Social license reflects environmental and social change, and sees community as an important stakeholder and partner. Science, scientists, and science policy have a key role in the processes that generate social license. In this paper, we focus on the interaction between science and social license in salmon aquaculture in south-eastern Tasmania. This research suggests that social license will be supported by distributed and credible knowledge co-production. Drawing on qualitative, interpretive social research we argue that targeted science, instilled by appropriate science (...) policy, can underpin social license by supporting emerging, distributed, and pluralistic knowledge production. Where social license is important and environmental contexts are complex, such knowledge production might support environmental governance, and so improve outcomes in coastal zone management and beyond. (shrink)

This article challenges the idea that success of boundary organizations is marked primarily by the stability of the science–policy interface. We review key theory in the literature on boundary work and boundary organizations. We then present a case, the Derwent Estuary Program in South East Tasmania, Australia, to explore the evolution of successful boundary organization. We detail how a science-oriented program of work achieved success, through early wins that cemented its support and created a relatively stable entity able to navigate (...) the expansion of its remit from managing controversy to implementing an integrated, systems approach to coastal zone management. The creation of “safe spaces” enabled contentious situations to be negotiated through well-established relationships and processes. The interaction among these elements, supported by exemplary leadership, was critical to reframing the problem. We suggest that it is through these abilities to navigate controversy and mediate among divergent interests, while maintaining a committed focus on science, that boundary organizations can succeed. Success in this context is achieved through using credible science to reframe problems. Success is further indicated not just by surviving periodic controversies but by being able to benefit from them, building legitimacy among partners and stakeholders through successfully navigating unforeseen events. (shrink)

To ensure that the information resulting from research is relevant to patients, the Patient‐Centered Outcomes Research Institute eschews the “traditional health research” paradigm, in which investigators drive all aspects of research, in favor of one in which patients assume the role of research partner. If we accept the premise that patient engagement can offer fresh perspectives that shape research in valuable ways, then at least two important sets of questions present themselves. First, how are patients being engaged—and how should they (...) be engaged? Second, which patients are being engaged—and which patients should be? This set has received relatively less attention, and the neglect is surprising, given that the “who” question is conceptually prior to the question of “how.”This article focuses attention on the “who” of patient engagement in research. First, we provide background on the rationale for patient engagement, underscoring the importance of ensuring the representativeness of engaged patients. Second, we present what little is known about patients engaged in PCORI‐funded research. Third, we identify and discuss the ethical implications of ways in which current practices of patient identification and recruitment may lead to a lack of representativeness. These practices include reliance on the well‐connected and well‐informed, reliance on patients who are not well trained or well‐informed, and reliance on patient advocacy organizations. Finally, we consider several strategies for addressing these pitfalls in order to maximize the positive goals of patient engagement. Patient engagement is intended to address the inability of researchers, funders, and others to fully represent patient views and priorities, but without sufficient attention, the patients selected for this role may still leave important gaps. (shrink)

Interest in the use of medical data for health research is increasing. Yet, as Elizabeth Ford and colleagues rightly note, there are open questions about the suitability of existing ethical and regulatory oversight frameworks for these research approaches. In their feature article, ‘Should free text data in electronic medical records be shared for research? A citizen’s jury study in the United Kingdom’, Ford et al report the results of a deliberative engagement study in which 18 members of the public were (...) asked whether and under what conditions free text data from medical records should be shared for research purposes. The authors’ explicit aim was to inform national policy on sharing medical text. Public attitudes—stated otherwise, the attitudes of patients whose medical information will ultimately be used under any data sharing policy—are a necessary input into ethical and regulatory decision-making about use of medical data for health research. Though public attitudes will rarely be determinative, they must be weighed in order to uphold the ethical principle of respect for persons.1 Ford et al ’s article is, therefore, an important contribution to …. (shrink)

