Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (shrink)

In their target article, Morain and colleagues (2019) tackle the long-standing and thorny issue of whether and when it might be ethical for a physician-investigator to obtain research consent from...

The late twentieth century has provided both reasons and occasions for reassessing just war theory as an organizing framework for the moral analysis of war. Books by G. Scott Davis, James T. Johnson, and John Kelsay, together with essays by Jeffrey Stout, Charles Butterworth, David Little, Bruce Lawrence, Courtney Campbell, and Tamara Sonn, signal a remarkable shift in war studies as they enlarge the cultural lens through which the interests and forces at play in political violence are identified and evaluated. (...) In his review of the contribution made by these texts, the author focuses on the cohesion of just war theory, the asymmetry between Christian and Islamic attitudes toward holy war, and the need to develop just war theory into a tool adequate to assist in the moral evaluation of violent conflicts within, not just between, nation-states. (shrink)

Lynch and colleagues describe positive and cautionary lessons learned from recent extraordinary research efforts to develop COVID-19 vaccines and therapeutics and consider whether some of th...

English summary: According to a current prejudice, the God of reason does not have a home in Protestantism. On the basis of model studies on the connection between biblical, Platonic and Aristotelian themes in the development of the Christian concept of God in late antiquity, the Middle Ages and the Renaissance, the authors of this volume show that the reformers did not at all flatly dismiss the rationality of faith. The articles focus on the modern transformations of the concept of (...) God in the 18th and 19th centuries. The volume, a collection of case studies of the history of the problem of the Christian concept of God, concludes with prominent syntheses of revelation and reason in the 20th century. German description: Einem gangigen Vorurteil zufolge hat der Gott der Vernunft im Protestantismus keine Heimat. Nach exemplarischen Studien zur Verbindung von biblischen mit platonischen und aristotelischen Motiven bei der Entfaltung des christlichen Gottesgedankens in Spatantike, Mittelalter und Renaissance zeigt der vorliegende Band aber, dass die Reformatoren der Vernunft des Glaubens keineswegs pauschal den Abschied gaben. Der Schwerpunkt der Beitrage liegt auf den neuzeitlichen Transformationen des Gottesgedankens im 18. und 19. Jh. Prominente Synthesen von Offenbarung und Vernunft im 20. Jh. schliessen den Band ab, der Fallstudien zu einer Problemgeschichte des christlichen Gottes-Denkens versammelt. Mit Beitragen von: Martin Arneth, Christine Axt-Piscalar, Ulrich Barth, Markus Buntfuss, Jorg Dierken, Douglas Hedley, Thomas Kaufmann, Dietrich Klein, Dietrich Korsch, Martin Laube, Jorg Lauster, Friederike Nussel, Bernd Oberdorfer, Joachim Ringleben, Friedemann Voigt, Dorothea Wendebourg, Gunther Wenz. (shrink)

The Covid‐19 pandemic has highlighted many of the difficult ethical issues that health care professionals confront in caring for patients and families. The decisions such workers face on the front lines are fraught with uncertainty for all stakeholders. Our focus is on the implications for nurses, who are the largest global health care workforce but whose perspectives are not always fully considered. This essay discusses three overarching ethical issues that create a myriad of concerns and will likely affect nurses globally (...) in unique ways: the safety of nurses, patients, colleagues, and families; the allocation of scarce resources; and the changing nature of nurses’ relationships with patients and families. We urge policy‐makers to ensure that nurses’ voices and perspectives are integrated into both local and global decision‐making so as to minimize the structural injustices many nurses have faced to date. Finally, we urge nurses to seek sources of support throughout this pandemic. (shrink)

