The FDA's new table of surrogate endpoints used for drug approvals is an important step forward for overseeing the use of biomarkers in clinical trials. Nevertheless, we present several ways in which the table can be improved.

The Covid‐19 pandemic highlighted the need to examine public trust in the U.S. Food and Drug Administration (FDA) vaccine approval process and the role of political influence in the FDA's decisions. Ensuring that the FDA is itself trustworthy is important for justifying public trust in its actions, like vaccine approvals, thereby promoting public health. We propose five conditions of trustworthiness that the FDA should meet when it reviews vaccines, even during emergencies: consistency with rules, proper expert or political decision‐makers, proper (...) decision‐making and noninterference, connection to public preference, and transparency of both reasons and procedures. The five conditions provide a road map of procedural and substantive requirements, which the FDA has variably implemented, focused on ensuring appropriate influence of political interests. While being a trustworthy agency cannot guarantee the public's trust, implementing these conditions builds a groundwork for public trust. (shrink)

The authors respond to a letter by Mitchell Berger in the March‐April 2024 issue of the Hastings Center Report concerning their essay “Securing the Trustworthiness of the FDA to Build Public Trust in Vaccines.”.

In this article I defend innocuousism– a weak form of Epicureanism about the putative badness of death. I argue that if we assume both mental statism about wellbeing and that death is an experiential blank, it follows that death is not bad for the one who dies. I defend innocuousism against the deprivation account of the badness of death. I argue that something is extrinsically bad if and only if it leads to states that are intrinsically bad. On my view, (...) sometimes dying may be less good than living, but it is never bad to die. (shrink)

How do we know right from wrong? Do we even have moral knowledge? Moral epistemology studies these and related questions about our understanding of virtue and vice. It is one of philosophy’s perennial problems, reaching back to Plato, Aristotle, Aquinas, Locke, Hume and Kant, and has recently been the subject of intense debate as a result of findings in developmental and social psychology. Throughout the book Zimmerman argues that our belief in moral knowledge can survive sceptical challenges. He also draws (...) on a rich range of examples from Plato’s Meno and Dickens’ David Copperfield to Bernard Madoff and Saddam Hussein. (shrink)

Kant’s moral philosophy both enjoins the acquisition of self-knowledge as a duty, and precludes certain forms of its acquisition via what has become known as the Opacity Thesis. This article looks at several recent attempts to solve this difficulty and argues that they are inadequate. I argue instead that the Opacity Thesis rules out only the knowledge that one has acted from genuine moral principles, but does not apply in cases of moral failure. The duty of moral self-knowledge applies therefore (...) only to one’s awareness of one’s status as a moral being and to the knowledge of one’s moral failings, both in particular actions and one’s overall character failings, one’s vices. This kind of knowledge is morally salutary as an aid to discovering one’s individual moral weakness as well as the subjective ends for which one acts, and in this way for taking up the morally required end of treating human beings as human beings. In this way, moral self-knowledge can be understood as a necessary element of moral improvement, and I conclude by suggesting several ways to understand it thereby as genuinely primary among the duties to oneself. (shrink)

Merold Westphal's book is a wonderful introduction to the history of philosophy.

What is death? Do people survive death? What do we mean when we say that someone is "dying"? Presenting a clear and engaging discussion of the classic philosophical questions surrounding death, this book studies the great metaphysical and moral problems of death. In the first part, Feldman shows that a definition of life is necessary before death can be defined. After exploring several of the most plausible accounts of the nature of life and demonstrating their failure, he goes on (...) to propose his own conceptual scheme for death and related concepts. In the second part, Feldman turns to ethical and value-theoretical questions about death. Addressing the ancient Epicurean ethical problem about the evil of death, he argues that death can be a great evil for those who die, even if they do not exist after death, because it may deprive them of the goods they would have enjoyed if they had continued to live. Confrontations with the Reaper concludes with a novel consequentialist theory about the morality of killing, applying it to such thorny practical issues as abortion, suicide, and euthanasia. (shrink)

