No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (shrink)

Bioethics has paid surprisingly little attention to the special problems faced by women and to feminist analyses of current health care issues other than ...

Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.

The goal of this paper is to show that Callahan's reasons for withholding life extending care cannot be made out exclusively in terms of contemporary notions of distributive justice and fair allocation. I argue that by relying on a notion of justice which links the merit of the individual with the fairness of a social pattern of shares, Callahan imputes vice to the elderly as he denies them eligibility for life-prolonging care. Aristotle's doctrine of the mean is a useful tool (...) for character evaluation. One can speak meaningfully of a proper disposition of a person of a certain type (an elderly person) with respect to the good of continued life. I claim that the mean of one's disposition with respect to the good of continued life would be relative to one's age group, and would be determined by that principle by which an elderly person of practical wisdom would determine it. This leads to very different conclusions than those drawn by Callahan. (shrink)

Kant objects on principle to any duty of moral self-perfection that would aim at the moral self-perfection of another person. Yet, despite the apparent barrier posed by the introspective technique of self-perfecting effort, I argue that such a duty is both possible and desirable as a part of moral friendship. Through mutual sincere efforts at self-disclosure, we escape the prison of mutual distrust which otherwise characterizes social life and consolidate the very sincerity necessary for moral improvement.

This paper examines Hutcheson’s moral sense theory’s attack on internalism and his defense of an innovative version of externalism. I show that Hutcheson’s distinction between exciting and justifying reasons supports a type of externalist theory not anticipated by Brink, Smith, or McDowell. In Moral Sense Externalism, moral judgment relies upon the perceptions of a moral sense, and the felt quality of these perceptions introduces to judgment an affective dimension. Thus feeling is a constituitive part of what it is to have (...) a justifying reason for a moral act even when it is not the direct motive to action. (shrink)

Genomic research results and incidental findings with health implications for a research participant are of potential interest not only to the participant, but also to the participant's family. Yet investigators lack guidance on return of results to relatives, including after the participant's death. In this paper, a national working group offers consensus analysis and recommendations, including an ethical framework to guide investigators in managing this challenging issue, before and after the participant's death.

In lieu of an abstract, here is a brief excerpt of the content:Hume Studies Volume XXIII, Number 2, November 1997, pp. 195-212 The Moral Self and the Indirect Passions SUSAN M. PURVIANCE David Hume1 and Immanuel Kant are celebrated for their clear-headed rejection of dogmatic metaphysics, Hume for rejecting traditional metaphysical positions on cause and effect, substance, and personal identity, Kant for rejecting all judgments of experience regarding the ultimate ground of objects and their relations, not just judgments of (...) cause and substantiality. Nevertheless, each argues that practical activity is not compromised by the rejection of metaphysical claims that others had taken to be crucial. Kant and Hume thought that political and moral life did not depend upon theoretical knowlege of the nature of the self, free will, or knowledge of the true motives of actions or the character of the agent. Because the grounds of morality and politics were too important to leave to the mercies of speculative metaphysics, each moved their foundations to higher ground, insulating the grounds of practical activity from the threat of metaphysical turmoil and skepticism. Contemporary philosophers have generally followed Hume and Kant in this regard, but often select very different strategies. Some think that the best way to avoid the problems associated with contemporary scientific ontologies is to separate ethics from the factual domain entirely. Some give moral and political language a noncognitivist interpretation, and others have interpreted values as a projection of the passions and affections of the subject or as the constructions of suitably situated practical reasoners.2 At the same time there has been a resurgence of interest in moral realism. Moral realists think that the objectivity of moral discourse, and hence the Susan M. Purviance is at the Department of Philosophy, The University of Toledo, Toledo OH 43606-3390 USA. 196 Susan M. Purviance possibility of moral truth, depend upon the existence of moral facts.3 Moral realists have tended to concentrate on the role of facts in establishing the truth of general moral principles, or the Tightness or moral value of particular individual actions. For moral realists, moral facts are the states of affairs that make general moral principles or particular moral judgments true. Whether these facts are of a naturalistic sort or not, whether they are literally on a par with natural facts, or whether they simply play the same role in practical knowledge that natural facts play in theoretical knowledge, is an open question. Moral realists often are naturalists, like David O. Brink and Jonathan Dancy, but they may be nonnaturalists, like G. E. Moore.4 Ethical naturalism accounts for moral motivation and the cultivation of good character in terms of moral qualities, and many hope to ground it in (or at least show that it is compatible with) the scientific understanding of objects and their relations and qualities. Naturalism is only one option, but realism has received support because it is not clear that antirealists have developed a convincing alternative to the grounding of concepts of moral agency and moral judgment in some sort of moral facts. Questions abound about what it means to ascribe responsibility to a moral self and how we can defend a notion of enduring character. Although moral realists have paid less attention to the ontological status of virtues and character traits than to moral principles, their status is equally important. Here the concern is with the sort of metaphysics of the self thought to be necessary to account for moral agency, responsibility, praise, and blame. I shall argue that there is a class of moral facts that justify or perhaps merely vindicate the ascription of moral powers to agents, and that these are the sorts of facts another sort of theorist is interested in, whereas the states of affairs that make moral judgments true are the sorts of facts that moral realists have been interested in. In order to distinguish this use of moral facts I shall call this sort of theory a Fact of Agency Theory, and it is a version of this theory that can be found in Hume's discussion of the problem of the self and the indirect passions. A realist metaphysics of morals needs to address two questions, the question of the reality of the... (shrink)

