Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of human (...) subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research. (shrink)

Over the past decade, the number of clinical trials registered with the Food and Drug Administration has increased dramatically. The business of clinical research has become more diverse, involving academic institutions, clinician-researchers in community settings, pharmaceutical companies, and contract research organizations. This growth has been accompanied by increasing concerns about the ethical conduct of research. Much of this concern has been directed to procedural issues including institutional review board review, data monitoring, and informed consent forms. However, the protection of human (...) subjects cannot be achieved by relying solely on procedural safeguards. There are more nuanced issues related to recruitment and retention of subjects, and to the process of informed consent, that are generated during the interaction between study staff and subjects. It is only through an examination of these relationships that one can more fully define and understand the challenges of protecting subjects in research. (shrink)

The American Journal of Bioethics, Volume 12, Issue 5, Page 13-14, May 2012.

In the US, research payments are technically taxable income. This article argues that tax liability is a form of possible economic and legal risk of paid research participation. Findings are presented from empirical research on Phase I healthy volunteer trials. The article concludes by discussing the implications of these findings for the informed consent process, as well as for broader ethical issues in whether and how payments for research participation should be regulated.

Our aim in this article is to define the difficulties that clinical ethics services encounter when they are asked to demonstrate the value a clinical ethics service (CES) could and should have for an institution and those it serves. The topic emerged out of numerous related presentations at the Un- Conference hosted by the Cleveland Clinic in August 2018 that identified challenges of articulating the value of clinical ethics work for hospital administrators. After a review these talks, it was apparent (...) that the field of clinical ethics may be at a crisis of sorts due to increased pressure to provide explicit measures to healthcare institutions to concretely demonstrate that CESs make a valuable difference in healthcare delivery. In this article, we grapple with how to satisfy the need for demonstrable value in a field in which metrics alone may not capture the scope of clinical ethics practice. We suggest that capturing the value of a CES has been difficult because the benefits of ethics consultation may be overt or attributable to the CES, but are often hidden due to the systems-level and process-oriented nature of clinical ethics work. Part of the difficulty in demonstrating the value of CESs is capturing and conveying all of the ways the integration of a CES throughout an institution positively affects patients, families, visitors, healthcare professionals, administrators, and the institution itself. Our aim is to (1) elucidate the multifaceted value added by a CES, including value that tends to be hidden and (2) suggest how to demonstrate value to others in a way that is not simplistic or reductionistic. (shrink)

This paper analyses the activities of five organizations shaping the debate over the global governance of genome editing in order to assess current approaches to public engagement (PE). We compare the recommendations of each group with its own practices. All recommend broad engagement with the general public, but their practices vary from expert-driven models dominated by scientists, experts, and civil society groups to citizen deliberation-driven models that feature bidirectional consultation with local citizens, as well as hybrid models that combine elements (...) of both approaches. Only one group practices PE that seeks community perspectives to advance equity. In most cases, PE does little more than record already well-known views held by the most vocal groups, and thus is unlikely to produce more just or equitable processes or policy outcomes. Our exploration of the strengths, weaknesses, and possibilities of current forms of PE suggests a need to rethink both “public” and “engagement.”. (shrink)

Advances in genomics have led to calls for developing population-based preventive genomic sequencing programs with the goal of identifying genetic health risks in adults without known risk factors. One critical issue for minimizing the harms and maximizing the benefits of PGS is determining the kind and degree of control individuals should have over the generation, use, and handling of their genomic information. In this article we examine whether PGS programs should offer individuals the opportunity to selectively opt out of the (...) sequencing or analysis of specific genomic conditions or whether PGS should be implemented using an all-or-nothing panel approach. We conclude that any responsible scale-up of PGS will require a menu approach that may seem impractical to some, but that draws its justification from a rich mix of normative, legal, and practical considerations. (shrink)

