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)

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)

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

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.

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.

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)

Using the infamous research studies in Tuskegee and Guatemala, the article examines the difference between victims and bystanders. The victims can include families, sexual partners, and children not just the participants. There are also the bystanders in the populations who are affected, even vaguely, decades after the initial studies took place. Differing reparations for victims and bystanders through lawsuits and historical acknowledgments has to be part of broader discussions of historical justice, and the weighing of the impact of racism and (...) imperial research endeavors. (shrink)

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.

This paper explores definitions of death from the perspectives of several world and indigenous religions, with practical application for health care providers in relation to end of life decisions and organ and tissue donation after death. It provides background material on several traditions and explains how different religions derive their conclusions for end of life decisions from the ethical guidelines they proffer.

Successful preimplantation genetic diagnosis to avoid creating a child affected by a genetically-based disorder was reported in 1989. Since then PGD has been used to biopsy and analyze embryos created through in viuo fertilization to avoid transferring to the mother’s uterus an embryo affected by a mutation or chromosomal abnormality associated with serious illness. PGD to avoid serious and early-onset illness in the child-to-be is widely accepted. PGD prevents gestation of an affected embryo and reduces the chance that the parents (...) will be faced with a difficult decision of whether to terminate the pregnancy. More controversial have been PGD to select the sex of the child-to-be for “family balancing”, PGD for mere susceptibility to disease and for late-onset disorders such as Alzheimer diseas, and most controversially, PGD to create a donor child who is Human Leukocyte Antigen (HLA-matched with a preexisting sibling in need of stem cell transplant. (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)

Moral debate over vegetarianism forms the backdrop to a preliminary consideration of the questions: Is it ethical to produce, sell and eat faux meat? Is it ethical to produce, sell and wear fake animal skin? Is it ethical to sell or wear secondhand or thriftshop genuine animal skin? If vegetarianism is morally required, the question of just what uses of nonhuman animals are ethical or unethical and on what grounds is always on tap. In this piece, I examine the above (...) questions in light of deontological then utilitarian reasons for vegetarianism. I conclude deontological or animal rights grounds entail the moral condemnation of faux meat and fake and secondhand animal skin. I conclude utilitarian or animal welfare grounds entail, with some qualification, the moral acceptability of faux meat and fake animal skin but the clear moral unacceptability of secondhand animal skin. (shrink)

This study investigates the effectiveness of pedagogical practices used to teach business ethics. The business community has greatly increased its demands for better ethics education in business programs. Educators have generally agreed that the ethical principles of business people have declined. It is important, then, to examine how common methods of instruction used in business ethics could contribute to the development of higher levels of moral judgment competence for students. To determine the effectiveness of these methods, moral judgment competence levels (...) for undergraduate and graduate students from three institutions were measured and compared based upon the pedagogical method used in a business class. Significant differences were found for moral reasoning and moral competence scores depending on the method used for ethics instruction. Students in classes with more highly integrated ethics coverage scored higher in moral reasoning and moral competence. (shrink)

Developing ethical standards for clinical use of large-scale genome and exome sequencing has proven challenging, in part due to the inevitability of incidental or secondary findings. Policy of the American College of Medical Genetics and Genomics has evolved but remains problematic. In 2013, ACMG issued policy recommending mandatory analysis of 56 extra genes whenever sequencing was ordered for any indication, in order to ascertain positive findings in pathogenic and actionable genes. Widespread objection yielded a 2014 amendment allowing patients to opt-out (...) from analysis of the extra genes. In 2015, ACMG published the amended policy, providing that patients could opt out of the full set of extra genes, but not a subset. In 2016, ACMG enlarged the set and indicated planned expansion of the roster of extra genes to include pharmacogenetic findings. ACMG policy does not protect the respect for patient choice that prevails in other domains of clinical medicine, where informed consent allows patients to opt in to desired testing. By creating an expanding domain of genomic testing that will be routinely conducted unless patients reject the entire set of extra tests, ACMG creates an exceptional domain clinical practice that is not supported by ethics or science. (shrink)

Successful preimplantation genetic diagnosis to avoid creating a child affected by a genetically-based disorder was reported in 1989. Since then PGD has been used to biopsy and analyze embryos created through in viuo fertilization to avoid transferring to the mother’s uterus an embryo affected by a mutation or chromosomal abnormality associated with serious illness. PGD to avoid serious and early-onset illness in the child-to-be is widely accepted. PGD prevents gestation of an affected embryo and reduces the chance that the parents (...) will be faced with a difficult decision of whether to terminate the pregnancy. More controversial have been PGD to select the sex of the child-to-be for “family balancing”, PGD for mere susceptibility to disease and for late-onset disorders such as Alzheimer diseas, and most controversially, PGD to create a donor child who is Human Leukocyte Antigen (HLA-matched with a preexisting sibling in need of stem cell transplant. (shrink)

