An international legal agreement governing the global antimicrobial commons would represent the strongest commitment mechanism for achieving collective action on antimicrobial resistance (AMR). Since AMR has important similarities to climate change—both are common pool resource challenges that require massive, long-term political commitments—the first article in this special issue draws lessons from various climate agreements that could be applicable for developing a grand bargain on AMR. We consider the similarities and differences between the Paris Climate Agreement and current governance structures for (...) AMR, and identify the merits and challenges associated with different international forums for developing a long-term international agreement on AMR. To be effective, fair, and feasible, an enduring legal agreement on AMR will require a combination of universal, differentiated, and individualized requirements, nationally determined contributions that are regularly reviewed and ratcheted up in level of ambition, a regular independent scientific stocktake to support evidence informed policymaking, and a concrete global goal to rally support. (shrink)

Antimicrobial resistance (AMR) is an urgent threat to global public health and development. Mitigating this threat requires substantial short-term action on key AMR priorities. While international legal agreements are the strongest mechanism for ensuring collaboration among countries, negotiating new international agreements can be a slow process. In the second article in this special issue, we consider whether harnessing existing international legal agreements offers an opportunity to increase collective action on AMR goals in the short-term. We highlight ten AMR priorities and (...) several strategies for achieving these goals using existing “legal hooks” that draw on elements of international environmental, trade and health laws governing related matters that could be used as they exist or revised to include AMR. We also consider the institutional mandates of international authorities to highlight areas where additional steps could be taken on AMR without constitutional changes. Overall, we identify 37 possible mechanisms to strengthen AMR governance using the International Health Regulations, the Agreement on the Application of Sanitary and Phytosanitary Measures, the Agreement on Trade-Related Aspects of Intellectual Property Rights, the Agreement on Technical Barriers to Trade, the International Convention on the Harmonized Commodity Description and Coding System, and the Basel, Rotterdam, and Stockholm conventions. Although we identify many shorter-term opportunities for addressing AMR using existing legal hooks, none of these options are capable of comprehensively addressing all global governance challenges related to AMR, such that they should be pursued simultaneously with longer-term approaches including a dedicated international legal agreement on AMR. (shrink)

Antimicrobial resistance is one of the greatest public health crises of our time. The natural biological process that causes microbes to become resistant to antimicrobial drugs presents a complex social challenge requiring more effective and sustainable management of the global antimicrobial commons—the common pool of effective antimicrobials. This special issue of Health Care Analysis explores the potential of two legal approaches—one long-term and one short-term—for managing the antimicrobial commons. The first article explores the lessons for antimicrobial resistance that can be (...) learned from recent climate change agreements, and the second article explores how existing international laws can be adapted to better support global action in the short-term. (shrink)

Antimicrobial resistance is a global collective action problem with dire consequences for human health. This article considers how domestic and international legal mechanisms can be used to address antimicrobial resistance and overcome the governance and political economy challenges that accelerate it.

Ensuring that life-saving antimicrobials remain available as effective treatment options in the face of rapidly rising levels of antimicrobial resistance will require a massive and coordinated global effort. Setting a collective direction for progress is the first step towards aligning global efforts on AMR. This process would be greatly accelerated by adopting a unifying global target — a well-defined global target that unites all countries and sectors. The proposed pandemic instrument — with its focus on prevention, preparedness and response — (...) represents an ideal opportunity to develop and adopt a unifying global target that catalyzes global action on AMR. We propose three key characteristics of a unifying global target for AMR that — if embedded within the pandemic preparedness instrument — could rally public support, funding, and political commitment commensurate with the scale of the AMR challenge. (shrink)

In the wake of COVID-19, the World Health Organization established an Intergovernmental Negotiating Body to negotiate a new instrument for pandemic prevention, preparedness, and response. This special issue of the Journal of Law, Medicine & Ethics brings together multidisciplinary scholarship to address the question of whether antimicrobial resistance should be included in this new instrument. Drawing from disciplines including law, anthropology, history, public health, public policy, economics, and veterinary medicine, this special issue explores the inclusion of AMR within the Pandemic (...) Instrument from three perspectives: first, through the lens of global AMR governance, second, from the perspective of technical governance challenges and opportunities affecting the global ability to address AMR and future pandemics, and third, from the perspective of pandemic instrument mechanisms for strengthening global AMR governance. Each paper makes a concrete recommendation with respect to the importance of including AMR within the scope of the pandemic instrument. (shrink)

