The organizations that fund bioethics research receive many more eligible grant applications than they can support. Academic positions that support bioethics research are likewise scarce. As a resu...

The Global Forum on Bioethics in Research (GFBR) served as a global platform for debate on ethical issues in international health research between 1999 and 2008, bringing together research ethics experts, researchers, policy makers and community members from developing and developed countries. In total, nine GFBR meetings were held on six continents. Work is currently underway to revive the GFBR. This paper describes the purpose and history of the GFBR and presents key elements for its reinstatement, (...) future functioning and sustainability. Potential participants and sponsors are encouraged to contribute actively to the future of this unique international research ethics event. (shrink)

Sacrificial dilemmas such as the trolley problem play an important role in experimental philosophy (x-phi). But it is increasingly argued that, since we are not likely to encounter runaway trolleys in our daily life, the usefulness of such thought experiments for understanding moral judgments in more ecologically valid contexts may be limited. However, similar sacrificial dilemmas are experienced in real life by animal research decision makers. As part of their job, they must make decisions about the suffering, and often (...) the death, of many non-human animals. For this reason, a context-specific investigation of so-called “3R dilemmas” (i.e., dilemmas where there is a conflict between the principles of replacement, reduction, and refinement of the use of animals in research) is essential to improve the situation of both non-human animals and human stakeholders. An approach well suited for such investigation is experimental philosophical bioethics (“bioxphi”), which draws on methods similar to x-phi to probe more realistic, practical scenarios with an eye to informing normative debates and ethical policy. In this article, we argue for a need to investigate 3R dilemmas among professional decision-makers using the tools of bioxphi. In a first step, we define 3R dilemmas and discuss previous investigations of professionals’ attitudes in such cases. In a second step, we show how bioxphi is a promising method to investigate the whys and hows of professional decision-making in 3R dilemmas. In a last step, we provide a bioxphi template for 3R dilemmas, give recommendations on its use, explore the normative relevance of data collected by such means, and discuss important limitations. (shrink)

The distinction between clinical research and clinical practice directs how we partition medicine and biomedical science. Reasons for a sharp distinction date historically to the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, especially to its analysis of the “boundaries” between research and practice in the Belmont Report (1978). Belmont presents a segregation model of the research-practice distinction, according to which research and practice form conceptually exclusive sets (...) of activities and interventions. This model is still the standard in federal regulations today. However, the Commission’s deliberations and conclusions about the boundaries are more complicated, nuanced, and instructive than has generally been appreciated. The National Commission did not conclude that practice needs no oversight comparable to the regulation of research. It debated the matter and inclined to the view that the oversight of practice needed to be upgraded, though the Commission stopped short of proposing new regulations for its oversight, largely for prudential political reasons. (shrink)

This entry summarizes an emerging subdiscipline of both empirical bioethics and experimental philosophy (“x-phi”) which has variously been referred to as experimental philosophical bioethics, experimental bioethics, or simply “bioxphi”. Like empirical bioethics, bioxphi uses data-driven research methods to capture what various stakeholders think (feel, judge, etc.) about moral issues of relevance to bioethics. However, like its other parent discipline of x-phi, bioxphi tends to favor experiment-based designs drawn from the cognitive sciences – including psychology, (...) neuroscience, and behavioral economics – to tease out why and how stakeholders think as they do. (shrink)

Human dignity—is it a useful concept in bioethics, one that sheds important light on the whole range of bioethical issues, from embryo research and assisted reproduction, to biomedical enhancement, to care of the disabled and the dying? Or is it, on the contrary, a useless concept—at best a vague substitute for other, more precise notions, at worst a mere slogan that camouflages unconvincing arguments and unarticulated biases?

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers (...) of research but largely silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

Blumenthal-Barby and her colleagues (2022) situate their discussion of philosophy and bioethics in the context of (reportedly) widely held assumption that, when compared to the early days of bioethics, the role of philosophy is now diminished across the field – the assumption we call the Disconnection Thesis. This assumption can be summarized, to use the authors’ own words, by the phrase “philosophy’s glory days in bioethics are over“. While in no place of the article they explicitly endorse (...) the Disconnection Thesis, at least some of the authors had previously endorsed it in print (Savulescu 2015). Such expressions of collective expert wisdom might be a valuable source of information on the discipline's history, but they should not be accepted uncritically. Given the explosion in the size and scope of bioethical research in recent decades, any scholar’s familiarity with the area is necessarily based on selective reading and might be biased. Hence, in this commentary, we examine what kind of more rigorous evidence could corroborate the Disconnection Thesis. In other words, if the role of philosophy in bioethics has been indeed diminishing, what kind of observable patterns should we expect to see? Drawing on our previous research (Bystranowski, Dranseika, Żuradzki 2022), here we focus on two useful perspectives: citation analysis and topic modeling. While the first approach allows us to indirectly measure the level of engagement of bioethicists with philosophical literature (by measuring the proportion of references from articles published in journals in bioethics that cite philosophy journals), the latter provides a window into the content and argumentative style of bioethical texts. (shrink)

