AJOB Empirical Bioethics最新文献

Background: The world has come closer than ever to discovering a viable HIV vaccine. However, it remains less certain whether HIV vaccines should be made available to participants and communities in which trials are run no or subsidized cost. Hence the essence of this inquiry.

Methodology: This is a case study design using in-depth interviews (IDI) and focus group discussions (FGD) with researchers of HIV vaccine trials, institutional review board (IRB) members, HIV advocates, a policy maker, and members of community advisory board (CAB) in Tanzania. Participants were purposively selected and data thematically analyzed using MAXQDA software.

Results: Hosting a vaccine trial and the financial incapacity of individuals at increased risk of HIV were among the reasons in favor of free access to HIV vaccines. In contrast, the view that vaccines should be provided at a subsidized cost was related to high costs of vaccine development, financial return expectations by investors, and the fear of labeling the free vaccine as less important. Moreover, apart from governments and international organizations, well-off individuals could share the cost burden.

Conclusion: Stakeholders engaging in active discussion about sharing the viable vaccine ought to take the aforementioned concerns into account and ensure unhindered access to individuals and host communities in Tanzania and beyond.

Objective: Moral distress is a complex phenomenon experienced by healthcare professionals. This study examined the relationships between key dimensions of Organizational Culture in Healthcare (OCHC)-perceived psychological safety, ethical climate, patient safety-and healthcare professionals' perception of moral distress.

Design: Cross-sectional survey.

Setting: Pediatric and adult critical care medicine, and adult hospital medicine healthcare professionals in the United States.

Participants: Physicians (n = 260), nurses (n = 256), and advanced practice providers (n = 110) participated in the study.

Main outcome measures: Three dimensions of OCHC were measured using validated questionnaires: Olson's Hospital Ethical Climate Survey, Agency for Healthcare Research and Quality's Patient Safety Culture Survey, and Edmondson's Team Psychological Safety Survey. The perception of moral distress was measured using the Moral Distress Amidst a Pandemic Survey. The hypothesized relationships between various dimensions were tested with structural equation modeling (SEM).

Results: Adequate model fit was achieved in the SEM: a root-mean-square error of approximation =0.072 (90% CI 0.069 to 0.075), standardized root mean square residual = 0.056, and comparative fit index =0.926. Perceived psychological safety (β= -0.357, p <.001) and patient safety culture (β = -0.428, p<.001) were negatively related to moral distress experience. There was no significant association between ethical climate and moral distress (β = 0.106, p = 0.319). Ethical Climate, however, was highly correlated with Patient Safety Culture (factor correlation= 0.82).

Conclusions: We used structural equation model to test a theoretical model of multi-dimensional organizational culture and healthcare climate (OCHC) and moral distress.Significant associations were found, supporting mitigating strategies to optimize psychological safety and patient safety culture to address moral distress among healthcare professionals. Future initiatives and studies should account for key dimensions of OCHC with multi-pronged targets to preserve the moral well-being of individuals, teams, and organizations.

Background: Researchers engaged in the study of the ethical, legal, and social implications (ELSI) of genetics and genomics are often publicly funded and intend their work to be in the public interest. These features of U.S. ELSI research create an imperative for these scholars to demonstrate the public utility of their work and the expectation that they engage in research that has potential to inform policy or practice outcomes. In support of the fulfillment of this "translational mandate," the Center for ELSI Resources and Analysis (CERA), funded by the National Human Genome Research Institute (NHGRI), aims to facilitate community-informed, ELSI research results synthesis and dissemination. However, little is known about how ELSI research scholars define the goals of translation and imagine the intended users of their research findings.

Methodology: We distributed a Qualtrics survey to ELSI scholars that aimed to determine: (1) researchers' expectations for their research findings in relation to policy or practice outcomes, (2) the stakeholder groups researchers believe could benefit from their research findings, and (3) the methods researchers use to foster the uptake of their findings by those stakeholders.

Results: Most ELSI researchers surveyed thought there were stakeholders that could benefit from their research findings, including health care professionals, at-risk individuals, patients, and their family members, policy-makers, and researchers/scientists, and expected their research findings to inform the creation or revision of laws, policies, or practice guidelines. Most researchers planned to disseminate findings directly to relevant stakeholders, with fewer expecting dissemination support from research funders, universities, or other entities.

Conclusion: The broad range of research topics, disciplines, and set of potential end users represented in ELSI reseach complicate the work of a knowledge broker. Nonetheless, the CERA can play an important role in disseminating ELSI results to relevant stakeholders. Further research should explore outreach mechanisms.

Background: Over the last decade, the return of results (ROR) in precision medicine research (PMR) has become increasingly routine. Calls for individual rights to research results have extended the "duty to report" from clinically useful genetic information to traits and ancestry results. ROR has thus been reframed as inherently beneficial to research participants, without a needed focus on who benefits and how. This paper addresses this gap, particularly in the context of PMR aimed at increasing participant diversity, by providing investigator and researcher perspectives on and questions about the assumed value of ROR in PMR.

Methods: Semi-structured interviews with a purposive sample of investigators and researchers across federally funded PMR studies in three national consortia, as well as observations of study activities, focused on how PM researchers conceptualize diversity and implement inclusive practices across research stages, including navigating ROR.

Results: Interviewees (1) validated the value of ROR as a benefit of PMR, while others (2) questioned the benefit of clinically actionable results to individuals in the absence of sufficient resources for translating findings into health care for diverse and disadvantaged populations; (3) expressed uncertainties in applying the presumed value of ROR as a benefit for non-clinical results; and (4) and debated when the promise of the value of ROR may undermine trust in PMR, and divert efforts to return value beyond ROR.

Conclusions: Conceptualizations of diversity and inclusion among PM researchers and investigators raise unique ethical questions where unexamined assumptions of the value of ROR inform study recruitment efforts to enroll minoritized and under-represented populations. A lack of consideration for resources and infrastructure necessary to translate ROR into actionable information may hinder trustworthy community-research relationships. Thus, we argue for a more intentional interrogation of ROR practices as an offer of benefit and for whom.

Background: Informed consent for genetic tests is a well-established practice. It should be based on good quality information and in keeping with the patient's values. Existing informed consent assessment tools assess knowledge and values. Nevertheless, there is no consensus on what specific elements need to be discussed or considered in the consent process for genetic tests.Methods: We performed a systematic review to identify all factors involved in the decision-making and consent process about genetic testing, from the perspective of patients. Through public databases, we identified studies reporting factors that influence the decision to accept or decline genetic testing. Studies were included if they reported the perspective of patients or at-risk individuals. All articles were thematically coded.Results: 1989 articles were reviewed: 70 met inclusion criteria and 12 additional articles were identified through the references of included studies. Coding of the 82 articles led to the identification of 45 factors involved in decision-making and consent, which were initially divided into three domains: in favor of, against or with an undetermined influence on genetic testing. Each factor was also divided into three subdomains relating to the informed choice concept: knowledge, values or other. The factors in the "other" subdomain were all related to the context of testing (e.g. timing, cost, influence of family members, etc), and were present in all three domains.Conclusions: We describe the network of factors contributing to decision-making and consent process and identify the context of genetic testing as a third component to influence this process. Future studies should consider the evaluation of contextual factors as an important and relevant component of the consent and decision-making process about genetic tests. Based on these results, we plan to develop and test a more comprehensive tool to assess informed consent for genetic testing.