We use Nietzsche’s On the Genealogy of Morality as a touchstone for comprehending Trump’s appeal and victory. Following Nietzsche’s concerns, the most noteworthy puzzle is that of Trump’s peculiar popularity, especially given his impolitic statements and policy proposals that often appear in tension with the interests of his voter base. While Nietzsche’s discussions of power and resentment would seem obvious starting points to examine the success of Trump and Trumpism, we contend that these provide largely superficial and, at best, incomplete (...) explanations. Instead, informed by Nietzsche’s moral psychology, we analyze Trump’s strategy in the context of the instinctual need for self-preservation. Trump’s amplification of this need through his rhetoric and cultivation of negative emotions, including resentment, has led to a revaluation that diminishes humanity. We conclude by drawing out the implications of Nietzsche’s view, revealing a forceful Nietzschean critique of Trump’s methods and values. (shrink)

It is widely held that, in his pre-Critical works, Kant endorsed a necessitation account of laws of nature, where laws are grounded in essences or causal powers. Against this, I argue that the early Kant endorsed the priority of laws in explaining and unifying the natural world, as well as their irreducible role in in grounding natural necessity. Laws are a key constituent of Kant’s explanatory naturalism, rather than undermining it. By laying out neglected distinctions Kant draws among types of (...) natural law, grounding relations, and ontological levels, I show that his early works present a coherent and sophisticated laws-first account of the natural order. (shrink)

In this paper I will address a few of the many questions that fall under the general heading of “the ethics of belief.” In section I I will discuss the adequacy of what has come to be known as the “deontological conception of epistemic justification” in the light of our apparent lack of voluntary control over what we believe. In section II I’ll defend an evidentialist view about what we ought to believe. And in section III I will briefly discuss (...) apparent conflicts between epistemic considerations and moral or other considerations. (shrink)

In this paper I will address a few of the many questions that fall under the general heading of “the ethics of belief.” In section I I will discuss the adequacy of what has come to be known as the “deontological conception of epistemic justification” in the light of our apparent lack of voluntary control over what we believe. In section II I’ll defend an evidentialist view about what we ought to believe. And in section III I will briefly discuss (...) apparent conflicts between epistemic considerations and moral or other considerations. (shrink)

Little is known about the mechanisms by which psychology graduate programs transmit responsible conduct of research (RCR) values. A national sample of 968 current students and recent graduates of mission-diverse doctoral psychology programs completed a Web-based survey on their research ethics challenges, perceptions of RCR mentoring and department climate, whether they were prepared to conduct research responsibly, and whether they believed psychology as a discipline promotes scientific integrity. Research experience, mentor RCR instruction and modeling, and department RCR policies predicted student (...) RCR preparedness. Mentor RCR instruction, department RCR policies, and faculty modeling of RCR behaviors predicted confidence in the RCR integrity of the discipline. Implications for training are discussed. (shrink)

It is now medically possible for a baby to have two biological mothers. A fertilized ovum from one woman can be implanted into a second woman for gestation in her uterus. In fact, there have been several such cases. The ova donor is the mother in the genetic sense: her genetic material,along with that of the sperm donor,appears in the developing baby. The uterine hostess is the birth mother: she gestates the fetus and gives birth to it. In essence, the (...) two female reproductive functions, genetic and gestational, can be and have been divided from each other. Our current conception of biological maternity has lagged behind these technological marvels and still assumes that both functions will be performed by the same woman. At a time when two "biological mothers" can and do make claims for the same child,each on the ground that she is the "true mother", it is crucial to examine our concepts of biological maternity and their relation to our social policies about maternity in these cases. In this paper I will argue that the best social and legal policy would involve a prima facie preference for the claims of the gestational mother over the claims of the genetic mother for custody of the child in a contest (if there is no question of parental unfitness on either side). That is, in any dispute, presumption should be in favor of the gestational mother. This argument is made independent of considerations about pre-birth and pre-conception contracts, because the issues raised about the roles of gestational and genetic maternity are substantial in themselves and have obvious implications about the acceptability of such contracts.Rather, I argue that a revision of our concept of biological maternity which emphasizes the importance of gestation and which would prefer the claims of the gestational over the genetic mother would have positive benefits for both women and newborns. (shrink)