English-speaking research on morally right decisions in a healthcare context over the past three decades has been dominated by two major perspectives, namely, the Four Principles, of which the principle of respect for autonomy has been most salient, and the ethic of care, often presented as a rival to not only a focus on autonomy but also a reliance on principles more generally. In my contribution, I present a novel ethic applicable to bioethics, particularly as it concerns human (...) procreation, that I argue is a promising alternative to these two approaches. According to this new moral theory, an act is right just insofar as it treats people’s capacity to commune with respect, where communing is a matter of identifying with others and exhibiting solidarity with them. This ethic is inspired by relational ideals of communion and harmony from the African philosophical tradition, but is shown to be attractive to a broad, indeed global, audience, with regard to its implications for the morality of reproduction. (shrink)

Purpose/Background. The present research focuses on the debate on transhumanism/bioconservatism from the perspective of empirical bioethics, that is, making use of em-pirical evidence in the process of moral reasoning. Its objective is to propose a metho-dological guide for the approach and resolution of moral problems concerning human enhancement. Methodology/Approach. The method Step-wise Ethical Human Enhancemet (SWEH) is proposed. It is a guide consisting of 11 questions that are the result of the adaptation of the guidelines for identifying a (...) human enhancement procedure as ethical developed by Julian Savulescu to the method of Step-wise Empirical Contributions elaborated by Pascal Borry. An applicative example on the morality of biohacking RFID implants is provided. Results/Findings. SWEH proposes that human enhancement procedures might be approached as specific problems and that the identified moral norm might be rewritten as a descriptive proposition that serves as a hypothesis that will be evaluated in the light of empirical evidence. The evaluation of the proposition, and thus of moral reasoning, will be done with the help of the information gathered by the 11 questions. Discussion/Conclusions/Contributions. SWEH can serve to provide a first answer on the morality of a specific human enhancement procedure, but not an absolute one, as the result may vary depending on the information obtained in the future. It also highli-ghts gaps in empirical research related to the procedure it addresses. The method is a first methodological guide that could be revised and improved. (shrink)

Pain medication is one of the responses to the mercy argument that utilitarian ethicists use for justifying active euthanasia on the grounds of prevention of cruelty and appeal to beneficence. The researcher reinforces the significance of pain medication in meeting this challenge and considers it the most preferred response among various other responses. It is because of its realism and effectiveness. In exploring the mechanism and considerations related to pain medication, the researcher briefly touches the Catholic ethical position on the (...) issue, a position that cannot be ignored in the development of contemporary bioethics. The researcher particularly deliberates on the contemporary Islamic discourse on the issue; by furthering the debate in line with the Islamic legal maxims and general guidance from the primary sources of Islamic law and ethics. The resolution on the issue is sought by synthesizing the views and legal maxims (al-Qawaid al-Fiqhiyyah) on the issue, which in conclusion provide justification for pain medication by considerably regarding pain as necessity and pressing need. However, such resolution allows pain medication to the limit and proportion that removes the pain and prohibits overdosing the patient with medication that may directly cause the death. (shrink)

For Van Rensselaer Potter (1911–2001), Global Bio-Ethics is about building on the legacy of Aldo Leopold (1887–1948), one of the most notable forest managers of the twentieth century who brought to light the importance of pragmatism in the sciences and showed us a new way to proceed with environmental ethics. Following Richard Huxtable and Jonathan Ives's methodological 'Framework for Empirical Bioethics Research Projects' called 'Mapping, framing, shaping,' published in BMC Medicine Ethics (2019)), we propose operationalizing a framework for (...) Global Bio-Ethics by hybridizing approaches in empirical bioethics and ecosystem management. We explain this framework using the metaphor of forest management. This mixed approach is articulated through three phases: (1) mapping the “landscape” to build a working theory, (2) framing the “scene” to prepare the fieldwork, and (3) shaping bioethics “tools” to stimulate cooperation. Applying this methodology, an adaptive management cycle is outlined to help ensure that political processes are sustainable and socially acceptable, still based on strategic and ethical thinking, but also capable of reshaping failing policies. (shrink)

Bioethicists’ views diverge public opinion on various ethical issues, particularly in healthcare. For instance, bioethicists generally oppose payment for organs and advocate for preventing death at any age, whereas the public is more supportive of organ payment and prioritizing younger patients. I offer four arguments on how best to view this divergence. (a) Bioethicists’ specialized training, objectivity, and reliance on research often lead to views that differ from those of the public, which may be less informed and more influenced (...) by biases. (b) Further, divergence between expert and public opinion is a normal and sometimes necessary aspect of bioethics. Divergence can lead to more informed and progressive ethical practices. (c) While public input is valuable, achieving meaningful engagement is difficult due to varying values, risk perceptions, and socioeconomic circumstances. Effective bioethics would balance expert knowledge with public input, aiming for policies that are both scientifically sound and democratically legitimate. (d) Maintaining public trust in bioethics does not require full alignment with public opinion. Instead, bioethicists should focus on educating the public and incorporating informed public perspectives into their analysis and recommendations. (shrink)

