AJOB Empirical Bioethics最新文献

Background: Student-run clinics (SRCs) are a unique medical education and healthcare delivery model. On one hand, SRCs have the potential to bridge important care gaps and train future practitioners to address complex health disparities. On the other, allowing students to administratively "run" a clinic for the indigent, with varying levels of oversight, raises ethical questions. This review attempts to identify and synthesize the major ethical concerns scholars have raised about SRCs.

Methods: We searched PubMed, Embase, Ovid Medline, Web of Science, and SCOPUS, reviewed all publications in the non-indexed Journal of Student Run Clinic and The Free Clinic Research Collective, and iteratively snowball sampled the bibliographies and Google Scholar "cited by" results of included publications until saturation. We performed thematic analysis of included publications.

Results: Of 7,584 initial results, we identified 503 publications on SRCs and 22 relevant to this review. In total, 4.3% (22/503) of the SRC literature focuses on ethical concerns, which we inductively categorize as: 1) Structural and systemic problems, 2) Lack of consistent administrative and clinical oversight, 3) Substandard quality-of-care, 4) Undue influence on patients, 5) Negative impact on trainees, and 6) Inadequate involvement of the community.

Discussion: SRCs are a growing part of the U.S. healthcare safety net system. They are also an important nexus of ethical questions that impact patient care and trainee education. Many identified concerns relate to administrative, structural, and sociological issues which may be outside the direct training (and potentially awareness) of most medical students. Some work cautions that SRCs have potential to produce results discordant with their core aims, such as racial equity, health equity, and training service-oriented healthcare professionals. Increased awareness of these potential pitfalls offers new avenues for bioethical investigation and practical opportunities to support students and faculty in positioning these unique clinics for success.

Background: With the emergence of voice as a digital biomarker for various health conditions over the last decade, healthcare institutions are exploring avenues to leverage this technology to improve patient outcomes and clinical workflow efficiencies. Voice analysis technologies have the potential to streamline clinical care from speech-based diagnoses to assessing disease risk. This interest in healthcare innovation must also correspond with an understanding of the scope of ethical concerns and focal points that exist within this emerging literature.

Methods: Given the significant discourse outside traditional ethics journals, we conducted a review of the literature focusing on artificial intelligence (AI)-enabled voice analysis technologies for clinical diagnosis and monitoring purposes to inform the practice of AI ethics scholars, consultants, and instructors. Studies were published between 2010 and 2023 in PubMed, Web of Science, Scopus, OVID Embase, or Google Scholar. We evaluated 1871 articles, with 48 articles included in the final review that explore the ethics of clinical applications.

Results: Clinical applications of these technologies centered around using voice data for diagnosis of pulmonary and neurological conditions, mental health screening, provider decision-making assistance, and remote patient monitoring. Key themes related to ethics included: ethical design and validation; data privacy and security; health equity; trust, transparency, and accountability; alterations to the physicia-patient relationship; and current guidelines and policies.

Conclusions: As healthcare systems work to create policies and best practices for voice analysis technologies, further research is necessary to understand the perspectives of stakeholders who will be essential for the adoption of these technologies.

Background: Despite major shifts in U.S. federal government data sharing requirements, their impact, and relation to researcher choice of database, are underexplored. This study surveyed genetic researchers regarding trends, priorities, perceptions of quality, impact on research outcomes, and genomic data sharing and use across government, consortium, and private databases.

Methods: As part of an exploratory sequential mixed methods project, we surveyed 294 U.S.-based genomic academic researchers.

Results: Genetic researchers generally have a choice between databases, which allows them to prioritize data quality. This might explain recent trends toward the use of government and consortium databases away from private ones. Respondents reported several significant differences in the requirements that different data stewards place on them, which impact their work. Private data stewards generally had the most restrictions and were the least likely to allow users to release the full dataset at completion, despite over 50% of respondents reporting the use of federal funds for such research. Our findings indicate that upstream benefits (i.e., access, database features) are more impactful on researchers' choice in databases than downstream publication limitations (e.g., co-authorship, limited data release). Respondents also reported the time necessary to share data as the biggest barrier to contributing to government databases and non-comprehensiveness as the biggest challenge to using existing government data.

Conclusions: The federal government can leverage these findings about researcher priorities to continue attracting researchers, to push forward goals related to open science and enabling advances for patients underrepresented in genetic research, and to found new genomic data sharing policy moving forward.

