During the set-up phase of an international study of genetic influences on outcomes from sepsis, we aimed to characterise potential differences in ethics approval processes and outcomes in participating European countries. Between 2005 and 2007 of the FP6-funded international Genetics Of Sepsis and Septic Shock project, we asked national coordinators to complete a structured survey of research ethic committee approval structures and processes in their countries, and linked these data to outcomes. Survey findings were reconfirmed or modified in 2017. Eighteen (...) countries participated in the study, recruiting 2257 patients from 160 ICUs. National practices differed widely in terms of composition of RECs, procedures and duration of the ethics approval process. Eight countries used a single centralised process for approval, seven required approval by an ethics committee in each participating hospital, and three required both. Outcomes of the application process differed widely between countries because of differences in national legislation, and differed within countries because of interpretation of the ethics of conducting research in patients lacking capacity. The RECs in four countries had no lay representation. The median time from submission to final decision was 1.5 months; in nine approval was received within 1 month; six took over 6 months, and in one 24 months; had all countries been able to match the most efficient approvals processes, an additional 74 months of country or institution-level recruitment would have been available. In three countries, rejection of the application by some local RECs resulted in loss of centres; and one country rejected the application outright. The potential benefits of the single application portal offered by the European Clinical Trials Regulation will not be realised without harmonisation of research ethics committee practices as well as national legislation. (shrink)

In this paper we discuss the epistemological positions of evolution theories. A sharp distinction is made between the theory that species evolved from common ancestors along specified lines of descent (here called the theory of common descent), and the theories intended as causal explanations of evolution (e.g. Lamarck's and Darwin's theory). The theory of common descent permits a large number of predictions of new results that would be improbable without evolution. For instance, (a) phylogenetic trees have been validated now; (b) (...) the observed order in fossils of new species discovered since Darwin's time could be predicted from the theory of common descent; (c) owing to the theory of common descent, the degrees of similarity and difference in newly discovered properties of more or less related species could be predicted. Such observations can be regarded as attempts to falsify the theory of common descent. We conclude that the theory of common descent is an easily-falsifiable & often-tested & still-not-falsified theory, which is the strongest predicate a theory in an empirical science can obtain. Theories intended as causal explanations of evolution can be falsified essentially, and Lamarck's theory has been falsified actually. Several elements of Darwin's theory have been modified or falsified: new versions of a theory of evolution by natural selection are now the leading scientific theories on evolution. We have argued that the theory of common descent and Darwinism are ordinary, falsifiable scientific theories. (shrink)

Bioethicists have long been concerned that seriously ill patients entering early phase (‘phase I’) treatment trials are motivated by therapeutic benefit even though the likelihood of benefit is low. In spite of these concerns, consent forms for phase I studies involving seriously ill patients generally employ indeterminate benefit statements rather than unambiguous statements of unlikely benefit. This seeming mismatch between attitudes and actions suggests a need to better understand research ethics committee members’ attitudes toward communication of potential benefits and risks (...) of early phase studies to potential subjects. We surveyed the members of two U.S. research ethics committees using a phase I gene transfer study scenario, and compared the results to a previous survey of potential subjects’ perceptions and attitudes toward benefit and risk for the same protocol. The results show that there is indeed a gap between the subjects’ perceptions and the committee members’ views on what is appropriate to be communicated to research subjects. This discrepancy is the product of both the commonly assumed optimism of the subjects and to a “protective pessimism” of the research ethics committee members. We discuss this discrepancy using “frameworks of trust” and demonstrate the need to incorporate these frameworks into the existing model of informed consent. (shrink)