The current ethical norms of genomic biobanking creating and maintaining large repositories of human DNA and/or associated data for biomedical research have generated criticism from every angle, at both the practical and theoretical levels. The traditional research model has involved investigators seeking biospecimens for specific purposes that they can describe and disclose to prospective subjects, from whom they can then seek informed consent. In the case of many biobanks, however, the institution that collects and maintains the biospecimens may not itself (...) be directly involved in research, instead banking the biospecimens and associated data for other researchers. Moreover, the future uses of biospecimens may be unknown, if not unknowable, at the time of collection. Biobanking may thus stretch the meanings of inform and consent to their breaking point: if you cannot inform subjects about what their biospecimens will be used for, what can they consent to? Given that informed consent by individual subjects is the ethical gold standard, the seeming dilution of the concept in the context of biobanking is a profound problem. (shrink)

Research uses of human bodies maintained by mechanical ventilation after being declared dead by neurological criteria, were first published in the early 1980s with a renewed interest in research on the newly or nearly dead occurring in about last decade. While this type of research may take many different forms, recent technologic advances in genomic sequencing along with high hopes for genomic medicine, have inspired interest in genomic research with the newly dead. For example, the Genotype-Tissue Expression program through the (...) National Institutes of Health aims to collect large numbers of diverse human tissues with the eventual goal of elucidating the genetic bases of common diseases through a better understanding of the relationship between genetic variation and gene expression. (shrink)

Recent advances in next generation sequencing along with high hopes for genomic medicine have inspired interest in genomic research with the newly dead. However, applicable law does not adequately determine ethical or policy responses to such research. In this paper we propose that such research stands at a crossroads between other more established biomedical clinical and research practices. In addressing the ethical and policy issues raised by a particular research project within our institution comparatively with these other practices, we illustrate (...) the moral significance of paying careful heed to where one looks for guidance in responding to ethical questions raised by a novel endeavor. (shrink)

Background: A growing literature has raised—skeptically—the question of whether cutting-edge scientific research can identify and address broader ethical and policy considerations in real time. In genomics, the question is: Can ELSI contribute to genomics in real time, or will it be relegated to its historical role of after-the-fact outsider critique? We address this question against the background of a genomic screening project where we participated as embedded, real-time ELSI researchers and observers, from its initial design through its conclusion.Methods: As part (...) of the ELSI study design, the project included an ongoing reflexive ethnography in which the authors studied the process of its design and implementation. The authors were true participant observers, serving as members of various task-oriented groups while recording meetings and other events for ongoing qualitative analysis. We also conducted and analyzed interviews of multiple participants at the conclusion of the project.Results: Our real-time ELSI initiative had a mixed record of successes and challenges. If we define success as ELSI researchers having had an opportunity to participate fully in the project and to make the ELSI perspective heard, then our assessment is largely positive. If, however, we define successes as instances where real-time ELSI contributions changed the direction of the genomic or public health aspects of the GeneScreen project or, after careful deliberation, confirmed the appropriateness of the status quo, then we can identify only a few examples. While we had a seat at the table, we were, for the most part, tolerated guests.Conclusions: We conclude that there are significant barriers to real-time ELSI influence. The difficulty does not reside in any intended exclusion of an ELSI perspective, but in factors endemic to genomic research, including knowledge disparities, epistemological biases, and the pressures of time and money. (shrink)

The growing practice of returning individual results to research participants has revealed a variety of interpretations of the multiple and sometimes conflicting duties that researchers may owe to participants. One particularly difficult question is the nature and extent of a researcher’s duty to facilitate a participant’s follow-up clinical care by placing research results in the participant’s medical record. The question is especially difficult in the context of genomic research. Some recent genomic research studies — enrolling patients as participants — boldly (...) address the question with protocols dictating that researchers place research results directly into study participants’ existing medical records, without participant consent. Such privileging of researcher judgment over participant choice may be motivated by a desire to discharge a duty that researchers perceive themselves as owing to participants. However, the underlying ethical, professional, legal, and regulatory duties that would compel or justify this action have not been fully explored. (shrink)

