Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four (...) major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs. (shrink)

Background Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. Methods We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Results Our (...) review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. Conclusion The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs. (shrink)

1. Implicature: some basic oppositions IMPLICATURE is a component of speaker meaning that constitutes an aspect of what is meant in a speaker’s utterance without being part of what is said. What a speaker intends to communicate is characteristically far richer than what she directly expresses; linguistic meaning radically underdetermines the message conveyed and understood. Speaker S tacitly exploits pragmatic principles to bridge this gap and counts on hearer H to invoke the same principles for the purposes of utterance interpretation. (...) The contrast between the said and the meant, and derivatively between the said and the implicated (the meant-but-unsaid), dates back to the fourth century rhetoricians Servius and Donatus, who characterized litotes—the figure of pragmatic understatement—as a figure in which we say less but mean more (“minus dicimus et plus significamus”; see Hoffmann 1987 and Horn 1991a for discussion). In the classical Gricean model, the bridge from what is said (the literal content of the uttered sentence, computed directly from its grammatical structure with the reference of indexicals resolved) to what is communicated is constructed through implicature. As an aspect of speaker meaning, implicatures are by definition distinct from the non-logical inferences that the hearer draws; it is a category mistake to attribute implicatures either to hearers or to sentences (e.g. P and Q) and subsentential expressions (e.g. some). But we can systematically (at least for generalized implicatures; see below) correlate the speaker’s intention to implicate q (in uttering p in context C), the expression p that carries the implicature in C, and the inference of q induced by the speaker’s utterance of p in C. (shrink)

In order to graduate, Florida's high school students by law must learn that Communism is evil, dangerous, and fallacious. All students must learn that the U.S. produces the highest standard of living and more freedom than any other economic system on earth. State universities in Florida are creating a curriculum to implement the Americanism versus Communism Act of 1961 and the Free Enterprise and Consumer Education Act of 1975. ;The Florida Department of Education says that ideology, noncritical thinking, is superior (...) to critical thinking and that the superiority of the U.S. political economy and the dignity of the individual rest in part on peoples' being able to express themselves freely. ;Florida's A.V.C. and F.E.C.E.A. proponents have a special way of convincing audiences that they will develop loyalty while at the same time imposing a set of ideas not open to question. ;This work argues that, intentionally or not, Florida's legislature and Department of Education have set up an official ideology and the mechanism to purvey it. This ideological approach defeats the aim of comparing systems objectively. While the stated aim is to promote critical thinking, the D.O.E.'s special philosophy underscoring words like "democracy" results in indoctrinating students with a questionable description of the U.S. system. (shrink)

Vor dem Hintergrund der aktuellen Frage nach einer angemessenen Einladungspolitik für akademische Veranstaltungen wird zunächst betont, dass das Recht auf freie Meinungsäußerung zum absoluten Kern jeder liberalen politischen Ordnung gehört. Seine Wahrnehmung unterliegt jedoch zugleich klaren Bedingungen und weist Legitimitätsgrenzen auf. Im vorliegenden Artikel werden fünf solche Bedingungen genereller Art formuliert, nämlich ein a) Moralitätskriterium, b) ein Reziprozitätskriterium, c) ein Legalitätskriterium, d) ein republikanisches Gemeinwohlkriterium und e) ein Relevanzkriterium. Es folgen weitere sechs Kriterien für die Limitierung des wissenschaftstypischen Gebrauchs von (...) Meinungsfreiheit: f) das Sozialisationskriterium, g) das Expertisekriterium, h) das Einschlägigkeitskriterium, i) das Methodenkriterium, j) das Qualitätskriterium und k) das Objektivitätskriterium. Illiberale Positionen werden sodann als solche definiert, die das Prinzip des Vorrangs der Grundfreiheiten nicht anerkennen. Schließlich stelle ich Überlegungen zum Toleranzbegriff mit dem Ergebnis an, dass gegenüber illiberalen Positionen Toleranz in der Regel nicht angemessen ist. (shrink)