Bioethics tends to be dominated by discourses concerned with the ethical dimension of medical practice, the organization of medical care, and the integrity of biomedical research involving human subjects and animal testing. Jacques Derrida has explored the fundamental question of the “limit” that identifies and differentiates the human animal from the nonhuman animal. However, to date his work has not received any reception in the field of biomedical ethics. In this paper, I examine what Derrida’s thought about this (...) limit might mean for the use/misuse/abuse of animals in contemporary biomedical research. For this, I review Derrida’s analysis and examine what it implies for scientific responsibility, introducing what I have coined the “Incompleteness Theorem of Bioethics.”. (shrink)

Alongside a revival of interest in Thomism in philosophy, scholars have realised its relevance when addressing certain contemporary issues in bioethics. This book offers a rigorous interpretation of Aquinas's metaphysics and ethical thought, and highlights its significance to questions in bioethics. Jason T. Eberl applies Aquinas’s views on the seminal topics of human nature and morality to key questions in bioethics at the margins of human life – questions which are currently contested in the academia, politics and (...) the media such as: When does a human person’s life begin? How should we define and clinically determine a person’s death? Is abortion ever morally permissible? How should we resolve the conflict between the potential benefits of embryonic stem cell research and the lives of human embryos? Does cloning involve a misuse of human ingenuity and technology? What forms of treatment are appropriate for irreversibly comatose patients? How should we care for patients who experience unbearable suffering as they approach the end of life? _Thomistic Principles and Bioethics_ presents a significant philosophical viewpoint which will motivate further dialogue amongst religious and secular arenas of inquiry concerning such complex issues of both individual and public concern. (shrink)

Should we do whatever science lets us do? This short introduction in the 'All That Matters' series shows how developments in biotechnology, such as genetics, stem cell research and artificial reproduction, arouse both our greatest hopes and our greatest fears. Many people invest the new biotechnology with all the aspirations and faith once accorded to religious salvation. But does everyone benefit equally from scientific progress? This book argues that although we've entered new scientific territory, there is no need to (...) jettison our existing moral sense. By discussing a range of real-life cases, it equips readers to make up their own minds on these important questions. Good science and good ethics needn't be contradictory. (shrink)

Like most bioethical discussion, examination of human biobanks has been largely framed in terms of research subjects’ rights, principally informed consent, with some gestures toward public benefits. However, informed consent is for the competent, rights-bearing individual: focussing on the individual, it thus neglects social, economic and even political matters; focussing on the competent rights-bearer, it does not serve situations where consent is plainly inappropriate (eg, the young child) or where coercion can obviously be justified (the criminal). Using the British (...) experience of large-scale biobanking, I argue that the focus on consenting individuals distorts our ways of thinking about biobanks and has serious practical ramifications. This becomes clear if we contrast the case of adult biobanks intended for medical research with two other forms of biobanking. Thus child cohort studies – vital for sound scientific investigation of the interplay of genetics and environment in health – have been very badly funded next to adult studies. On the other hand, forensic databases have attracted massive investment, but little debate – partly owing to a sense that here, at least, is a case where consent is not relevant. Contrasting these central types of biobanking, I will suggest that there are powerful factors at work in limiting ‘ethics’ to individual rights. Projects of this size should direct our attention to more overtly political questions concerning priority setting and organisation of medical research. (shrink)

This article aims to develop a Lacanian approach to bioethics. Point of departure is the fact that both psychoanalysis and bioethics are practices of language, combining diagnostics with therapy. Subsequently, I will point out how Lacanian linguistics may help us to elucidate the dynamics of both psychoanalytical and bioethical discourse, using the movie One flew over the Cuckoo’s Nest and Sophocles’ tragedy Antigone as key examples. Next, I will explain the ‘topology’ of the bioethical landscape with the help (...) of Lacan’s three dimensions: the imaginary, the symbolical and the real. This will culminate in an assessment of the dynamics of bioethical discourse with the help of Lacan’s theorem of the four discourses. Bioethics, I will argue, is not a homogeneous discourse. Rather, four modalities of bioethical discourse can be distinguished, all of them displaying specific weaknesses and strengths, opportunities and threats. This will be elucidated with the help of two case studies, namely the debates on human reproductive technologies and on the use of animals as biomedical research models. (shrink)

