The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided to (...) largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary's Advisory Committee on Human Research Protections, and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation. (shrink)

In “Meeting the Moment: Bioethics in the Time of Black Lives Matter,” Camisha Russell calls for transforming “bioethics-as-usual” with help from “outsiders”. Prior scholars agree...

Answering important public health questions often requires collection of sensitive information about individuals. For example, our understanding of how HIV is transmitted and how to prevent it only came about with people's willingness to share information about their sexual and drug-using behaviors. Given the scientific need for sensitive, personal information, researchers have a corresponding ethical and legal obligation to maintain the confidentiality of data they collect and typically promise in consent forms to restrict access to it and not to publish (...) identifying data.The interests of others, however, can threaten researchers' promises of confidentiality when legal demands are made to access research data. In some cases, the subject of the litigation is tightly connected to the research questions, and litigants' interest in the data is not surprising. Researchers conducting studies on tobacco or occupational or other chemical exposures, for example, are relatively frequent targets of subpoenas. (shrink)

Capitalizing on the hype surrounding stem cell research, numerous clinics around the world offer “stem cell therapies” for a variety of medical conditions. Despite questions about the safety and efficacy of these interventions, anecdotal evidence suggests a relatively large number of patients are traveling to receive these unproven treatments — a practice called “stem cell tourism.” Because these unproven treatments pose risks to individual patients and to legitimate translational stem cell research, stem cell tourism has generated substantial policy concern and (...) inspired attempts to reduce these risks through the development of guidelines for patients and medical practitioners. This paper examines the roles and responsibilities of physicians in patients' home countries with respect to patients' decisions to try unproven stem cell therapies abroad. Specifically, it examines professional guidance from two organizations — the American Medical Association and the International Society for Stem Cell Research — and assesses physicians' professional and legal obligations to patients considering unproven stem cell therapies. Then, drawing on qualitative interviews conducted with patients who traveled abroad for unproven stem cell treatments, it explores the roles that physicians actually play in patients' decisions and compares these actual roles with their professional and legal responsibilities. The paper concludes with a discussion of strategies to help improve the guidance physicians provide to patients considering unproven treatments. (shrink)

Stem cell science, using both embryonic and a variety of tissue-specific stem cells, is advancing rapidly and offers promise to improve medical care in the future. Yet, with the notable exception of hematopoietic stem cell transplantation, a long-established approach to treating certain cancers of the blood system, this promise is long term and most stem cell research focuses on basic scientific questions or the collection of pre-clinical data. Although some clinical trials are underway, most are focused on safety, and novel (...) effective therapy is likely a long way off. Despite the preliminary nature of most stem cell research, however, numerous clinics around the world offer stem cell “therapies” to patients today outside the context of a clinical trial. Although the number of patients who have received these stem cell-based interventions is unknown, anecdotal reports suggest a substantial population of patients is willing to try them, despite unresolved questions about their safety and efficacy. (shrink)

Researchers now commonly collect biospecimens for genomic analysis together with information from mobile devices and electronic health records. This rich combination of data creates new opportunities for understanding and addressing important health issues, but also intensifies challenges to privacy and confidentiality. Here, we elucidate the “web” of legal protections for precision medicine research by integrating findings from qualitative interviews with structured legal research and applying them to realistic research scenarios involving various privacy threats.

Administraation of antiretroviral therapy to women during pregnancy, labor and delivery, and to infants postnatally can dramatidy reduce mother-to- child HIV transmission. However, pregnant women need to know that they are HIV-infected to take advantage of antiretroviral therapy, and many women do not know their HIV status. One-half of HIV-infected infants in the United States were bornto women who had not been tested for HIV or for whom the time of testing was not known. Although fewer than 400infants are infected (...) perinatally in the United States each year, that number could be reduced even further through policies aimed at HIV testing during pregnancy.The reasons toadopt such a policy are strong: the pathophysiology of perinatal transmission is clear, prophylaxis is effective and safe, and the intended beneficiaries of the intervention - babies - cannot protect themselves. (shrink)

