Research opportunities and ethical considerations for heart and lung xenotransplantation research: A report from the National Heart, Lung, and Blood Institute workshop.

Xenotransplantation offers the potential to meet the critical need for heart and lung transplantation presently constrained by the current human donor organ supply. Much was learned over the past decades regarding gene editing to prevent the immune activation and inflammation that cause early organ injury, and strategies for maintenance of immunosuppression to promote longer-term xenograft survival. However, many scientific questions remain regarding further requirements for genetic modification of donor organs, appropriate contexts for xenotransplantation research (including nonhuman primates, recently deceased humans, and living human recipients), and risk of xenozoonotic disease transmission. Related ethical questions include the appropriate selection of clinical trial participants, challenges with obtaining informed consent, animal rights and welfare considerations, and cost. Research involving recently deceased humans has also emerged as a potentially novel way to understand how xeno-organs will impact the human body. Clinical xenotransplantation and research involving decedents also raise ethical questions and will require consensus regarding regulatory oversight and protocol review. These considerations and the related opportunities for xenotransplantation research were discussed in a workshop sponsored by the National Heart, Lung, and Blood Institute, and are summarized in this meeting report.

Ventilator Triage Policies During the COVID-19 Pandemic at U.S. Hospitals Associated With Members of the Association of Bioethics Program Directors.

BACKGROUND: The coronavirus disease 2019 pandemic has or threatens to overwhelm health care systems. Many institutions are developing ventilator triage policies. OBJECTIVE: To characterize the development of ventilator triage policies and compare policy content. DESIGN: Survey and mixed-methods content analysis. SETTING: North American hospitals associated with members of the Association of Bioethics Program Directors. PARTICIPANTS: Program directors. MEASUREMENTS: Characteristics of institutions and policies, including triage criteria and triage committee membership. RESULTS: Sixty-seven program directors responded (response rate, 91.8%); 36 (53.7%) hospitals did not yet have a policy, and 7 (10.4%) hospitals' policies could not be shared. The 29 institutions providing policies were relatively evenly distributed among the 4 U.S. geographic regions (range, 5 to 9 policies per region). Among the 26 unique policies analyzed, 3 (11.3%) were produced by state health departments. The most frequently cited triage criteria were benefit (25 policies [96.2%]), need (14 [53.8%]), age (13 [50.0%]), conservation of resources (10 [38.5%]), and lottery (9 [34.6%]). Twenty-one (80.8%) policies use scoring systems, and 20 of these (95.2%) use a version of the Sequential Organ Failure Assessment score. Among the policies that specify the triage team's composition (23 [88.5%]), all require or recommend a physician member, 20 (87.0%) a nurse, 16 (69.6%) an ethicist, 8 (34.8%) a chaplain, and 8 (34.8%) a respiratory therapist. Thirteen (50.0% of all policies) require or recommend that those making triage decisions not be involved in direct patient care, but only 2 (7.7%) require that their decisions be blinded to ethically irrelevant considerations. LIMITATION: The results may not be generalizable to institutions without academic bioethics programs. CONCLUSION: Over one half of respondents did not have ventilator triage policies. Policies have substantial heterogeneity, and many omit guidance on fair implementation. PRIMARY FUNDING SOURCE: None.

Ethical Challenges Arising in the COVID-19 Pandemic: An Overview from the Association of Bioethics Program Directors (ABPD) Task Force.

The COVID-19 pandemic has raised a host of ethical challenges, but key among these has been the possibility that health care systems might need to ration scarce critical care resources. Rationing policies for pandemics differ by institution, health system, and applicable law. Most seem to agree that a patient's ability to benefit from treatment and to survive are first-order considerations. However, there is debate about what clinical measures should be used to make that determination and about other factors that might be ethically appropriate to consider. In this paper, we discuss resource allocation and several related ethical challenges to the healthcare system and society, including how to define benefit, how to handle informed consent, the special needs of pediatric patients, how to engage communities in these difficult decisions, and how to mitigate concerns of discrimination and the effects of structural inequities.

Ethically cleared to launch?

Rules are needed for human research in commercial spaceflight.

