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

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.

Equity in Clinical Care and Research Involving Persons with Disorders of Consciousness.

People with disorders of consciousness (DoC) are characteristically unable to synchronously participate in decision-making about clinical care or research. The inability to self-advocate exacerbates preexisting socioeconomic and geographic disparities, which include the wide variability observed across individuals, hospitals, and countries in access to acute care, expertise, and sophisticated diagnostic, prognostic, and therapeutic interventions. Concerns about equity for people with DoC are particularly notable when they lack a surrogate decision-maker (legally referred to as "unrepresented" or "unbefriended"). Decisions about both short-term and long-term life-sustaining treatment typically rely on neuroprognostication and individual patient preferences that carry additional ethical considerations for people with DoC, as even individuals with well thought out advance directives cannot anticipate every possible situation to guide such decisions. Further challenges exist with the inclusion of people with DoC in research because consent must be completed (in most circumstances) through a surrogate, which excludes those who are unrepresented and may discourage investigators from exploring questions related to this population. In this article, the Curing Coma Campaign Ethics Working Group reviews equity considerations in clinical care and research involving persons with DoC in the following domains: (1) access to acute care and expertise, (2) access to diagnostics and therapeutics, (3) neuroprognostication, (4) medical decision-making for unrepresented people, (5) end-of-life decision-making, (6) access to postacute rehabilitative care, (7) access to research, (8) inclusion of unrepresented people in research, and (9) remuneration and reciprocity for research participation. The goal of this discussion is to advance equitable, harmonized, guideline-directed, and goal-concordant care for people with DoC of all backgrounds worldwide, prioritizing the ethical standards of respect for autonomy, beneficence, and justice. Although the focus of this evaluation is on people with DoC, much of the discussion can be extrapolated to other critically ill persons worldwide.

Ethics and accountability for clinical trials.

In May 2023, a disclaimer posted on ClinicalTrials.gov dismisses accountability for the accuracy of registered information. For spinal cord injury, inconsistencies in intervention classification, phase designation, and lack of study protocols and results threaten the integrity of the database and put users at risk. An investment in what the resource should be rather than what it is not will give it the authority commensurate with the requirements for its regulatory use and informed decision-making for prospective trial participants.

Toward a person-centered ethics framework for autonomy in spinal cord injury research and rehabilitation.

In this paper, we explore how the concepts of autonomy and autonomous choice are understood in the context of spinal cord injury in the academic literature, both in reporting on research results and more broadly on outcomes and quality of life. We find inconsistent, framework-absent portrayals of autonomy as well as an absence of discourse that draws upon ethical constructs and theory. In response, we advance a person-centered framework for spinal cord injury research that combines both lived experience and a disability ethics approach to fill this gap.

Bridges of perspectives: representation of people with lived experience of spinal cord injury in editorial boards and peer review.

BACKGROUND: Diversity among editorial boards and in the peer review process maximizes the likelihood that the dissemination of reported results is both relevant and respectful to readers and end users. Past studies have examined diversity among editorial board members and reviewers for factors such as gender, geographic location, and race, but limited research has explored the representation of people with disabilities. Here, we sought to understand the landscape of inclusivity of people with lived experience of spinal cord injury specifically in journals publishing papers (2012-2022) on their quality of life. METHODS: An open and closed 12-question adaptive survey was disseminated to 31 journal editors over a one-month period beginning December 2022. RESULTS: We received 10 fully completed and 5 partially completed survey responses (response rate 48%). Notwithstanding the small sample, over 50% (8/15) of respondents indicated that their journal review practices involve people with lived experience of spinal cord injury, signaling positive even if incomplete inclusivity practices. The most notable reported barriers to achieving this goal related to identifying and recruiting people with lived experience to serve in the review and editorial process. CONCLUSIONS: In this study we found positive but incomplete trends toward inclusivity in journal practices involving people with lived experience of spinal cord injury. We recommend, therefore, that explicit and genuine efforts are directed toward recruitment through community-based channels. To improve representation even further, we suggest that editors and reviewers be offered the opportunity to self-identify as living with a disability without discrimination or bias.

Ethical Imperatives for Working With Diverse Populations in Digital Research.

Digital research methodologies are driving a revolution in health technology but do not yet fully engage diverse and historically underrepresented populations. In this paper, we explore the ethical imperative for such engagement alongside accompanying challenges related to recruitment, appreciation of risk, and confidentiality, among others. We critically analyze existing research ethics frameworks and find that their reliance on individualistic and autonomy-focused models of research ethics does not offer adequate protection in the context of the diversity imperative. To meet the requirements of justice and inclusivity in digital research, methods will benefit from a reorientation toward more participatory practices.

Open science in play and in tension with patent protections.

The open science (OS) movement has garnered increasing support in academia alongside continued financial and reputational incentives to obtain intellectual property (IP) protections over research outputs. Here, we explore stakeholder perspectives about intersections between OS and IP to inform the development of institutional OS guidelines for the neurosciences in Canada. We held six focus groups and three interviews with 29 faculty members from a major research and clinical center in Canada. The semi-structured interview guide probed perspectives on the respective roles of patents and OS in neuroscience-related research. We applied thematic content analysis to the transcript data, and extracted 12 major themes and 30 subthemes. Participants perceived a conflict between OS ideologies and the inherently restrictive nature of patents, and highlighted the importance of autonomy, justice, and respectful, culturally safe research practices in any future adoption of OS. Overall, the data suggest that a hybrid OS-IP policy model supported by local expertise may be best suited to meet the priorities and values of the community while mitigating perceived threats. This model includes expanded education about patenting, incentivized data sharing and collaboration, and tangible resources to support implementation of OS that includes skilled support in digital research infrastructures.

