSI challenges associated with pMRI research and recommended solutions. In this article, we distill those detailed recommendations into a Portable MRI Research ELSI Checklist that offers practical operational guidance for researchers contemplating using this technology.

People of low socioeconomic status (SES) are often underrepresented in biomedical research. The importance of demographically diverse research samples is widely recognized, especially given socioeconomic disparities in health, but have been challenging to achieve. One barrier to research participation by low SES individuals is their distance from research centers and the difficulty of traveling. This article examines the promise of portable magnetic resonance imaging (pMRI) for enrolling participants of diverse SES in structural neuroimaging studies, and anticipates some of the challenges, practical and ethical, that may arise in the course of such research.

The application of advanced biopreservation to organs donated for transplantation may make possible their indefinite storage and thereby improve the utility and equity they provide to patients. The technology is still at a preclinical stage, with many difficult, scientific issues that remain to be answered. At the moment, however, the actual capabilities of the technology are too indefinite to begin formulating the statutes, regulations, and ethical guidance that will be needed to obtain the benefits expected from its use.

This article argues that beneath the veneer of legitimacy in the organ, tissue, and body part transplantation systems exists a horrifying history of human commodification whose vestiges surprisingly linger in contemporary supply and allocation systems. This history, as the Article demonstrates, dates back to the colonial period in the United States, where “grave robbing” became an important feature in the advancement of medicine. This legacy lives on.

Biomedical research on advanced cryopreservation has spillover effects on innovation in the food and agricultural sector. Advanced biopreservation technology has three key domains of impact in the food system: (1) improving efficiencies in storage and utilization of gametes and organoids for plant and animal breeding; (2) isochoric methods for preservation of fresh food products; and (3) in biorepositories for storage of genetic resources for agriculturally significant plants and livestock species.

This article presents a framework of ethical analysis for anticipatory evaluation of advanced biopreservation technologies and employs the framework illustratively in three domains. The framework features four clusters of general ethical considerations: (1) Producing Benefits, Minimizing Harms, Balancing Benefits, Risk, and Costs; (2) Justice, Fairness, Equity; (3) Respect for Autonomy; and (4) Transparency, Trustworthiness, and Public Trust.

The Cleveland Clinic Innovation Management and Conflict of Interest (“IM&COI”) Program implemented a policy on Conflicts of Interest in Clinical Practice in 2013. The policy requires review of financial interests greater than $20,000 in a year, or more than 5% equity in a company, when the clinician is prescribing or using products of the company with which they have a relationship. The IM&COI Committee developed definitions for low, medium and high levels of annual compensation and risk and uses a “Matrix” to guide disclosure based on these factors.

In this issue, Zakout discusses European Union (EU) legal provisions for inclusion of patients of all types in clinical trials.1 Shee highlights the unfortunate failure to include adequate numbers of older adults and adults with disabilities in clinical trials of anti-cancer agents. We agree with her argument that this is an ethical issue as well as a scientific and clinical issue.