In this issue of the Hastings Center Report, James Sabin and his colleagues ask what responsibility investigators in a learning health organization have to patients when research—particularly research of which patients might be unaware—illuminates problematic aspects of the patients' care. Sabin and his colleagues were confronted by this question in the midst of designing a randomized controlled trial that sought to determine if an educational intervention targeted at patients with atrial fibrillation and their clinicians reduces underuse of oral anticoagulants. Worried (...) about harm that might befall patients in the control group and fearing that they would be negligent bystanders if they knew these patients were at risk and did nothing, the investigators adopted a “workaround.” But the “workaround,” I suggest, was not a solution to the negligent bystander problem. Nor was it a solution to the problem as I would alternatively frame it—how to address instances of suboptimal patient care identified through research within learning health organizations. (shrink)

Topics related to ethical issues in agricultural production, particularly farm animal welfare, are increasingly featured in mainstream news media. Media representations of farm animal welfare issues are important because the media is a significant source of information, but also because the way that the issues are represented, or framed, defines these issues in particular ways, suggests causes or solutions, and provides moral evaluations. As such, analysis of media frames can reveal how issues are being made public and identify the cues (...) that audiences are given to help them make sense of complex ethical issues. Previous research on media frames and animal welfare has tended to focus on single issues or events; however we sought to identify whether media frames extended across different farm animal welfare-related issues to investigate whether there is any commonality between issues. We analysed articles published in the mainstream press in Australia between 2014 and 2016 related to farm animal welfare, and identified two dominant frames: that governments and the farm animal production industries cannot be trusted to ensure good farm animal welfare; and that consumers can act to improve animal welfare through ethical consumption. These frames have implications for how the Australian public interpret and understand the roles and responsibilities of different actors in the food production system. This research also contributes to discussion about the role of the media in shaping public opinion about ethical issues in agriculture and how, in turn, the media landscape itself is being shaped by consumer attitudes. (shrink)

Coregulation refers to the process by which relationship partners form a dyadic emotional system involving an oscillating pattern of affective arousal and dampening that dynamically maintains an optimal emotional state. Coregulation may represent an important form of interpersonal emotion regulation, but confusion exists in the literature due to a lack of precision in the usage of the term. We propose an operational definition for coregulation as a bidirectional linkage of oscillating emotional channels between partners, which contributes to emotional stability for (...) both partners. We propose several distinctions and raise unanswered questions that will need to be addressed in order to understand the relevance of coregulation for well-being in adulthood. (shrink)

During spring of 2020, environmental ethics students at a medium sized metropolitan university in the Southeastern United States were asked to read and comment on classic essays from Robert Heilbroner and Garrett Hardin, essays regarding our responsibilities towards future generations. In general, students seemed to hold more with Heilbroner’s stance, which left room for compassion, while condemning Hardin’s harshness. Students were then asked to provide written responses stating whether they would personally sacrifice their eventual retirement in order to stop COVID-19 (...) and the reasons for their views. Responses were analyzed and categorized to detect inconsistencies between students’ described views and their willingness to personally sacrifice for the sake of others. Almost 72% of respondents asserted that they would be willing to intervene to stop the novel coronavirus by sacrificing their retirement. A fair number of respondents that stated they would sacrifice said that they would do so because they would benefit personally from the avoidance of guilt and/or from the opportunity to feel good about themselves, suggesting that even seemingly selfless behaviors are sometimes driven by egoistic motivations. Forty percent of all respondents held inconsistent views. Most notably, a number of students condemned Hardin for his lack of compassion, yet were not willing to act compassionately themselves. (shrink)

The COVID-19 pandemic has been devastating for people living with dementia (PLWD) and their caregivers. While prior research has documented these effects, it has not delved into their specific causes or how they are modified by contextual variation in caregiving circumstances.