Hospital systems commonly face the challenge of determining just ways to allocate scarce drugs during national shortages. There is no standardised approach of how this should be instituted, but principles of distributive justice are commonly used so that patients who are most likely to benefit from the drug receive it. As a result, clinical indications, in which the evidence for the drug is assumed to be established, are often prioritised over research use. In this manuscript, we present a case of (...) a phase II investigational trial of intravenous thiamine for delirium prevention in patients undergoing haematopoietic stem cell transplantation to emphasise several shortcomings in the overarching prioritisation of clinical over research uses of scarce drugs. Specifically, we present the following considerations: clinical use may not have stronger evidence than research use; a strong scientific rationale for research use may outweigh the claim for clinical indications in which there is weak evidence; treatment within the context of a clinical trial may be the standard of care; and research use may not only benefit patients receiving the treatment but also offers the prospect of improving future clinical care. In summary, we argue against allocation schemes that prohibit all research uses of scarce drugs and instead recommend that allocation schemes include a balanced approach that weighs risks and benefits of access to scarce drugs irrespective of the research versus clinical use designation. (shrink)

With their comprehensive categorization of “ambivalence-related phenomena,” Moore et al. helpfully clarify and contextualize these decisional states as they arise in patient care. Given the...

Julie Childers and Bob Arnold’s (2019) article, “The Inner Lives of Doctors: Physician Emotion in the Care of the Seriously Ill,” uses Kübler-Ross’s influential work on death and dying to remind us...

The growing practice of returning individual results to research participants has revealed a variety of interpretations of the multiple and sometimes conflicting duties that researchers may owe to participants. One particularly difficult question is the nature and extent of a researcher’s duty to facilitate a participant’s follow-up clinical care by placing research results in the participant’s medical record. The question is especially difficult in the context of genomic research. Some recent genomic research studies — enrolling patients as participants — boldly (...) address the question with protocols dictating that researchers place research results directly into study participants’ existing medical records, without participant consent. Such privileging of researcher judgment over participant choice may be motivated by a desire to discharge a duty that researchers perceive themselves as owing to participants. However, the underlying ethical, professional, legal, and regulatory duties that would compel or justify this action have not been fully explored. (shrink)

Philosophy has much to offer psychiatry, not least regarding ethical issues, but also issues regarding the mind, identity, values, and volition. This has become only more important as we have witnessed the growth and power of the pharmaceutical industry, accompanied by developments in the neurosciences. However, too few practising psychiatrists are familiar with the literature in this area. -/- The Oxford Handbook of Philosophy and Psychiatry offers the most comprehensive reference resource for this area ever published. It assembles challenging and (...) insightful contributions from key philosophers and others to the interactive fields of philosophy and psychiatry. Each contributions is original, stimulating, thorough, and clearly and engagingly written - with no potentially significant philosophical stone left unturned. Broad in scope, the book includes coverage of several areas of philosophy, including philosophy of mind, science, and ethics. For philosophers and psychiatrists, The Oxford Handbook of Philosophy and Psychiatry is a landmark publication in the field - one that will be of value to both students and researchers in this rapidly growing area. (shrink)

Modified Theistic Activism is the view that abstract objects not essentially possessed by God fall under God’s creative activity in one way or another. Michelle Panchuk has argued that this position succumbs to the bootstrapping problem such that God is and is not logically prior to his properties—an incoherent and necessarily false state of affairs. In this essay we respond to Panchuk by arguing that our neo-Aristotelian account of substance and property possession successfully avoids the bootstrapping problem. Moreover, her own (...) neo-Augustinian account of universals contains many conceptual deficiencies and ultimately succumbs to an epistemic iteration of the bootstrapping problem. Finally, we argue that the reasons provided for thinking only created beings need universals to ground character is unmotivated. In clarifying and defending our position, our hope is to bury once and for all the familiar claim that traditional theists cannot be realists with respect to abstract objects because of divine bootstrapping. (shrink)