Emerging neurotechnologies for lie-detection: promises and perils.

Detection of deception and confirmation of truth telling with conventional polygraphy raised a host of technical and ethical issues. Recently, newer methods of recording electromagnetic signals from the brain show promise in permitting the detection of deception or truth telling. Some are even being promoted as more accurate than conventional polygraphy. While the new technologies raise issues of personal privacy, acceptable forensic application, and other social issues, the focus of this paper is the technical limitations of the developing technology. Those limitations include the measurement validity of the new technologies, which remains largely unknown. Another set of questions pertains to the psychological paradigms used to model or constrain the target behavior. Finally, there is little standardization in the field, and the vulnerability of the techniques to countermeasures is unknown. Premature application of these technologies outside of research settings should be resisted, and the social conversation about the appropriate parameters of its civil, forensic, and security use should begin.

Property and privacy paradigms of "marketable spit": an ethical and legal counterpart to blood?

Major advances in the testing of oral fluid (e.g., saliva) may lead to the diagnosis and treatment of previously undiagnosed conditions and may enable dentists to manage oral disease more effectively. Such use of another body fluid, blood, is already well established. Blood is a complex tissue that has been extensively researched and is now used for a wide variety of diagnostic tests. It is also regarded as a form of property with ethical and legal dimensions. If saliva is to fulfill a similar role, it should perhaps be granted those same protections. This paper advances the concept that saliva should be considered a form of property, possibly within personal biological materials law. The emerging potential for the development of marketable products from oral fluids raises the issue of protecting the research participant's ethical and legal rights. In particular, violation of privacy and genetic discrimination may arise from the testing of salivary DNA. Respect for autonomy requires that the clinician inform a patient or research participant about his or her rights to property and privacy as these may pertain to oral fluid.

Rethinking Ethical Categories in the Age of Technology.

Over time, ethical judgments evolve, but so do the phenomena they are applied to. For example, plagiarism is a modern concept. Before the early eighteenth century, works did not generally have references or acknowledgments, and ideas were freely exchanged. As writing became an occupation, copying others' words became "unethical." As cut and paste, music mash-up, and other technological forms of exchange make copying the works of others simple, the idea of plagiarism is eroding, and perhaps will eventually even be discarded. The same may be true with privacy. As with plagiarism, it was not really until the eighteenth century that our modern idea of privacy was established. To younger generations, raised on social media, online life is predicated on trading personal information for access. The undermining of former standards of privacy may suggest that privacy may also eventually become an outmoded concept.

Ethical challenges in nephrology: a call for action.

The American Society of Nephrology, the European Renal Association-European Dialysis and Transplant Association and the International Society of Nephrology Joint Working Group on Ethical Issues in Nephrology have identified ten broad areas of ethical concern as priority challenges that require collaborative action. Here, we describe these challenges - equity in access to kidney failure care, avoiding futile dialysis, reducing dialysis costs, shared decision-making in kidney failure care, living donor risk evaluation and decision-making, priority setting in kidney disease prevention and care, the ethical implications of genetic kidney diseases, responsible advocacy for kidney health and management of conflicts of interest - with the aim of highlighting the need for ethical analysis of specific issues, as well as for the development of tools and training to support clinicians who treat patients with kidney disease in practising ethically and contributing to ethical policy-making.

Emerging neurotechnologies for lie-detection: promises and perils.

Detection of deception and confirmation of truth telling with conventional polygraphy raised a host of technical and ethical issues. Recently, newer methods of recording electromagnetic signals from the brain show promise in permitting the detection of deception or truth telling. Some are even being promoted as more accurate than conventional polygraphy. While the new technologies raise issues of personal privacy, acceptable forensic application, and other social issues, the focus of this paper is the technical limitations of the developing technology. Those limitations include the measurement validity of the new technologies, which remains largely unknown. Another set of questions pertains to the psychological paradigms used to model or constrain the target behavior. Finally, there is little standardization in the field, and the vulnerability of the techniques to countermeasures is unknown. Premature application of these technologies outside of research settings should be resisted, and the social conversation about the appropriate parameters of its civil, forensic, and security use should begin.