The quantitative problem of old evidence is the problem of how to measure the degree to which e confirms h for agent A at time t when A regards e as justified at t. Existing attempts to solve this problem have applied the e-difference approach, which compares A's probability for h at t with what probability A would assign h if A did not regard e as justified at t. The quantitative problem has been widely regarded as unsolvable primarily on (...) the grounds that the e-difference approach suffers from intractable problems. Various philosophers have proposed that 'Bayesianism' should be rejected as a research strategy in confirmation theory in part because of the unsolvability of this problem. I develop a version of the e-difference approach which overcomes these problems and possesses various advantages (but also certain limitations). I develop an alternative 'theistic' approach which handles many cases that my development of the e-difference approach does not handle. I conclude with an assessment of the significance of the quantitative problem for Bayesianism and argue that this problem is misunderstood in so far as it is regarded as unsolvable, and in so far as it is regarded as a problem only for Bayesians. (shrink)

In this paper, the class of Fidel-structures for the paraconsistent logic mbC is studied from the point of view of Model Theory and Category Theory. The basic point is that Fidel-structures for mbC can be seen as first-order structures over the signature of Boolean algebras expanded by two binary predicate symbols N and O satisfying certain Horn sentences. This perspective allows us to consider notions and results from Model Theory in order to analyze the class of mbC-structures. Thus, substructures, union (...) of chains, direct products, direct limits, congruences and quotient structures can be analyzed under this perspective. In particular, a Birkhoff-like representation theorem for mbC-structures as subdirect products in terms of subdirectly irreducible mbC-structures is obtained by adapting a general result for first-order structures due to Caicedo. Moreover, a characterization of all the subdirectly irreducible mbC-structures is also given. An alternative decomposition theorem is obtained by using the notions of weak substructure and weak isomorphism considered by Fidel for \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}$$C_n$$\end{document}-structures. (shrink)

The December 2008 White Paper (WP) on “Brain Death” published by the President’s Council on Bioethics (PCBE) reaffirmed its support for the traditional neurological criteria for human death. It spends considerable time explaining and critiquing what it takes to be the most challenging recent argument opposing the neurological criteria formulated by D. Alan Shewmon, a leading critic of the “whole brain death” standard. The purpose of this essay is to evaluate and critique the PCBE’s argument. The essay begins with a (...) brief background on the history of the neurological criteria in the United States and on the preparation of the 2008 WP. After introducing the WP’s contents, the essay sets forth Shewmon’s challenge to the traditional neurological criteria and the PCBE’s reply to Shewmon. The essay concludes by critiquing the WP’s novel justification for reaffirming the traditional conclusion, a justification the essay finds wanting. (shrink)

At the intersection of meta-ethics and philosophy of science, Nicholas Sturgeon’s “Moral Explanation” ([1985] 1988), Richard Boyd’s “How to be a Moral Realist” (1988), and David Brink’s Moral Realism and the Foundations of Ethics (1989) inaugurated a sustained argument for the claim that moral kinds like right action and virtuous agent are scientifically investigable natural kinds. The corresponding position is called “non-reductive ethical naturalism,” or “NEN.” Ethical nonnaturalists, by contrast, argue that moral kinds are genuine and objective, but not natural. (...) This dissertation is largely a challenge to non-reductive ethical naturalism from the viewpoint of ethical nonnaturalism. An introduction, four fairly independent chapters, and a conclusion comprise this dissertation. The introduction (chapter one) situates and summarizes the arguments in the four chapters that immediately follow, and the concluding chapter (chapter six) describes future work related to the arguments in this dissertation. I now turn to chapters two through five. In chapter two, I shore up what I believe are weakness in Derek Parfit’s Triviality Objection to reductive ethical naturalism and then present a challenge to the NEN theorist, which, I argue, the NEN theorist must but ultimately cannot meet. The challenge is to sketch an empirical experiment whereby we can adjudicate between competing moral hypotheses. I explain in terms of experimental design and evaluation why the challenge cannot be met. Chapters three and four focus on the semantics and reference relations of kind terms. In chapter three, I defend the Causal Externalist (CE) theory of semantics and reference against an objection distilled from two articles by Åsa Marie Wikforss. The objection is that CE implies a paradox, escape from which forces the CE theorist upon the horns of a dilemma. I show how the CE theorist can avoid the dilemma by allowing that the intensions of some artificial-kind terms (e.g., ‘jade’) are not given by descriptions associated with the terms. One consequence of this move, however, is that it casts doubt upon the coherence of the claim that moral-kind terms (e.g., ‘morally required action’) are natural-kind terms. In chapter four, I defend Terence Horgan and Mark Timmons’s Moral-Twin Earth argument from three critical responses put forward in recent paper by David Merli. NEN theorists claim that CE can account for the semantics and reference of moral-kind terms. As per Horgan and Timmons (H&T), however, our responses to the Moral-Twin Earth thought experiment give us reason to doubt the NEN theorists’ claim. Against H&T’s argument, however, Merli presents three independent, critical responses, and in this chapter I defend H&T’s argument in a way that is friendly to the ethical nonnaturalist. One upshot is, I contend, that the ethical nonnaturalist can and indeed should co-opt H&T’s argument for his own use. In chapter five, I return to kinds themselves, specifically those in biology. I first point out that ethical nonnaturalism appeals to a metaphysical thesis about nonnatural value, which need not be limited to the moral domain. Then, I argue that biological naturalism alone cannot give a satisfying realist account of biological kinds like HEART and NEURON. Finally, I show that by conjoining the concept of Cummins functions as recently defended by Paul Davies, a thesis about nonnatural value, and Ned Block’s Disney Principle regarding structural properties, the nonnaturalist, unlike the naturalist, can offer a satisfying realist account of biological kinds. (shrink)

