How to Rethink the Fourteen‐Day Rule

Recently, attention has been drawn to the basic principles governing the use of human embryos in research: specifically, the so‐called fourteen‐day rule. This rule stipulates that human embryos should not be allowed to grow in vitro past fourteen days of development. For years, the fourteen‐day limit was largely theoretical, since culture techniques were not sufficient to maintain embryos up to this point. Yet in the past year, research has suggested that growing embryos beyond fourteen days might be feasible and scientifically valuable. At the same time, work with pluripotent stem cells, including human PSCs, has shown that under certain conditions, they can form structures that recapitulate developmental features of the postimplantation embryo. This raises the possibility that PSCs could generate embryo‐like structures in vitro, even “synthetic embryos,” that might provoke moral concern but would not fall under most current embryo research policies. In countries that permit embryo research, the fourteen‐day rule has long been the linchpin of an effective policy compromise between what remain deeply divided moral positions on the human embryo's status. It has also, particularly in the United Kingdom, been influential in establishing a bioethics public‐policy process. Any moves to change the rule must consider not just the implications for the use of embryos but also the potential impact of this model of bioethical governance of science.     

Beecher Reconsidered

In 1962, Harvard professor of anesthesiology Henry Beecher wrote to Senator Estes Kefauver about certain additions to the federal Food and Drug Act then being considered. According to The Antibiotic Era, the Maryland congressman Samuel Friedel had introduced language that would require informed consent in clinical research. Beecher joined a number of other distinguished medical scientists warning that such a requirement would “cripple” American medical research. A year before, Beecher had protested the U.S. Army's inclusion of the Nuremberg Code in its contracts. Beecher's commitment to a medical ethics of virtue rather than one of oversight suggests that he was a far more interesting person than the cardboard cutout so often vaguely referenced in bioethics as an icon of the rights of human subjects. His thinking about research ethics was rooted in his post‐World War II laboratory work with LSD.     

Community Engagement and Field Trials of Genetically Modified Insects and Animals

New techniques for the genetic modification of organisms are creating new strategies for addressing persistent public health challenges. For example, the company Oxitec has conducted field trials internationally—and has attempted to conduct field trials in the United States—of a genetically modified mosquito that can be used to control dengue, Zika, and some other mosquito‐borne diseases. In 2016, a report commissioned by the National Academies of Sciences, Engineering, and Medicine discussed the potential benefits and risks of another strategy, using gene drives. Driving a desired genotype through a population of wild animals or insects could lead to irreversible genetic modification of an entire species. The NASEM report recommends community, stakeholder, and public engagement about potential uses of the technology, and it argues that the engagement should occur as research advances, well before gene drives are deployed. Yet what “engagement” means in practice is unclear. This article seeks clarity on this problem by offering a justification for community engagement and drawing out implications of this argument for the implementation and desired outcomes of community engagement. Community engagement is essential when it comes to research that would release genetically modified insects or animals into the environment. By contrast, obtaining informed consent from people who live near such a proposed field trial is neither necessary nor sufficient. Drawing on the epistemic and moral arguments for deliberative democracy, I propose two discrete mechanisms of community engagement: community advisory boards and deliberative forums, neither of which has been systematically incorporated into research governance. The proposed mechanisms would engender respect for persons who live near field trials, even when the results of deliberation override some individuals’ preferences. Community engagement foregrounds the community in our thinking about humans’ relationship to nature, and it implies that deciding to release genetically modified insects or animals into the wild ought to be a collective decision, not one made by product developers, policy‐makers, private companies, research funders, or scientists alone.     

Surplus embryos,nonreproductive cloning,and the intend/foresee distinction

There is, as some public figures have asserted, a real moral difference between creating embryos expressly for medical research and conducting research on embryos that are left over from infertility treatments. To create an embryo intending all along to destroy it is worse. But in the end, it isn't so much worse that we should ban all nonreproductive cloning.     

Change without Change? Assessing Medicare Reimbursement for Advance Care Planning

In January 2016, Medicare began reimbursing clinicians for time spent engaging in advance care planning with their patients or patients’ surrogates. Such planning involves discussions of the care an individual would want to receive should he or she one day lose the capacity to make health care decisions or have conversations with a surrogate about, for example, end‐of‐life wishes. Clinicians can be reimbursed for face‐to‐face explanation and discussion of care and advance directives and for the completion of advance care planning forms. Although it seems that political barriers to reimbursement for such planning have largely faded, the Medicare policy's impact on provider billing practices appears to be limited, suggesting other barriers to clinician engagement in advance care planning. Additionally, the effects of this policy on patient behavior and the clinician‐patient relationship are not yet known.     

