The target articles by blumberg et al. and berkley reflect some of the recent major theoretical and clinical advances in two areas of pain research. These two articles also represent two very different approaches to which type of variables are considered relevant to the study of pain. These different approaches are contrasted in the context of the different emphases in pain and pleasure research.

Despite more than a century of research on sexual dysfunction, there has been limited attention to ethical concerns. This is problematic because sex research involves complex ethical questions that generate confusion for ethics review and have not been addressed by ethical guidelines. We analyze two questions. First, does sexual content raise the risk profile of a research protocol? We argue that there is nothing inherent in sexual content that makes a study high risk and that many sexual dysfunction studies involve (...) no more than minimal risk. Second, we ask whether research interventions that involve seeing participants undressed or having physical contact with a research subject are permissible? We argue that these interventions raise an important ethical challenge—they often involve sexual dysfunction researchers engaging in interventions that would not be conducted in their standard practice. To resolve this, we propose an expertise-based account of the permissibility of sexual dysfunction research. (shrink)

To protect children in research, procedures that are not administered in the medical interests of a child must be restricted. The risk threshold for these procedures is generally measured according to the concept of minimal risk. Minimal risk is often defined according to the risks of “daily life.” But it is not clear whose daily life should serve as the baseline; that is, it is not clear to whom minimal risk should refer. Commentators in research ethics often argue that “minimal (...) risk” should refer to healthy children or the subjects of the research. I argue that neither of these interpretations is successful. I propose a new interpretation in which minimal risk refers to children who are not unduly burdened by their daily lives. I argue that children are not unduly burdened when they fare well, and I defend a substantive goods account of children’s welfare. (shrink)

Ethics guidelines and commentary suggest that a central function of research ethics committees is to assess the scientific merit of the protocols they review. However, some commentators object to this role, and evidence suggests that the assessment of scientific merit is a significant source of confusion and animosity between ethics committees and clinical investigators. In this essay, we argue that ethics committees should assess the scientific value and validity of research protocols and that new decision-making tools are needed to help (...) them do so in a systematic, transparent, and reliable way. We present a novel ethical framework that can assist in this task. (shrink)

Minimal risk is a central concept in the ethical analysis of research with children. It is defined as the risks “. . . ordinarily encountered in daily life . . . .” But the question arises: who is the referent for minimal risk? Commentators in the research ethics literature often answer this question by endorsing one of two possible interpretations: the uniform interpretation or the relative interpretation of minimal risk. We argue that describing the debate over minimal risk as a (...) disagreement between the uniform and the relative interpretation impedes progress on the identification of a justifiable referent for minimal risk. There are two main problems with this approach: constructing the debate over minimal risk as a disagreement between a uniform and a relative interpretation misconstrues the main difference between competing interpretations and neither the uniform nor the relative interpretation identifies one unique and consistent group of children as the referent for minimal risk. We conclude that progress on the debate over minimal risk requires that we abandon the uniform and relative interpretations and address the main moral problem at stake: whether healthy children or the subjects of the research should be the referent for minimal risk. (shrink)

Controlled human infection model (CHIM) studies involve the intentional exposure of healthy research volunteers to infectious agents. These studies contribute to knowledge about the cause or development of disease and to the advancement of vaccine research. But they also raise ethical questions about the kinds of risks that should be permissible and whether limits should be imposed on research risks in CHIM studies. Two possible risk thresholds have been considered for CHIM studies. The first suggests constraining ethically permissible risks according (...) to a minimal risk threshold and the second endorses a higher risk threshold that excludes irreversible or fatal infections. I argue that neither of these thresholds is persuasive and situate questions about risk thresholds in CHIM studies within a broader debate about permissible risks in research. I argue that risks in CHIM studies should be constrained according to limits on research risks that do not offer corresponding benefits in all studies rather than developing a unique risk threshold for CHIM studies. I then propose five recommendations for the ethical assessment of risk in CHIM studies. (shrink)

Most agree that clinical research offers one of the best prospects of improving pediatric medicine. Most also agree that children may be exposed to some degree of risk while participating in clinical trials. But the degree of risk that should be permitted and the reasons for which it should be permitted remain controversial. In this paper, I examine a central risk threshold in research with children—the threshold constraining risks that do not offer research subjects the prospect of direct medical benefit. (...) That is, the threshold for research risks undertaken in the interests of deriving valuable knowledge that may benefit future children, but not the research subjects themselves. I examine competing... (shrink)

