Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. (...) Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated. (shrink)

BackgroundFor over 35 years, Africa has continued to host HIV vaccine trials geared towards overturning the HIV/aids pandemic in the continent. However, the methods of sharing the vaccines, when available remain less certain. Therefore, the study aims to explore stakeholders’ perspectives in the global South, in this case, Tanzania, on how HIV vaccines ought to be fairly shared.MethodsThe study deployed a qualitative case study design. Data were collected through in-depth interviews and focus group discussions with a total of 37 purposively (...) selected participants. This included researchers, institutional review board members, a policymaker, HIV/aids advocates, and community advisory board members. The data obtained were inductively and deductively analyzed.Results Findings indicate that HIV vaccines can be shared fairly under the principles of distributive justice (contribution, need and equality). Thus, contribution-based sharing ought to be utilized upon the necessity to prioritize vaccine access or subsidized trial benefits to host communities. Need-based sharing ought to be considered for non-host communities that are at an increased risk of HIV infection. Lastly, equal-based sharing would be useful at later stages of vaccine distribution or when the aforementioned principles are deemed morally inappropriate. However, none of the benefit-sharing approaches is free of limitations and a counterbalancing sense of unfairness.ConclusionFair sharing of HIV vaccines, when available, ought to be informed by the contribution, need and equality principles of distributive justice. Countries in the global south including Tanzania are likely to be prioritized during the distribution of the HIV vaccines due to their participation in HIV vaccine trials and due to the disproportionate HIV burden evident in the region. (shrink)

Dr. McGee presents a cogent argument for the patentability of the diagnosis of gene forms that are found to be associated with disease or other phenotypic manifestations. We're convinced he's wrong. An analogy will help explain why.

Physicians and other health care providers owe ethical and legal duties to patients to maintain the secrecy of the information learned during the course of patient care. This obligation is fulfilled by limiting access to such information to only those involved in the patient's care-that is, to those within the “circle of confidentiality.” As a general rule, providers may only disclose to others with the written prior consent of the patient. Exceptions may be “ethically and legally justified because of overriding (...) social considerations,” when permitted or compelled by law. For example, eleven states permit providers to disclose identified records to approved researchers.’ Many states compel disclosure in cases where a patient threatens serious bodily harm to another; require reporting to health or law enforcement authorities of communicable diseases, gunshot or knife wounds, or child abuse; and mandate reporting of cancer or other health care cases to state registries. (shrink)

Before we respond to Tamara Browne's proposal for an external ethics advisory review panel to oversee content in the Diagnostic and Statistical Manual of Mental Disorders, we wish to introduce ourselves. One of us is a professor of bioethics, a lawyer, and a doctor of public policy, and one of us is a philosopher of psychiatry who studies psychiatric nosology, and who has done bioethics work for two congressional advisory agencies. Based on our backgrounds, we flatter ourselves that we might (...) be considered as members of the DSM ethical review panel Browne proposes. However, we realize that one of us would likely be ineligible because of a lack of experience in psychiatry, and the other would... (shrink)

This paper examines a number of questions about the degree to which the clinical practice of medicine is affected, if at all, by the legal systems in four countries: Chile, Germany, Japan and the United States. The focus on these four countries in four different regions of the world offers a unique perspective within which to examine medical treatment decisions made by patients and their proxies or surrogates, the potential role for universal written instruments such as advance directives, the cross-professional (...) tensions between clinical and legal concerns in very distinct cultures, and the degree to which legal activities can change or affect clinical realities in the context of these different political and health care systems. We have incorporated, whenever relevant, the insights of many disciplines, including the social sciences, in analyzing the existing interrelations between law and behavior in this specific context. Der Beitrag untersucht, inwieweit die klinische Praxis in vier Ländern mit unterschiedlichen Rechtssystemen und Berufskulturen durch Rechtsnormen oder das Verständnis von Recht beeinflußt wird. Es wird gefragt, welche Funktion rechtliche Interventionen bei der Veränderung von Verhaltensnormen in unterschiedlichen Gesundheitssystemen haben können. Folgende Themenbereiche werden diskutiert: Entscheidungen über die medizinische Behandlung, die von Patienten und ihren Angehörigen oder Stellvertretern getroffen werden; die mögliche Rolle umfassender schriftlicher Verfügungen wie z.B. der Patiententestamente ; die berufsübergreifenden Spannungen zwischen medizinischen und rechtlichen Belangen in sehr unterschiedlichen Kulturen; der Einfluß, den gesetzgeberische Aktivitäten im Kontext der verschiedenen politischen und Gesundheitssysteme auf die medizinische Wirklichkeit haben. Bei ihrer Analyse der in diesem Zusammenhang bestehenden Beziehungen im Verhältnis von Recht und Verhalten haben die Autoren die Erkenntnisse vieler Disziplinen unter Einschluß der Sozialwissenschaften, soweit sie als relevant erscheinen, in ihren Beitrag eingearbeitet. (shrink)