The apriority of moral feeling is an indispensable part of Kant's insistence on moral certainty as a foundation for ethics. Even though the moral feeling of respect cannot be the source of our knowledge of the authority of the moral law, moral feeling is a catalyst to self-criticism and moral self-confidence. It is argued that moral feeling reveals a nonempirical object, one's moral character. In fact, moral feeling plays a representational role that parallels sense experience, but does not derive from (...) sense experience. His general remarks on sensibility and representations and his specific discussion of moral sensibility make it hard to take feeling as central to his ethics, but this paper explains how they in no way preclude a representational function for moral sense. (shrink)

The Covid‐19 pandemic has exposed four myths in bioethics. First, the flood of bioethics publications on how to allocate scarce resources in crisis conditions has assumed authorities would declare the onset of crisis standards of care, yet few have done so. This leaves guidelines in limbo and patients unprotected. Second, the pandemic's realities have exploded traditional boundaries between clinical, research, and public health ethics, requiring bioethics to face the interdigitation of learning, doing, and allocating. Third, without empirical research, the success (...) or failure of ethics guidelines remains unknown, demonstrating that crafting ethics guidance is only the start. And fourth, the pandemic's glaring health inequities require new commitment to learn from communities facing extraordinary challenges. Without that new learning, bioethics methods cannot succeed. The pandemic is a wake‐up call, and bioethics must rise to the challenge. (shrink)

A Skeptical View of the Liberal Peace reflects on the place of democracy in the global community. The article pays particular attention to the widespread assumption that there is an inherent relationship between democracy and peace, and that peace most assuredly is derived from democracy itself. I find these assertions to be highly questionable and overstated. Reflection on the philosophy which underpins these claims can only be helpful for international relations. In particular, given the United States’ apparent imperialistic urge to (...) force democracies on other nations as Iraq, the article seems especially timely. (shrink)

From the foregoing discussion we can note that whilst Marx transcends the fact-value distinction he embraces neither a scientistic approach nor a moral theory. Rather he gives a sociological account of morality, illustrating that description and evaluation cannot be separated and that juridical conceptions need to be understood in relation to the mode of production in which they arise.30 In the absence of an absolute notion of justice it is mistaken to see Marx as offering a critique of capitalism based (...) on moral principles. Of course Marx had reasons for attacking capitalism but these are contained within his account of the capitalist mode of production. Yet whilst this theory is not a moral theory it cannot be described as a descriptive theory either. In Marx's work description and evaluation cannot be meaningfully separated.In portraying Communist society as the solution to problems generated within capitalist society Marx is not sketching out a picture of a morally superior society but rather considering the possibilities of an alternative way of life with its own moral and judicial standards. Indeed the fact that Marx did not provide blueprints for future Communist society is itself symptomatic of his awareness of the difficulties involved in the attempt to describe in detail a form of social life based upon principles different from our own. (shrink)