Making Reproductive Choices in the Face of Genetic Uncertainty

In the engaging and thought‐provoking book The Gene Machine: How Genetic Technologies Are Changing the Way We Have Kids and the Kids We Have, Bonnie Rochman addresses the question of choice in human reproduction through the lens of knowledge. Asserting that the desire for knowledge is the central theme of modern‐day reproduction, she asks, “Is genetic knowledge empowering or fear‐inducing or both?” Yet the question at the heart of the book goes beyond knowledge. Rochman delves into whether genetic information is actionable and then examines the corollary question of whether individuals should make decisions based on this data. Do parents want to choose the kinds of kids they have? Certainly, most parents would do what they could to prevent their child from having a painful, life‐limiting disease. But that is the extreme. And while genetic technologies generally start by targeting the extreme, the inevitable byproduct is the ability to know about and affect the fringe. It is at the borders that the critical questions lie. Taking advantage of reproductive choices has potentially life‐altering and permanent consequences not only for the chooser but also for the resulting child, the family unit, and society.     

Embryonic stem cells and property rights

This article contributes to the current debate on human embryonic stem cell researchers' possible complicity in the destruction of human embryos and the relevance of such complicity for the issue of commodification of human embryos. I will discuss if, and to what extent, researchers who destroy human embryos, and researchers who merely use human embryos destroyed by others, have moral use rights, and/or moral property rights, in these embryos. I argue that the moral status of the human embryo, however justified, places few restrictions on the latter researchers' use of it, and property rights in it, once it is destroyed. I argue that the former researchers have no property rights in the destroyed embryo but use rights in it to the extent allowed by the legitimate owners of the destroyed embryo. I discuss the implications of this account for previous and current US federal law regulating human embryonic stem cell research.     

Researchers and firing squads: questions concerning the use of frozen human embryos

Is it morally acceptable to use human embryos left over from fertility treatments in research that would harm or destroy them? Many answer "no" to this question on the grounds that all human beings, including human embryos, have a basic moral status that forbids such use. There are some, though, who accept this claim about the basic moral status of human embryos but who believe nevertheless that frozen human embryos which were generated for fertility treatments but which are no longer wanted for that project are a morally acceptable source of human embryonic stem cells and are acceptable subjects of other forms of research that would destroy them in course. The reasoning offered in defense of this position typically employs the claim that since these embryos are going to be discarded anyway, their possibly fruitful use by researchers is a preferable alternative and one that is not inconsistent with their basic moral status. Howard Curzer has offered a well-developed argument of this sort, defending the use of these embryos in the ways mentioned while at the same time allowing for their equal basic moral status. This article challenges Curzer's case and offers reasons to reject the moral acceptability of using even these to-be-discarded embryos as research material.     

The Influenza Controversy: Should Limits Be Placed on Science?

Should government have the power to place limits on a scientific pursuit that holds the potential for both good and harm—on what is called “dual‐use research”? That is the highly charged question surrounding research to genetically modify influenza A (H5N1) to render it more easily transmissible from human to human. There is seldom a “right” answer to dual‐use research, but a fair, inclusive, and transparent process—building on the NSABB model—should improve decision‐making. A local institutional panel should evaluate dual‐use research based on the following structured ethical framework.     

An Argument for Fewer Clinical Trials

The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees (RECs) should prohibit all other, lower‐quality research, even when it might appear to meet some minimal ethical standard. Following a close analysis of the social‐value requirement of ethical clinical research, I argue that this proposal is defensible. The problem identified in this paper has two parts, quantity and quality, and some clarification is needed about the latter because “quality” is a highly contested term in the medical literature. When some scholars advocate for high‐quality trials, they mean large‐scale, simple, explanatory randomized controlled trials. Others, including myself, have defended a different characterization of high‐quality research that tends more toward pragmatic trial design and the use of methods other than RCTs. Pragmatic trials aim to provide evidence that directly supports clinical decision‐making in “usual” care settings. Unlike explanatory trials, which aim to abstract away from particular settings and patients, in the hopes of creating ideal conditions for the success of an intervention, pragmatic trials deliberately pursue knowledge of high applicability, through the use of representative subjects, clinically important questions, flexible treatment protocols, patient‐oriented outcome measures, and so on. I see applicability as a marker of high‐quality research. The context in which research is meant to be applied should be the context in which new interventions are evaluated.     