A new theory of how the brain constructs emotions that could revolutionize psychology, health care, law enforcement, and our understanding of the human mind Emotions feel automatic, like uncontrollable reactions to things we think and experience. Scientists have long supported this assumption by claiming that emotions are hardwired in the body or the brain. Today, however, the science of emotion is in the midst of a revolution on par with the discovery of relativity in physics and natural selection in biology--and (...) this paradigm shift has far-reaching implications for us all. Leading the charge is psychologist and neuroscientist Lisa Feldman Barrett, whose theory of emotion is driving a deeper understanding of the mind and brain, and shedding new light on what it means to be human. Her research overturns the widely held belief that emotions are housed in different parts of the brain and are universally expressed and recognized. Instead, she has shown that emotion is constructed in the moment, by core systems that interact across the whole brain, aided by a lifetime of learning. This new theory means that you play a much greater role in your emotional life than you ever thought. Its repercussions are already shaking the foundations not only of psychology but also of medicine, the legal system, child-rearing, meditation, and even airport security. Why do emotions feel automatic? Does rational thought really control emotion? How does emotion affect disease? How can you make your children more emotionally intelligent? How Emotions Are Made answers these questions and many more, revealing the latest research and intriguing practical applications of the new science of emotion, mind, and brain. (shrink)

This collection of essays is the first of its kind to focus on the relationship between composition and identity. Twelve original articles--written by internationally renowned scholars and rising stars in the field--argue for and against the controversial doctrine that composition is identity.--Provided by publisher.

Adam Smith sought to explain the persistence of slavery as an institution in Wealth of Nations and Lectures on Jurispridence. In order to accomplish this he also drew on arguments he had developed in the Theory of Moral Sentiments. The result was a sophisticated explanation which bridged economic, psychological, and moral considerations. After presenting Smith’s explanation I will consider a discussion of the moral wrong of slavery in Ottobah Cugoano, the author of the incisive criticism of the slave trade Thoughts (...) and Sentiments on the Evil of Slavery (1787). I will suggest that Cugoano’s account of what is morally wrong in slavery shows an important lacuna in Smith‘s views. (shrink)

One of the most profound interactions that can occur between people, apologies have the power to heal humiliations, free the mind from deep-seated guilt, remove the desire for vengeance, and ultimately restore broken relationships. With On Apology, Aaron Lazare offers an eye-opening analysis of this vital interaction, illuminating an often hidden corner of the human heart. He discusses the importance of shame, guilt, and humiliation, the initial reluctance to apologize, the simplicity of the act of apologizing, the spontaneous generosity (...) and forgiveness on the part of the offended, the transfer of power and respect between two parties, and much more. Readers will not only find a wealth of insight that they can apply to their own lives, but also a deeper understanding of national and international conflicts and how we might resolve them. The act of apologizing is quite simply immensely fulfilling. On Apology opens a window onto this common occurrence to reveal the feelings and actions at the heart of this profound interaction. (shrink)