Growing interest in embedded research approaches—where research is incorporated into clinical care—has spurred numerous studies to generate knowledge relevant to the real-world needs of patients and other stakeholders. However, it also has presented ethical challenges. An emerging challenge is how to understand the nature and extent of investigators’ obligations to patient-subjects. Prior scholarship on investigator duties has generally been grounded upon the premise that research and clinical care are distinct activities, bearing distinct duties. Yet this premise—and its corresponding implications—are challenged (...) when research and clinical care are deliberately integrated. After presenting three case studies from recent pragmatic clinical trials, we identify six differences between explanatory trials and embedded research that limit the application of existing scholarship for ascertaining investigator duties. We suggest that these limitations indicate a need to account for the implications of usual care and to move beyond a narrow focus on the investigator-subject dyad, one that better reflects the team- and institution-based nature of contemporary health systems. (shrink)

This groundbreaking interactive book contains the tools that you will need in order to clean your emotional house from top to bottom. It includes a journal as well as access to audio meditations for you to listen along to as you read. The meditations will help you dig deep into past trauma and discover when and how trauma took root, learn to get in touch with various parts of the physical and energy body, and how to use them to let (...) go of stored traumas. From this, you will learn to live from a new mindful and powerful space. (shrink)

This article examines five different Medical-Legal Partnerships associated with Yale Law School in New Haven, Connecticut to illustrate how MLP addresses the social determinants of poor health. These MLPs address varied and distinct health and legal needs of unique patient populations, including: 1) children; 2) immigrants; 3) formerly incarcerated individuals; 4) patients with cancer in palliative care; and 5) veterans. The article charts a research agenda to create the evidence base for quality and evaluation metrics, capacity building, sustainability, and best (...) practices; it also focuses specifically on a research agenda that identifies the value of the lawyers in MLP. Such a focus on the “L” has been lacking and is overdue. (shrink)

California has focused on health equity in the state’s COVID-19 reopening plan. The Blueprint for a Safer Economy assigns each of California’s 58 counties into 1 of 4 tiers based on 2 metrics: test positivity rate and adjusted case rate. To advance to the next less-restrictive tier, counties must meet that tier’s test positivity and adjusted case rate thresholds. In addition, counties must have a plan for targeted investments within disadvantaged communities, and counties with more than 106 000 residents must (...) meet an equity metric. California's explicit incorporation of health equity into its reopening plan underscores the interrelated fate of its residents during the COVID-19 pandemic and creates incentives for action. This article evaluates the benefits and challenges of this novel health equity focus, and outlines recommendations for other US states to address disparities in their reopening plans. (shrink)

Discourse on communities and aging traditionally has focused on the availability, accessibility, and quality of local services to support older adults in need of assistance. More recently, however, a growing worldwide “age‐friendly” movement has pushed the conceptualization of community supports for an aging society beyond service provision. The term “age friendly” is used in considering how various aspects of a community facilitate or impede the health and well‐being of individuals as they experience long lives.Frameworks on age friendliness include attention to (...) health and community services for older adults but also encompass other aspects of communities, such as the physical design of outdoor spaces and buildings, the diversity of mobility options for drivers and nondrivers alike, and the availability of safe, affordable, and various types of housing. Age‐friendly frameworks also highlight how the very social fabric of a community can influence older residents’ quality of life. Over the past decade, a growing number of cities and communities have launched age‐friendly initiatives as organized and comprehensive efforts to make localities better for residents as they age. This essay begins to explore how AFIs can address social inequalities in health and aging. It concludes by describing how embedding a spatial justice lens within age‐friendly efforts could help AFIs realize more fully the changes that they seek to create at the local, national, and global levels. (shrink)

The Covid-19 pandemic elevated global attention to the complex problem of allocating and disseminating newly approved vaccines. Following early calls for vaccine equity,1 global health leaders made progress but struggled to fully realize distribution goals.2 With respect to vaccination rates, low and middle income countries have not achieved full parity with high income countries.3 In this issue, Harmon, Kholina, and Graham follow longstanding critiques of market-based vaccine procurement to propose “legal and practical solutions for realizing a new access to vaccines (...) environment”4 that will, they suggest, further the goal of global health justice. (shrink)

Medical ethics assumes a clear boundary between clinical research and clinical medicine: one produces knowledge for the benefit of future patients, while the other provides optimal care to individuals right now. It also assumes that the two cannot be integrated without sacrificing the needs of the current patient to those of future patients. But integration could allow us to provide better care to everyone, now and in the future.