Governments can practically and efficiently address zoonoses and AMR –– within the text of the new pandemic instrument. We map the overlaps between the efforts needed to address both pandemic threats, including (a) equitable access to medical countermeasures, (b) globally integrated One Health surveillance and monitoring systems, (c) increased technical and laboratory capacity in low- and middle-income countries, and (d) a regulatory framework governing the stewardship of antimicrobials. By outlining potential dual-purpose provisions that could be included in a pandemic instrument, (...) we argue that addressing AMR in the pandemic instrument is practicable, the most effective use of limited time and resources, and provides the best opportunity for future global pandemic readiness. (shrink)

Despite recognition of the health threat posed at the human-animal-environment interface long ago, One Health has yet to be meaningfully integrated into global pandemic prevention, preparedness, and response. With the negotiation of the forthcoming pandemic instrument under the auspices of the World Health Organization (WHO) — which is inherently restricted by its own constitutional mandate of human health — One Health risks being sidelined once again. Genuine integration of a One Health approach into this treaty will require the institutionalization of (...) formal One Health coordination mechanisms. (shrink)

To address the complex challenge of global antimicrobial resistance (AMR), a pandemic treaty should include mechanisms that 1) equitably address the access gap for antimicrobials, diagnostic technologies, and alternative therapies; 2) equitably conserve antimicrobials to sustain effectiveness and access across time and space; 3) equitably finance the investment, discovery, development, and distribution of new technologies; and 4) equitably finance and establish greater upstream and midstream infection prevention measures globally. Biodiversity, climate, and nuclear governance offer lessons for addressing these challenges.

Antimicrobial resistance (AMR) is one of the defining global health threats of our time, but no international legal instrument currently offers the framework and mechanisms needed to address it. Fortunately, the actions needed to address AMR have considerable overlap with the actions needed to confront other pandemic threats.

The inclusion of antimicrobial resistance (AMR) and increased research and development (R&D) capabilities in the most recent outline of the World Health Organization’s (WHO’s) international pandemic instrument signals an opportunity to reshape pharmaceutical R&D system in favour of antimicrobial product development. This article explains why the current innovation ecosystem has disadvantaged the creation of antimicrobial products for human use. It also highlights how the COVID-19 pandemic experience can inform and stimulate international cooperation to implement innovative R&D incentives to bring new, (...) life-saving antimicrobial products to the market. (shrink)

A crisis looms over the scientific enterprise. Not a day passes without news of retractions, failed replications, fraudulent peer reviews, or misinformed science-based policies. The social implications are enormous, yet this crisis has remained largely uncharted-until now. In Science on the Verge, luminaries in the field of post-normal science and scientific governance focus attention on worrying fault-lines in the use of science for policymaking, and the dramatic crisis within science itself. This provocative new volume in The Rightful Place of Science (...) also explores the concepts that need to be unlearned, and the skills that must be relearned and enhanced, if we are to restore the legitimacy and integrity of science. (shrink)

Humans are experts in cooperating with each other when trying to accomplish tasks they cannot achieve alone. Recent studies of joint action have shown that when performing tasks together people strongly rely on the neurocognitive mechanisms that they also use when performing actions individually, that is, they predict the consequences of their co‐actor’s behavior through internal action simulation. Context‐sensitive action monitoring and action selection processes, however, are relatively underrated but crucial ingredients of joint action. In the present paper, we try (...) to correct the somewhat simplified view on joint action by reviewing recent studies of joint action simulation, monitoring, and selection while emphasizing the intricate interrelationships between these processes. We complement our review by defining the contours of a neurologically plausible computational framework of joint action. (shrink)

In this paper we aim to shed light on the dynamics of regional identity construction and deconstruction. We will argue that four forms of identity can be identified that are linked through various processes of change. To that end, we will theoretically conceptualise 'identity' by discussing historical and current scholarly debates on identity in a variety of scientific disciplines. Then, we will argue that the mutual contradiction of the current theories is a paradox if seen from the angle of regional (...) identity construction and deconstruction. Building upon elements from the various theoretical approaches, we propose a heuristic model describing the dynamics of identity construction and deconstruction, which will be explored by means of the example of the Green Heart region, a spatial planning concept in western Holland. (shrink)

The fracking debate is a product of the tension between the environmental degradation it may cause, on the one hand, and on the other the greater energy demands of a rapidly increasing South African population with expectations of an ever-increasing standard of living. Shale gas fracking in the Karoo of South Africa promises to make vast reserves of oil and gas available to help meet a significant percentage of the country’s energy needs for many years to come. This will aid (...) development and contribute to raising the standard of living of many. This article seeks to apprise the South African faith communities of the technology and risks involved. Christian theological guidelines are presented by which its benefits and dangers may be interrogated so that the community may be able come to an informed decision as to whether or not to support fracking. (shrink)

Wendy Rogers ist Professorin für klinische Ethik und Catriona Mackenzie ist Professorin für Philosophie. Beide lehren an der Macquarie University in Sydney, Australien. Susan Dodds ist Professorin für Philosophie an der La Trobe University in Melbourne, Australien. Alle drei befassen sich seit Jahren intensiv mit feministischer Theorie, angewandter und biomedizinischer Ethik sowie mit Moralphilosophie.