Although women are severely under-represented in national politics in Europe, in the European Parliament they are better represented than they are in the national parliaments of the EEC member states. This book examines why this is so. Based largely on their detailed interviews with women MEPs, the authors describe the latter's backgrounds, attitudes and political experience. They also explain the history, structure and organisation of the European Parliament and outline the complexities of the European legal system. A particular concern of (...) the book is the contribution that women MEPs have made to legislation and policy, expecially in the context of recent Community legislation on sex equality, and what impact their presence has had on issues relating to women's interests. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:News from the President’s Council on BioethicsDiane M. Gianelli (bio) and F. Daniel Davis (bio)Although the President's Council has moved into several new areas of interest during the past year, it also has devoted considerable effort to finalizing several upcoming reports and white papers. In early 2008, the Council will publish a collection of essays on human dignity and bioethics, a report on organ transplantation, and a white (...) paper on "brain death."The Council's report on organ transplantation—now near the end of the drafting and editing phases—has the public as its main audience and, as such, seeks to promote greater understanding of the ethical issues in organ procurement, allocation, and transplantation. The report situates these issues within the contexts of the history of transplantation, the clinical realities of this therapeutic modality, and the current policy framework of state and federal law and regulation.The Council is aware that other bodies—such as the Institute of Medicine—have, in recent years, produced excellent reports on transplantation. The Council's report, however, has a different focus. It explores such foundational issues as the meaning and experience of human embodiment, the philosophy of giving and receiving, and transplantation in relation to the ends and aims of medicine.The report also analyzes the ethics of deceased organ donation, living organ donation, organ allocation, and various proposals for increasing the supply of organs, with a focus on those that call for the replacement of the organ-as-gift philosophy with a market-oriented ethic of selling and buying.In another upcoming publication, the Council revisits the notion of "brain death." The Council did not plan to take on this issue when it began its organ transplantation project. But when researching material for that report, it became clear that—in recent years—some serious criticisms of the neurological standard for declaring death have arisen. Since the vast majority of organs procured from the dead come from "brain dead" patients—that is, those declared dead by the neurological standard—this presented an issue ripe for exploration.The last time a national bioethics body looked at the criteria for determining death was in 1981, when The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research issued "Defining Death," its seminal report that articulated and defended the neurological standard for declaring death. It also proposed a uniform statute for states to adopt based [End Page 397] on that standard. After its publication, states that had not already rewritten their laws to recognize the new neurological standard did so. The Council's white paper on the topic takes a new look at "brain death" in light of the recent evidence and arguments on both sides of the issue.In the Council's last report to the Kennedy Institute of Ethics Journal (December 2006), its upcoming volume on "Dignity" was described. Scholars from a variety of disciplines—and opinions—have written essays on "dignity and bioethics." The volume is ready to go to press.In addition to these documents, the Council, after devoting a number of sessions to the topic over the past couple of years, is considering publication of a white paper on newborn screening, with a probable focus on the benefits, harms, and burdens of mandated screening, and a look at the broader human significance of genetic information. The paper probably also will address the moral precepts that should guide such testing, as well as the precepts that should guide the acquisition and use of the genetic information gained through this process.Venturing into new territory this year, the Council heard from several speakers on "the healing professions" and "the ethical foundations of health care." Both of these topics are the subject of considerable attention and debate in the ethics literature. There is some concern, for example, that medicine and the other healing professions have lost—or are in danger of losing—their moral bearings. And in the controversies surrounding health care reform policies, what is at stake ethically often is obscured, confused, or lacking altogether.Under the rubric of "the professions," the Council heard various dimensions of the issue: the "crisis" in the ethics... (shrink)