The rule of rescue describes the moral impulse to save identifiable lives in immediate danger at any expense. Think of the extremes taken to rescue a small child who has fallen down a well, a woman pinned beneath the rubble of an earthquake, or a submarine crew trapped on the ocean floor. No effort is deemed too great. Yet should this same moral instinct to rescue, regardless of cost, be applied in the emergency room, the hospital, or the community clinic? (...) -/- In health care, the desire to save lives at any cost must be reconciled with the reality of resource scarcity. As one example, the estimated cost for prophylactic Factor VIII to treat one patient with hemophilia for one year is $300,000. Costs of this magnitude have been accepted by public and private insurers in the developed world, even though, in principle, these sums could provide greater overall health benefit if allocated to pay for the unmet health care needs of many other patients. Looking forward, however, broad application of the rule of rescue will be increasingly untenable. But the moral instinct will remain: the desire to help those weakest among us, especially when their small numbers allow us to see them as unique individuals. What, then, is the ethical framework that can guide coverage and reimbursement decisions for orphan drugs into the future? (shrink)

Research that is integrated into ongoing clinical activities holds the potential to accelerate the generation of knowledge to improve the health of individuals and populations. Yet integrating research into clinical care presents difficult ethical and regulatory challenges, including how or whether to obtain informed consent. Multiple empirical studies have explored patients' and the public's attitudes toward approaches to consent for pragmatic research. Questions remain, however, about how to use the resulting empirical data in resolving normative and policy debates and what (...) kind of data warrants the most consideration. We recommend prioritizing data about what people consider acceptable with respect to consent for pragmatic research and data about people's informed, rather than initial, preferences on this subject. In addition, we advise caution regarding the weight given to majority viewpoints and identify circumstances when empirical data can be overridden. We argue that empirical data bolster normative arguments that alterations of consent should be the default in pragmatic research; waivers are appropriate only when the pragmatic research would otherwise be impracticable and has sufficiently high social value. (shrink)

We argued last year in this journal that extensive integration of research and care is a worthy goal of health system design, and we second the call from Ruth Faden and colleagues to move toward learning health care systems. As they recognize, learning health care systems demand the coordination of research and medical ethics—two sets of normative commitments that have long been considered distinct. In offering a novel ethics framework for such systems, Faden et al. advance the scholarly debate about (...) how best to do this and challenge us to think more deeply about its practical implications. However, we believe that at least three issues they raise require additional attention. First, the research‐care distinction has more normative bite than they are willing to concede. Second, the role for independent oversight requires clarification. Finally, they neglect the concept of stewardship as a guiding obligation of learning health care systems. (shrink)

Coregulation refers to the process by which relationship partners form a dyadic emotional system involving an oscillating pattern of affective arousal and dampening that dynamically maintains an optimal emotional state. Coregulation may represent an important form of interpersonal emotion regulation, but confusion exists in the literature due to a lack of precision in the usage of the term. We propose an operational definition for coregulation as a bidirectional linkage of oscillating emotional channels between partners, which contributes to emotional stability for (...) both partners. We propose several distinctions and raise unanswered questions that will need to be addressed in order to understand the relevance of coregulation for well-being in adulthood. (shrink)

Everything is constantly changing. Our emotions are one of the primary ways we track, evaluate, organize, and motivate responsive action to those changes. Furthermore, emotions are inherently interpersonal. We learn what to feel from others, especially when we are children. We “catch” other people’s emotions just by being around them. We get caught in escalating response–counterresponse emotional sequences. This all takes place in time, generating complex patterns of interpersonal emotional dynamics. This review summarizes theory, empirical findings, and key challenges for (...) future research regarding three processes that contribute to interpersonal affective dynamics: (a) Convergence of social partners’ emotional responses to the external world, (b) emotional reactivity of social partners to each other, and (c) interpersonal emotion regulation. (shrink)