This is the second edition of the textbook Bioethics in Canada. It is the most up to date bioethics textbook on the Canadian market. Twenty-nine of its 54 contributions are by Canadians. All the chapters carried over from the first edition are revised in full (especially the chapters on obligations to the global poor, on medical assistance in dying, and on public health). It comprises *new* chapters on emerging genetic technologies and on indigenous peoples' health. It contains *new* (...) case studies focusing on ethical issues and problems of relevance to Canadians. From the Preface: This anthology is designed for those teaching bioethics in colleges and universities in Canada. It comprises articles from researchers exploring the main problems of bioethics from a diversity of perspectives and ethical traditions. It includes in particular articles by Canadian researchers who appear in anthologies less often than they should. The hope is that the reader will, as a result, better appreciate the rich reservoir of talent present among those working in bioethics in Canada and Canadian bioethicists working abroad. In addition, this volume intentionally aims to educate the reader about the policies and laws regulating the most important and pressing bioethical problems facing Canadians. The hope is that the reader will develop a nuanced view of the nature, importance, and impact of bioethics in Canada. (shrink)

We argue that charging people to participate in research is likely to undermine the fundamental ethical bases of clinical research, especially the principles of social value, scientific validity, and fair subject selection.

Introductory and advanced textbooks in bioethics focus almost entirely on issues that disproportionately affect disabled people and that centrally deal with becoming or being disabled. However, such textbooks typically omit critical philosophical reflection on disability, lack engagement with decades of empirical and theoretical scholarship spanning the social sciences and humanities in the multidisciplinary field of disability studies, and avoid serious consideration of the history of disability activism in shaping social, legal, political, and medical understandings of disability over the last (...) fifty years. For example, longstanding discussions on topics such as euthanasia, physician aid-in-dying, pre-implantation genetic diagnosis, prenatal testing, selective abortion, enhancement, patient autonomy, beneficence, non-maleficence, and health care rationing all tend to be premised on shared and implicit assumptions regarding disability, especially in relation to quality of life, yet with too little recognition of the way that “disability” is itself a topic of substantial research and scholarly disagreement across multiple fields. This is not merely a concern for academic and medical education; as an applied field tied to one of the largest economic sectors of most industrialized nations, bioethics has a direct impact on healthcare education, practice, policy, and, thereby, the health outcomes of existing and future populations. It is in light of these pressing issues that the Disability Bioethics Reader is the first reader to introduce students to core bioethical issues and concepts through the lens of critical disability studies and philosophy of disability. The Disability Bioethics Reader will include over thirty-five chapters covering key areas such as: critical histories and state-of-the-field analyses of modern medicine, bioethics, disability studies, and philosophy of medicine; methods in bioethics; concerns at the edge- and end-of-life; enhancement; disability, quality of life, and well-being; prenatal testing and abortion; invisible disabilities; chronic illness; healthcare justice; genetics and genomics; intellectual disability and neurodiversity; ethics and diagnosis; and epistemic injustice in healthcare. (shrink)

Research on research ethics—regarding both the governance and practice of the ethical review of human subjects research—has a tumultuous history in North America and Europe. Much of the academic literature focuses on issues to do with regulating the conduct and quality of ethics review of research protocols by ethics committees (research ethics boards (REBs) in Canada and institutional review boards (IRBs) in the United States). In addition, some of the literature attends to issues particular to (...) the review of qualitative research, and still other literature addresses the challenges posed by and the need for research on REBs/IRBs. It is this third group of literature within which our article is situated. (shrink)

The advancement of and prospects for stem cell research raise a number of specific ethical issues. While navigating the ethical landscape of stem cell research is often challenging for biology researchers and biotechnology innovators, it is also difficult for the public and other persons of concern (from ethicists to policy-makers) to grasp the technicalities of a burgeoning field that develops in many directions. Organoids are one of these new biotechnological constructs that are currently eliciting a rich debate in (...) bioethics. In this guide, we argue that different types of organoids have different emerging properties with different ethical implications. Going from general properties to particular ones, we propose a typology of organoid technology and other associated biotechnology from a philosophical and ethical perspective. We point to relevant ethical issues and try to convey the sense of uncertainty peculiar to ongoing research and emerging technological objects. (shrink)

In the past decade, policy-makers in science have been concerned with harmonizing research integrity standards across Europe. These standards are encapsulated in the European Code of Conduct for Research Integrity. Yet, almost every European country today has its own national-level code of conduct for research integrity. In this study we document in detail how national-level codes diverge on almost all aspects concerning research integrity – except for what constitutes egregious misconduct. Besides allowing for potentially unfair responses (...) to joint misconduct by international collaborations, we argue that the divergences raise questions about the envisaged self-regulatory function of the codes of conduct. (shrink)

The “affirming” healthcare model for gender-distressed youth is endorsed by the medical establishment in the United States, but many European nations have retreated from it. This controversy would be expected to attract the interest of philosophers and bioethicists, with a diverse range of opinions appearing in academic articles. However, when philosophers and bioethicists have ventured into print, they have almost invariably endorsed the affirmative approach, which involves life-changing medical interventions on children with psychological problems. This is a sign that the (...) process of academic research and writing is not functioning as it should. -/- We recount the failure of philosophy and bioethics to address the issues raised by gender-affirming healthcare. We also offer an explanation of this failure, and in the final section make some recommendations for improving academic integrity. (shrink)