The inclusion of children in research gives rise to a difficult ethical question: What justifies children's research participation and exposure to research risks when they cannot provide informed consent? This question arises out of the tension between the moral requirement to obtain a subject's informed consent for research participation, on the one hand, and the limited capacity of most children to provide informed consent, on the other. Most agree that children's participation in clinical research can be justified. But the ethical (...) justification for exposing children to research risks in the absence of consent remains unclear. One prevalent group of arguments aims to justify children's risk exposure by appealing to the concept of benefit. I call these ‘benefit arguments’. Prominent versions of this argument defend the idea that broadening our understanding of the notion of benefit to include non-medical benefits helps to justify children's research participation. I argue that existing benefit arguments are not persuasive and raise problems with the strategy of appealing to broader notions of benefit to justify children's exposure to research risk. (shrink)

Iris Marion Young, On female body experience: “Throwing like a girl” and other essays, New York: Oxford University Press, 2005, reviewed by Ariella Binik.

Ethics has been identified as a central reason for choosing the stepped wedge trial over other kinds of trial designs. The potential advantage of the stepped wedge design is that it provides all arms of the trial with the active intervention over the course of the study. Some groups receive it later than others, but the study intervention is not withheld from any group. This feature of the stepped wedge design seems particularly ethically advantageous in two instances: when the study (...) intervention appears especially likely to be effective and when the consequences of not receiving the intervention may be dire. But despite an increase in the use of the stepped wedge design and appeals to its ethical superiority as the motivation for its selection, there has been limited attention to the stepped wedge trial in the ethics literature. In the following, I examine whether there are persuasive ethical reasons to prefer or to require a stepped wedge trial. I argue that while the stepped wedge design is ethically permissible, it is not morally superior to other kinds of trials. To this end, I examine the ethical justification for providing, withholding, and delaying interventions in research. (shrink)

The American Journal of Bioethics, Volume 11, Issue 6, Page 25-27, June 2011.

This thesis is a contribution to the ethical justification for clinical research with children. A research subject’s participation in a trial is usually justified, in part, by informed consent. Informed consent helps to uphold the moral principle of respect for persons. But children’s limited ability to make informed choices gives rise to a problem. It is unclear what, if anything, justifies their participation in research. Some research ethicists propose to resolve this problem by appealing to social utility, proxy consent, arguments (...) explaining why it is permissible to expose children to some harm, and an argument concerning the appropriate balance between research harms and benefits. I argue that each of these is a necessary part of the justification for research with children, but that the argument concerning harms and benefits is under-developed. It relies on the concept of minimal risk, but minimal risk is inadequately justified. I propose an interpretation of minimal risk. I defend the idea that minimal risk should be interpreted according to the risks of daily life. I reject the most prominent defense of daily life, which claims that daily risks are morally relevant because they replace, rather than add to, the risks a child would ordinarily face. Instead, I propose that these risks are part of a reasonable trade-off between personal safety and our ability to pursue meaningful lives. I then examine whose daily life should be captured in the concept of minimal risk. I reject arguments that minimal risk should refer to healthy children or the subjects of the research and propose instead that the referent should be children who are not unduly burdened by their lives. I argue that children are not unduly burdened when they fare well and defend the idea that children fare well when they possess sufficiently high degrees of the substantive goods of childhood. I conclude by analyzing a controversial case study using my interpretation of minimal risk. I draw on this case to argue that my interpretation offers clear guidance for research ethics review and contributes to a determination that is more plausible than its rivals. (shrink)

One of the central problems concerning research with children is the delineation of appropriate levels of risk exposure. In the U.S. Code of Federal Regulations, the "minimal risk" concept serves as an anchoring measure for allowable risk. While the regulations sought to promote a balance between scientific advances and the protection of children's vulnerable status, ambiguities in the language of the regulations and the regulatory definition of "minimal risk" have given rise to a great deal of confusion. Research ethics boards (...) and the medical community espouse a multitude of varying opinions regarding the interpretation and application of the federal regulations with more recent research demonstrating an apparent increase in risk without corresponding benefit in pediatric research. Informed by ethical theory, law, and science, this project analyzes the apparent increase in allowable risk, calls for a reassessment of the concept of "minimal risk," and recommends modifications to the federal regulations. (shrink)

