Defining ethical criteria to guide the expanded use of Noninvasive Prenatal Screening (NIPS): Lessons about severity from preimplantation genetic testing.

We hypothesized that ethical criteria that guide the use of preimplantation genetic testing (PGT) could be used to inform policies about expanded use of non-invasive prenatal screening (NIPS). We used a systematic review of reasons approach to assess ethical criteria used to justify using (or not using) PGT for genetic conditions. Out of 1135 identified documents, we retained and analyzed 216 relevant documents. Results show a clear distinction in acceptability of PGT for medical vs. non-medical conditions. Criteria to decide on use of PGT for medical conditions are largely based on their severity, but there is no clear definition of "severity". Instead, characteristics of the condition that relate to severity are used as sub-criteria to assess severity. We found that characteristics that are used as sub-criteria for assessing severity include monogenic etiology, high penetrance, absence of treatment, early age of onset, shortened lifespan, and reduced quality of life. Consensus about the use of PGT is highest for conditions that meet most of these criteria. There is no consensus around the acceptability of using PGT to detect non-medical conditions. We propose that the same severity criteria could be used by policymakers to assess the acceptability of using other genetic tests in screening and practice, including for the use of NIPS for additional conditions as indications broaden.

Mapping ethical, legal, and social implications (ELSI) of fertility preservation.

RESEARCH QUESTION: The study examines the ethical, legal, and social implications of fertility preservation, highlighting its importance across oncofertility, elective egg freezing, and posthumous assisted reproduction, as well as its impact on transgender individuals undergoing gender-affirming surgeries. DESIGN: A comprehensive analysis of 600 articles, focusing on a diverse range of disciplines, including bioethics, psychology, and sociology, to explore public and healthcare professionals' knowledge, patient experiences, and regulatory constraints. RESULTS: The body of literature is growing, indicating increasing recognition of FP's significance. Key themes included the centrality of counseling and informed decision-making, especially in oncofertility and EEF, and ethical debates surrounding informed consent and the autonomy of involved individuals. The analysis underscored a western-centric bias in current research, emphasizing the need for more inclusive and culturally sensitive studies. CONCLUSIONS: The study calls for a nuanced understanding of FP, advocating for policies that consider ethical, cultural, and social dimensions. It suggests the necessity for interdisciplinary research to address identified gaps, particularly in understanding non-Western perspectives and ensuring equitable access to FP services globally. Moreover, the review emphasizes the importance of integrating patient-centric approaches and ethical frameworks to guide FP practices and policies, ensuring they respect diverse values and meet individuals' needs.

Mapping Ethical, Legal, and Social Implications (ELSI) of gamete donation.

RESEARCH QUESTION: This scoping review investigates the Ethical, Legal, and Social Implications (ELSI) of gamete donation, a critical facet of Assisted Reproductive Technologies, by analyzing the evolving research scope, methodological approaches, and the geographical skew in the literature. Despite the increased global uptake of donor gametes, current scholarship predominantly emanates from Western contexts and focuses on majoritized groups. This bias constrains the universality of research findings and limits their applicability across varied legal, cultural, and social contexts, underscoring a need for broader inclusivity. DESIGN: We addressed 867 pivotal articles published between 1999 and 2019. RESULTS: Our analysis reveals a discernible escalation in research volume, with 62% based on empirical research. The intellectual landscape unfolds into four dominant clusters: Regulatory Frameworks, Incentives, and Access; Family Dynamics and Genetic Linkages; Identity and Privacy in Donor Conception; and Cultural and Societal Attitudes towards GD. Each cluster highlights nuanced dimensions of gamete donation, from regulatory intricacies and psychological welfare to identity ethics and cultural perceptions. CONCLUSION: Our findings advocate for a shift towards more globally representative and methodologically inclusive research. By integrating diverse cultural narratives and expanding geographical breadth, future research can offer holistic understandings of gamete donation, fostering equitable and culturally resonant practices and policies worldwide.

Unpacking the notion of "serious" genetic conditions: towards implementation in reproductive decision-making?

The notion of a "serious" genetic condition is commonly used in clinical contexts, laws, and policies to define and delineate both the permissibility of and, access to, reproductive genomic technologies. Yet, the notion lacks conceptual and operational clarity, which can lead to its inconsistent appraisal and application. A common understanding of the relevant considerations of "serious" is lacking. This article addresses this conceptual gap. We begin by outlining existing distinctions around the notion of "serious" that will factor into its appraisal and need to be navigated, in the context of prenatal testing and the use of reproductive genomic technologies. These include tensions between clinical care and population health; the impact of categorizing a condition as "serious"; and the role of perception of quality of life. We then propose a set of four core dimensions and four procedural elements that can serve as a conceptual tool to prompt a mapping of the features of seriousness in any given context. Ultimately, consideration of these core dimensions and procedural elements may lead to improvements in the quality and consistency of decision-making where the seriousness of a genetic condition is a pivotal component at both a policy and practice level.