Much attention has been focused in recent years on the ethical acceptability of physicians receiving gifts from drug companies. Professional guidelines recognize industry gifts as a conflict of interest and establish thresholds prohibiting the exchange of large gifts while expressly allowing for the exchange of small gifts such as pens, note pads, and coffee. Considerable evidence from the social sciences suggests that gifts of negligible value can influence the behavior of the recipient in ways the recipient does not always realize. (...) Policies and guidelines that rely on arbitrary value limits for gift-giving or receipt should be reevaluated. (shrink)

BackgroundConcurrent with efforts to establish national and regional biorepositories in Africa is widespread endorsement of ethics committees as stewards of the interests of individual donors and their communities. To date, ethics training programs for IRB members in Botswana have focused on ethical principles and international guidelines rather than on the ethical dimensions of specific medical technologies and research methodologies. Little is known about the knowledge and concerns of current and prospective IRB members in Botswana with respect to export, reuse, storage, (...) and benefit-sharing of biospecimens.MethodsThis qualitative study examined perspectives of IRB members in Botswana about the collection and use of biospecimens in research. Forty-one IRB members representing five committees in Botswana participated in discussions groups in March 2013. Transcriptions of audiotapes and field notes were analyzed to identify issues of concern that might be alleviated through education and capacity-building, and areas that required ongoing discussion or additional regulatory guidance.ResultsAreas of concern included lack of understanding among patients and providers about the use of biospecimens in clinical care and research; reuse of biospecimens, particularly issues of consent, ownership and decision-making; export of specimens and loss of control over reuse and potential benefits; and felt need for regulatory guidance and IRB-member training. Local belief systems about bodily integrity and strong national identity in the construct of benefits may be at odds with initiatives that involve foreign biorepositories or consider such collections to be global public goods.ConclusionEducation is needed to strengthen IRB-member capacity to review and monitor protocols calling for the collection and use of biospecimens, guided by clear national policy on priority-setting, partnerships, review, and oversight. Engagement with local stakeholders is needed to harmonize fundamentally different ways of understanding the human body and community identity with the aims of contemporary biomedicine. (shrink)

This article presents a review of the literature, summarizes current initiatives, and provides a heuristic for assessing the effectiveness of a range of institutional review board collaborative strategies that can reduce the regulatory burden of ethics review while ensuring protection of human subjects, with a particular focus on international research. Broad adoption of IRB collaborative strategies will reduce regulatory burdens posed by overlapping oversight mechanisms and has the potential to enhance human subjects protections.

Background A morally sound framework for benefit-sharing is crucial to minimize research exploitation for research conducted in developing countries. However, in practice, it remains uncertain which stakeholders should be involved in the decision-making process regarding benefit-sharing and what the implications might be. Therefore the study aimed to empirically propose a framework for benefit-sharing negotiations in research by taking HIV vaccine trials as a case. Methods The study was conducted in Tanzania using a case study design and qualitative approaches. Data were (...) collected using in-depth interviews (IDI) and focus group discussions (FGD). A total of 37 study participants were selected purposively comprising institutional review board (IRB) members, researchers, community advisory board (CAB) members, a policymaker, and HIV/AIDS advocates. Deductive and inductive thematic analysis approaches were deployed to analyze collected data with the aid of MAXQDA version 20.4.0 software. Results The findings indicate a triangular relationship between the research community, researched community and intermediaries. However, the relationship ought to take into consideration the timing of negotiations, the level of understanding between parties and the phase of the clinical trial. The proposed framework operationalize partnership interactions in community-based participatory research. Conclusion In the context of this study, the suggested framework incorporates the research community, the community being researched, and intermediary parties. The framework would guarantee well-informed and inclusive decision-making regarding benefit-sharing in HIV vaccine trials and other health-related research conducted in resource-limited settings. (shrink)