Human challenge studies, in which human research subjects are intentionally exposed to pathogens to contribute to scientific knowledge, raise many ethical complexities. One controversial question is whether it is ethically permissible to include children as participants. Commentary of the past decades endorses the exclusion of children, while new guidance suggests that pediatric human challenge studies can be ethically permissible. This paper argues that neither children's exclusion nor their inclusion are well justified. I examine and reject three arguments for exclusion, but (...) suggest that these arguments establish pediatric human challenge studies as a complex ethical category of research that requires caution. I then argue for a strong presumption against children's inclusion, by drawing on an analogy to children's inclusion in phase I trials, emphasizing a requirement of necessity, and suggesting that accommodating children's vulnerability promotes an age de-escalation approach for pediatric human challenge studies research. In the final section, I suggest a procedure for ethics review. (shrink)

COVID-19 poses an exceptional threat to global public health and well-being. Recognition of the need to develop effective vaccines at unprecedented speed has led to calls to accelerate research pathways ethically, including by conducting challenge studies ) with SARS-CoV-2. Such research is controversial, with concerns being raised about the social, legal, ethical and clinical implications of infecting healthy volunteers with SARS-CoV-2 for research purposes. Systematic risk evaluations are critical to inform assessments of the ethics of any proposed SARS-CoV-2 CHIs. Such (...) evaluations will necessarily take place within a rapidly changing and at times contested epidemiological landscape, in which differing criteria for the ethical acceptability of research risks have been proposed. This paper critically reviews two such criteria and evaluates whether the use of effective treatment should be a necessary condition for the ethical acceptability of SARS-CoV-2 CHIs, and whether the choice of study sites should be influenced by COVID-19 incidence levels. The paper concludes that ethical evaluations of proposed SARS-CoV-2 CHIs should be informed by rigorous, consultative and holistic approaches to systematic risk assessment. (shrink)

Claims for improving migrants’ access to care often draw on universalistic ethical notions, such as the principle of equity as it is specified in human rights law and public health ethics. These claims contrast with political realities across most welfare states. In the underlying public discourses, the frontline arguments against greater inclusion have often focused on practical concerns, such as the costs of healthcare provision. Yet it has also been suggested that ultimately context‐specific moral frameworks play a key role in (...) demarcating legitimate right‐holders from undeserving others. Hence, is this a conflict between ethical principles and practical concerns? Or between different ethical perspectives? And why would that question matter? We propose that awareness of the nature of the arguments involved and respect for different ethical views are critical for coherent and constructive debates. This paper looks at the ways in which ethical concepts are used to justify exclusionary policy decisions. In particular, it examines the rationales that inform health policies towards documented and undocumented labor migrants in two welfare states, Germany and Israel, through the qualitative analysis of policy documents and 71 in‐depth interviews. The study points to the central role of particular concepts of health‐related deservingness. These results lead to the proposition that the fundamental clash in the discussion on migrants’ access to care is one, albeit not solely, between contrasting ethical perspectives. Drawing on process‐oriented approaches to ethical decision‐making, the paper concludes with three suggestions for moving forward with the migrant health rights debate. (shrink)

Infants are unable to make their own decisions or express their own wishes about medical procedures and treatments. They rely on surrogates to make decisions for them. Who should be the decision-maker when an infant’s biological parents are also minors? In this paper, we analyse a case in which the biological mother is a child. The central questions raised by the case are whether minor parents should make medical decisions on behalf of an infant, and if so, what are the (...) limits to this decision-making authority? In particular, can they refuse treatment that might be considered best for the infant? We examine different ethical arguments to underpin parental decision-making authority; we argue that provided that minor parents are capable of fulfilling their parental duties, they should have a right to make medical decisions for their infant. We then examine the ethical limits to minor parents’ decision-making authority for their children. We argue that the restricted authority that teenagers are granted to make medical decisions for themselves looks very similar to the restricted autonomy of all parents. That is, they are permitted to make choices, but not harmful choices. Like all parents, minor parents must not abuse or neglect their children and must also promote their welfare. They have a moral right to make medical decisions for their infants within the same ‘zone of parental discretion’ that applies to adult parents. We conclude that adult and minor parents should have comparable decision-making authority for their infants. (shrink)