Mapping the Landscape of Equitable Access to Advanced Neurotechnologies in Canada.

Geographic, social, political, and economic factors shape access to advanced neurotechnologies, yet little previous research has explored the barriers, enablers, and areas of opportunity for equitable and meaningful access for diverse patient communities across Canada. We applied a mixed-mode approach involving semi-structured interviews and rating scale questions to consult with 24 medical experts who are involved in the care of patients who undergo functional neurosurgery targeting the brain. Seven major themes emerged from the qualitative analysis: Health care system, Neurotechnology features, Patient demographics, Target condition features, Ethics, Upstream barriers and enablers, and Areas of opportunity. Descriptive statistics of the Likert-scale responses suggest that interviewees perceive a disparity between the imperative of access to advanced neurotechnologies for people living in rural and remote areas and the likelihood of achieving such access. The results depict a complex picture of access to functional neurosurgery in Canada with pockets of excellence and a motivation to improve the availability of care for vulnerable populations through the expansion of distributed care models, improved health care system efficiencies, increasing funding and support for patient travel, and increasing awareness about and advocacy for advanced neurotechnologies.

Neuromodulation and Opioid Use Disorder: Ethical Opportunities for Canada.

Despite increased efforts of government and non-government organisations to intervene via harm reduction and education initiatives, the opioid crisis has continued to worsen and has been exacerbated by the COVID-19 pandemic. In British Columbia, Canada, opioid overdose deaths in 2021 are the highest ever recorded. Neuromodulation procedures such as deep brain stimulation and repetitive transcranial magnetic stimulation have gained traction as treatments for opioid use disorder in various countries such as Germany, the Netherlands, the United States and China. However, these treatment options have been met with apprehension from both clinicians and patients, likely owing to fear, stigma and reluctance to label addiction as a brain disorder. Further complicating this landscape are socio-demographic factors, as marginalised communities are disproportionately burdened by addiction, while having poor access to care and a history of distrust in the health system. This multifactorial challenge involving many sociocultural factors requires culturally sensitive, interdisciplinary approaches to ensure direct-to-brain innovations are implemented ethically and equitably. This review summarises the state of the science for using neuromodulation to treat opioid use disorder, as well as the available ethical discourse surrounding the expansion of clinical trials and eventual widespread clinical implementation. Additional ethics discussions highlight opportunities for the engineering and clinical evolution of neuromodulation for opioid use disorder trials.

Strengths, gaps, and future directions on the landscape of ethics-related research for spinal cord injury.

Spinal cord injury (SCI) affects between 250,000-500,000 people globally each year. While the medical aspects of SCI have received considerable attention in the academic literature, discourse pertaining to its ethical implications is more limited. The experience of SCI is shaped by intersecting demographic and identity factors such as gender, race, and culture that necessitate an intersectional and value-based approach to ethics-related research that is properly situated in context. Given this background, we conducted a content analysis of academic studies exploring the perspectives and priorities of individuals with SCI published in peer-reviewed journals in the decade between 2012-2021. Terms pertaining to SCI and ethics were combined in a search of two major publication databases. We documented overall publication patterns, recruitment and research methods, reporting of demographic variables, and ethics-related discourse. Seventy (70) papers met inclusion criteria and were categorized by their major foci. Findings reveal a gap in reporting of participant demographics, particularly with respect to race and ethnicity, geographic background, and household income. We discuss these person-centered themes and gaps that must be closed in the reporting and supporting of SCI research.

Ethics Along the Continuum of Research Involving Persons with Disorders of Consciousness.

Interest in disorders of consciousness (DoC) has grown substantially over the past decade and has illuminated the importance of improving understanding of DoC biology; care needs (use of monitoring, performance of interventions, and provision of emotional support); treatment options to promote recovery; and outcome prediction. Exploration of these topics requires awareness of numerous ethics considerations related to rights and resources. The Curing Coma Campaign Ethics Working Group used its expertise in neurocritical care, neuropalliative care, neuroethics, neuroscience, philosophy, and research to formulate an informal review of ethics considerations along the continuum of research involving persons with DoC related to the following: (1) study design; (2) comparison of risks versus benefits; (3) selection of inclusion and exclusion criteria; (4) screening, recruitment, and enrollment; (5) consent; (6) data protection; (7) disclosure of results to surrogates and/or legally authorized representatives; (8) translation of research into practice; (9) identification and management of conflicts of interest; (10) equity and resource availability; and (11) inclusion of minors with DoC in research. Awareness of these ethics considerations when planning and performing research involving persons with DoC will ensure that the participant rights are respected while maximizing the impact and meaningfulness of the research, interpretation of outcomes, and communication of results.

Strategic and principled approach to the ethical challenges of epilepsy monitoring unit triage.

Electroencephalographic monitoring provides critical diagnostic and management information about patients with epilepsy and seizure mimics. Admission to an epilepsy monitoring unit (EMU) is the gold standard for such monitoring in major medical facilities worldwide. In many countries, access can be challenged by limited resources compared to need. Today, triaging admission to such units is generally approached by unwritten protocols that vary by institution. In the absence of explicit guidance, decisions can be ethically taxing and are easy to challenge. In an effort to address this gap, we propose a two-component approach to EMU triage that takes into account the unique landscape of epilepsy monitoring informed by triage literature from other areas of medicine. Through the strategic component, we focus on the EMU wait list management infrastructure at the institutional level. Through the principled component, we apply a combination of the ethical principles of prioritarianism, utilitarianism and justice to triage; and we use individual case examples to illustrate how they apply. The effective implementation of this approach to specific epilepsy centres will need to be customised to the nuances of different settings, including diverse practice patterns, patient populations and constraints on resource distribution, but the conceptual consolidation of its components can alleviate some of the pressures imposed by the complex decisions involved in EMU triage.