No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

Concern for human vulnerability seems to be at the heart of bioethical inquiry, but the concept of vulnerability is under-theorized in the bioethical literature. The aim of this article is to show why bioethics needs an adequately theorized and nuanced conception of vulnerability. We first review approaches to vulnerability in research ethics and public health ethics, and show that the bioethical literature associates vulnerability with risk of harm and exploitation, and limited capacity for autonomy. We identify some of the challenges (...) emerging from this literature: in particular, how to reconcile universal human vulnerability with a context-sensitive analysis of specific kinds and sources of vulnerability; and how to reconcile obligations to protect vulnerable persons with obligations to respect autonomy. We then briefly survey some of the theoretical resources available within the philosophical literature to address these challenges, and to assist in understanding the conceptual connections between vulnerability and related concepts such as harm, exploitation, needs, and autonomy. We also sketch out a taxonomy of sources and kinds of vulnerability. Finally, we consider the implications for policy evaluation of making vulnerability an explicit and central focus of bioethics. Our investigation is in the form of a broad survey motivating a research agenda rather than a detailed analysis. (shrink)

Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.

Gaisi Takeuti has recently proposed a new operation on orthomodular lattices L, ⫫: $\scr{P}\rightarrow L$ . The properties of ⫫ suggest that the value of ⫫ $$ corresponds to the degree in which the elements of A behave classically. To make this idea precise, we investigate the connection between structural properties of orthomodular lattices L and the existence of two-valued homomorphisms on L.

This volume breaks new ground by investigating the ethics of vulnerability. Drawing on various ethical traditions, the contributors explore the nature of vulnerability, the responsibilities owed to the vulnerable, and by whom.

Elicitation materials like language portraits are useful to investigate people’s perceptions about the languages that they know. This study uses portraits to analyse the underlying conceptualisations people exhibit when reflecting on their language repertoires. Conceptualisations as manifestations of cultural cognition are the purview of cognitive sociolinguistics. The present study advances portrait methodology as it analyses data from structured language portraits of 105 South African youth as a linguistic corpus from both qualitative and quantitative perspectives. The approach enables the uncovering of (...) (a) prominent underlying conceptualisations of African language(s) and the body, and (b) the differences and similarities of these conceptualisations vis-à-vis previous cognitive (socio)linguistic studies of embodied language experiences. In our analysis, African home languages emerged both as ‘languages of the heart’ linked to cultural identity and as ‘languages of the head’ linked to cognitive strength and control. Moreover, the notion of ‘degrees of proficiency’ or ‘magnitude’ of language knowledge emerged more prominently than in previous studies of embodied language experience. (shrink)

In this paper we aim to shed light on the dynamics of regional identity construction and deconstruction. We will argue that four forms of identity can be identified that are linked through various processes of change. To that end, we will theoretically conceptualise 'identity' by discussing historical and current scholarly debates on identity in a variety of scientific disciplines. Then, we will argue that the mutual contradiction of the current theories is a paradox if seen from the angle of regional (...) identity construction and deconstruction. Building upon elements from the various theoretical approaches, we propose a heuristic model describing the dynamics of identity construction and deconstruction, which will be explored by means of the example of the Green Heart region, a spatial planning concept in western Holland. (shrink)

Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research Consortium. The authors then (...) negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death. (shrink)

Several foundational documents of bioethics mention the special obligation researchers have to vulnerable research participants. However, the treatment of vulnerability offered by these documents often relies on enumeration of vulnerable groups rather than an analysis of the features that make such groups vulnerable. Recent attempts in the scholarly literature to lend philosophical weight to the concept of vulnerability are offered by Luna and Hurst. Luna suggests that vulnerability is irreducibly contextual and that Institutional Review Boards (Research Ethics Committees) can only (...) identify vulnerable participants by carefully examining the details of the proposed research. Hurst, in contrast, defines the vulnerable as those especially at risk of incurring the wrongs to which all research ethics participants are exposed. We offer a more substantive conception of vulnerability than Luna but one that gives rise to a different rubric of responsibilities from Hurst's. While we understand vulnerability to be an ontological condition of human existence, in the context of research ethics, we take the vulnerable to be research subjects who are especially prone to harm or exploitation. Our analysis rests on developing a typology of sources of vulnerability and showing how distinct sources generate distinct obligations on the part of the researcher. Our account emphasizes that the researcher's first obligation is not to make the research participant even more vulnerable than they already are. To illustrate our framework, we consider two cases: that of a vulnerable population involved in international research and that of a domestic population of people with diminished capacity. (shrink)