Administraation of antiretroviral therapy to women during pregnancy, labor and delivery, and to infants postnatally can dramatidy reduce mother-to- child HIV transmission. However, pregnant women need to know that they are HIV-infected to take advantage of antiretroviral therapy, and many women do not know their HIV status. One-half of HIV-infected infants in the United States were bornto women who had not been tested for HIV or for whom the time of testing was not known. Although fewer than 400infants are infected (...) perinatally in the United States each year, that number could be reduced even further through policies aimed at HIV testing during pregnancy.The reasons toadopt such a policy are strong: the pathophysiology of perinatal transmission is clear, prophylaxis is effective and safe, and the intended beneficiaries of the intervention - babies - cannot protect themselves. (shrink)

American Academy of Pediatrics (AAP) and American College of Medical Genetics (ACMG) recently provided two recommendations about predictive genetic testing of children. The Clinical Sequencing Exploratory Research Consortium's Pediatrics Working Group compared these recommendations, focusing on operational and ethical issues specific to decision making for children. Content analysis of the statements addresses two issues: (1) how these recommendations characterize and analyze locus of decision making, as well as the risks and benefits of testing, and (2) whether the guidelines conflict or (...) come to different but compatible conclusions because they consider different testing scenarios. These statements differ in ethically significant ways. AAP/ACMG analyzes risks and benefits using best interests of the child and recommends that, absent ameliorative interventions available during childhood, clinicians should generally decline to order testing. Parents authorize focused tests. ACMG analyzes risks and benefits using the interests of the child and other family members and recommends that sequencing results be examined for additional variants that can lead to ameliorative interventions, regardless of age, which laboratories should report to clinicians who should contextualize the results. Parents must accept additional analysis. The ethical arguments in these statements appear to be in tension with each other. (shrink)

The pandemic creates unprecedented challenges to society and to health care systems around the world. Like all crises, these provide a unique opportunity to rethink the fundamental limiting assumptions and institutional inertia of our established systems. These inertial assumptions have obscured deeply rooted problems in health care and deflected attempts to address them. As hospitals begin to welcome all patients back, they should resist the temptation to go back to business as usual. Instead, they should retain the more deliberative, explicit, (...) and transparent ways of thinking that have informed the development of crisis standards of care. The key lesson to be learned from those exercises in rational deliberation is that justice must be the ethical foundation of all standards of care. Justice demands that hospitals take a safety‐net approach to providing services that prioritizes the most vulnerable segments of society, continue to expand telemedicine in ways that improve access without exacerbating disparities, invest in community‐based care, and fully staff hospitals and clinics on nights and weekends. (shrink)

This study examined how research conducted at several federally funded institutions designated as Clinical Research Centers or Specialized Programs of Research Excellence addressed the issues of consent, control over biological materials, confidentiality, and disclosure of results in protocols and consent forms for genetic research with stored biological materials. Although a majority of the documents reviewed addressed most of the issues raised in the research ethics literature, topics identified in the literature that were missing include the return of research results, the (...) right to withdraw from research involving biological materials, and the consent of children when they become legal adults. If typical, these findings suggest greater educational efforts may be needed to prompt investigators and IRBs to consider these and other issues that were either not addressed in the protocols or consent forms or were addressed inadequately. (shrink)

Sexual Violation in Islamic Law: Substance, Evidence, and Procedure By AzamHina, xi + 270 pp. Price HB £60.00. EAN 978–1107094246.

This book should be read by anyone with an interest in American Islam. After a brief introduction by the editor, Edward E. Curtis IV, twelve chapters explore va.

The U.S. Department of Health and Human Services has proposed substantial changes to the current regulatory system governing human subjects research in its Advanced Notice of Proposed Rulemaking, entitled “Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators.” Some of the most significant proposed changes concern the use of biospecimens in research. Because research involving biological materials begins with an initial interaction with an individual, such research falls squarely within the human subjects (...) research regulatory framework known as the “Common Rule,” which applies to research conducted or funded by the HHS and the other signatory agencies and departments. However, as described in detail below, much biospecimen research may fall within exemptions and exceptions under the Common Rule and, thus, may be conducted without consent. The ANPRM proposes requiring written consent for research use of biospecimens, even if the biospecimens were initially collected for a purpose other than research or have been stripped of identifiers. (shrink)

In this thorough compendium, nineteen accomplished scholars explore, in some manner the values they find inherent in the world, their nature, and revelence through the thought of Frederick Ferré. These essays, informed by the insights of Ferré and coming from manifold perspectives—ethics, philosophy, theology, and environmental studies, advance an ambitious challenge to current intellectual and scholarly fashions.