Adrienne Asch pioneered a way of doing bioethics that few are brave enough to attempt. In addition to summoning logic, arguing values, and applying reasoning to cases, Adrienne lived bioethics. Without compromising the strength of her analysis, she grounded that analysis explicitly in her own lived experience of disability. Hers was the view from somewhere—a deep invitation to others to rethink everything from embryo selection to end‐of‐life decisions through the lens of lived disability.

Is the lower rate of kidney transplantation into African Americans medically and ethically justifiable? Or is it a form of racial discrimi nation comparable to if not worse than denial of employment opportunities, housing, and educational opportunities? This essay focusses on the medical problems associated with matching antigens in donors and recipients, and the implications of those problems for social justice.1 Racially discriminatory practices in bank lending, education, and hiring provide a context for understanding how medical criteria treat black recipients (...) unfairly. Although antigen matching is only one aspect of the general problem of finding medically suitable black recipients, it presents an especially interesting challenge for theories of justice, as well as for medical research. (shrink)

Health care reform proposals threaten to exacerbate tensions physicians already face in trying to balance traditional duties to individual patients against increasing pressure to serve broader societal and institutional goals. To cope with reform, medical ethics must clarify physicians' moral obligations, change existing ethical codes, and develop an ethics of institutions.

The current explosion of genetic knowledge and the rapid proliferation of genetic tests has rightly provoked concern that we are approaching a future in which people will be labeled and disadvantaged based on genetic information. Indeed, some have already suffered harm, including denial of health insurance. This concern has prompted an outpouring of analysis. Yet almost all of it approaches the problem of genetic disadvantage under the rubric of “genetic discrimination.”This rubric is woefully inadequate to the task at hand. It (...) ignores years of commentary on race and gender demonstrating the limits of antidiscrimination analysis as an analytic framework and corrective tool. Too much discussion of genetic disadvantage proceeds as if scholars of race and gender had not spent decades critiquing and developing antidiscrimination theory.Indeed, there are multiple links among race, gender, and genetics. Dorothy Roberts has discussed the historical links between racism and genetics, while she and others have begun to map connections between gender and genetics. (shrink)

A critical difference between 1978, the first time the U.S. Supreme Court heard on its merits a case involving affirmative action policies (AAPs), and its 2003 revisiting of the issue was that the context for hearing the issue had significantly changed from that of medical education to that of undergraduate and law school programs. This shift in context mattered. I argue here that medicine has particular interests and insights into the problem of race, and in this, its participation in the (...) debate is critical not only for medical education and practice but for the development of sound judicial approaches to AAPs. (shrink)

In this paper I examine the particularist attack on deductive uses of moral principles, reviewing the critiques of the uniformity of moral reasons and impartiality in ethics, looking principally at arguments from Larry Blum, Jonathan Dancy, and Margaret Walker. I defend the action-guiding-ness of moral principles themselves, but consider various ways to accommodate the objections coming fromparticularism. I conclude that one objection to the impartialist theory of value must be conceded without qualification: generalism is unable to account for the unique (...) and irreplaceable value of individual persons. I present an example which supports my view andshows that, in the context of lived experience, replaceability is contradicted. Indeed there may be few constants of value in the narrative of one’s life, as experiences overlay supposed constants with continual new shading, and create even deeper sorts of transformation in valuing. In the end, both particularized moral judgment and the articulation of fact with principle contribute to moral discernment. (shrink)

The Moral Economies of American Authorship argues that the moral character of authors became a kind of literary property within mid-nineteenth-century America's expanding print marketplace, shaping the construction, promotion, and reception of texts as well as of literary reputations.

