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...

Different types of consent are used to obtain human biospecimens for future research. This variation has resulted in confusion regarding what research is permitted, inadvertent constraints on future research, and research proceeding without consent. The National Institutes of Health Clinical Center's Department of Bioethics held a workshop to consider the ethical acceptability of addressing these concerns by using broad consent for future research on stored biospecimens. Multiple bioethics scholars, who have written on these issues, discussed the reasons for consent, the (...) range of consent strategies, and gaps in our understanding, and concluded with a proposal for broad initial consent coupled with oversight and, when feasible, ongoing provision of information to donors. This article describes areas of agreement and areas that need more research and dialogue. Given recent proposed changes to the Common Rule, and new guidance regarding storing and sharing data and samples, this is an important and tim.. (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)

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)

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.

The scientific, ethical, and policy issues raised by research involving the engraftment of human neural stem cells into the brains of nonhuman primates are explored by an interdisciplinary working group in this Policy Forum. The authors consider the possibility that this research might alter the cognitive capacities of recipient great apes and monkeys, with potential significance for their moral status.

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)

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...

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)

The prospect of using cell-based interventions to treat neurological conditions raises several important ethical and policy questions. In this target article, we focus on issues related to the unique constellation of traits that characterize CBIs targeted at the central nervous system. In particular, there is at least a theoretical prospect that these cells will alter the recipients' cognition, mood, and behavior—brain functions that are central to our concept of the self. The potential for such changes, although perhaps remote, is cause (...) for concern and careful ethical analysis. Both to enable better informed consent in the future and as an end in itself, we argue that early human trials of CBIs for neurological conditions must monitor subjects for changes in cognition, mood, and behavior; further, we recommend concrete steps for that monitoring. Such steps will help better characterize the potential risks and benefits of CBIs as they are tested and potentially used for treatment. (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.

Much of the legal and social interest in new neuroimaging techniques stems from the belief that they can deliver on the materialist understanding of the relationship between the brain and the mind. This article looks at predictions about the future both of scientific advances and of social reactions to those predictions. It looks at the likely technical limits on neuroscience-based mindreading, then at the likely limits in how the law might use such technologies. It describes three kinds of technical barriers (...) to detailed and useful mindreading: the likely impossibility of making a complete and accurate model of a human brain in light of its incredible complexity, the problems of interpersonal and intrapersonal plasticity, and the problem of trying to read, now, someone's past mental state. The potential changes to the operation of the law, through the use of mindreading as evidence of pain, deception, or bias, among other things, could be extremely important. (shrink)

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)

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)

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)

In 2011, the Department of Health and Human Services proposed changes to the regulations that govern human subjects protection in federally funded research. The proposed changes involve modifying inclusion standards for minimal-risk research and removing the necessity of review from certain categories of noninvasive research. All studies would instead be required to comply with privacy protections as initiated by the Health Information Portability and Accountability Act . We argue that relying on HIPAA to protect participants from participation-related risks in noninvasive (...) research is insufficient to protect the autonomy and psychological health of potential research participants. Instead, we suggest a streamlined review format for these categories of research. (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)

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.

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)

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...