In this thorough compendium, nineteen accomplished scholars explore, in some manner the values they find inherent in the world, their nature, and revelence through the thought of Frederick FerrZ. These essays, informed by the insights of FerrZ and coming from manifold perspectives—ethics, philosophy, theology, and environmental studies, advance an ambitious challenge to current intellectual and scholarly fashions.

This article reviews recent developments in health care law, focusing on the engagement of law as a partner in health care innovation. The article addresses: the history and contents of recent United States federal law restricting the use of genetic information by insurers and employers; the recent federal policy recommending routine HIV testing; the recent revision of federal policy regarding the funding of human embryonic stem cell research; the history, current status, and need for future attention to advance directives; the (...) recent emergence of medical–legal partnerships and their benefits for patients; the obesity epidemic and its implications for the child’s right to health under international conventions. (shrink)

This article reviews recent developments in health care law, focusing on the engagement of law as a partner in health care innovation. The article addresses: the history and contents of recent United States federal law restricting the use of genetic information by insurers and employers; the recent federal policy recommending routine HIV testing; the recent revision of federal policy regarding the funding of human embryonic stem cell research; the history, current status, and need for future attention to advance directives; the (...) recent emergence of medical–legal partnerships and their benefits for patients; the obesity epidemic and its implications for the child’s right to health under international conventions. (shrink)

This article reviews recent developments in health care law, focusing on controversy at the intersection of health care law and culture. The article addresses: emerging issues in federal regulatory oversight of the rapidly developing market in direct-to-consumer genetic testing, including questions about the role of government oversight and professional mediation of consumer choice; continuing controversies surrounding stem cell research and therapies and the implications of these controversies for healthcare institutions; a controversy in India arising at the intersection of abortion law (...) and the rights of the disabled but implicating a broader set of cross-cultural issues; and the education of U.S. health care providers and lawyers in the theory and practice of cultural competency. (shrink)

From 1876, this influential work in the history of ideas focuses on the eighteenth-century deist controversy and its effects.

Bringing these two emergent areas of thought into direct conversation in Before the Law, Cary Wolfe fosters a new discussion about the status of nonhuman animals and the shared plight of humans and animals under biopolitics.

RésuméCeci est une réponse à l'étude critique de Vance Maxwell, «Making God Go Away», consacrée au livre de Leslie Armour, Being and IdeaLa discussion porte sur la question suivante : est-ilpossible qu'il y ait une signification transcendante à nos vies sans un Dieu tyrannique? Le livre traitait, de manière centrale, du fait que les réponses affirmatives à cette question exigent une unification du savoir. Maxwell suggère que le livre est un commentaire de Spinoza et de Hegel—malgré son soustitre :Developments (...) of Some Themes in Spinoza and HegelEt il ignore la tentative qui s'y trouve poursuivie de construire un systeme nouveau. Le preésent article explique ce système et défend certaines lectures de Spinoza. (shrink)

Rothstein (2010) argues that groups may be harmed by research on deidentified data. He concludes that researchers are obligated to minimize group harms and demonstrate respect for a studied group t...

Through a witty and engaging style, this book is for anyone who has a job (employees, managers, and leaders), and who wants to do the right thing, but aren't always sure what that means, how to go about it, or how to withstand the forces that push all of us away from being ethical. By poking fun at the ironies and hypocrisies of human behavior, Exercising Your Ethics prompts readers to leverage techniques that can help us become more deliberate about (...) choosing value-driven actions. In a world that seems to reward winning, regardless of how it is achieved, we need a clearer reason for wanting to be and become our best selves. This approach to business ethics is innovative, fresh, and evocative in that the serious subject is treated in an informal and adventurous manner, poking fun at the ironies and hypocrisies of human behavior. Readers will see how our race to achieve quarterly profits, combined with a self-indulgent consumption-based economy, has shaped our entire lives. Readers will delight in the book's humor, as the ironies of human interaction prompt introspection to consider how to better equip oneself with the knowledge, tools, and techniques to engage in and support others in the path to moral action at work. Bringing Ethics to Work explains business ethics in a way that is engaging, understandable and enables the reader to recognise behaviors in themselves and others. It is ideal for adult education (students in undergraduate, Masters, or professional degree programs) and training within organizational settings (employees, management, and future leaders). HR professionals, team leaders, professional coaches, and organizational ethics trainers will find the book particularly insightful and useful. (shrink)