Some advances in bioethics regarding ethical considerations that arise in the context of medical research can also be relevant when thinking about the ethical considerations that arise in the context of SoTL research. In this article, I aim to bring awareness to two potential ethical challenges SoTL researchers might face when playing a dual role of teacher and researcher that are similar to the challenges physicians face in their dual role of physician and researcher. In this article, (...) I argue that two commonly discussed concerns in bioethics---the need for clinical equipoise and the possibility of a therapeutic misconception---have analogies when conducting some types of research on students. I call these counterparts educational equipoise and the educational misconception. (shrink)

One interesting aspect of the Hwang-case has been the way in which this affair was assessed by academic journals such as Nature. Initially, Hwang’s success was regarded as evidence for the detrimental effects of research ethics, slowing down the pace of research in Western countries. Eventually, however, Hwang’s debacle was seen as evidence for the importance of ethics in the life sciences. Ironically, it was concluded that the West maintains its prominence in science (as a global endeavour) precisely (...) because it has its ethics in place. Bioethics was now seen as an indispensable part of quality control. In this article, I will claim that the Hwang case rather reveals that there is no reason for complacency and that there are substantial challenges awaiting us. They have to do with major transformations in the way knowledge is produced and research in the life sciences is conducted (such as the increase in pace and scale, globalisation and the growing importance of ICT and bioinformation). These transformations call for a different kind of bioethics. The focus must shift from duties of autonomous researchers concerning visible research subjects (“micro-ethics”) to responsibilities of institutionalised research networks in managing and processing large amounts of bioinformation (“macro-ethics”). Concepts such as transparency, reliability and benefit-sharing will become more important than concepts such as informed consent. Basically, it is a resurgence of the tension between the Kantian and the Hegelian view of ethics. The contours of macro-ethics will be elaborated notably as it is emerging in bioethical debates over biobanking and genetic databanks. (shrink)

When many people think of bioethics, they think of gripping issues in clinical medicine such as end-of-life decision-making, controversies in biomedical research such as that over work with stem cells, or issues in allocating scarce health-care resources such as organs or money. The term “bioethics” may evoke images of moral controversies being discussed on news programs and talk shows. But this “controversy of the day” focus often treats ethical issues in medicine superficially, for it addresses them as (...) if they could be examined and discussed in isolation from the context in which they are situated. Such a focus on the latest controversies fails to take into account that medicine is a social institution and that the controversies in bioethics often reflect deeper social and moral issues that transcend the boundaries of medicine and ethics. If one moves beyond the issue-of-the-day approach to bioethics, one can see that the field must address these deeper issues. (shrink)

The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation (...) are outweighed by the potential clinical benefits for the individual research participant. Furthermore, current proposals do not address the worry that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorization. In this paper, we show how the standard view of informed consent – consent as autonomous authorization – can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. (shrink)

This project considers whether and how research ethics can contribute to the provision of cost-effective medical interventions. Clinical research ethics represents an underexplored context for the promotion of cost-effectiveness. In particular, although scholars have recently argued that research on less-expensive, less-effective interventions can be ethical, there has been little or no discussion of whether ethical considerations justify curtailing research on more expensive, more effective interventions. Yet considering cost-effectiveness at the research stage can help ensure that (...) scarce resources such as tissue samples or limited subject popula- tions are employed where they do the most good; can support parallel efforts by providers and insurers to promote cost-effectiveness; and can ensure that research has social value and benefits subjects. I discuss and rebut potential objections to the consideration of cost-effectiveness in research, including the difficulty of predicting effectiveness and cost at the research stage, concerns about limitations in cost-effectiveness analysis, and worries about overly limiting researchers’ freedom. I then consider the advantages and disadvantages of having certain participants in the research enterprise, including IRBs, advisory committees, sponsors, investigators, and subjects, consider cost-effectiveness. The project concludes by qualifiedly endorsing the consideration of cost-effectiveness at the research stage. While incorporating cost-effectiveness considerations into the ethical evaluation of human subjects research will not on its own ensure that the health care system realizes cost-effectiveness goals, doing so nonetheless represents an important part of a broader effort to control rising medical costs. (shrink)

The recent publications reported in 2022 reveal the possibility of obtaining mouse embryos without the need for egg or sperm. These ‘artificial embryos’ can recapitulate some stages of development ex utero – from neurulation to organogenesis – without implantation. Synthetic mouse embryos might serve as a valuable model to gain further insights into early developmental stages. Indeed, it is expected for these models to be replicated by employing human cells. This promising research raises ethical issues and expands the horizon (...) of ethics in regard to the development of the human embryo. From this point of view, we state some of the new open venues for bioethical research. (shrink)