Recent magnetic resonance imaging and pathological studies have indicated that axonal loss is a major contributor to disease progression in multiple sclerosis. 1 H magnetic resonance spectroscopy, through measurement of N -acetyl aspartate, a neuronal marker, provides a unique tool to investigate this. Patients with primary progressive multiple sclerosis have few lesions on conventional MRI, suggesting that changes in normal appearing white matter, such as axonal loss, may be particularly relevant to disease progression in this group. To test this hypothesis (...) NAWM was studied with MRS, measuring the concentration of N -acetyl derived groups. Single-voxel MRS using a water-suppressed PRESS sequence was carried out in 24 patients with primary progressive multiple sclerosis and in 16 age-matched controls. Ratios of metabolite to creatine concentration were calculated in all subjects, and absolute concentrations were measured in 18 patients and all controls. NA/Cr was significantly lower in NAWM in patients than in controls, as was the absolute concentration of NA. There was no significant difference in the absolute concentration of creatine between the groups. This study supports the hypothesis that axonal loss occurs in NAWM in primary progressive multiple sclerosis and may well be a mechanism for disease progression in this group. (shrink)

In this introduction to Part 1 of the Common Knowledge symposium, “Fuzzy Studies,” the journal's editor discusses four essays from the 1980s by Richard Rorty, in which Rorty chose to associate himself with various neopragmatists, Continental thinkers, and “left-wing Kuhnians” under the rubric of the “new fuzziness.” The term had been introduced as an insult by a philosopher of science with positivist leanings, but Rorty took it up as an “endearing” compliment, arguing that “to be less fuzzy” was also to (...) be “less genial, tolerant, open-minded, and fallibilist.” He defined the “new fuzziness” as “an attempt to blur just those distinctions between the objective and subjective and between fact and value which the critical conception of rationality has developed.” This introduction also examines W. V. Quine's essay “Speaking of Objects” (1957), which describes objects as fuzzy “half-entities”; Clifford Geertz's essay “Blurred Genres” (1980), which advises social scientists that being “taxonomically upstanding” is futile; and Lofti Zadeh's article “The Concept of a Linguistic Variable and Its Application to Approximate Reasoning” (1975), which abandons “Aristotelian, bivalent logic” in favor of a “fuzzy logic” based on Zadeh's “fuzzy set theory.” This introductory piece relates these theoretical works of the past half-century to the sorites paradox and to classical issues of vagueness raised and still unresolved in Western philosophy. Returning then to Rorty, the author questions how Rorty expected his endorsement of the “new fuzziness” to be applied, as proposed, to theology and politics. Suggesting that such applications are the natural work of historians, the author, having asked the historian Natalie Zemon Davis for comment, then quotes her response—which associates fuzzy studies, “common knowledge,” and peacemaking—at length. (shrink)

In this introduction to Part 1 of the Common Knowledge symposium, “Fuzzy Studies,” the journal's editor discusses four essays from the 1980s by Richard Rorty, in which Rorty chose to associate himself with various neopragmatists, Continental thinkers, and “left-wing Kuhnians” under the rubric of the “new fuzziness.” The term had been introduced as an insult by a philosopher of science with positivist leanings, but Rorty took it up as an “endearing” compliment, arguing that “to be less fuzzy” was also to (...) be “less genial, tolerant, open-minded, and fallibilist.” He defined the “new fuzziness” as “an attempt to blur just those distinctions between the objective and subjective and between fact and value which the critical conception of rationality has developed.” This introduction also examines W. V. Quine's essay “Speaking of Objects”, which describes objects as fuzzy “half-entities”; Clifford Geertz's essay “Blurred Genres”, which advises social scientists that being “taxonomically upstanding” is futile; and Lofti Zadeh's article “The Concept of a Linguistic Variable and Its Application to Approximate Reasoning”, which abandons “Aristotelian, bivalent logic” in favor of a “fuzzy logic” based on Zadeh's “fuzzy set theory.” This introductory piece relates these theoretical works of the past half-century to the sorites paradox and to classical issues of vagueness raised and still unresolved in Western philosophy. Returning then to Rorty, the author questions how Rorty expected his endorsement of the “new fuzziness” to be applied, as proposed, to theology and politics. Suggesting that such applications are the natural work of historians, the author, having asked the historian Natalie Zemon Davis for comment, then quotes her response—which associates fuzzy studies, “common knowledge,” and peacemaking—at length. (shrink)

