This chapter explores the questions “What policy tools do we have to deal with human biological enhancements?” as well as “What policy tools do we need?.” After discussing the policy tools available in the United States, it examines their adequacy in coping with human biological enhancements in two respects – how easy they would be to adopt and how easy they would be to enforce. In each category, three major issues raised by human biological enhancement are considered: safety, coercion, and (...) fairness. It looks first at the adoption of, then at the enforcement of, policy tools available in the United States to cope with three real problems raised by such enhancements. It concludes that some policy tools needed to deal with enhancement already exist but need to be better focused. New legislation is the most direct way for the federal government to implement policy, but it is rarely easy. (shrink)

Human brain research is moving into a dilemma. The best way to understand how the human brain works is to study living human brains in living human beings, but ethical and legal standards make it d...

Direct-to-Consumer genomics has been a controversial topic for over a decade. Much work has been done on the legal issues it raises. This article asks a different question: What will DTC genomics and its legal issues look like in ten to twenty years? After discussing the five current uses of DTC genomics, it describes three current legal issues: medical uses, privacy of genomic information, and privacy in collection and analysis of human DNA. It then suggests that changes in human genomics (...) and how it is used will make the first of those DTC genomics legal issues less important in the future, but that the third will be increasingly significant. (shrink)

The authors examine the scientific possibility and the legal and ethical implications of using DNA forensic technology, through partial matches to DNA from crime scenes, to turn into suspects the relatives of people whose DNA profiles are in forensic databases.

I have been involved with the current interest in de‐extinction since early 2012, nearly its beginning. I have given a lot of thought to the potential risks and benefits of de‐extinction. But only recently, after deep immersion in discussions around CRISPR‐Cas9, the hottest new tool in bioscience since polymerase chain reaction, have I thought about a more fundamental question: how, if at all, is de‐extinction special? Are “revived species” just another kind of genetically modified organism, raising essentially the same general (...) concerns? I answer, for the most part, yes. De‐extinction is not (very) special. New biotechnologies are giving humans even more power to change the biosphere but more directly, more quickly, and more utterly than ever before. De‐extinction is just one possible, and probably small, use of those technologies. Our attention, for the most part, should be on the bigger issues of regulating this power, rather than focusing specifically on their application to de‐extinction. (shrink)

Neuroscience is clearly making enormous progress toward understanding how human brains work. The implications of this progress for ethics, law, society, and culture are much less clear. Some have argued that neuroscience will lead to vast changes, superseding much of law and ethics. The likely limits to the explanatory power of neuroscience argue against that position, as do the limits to the social relevance of what neuroscience will be able to explain. At the same time neuroscience is likely to change (...) societies through increasing their abilities to predict future behavior, to infer subjective mental states by observing physical brain states (“read minds”), to provide evidence in some cases relevant to criminal responsibility, to provide new ways to intervene to “treat antisocial brains,” and to enhance healthy brains. Neuroscience should make important cultural changes in our special, and specially negative, views of “mental” versus “physical” illness by showing that mental illness is a dysfunction of a physical organ. It will not likely change our beliefs, implicit or explicit, in free will, or spark a new conflict between science and religion akin to the creationism controversy. (shrink)

“The sins of the fathers are to be laid upon the children.”Just after midnight on March 21, 2003, a drunk stood on a footbridge over a motorway in a village in Surrey in southern England. After eight pints of beer, he was drunk enough to decide to drop a brick from the overpass into traffic to see if he could hit something; unfortunately, he was not so drunk that he missed. The brick crashed through the windshield on the driver's side (...) of a truck. It hit the driver, Michael Little, in the chest, triggering a fatal heart attack. He stayed conscious long enough to pull the truck safely to the side of the road, thereby perhaps saving other motorists; then he died. The crime was widely publicized, as was the driver's role in preventing any further accidents. (shrink)