Crowdsourcing the Moral Limits of Human Gene Editing?

In 2015, a flourish of “alarums and excursions” by the scientific community propelled CRISPR/Cas9 and other new gene‐editing techniques into public attention. At issue were two kinds of potential gene‐editing experiments in humans: those making inheritable germ‐line modifications and those designed to enhance human traits beyond what is necessary for health and healing. The scientific consensus seemed to be that while research to develop safe and effective human gene editing should continue, society's moral uncertainties about these two kinds of experiments needed to be better resolved before clinical trials of either type should be attempted. In the United States, the National Academies of Science, Engineering and Medicine (NASEM) convened the Committee on Human Gene Editing: Scientific, Medical and Ethical Considerations to pursue that resolution. The committee's 2017 consensus report has been widely interpreted as “opening the door” to inheritable human genetic modification and holding a line against enhancement interventions. But on a close reading it does neither. There are two reasons for this eccentric conclusion, both of which depend upon the strength of the committee's commitment to engaging diverse public voices in the gene‐editing policy‐making process.     

Beyond Primates: Research Protections and Animal Moral Value

Should monkeys be used in painful and often deadly infectious disease research that may save many human lives? This is the challenging question that Anne Barnhill, Steven Joffe, and Franklin G. Miller take on in their carefully argued and compelling article “The Ethics of Infection Challenges in Primates.” The authors offer a nuanced and even‐handed position that takes philosophical worries about nonhuman primate moral status seriously and still appreciates the very real value of such research for human welfare. Overall, they argue for an extension and revision of the recommendations regarding chimpanzee research offered by the Institute of Medicine in 2011; the practical upshot of their argument would allow for infection challenge research for promising interventions for Ebola and Marburg virus diseases but not for smallpox or the common cold. The IOM recommendations regarding chimpanzee research put in motion an exceptionalist policy for this great ape population. Barnhill and colleagues’ proposal would enlarge the scope of that exceptionalism to embrace NHPs other than great apes. But is such exceptionalism warranted? It is not obvious to me either that the more sophisticated capacities of a species as a whole give it greater ethical protections or that less intellectually or socially sophisticated animals ought to therefore receive less protection when it comes to painful experimental interventions.     

The Next Wave in Health Care Priority Setting

A new problem in health care priority‐setting is currently emerging for wealthy countries: what should be done when a new drug is considered cost effective but implementing it would still be unaffordable? The standard approach to setting priorities in health care rests on cost effectiveness. This approach is now being tested by new drugs that are highly effective but very costly. Because they are so effective, these drugs deliver “value for money” despite their high cost. However, when the targeted condition affects a sizeable number of patients, implementing the drugs becomes unaffordable. There are no easy alternatives. A key virtue of setting health care priorities with a presumptive cost‐effectiveness threshold is that it provides all patients a prima facie equal claim on the available resources, and alternative approaches to addressing affordability face their own challenges.     

The embryo in relationships: a French debate on stem cell research

While many European countries are entering unknown legal terrain where the embryo in vitro is concerned, France can already look back on a long tradition of public discussion and legal codification of ways of dealing with in vitro embryos. In its comprehensive law of 1994, France had still rejected embryo research; however, due to the promising perspectives of stem cell research, the new law now pending implies a clear liberalization of the 1994 provisions. Both the French lawmakers and the National Ethics Commission have repeatedly argued that possible utilization of embryos for research purposes may seem legitimate from the moment that there is no more "parental project." De facto, this concept implies that an embryo can be transformed into an object from the moment that the parents cease to desire it and that the value of protection is solely dependent on the will of third persons. At the same time, France is still speaking of guaranteeing respect for the "dignity of the embryo," which would mean that an embryo must not be reduced to a thing and treated for purposes which are not his own. Therefore, the French solution is not a consistent and honest solution, and in its new legal provisions, France has involved herself in manifold contradictions. France has rejected the conception of pre-embryo, but is de facto following Britain's model without making it explicit.     