War, Bioethics, and Public Health.

This paper argues that bioethics as a field should broaden its scope to include the ethics of war, focusing on war's public health effects. The "Introduction" section describes the bioethics literature on war, which emphasizes clinical and research topics while omitting public health. The section, "War as a public health crisis" demonstrates the need for a public health ethics approach by framing war as a public health crisis. The section, "Bioethics principles for war and public health" proposes six bioethics principles for war that address its public health dimensions: health justice, accountability, dignified lives, public health sustainability, nonmaleficence, and public health maximization. The section, "Justifying and applying bioethical principles" shows how these principles inform ethical analysis, including just war theory and military ethics. The section, "From principles to practice" envisions ways in which bioethicists can promote these principles in practice through research, teaching, and service. The "Conclusion" section urges bioethicists to engage with war as a public health crisis, including calling attention to war's impact on civilians, especially women, children, and other vulnerable groups.

Stakeholder perspectives on ethical and trustworthy voice AI in health care.

Objective: Voice as a health biomarker using artificial intelligence (AI) is gaining momentum in research. The noninvasiveness of voice data collection through accessible technology (such as smartphones, telehealth, and ambient recordings) or within clinical contexts means voice AI may help address health disparities and promote the inclusion of marginalized communities. However, the development of AI-ready voice datasets free from bias and discrimination is a complex task. The objective of this study is to better understand the perspectives of engaged and interested stakeholders regarding ethical and trustworthy voice AI, to inform both further ethical inquiry and technology innovation. Methods: A questionnaire was administered to voice AI experts, clinicians, scholars, patients, trainees, and policy-makers who participated at the 2023 Voice AI Symposium organized by the Bridge2AI-Voice AI Consortium. The survey used a mix of Likert scale, ranking and open-ended questions. A total of 27 stakeholders participated in the study. Results: The main results of the study are the identification of priorities in terms of ethical issues, an initial definition of ethically sourced data for voice AI, insights into the use of synthetic voice data, and proposals for acting on the trustworthiness of voice AI. The study shows a diversity of perspectives and adds nuance to the planning and development of ethical and trustworthy voice AI. Conclusions: This study represents the first stakeholder survey related to voice as a biomarker of health published to date. This study sheds light on the critical importance of ethics and trustworthiness in the development of voice AI technologies for health applications.

Cell Maps for Artificial Intelligence: AI-Ready Maps of Human Cell Architecture from Disease-Relevant Cell Lines.

This article describes the Cell Maps for Artificial Intelligence (CM4AI) project and its goals, methods, standards, current datasets, software tools , status, and future directions. CM4AI is the Functional Genomics Data Generation Project in the U.S. National Institute of Health's (NIH) Bridge2AI program. Its overarching mission is to produce ethical, AI-ready datasets of cell architecture, inferred from multimodal data collected for human cell lines, to enable transformative biomedical AI research.

Pandemics, intellectual property and 'our economy': A worldview analysis of Canada's role in compromising global access to COVID-19 vaccines.

Despite self-congratulatory rhetoric, Canada compromised COVID-19 vaccine equity with policies impeding a proposed global waiver of vaccine intellectual property (IP) rules. To learn from Canada's vaccine nationalism we explore the worldview - a coherent textual picture of the world - in a sample of Government of Canada communications regarding global COVID-19 vaccine sharing. Analysed documents portray risks and disparities as unrelated to the dynamics and power relations of the Canadian and international economies. Against this depoliticised backdrop, economic growth fueled by strict IP rules and free trade is advanced as the solution to inequities. Global vaccine access and distribution are pursued via a charity-focused public-private-partnership approach, with proposals to relax international IP rules dismissed as unhelpful. Rather than a puzzling lapse by a good faith 'middle power', Canada's obstruction of global COVID-19 vaccine equity is a logical and deliberate extension of dominant neoliberal economic policy models. Health sector challenges to such models must prioritise equity in global pandemic governance via politically assertive and less conciliatory stances towards national governments and multilateral organisations. Mobilisation for health equity should transform the overall health-damaging macroeconomic model, complementing efforts based on specific individual health determinants or medical technologies.

Mapping ethical, legal, and social implications (ELSI) of preimplantation genetic testing (PGT).