Purpose/methods: This study investigated the relationship between ethics education and training, and the use and usefulness of ethics resources, confidence in moral decisions, and moral action/activism through a survey of practicing nurses and social workers from four United States (US) census regions. Findings: The sample (n = 1215) was primarily Caucasian (83%), female (85%), well educated (57% with a master's degree). no ethics education at all was reported by 14% of study participants (8% of social workers had no ethics education, (...) versus 23% of nurses), and only 57% of participants had ethics education in their professional educational program. Those with both professional ethics education and in-service or continuing education were more confident in their moral judgments and more likely to use ethics resources and to take moral action. Social workers had more overall education, more ethics education, and higher confidence and moral action scores, and were more likely to use ethics resources than nurses. Conclusion: Ethics education has a significant positive influence on moral confidence, moral action, and use of ethics resources by nurses and social workers. (shrink)

The late twentieth century has provided both reasons and occasions for reassessing just war theory as an organizing framework for the moral analysis of war. Books by G. Scott Davis, James T. Johnson, and John Kelsay, together with essays by Jeffrey Stout, Charles Butterworth, David Little, Bruce Lawrence, Courtney Campbell, and Tamara Sonn, signal a remarkable shift in war studies as they enlarge the cultural lens through which the interests and forces at play in political violence are identified and evaluated. (...) In his review of the contribution made by these texts, the author focuses on the cohesion of just war theory, the asymmetry between Christian and Islamic attitudes toward holy war, and the need to develop just war theory into a tool adequate to assist in the moral evaluation of violent conflicts within, not just between, nation-states. (shrink)

Vulnerability is one of the least examined concepts in research ethics. Vulnerability was linked in the Belmont Report to questions of justice in the selection of subjects. Regulations and policy documents regarding the ethical conduct of research have focused on vulnerability in terms of limitations of the capacity to provide informed consent. Other interpretations of vulnerability have emphasized unequal power relationships between politically and economically disadvantaged groups and investigators or sponsors. So many groups are now considered to be vulnerable in (...) the context of research, particularly international research, that the concept has lost force. In addition, classifying groups as vulnerable not only stereotypes them, but also may not reliably protect many individuals from harm. Certain individuals require ongoing protections of the kind already established in law and regulation, but attention must also be focused on characteristics of the research protocol and environment that present ethical challenges. (shrink)

Well before patient-centered or patient-controlled research became trendy, and earlier than calls to preferentially refer to research subjects as participants, Bob Veatch wrote “The Patient as Partner” Veatch presciently argued that research patients should not be thought of as passive subjects nor material from which to obtain data, but rather as partners in discovery. In this manuscript, I will explore Veatch’s conception of patient as partner in research and how that idea has evolved and been implemented over time and consider (...) some of the remaining challenges. Complexities of patient partnership include: clarifying the types of research in which patient partnership is most appropriate, recognizing the various possible levels of patient engagement in each case, avoiding tokenism and striving for respectful partnership, and keeping in mind the appropriate implementation of protections and safeguards. Bob Veatch would be pleased with the progress that has been made in creating research partnerships with patients, while also undoubtedly pushing us to continue to do better. (shrink)

Research participants' views about investigator financial interests were explored. Reactions ranged from concern to acceptance, indifference, and even encouragement. Although most wanted such information, some said it did not matter, was private, or was burdensome, and other factors were more important to research decisions. Very few said it would affect their research decisions, and many assumed that institutions managed potential conflicts of interest. Although disclosure of investigator financial interest information to research participants is often recommended, its usefulness is limited, especially (...) when participation is desired because of illness. (shrink)

An accessible guide to philosophy, presenting a collection of 70 essays covering the major themes, theories and arguments of the most prominent thinkers of ancient Greece.

Payment to recruit research subjects is a common practice but raises ethical concerns relating to the potential for coercion or undue influence. We conducted the first national study of IRB members and human subjects protection professionals to explore attitudes as to whether and why payment of research participants constitutes coercion or undue influence. Upon critical evaluation of the cogency of ethical concerns regarding payment, as reflected in our survey results, we found expansive or inconsistent views about coercion and undue influence (...) that may interfere with valuable research. In particular, respondents appear to believe that coercion and undue influence lie on a continuum; by contrast, we argue that they are wholly distinct: whereas undue influence is a cognitive distortion relating to assessment of risks and benefits, coercion is a threat of harm. Because payment is an offer, rather than a threat, payment is never coercive. (shrink)

Volume 19, Issue 9, September 2019, Page 5-7.