A new realislic local model of light propagation and detection is described. The authors propose a novel stochastic model of low-intensity photon detection in which background noise is added to a part of the photon prior to absorption. In this model, in agreement with Planck, there is no quantization of the propagating field. The model has some similarities to theories advanced by E. Santos and T. Marshall in the last decade, but also has substantial deviations from these. A mechanism, conserving (...) energy and momentum, is proposed by which a sudden collapse of the wave-packet is avoided. The experimental Bell inequality violation of Aspect. Grangier and Roger [Phys. Rev. Lett.47, 460 (1981)]is discussed. The authors have carried out a computer simulation of a radio frequency (RF) analogue of the Einstein-Podolsky-Rosen thought experiment to illustrate how the manipulation of certain factors, especially signal to noise ratio, detector threshold and characteristics of the noise, enables the same Bell inequality to be either satisfied or violated by a realistic local model. Building on arguments by Santos. [Phys. Rev. A46. 3646 (1992)],the appropriateness of this Bell lest is discussed. Neither the authors' stochastic-optical model, nor their RF analogue, involves an enhancement assumption of the type defined by Clauser and Horne [Phys. Rev. D10, 526 (1974)]. (shrink)

In R. C. Flickinger's (3rd ed. second impression 1929) we read on pp. 171In the iambic trimeters written by Aeschylus a trisyllabic substitution (tribrach, anapaest or dactyl) for the pure disyllabic iambus occurs only once in about twenty-five verses.Tragic Drama of the Greekstrimeters’ lines like.

Most authors who work with moral status automatically dismiss the possibility that plants are the kinds of entities that have moral status. This dismissal coheres with our intuitions about common-sense morality: if plants do not have moral status then we do not have any direct moral obligations to plant life. An implication of such a view is that any suggestion otherwise commits one to be in favour of an absurd conclusion. However, given the recent literature and empirical evidence on plant (...) minds, there are reasons to accept a different perspective that finds the absurd conclusion plausible. (shrink)

It has frequently been observed that the Prometheus Vinctus shows certain Sophoclean characteristics of rhythm. In order to vary the rhythm of his iambics and to avoid monotony, Sophocles often knits consecutive trimeters closely together by placing at the end of one line some word which looks forward to the next line, and so precludes the reader from stopping for the natural pause after the sixth foot. Sometimes he uses in this way subordinating words which introduce a dependent clause in (...) the next line ; sometimes proclitics or quasi-proclitics. (shrink)

Towards the conclusion of his interesting remarks on the meaning of the Homeric phrase, τ δ' πτερος πλετο μθος, Professor J. A. K. Thomson writes, ‘When a classical author uses the word πτερος it means “wingless” or “featherless” and nothing else,’ and he accordingly rejects Headlam's interpretation of πτερος φτις at Aesch. Ag. 288 together with the same scholar's proposal to read at P. V. 707 πτερος for the unmetrical απνδιος It may be true that the phrase, πτρ τάχει, which (...) Headlam adduced in his note on the Agam. passage in support of his rendering, is not by itself convincing, but there are other considerations which Professor Thomson has, I imagine, overlooked. What follows is not an attempt to demonstrate that πτερος does mean ‘wing-swift’ in Aeschylus, but only to suggest that there is evidence to show that the word could bear that meaning in classical Greek authors, and that Headlam's interpretation and emendation should therefore not be rejected out of hand. (shrink)