This paper assesses the state of research ethics in low- and middle-income countries and the achievements of the Fogarty International Center's bioethics training program since 2000. The vision of FIC for the next decade of research ethics education is encapsulated in four proposed goals: (1) Ensure sufficient expertise in ethics review by having someone with long-term training on every high-workload REC; (2) Develop LMIC capacity to conduct original research on critical ethical issues by supporting doctoral and (...) postdoctoral training and career paths for research ethicists; (3) Make research training and review at LMIC institutions sustainable by identifying additional funding mechanisms and models; (4) Make institutional research systems more ethical and efficient through context-specific training integrated into all levels of scientific training. (shrink)

In this article, I present a new interpretation of the pro-life view on the status of early human embryos. In my understanding, this position is based not on presumptions about the ontological status of embryos and their developmental capabilities but on the specific criteria of rational decisions under uncertainty and on a cautious response to the ambiguous status of embryos. This view, which uses the decision theory model of moral reasoning, promises to reconcile the uncertainty about the ontological status of (...) embryos with the certainty about normative obligations. I will demonstrate that my interpretation of the pro-life view, although seeming to be stronger than the standard one, has limited scope and cannot be used to limit destructive research on human embryos. (shrink)

Debates about obesity in bioethics tend to unfold in predictable epicycles between individual choices and behaviours and the oppressive socio-economic structures constraining them. Here, we argue that recent work from two cutting-edge research programmes in microbiology and social psychology can advance this conceptual stalemate in the literature. We begin in section 1 by discussing two promising lines of obesity research involving the human microbiome and relationship partners. Then, in section 2, we show how this research has (...) made viable novel strategies for fighting obesity, including microbial therapies and dyad-level interventions. Finally, in section 3, we consider objections to our account and conclude by arguing that attention to the most immediate features of our biological and social environment offers a middle ground solution, while also raising important new issues for bioethicists. (shrink)

Growing awareness of the ethical implications of neuroscience in the early years of the 21st century led to the emergence of the new academic field of “neuroethics,” which studies the ethical implications of developments in the neurosciences. However, despite the acceleration and evolution of neuroscience research on nonhuman animals, the unique ethical issues connected with neuroscience research involving nonhuman animals remain underdiscussed. This is a significant oversight given the central place of animal models in neuroscience. To respond to (...) these concerns, the Center for Neuroscience and Society and the Center for the Interaction of Animals and Society at the University of Pennsylvania hosted a workshop on the “Neuroethics of Animal Research” in Philadelphia, Pennsylvania. At the workshop, expert speakers and attendees discussed ethical issues arising from neuroscience research involving nonhuman animals, including the use of animal models in the study of pain and psychiatric conditions, animal brain-machine interfaces, animal–animal chimeras, cerebral organoids, and the relevance of neuroscience to debates about personhood. This paper highlights important emerging ethical issues based on the discussions at the workshop. This paper includes recommendations for research in the United States from the authors based on the discussions at the workshop, loosely following the format of the 2 Gray Matters reports on neuroethics published by the Presidential Commission for the Study of Bioethical Issues. (shrink)

Current challenges in medical practice, research, and administration demand physicians who are familiar with bioethics, health law, and health economics. Curriculum directors at American Association of Medical Colleges-affiliated medical schools were sent confidential surveys requesting the number of required hours of the above subjects and the years in which they were taught, as well as instructor names. The number of relevant publications since 1990 for each named instructor was assessed by a PubMed search.In sum, teaching in all three (...) subjects combined comprises less than two percent of the total hours in the American medical curriculum, and most instructors have not recently published articles in the fields they teach. This suggests that medical schools should reevaluate their curricula and instructors in bioethics, health law, and health economics. (shrink)

On most accounts, beliefs are supposed to fit the world rather than change it. But believing can have social consequences, since the beliefs we form underwrite our actions and impact our character. Because our beliefs affect how we live our lives and how we treat other people, it is surprising how little attention is usually given to the moral status of believing apart from its epistemic justification. In what follows, I develop a version of the harm principle that applies to (...) beliefs as well as actions. In doing so, I challenge the often exaggerated distinction between forming beliefs and acting on them.1 After developing this view, I consider what it might imply about controversial research the goal of which is to yield true beliefs but the outcome of which might include negative social consequences. In particular, I focus on the implications of research into biological differences between racial groups. (shrink)