In this set of contributions to the Kennedy Institute of Ethics Journal celebrating the significant work and contributions of LeRoy Walters, we aim to bring new perspectives to topics that Dr. Walters helped to pioneer and continue his tradition of bringing moral insights and arguments to bear on the development of practical public and professional policies. Dr. Walters is well known for his invaluable service as member and chair of the Recombinant DNA Advisory Committee at the National Institutes of Health. (...) He also made major contributions to a variety of other committees responsible for the oversight of research and science, and to the development and implementation of influential... (shrink)

Several studies conducted in the 1970's by western analysts concluded that Buddhism is the main obstacle to economic development in Thailand. This view typifies the reasoning of mainstream modernization and development practices in Third World countries. Yet in recent years, Post World War II policies based upon the goal of modernization have been under attack for the environmental disasters they have generated, for their failure to improve human conditions where they have been implemented, and for their assumption that the western (...) world's high levels of production and consumption are superior to all other socio-economic possibilities. This dissertation focuses on Buddhist community and environmental action as a response to the hardships generated by modernization, and the ethical and spiritual system on which this action is based, especially as demonstrated by Thailand's forest monks. ;Chapter 1 examines traditionally accepted views of Buddhist ethics, the background against which new environmental interpretations emerge. Chapter 2 surveys the present trend of Buddhist social action, the application of Buddhist philosophy to contemporary social issues. Socially-engaged Buddhism is also considered with a view to its scriptural justification. Chapter 3 explores both the ethics and social action of Buddhism with specific reference to the conservation of nature. ;At this point in the modernization of Thailand, poverty is growing in rural areas, compounded by increasing drought and environmental adversity. At the same time, expanded corporate and governmental control over arable land and forests assumes command of the nation's remaining natural resources. Chapter 4 discusses this recent history. Chapter 5 concentrates on Thailand's conservationist forest monks, their ethical philosophy, the social and natural environments they are endeavoring to preserve or recover, and their work with villagers whose well-being is at stake. ;The concluding chapter investigates the western model of economic development, criticizing its universalizability, its underlying values, and its outcomes. I argue that the challenge to contemporary economic practices and lifestyles represented by the conservationist forest monks' revitalization of Buddhist tradition offers Thailand's rural poor the potential for a more satisfying and beneficial way of life. (shrink)

Psychiatric diagnoses such as Autism Spectrum Disorder (ASD) are primarily attributed on the basis of behavioral criteria. The aim of most of the biomedical research on ASD is to uncover the underlying mechanisms that lead to or even cause pathological behavior. However, in the philosophical and sociological literature, it has been suggested that autism is also to some extent a ‘social construct’ that cannot merely be reduced to its biological explanation. We show that a one-sided adherence to either a biological (...) or a social explanation leads to a moral dilemma, a Catch-22, for autistics and for those living with them. Such explanations close the space for self-identifying as autistic and at the same time being considered to be in good mental health. They foreclose the possibility of making sense of the lived experience of (and with) autistics. In this paper we argue that such lack of space for moral imagination inherently leads to scientific stalemate. We propose that one can only go beyond this stalemate by taking an ethical stance in theorizing, one that enables better intersubjective understanding. Only on such a view can behavior and biology be linked without either disconnecting them or reducing the one to the other. (shrink)