Over the past twenty-five years, no one has done more than J. P. Moreland to equip Christians to love God with their minds. In his work as a Christian philosopher, scholar, and apologist, he has influenced thousands of students, written groundbreaking books, and taught multitudes of Christians to defend their faith. -/- In honor of Moreland's ministry, general editors Paul M. Gould and Richard Brian Davis have assembled a team of friends and colleagues to celebrate his work. In three (...) major parts devoted to philosophy, apologetics, and spiritual formation, scholars such as Stewart Goetz, Paul Copan, Douglas Groothuis, Scott Rae, and Klaus Issler interact with Moreland's thought and make their own contributions to these important subjects. Moreland concludes the volume with his own essay, "Reflections on the Journey Ahead.". (shrink)

Obtaining informed consent, an ethical obligation of nurses and other health care providers, occurs routinely when patients make health care decisions. The values underlying informed consent (promotion of patients’ well-being and respect for their self-determination) are embedded in the dominant American culture. Nurses who apply the USA’s cultural values of informed consent when caring for patients who come from other cultures encounter some ethical dilemmas. This descriptive study, conducted with Latino, Chinese and Anglo-American cancer patients in a large, public, west-coast (...) clinic, describes constraints on the informed consent process in a multicultural setting, including language barriers, the clinical environment, control in decision making, and conflicting desired health outcomes for health care providers and patients, and suggests some implications for nursing practice. (shrink)

Recent public hearings on misconduct charges belie the conjecture that due process will perforce defeat informed scientific reasoning. One notable case that reviewed an obtuse description of experimental methods displays some of the subtleties of differentiating carelessness from intent to deceive. There the decision of a studious nonscientist panel managed to reach sensible conclusions despite conflicting expert testimony. The significance of such a result may be to suggest that to curtail due process would be both objectionable and unproductive.

After introducing the new field of cultural evolution, we review a growing body of empirical evidence suggesting that culture shapes what people attend to, perceive and remember as well as how they think, feel and reason. Focusing on perception, spatial navigation, mentalizing, thinking styles, reasoning (epistemic norms) and language, we discuss not only important variation in these domains, but emphasize that most researchers (including philosophers) and research participants are psychologically peculiar within a global and historical context. This rising tide of (...) evidence recommends caution in relying on one’s intuitions or even in generalizing from reliable psychological findings to the species, Homo sapiens. Our evolutionary approach suggests that humans have evolved a suite of reliably developing cognitive abilities that adapt our minds, information-processing abilities and emotions ontogenetically to the diverse culturally-constructed worlds we confront. (shrink)

Although medical providers rely on similar tools to “treat” intersex and trans individuals, their enactment of medicalization practices varies. To deconstruct these complexities, we employ a comparative analysis of providers who specialize in intersex and trans medicine. While both sets of providers tend to hold essentialist ideologies about sex, gender, and sexuality, we argue they medicalize intersex and trans embodiments in different ways. Providers for intersex people are inclined to approach intersex as an emergency that necessitates medical attention, whereas providers (...) for trans people attempt to slow down their patients’ urgent requests for transitioning services. Building on conceptualizations of “giving gender,” we contend both sets of providers “give gender” by “giving sex.” In both cases too, providers shift their own responsibility for their medicalization practices onto others: parents in the case of intersex, or adult recipients of care in the case of trans. According to the accounts of most providers, successful medical interventions are achieved when a person adheres to heteronormative gender practices. (shrink)