This essay focuses on possible nonhuman applications of CRISPR/Cas9 that are likely to be widely overlooked because they are unexpected and, in some cases, perhaps even “frivolous.” We look at five uses for “CRISPR Critters”: wild de-extinction, domestic de-extinction, personal whim, art, and novel forms of disease prevention. We then discuss the current regulatory framework and its possible limitations in those contexts. We end with questions about some deeper issues raised by the increased human control over life on earth offered (...) by genome editing. (shrink)

True revolutions turn the entire world upside down, in ways expected and surprising, profound and mundane. The revolution spawned by advances in molecular biology is no exception. Most of the attention has gone, deservedly, to the possible effects of these advances on medicine, on society, and on our understanding of what it means to be human. But the revolution has already had effects—large and small, good and bad—in other areas. This paper analyzes one aspect of the industry created by that (...) revolution in molecular biology–biotechnology. Specifically, it surveys the various kinds of conflicting interests, both real and perceived, that develop among commercial enterprises, government, and institutions in biotechnology; and it examines the legal implications and public policy concerns of these conflicting interests.The paper focuses on three different kinds of conflicting interests that confront private and public enterprises competing or collaborating in the biotechnology industry: those among businesses involved within the industry; those in relationships between industry and government; and those in relationships between industry and universities. These types of conflicts raise very different issues, but each stems from circumstances unique to the young biotechnology industry. (shrink)

True revolutions turn the entire world upside down, in ways expected and surprising, profound and mundane. The revolution spawned by advances in molecular biology is no exception. Most of the attention has gone, deservedly, to the possible effects of these advances on medicine, on society, and on our understanding of what it means to be human. But the revolution has already had effects—large and small, good and bad—in other areas. This paper analyzes one aspect of the industry created by that (...) revolution in molecular biology–biotechnology. Specifically, it surveys the various kinds of conflicting interests, both real and perceived, that develop among commercial enterprises, government, and institutions in biotechnology; and it examines the legal implications and public policy concerns of these conflicting interests.The paper focuses on three different kinds of conflicting interests that confront private and public enterprises competing or collaborating in the biotechnology industry: those among businesses involved within the industry; those in relationships between industry and government; and those in relationships between industry and universities. These types of conflicts raise very different issues, but each stems from circumstances unique to the young biotechnology industry. (shrink)

In April 2019 Yale Professor Nenad Sestan’s “BrainEx” experiments startled the world (Vrselja 2019). Four hours after pigs were decapitated, researchers perfused the pigs’ brains using what they ca...

Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons. We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.

For the average person, genetic testing has two very different faces. The rise of genetic testing is often promoted as the democratization of genetics by enabling individuals to gain insights into their unique makeup. At the same time, many have raised concerns that genetic testing and sequencing reveal intensely personal and private information. As these technologies become increasingly available as consumer products, the ethical, legal, and regulatory challenges presented by genomics are ever looming. Assembling multidisciplinary experts, this volume evaluates the (...) different models used to deliver consumer genetics and considers a number of key questions: How should we mediate privacy and other ethical concerns around genetic databases? Does aggregating data from genetic testing turn people into products by commercializing their data? How might this data reduce or exacerbate existing healthcare disparities? Contributing authors also provide guidance on protecting consumer privacy and safety while promoting innovation. (shrink)

This article is the lead piece in a special report that presents the results of a bioethical investigation into chimeric research, which involves the insertion of human cells into nonhuman animals and nonhuman animal embryos, including into their brains. Rapid scientific developments in this field may advance knowledge and could lead to new therapies for humans. They also reveal the conceptual, ethical, and procedural limitations of existing ethics guidance for human‐nonhuman chimeric research. Led by bioethics researchers working closely with an (...) interdisciplinary work group, the investigation focused on generating conceptual clarity and identifying improvements to governance approaches, with the goal of helping scholars, funders, scientists, institutional leaders, and oversight bodies (embryonic stem cell research oversight [ESCRO] committees and institutional animal care and use committees [IACUCs]) deliver principled and trustworthy oversight of this area of science. The article, which focuses on human‐nonhuman animal chimeric research that is stem cell based, identifies key ethical issues in and offers ten recommendations regarding the ethics and oversight of this research. Turning from bioethics’ previous focus on human‐centered questions about the ethics of “humanization” and this research's potential impact on concepts like human dignity, this article emphasizes the importance of nonhuman animal welfare concerns in chimeric research and argues for less‐siloed governance and oversight and more‐comprehensive public communication. (shrink)

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (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.