This article reviews four areas of pediatric research in which we have identified questionable levels of allowable risk, exceeding those foreseen by the Commission. They are the following: the categorization of increasingly risky interventions as minimal risk in a variety of protocols; the increasing number of applications for federal panel review of research not otherwise approvable because of higher projected risk levels; research on asymptomatic at risk children; and the inclusion of children and adolescents in placebo-controlled trials for participants of (...) all ages without performing subgroup analysis. While embracing the imperative to include children in research is an encouraging step towards providing the pediatric population with effective medical care and finally eradicating the therapeutic orphan, we must ensure that this research does not become overly permissive. (shrink)

The use of charged-particle radiation therapy is an increasingly important development in the treatment of cancer. One of the most pressing controversies about the use of this technology is whether randomised controlled trials are required before this form of treatment can be considered to be the treatment of choice for a wide range of indications. Equipoise is the key ethical concept in determining which research studies are justified. However, there is a good deal of disagreement about how this concept is (...) best understood and applied in the specific case of CPRT. This report is a position statement on these controversies that arises out of a workshop held at Wolfson College, Oxford in August 2011. The workshop brought together international leaders in the relevant fields , including proponents on both sides of the debate, in order to make significant progress on the ethical issues associated with CPRT research. This position statement provides an ethical platform for future research and should enable further work to be done in developing international coordinated programmes of research. (shrink)

Was the above-named bill, which was brought forward in 122 b.c. by the tribune M. Liuius Drusus, and provided that the Latins should under all circumstances be exempt from the penalty of scourging, duly passed by the Roman Assembly and entered upon the statute-book?

David Hume was a highly original thinker. Nevertheless, he was a writer of his time and place in the history of philosophy. In this book, M. A. Stewart puts Hume’s writing in context, particularly that of his native Scotland, but also that of British and European philosophy more generally. Through meticulous research Stewart brings to life the circumstances by means of which we can get a deeper understanding of Hume’s writings on the nature and reach of human reason, the foundation (...) of morals, and, especially, on the philosophy of religion. Stewart pays particular attention to Hume’s intellectual development, beginning with his education at the College of Edinburgh, the writing of his Treatise of Human Nature, and his subsequent philosophical responses to criticisms of that book. He argues that Hume’s scepticism set him at odds with the Christian Stoicism of Scottish contemporaries including that of Francis Hutcheson - and shows that this conflict played a major role in his failure to obtain the Edinburgh Moral Philosophy Chair in 1745. Stewart’s detailed study of the physical character of Hume’s surviving manuscripts in Chapters 8 and 9 provides the best available dating of his early ‘Essay on Modern Chivalry’, his ‘Early Fragment on Evil’ and the periods of composition of his Dialogues Concerning Natural Religion. Other chapters compare Hume’s theory of abstraction with that of Locke and Berkeley, provide the 17th and 18th century philosophical context of the central argument of his essay ‘Of miracles’, and consider the 18th and 19th century reception of his writings in England and Ireland. (shrink)

The philosophy of Max Scheler is hardly of the type that can stand compendious presentation. Obsessed by such clear distinctions as the analytic vs. the synthetic, mind vs. matter, and metaphysics vs. science, Scheler proposed still further ontological distinctions which often presented more problems than the distinctions they were designed to replace. Moreover, having renounced any diagnostic use of scientific materials, Scheler had to resort to tedious descriptions that would allow him to bridge the gap between common sense and rational (...) consistency. When the presentation of his doctrine is simply outlined, as it is in this book, the play with alternative ontological distinctions becomes conspicuously irrelevant. The rich insight so frequently hiding in descriptive detail and suggesting a myriad of fertile directions, cannot be reduced to the outline's topic headings. One wonders if any critical examination of Scheler in these terms can be fair, or even if it is worthwhile to know only that much about Scheler.--A. M. (shrink)