Simulation-based medical education: an ethical imperative.

Medical training must at some point use live patients to hone the skills of health professionals. But there is also an obligation to provide optimal treatment and to ensure patients' safety and well-being. Balancing these two needs represents a fundamental ethical tension in medical education. Simulation-based learning can help mitigate this tension by developing health professionals' knowledge, skills, and attitudes while protecting patients from unnecessary risk. Simulation-based training has been institutionalized in other high-hazard professions, such as aviation, nuclear power, and the military, to maximize training safety and minimize risk. Health care has lagged behind in simulation applications for a number of reasons, including cost, lack of rigorous proof of effect, and resistance to change. Recently, the international patient safety movement and the U.S. federal policy agenda have created a receptive atmosphere for expanding the use of simulators in medical training, stressing the ethical imperative to "first do no harm" in the face of validated, large epidemiological studies describing unacceptable preventable injuries to patients as a result of medical management. Four themes provide a framework for an ethical analysis of simulation-based medical education: best standards of care and training, error management and patient safety, patient autonomy, and social justice and resource allocation. These themes are examined from the perspectives of patients, learners, educators, and society. The use of simulation wherever feasible conveys a critical educational and ethical message to all: patients are to be protected whenever possible and they are not commodities to be used as conveniences of training.

Reply to Barbara Pfeffer Billauer's "On Judaism and genes.

The response of Barbara Pfeffer Billauer to my article "If I Am Only My Genes, What Am I? Genetic Essentialism and a Jewish Response" highlights the conflict between a sociological understanding of religion and the resistance to such analysis from within a faith tradition. Ms. Billauer makes three main points; the first strangely credits to me, and then attacks, an argument the article takes great pains to refute, but does so to emphasize the faith's prescient guidance in matters scientific. The second attempts to rebut my critical analysis of the tensions inhernet in Jewish views of the body with an insistence that Judaism so perfectly balances the relation between the sacred and profane that there is not now, and never was, the slightest tension between corporeality and divinity in the Jewish corpus. The third uses my article as vehicle for her to expound on an interesting but tangential formulation of three Jewish terms. In all, the need to defend her interpretation of Judaism's solutions to the problems the article raises results in un-self-critical and ahistorical theorizing, making the utility of her arguments in a discussion of the sociology of religion unsatisfactory.

If I am only my genes, what am I? Genetic essentialism and a Jewish response.

With the advent of the Genetic Age comes a unique new set of problems and ethical decisions. There is a tendency to take the scientific developments presented by modern genetics at face value, as if the science itself were value-neutral and not influenced by cultural and religious images. One example of the fallout of the Genetic Age is the development of a "genetic self," the idea that our essential selfhood lies in our genes. It is important to understand the assumptions of the Genetic Age, the development of genetic selfhood, and the broader cultural trends and assumptions that underlie modern genetic thinking. It is equally important, however, to shape a reaction to the concept of a genetic self. Judaism has long carried on a unique discussion about the nature of selfhood in different times and places and about the relation of the corporeal self to the essential self. Insights from Judaism therefore may help to craft a reaction to the modern genetic self that incorporates the best of modern genetics as well as the integrity of a more transcendent selfhood.

Treatment as prevention and cure towards global eradication of hepatitis C virus.

The availability of curative, direct-acting antiviral drugs against hepatitis C virus (HCV) sparks an ethical call for HCV eradication and provides essential tools to spearhead the effort. Challenges include increasing awareness of the chronic hepatitis C epidemic, garnering sufficient public, private, and governmental financial will to invest in the necessary resources, developing pangenotypic drug regimens for global application, and mitigating ethical concerns. To achieve these goals, stakeholders including clinicians, public health professionals, legislators, advocates, and industry can employ a variety of strategies such as increasing HCV screening, implementing treatment as prevention, and improving linkage to care, as well as developing innovative pricing and payment solutions, stimulating innovation through local drug development in high-prevalence regions, continuing vaccine development, and creating efficiencies in the marketing and distribution of educational materials and drug treatments.