Background: Little is understood on how intersectionality and social background of patients and families influence ethical and clinical decision-making, particularly in the critical care setting. This study aims to explore how family identity and socioeconomic features influence the perceived medical appropriateness and ethical permissibility of treatment options for NICU patients when controlling for patient diagnosis and prognosis.

Methods: We conducted focus groups (n = 7) with interdisciplinary Neonatal Intensive Care Unit (NICU) health care professionals (N = 33) at a single Level IV NICU over an 8-month period. Participants reviewed and discussed a hypothetical case of a neonate with severe neurological impairment. Focus groups received the same medical information regarding the patient and prognosis but were provided 1 of 2 social scenarios where the family's contextual information (parental education, first language, religion, medical literacy, access to care, family structure, and parental presence at the bedside) were intentionally varied. Comparative thematic analysis was performed.

Results: Critical differences were identified in the way participants: (1) responded to parental requests for continued intervention and (2) incorporated the family's education, income, geography, medical literacy, and active presence on the unit in their medical recommendations. Specifically, we found that teams were more open to the idea of accommodating parental requests in the context of increased family resources, than they were in the context of lower family resources.

Conclusion: Interpretation of family social context by NICU care teams can produce disparities in which interventions are offered, and which parental preferences are accommodated, underscoring the impact of family and social characteristics on clinical care.

Background: Making clinical ethics consultation (CEC) services available to patients and their family members is a best practice most hospitals in the United States claim to follow. However, patients and families often lack awareness of CEC and rarely request CEC services. One reason patients and families might underutilize CEC is they lack access to important information about hospitals' CEC services.

Methods: Since patients and families often use hospital websites to find information about services, we applied a standardized search protocol to characterize information about CEC services hospitals have published on their own websites or websites of their academic affiliates. Our sample included the top 100 general, adult hospitals in the US identified by Newsweek and Statista in their 2024 ranking of hospitals around the world.

Results: We found 88 hospitals (88%) had information on their websites indicating availability of CEC services, with 79 (79%) indicating patients and families may request those services. Hospitals with websites indicating availability of CEC services often provided information about how to request CEC (77.3%), how CEC might benefit requesters (69.3%), and a specific phone number for making requests (58%). Other types of potentially important information appeared less often on the hospitals' websites, such as the names of people who provide CEC (27.3%), an email address for requesting CEC (20.5%), and whether and how the hospital charges for CEC (19.3%).

Conclusions: This study reveals both needed improvements and potential models of best practice related to providing information about CEC services for patients and families on the websites of leading hospitals in the United States. US hospitals have an opportunity to promote accessibility of CEC by improving the quality of information about CEC services on their websites.

Background: Automated approaches to cognitive impairment screening may soon achieve sufficient levels of accuracy for clinical implementation but they present potentially serious ethical challenges. Overcoming such challenges for successful implementation of automated screening may depend on the perspective of the clinicians who are its intended users.

Methods: We conducted a qualitative study of internal medicine, geriatrics and family medicine physicians recruited from ambulatory practices in New York City, NY to identify ethical challenges of implementing automated CI screening (n = 22). In four focus groups, we explored attitudes and beliefs about routine manual screening for cognitive impairment and automated screening based in machine learning models of data from electronic medical records (EMR) or patient audio recordings, using hypothetical scenarios. Focus group recordings were transcribed and analyzed using grounded theory.

Results: Participants reported routine screening for cognitive impairment only in the context of the Medicare annual wellness visit and generally avoided routine screening because of limited treatment options to support patients, such as poor access to geriatrics/neuropsychiatric services. Thematic analysis revealed several perceived benefits: enhanced clinical efficiency, engagement in cognitive healthcare of their patients, and expanded access to cognitive care. They identified several potential challenges with ethics implications: concerns about accuracy of the technology, bias, difficulty communicating the technology and results to patients and caregivers that could impact their ability to provide informed consent, and risks to patients (privacy, stigmatization and insurability). They noted that without more health system infrastructure to support patients with dementia, the benefits of automated screening would be limited.

Conclusions: Physicians identified several critical ethical challenges to automated CI screening. Health systems will need to address these challenges to ensure benefit for and the safety, autonomy and privacy of patients and ultimately, the successful implementation of such technology.

Background: Increasingly, researchers are leveraging social science survey data and genomic samples from millions of biobank participants to develop polygenic indices (PGIs) for social and behavioral traits.

Methods: This article utilizes horizon scanning methodology to track academic and lay literature regarding PGIs.