Over the course of human life, health care decision‐making is often interdependent. In this article, we use “interdependence” to refer to patients’ engagement of nonclinicians—for example, family members or trusted friends—to reach health care decisions. Interdependence, we suggest, is common for patients in all stages of life, from early childhood to late adulthood. This view contrasts with the common bioethical assumption that medical decisions are either wholly independent or dependent and that independence or dependence is tightly coupled with a person's (...) decision‐making capacity. In this article, we array various approaches to decision‐making along a continuum of interdependence. An appreciation of this continuum can empower patients and elucidate ethical challenges that arise when people transition between different kinds of interdependence across the life span. (shrink)

Non-pharmaceutical interventions, including social distancing, quarantine, and isolation, are a potentially attractive means to limit the transmission of a pandemic virus. Many of these interventions are directed at children given children’s disproportionate role in amplifying epidemics. The ethics of non-pharmaceutical interventions can be analyzed using Nancy Kass’ ethics framework for public health. Such an analysis highlights the limited data supporting these interventions’ effectiveness. It also suggests the framework itself needs to be expanded to consider harms other than constraints on liberty (...) and to consider affirmative programs to mitigate these broader harms. (shrink)

Background Diversity in Institutional Review Board (IRB) membership is important for both intrinsic and instrumental reasons, including fairness, promoting trust, improving decision quality, and responding to systemic racism. Yet U.S. IRBs remain racially and ethnically homogeneous, even as gender diversity has improved. Little is known about IRB chairpersons’ perspectives on membership diversity and barriers to increasing it, as well as current institutional efforts to promote diversity, equity, and inclusion (DEI) within IRB membership.Methods We surveyed IRB chairpersons leading U.S. boards registered (...) with the Office for Human Research Protections. Here, we focus exclusively on responses from a subset of 388 chairpersons of IRBs at universities and academic medical centers (AMCs).Results Board chairs were predominantly white and evenly split between men and women. Only about half reported that their boards had at least one member who is Black or African American (51%), Asian (56%), or Hispanic (48%), with 85% of university/AMC boards comprised entirely (15%) or mostly (70%) of white members. Most IRB chairpersons (64%) reported satisfaction with the current diversity of their membership. Participants largely agreed that considering diversity in the selection of IRB members is important (91%), including to improve the quality of IRB deliberation (80%), with an emphasis on racial/ethnic (85%) and gender diversity (74%). Most participants (80%) reported some type of active DEI effort regarding board membership at their university/AMC and just over half (57%) expressed satisfaction with these efforts.Conclusions Our national survey found that although university/AMC IRB chairpersons report valuing diversity in board membership, it may be lacking in key areas. Going forward, it will be important to specify clear reasons for diversity in the IRB context, as well to establish targets for acceptable levels of board diversity and to match DEI efforts to those targets. (shrink)

Some individuals facing dementia contemplate hastening their own death: weighing the possibility of living longer with dementia against the alternative of dying sooner but avoiding the later stages of cognitive and functional impairment. This weighing resonates with an ethical and legal consensus in the United States that individuals can voluntarily choose to forgo life‐sustaining interventions and also that medical professionals can support these choices even when they will result in an earlier death. For these reasons, whether and how a terminally (...) ill individual can choose to control the timing of their death is a topic that cannot be avoided when considering the dementia trajectory. With a focus on the U.S. context, this landscape review considers the status of provisions that would legally permit people facing dementia to hasten death with appropriate support from medical professionals. This review can be used to plan and guide clinical and legal practitioner discussion and policy development concerning evolving questions not fully covered by existing medical decision‐making provisions. (shrink)

In Living for Pleasure, philosopher Emily Austin offers a lively, jargon-free tour of Epicurean strategies for diminishing anxiety, achieving satisfaction, and relishing joys.