Despite enthusiastic claims around the benefits of corporate volunteering for the workplace and its widespread implementation, the impact of such programs for beneficiaries and non-profit organizations remains uncertain, particularly when employees’ participation is one-off. Previous research suggests that the benefits of CV for employees, businesses, and society are more likely to occur if employees internalize a volunteer identity—that is, if being a volunteer becomes a part of their self. This leads them to sustain their participation in CV over time, maximizing (...) CV’s positive effects on all stakeholders. This study explores the factors explaining why employees internalize a volunteer identity in a corporate context. We do so by empirically testing Grant’s :589-615, 2012) volunteer work design theoretical model with a sample of 619 employees involved in CV programs, and by comparing its relevance with an alternative, extended model relying on insights from self-determination theory. Whereas we find only partial and weak empirical support for the VWD model, our SDT-extended model is supported empirically. These results show that the quality of motivation that employees experience while volunteering plays a more important role than repeated participation, as it illuminates the process of how factors such as the quality of the projects, organizational support for CV, as well as the causes targeted affect the internalization of a volunteer identity. In particular, we show that employees are more likely to internalize a volunteer identity if they can choose what cause to engage for and if they feel that the projects they participate in are meaningful. Surprisingly, we also show that a prestigious cause as well as recognition and managerial support foster a controlled form of motivation for employees, which are then unlikely to internalize a volunteer identity. In doing so, we contribute to a better understanding of how CV can have lasting benefits for both business and society, and provide business leaders with actionable insights about how to design impactful CV programs. (shrink)

These essays apply influential, pathbreaking psychological studies about women's lives to literature. In their analyses of fictional portraits, contributors both challenge and confirm psychological theories about female identity, about 'connection/separation' as developmental catalysts, and about the impact of gender on 'voice,' moral decision-making, and epistemology in relation to classical and contemporary literary texts, written by both women and men.

BackgroundInaccurate, false or incomplete research publications may mislead readers including researchers and decision-makers. It is therefore important that such problems are identified and rectified promptly. This usually involves collaboration between the research institutions and academic journals involved, but these interactions can be problematic.MethodsThese recommendations were developed following discussions at World Conferences on Research Integrity in 2013 and 2017, and at a specially convened 3-day workshop in 2016 involving participants from 7 countries with expertise in publication ethics and research integrity. The (...) recommendations aim to address issues surrounding cooperation and liaison between institutions and journals about possible and actual problems with the integrity of reported research arising before and after publication.ResultsThe main recommendations are that research institutions should: develop mechanisms for assessing the integrity of reported research that are distinct from processes to determine whether individual researchers have committed misconduct;release relevant sections of reports of research integrity or misconduct investigations to all journals that have published research that was investigated;take responsibility for research performed under their auspices regardless of whether the researcher still works at that institution or how long ago the work was done;work with funders to ensure essential research data is retained for at least 10 years.Journals should: respond to institutions about research integrity cases in a timely manner;have criteria for determining whether, and what type of, information and evidence relating to the integrity of research reports should be passed on to institutions;pass on research integrity concerns to institutions, regardless of whether they intend to accept the work for publication;retain peer review records for at least 10 years to enable the investigation of peer review manipulation or other inappropriate behaviour by authors or reviewers.ConclusionsVarious difficulties can prevent effective cooperation between academic journals and research institutions about research integrity concerns and hinder the correction of the research record if problems are discovered. While the issues and their solutions may vary across different settings, we encourage research institutions, journals and funders to consider how they might improve future collaboration and cooperation on research integrity cases. (shrink)

A brain-computer interface technology that can decode the neural signals associated with attempted but unarticulated speech could offer a future efficient means of communication for people with severe motor impairments. Recent demonstrations have validated this approach. Here we assume that it will be possible in future to decode imagined (i.e., attempted but unarticulated) speech in people with severe motor impairments, and we consider the characteristics that could maximize the social utility of a BCI for communication. As a social interaction, communication (...) involves the needs and goals of both speaker and listener, particularly in contexts that have significant potential consequences. We explore three high-consequence legal situations in which neurally-decoded speech could have implications:Testimony, where decoded speech is used as evidence;Consent and Capacity, where it may be used as a means of agency and participation such as consent to medical treatment; andHarm, where such communications may be networked or may cause harm to others. We then illustrate how design choices might impact the social and legal acceptability of these technologies. (shrink)