abstractBackground: Evidence shows both a tendency for research participants to conflate research and clinical care and a limited public understanding of research. Conflation of research and care by participants is often referred to as the therapeutic misconception. Despite this evidence, few studies have explicitly asked participants, and especially minors, to explain what they think research is and how they think it differs from regular medical care. Methods: As part of a longer semistructured interview evaluating assent and parental permission for research, (...) adolescent research participants (n = 177), including adolescents with illnesses and healthy volunteers, and their parents (n = 177) were asked to describe medical research in their own words and say whether and how they thought being in medical research was different from seeing a regular doctor. Qualitative responses were coded and themes were identified through an iterative process. Results: When asked to describe medical research, the majority described research in terms of its goals of helping to advance science, develop treatments and medicines, and help others; fewer described research as having the goal of helping particular research participants, and fewer still in terms of the methods used in research. The majority of teen and parent respondents said being in research is different than seeing a regular doctor and explained this by describing different goals, different or more procedures, differences in the engagement of the doctors/researchers, and differences in logistics. Conclusions: Adolescents participating in clinical research and their parents generally describe medical research in terms of its goals of advancing science and finding new medicines and treatments, sometimes in combination with helping the enrolled individuals. The majority perceive a difference between research and regular medical care and described these differences in various ways. Further exploration is warranted about how such perceived differences matter to participants and how this understanding could be used to enhance informed consent and the overall research experience. (shrink)

Nursing and bioethics have a lot in common because they share concerns about life and death, illness and health, the rights of individuals and communities, ethical patient care, health care delivery, and public health. Nurses and bioethicists contribute to ethical practice, ethics scholarship, and health policy‐making in a variety of ways. Some nurses have bioethics education or experience, some bioethicists study or collaborate closely with nurses, and some of us proudly identify as both bioethicists and as nurses. Despite certain shared (...) and interwoven aims, bioethicists and nurses often accomplish their goals in dissimilar ways, have diverse educational and training trajectories as well as distinct roles and responsibilities, and are viewed differently within health care organizations. Yet the work of bioethics and nursing can be, and in my view should more often be, synergistic. That synergism may be especially critical in the arena of health policy and ethics. Nurses can bring extraordinary insights and real‐world experiences to the policy table but are not always considered essential contributors. (shrink)

The aim of this article is to analyse the relation between the second law of thermodynamics and the so-called arrow of time. For this purpose, a number of different aspects in this arrow of time are distinguished, in particular those of time-reversal (non-)invariance and of (ir)reversibility. Next I review versions of the second law in the work of Carnot, Clausius, Kelvin, Planck, Gibbs, Caratheodory and Lieb and Yngvason, and investigate their connection with these aspects of the arrow of time. It (...) is shown that this connection varies a great deal along with these formulations of the second law. According to the famous formulation by Planck, the second law expresses the irreversibility of natural processes. But in many other formulations irreversibility or even time-reversal non-invariance plays no role. I therefore argue for the view that the second law has nothing to do with the arrow of time. (shrink)

Ethically challenging situations routinely arise in the course of illness and healthcare. However, very few studies have surveyed patients and family members about their experiences with ethically challenging situations. To address this gap in the literature, we surveyed patients and family members at three hospitals. We conducted a content analysis of their responses to open-ended questions about their most memorable experience with an ethical concern for them or their family member. Participants described 219 unique ethical experiences that spanned many of (...) the prevailing themes of bioethics, including the patient-physician relationship, end-of-life care, decision-making capacity, healthcare costs, and genetic testing. Participants focused on relational issues in the course of experiencing illness and receiving medical care and concerns regarding the patient-physician encounters. Many concerns arose outside of a healthcare setting. These data indicate areas for improvement for healthcare providers but some concerns may be better addressed outside of the traditional healthcare setting. (shrink)

The target article by Locke & Bogin (L&B) focuses on the evolution of language as a communicative tool. They neglect, however, that from infancy onwards humans have the ability to go beyond successful behaviour and to reflect upon language (and other domains of knowledge) as a problem space in its own right. This ability is not found in other species and may well be what makes humans unique.