Results: We identified and coded 441 academic and 123 lay literature items, tracking the traits, sources of genetic and health data, and how each item discussed the harms, benefits, and limitations of sociogenomic PGIs.

Conclusion: This in-depth review highlights variation in the portrayal of PGI research across academic and lay literature. Beyond simply elucidating what is being studied, and in which populations, this research shows how results are communicated, which messages are shown to academic and/or public audiences, and potential disconnects between how sociogenomic researchers and the lay literature describe the values and implications of the research.

Introduction: The 2022 Russian invasion of Ukraine prompted diverse responses from global corporations. This study investigates the perspectives and actions of leading pharmaceutical companies amidst this geopolitical crisis, focusing on their public response to Russia's invasion.

Methods: Three rankings were used to identify top global pharmaceutical companies by revenue in 2022. Public statements, collected from public-facing company websites and archival websites, were analyzed via thematic content analysis to understand the responses of individual companies.

Results: Five key themes emerged: (1) Solidarity: expressions of support for Ukraine and condemnation of Russia; (2) Scaling-back: suspension of non-essential operations, including new clinical trials and investments; (3) Essential Medicines: commitment to maintaining the supply of life-saving medications; (4) Sanction Compliance: adherence to international sanctions; and (5) Donations: increased humanitarian aid. A majority of companies affirmed a commitment to the continued sales of essential medicines while simultaneously scaling back non-essential activities in the Russian market. Less than half of companies explicitly condemned Russia. Humanitarian donations were frequently mentioned.

Conclusion: Pharmaceutical companies adopted a nuanced approach, balancing ethical obligations to provide essential medicines with responses to the conflict. The findings highlight the complex decision-making processes faced by multinational corporations during international conflicts, revealing a strategic response that prioritizes humanitarian needs and regulatory compliance alongside business continuity.

Background. Prodromal Alzheimer's disease (AD) clinical trials enroll patients with mild cognitive impairment (MCI) and their study partners. This study examined trial enrollment decision-making and risk for misunderstanding trial information presented in an informed consent process for prodromal AD trials.

Methods. We performed structured interviews with patients with MCI and individuals who could serve as their study partners. We presented details of a hypothetical prodromal AD trial, followed by questionnaires to assess involvement of the study partner in trial decisions, patient capacity to consent, and patient health numeracy skills.

Results. Among 65 patient participants, most were male (66%) and non-Hispanic White (88%) with a mean (standard deviation) age of 74.9 (8.4) years. Among 57 study partners, most were spouses (83%), female (74%), and non-Hispanic White (91%) with a mean (standard deviation) age of 70.3 (13.6). Most patient participants (66%) and study partners (72%) reported they would make enrollment decisions in partnership; 28% of patient participants said they would make the decision themselves, with input from a study partner. Twenty-five patient participants (38%) lacked capacity to consent to the trial; 38% demonstrated impaired health numeracy. Seventeen patient participants (26%) demonstrated both a lack of capacity and impaired health numeracy, among whom seven reported they would make enrollment decisions on their own, with input from a study partner.

Conclusions. Some patients with MCI demonstrated a lack of capacity to consent, impaired health numeracy, or both, putting them at risk for misunderstanding trial information in the consent process for a prodromal AD clinical trial.

Background: Classic psychedelics, such as psilocybin and LSD, evoke certain kinds of altered states of consciousness. Specific features of the experience, such as its allegedly ineffable nature, have been discussed as posing challenges to the informed consent process. A growing call for tailored informed consent documents (ICDs) in the psychedelic bioethics literature raises the question of how closely ICDs used in contemporary psychedelic trials reflect the concrete suggestions and proposals offered by psychedelic bioethicists.

Methods: In this article, we review ICDs from psilocybin clinical trials in the United States. Using a content analysis approach, we provide a systematic qualitative description of the ICDs which comprise our final sample (N = 28; 28 clinical trials across 13 unique sites). Coders demonstrated good reliability (κ = .683).

Results: Qualitative analyses revealed that most of the coding aligned with expectations based upon the psychedelics bioethics literature, such as the emphasis on mental health risks and physical risks in ICDs. Notably, psychedelic-specific codes (e.g., ineffability, therapeutic touch) did not appear as frequently in ICDs.

Conclusions: Scholars in psychedelic bioethics have called for the inclusion of a variety of potential risks and benefits in ICDs. It will be important to continue debating which elements are worth including in ICDs such that potential research participants are presented with the most salient factors relevant to their decision about joining a study. We provide a table of best practices applied by our sample of ICDs.