We study 944 shareholder proposals submitted to 343 U.S. firms on climate change issues during 2009–2022. We use logistic and two-stage regression to estimate the propensity for a firm to be targeted or subjected to a vote at the annual general meeting and, for voted proposals, the determinants of that vote. We also examine whether climate-related proposals affect investor returns and how they relate to firms’ future environmental performance and greenhouse gas emissions. Compared to a matched sample, we first find (...) that activists target larger, more carbon-intensive, and less R&D-active firms. Second, voting likelihood is higher for firms with repeated and operations-related proposals and lower pre-proposal environmental ratings. By contrast, disclosure-related proposals are likelier to be negotiated and withdrawn. Third, repeated and operations-related proposals receive higher votes in favor, whereas votes on carbon-intensive firms do not. Fourth, building on the theory that investors act as if they distinguish among the different shareholder proposals based on the expected cost to the firm, we find evidence to support this idea. We find that investors respond negatively to ex-ante costlier proposals, such as those that relate to emissions reduction and target carbon-intensive firms. Fifth, targets’ future environmental performance rating is almost twenty percent higher after a proposal than before compared to the matched sample, whereas emissions do not budge appreciably. (shrink)

There is a growing body of literature on the research ethics review process, a process that can have important effects on the nature of research in contemporary times. Yet, many people know little about what the actual process entails once an application has been submitted for review. This lack of knowledge can affect researchers and committee members' responses to the review process. Based on ethnographic research on the ethics review process in 5 countries (Australia, Canada, New Zealand, the United States, (...) and the United Kingdom) this article takes the reader through common aspects of the research ethics review process, including some of the kinds of narratives that influence decision making. Greater understanding of the nature of the review process and the narratives that often form the core of the process can help contextualize responses that researchers get from committees so they can better address them. It may also help committee members reflect on how these narratives influence their decision making and the responses they make to researchers. (shrink)

Recovering Reason: Essays in Honor of Thomas L. Pangle is a collection of essays composed by students and friends of Thomas L. Pangle to honor his seminal work and outstanding guidance in the study of political philosophy. These essays examine both Socrates' and modern political philosophers' attempts to answer the question of the right life for human beings, as those attempts are introduced and elaborated in the work of thinkers from Homer and Thucydides to Nietzsche and Charles Taylor.

This paper examines the strengths and weaknesses of one of science's most pervasive and flexible metaprinciples;optimalityis used to explain utility maximization in economics, least effort principles in physics, entropy in chemistry, and survival of the fittest in biology. Fermat's principle of least time involves both teleological and causal considerations, two distinct modes of explanation resting on poorly understood psychological primitives. The rationality heuristic in economics provides an example from social science of the potential biases arising from the extreme flexibility of (...) optimality considerations, including selective search for confirming vidence, ex post rationalization, and the confusion of prediction with explanation. Commentators are asked to reflect on the extent to which optimality is an organizing principle of nature, a set of relatively unconnected techniques of science, a normative principle for rational choice and social organization, a metaphysical way of looking at the world, or something else still. (shrink)

Book reviewed in this article: Bioethics and Secular Humanism: The Search for a Common Morality. By H. Tristram Engelhardt, Jr.

The U.S. Food and Drug Administration's rationale for supporting the development and approval of BiDil for heart failure specifically in black patients was based on under-powered, post hoc subgroup analyses of two relatively old trials , which were further complicated by substantial covariate imbalances between racial groups. Indeed, the only statistically significant difference observed between black and white patients was found without any adjustment for potential confounders in samples that were unlikely to have been adequately randomized. Meanwhile, because the accepted (...) baseline therapy for heart failure has substantially improved since these trials took place, their results cannot be combined with data from the more recent trial amongst black patients alone. There is therefore little scientific evidence to support the approval of BiDil only for use in black patients, and the FDA's rationale fails to consider the ethical consequences of recognizing racial categories as valid markers of innate biological difference, and permitting the development of group-specific therapies that are subject to commercial incentives rather than scientific evidence or therapeutic imperatives. This paper reviews the limitations in the scientific evidence used to support the approval of BiDil only for use in black patients; calls for further analysis of the V-HeFT I and II data which might clarify whether responses to H-I vary by race; and evaluates the consequences of commercial incentives to develop racialized medicines. We recommend that the FDA revise the procedures they use to examine applications for race-based therapies to ensure that these are based on robust scientific claims and do not undermine the aims of the 1992 Revitalization Act. (shrink)