Background Respect for autonomy is a key principle in bioethics. However, respecting autonomy in practice is complex because most people define themselves and make decisions influenced by a complex network of social relationships. The extent to which individual autonomy operates for each partner within the context of decision-making within marital or similar relationships is largely unexplored. This paper explores issues related to decision-making by couples for health care and the circumstances under which such a practice should be respected as compatible (...) with autonomous decision-making. Discussion We discuss the concept of autonomy as it applies to persons and to actions, human interdependency and gender roles in decision-making, the dynamics and outcomes of couples’ joint decision-making, and the ethics of couples’ joint decision-making. We believe that the extent to which couples’ joint decision-making might be deemed ethically acceptable will vary depending on the context. Given that in many traditional marriages the woman is the less dominant partner, we consider a spectrum of scenarios of couples’ joint decision-making about a woman’s own health care that move from those that are acceptably autonomous to those that are not consistent with respecting the woman’s autonomous decision-making. To the extent that there is evidence that both members of a couple understand a decision, intend it, and that neither completely controls the other, couples’ joint decision-making should be viewed as consistent with the principle of respect for the woman’s autonomy. At the other end of the spectrum are decisions made by the man without the woman’s input, representing domination of one partner by the other. Conclusions We recommend viewing the dynamics of couples’ joint decision-making as existing on a continuum of degrees of autonomy. This continuum-based perspective implies that couples’ joint decision-making should not be taken at face value but should be assessed against the specific cultural, ethnic, and religious backgrounds and personal circumstances of the individuals in question. (shrink)

Using payment to recruit research subjects is a common practice, but it raises ethical concerns that coercion or undue inducement could potentially compromise participants’ informed consent. This is the first national study to explore the attitudes of IRB members and other human subjects protection professionals concerning whether payment of research participants constitutes coercion or undue influence, and if so, why. The majority of respondents expressed concern that payment of any amount might influence a participant’s decisions or behaviors regarding research participation. (...) Respondents expressed greater acceptance of payment as reimbursement or compensation than as an incentive to participate in research, and most agreed that subjects are coerced if the offer of payment makes them participate when they otherwise would not or when the offer of payment causes them to feel that they have no reasonable alternative but to participate . Views about undue influence were similar. We conclude that human subjects protection professionals hold expansive and inconsistent views about coercion and undue influence that may interfere with the recruitment of research participants and impede valuable research. (shrink)

Some are concerned about the possibility that offering money for research participation can constitute coercion or undue influence capable of distorting the judgment of potential research subjects and compromising the voluntariness of their informed consent. The author recognizes that more often than not there are multiple influences leading to decisions, including decisions about research participation. The concept of undue influence is explored, as well as the question of whether or not there is something uniquely distorting about money as opposed to (...) a chance for treatment or medical care. An amount of money that is not excessive and is calculated on the basis of time or contribution may, rather than constitute an undue inducement, be an indication of respect for the time and contribution that research subjects make. (shrink)

Research ethics consultation is increasingly recognized as a potentially valuable mechanism for addressing the depth and breadth of ethical issues that arise in research related to human health and well-being. However, fundamental questions remain, including: What is “research ethics consultation”? And what is its justification beyond the purposes already served by existing entities? We examine how a research ethics consultation service may differ from or complement the role of an institutional review board by offering a definition of research ethics consultation (...) and by exploring the potential scope of a consultation service in terms of types of clients served, questions addressed, and advice provided at various stages of the research process. We then consider the relationship between research ethics consultation services and IRBs, as well as the issues that may arise between them, including possible conflicts of interest. (shrink)

In the scholium to proposition 49 of Part 2 of the Ethics, Spinoza addresses a number of prejudices that tend to obscure the essentially judgmental nature of ideas. One warning is issued against those who do not distinguish accurately between ideas and images, and, for this exact reason, fail to see that every idea, insofar as it is an idea, always involves an affirmation that something is the case. This paper shows that in order to properly understand Spinoza's remarks in (...) this passage, we must redirect attention to Descartes’ Meditations on First Philosophy, and more particularly to the objections raised against them by Hobbes. Specifically, I argue for the identification of Hobbes and other likeminded “imagists” as Spinoza's main targets, and not, as is often assumed, Descartes himself or Cartesians in general. My identification not only resolves interpretative confusion surrounding this passage, but it also confirms Spinoza's commitment to a key rationalist assumption: the existence of a mind that can grasp or exhibit natures by clear and distinct perceptions. While both adequate and inadequate ideas are necessitated beliefs or judgments in which we assent to something, virtue consists in being propelled by the intellect. (shrink)