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Economics is the primary discipline used to understand supply chain design, scale-up, and management. For example, antibiotics can be compared to other forms of “tragedy of the commons,” whereby a common good (effective treatment of infections) is jeopardized by individual consumption and lack of community oversight and stewardship. While economic analysis can explain innovation decline in terms of market failure, one pitfall of an early-stage focus on research and development is a failure to challenge the discovery narrative. Ethics also has a distinct place in helping us envision alternatives to what markets can produce. This article advances a more contextualized view of how science and technology policy has shaped antibiotic supply chains over many years, emphasizing how shifting the story we tell about past successes is central to securing a reliable antibiotic supply chain in the future. [ABSTRACT FROM AUTHOR]

INTRODUCTION 1274 I. RESEARCH ETHICS, REGULATION, AND GOVERNANCE OF GENE 1277 TECHNOLOGIES A. Standard Research Ethics, Animal Ethics, and U.S. 1279 Institutional Oversight B. U.S. Coordinated Framework for Federal Regulation [...], The development of accelerated gene-editing techniques, including clustered regularly interspaced short palindromic repeats (CRISPR), carries ethical, legal, and social implications for agriculture. There are some in the genomic sciences who dread continuation of--and others who hope to reset--fractious moral debates characteristic of social discourse during the advent of genetically engineered plants in the 1990s. First, we review the current ethical principles underlying regulation and governance of genetic technologies and research involving nonhuman animals. Second, we explore existing ethical tensions and social debates about hog farming, nuisance suits, and Right-to-Farm legislation in North Carolina, a U.S. context into which gene-edited pigs are likely to be introduced. The ethical issues of land use, environmental justice, global food security, and food ethics reach far beyond risk-based ethics frameworks that often lie behind standard research ethics and U.S. regulatory approaches. Third, we argue that gene editing in agriculture calls for a broader bioethics. We consider lessons learned and limitations of community engagement currently taking place around gene drives for reducing mosquito-borne illnesses. Bioethics can improve and develop new modes of engagement to bridge important policy gaps through novel forms of engagement among stakeholders, including those with genetic, farming, environmental, and local knowledge.

One Health—a holistic approach to health that brings the moral status of animals and environments into consideration—is understood as a “professional imperative,” a value-laden obligation that flows from the scope and objectives of professional roles. In this article, antimicrobial resistance provides a case study to demonstrate the fruitfulness of public health and bioethics collaborations by applying One Health key concepts of interconnection and interdependence. Moving toward an ethics of One Health requires a more nuanced analysis of ecological relationships, including humans’ connections to other species as hosts, vectors, domestic companions, meat-eaters’ food, and farmers’ livelihood. [ABSTRACT FROM AUTHOR]

As pharmacogenomic (PGx) testing increases in popularity, lay concepts of drug‐gene interactions set the stage for shared decision making in precision medicine. Few studies explore what recipients of PGx results think is happening in their bodies when a drug‐gene interaction is discovered. To characterize biobank participants' understanding of PGx research results, we conducted a focus group study, which took place after PGx variants conferring increased risk of dihydropyrimidine dehydrogenase (DPD) deficiency were disclosed to biobank contributors. DPD deficiency confers an increased risk of adverse reaction to commonly used cancer chemotherapeutics. Ten focus groups were conducted, ranging from two to eight participants. Fifty‐four individuals participated in focus groups. A framework approach was used for descriptive and explanatory analysis. Descriptive themes included participants' efforts to make sense of PGx findings as they related to: (1) health implications, (2) drugs, and (3) genetics. Explanatory analysis supplied a functional framework of how participant word choices can perform different purposes in PGx communication. Results bear three main implications for PGx research‐related disclosure. First, participants' use of various terms suggest participants generally understanding their PGx results, including how positive PGx results differ from positive disease susceptibility genetic results. Second, PGx disclosure in biobanking can involve participant conflation of drug‐gene interactions with allergies or other types of medical reactions. Third, the functional framework suggests a need to move beyond a deficit model of genetic literacy in PGx communication. Together, findings provide an initial evidence base for supporting bidirectional expert‐recipient PGx results communication. [ABSTRACT FROM AUTHOR]

For years, genomic medicine-medicine based on the growing understanding of the genetic contribution to many diseases and conditions-has been hailed as the future of medical treatment, but it has thus far had limited effect on day-to-day medical practice. The ultimate goal of genomic medicine has always been the ability not just to identify dangerous gene mutations, but to fix them. Now CRISPR and related genome-editing technologies may have the potential to provide a safe and effective way to repair dangerous mutations. In the wake of ethically dubious experiments with human embryos in China, the international governance of human genome editing is emerging as an urgent topic for scientists, regulators, and the public. Efforts to develop a governance model are underway at national and international levels. These efforts are the subject of multiple initiatives by national and international health and science organizations and are topics of discussion at scientific conferences, summits, and meetings. This Article reports on the Authors' multi-year, interdisciplinary project to identify and investigate the practical, ethical, and policy considerations that are emerging as the greatest concerns about human genome editing, and ultimately to develop policy options. The project involves monitoring the discussions of groups, both government-sponsored and private, that are considering how genome editing should be governed; observing conferences where the topic is discussed; analyzing emerging policy reports by national and international bodies; and interviewing a wide range of stakeholders, including scientists, ethicists, and those who make and comment on public policy. The Article identifies several stakeholder concerns that are especially prominent in the research to date and begins to explore the implications of these concerns for alternative models of governance. There are current indications that, for practical purposes, a focus on "soft," hybrid forms of governance based on networks of multiple public and private stakeholders may turn out to be the most promising course to pursue. The "new governance" paradigm developed in the corporate and financial sectors offers a useful model for understanding the dynamics of this approach.