My topic is the materialist appropriation of empiricism – as conveyed in the ‘minimal credo’ nihil est in intellectu quod non fuerit in sensu (which interestingly is not just a phrase repeated from Hobbes and Locke to Diderot, but is also a medical phrase, used by Harvey, Mandeville and others). That is, canonical empiricists like Locke go out of their way to state that their project to investigate and articulate the ‘logic of ideas’ is not a scientific project: “I shall (...) not at present meddle with the Physical consideration of the Mind” (Essay, I.i.2, in Locke 1975; which Kant gets exactly wrong in his reading of Locke, in the Preface to the A edition of the first Critique). Indeed, I have suggested elsewhere, contrary to a prevalent reading of Locke, that the Essay is not the extension to the study of the mind of the methods of natural philosophy; that he is actually not the “underlabourer” of Newton and Boyle he claims politely to be in the Epistle to the Reader (Wolfe and Salter 2009, Wolfe 2010). Rather, Locke says quite directly if we pay heed to such passages, “Our Business here is not to know all things, but those which concern our Conduct” (Essay, I.i.6). There would be more to say here about what this implies for our understanding of empiricism (see Norton 1981 and Gaukroger 2005), but instead I shall focus on a different aspect of this episode: how a non-naturalistic claim which falls under what we now call epistemology (a claim about the senses as the source of knowledge) becomes an ontology – materialism. That is, how an empiricist claim could shift from being about the sources of knowledge to being about the nature of reality (and/or the mind, in which case it needs, as David Hartley saw and Denis Diderot proclaimed more overtly, an account of the relation between mental processes and the brain). (David Armstrong, for one, denied that there could be an identification between empiricism and materialism on this point: eighteenth-century history of science seems to prove him wrong: see Armstrong 1968 and 1978.) Put differently, I want to examine the shift from the logic of ideas in the seventeenth century (Locke) to an eighteenth-century focus on what kind of ‘world’ the senses give us (Condillac), to an assertion that there is only one substance in the universe (Diderot, giving a materialist cast to Spinozism), and that we need an account of the material substrate of mental life. This is neither a ‘scientific empiricism’ nor a linear developmental process from philosophical empiricism to natural science, but something else again: the unpredictable emergence of an ontology on empiricist grounds. (shrink)

Sensibility, in any of its myriad realms – moral, physical, aesthetic, medical and so on – seems to be a paramount case of a higher-level, intentional property, not a basic property. Diderot famously made the bold and attributive move of postulating that matter itself senses, or that sensibility (perhaps better translated ‘sensitivity’ here) is a general or universal property of matter, even if he at times took a step back from this claim and called it a “supposition.” Crucially, sensibility is (...) here playing the role of a ‘booster’: it enables materialism to provide a full and rich account of the phenomena of conscious, sentient life, contrary to what its opponents hold: for if matter can sense, and sensibility is not a merely mechanical process, then the loftiest cognitive plateaus are accessible to materialist analysis, or at least belong to one and the same world as the rest of matter. This was noted by the astute anti-materialist critic, the Abbé Lelarge de Lignac, who, in his 1751 Lettres à un Amériquain, criticized Buffon for “granting to the body [la machine, a common term for the body at the time] a quality which is essential to minds, namely sensibility.” This view, here attributed to Buffon and definitely held by Diderot, was comparatively rare. If we look for the sources of this concept, the most notable ones are physiological and medical treatises by prominent figures such as Robert Whytt, Albrecht von Haller and the Montpellier vitalist Théophile de Bordeu. We then have, or so I shall try to sketch out, an intellectual landscape in which new – or newly articulated – properties such as irritability and sensibility are presented either as an experimental property of muscle fibers, that can be understood mechanistically (Hallerian irritability, as studied recently by Hubert Steinke and Dominique Boury) or a property of matter itself (whether specifically living matter as in Bordeu and his fellow montpelliérains Ménuret and Fouquet, or matter in general, as in Diderot). I am by no means convinced that it is one and the same ‘sensibility’ that is at issue in debates between these figures (as when Bordeu attacks Haller’s distinction between irritability and sensibility and claims that ‘his own’ property of sensibility is both more correct and more fundamental in organic beings), but I am interested in mapping out a topography of the problem of sensibility as property of matter or as vital force in mid-eighteenth-century debates – not an exhaustive cartography of all possible positions or theories, but an attempt to understand the ‘triangulation’ of three views: a vitalist view in which sensibility is fundamental, matching up with a conception of the organism as the sum of parts conceived as little lives (Bordeu et al.); a mechanist, or ‘enhanced mechanist’ view in which one can work upwards, step by step from the basic property of irritability to the higher-level property of sensibility (Haller); and, more eclectic, a materialist view which seeks to combine the mechanistic, componential rigour and explanatory power of the Hallerian approach, with the monistic and metaphysically explosive potential of the vitalist approach (Diderot). It is my hope that examining Diderot in the context of this triangulated topography of sensibility as property sheds light on his famous proclamation regarding sensibility as a universal property of matter. (shrink)

