AJOB Empirical Bioethics最新文献

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.

Background: Participation in a therapeutic clinical trial can be a challenging decision for patients with cancer and their family caregivers. Despite the implications of clinical trials for caregivers, there is little empirical research about how caregivers participate in clinical trial decision-making. This qualitative study sought to identify how caregivers view their role in these decisions and the attitudes and experiences of clinical trial staff regarding inclusion of caregivers in the informed consent process.

Methods: We performed four focus groups-two with clinical trial staff and two with caregivers of patients offered a cancer clinical trial-followed by 15 semi-structured interviews with caregivers. Focus group results informed interview guide development. Transcripts were analyzed using an abductive approach to content analysis, incorporating the theory of relational autonomy.

Results: Caregivers viewed their role as enhancing patient autonomy by helping to interpret clinical trial information and acting as a sounding board. They expressed ambivalence regarding the appropriate degree of influence caregivers should have in the final decision and were cautious not to overly sway patients. Clinical trial staff viewed caregivers as highly influential in decision-making and vital to supporting patient adherence to the study protocol. Caregiver relationships with the oncologist and research staff were influential in their perception of the benefits of the clinical trial and comfort with their loved one participating.

Conclusions: Caregivers' key role in facilitating clinical trial decision-making and protocol adherence merits further attention from bioethicists and researchers. Uncertainty regarding their appropriate decisional role highlights the need for assessment of shared decision-making (SDM) preferences to include caregivers in addition to the traditional patient-physician dyad. Future research should develop and test SDM tools incorporating relational autonomy to identify appropriate decisional roles based on patient-caregiver relationship dynamics and values.

Background: Clinical trials of medical therapies are critical for the advancement of care and are expensive. Sometimes, the costs of study drugs are not covered by insurance or the sponsor, and trial participants bear the costs. Participant costs in trials have been ethically controversial; review boards must decide whether to approve these trials and how to address costs. Because little is known about how participants view these costs, we evaluated patients' perspectives about being asked to pay for drugs in a clinical trial.

Methods: We interviewed 33 patients recruited from oncology and cardiology clinics. Interviews included two hypothetical scenarios of trials involving costs: (1) a randomized trial of two current medications with moderate but different out-of-pocket costs; and (2) a trial involving a more expensive investigational drug. Patients were asked to share reactions, concerns, preferences about being approached, and what should happen if removed from the trial due to safety concerns.

Results: Patients expressed a variety of concerns and expectations associated with being asked to bear trial costs, as well as suggestions to reduce costs to research participants. Concerns included the study drug expense, fairness of asking research participants to bear study costs, and that disadvantaged individuals could be excluded. Despite sharing these concerns, patients prioritized autonomy in allowing patients to decide whether to participate, felt that "pay-to-participate" trials should be allowed to occur, and thought potential benefits from trial interventions, along with personal financial situation, would drive participation decisions.

Conclusions: Despite mixed reactions about being asked to pay for study drugs, the majority of patients felt that people should not be prevented from having the option to participate and thus that these trials should not be prohibited. Continued understanding of patient views of research participation and the costs involved can guide how review boards and researchers address these trials.

Background: A number of patient organizations have recently embraced venture philanthropy, a model of patient advocacy that purports to use practices from venture capitalism in pursuit of philanthropic goals. However, a clear understanding of what venture philanthropy entails and what these organizations do remains elusive, hindering efforts to assess ethical implications of the model's growth.

Methods: We conducted a qualitative content analysis of self-reported profiles of 130 organizations in an affinity network promoting principles of venture philanthropy. We analyzed organizations' research goals, funding strategies, activities, and patient engagement efforts.

Results: Despite finding substantial variation in age, revenue, and disease focus, we identified shared assumptions and approaches that represent defining characteristics of venture philanthropy. First, organizations consistently present facilitating the development of new therapies as the most urgent need for patients. Second, organizations participate in financing and managing research across the development pipeline, rather than focusing on basic research as many patient organizations historically have done. Third, organizations seek to position themselves within established research and drug development networks, fostering collaborative relationships with key stakeholders, including pharmaceutical companies. We also find that some of the most transformative practices associated with venture philanthropy, such as direct investment in for-profit companies, remain relatively uncommon.