Technology has outpaced the capacity of researchers performing research on human participants to interpret all data generated and handle those data responsibly. This poses a critical challenge to existing rules governing human subjects research. The technologies used in research to generate images, scans, and data can now produce so much information that there is significant potential for incidental findings, findings generated in the course of research but beyond the aims of the study. Neuroimaging scans may visualize the entire brain and (...) even the entire head; computed tomography colonography research may visualize the entire torso, from the base of the lungs to the pubis; genetics studies may reveal “extra” and sometimes unwanted information about the family, such as misattributed paternity and undisclosed adoption; and genomic microarray research increasingly involves whole-genome analysis revealing an individual’s complete genotype, with enormous potential for uncovering unexpected information about an individual’s genetics and risks of developing future conditions. (shrink)

This piece explores the proposition that environmental restoration is the only acceptable alternative to a world left with diminishing natural regions. The article reviews the ethical debate concerning the moral obligation of humankind to restore regions that have been stripped of their resources. It demonstrates thatthrough the assistance of both legislative and technological measures nature can be renewed to spawn healthy ecosystems when permitted to do so. Furthermore, the article claims that the restoration thesis is proven by the paradigm of (...) the Adirondack region – a region that was once clear-cut and enabled to restore itself through both rewilding and the “Forever Wild” clause in the New York State Constitution. The article is particularly timely and provocative given the current Bush Administration’s environmental policies. (shrink)

In confronting the insalubrious ramifications of globalization, human rights scholars and activists have argued for greater national and international responsibility pursuant to the human right to health. Codified seminally in Article 12 of the International Covenant on Economic, Social and Cultural Rights, the right to health proclaims that states bear an obligation to realize the “highest attainable standard” of health for all. However, in pressing for the highest attainable standard for each individual, the right to health has been ineffective in (...) compelling states to address burgeoning inequalities in underlying determinants of health, focusing on individual medical treatments at the expense of public health systems. This article contends that the paradigm of individual health, focused on a right to individual medical care, is incapable of responding to health inequities in a globalized world and thereby hampers efforts to operationalize health rights through public health systems. While the right to health has evolved in international discourse over time, this evolution of the individual right to health cannot address the harmful societal ramifications of economic globalization. Rather than relying solely upon an individual right to medical care, envisioning a collective right to public health – a right applied at the societal level to address underlying determinants of health – would alleviate many of the injurious health inequities of globalization. (shrink)

This article examines two questions pertaining to the extension of infertility treatment to postmenopausal women. First, what concepts and principles of infertility practice apply to assisted reproduction for the postmenopausal patient? Second, what role should these concepts play in the development of an ethical justification for extending women's reproductive lives past the menopausal boundary? The argument offered here supports their claim to infertility services on the basis of the formal principle of justice, which requires that similar cases be treated similarly. (...) The cases of many postmenopausal patients are argued to be relevantly similar to classes of patients who already receive assistance in reproduction. (shrink)

Oversight of human gene transfer research presents an important model with potential application to oversight of nanobiology research on human participants. Gene therapy oversight adds centralized federal review at the National Institutes of Health's Office of Biotechnology Activities and its Recombinant DNA Advisory Committee to standard oversight of human subjects research at the researcher's institution and at the federal level by the Office for Human Research Protections. The Food and Drug Administration's Center for Biologics Evaluation and Research oversees human gene (...) transfer research in parallel, including approval of protocols and regulation of products. This article traces the evolution of this dual oversight system; describes how the system is already addressing nanobiotechnology in gene transfer: evaluates gene therapy oversight based on public opinion, the literature, and preliminary expert elicitation; and offers lessons of the gene therapy oversight experience for oversight of nanobiotechnology. (shrink)