While the idea of philosophy as conceptual analysis has attracted many adherents and undergone a number of variations, in general it suffers from an authority problem with two dimensions. First, it is unclear why the analysis of a concept should have objective authority: why explicating what we mean should express how things are. Second, conceptual analysis seems to lack intersubjective authority: why philosophical analysis should apply to more than a parochial group of individuals. I argue that Hegel’s conception of social (...) ontology, focused on his concept of “ethical life” (Sittlichkeit), helps to explain how concepts (and their explication) have both objective and intersubjective authority in the social domain. Hegel claims that modern institutions are the product of self-conscious purposes, so that they are conceptually constituted. Concepts do not just represent these objects and so depend on a contingent relation to them. As many contemporary social ontologists agree, this means that our concepts of these institutions are uniquely epistemically “transparent.” They have objective authority. Concepts have intersubjective authority in the modern world as well, according to Hegel. However, I show that this feature of Hegel’s account does not rely on the solution to a philosophical problem. Rather, since the concepts of modern ethical life are “essentially contested,” their content depends on the practical and political agreement of modern subjects. This means that concepts can only have objective authority if some prior intersubjective agreement has been reached. The role of philosophy as conceptual analysis is thus importantly dependent on political developments. (shrink)

A unique and interdisciplinary collection in which scholars from Philosophy join those from Film Studies, English, and Comparative Literature to explore the nature and limits of love through in-depth reflection on particular works of literature and film.

Venturing into ethics -- Morality and ethics -- History of the development of ethics -- Formalization of ethics -- Institutional Review Boards -- Informal ethics -- Do no harm -- Transparency and accountability -- Informed consent -- Human terrsin system -- Future 1 -- Future 2 -- Yanomami -- Napoleon A. Chagnon -- Secrets of the tribe -- The Other.

Robert Wolfe writes about the nature of the ajata teachings, or the nature of emptiness and absolute reality.

Over six previous editions, Twelve Theories of Human Nature has been a remarkably popular introduction to some of the most influential developments in Western and Eastern thought. Now titled Thirteen Theories of Human Nature, this text continues to be an ideal introduction to human nature andintellectual history. This unique volume will engage and motivate students to consider how we can understand and improve both ourselves and human society.

The term 'agnostic' was probably coined by T. H. Huxley during a speech to the Metaphysical Society in 1869. From the Greek 'agnostos', 'unknown', it was derived from St Paul's mention of an Athenian altar inscribed 'to the unknown god'. With these overtones of ancient philosophy, agnosticism became the tag of an emergent school of thought which posited that the existence of anything beyond the material and measurable should be considered unknowable. In this collection of seven essays, first published as (...) one volume in 1893, Leslie Stephen makes a study of the 'unknown'. Across the essays, he presents arguments for the intrinsic agnosticism of many of the basic tenets of deism, explores the way in which humans construct dreams and realities, and examines the relationship between physics and philosophy. This readable and entertaining book will be of interest to students of both theology and philosophy. (shrink)