This research investigates the development of transferable - "adaptive" expertise. The study contrasts problem-solving performance of two kinds of experts (business consultants and restaurant managers) on novel problems at the intersection of their two domains, as well as a group of novices (non-business undergraduates). Despite a lack of restaurant experience, consultants performed better than restaurant managers and undergraduates, even though the problems concerned a restaurant. Process measures suggest this was due to the use of more theoretical reasoning. Analyses show this (...) resulted from differences in work experience and not other factors (e.g., education). We discuss aspects of experience that might be responsible for development of theoretical understanding and, thus, expertise that transfers to novel problems. One possible explanation, consistent with existing research from multiple approaches, is that to transfer to novel problems, experience must include substantive variability. The social context of learning may also play a role. (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)

It was thus the combination of observational and experimental approaches that ultimately led to confirmation of the outgrowth theory. The observational method was essential for defining various possible methods of nerve fiber development. The multicellular, protoplasmic bridge and outgrowth theories were each postulated to explain purely observational evidence. However, the lack of truly suitable equipment and techniques to study the developing nervous system made it impossible to agree on a single theory on this basis alone. The experimental method provided a (...) means of choosing between these theories. Without the preceding observations that had led to the formulation of various hypotheses, however, the experimental approach might not have been so successful, for the power of this method is more of selection than of generation.Therefore it is impossible to weigh separately the contributions of the observational and experimental approaches to the question of nerve fiber development. Both were necessary for the ultimate acceptance of the outgrowth theory. *** DIRECT SUPPORT *** A8402051 00004. (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.

Book reviewed in this article: Subjected to Science: Human Experimentation in America before the Second World War. By Susan E. Lederer.

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)

"Reasonably priced and beautifully produced. A clear and helpful introduction by Susan Okin, one of the leading feminist scholars of our generation, as well as a useful bibliography and chronology of Mill's life.... Invaluable for teaching and scholarship alike." --Ian Shapiro, Yale University.

In museum settings, caregivers support children's learning as they explore and interact with exhibits. Museums have developed exhibit design and facilitation strategies for promoting families' exploration and inquiry, but these strategies have rarely been contrasted. The goal of the current study was to investigate how prompts offered through staff facilitation vs. labels printed on exhibit components affected how family groups explored a circuit blocks exhibit, particularly whether children set and worked toward their own goals, and how caregivers were involved in (...) children's play. We compared whether children, their caregivers, or both set goals as they played together, and the actions they each took to connect the circuits. We found little difference in how families set goals between the two conditions, but did find significant differences in caregivers' actions, with caregivers in the facilitation condition making fewer actions to connect circuits while using the exhibit, compared to caregivers in the exhibit labels condition. The findings suggest that facilitated and written prompts shape the quality of caregiver-child interactions in distinct ways. (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.

An overview and critical discussion of Christine Overall’s Pets and People: The Ethics of Our Relationships With Companion Animals. Argues that the book contains important contributions to many of the major ethical issues associated with the keeping of “pets” but is lacking in discussion of the most fundamental issue—namely, whether it is ethical to keep “pets” at all.

Volume 20, Issue 8, August 2020, Page 41-43.

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.

In The Ethics of Ambiguity , Simone de Beauvoir makes reference to an “apprenticeship of freedom,” but she does not directly address why freedom requires an apprenticeship or what such an apprenticeship entails. Working from Beauvoir’s discussion of freedom in The Ethics of Ambiguity and her discussion of apprenticeships in The Second Sex , I explicate the idea of an apprenticeship of freedom, establishing why an apprenticeship is a necessary condition of freedom and describing how such an apprenticeship is administered. (...) In doing so, I draw together two strands of thought within recent research on Beauvoir—first, that Beauvoir conceives of freedom as embodied and, second, that she conceives of freedom as interpersonal—to consider how adults’ interactions with a child either support or impede the realization of this child’s freedom. (shrink)

The phenotype of some spontaneous mutations in Drosophila can be modified by mutations at unlinked loci. The affected alleles are caused by the insertion of retroviral transposable elements. The idiosyncratic functional and structural properties of these elements play a key role in determining the expression characteristics of the genes into which they are inserted. These phenotypes are reversed or intensified by the allelic state of suppressor and enhancer loci through changes in the transcriptional properties of the transposable elements.