We argue that the value of authenticity does not explain the value of self-knowledge. There are a plurality of species of authenticity; in this paper we consider four species: avoiding pretense (section 2), Frankfurtian wholeheartedness (section 3), existential self-knowledge (section 4), and spontaneity (section 5). Our thesis is that, for each of these species, the value of (that species of) authenticity does not (partially) explain the value of self-knowledge. Moreover, when it comes to spontaneity, the value of (that species of) (...) authenticity conflicts with the value of self-knowledge. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Reviewed by:Vessel of Honor: The Virgin Birth and the Ecclesiology of Vatican II by Brian A. GraebeAaron Pidel S.J.Vessel of Honor: The Virgin Birth and the Ecclesiology of Vatican II. By Brian A. Graebe (Steubenville, OH: Emmaus Academic, 2021), 351 pp.Though Mary's undiminished virginity in giving birth (virginitas in partu) was long understood to be an event as miraculous and a teaching as authoritative as her virginity in conceiving (...) (virginitas ante partum), virginitas in partu underwent a kind of existential reinterpretation in the middle of the twentieth century. Authors such as Albert Mitterer and Karl Rahner suggested that, physically speaking, Jesus's birth might have happened like any other, rupturing the hymen, distending the birth canal, and causing Mary pain, albeit not in the spiritually disintegrating way common to postlapsarian humanity. These arguments effectively "unsettled" the traditional understanding of virginitas in partu, leading theologians of the highest stature to distinguish between the doctrine itself and the anatomical aspects attached to it over time. Fr. Brian Graebe has written a fine book arguing that the bodily dimensions of the virgin birth, including the physical "seal" of virginity, belong to the substance of the doctrine. This more inclusive understanding not only does better justice to the data of tradition, he argues, but illuminates the ecclesiology of the Second Vatican Council. The book impresses by its theologically reflective method, its clarity of exposition, [End Page 1106] and its depth of research—especially into the archival and antepreparatory sources of Vatican II.Vessel of Honor responds in effect to Rahner's argument that physical intactness is peripheral to the dogmatic core of Mary's virginity in partu. To show otherwise, Rahner contended, one would need to show that such a doctrine can be found directly in the apostolic teaching, or that it, "being implicitly contained therein, has grown out of the apostolic doctrine, by a legitimate historical, logical, and theological process, as its authentic development" (68–69). If the bodily aspects of this doctrine really belonged to the deposit of faith, in other words, one would need to show how they are implied in the traditio divino-apostolica, as well as how they cohere organically with the rest of the deposit. The two major parts of Vessel of Honor respond in turn to each aspect of Rahner's challenge.The first three chapters argue that Mary's bodily integrity in parturition belongs at least implicitly to the traditio divino-apostolica. Turning first to the postapostolic tradition, Fr. Graebe shows that—apart from the early exceptions of Origen and Tertullian—patristic sources either affirm or strongly imply a miraculous delivery. This constant witness culminates in the Lateran Council (649 AD), which, while not itself an ecumenical council, was received into the magisterium of Pope Martin and affirmed by the Third Council of Constantinople (680 AD). Its teaching that Mary "gave birth without corruption" (incorruptibiliter... genuisse) would be defended by Paschasius, Ratramnus, Thomas Aquinas, and others. This consensus remained undisturbed until the eve of Vatican II.Even at Vatican II, Fr. Graebe argues in the next chapter, the Council Fathers intended to reaffirm the more inclusive idea of virginitas in partu against those who would marginalize its bodily dimensions. Here he really breaks new ground, delving deep into the antepreparatory, preparatory, and conciliar drafting history. He shows convincingly that many of the chief drafters of the final formula—"Our Lord, who did not diminish his mother's virginal integrity but sanctified it..." (Lumen Gentium §57)—saw it as excluding Rahner's and Mitterer's minimalizing interpretations. Drawing on material from the Vatican Apostolic Archives, Fr. Graebe shows that some of the very theologians who voted to omit the pointed phrase "in the birth itself" (in ipsomet partu) did so for tonal rather than substantive reasons.The third chapter argues that Mary's physical integrity in birth is to be believed with divine and Catholic faith, despite the ongoing confusion introduced by Rahner and others. Admittedly, Vatican II did not define but merely reaffirmed the traditional understanding of virginitas in partu. But there are other reasons for including it in the traditio divino-apostolica. [End Page 1107] Drawing heavily... (shrink)