PURPOSE: Preimplantation Genetic Testing (PGT) has attracted considerable ethical, legal, and social scrutiny, but academic debate often fails to reflect clinical realities. METHODS: Addressing this disconnect, a review of 506 articles from 1999 to 2019 across humanities and social sciences was conducted to synthesize the Ethical, Legal, and Social Implications (ELSI) of PGT. This review mined PubMed, WoS, and Scopus databases, using both MeSH terms and keywords to map out the research terrain. RESULTS: The findings reveal a tenfold increase in global research output on PGT's ELSI from 1999 to 2019, signifying rising interest and concern. Despite heightened theoretical discourse on selecting "optimal" offspring, such practices were scarcely reported in clinical environments. Conversely, critical issues like PGT funding and familial impacts remain underexplored. Notably, 86% of the ELSI literature originates from just 12 countries, pointing to a research concentration. CONCLUSION: This review underscores an urgent need for ELSI research to align more closely with clinical practice, promoting collaborations among ethicists, clinicians, policymakers, and economists. Such efforts are essential for grounding debates in practical relevance, ultimately steering PGT towards ethical integrity, societal acceptance, and equitable access, aiming to harmonize PGT research with real-world clinical concerns, enhancing the relevance and impact of future ethical discussions.

Ethical, legal, social, and policy issues of ovarian tissue cryopreservation in prepubertal girls: a critical interpretive review.

PURPOSE: Despite the increasing number of childhood cancer survivors, significant advances in ovarian tissue cryopreservation (OTC) technique and medical societies' recommendations, fertility preservation (FP) and FP discussions are not always offered as a standard of care in the pediatric context. The aim of this literature review is to understand what ethical, legal, social, and policy issues may influence the provision of FP by OTC in prepubertal girls with cancer. METHODS: A critical interpretive review of peer-reviewed papers published between 2000 and January 2023 was conducted, guided by the McDougall's version of the critical interpretive synthesis (Dixon-Woods), to capture recurring concepts, principles, and arguments regarding FP by OTC for prepubertal girls. RESULTS: Of 931 potentially relevant papers, 162 were included in our analysis. Data were grouped into seven thematic categories: (1) risks of the procedure, (2) unique decision-making issues in pediatric oncofertility, (3) counseling, (4) cultural and cost issues, and (5) disposition of cryopreserved reproductive tissue. CONCLUSION: This first literature review focusing on ethical, legal, social, and policy issues surrounding OTC in prepubertal girls highlights concerns in the oncofertility debate. Although OTC is no longer experimental as of December 2019, these issues could limit its availability and the child's future reproductive autonomy. This review concludes that specific actions must be provided to enable the offer of FP, such as supporting families' decision-making in this unique and complex context, and providing pediatric patients universal and full access to free or highly subsidized OTC.

Proposed Principles for International Bioethics Conferencing: Anti-Discriminatory, Global, and Inclusive.

This paper opens a critical conversation about the ethics of international bioethics conferencing and proposes principles that commit to being anti-discriminatory, global, and inclusive. We launch this conversation in the Section, Case Study, with a case example involving the International Association of Bioethics' (IAB's) selection of Qatar to host the 2024 World Congress of Bioethics. IAB's choice of Qatar sparked controversy. We believe it also may reveal deeper issues of Islamophobia in bioethics. The Section, Principles for International Bioethics Conferencing, sets forth and defends proposed principles for international bioethics conferencing. The Section, Applying Principles to Site Selection applies the proposed principles to the case example. The Section, Applying Principles Beyond Site Selection addresses other applications of the proposed principles. The Section, Objections responds to objections. We close (in the Section, Conclusion) by calling for a wider discussion of our proposed principles. One-Sentence Capsule Summary: How should bioethicists navigate the ethics of global bioethics conferencing?

The misplaced embryo: legal parenthood in 'embryo mix-up' cases.

Recently in Israel, a woman was mistakenly implanted with an embryo that is genetically related to another couple. Unfortunately, this case is not an isolated occurrence, as other cases of embryo mix-ups have been reported in several countries, including the USA, China, the UK and various other countries within the European Union. Cases of mixed-up embryos are ethically and legally complex: the woman who carried the pregnancy and the woman who is genetically related to the resulting child-both of whom endured emotionally and physically demanding infertility treatments-along with their partners, may be unwilling to relinquish parental rights over the child.This article explores four possible approaches, found in numerous common law jurisdictions, which can be used to address cases involving embryo mix-ups. Our analysis reveals several avenues through which legal parentage can be established. It can be done through gestation and the marital presumption, genetic connections, by adhering to the principle of the best interests of the child, or by recognising multiple individuals as legal parents. We review the advantages and disadvantages of each approach, but we have one clear recommendation: resolving embryo mix-up cases should be done proactively through the establishment of legislation and guidelines, rather than relying on post hoc individual court decisions. Such legislation and guidelines should guarantee the consistency of values throughout diverse reproductive contexts and mandate that fertility clinics and medical professionals provide individuals with comprehensive information regarding the potential risks associated with assisted reproductive treatments.

Harvey and Gurvir's Law: Ontario Bill for Quality Prenatal Information about Down Syndrome: Terminology, Feasibility, and Ethical Issues.

Harvey and Gurvir's Law is a bill proposed to the Legislative Assembly of Ontario (Canada) to reduce stigma and bias associated with Down syndrome, by developing and disseminating quality information about Down syndrome in the context of prenatal testing.