Returning genomic research results to family members raises complex questions. Genomic research on life-limiting conditions such as cancer, and research involving storage and reanalysis of data and specimens long into the future, makes these questions pressing. This author group, funded by an NIH grant, published consensus recommendations presenting a framework. This follow-up paper offers concrete guidance and tools for implementation. The group collected and analyzed relevant documents and guidance, including tools from the Clinical Sequencing Exploratory Research Consortium. The authors then (...) negotiated a consensus toolkit of processes and documents. That toolkit offers sample consent and notification documents plus decision flow-charts to address return of results to family of living and deceased participants, in adult and pediatric research. Core concerns are eliciting participant preferences on sharing results with family and on choice of a representative to make decisions about sharing after participant death. (shrink)

Evolutionary theory assumed that mutations occur constantly, gradually, and randomly over time. This formulation from the “modern synthesis” of the 1930s was embraced decades before molecular understanding of genes or mutations. Since then, our labs and others have elucidated mutation mechanisms activated by stress responses. Stress‐induced mutation mechanisms produce mutations, potentially accelerating evolution, specifically when cells are maladapted to their environment, that is, when they are stressed. The mechanisms of stress‐induced mutation that are being revealed experimentally in laboratory settings provide (...) compelling models for mutagenesis that propels pathogen–host adaptation, antibiotic resistance, cancer progression and resistance, and perhaps much of evolution generally. We discuss double‐strand‐break‐dependent stress‐induced mutation in Escherichia coli. Recent results illustrate how a stress response activates mutagenesis and demonstrate this mechanism's generality and importance to spontaneous mutation. New data also suggest a possible harmony between previous, apparently opposed, models for the molecular mechanism. They additionally strengthen the case for anti‐evolvability therapeutics for infectious disease and cancer. (shrink)

Both bioethics and law have governed human genomics by distinguishing research from clinical practice. Yet the rise of translational genomics now makes this traditional dichotomy inadequate. This paper pioneers a new approach to the ethics of translational genomics. It maps the full range of ethical approaches needed, proposes a “layered” approach to determining the ethics framework for projects combining research and clinical care, and clarifies the key role that return of results can play in advancing translation.

Participant-driven research is a burgeoning domain of research innovation, often facilitated by mobile technologies. Return of results and data are common hallmarks, grounded in transparency and data democracy. PDR has much to teach traditional research about these practices and successful engagement. Recommendations calling for new state laws governing research with mHealth modalities common in PDR and federal creation of review mechanisms, threaten to stifle valuable participant-driven innovation, including in return of results.

In 2004, the United States Sentencing Commission amended the Federal Sentencing Guidelines to allow firms that create “effective compliance and ethics programs” to receive better treatment if prosecuted for fraud. Effective compliance and ethics, however, appear to be limited to activities focused on complying with the firms’ internal legal and ethical standards. We explored a potential connection between the firms’ external corporate social responsibility (CSR) behaviors and internal compliance: Is there an organizationally valid relationship between these two firm activities? That (...) is, when organizations demonstrate CSR with behaviors external to the firm, such as employee volunteerism, are their employees more likely to demonstrate uncompromised legal and ethical compliance behavior internally? We collected data from 164 working professionals enrolled in a top-tier MBA program in the southeastern United States regarding their employer-sponsored volunteer activities and their intentions to comply in various organizational compliance vignettes. We found that employer-sponsored volunteerism is associated with uncompromised compliance choices in one of the three vignettes. This finding indicates preliminary support for further inquiry into the relationship within the firm between external CSR behaviors and policies regarding organizational compliance. Post hoc analyses suggest that employer-sponsored volunteerism is strongly associated with a positive organizational identity, but organizational identity is not associated with the significant compliance vignette. This evidence suggests that the underlying mechanism that connects external CSR behaviors and internal compliance intentions is complex and requires future study. (shrink)

It is argued that the key to understanding the Doctrine of the Fact of reason lies in clarifying what Kant meant by a fact for moral practice. It is suggested that the facticity of the Fact of Reason must be understood in both a noetic and a performative aspect. Dietrich Henrich's interpretation is discussed, and it is argued that it risks reducing the Fact of Reason exclusively to its noetic function in moral ontology, and that it ignores the fact that (...) this is a doctrine of self-discovery, not of self-constitution. (shrink)