By contributing a few hundred dollars to a charity like UNICEF, a prosperous person can ensure that fewer poor children die, and that more will live reasonably long, worthwhile lives. Even when knowing this, however, most people send nothing, and almost all of the rest send little. What is the moral status of this behavior? To such common cases of letting die, our untutored response is that, while it is not very good, neither is the conduct wrong. What is the (...) source of this lenient assessment? In this contentious new book, one of our leading philosophers argues that our intuitions about ethical cases are generated not by basic moral values, but by certain distracting psychological dispositions that all too often prevent us from reacting in accord with our commitments. Through a detailed look at how these tendencies operate, Unger shows that, on the good morality that we already accept, the fatally unhelpful behavior is monstrously wrong. By uncovering the eminently sensible ethics that we've already embraced fully, and by confronting us with empirical facts and with easily followed instructions for lessening serious suffering appropriately and effectively, Unger's book points the way to a compassionate new moral philosophy. (shrink)

Within the context of service inquiries, and the specialized inferential logic associated with the particularized activities there is a gap in the orientations of customers and service representatives. Specifically, one problem that arises in customer service encounters is that customers and service representatives appear to arrive at different understandings of what constitutes a relevant response to a service inquiry. By examining one type of customer service context, calls to an electronic repair facility, this article offers a conversation analytic account of (...) how customers use formulations to collaboratively achieve a mutually agreed upon answer to their service inquiry and close the gap in the underlying logics that emerge in these calls. (shrink)

The central focus of Peirce’s work is the development of self-control through engaging in a critical, reflective practice of habit development. This book details that development from a philosophical, pragmatic perspective.

The students and colleagues of Roderick Chisholm admired and respected Chisholm. Many were filled not only with admiration, but with affection and gratitude for Chisholm throughout the time we knew him. Even now that he is dead, we continue to wish him well. Under the circumstances, many of us probably think that that wish amounts to no more than this: we hope that things went well for him when he lived; we hope that he had a good life.

Prior research on the influence of various ways of framing anthropogenic climate change do not account for the organized ACC denial in the U.S. media and popular culture, and thus may overestimate these frames' influence in the general public. We conducted an experiment to examine how Americans' ACC views are influenced by four promising frames for urging action on ACC —when these frames appear with an ACC denial counter-frame. This is the first direct test of how exposure to an ACC (...) denial message influences Americans' ACC views. Overall, these four positive frames have little to no effect on ACC beliefs. But exposure to an ACC denial counter-frame does significantly reduce respondents' belief in the reality of ACC, belief about the veracity of climate science, awareness of the consequences of ACC, and support for aggressively attempting to reduce our nation's GHG emissions in the near future. Furthermore, as expected by the Anti-Reflexivity Thesis, exposure to the ACC denial counter-frame has a disproportionate influence on the ACC views of conservatives, effectively activating conservatives' underlying propensity for anti-reflexivity. (shrink)

1. Introduction. In a famous passage near the beginning of A Theory of Justice, John Rawls discusses utilitarianism’s notorious difficulties with justice. According to classic forms of utilitarianism, a certain course of action is morally right if it produces the greatest sum of satisfactions. And, as Rawls points out, the perplexing implication is “…that it does not matter, except indirectly, how this sum of satisfactions is distributed among individuals any more than it matters, except indirectly, how one man distributes his (...) satisfactions over time.” He concludes the passage by saying that “[u]tilitarianism does not take seriously the distinction between persons.”. (shrink)

When citizens are pulled over by police for traffic violations, they often volunteer accounts for their driving conduct. These accounts convey important character qualities about the citizen, as well as exigencies that motivate officer response. We use the method of conversation analysis to show that where a citizen positions an account in the course of an encounter is subject to different interactional-organizational constraints, which in turn afford citizens different resources for self-presentation. We also show that officers are sensitive to citizens’ (...) accounts and respond to them in differentiated ways. In addition to being a resource for self-presentation, citizens’ volunteered accounts are a resource for motivating and shaping police action. (shrink)

Bayesian Conditionalization is a widely used proposal for how to update one’s beliefs upon the receipt of new evidence. This is in part because of its attention to the totality of one’s evidence, which often includes facts about what one’s new evidence is and how one has come to have it. However, an increasingly popular position in epistemology holds that one may gain new evidence, construed as knowledge, without being in a position to know that one has gained this evidence. (...) These are cases of KK-Failure, cases where one knows p but is not in a position to know that one knows p. This paper assumes that certain KK-Failures are possible and argues that Conditionalization goes wrong in those cases. (shrink)