Background The world has come closer than ever to discovering a viable HIV vaccine. However, it remains less certain whether HIV vaccines should be made available to participants and communities in which trials are run no or subsidized cost. Hence the essence of this inquiry.Methodology This is a case study design using in-depth interviews (IDI) and focus group discussions (FGD) with researchers of HIV vaccine trials, institutional review board (IRB) members, HIV advocates, a policy maker, and members of community advisory (...) board (CAB) in Tanzania. Participants were purposively selected and data thematically analyzed using MAXQDA software.Results Hosting a vaccine trial and the financial incapacity of individuals at increased risk of HIV were among the reasons in favor of free access to HIV vaccines. In contrast, the view that vaccines should be provided at a subsidized cost was related to high costs of vaccine development, financial return expectations by investors, and the fear of labeling the free vaccine as less important. Moreover, apart from governments and international organizations, well-off individuals could share the cost burden.Conclusion Stakeholders engaging in active discussion about sharing the viable vaccine ought to take the aforementioned concerns into account and ensure unhindered access to individuals and host communities in Tanzania and beyond. (shrink)

Between 1993 and 2002, 39 clinical trial staff were investigated for scientific misconduct by the Office of Research Integrity (ORI). Analysis of ORI case records reveals practices regarding workload, training and supervision that enable misconduct. Considering the potential effects on human subjects protection, quality and reliability of data, and the trustworthiness of the clinical research enterprise, regulations or guidance on use of clinical trial staff ought to be available. Current ORI regulations do not hold investigators or institutions responsible for supervision (...) and training of clinical trial staff. Given the important issues at stake, the definition of research misconduct should encompass the intentional or negligent mismanagement of scientific projects. Individual institutions and professional associations not only can but should adopt stricter standards of conduct than those reflected in federal regulations. (shrink)

Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to downstream research results and products may increase the financial risks (...) and cliniinish potential payoffs of — and therefore motivation for — performing downstream research and development. In addition, very broad patent claims allowed by the U.S. Patent and Trademark Office, the sheer growth in patents claiming genetic sequences, and threats of overlapping patents create a veritable minefield for researchers in both academia and industry. The concern is that research may be stifled because of the high cost and hassle of negotiating access. (shrink)

Objective Bayesianism is a methodological theory that is currently applied in statistics, philosophy, artificial intelligence, physics and other sciences. This book develops the formal and philosophical foundations of the theory, at a level accessible to a graduate student with some familiarity with mathematical notation.

This book brings together several directions of work in model theory between the late 1950s and early 1980s.

I discuss three recent counterexamples to the transitivity of grounding due to Jonathan Schaffer. I argue that the counterexamples don’t work and draw some conclusions about the relationship between grounding and explanation.

Most authors on metaphysical grounding have taken full grounding to be an internal relation in the sense that it's necessary that if the grounds and the grounded both obtain, then the grounds ground the grounded. The negative part of this essay exploits empirical and provably nonparadoxical self-reference to prove conclusively that even immediate full grounding isn't an internal relation in this sense. The positive, second part of this essay uses the notion of a “completely satisfactory explanation” to shed light on (...) the logic of ground in the presence of self-reference. This allows us to develop a satisfactory logic of ground and recover a sense in which grounding is still an internal relation. (shrink)

In this paper, I link philosophical discussion of policies for trans inclusion or exclusion, to a method of policy making. I address the relationship between concerns about safety, fairness, and inclusion in policy making about the inclusion of transwomen athletes into women’s sport. I argue for an approach based on lexical priority rather than simple ‘balancing’, considering the different values in a specific order. I present justifying reasons for this approach and this lexical order, based on the special obligations of (...) International Federations such as World Rugby. As a result, I provide a justificatory framework for the WR Guidelines that exclude transwomen from the women’s game in WR competitions. Finally, I give an account of a maximally safe, maximally fair and maximally inclusive form of sex categorisation in sport. (shrink)

Russo and Williamson put forward the following thesis: in order to establish a causal claim in medicine, one normally needs to establish both that the putative cause and putative effect are appropriately correlated and that there is some underlying mechanism that can account for this correlation. I argue that, although the Russo-Williamson thesis conflicts with the tenets of present-day evidence-based medicine, it offers a better causal epistemology than that provided by present-day EBM because it better explains two key aspects of (...) causal discovery. First, the thesis better explains the role of clinical studies in establishing causal claims. Second, it yields a better account of extrapolation. (shrink)

I systematically defend a novel account of the grounds for identity and distinctness facts: they are all uniquely zero‐grounded. First, this Null Account is shown to avoid a range of problems facing other accounts: a relation satisfying the Null Account would be an excellent candidate for being the identity relation. Second, a plenitudinist view of relations suggests that there is such a relation. To flesh out this plenitudinist view I sketch a novel framework for expressing real definitions, use this framework (...) to give a definition of identity, and show how the central features of the identity relation can be deduced from this definition. (shrink)