Institutional ethics consultation services for biomedical scientists have begun to proliferate, especially for clinical researchers. We discuss several models of ethics consultation and describe a team-based approach used at Stanford University in the context of these models. As research ethics consultation services expand, there are many unresolved questions that need to be addressed, including what the scope, composition, and purpose of such services should be, whether core competencies for consultants can and should be defined, and how conflicts of interest should (...) be mitigated. We make preliminary recommendations for the structure and process of research ethics consultation, based on our initial experiences in a pilot program. (shrink)

Science is driven by technical innovations, and perhaps nowhere as visibly as in neuroscience. In the past decade, advances in methods have led to an explosion of studies in cognitive (Gazzaniga et...

The contributors to The Moral of the Story, all preeminent political theorists, are unified by their concern with the instructive power of great literature. This thought-provoking combination of essays explores the polyvalent moral and political impact of classic world literatures on public ethics through the study of some of its major figures-including Shakespeare, Dante, Cervantes, Jane Austen, Henry James, Joseph Conrad, Robert Penn Warren, and Dostoevsky. Positing the uniqueness of literature's ability to promote dialogue on salient moral and intellectual (...) virtues, editor Henry T. Edmonson III has culled together a wide-ranging exploration of such fundamental concerns as the abuse of authority, the nature of good leadership, the significance of "middle class virtues" and the needs of adolescents. This collection reinvigorates the study of classic literature as an endeavor that is not only personally intellectually satisfying, but also an inimitable and unique way to enrich public discourse. (shrink)

Return to Good and Evil: Flannery O'Connor's Response to Nihilism is a superb guide to the works of Flannery O'Connor; and like O'Connor's stories themselves, it is captivating, provocative, and unsettling. Edmondson organizes O'Connor's thought around her principal concern, that with the nihilistic claim that "God is dead" the traditional signposts of good and evil have been lost. Edmondson's book demonstrates that the combination of O'Connor's artistic brilliance and philosophical genius provide the best response to the nihilistic despair of the (...) modern world—a return to "good and evil" through humility and grace. (shrink)

Return to Good and Evil: Flannery O'Connor's Response to Nihilism is a superb guide to the works of Flannery O'Connor; and like O'Connor's stories themselves, it is captivating, provocative, and unsettling. Edmondson organizes O'Connor's thought around her principal concern, that with the nihilistic claim that 'God is dead' the traditional signposts of good and evil have been lost. Edmondson's book demonstrates that the combination of O'Connor's artistic brilliance and philosophical genius provide the best response to the nihilistic despair of the (...) modern world—a return to 'good and evil' through humility and grace. (shrink)

The contributors to The Moral of the Story, all preeminent political theorists, are unified by their concern with the instructive power of great literature. This thought-provoking combination of essays explores the polyvalent moral and political impact of classic world literatures on public ethics through the study of some of its major figures-including Shakespeare, Dante, Cervantes, Jane Austen, Henry James, Joseph Conrad, Robert Penn Warren, and Dostoevsky. Positing the uniqueness of literature's ability to promote dialogue on salient moral and intellectual (...) virtues, editor Henry T. Edmonson III has culled together a wide-ranging exploration of such fundamental concerns as the abuse of authority, the nature of good leadership, the significance of "middle class virtues" and the needs of adolescents. This collection reinvigorates the study of classic literature as an endeavor that is not only personally intellectually satisfying, but also an inimitable and unique way to enrich public discourse. (shrink)