What makes a life go well for the one who lives it? Hedonists hold that pleasure enhances the value of a life; pain diminishes it. Hedonism has been subjected to a number of objections. Some are (a) based on the claim that hedonism is a form of “mental statism”. Others are (b) based on the claim that some pleasures are base or degrading. Yet others are (c) based on the claim that when a bad person enjoys a pleasure, his receipt (...) of that pleasure seem not to make the world better.It is important to keep in mind that hedonism is a theory about the value of a person's life for the person who lives it, and not for the world or for others. It is also important to distinguish between sensory hedonism and attitudinal hedonism.“Desert Adjusted Intrinsic Attitudinal Hedonism” appears to be immune to objections (a) and (b). A variant appears to be immune to all of them. Perhaps it is the answer to the question about the value of a life. (shrink)

: Contemporary common sense holds that authenticity is an ethical ideal: that there is something bad about inauthenticity, and something good about authenticity. Here we criticize the view that authenticity is bad because it detracts from the wellbeing of the inauthentic person, and propose an alternative moral account of the badness of inauthenticity, based on the idea that inauthentic behaviour is potentially misleading.

1. Introduction. In a famous passage near the beginning of A Theory of Justice, John Rawls discusses utilitarianism’s notorious difficulties with justice. According to classic forms of utilitarianism, a certain course of action is morally right if it produces the greatest sum of satisfactions. And, as Rawls points out, the perplexing implication is “…that it does not matter, except indirectly, how this sum of satisfactions is distributed among individuals any more than it matters, except indirectly, how one man distributes his (...) satisfactions over time.” He concludes the passage by saying that “[u]tilitarianism does not take seriously the distinction between persons.”. (shrink)

I reconstruct J. H. Lambert’s views on how practical grounds relate to epistemic features, such as certainty. I argue, first, that Lambert’s account of moral certainty does not involve any distinctively practical influence on theoretical belief. However, it does present an interesting form of fallibilism about justification as well as a denial of a tight link between knowledge and action. Second, I argue that for Lambert, the persistence principle that underwrites induction is supported by practical reasons to believe; this indicates (...) that Lambert is a moderate pragmatist about reasons for theoretical belief. (shrink)

Does a commitment to mereological universalism automatically bring along a commitment to the controversial doctrine of mereological extensionalism—the view that objects with the same proper parts are identical? A recent argument suggests the answer is ‘yes’. This paper attempts a systematic response to the argument, considering nearly every available line of reply. It argues that only one approach—the mutual parts view—can yield a viable mereology where universalism does not entail extensionalism.

The aim of this paper is to bring recent work on metaphysical grounding to bear on the phenomenon of social construction. It is argued that grounding can be used to analyze social construction and that the grounding framework is helpful for articulating various claims and commitments of social constructionists, especially about social identities, e.g., gender and race. The paper also responds to a number of objections that have been leveled against the application of grounding to social construction from Elizabeth Barnes, (...) Mari Mikkola, and Jessica Wilson. (shrink)

The amount of biomedical research being conducted around the world has greatly expanded over the past 15 years, with particularly large growth occurring in low- and middle-income countries. This increased focus on understanding and responding to disease burdens around the world has brought forth a desire to help LMIC institutions enhance their own capacity to conduct scientifically and ethically sound research. In support of these goals the Johns Hopkins-Fogarty African Bioethics Training Program has, for the past six years, partnered with (...) three research institutions in Africa to support research ethics capacity. Each partnership began with a baseline evaluation of institutional research ethics environments in order to properly tailor capacity strengthening activities and help direct limited institutional resources. Through the course of these partnerships we have learned several lessons regarding the evaluation process and the framework used to complete the assessments. We believe that these lessons are generalizable and will be useful for groups conducting such assessments in the future. (shrink)