In this paper I discuss a new conception that has arrived relatively recently on the scene, in the context of the debate over the inclusion of transwomen (hereafter TW) in female sport. That conception is ‘Meaningful Competition’ (hereafter MC) – a term used by some of those who advocate for the inclusion of TW in female sport if and only if they reduce their testosterone levels. I will argue that MC is not fair. I understand MC as a substitute concept, (...) as an attempt to substitute for the perfectly serviceable concept of fair competition. It is an attempt at conceptual engineering that should be resisted. This is important because some International Federations have accepted MC as good coin, and the underlying theory of MC, which I explicate for the first time, underpins the stance taken by the IOC (International Olympic Committee) in its Framework Document. To establish that the inclusion of TW in female sport meets the criteria of MC in the sense I explicate here, does not show that the inclusion of TW in female sport is fair. Such inclusion is not fair, and the proper currency of sport is fair competition. ‘Meaningful Competition’, on the other hand, is a snare and a delusion. (shrink)

The chapter explores whether, or to what extent, recent work in experimental philosophy puts pressure on the idea that the concept of causation is ‘egalitarian’. Causal selection – where experimental subjects tend to rate the causal strength of (for example) a norm-violator more strongly than a non-norm-violator – is a well established phenomenon, and is in prima facie tension with an egalitarian conception of causation; it also, indirectly, puts prima facie pressure on the idea that causation is a worldly phenomenon (...) whose obtaining is independent of facts about norms. The chapter explores both the various psychological mechanisms and the broadly pragmatic approaches to explaining causal selection. It argues that the answer to the question whether or not the concept of causation is egalitarian is currently significantly empirically underdetermined, and suggests some avenues for further investigation. (shrink)

A logic of grounding where what is grounded can be a collection of truths is a “many-many” logic of ground. The idea that grounding might be irreducibly many-many has recently been suggested by Dasgupta. In this paper I present a range of novel philosophical and logical reasons for being interested in many-many logics of ground. I then show how Fine’s State-Space semantics for the Pure Logic of Ground can be extended to the many-many case, giving rise to the Pure Logic (...) of Many-Many Ground. In the second, more technical, part of the paper, I do two things. First, I present an alternative formalization of plg; this allows us to simplify Fine’s completeness proof for plg. Second, I formalize plmmg using an infinitary sequent calculus and prove that this formalization is sound and complete. (shrink)

This book is designed to remedy that lack.

Modern philosophy recognizes two major ethical theories: deontology, which encourages adherence to rules and fulfillment of duties or obligations; and consequentialism, which evaluates morally significant actions strictly on the basis of their actual or anticipated outcomes. Both involve the systematic application of universal abstract principles, reflecting the culturally dominant paradigm of technical rationality. Professional societies promulgate codes of ethics with which engineers are expected to comply, while courts and the public generally assign liability to engineers primarily in accordance with the (...) results of their work, whether intended or unintended. A third option, prominent in ancient philosophy, has reemerged recently: virtue ethics, which recognizes that sensitivity to context and practical judgment are indispensable in particular concrete situations, and therefore rightly focuses on the person who acts, rather than the action itself. Beneficial character traits—i.e., virtues—are identified within a specific social practice in light of the internal goods that are unique to it. This paper proposes a comprehensive framework for implementing virtue ethics within engineering. (shrink)

Fine (2012) is a pluralist about grounding. He holds that there are three fundamentally distinct notions of grounding: metaphysical, normative, and natural. Berker (2017) argues for monism on the grounds that the pluralist cannot account for certain principles describing how the distinct notions of grounding interact. This paper defends pluralism. By building on work by Fine (2010) and Litland (2015) I show how the pluralist can systematically account for Berker's interaction principles.

The study of intrapersonal economic relations, or economics , is still at the programmatic stage. There is no generally accepted paradigm, or even as well-defined set of problems that constitute it as a subdiscipline within economics. Some questions are, however, emerging as foci of interest for a small but increasing number of writers, not just in economics, but also in psychology and philosophy. The writings of Thomas Schelling on self-management, of George Ainslie on self-control, and of Derik Parfit on personal (...) identity testify to this convergence. (shrink)

Wilhelm has recently shown that widely accepted principles about immediate ground are inconsistent with some principles of propositional identity. This note responds to this inconsistency by developing two ground-theoretic accounts of propositional individuation. On one account some of the grounding principles are incorrect; on the other account, the principles of propositional individuation are incorrect.