One of the many proposals put forth recently in the revival of bioethics concerns solidarity, which is part of the agenda for the discipline in the twenty-first century. In this article, solidarity is proposed as a bioethical value, inasmuch as it cannot be achieved without considering the person towards whom one shows solidarity and without taking into account his or her environment. It is not possible to make bioethical judgments or to accomplish in-depth biological thinking when forgetting the person (...) who is at the source or heart of the matter. Based on a study of the experience of a group of health volunteers in Medellin (Colombia), this research found evidence of the existence of three elements that, together, serve as a hinge between solidarity and bioethics. -/- Entre las muchas propuestas que se han hecho recientemente en ese resurgir de la bioética se encuentra la solidaridad, consti­tuyéndose parte de la agenda del siglo XXI sobre esta disciplina. Proponemos la solidaridad como un valor bioético puesto que así como no se puede ser solidario sin tener en cuenta a la persona con quien soy solidario y su entorno, no se pueden emitir juicios bioéticos o hacer una reflexión bioética de fondo olvidando a quien se tiene en frente. A partir de un estudio de la expe­riencia de una población de voluntarios del sector salud en Medellín, Colombia, se logró evidenciar que existen tres elementos que, en conjunto, sirven de bisagra entre la solidaridad y la bioética. (shrink)

In response to the increasing need for research ethics expertise in low and middle income countries (LMICs), the NIH's Fogarty International Research Ethics Education and Curriculum Development Program has provided grants for the development of training programs in international research ethics for LMIC professionals since 2000. This collection of papers draws upon the combined expertise of Fogarty grantees, trainees, and other experts to assess the state of research ethics in LMICs, and the lessons learned over 12 (...) years of international research ethics education; to assess future needs; and to chart a way forward to meet those needs. In this introductory paper we briefly sketch the evolution of research ethics as applied to LMIC research, the underpinning and evolution of the Fogarty bioethics program, and summarize key conclusions from the other papers in the collection. (shrink)

Having scandalous unethical research practices in the mid and late 20th century, study protocols of biomedical research reviewed by the Ethics Committee (EC) has become the accepted international standard. The Declaration of Helsinki uniformly requires that all biomedical research involving human participants, including research on identifiable human material or data, should be approved by the EC. Today, concerns over the quality of the EC functions worldwide. There are research globally in this regard but no data (...) are available from Bangladesh. Hence, we conducted a questionnaire based pilot study on knowledge and attitude of EC members on bioethics and structure & function of EC in Bangladesh. (shrink)

NIH's fogarty international Center has provided grants for the development of training programs in international research ethics for low- and middle-income (LMIC) professionals since 2000. Drawing on 12 years of research ethics training experience, a group of Fogarty grantees, trainees, and other ethics experts sought to map the current capacity and need for research ethics in LMICs, analyze the lessons learned about teaching bioethics, and chart a way forward for research ethics training in a rapidly (...) changing health research landscape. This collection of papers is the result. (shrink)

In this essay I will illustrate how a Japanese philosopher reacted to a newly imported discipline, “bioethics,” in the 1980s and then tried to create an alternative way of looking at “life” in the field of philosophy. This essay might serve as an interesting case study in which a contemporary “western” way of thinking succeeded in capturing, but finally failed to persuade, a then-young Japanese researcher’s mind.

It is envisioned that one day xenotransplantation will bring about a future where transplantable organs can be safely and efficiently grown in transgenic pigs to help meet the global organ shortage. While recent advances have brought this future closer, worries remain about whether it will be beneficial overall. The unique challenges and risks posed to humans that arise from transplanting across the species barrier, in addition to the costs borne by non-human animals, has led some to question the value of (...) xenotransplantation altogether. In response, we defend the value of xenotransplantation research, because it can satisfy stringent welfare conditions on the permissibility of animal research and use. Along the way, we respond to the alleged concerns, and conclude that they do not currently warrant a cessation or a curtailing of xenotransplantation research. (shrink)

State militaries have strong interests in developing enhanced warfighters: taking otherwise healthy service personnel (soldiers, marines, pilots, etc.) and pushing their biological, physiological, and cognitive capacities beyond their individual statistical or baseline norm. However, the ethical and regulatory challenges of justifying research into these kinds of interventions to demonstrate the efficacy and safety of enhancements in the military has not been well explored. In this paper, we offer, in the context of the US Common Rule and Institutional Review Board (...) framework, potential justifications for justifying research into enhancing warfighters on the grounds of (1) individual and group risk reduction, (2) protection of third parties such as civilians, and (3) military effectiveness. (shrink)

The recent successful conversion of adult cells into induced pluripotent stem (iPS) cells through direct reprogramming opens a new chapter in the study of disease and the development of regenerative medicine. It also provides a historic opportunity to turn away from the ethically problematic use of embryonic stem cells isolated through the destruction of human embryos. Moreover, because iPS cells are patient specific, they render therapeutic cloning unnecessary. To maximize therapeutic benefit, adult stem cell research will need to be (...) pursued in parallel with studies using iPS cells. Among the four alternative methods presented by the President’s Council on Bioethics, direct reprogram- ming is the most ethically acceptable. Nonetheless, iPS cells are tainted by their association with the human embryonic stem cell lines, derived in the past, which will be required for their validation. This concern is one that can be resolved. Human iPS cells will serve to stem the tide of human embryonic stem cell research, changing it and diverting stem cell research in a more ethical direction. (shrink)

