Health care is transitioning from genetics to genomics, in which single-gene testing for diagnosis is being replaced by multi-gene panels, genome-wide sequencing, and other multi-genic tests for disease diagnosis, prediction, prognosis, and treatment. This health care transition is spurring a new set of increased or novel liability risks for health care providers and test laboratories. This article describes this transition in both medical care and liability, and addresses 11 areas of potential increased or novel liability risk, offering recommendations to both (...) health care and legal actors to address and manage those liability risks. (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.

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.

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.

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.

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)

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)

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)

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)

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.

The Tuskegee Syphilis Study is surrounded by illuminating misconceptions—myths that cannot be blithely dismissed because they actually provide some insight into the significance of the study. One of those is that the men were deliberately infected with syphilis; another is that they obtained no treatment for the disease. Some other errors are alleged in two recent articles about the study, but these articles themselves create their own fictions.

Hegel and Canada is a collection of essays that analyses the real, but under-recognized, role Hegel has played in the intellectual and political development of Canada. The volume focuses on the generation of Canadian scholars who emerged after World War Two: James Doull, Emil Fackenheim, George Grant, Henry S. Harris, and Charles Taylor.

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

ponsibilities compounds these challenges. This article presents an overview of research and standards of practice regarding children's participation in research and healthcare decisions. Further research on children's competence to participate in healthcare decisions is recommended. Reasons for and against children's increased involvement in healthcare decisions are included. There is a preponderance of support for involving children in the process, and a dearth of well-articulated reasons to exclude them....

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)

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)

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)

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.

This collection of essays examines how philosophers in the Western tradition have viewed and written about children through the ages. (Philosophy).

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)

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)

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)