Charles-Louis de Secondat, baron de La Brède et de Montesquieu, mentions Niccolò Machiavelli by name in his extant works just a handful of times. That, however, he read him carefully and thoroughly time and again there can be no doubt, and it is also clear that he couches his argument both in his Considerations on the Causes of the Greatness of the Romans and their Decline and in his Spirit of Laws as an appropriation and critique of the work of (...) the predecessor whom he termed ‘this great man’. In this paper I explore the manner in which the Frenchman redeployed the arguments advanced by the Florentine for the purpose of refuting the latter's conclusions. ☆ In citing Machiavelli, I employ N. Machiavelli, Tutte le opere, ed. M. Martelli (Florence, 1971), and I refer to the divisions within each work provided by the author. To make my references to Machiavelli's Discorsi sopra la prima deca di Tito Livio more precise, I sometimes also employ the paragraph enumeration added by the editors of N. Machiavelli, Discourses on Livy, tr. H. C. Mansfield and N. Tarcov (Chicago, 1996). In citing Montesquieu, wherever possible, I have employed the splendid new critical edition being produced by the Société Montesquieu: Charles-Louis de Secondat, baron de La Brède et de Montesquieu, Œuvres complètes de Montesquieu, ed. J. Ehrard, C. Volpilhac-Auger, et al., 22 vols. (Oxford, 1998-), which I cite as VF. I cite Montesquieu, Considérations sur les causes de la grandeur des Romains et de leur décadence (1734), ed. F. Weil and C. Courtney, as CR by chapter and, where appropriate, line from VF, ii, 89–285. I cite Montesquieu, De l’Esprit des lois (1757), as EL by part, book, chapter, and, where appropriate, page from Montesquieu, Œuvres complètes de Montesquieu, ed. R. Caillois, 2 vols. (Paris, 1949–51), ii, 225–995, and Charles-Louis de Secondat, baron de La Brède et de Montesquieu, Mes pensées as MP by number from Montesquieu, Œuvres complètes de Montesquieu, ed. A. Masson, 3 vols. (Paris, 1950–5), ii, 1–677. (shrink)

In a recent discussion about how scientific knowledge might potentially change our understanding of the nature and extent of human genetic, cultural, or biological variation, the sociologist David Skinner identified two competing visions of the future: one that was decidedly dystopian, which conjured up a “re-racialized” future, and an opposing utopian future in which the potential for racialized thinking might be finally overcome. We can situate the ongoing debates about the congestive heart failure drug BiDil, approved by the Food and (...) Drug Administration for use only by African Americans, in relation to these differing future prospects.When the FDA announced its approval of BiDil in June 2005, it located the drug, and perhaps the future of pharmaceutical development, within a particular vision of the future, heralding BiDil as “representing a step toward the promise of personalized medicine.” The discourse of “personalized medicine” can be characterized as part of a utopian future, one in which clinicians will be able to make increasingly individualized decisions based on each patient’s genetic makeup so that the drugs they take will be those that work best for them. (shrink)

The ongoing debate about the FDA approval of BiDil in 2005 demonstrates how the first racially/ethnically licensed drug is entangled in both Utopian and dystopian future visions about the continued saliency of race/ethnicity in science and medicine. Drawing on the sociology of expectations, this paper analyzes how scientists in the field of pharmacogenetics are constructing certain visions of the future with respect to the use of social categories of race/ethnicity and the impact of high-throughput genotyping technologies that promise to transform (...) scientific practices. (shrink)

While executive functions and self-regulated learning strategy use have been found to be related in several populations, this relationship has not been studied in adult online distance education. This is surprising as self-regulation, and thus using such strategies, is very important here. In this setting, we studied the relation between basic executive functions and reported SRL-strategy use within a correlational design with 889 adult online distance students. In this study, we performed regression analyses and took age and processing speed into (...) consideration, as processing speed and EFs decrease with age, whereas self-regulation is reported to increase with age. Cognitively measured working memory was not related to reported SRL-strategy use in adult ODE students. Thus, even though the SRL-components within the strategies seem to elicit working memory, reported SRL-strategy use is not related to the functioning of this basic EF. This means that if SRL-strategy use needs to be increased in adult ODE students, training of working memory might not be an effective manner for achieving that goal. Better shifting and processing speed were related to less reported SRL-strategy use, which might suggest that SRL-strategies might be used to compensate for lower shifting and lower processing speed. With increasing age, the number of contacts with peers or teachers decreases. This latter finding might be of relevance during the pandemic since contacts with others is importance during lockdown. (shrink)