The future of health research will be characterised by three continuing trends: rising demand for health data; increasing impracticability of obtaining specific consent for secondary research; and decreasing capacity to effectively anonymise data. In this context, governments, clinicians and the research community must demonstrate that they can be responsible stewards of health data. IRBs and RECs sit at heart of this process because in many jurisdictions they have the capacity to grant consent waivers when research is (...) judged to be of particular value. However, several different terms are used to refer to this value, indicating a lack of conceptual clarity regarding the appropriate test for access to health data for research without consent. In this paper we do three things. First we describe the current confusion and instability in terminology relating to public interest in the context of consent waivers. Second we argue for harmonisation of terminology on the grounds of clarity, transparency and consistency. Third we argue that the term ‘public interest’ best reflects the normative work required to justify consent waivers because it is the broadest of the competing terms. ‘Public interest’ contains within its scope positive and negative implications of a study, as well as welfare, justice and rights considerations. In making this argument, we explain the normative basis for consent waivers, and provide a starting place for further discussion about the precise conditions in which a given study can be said to advance the public interest. Ipsos MORI study found that: … the public would be broadly happy with administrative data linking for research projects provided Those projects have social value, broadly defined. Data are de-identified. Data are kept secure. Businesses are not able to access the data for profit. (shrink)

In bioethics, the first decade of the twenty-first century was characterized by the emergence of interest in the ethical, legal, and social aspects of neuroscience research. At the same time an ongoing extension of the topics and phenomena addressed by neuroscientists was observed alongside its rise as one of the leading disciplines in the biomedical science. One of these phenomena addressed by neuroscientists and moral psychologists was the neural processes involved in moral decision-making. Today both strands of (...) class='Hi'>research are often addressed under the label of neuroethics. To understand this development we recalled literature from 1995 to 2012 stored in the Mainz Neuroethics Database (i) to investigate the quantitative development of scientific publications in neuroethics; (ii) to explore changes in the topics of neuroethics research within the defined time interval; (iii) to illustrate the interdependence of different research topics within the neuroethics literature; (iv) to show the development of the distribution of neuroethics research on peer-reviewed journals; and (v) to display the academic background and affiliations of neuroethics Researchers ... (shrink)

The curriculum design, faculty characteristics, and experience of implementing masters' level international research ethics training programs supported by the Fogarty International Center was investigated. Multiple pedagogical approaches were employed to adapt to the learning needs of the trainees. While no generally agreed set of core competencies exists for advanced research ethics training, more than 75% of the curricula examined included international issues in research ethics, responsible conduct of research, human rights, philosophical foundations of research ethics, (...) and research regulation and ethical review process. Common skills taught included critical thinking, research methodology and statistics, writing, and presentation proficiency. Curricula also addressed the cultural, social, and religious context of the trainees related to research ethics. Programs surveyed noted trainee interest in Western concepts of research ethics and the value of the transnational exchange of ideas. Similar faculty expertise profiles existed in all programs. Approximately 40% of faculty were female. Collaboration between faculty from low- and middleincome countries (LMICs) and high-income countries (HICs) occurred in most programs and at least 50% of HIC faculty had previous LMIC experience. This paper is part of a collection of papers analyzing the Fogarty International Research Ethics Education and Curriculum Development program. (shrink)

The idea that payment for research participation can be coercive appears widespread among research ethics committee members, researchers, and regulatory bodies. Yet analysis of the concept of coercion by philosophers and bioethicists has mostly concluded that payment does not coerce, because coercion necessarily involves threats, not offers. In this article we aim to resolve this disagreement by distinguishing between two distinct but overlapping concepts of coercion. Consent-undermining coercion marks out certain actions as impermissible and certain agreements as unenforceable. (...) By contrast, coercion as subjection indicates a way in which someone’s interests can be partially set back in virtue of being subject to another’s foreign will. While offers of payment do not normally constitute consent-undermining coercion, they do sometimes constitute coercion as subjection. We offer an analysis of coercion as subjection and propose three possible practical responses to worries about the coerciveness of payment. (shrink)

Innovative practice occurs when a clinician provides something new, untested, or nonstandard to a patient in the course of clinical care, rather than as part of a research study. Commentators have noted that patients engaged in innovative practice are at significant risk of suffering harm, exploitation, or autonomy violations. By creating a pathway for harmful or nonbeneficial interventions to spread within medical practice without being subjected to rigorous scientific evaluation, innovative practice poses similar risks to the wider community of (...) patients and society as a whole. Given these concerns, how should we control and oversee innovative practice, and in particular, how should we coordinate innovative practice and clinical research? In this article, I argue that an ethical approach to overseeing innovative practice must encourage the early transition to rigorous clinical research without delaying or deferring the development of beneficial innovations or violating the autonomy rights of clinicians and their patients. (shrink)