The body of this book consists of facing English and Latin versions of Scotus' treatise prepared by Father Wolter from study of existing manuscripts. Textual variants are marked in frequent notes, but, perhaps because he doubts that one correct or personally written version ever existed, inconsistencies in the argument or apparent errors in the text are unremarked by the editor. Included as a 30 page appendix is Wolter's translation of Scotus' commentary on Peter Lombard's work, Two Questions from Lectures on (...) Book I of the Sentences. Wolter considers this to be an early version, of which the Treatise is the definitive argument. Scotus' demonstration intends to overcome two classical problems afflicting other proofs of the existence of God: the conclusion that the universe is eternal, and that either God's omnipotence or man's moral freedom is limited by His necessary inclusion in the causal order of the world. These metaphysical difficulties are avoided through Scotus' skilled use of modal logic. The book should be of great interest to students of logic and analytic philosophy on account of the display of technique in the logic of contingency and necessity, as well as to medievalists, for reasons of its substance. Wolter performs a real service in making available this workmanlike edition of a powerful and ingenious original.—M. B. M. (shrink)

Markovic draws upon the Zagreb school of Marx-interpretation, as well as on the data of the historical development of socialism in Yugoslavia in his attempt to develop a critical social theory. He constantly opposes the use of Marxian theory as an ideological orthodoxy simply legitimating political practice. And he points out how Marxian social thought may be a means of critically comprehending social processes, as well as a self-critical theory developing in relation to the historical data at whose evaluation it (...) is directed. Markovic insists that critical social theory must take as its subject matter a range of data comprised of contemporary phenomena, the history of such phenomena, and the human evaluations and aspirations which the historical situation engenders. This points up the importance of a theory of man for a critical social theory. Only an adequate theory of man enables social theory to comprehend and evaluate the goals arising from specific social processes. Markovic outlines elements of such a theory of man, as discoverable in Marx. With these guiding ideas, he examines specific themes such as economics and human values, technology, politics as a professional institution, and revolution. Markovic’s examinations valuably illustrate a balanced Marxian approach to social questions. It is argued, for example, that technological innovations must be analyzed in relation both to the concrete economic processes of given societies, and to the human needs operative in those societies. Markovic draws upon the Yugoslav experience to show the concrete nature of such an analysis. The viability of the professional political institution is discussed, with reference to specific productive relations in societies, and the political possibilities thereof. And in the context of a distinction between political and social revolution, he writes with sensitivity and discernment on the concept of revolution in Marx. Problematically, the precise status of a theory of man in a social theory of the Marxian variety remains unanswered herein. But the work stands as highly useful to those interested in non-ideological developments of Marxian social theory.—M.J.D. (shrink)

The present book is a reprint of the great Danish historian's fundamental study. Though the immense œuvre of Grönbech spreads over a wide variety of fields—mystics of India and Europe, Blake, Goethe, Dostoyevski, Jesus and the first Christian community, Greek religion and culture, and the philosophy of language—the two volumes of the culture and religion of the Germans belong to his most important achievements. The first part treats the great "ideas" of the early Germans: peace, honor, the soul, death, and (...) immortality. The second part is devoted to the institutions which have normative value in all societies and especially in archaic ones: war, the temple, the feast, the sacrifice, the play, etc. Grönbech attempts a total synthesis which goes beyond the temporal and tribal differences of this culture, which spread from Byzantium to Greenland. The whole work is organized around the Icelandic saga, perhaps the greatest gift the early Germans gave the world. At the end the assiduous reader is rewarded by a long and fascinating "excursus" on the cultic drama.—M. J. V. (shrink)