Conclusions: Venture philanthropy represents an evolution in the ambitions and activities of patient organizations, with organizations becoming more fully enmeshed in the drug development process. Our findings raise ethical questions about how patient organizations conceptualize and advance patient interests and about tradeoffs inherent to the venture philanthropy model.

Background: Increasingly long and complex informed consents have yielded studies demonstrating comparatively low participant understanding and satisfaction with traditional face-to-face approaches. In parallel, interest in electronic consents for clinical and research genomics has steadily increased, yet limited data are available for trio-based genomic discovery studies. We describe the design, development, implementation, and validation of an electronic iConsent application for trio-based genomic research deployed to support genomic studies of cerebral palsy.

Methods: iConsent development incorporated stakeholder perspectives including researchers, patient advocates, institutional review board members, and genomic data-sharing considerations. The iConsent platform integrated principles derived from prior electronic consenting research and elements of multimedia learning theory. Participant understanding was assessed in an interactive teachback format. The iConsent application achieved nine of ten proposed desiderata for effective patient-focused electronic consenting for genomic research.

Results: Overall, participants demonstrated high understanding and retention of key human subjects considerations. Enrollees reported high levels of satisfaction with the iConsent, and we found that participant understanding, iConsent clarity, privacy protections, and study goal explanations were associated with overall satisfaction.

Conclusions: Although opportunities exist to optimize iConsent, we show that such an approach is feasible, can satisfy multiple stakeholder requirements, and can realize high participant satisfaction and understanding while increasing study reach.

Background: Increasing interest in deploying artificial intelligence tools in clinical contexts has raised several ethical questions of both normative and empirical interest. One such question in the literature is whether "responsibility gaps" (r-gaps) are created when clinicians utilize or rely on such tools for providing care, and if so, what to do about them. These gaps are particularly likely to arise when using opaque, "black box" AI tools. Compared to normative and legal analysis of AI-generated responsibility gaps in health care, little is known, empirically, about health care providers views on this issue. The present study examines clinician perspectives on this issue in the context of black box AI decisional support systems (BBAI-DSS) in advanced heart failure.

Methods: Semi-structured interviews were conducted with 20 clinicians (14 cardiologists and 6 LVAD nurse coordinators). Interviews were transcribed, coded, and thematically analyzed for salient themes. All study procedures were approved by local IRB.

Results: We found that all clinicians voiced that, if someone were responsible for the use and outcomes of black box AI, it would be physicians. We compare clinician perspectives on the existence of r-gaps and their impact on responsibility for errors or adverse outcomes when BBAI-DSS tools are used against a taxonomy from the literature, finding some clinicians acknowledging an r-gap and others denying it or its relevance in medical decision-making.

Conclusion: Clinicians varied in their view about the existence of r-gaps but were united in their ascriptions of physician responsibility for the use of BBAI-DSS in clinical care. It was unclear at times whether these were descriptive or normative judgments (i.e., is it merely inevitable physicians will be responsible, or is it morally appropriate that they be held responsible?) or both. We discuss the likely normative inadequacy of such a conception of physician responsibility for BBAI tool use.

Background: There is a high prevalence of a history of traumatic experiences among those seeking obstetric/gynecologic care. OB/GYN clinicians must use trauma-informed care practices to avoid re-traumatization and to provide supportive care. The objective of this study was to describe the knowledge and use of trauma-informed care practices by OB/GYN residents in the outpatient setting.

Methods: A descriptive research design was used. In February 2022, an email with a link to an electronic survey was sent to US OB/GYN residency program directors via a listserv. OB/GYN program directors were asked to forward the survey to residents in their program. The survey included closed-response questions, some of which were Likert scale, to assess the frequency of use of certain trauma-informed care practices during the provision of pelvic examinations.

Results: Seventy US OB/GYN residents responded to the survey. Only half of residents surveyed reported that they practiced trauma-informed care and half reported either not receiving education or were not sure if they had training on the subject. Additionally, half of the respondents were unaware of the ACOG Committee Opinion 825: Care of Patients with History of Trauma.

Conclusion: There was limited use of trauma-informed care practices among OB/GYN residents in this study. Considering the high prevalence of traumatic experiences among individuals seeking gynecologic care, a framework for trauma-informed pelvic exams should be included in the residency curriculum and applied universally.