How does vagueness interact with metaphysical modality and with restrictions of it, such as nomological modality? In particular, how do definiteness, necessity (understood as restricted in some way or not), and actuality interact? This paper proposes a model-theoretic framework for investigating the logic and semantics of that interaction. The framework is put forward in an ecumenical spirit: it is intended to be applicable to all theories of vagueness that express vagueness using a definiteness (or: determinacy) operator. We will show how (...) epistemicists, supervaluationists, and theorists of metaphysical vagueness like Barnes and Williams (2010) can interpret the framework.  We will also present a complete axiomatization of the logic we recommend to both epistemicists and local supervaluationists. . (shrink)

This paper evaluates the proof-theoretic definition of ground developed by Poggiolesi in a range of recent publications and argues that her proposed definition fails. The paper then outlines an alternative approach where logical consequence relations and the logical operations are defined in terms of ground.

The cumulative impact of enhancement technologies may alter the human species in the very long-term future. In this article, I will start showing how radical genetic enhancements may accelerate the conversion into a novel species. I will also clarify the concepts of ‘biological species’, ‘transhuman’ and ‘posthuman’. Then, I will summarize some ethical arguments for creating a transhuman or posthuman species with a substantially higher level of well-being than the human one. In particular, I will present what I shall call (...) the Principle of the Best Interests of Posthumanity, which states that the enhancement of the human and transhuman species must be directed towards the creation of a posthuman existence that is substantially more valuable than its predecessors. I suggest that human extinction may be considered, within that principle, as one of the best interests of posthumanity. Finally, I will develop three objections that make that principle unattractive and that show that pursuing a full-blown programme of posthuman evolution is ethically flawed. (shrink)

The increasing application of artificial intelligence (AI) to healthcare raises both hope and ethical concerns. Some advanced machine learning methods provide accurate clinical predictions at the expense of a significant lack of explainability. Alex John London has defended that accuracy is a more important value than explainability in AI medicine. In this article, we locate the trade-off between accurate performance and explainable algorithms in the context of distributive justice. We acknowledge that accuracy is cardinal from outcome-oriented justice because it helps (...) to maximize patients’ benefits and optimizes limited resources. However, we claim that the opaqueness of the algorithmic black box and its absence of explainability threatens core commitments of procedural fairness such as accountability, avoidance of bias, and transparency. To illustrate this, we discuss liver transplantation as a case of critical medical resources in which the lack of explainability in AI-based allocation algorithms is procedurally unfair. Finally, we provide a number of ethical recommendations for when considering the use of unexplainable algorithms in the distribution of health-related resources. (shrink)

Could φ’s partially grounding ψ itself be a partial ground for ψ? I show that it follows from commonly accepted principles in the logic of ground that this sometimes happens. It also follows from commonly accepted principles that this never happens. I show that this inconsistency turns on different principles than the puzzles of ground already discussed in the literature, and I propose a way of resolving the inconsistency.

This paper develops a novel theory of abstraction—what we call collective abstraction. The theory solves a notorious problem for noneliminative structuralism. The noneliminative structuralist holds that in addition to various isomorphic systems there is a pure structure that can be abstracted from each of these systems; but existing accounts of abstraction fail for nonrigid systems like the complex numbers. The problem with the existing accounts is that they attempt to define a unique abstraction operation. The theory of collective abstraction instead (...) simultaneously defines a collection of distinct abstraction operations, each of which maps a system to its corresponding pure structure. The theory is precisely formulated in an essentialist language. This allows us to throw new light on the question to what extent structuralists are committed to symmetric dependence. Finally, we apply the theory of collective abstraction to solve a problem about converse relations. (shrink)

A normative Bayesian theory of deliberation and judgement requires a procedure for merging the evidence of a collection of agents. In order to provide such a procedure, one needs to ask what the evidence is that grounds Bayesian probabilities. After finding fault with several views on the nature of evidence (the views that evidence is knowledge; that evidence is whatever is fully believed; that evidence is observationally set credence; that evidence is information), it is argued that evidence is whatever is (...) rationally taken for granted. This view is shown to have consequences for an account of merging evidence, and it is argued that standard axioms for merging need to be altered somewhat. (shrink)

Ageism has unfortunately become a salient phenomenon during the COVID-19 pandemic. In particular, triage decisions based on age have been hotly discussed. In this article, I first defend that, although there are ethical reasons (founded on the principles of benefit and fairness) to consider the age of patients in triage dilemmas, using age as a categorical exclusion is an unjustifiable ageist practice. Then, I argue that ageism during the pandemic has been fueled by media narratives and unfair assumptions which have (...) led to an ethically problematic group homogenization of the older population. Finally, I conclude that an intersectional perspective can shed light on further controversies on ageism and triage in the post-pandemic future. (shrink)