The last‐half of seventeenth‐century England witnessed an increasing number of works published questioning the traditional notions of God's work of creation and providence. Ascribing agency to matter, motion, chance, and fortune, thinkers ranging from Hobbes, Spinoza, modern‐Epicureans, and other presented a challenge to the Anglican defenders of social and ecclesiastical order. By examining the genesis of the Boyle Lectures that began in 1692 with a bequest from Robert Boyle, we can see that while the Lecturers—three of whom will be examined (...) in detail (Richard Bentley, John Harris, and William Whiston)—assiduously defended classical notions of the God–world relationship, they did so without a great sense of panic or pessimism. This transitional period in the mode of conflict or concord between religion and science sheds interesting lights on matters such as argument from design, biogenesis without purposive, personal agents, and scriptural exegesis and scientific inquiries. (shrink)

This chapter contains sections titled: References Further Reading.

How should we assess the appeal of multiple scientific theories when they can all explain a particular empirical phenomenon of interest? We contrast Huygens' and Fermat's explanations of the law of refraction of light and find that neither dominates the other when considering multiple criteria for assessing the overall appeal of a scientific theory. The absence of teleology in Huygens' account is a strong plus compared to Fermat's. But Huygens' wave theory scores less well with respect to other desiderata for (...) a scientific theory. In this case, there does not appear to be a clear winner, nor need there be one. (shrink)

The seventh of the triennial Symposia Aristotelica was devoted to studies of Aristotle’s two major psychological treatises, the De anima and the Parva naturalia. All of the papers at that conference are presented here in revised form. In addition, the four papers not originally presented in either English or French have been translated into English for this volume. Perhaps the best way to present an initial sense of the range of topics is to list the table of contents: S. Mansion, (...) "Soul and Life in the De anima"; Charles Lefèvre, "Sur le statut de l'ame dans le De anima et les Parva naturalia"; Andreas Graeser, "On Aristotle’s Framework of Sensibilia"; M. Schofield, "Aristotle on the Imagination"; Enrico Berti, "The Intellection of Indivisibles According to Aristotle De anima 3.6"; David J. Furley, "Self Movers"; J. B. Skemp, "ὀρέξις in De anima 3.10"; G. Verbecke "Doctrine du pneuma et entelechisme chez Aristote"; G. E. R. Lloyd, "The Empirical Basis of the Physiology of the Parva naturalia"; Jurgen Wiesner, "The Unity of the De somno and the Physiological Explanation of Sleep in Aristotle"; and Paul Moraux, "Le De anima dans le tradition grecque: Quelques aspects de l'interpretation du traité, de Theophraste a [[sic]] Themistius." The work concludes with an index of sources, an index of technical terms, and an index of persons and subjects. (shrink)

While the dominant approaches to the current study of political philosophy are various, with some friendlier to religious belief than others, almost all place constraints on the philosophic and political role of revelation. Mainstream secular political theorists do not entirely disregard religion. But to the extent that they pay attention, their treatment of religious belief is seen more as a political or philosophic problem to be addressed rather than as a positive body of thought from which we might derive important (...) insights about the nature of politics and the truth of the human condition. In a one-of-a-kind collection, DeHart and Holloway bring together leading scholars from various fields, including political science, philosophy, and theology, to challenge the prevailing orthodoxy and to demonstrate the role that religion can and does play in political life. Contributing authors include such important thinkers as Peter Augustine Lawler, Robert C. Koons, J. Budziszewski, Francis J. Beckwith, and James Stoner. (shrink)