This book is primarily a survey of commonly accepted theories of memory. In the course of the book Locke attempts to show that the traditional theories of memory, that is the Representative and the Realist theories are inadequate because of certain mistaken assumptions adopted by the advocates of these views. For example, both of these theories’ proponents mistakenly assume that remembering is an occurrence, that this occurrence consists in a mental experience in the form of having mental images, and that (...) memory-knowledge is knowledge based on or derived from the memory-experience or the memory-image. These notions are mistaken, Locke claims, because memory consists in immediate knowledge of the past, not in the immediate experience of the past; and memory is a form of knowledge, not a form of quasi-perceptual awareness. The notion that memory is a form of knowledge is considered by Locke to be the standard contemporary account of the nature of memory. It is in these terms that he analyzes the different forms of memory: factual memory, which is defined as retained factual knowledge or knowledge we have possessed before and still possess; practical memory, which is defined as retained practical knowledge or knowledge that consists in possessing certain acquired abilities and skills; and personal memory, which is defined as memory of items that one has experienced for himself. The true test of the contemporary account, as Locke sees it, is whether it allows one to answer affirmatively the question "Is memory reliable?". In the final analysis, however, this seems to be impossible. Generally speaking, one believes that he is entitled to rely on something insofar as it can be established that what is relied upon is normally an accurate guide to the facts of the matter. Nevertheless, if one can never tell when memory is correct, it cannot be established that memory is a reliable guide to anything; thus, one can never be entitled to rely on memories. One solution to this dilemma seems to lie in the suggestion that even if one cannot demonstrate that memory is reliable, this is the simplest and possibly the only plausible assumption to make to explain the plain facts of the human situation. Moreover, one who rejects this pragmatic use of the reliability of memory is committed to saying that knowledge is impossible in any case. If there is no avenue to the past, then there is no assurance that anyone or anything has a past history at all. Without a past history, one has never acquired any information nor any reason for knowing anything, not even about the present. Memory-knowledge, then, is not a matter of simple utility, rather it is a matter of what presuppositions or assumptions have to be made if knowledge is to be possible at all. In effect, Locke sees this as simply a "transcendental argument" for the reliability of memory; that is, an argument that shows that a certain principle has to be accepted as true if a certain form of inquiry is to be possible.—T. L. M. (shrink)

This posthumous and unfinished book by the author of The Revolt of the Masses is in the continental tradition of philosophy as literature. The theme of this historical and etymological essay is the justification of that tradition. Ortega's writing is graceful, and includes aphorisms intended to evoke in the reader the philosophical frame of mind, and a sense of wonder. He finds that philosophy so far has provided no system which is adequately true for us; it is dialectical, revealing the (...) past as a defunct world of errors, which are at the same time involuntary instruments of future truth.. In ancient Greece man first felt an excess of possibilities over needs, both in economics and in explanation. The consequent necessity to choose brought about the phenomenon of rationalism. The means of choosing constitutes method. Science and theology thus emerge in Greece as secondary speculations on primary poetic-mythological explanations. In chapters on Parmenides and Heraclitus, Ortega analyzes the style of each, and illustrates his views on the relation between style and the growth of philosophy. His tool here he calls "etymology," although to those trained in the Anglo-American tradition, his word-analysis is more lyrical than analytic. He concludes that Heraclitus used the oracular or sibylline formula for expressing universal wisdom, and that this in fact is philosophy's most suitable vehicle of expression.—M. B. M. (shrink)

Listening to someone from some distance in a crowded room you may experience the following phenomenon: when looking at them speak, you may both hear and see where the source of the sounds is; but when your eyes are turned elsewhere, you may no longer be able to detect exactly where the voice must be coming from. With your eyes again fixed on the speaker, and the movement of her lips a clear sense of the source of the sound will (...) return. This ‘ventriloquist’ effect reflects the ways in which visual cognition can dominate auditory perception. And this phenomenological observation is one what you can verify or disconfirm in your own case just by the slightest reflection on what it is like for you to listen to someone with or without visual contact with them. (shrink)

Our research is based on a rather large "library" of various works by M. Drahomanov, which contains his views on religion. Among them: Paradise and Progress, From the History of Relations Between Church and State in Western Europe, Faith and Public Affairs, Fight for Spiritual Power and Freedom of Conscience in the 16th - 17th Centuries,, "Church and State in the Roman Empire", "The Status and Tasks of the Science of Ancient History," "Evangelical Faith in Old England," "Populism and Popular (...) Progress in Austrian Rus, Austrian-Russian Remembrance," "Pious The Legend of the Bulgarians "," The Issues of Religious Freedom in Russia, "" On the Brotherhood of the Baptist or the Baptist in Ukraine, "" The Foreword, " Shevchenko, Ukrainianophiles and Socialism "," Wonderful thoughts about the Ukrainian national affair "," Zazdri gods "," Slavic variants of one Gospel legend "," Resurrection of Christ ", etc. (shrink)

This volume offers the first-ever complete English translation of Leibniz’s Dissertatio De Arte Combinatoria together with a critical edition of the original Latin text on fa...

Despite the promise of international collaboration and sharing by bringing together bioethicists from throughout the world at the 2024 IAB conference in Qatar, I will not be attending. The authors...