Social Media,E‐Health,and Medical Ethics

Given the profound influence of social media and emerging evidence of its effects on human behavior and health, bioethicists have an important role to play in the development of professional standards of conduct for health professionals using social media and in the design of online systems themselves. In short, social media is a bioethics issue that has serious implications for medical practice, research, and public health. Here, we inventory several ethical issues across four areas at the intersection of social media and health: the impact of social networking sites on the doctor‐patient relationship, the development of e‐health platforms to deliver care, the use of online data and algorithms to inform health research, and the broader public health consequences of widespread social media use. In doing so, we review discussions of these topics and emphasize the need for bioethics to focus more deeply on the ways online technology platforms are designed and implemented. We argue that bioethicists should turn their attention to the ways in which consumer engagement, bias, and profit maximization shape online content and, consequently, human behavior and health. We also offer a set of recommendations and suggest future directions for addressing ethical challenges in these domains.     

The Social Science Blues

At the dawn of the new century, Robert Plomin was gloomy. As he recounts in Blueprint: How DNA Makes Us Who We Are, attempts to find the DNA responsible for the heritability of behavior failed. Month after month, journals would report new findings of specific genes for behavioral phenotypes, but they never replicated. One amazing genomic methodology after another was developed in biological genetics and applied to medicine, where it succeeded, and then to human behavior, where it failed. This was the moment of Plomin's despair. He had, with great intellectual courage, staked his reputation on the existence of actionable scientific knowledge of the DNA‐based genesis of twin‐based heritability. But Blueprint is hardly the product of a gloomy author. Quite the opposite: it is a declaration of victory of nature over nurture, a celebration of the vindication of Plomin as a scientist and of behavior genetics as a field of study. What happened between 2000 and 2019 to brighten Plomin's outlook so radically? Were the genes for schizophrenia and intelligence finally discovered? Are we at last on our way to understanding why, at a biological level, all differences in human behavior are substantially heritable? Alas, no. What happened is that Robert Plomin gave up on the search for individual genes that explain heritability and decided to be satisfied with much less.     

The Question of Human Cloning

The idea of splitting off cells from embryos to clone human beings sounds so bizarre and dangerous that one would think the practice should not be permitted. A closer look reveals its ethical acceptability.     

Human embryos in the original position?

Two different discussions in John Rawls' A Theory of Justice lead naturally to a rather conservative position on the moral status of the human embryo. When discussing paternalism, he claims that the parties in the original position would seek to protect themselves in case they end up as incapacitated or undeveloped human beings when the veil of ignorance is lifted. Since human embryos are examples of such beings, the parties in the original position would seek to protect themselves from their embryonic stages onward. When discussing the basis of equality, Rawls claims that the parties in the original position would guarantee basic rights for all those with the capacity to take part in this original position. To guarantee the basic rights of infants and young children, he goes on to interpret this capacity as a "potentiality that is ordinarily realized in due course." Since human embryos have this potentiality, they too should have basic rights.     

Asylum,Refuge, and Justice in Health

We are, as of May 2019, witnessing yet another “caravan” of people fleeing violence in Latin America, bonding together to reach the territory of safer states in the North. Similarly, in the fall of 2015, Europe experienced the movement of many refugees fleeing war, persecution, and grave human rights violations in Syria. These new waves of people on the move have raised anew important questions about asylum and refuge: who should be able to claim asylum? Should the fear of persecution be sufficient, or do asylum seekers need to show that they have actually suffered it? And maybe most controversially, how should asylum‐granting states respond to the plight of those asking for asylum on their territory? The moral principles guiding asylum and refuge are different from the rules usually regulating immigration, which are based on the principle of territorial sovereignty that allows nation‐states to discriminate and select among those who hope to immigrate. Asylum and refuge instead call upon nation‐states to provide refugees with a new home, protect human rights, and over time, provide access to the social, political and civic rights that characterize membership. Included in the list of human rights, I will argue, is the provision of the means for individual physical and psychological well‐being.     

What Is the Value of Three‐Parent IVF?

In February 2016, the Institute of Medicine released a report, commissioned by the United States Food and Drug Administration, on the ethical and social‐policy implications of so‐called three‐parent in vitro fertilization. The IOM endorses commencement of clinical trials on three‐parent IVF, subject to some initial limitations. Also called mitochondrial replacement or transfer, three‐parent IVF is an intervention comprising two distinct procedures in which the genetic materials of three people—the DNA of the father and mother and the mitochondrial DNA of an egg donor—can be used to create a child. Three‐parent IVF would enable a woman with mitochondrial disease to have a genetically related child without transmitting the disease to the child. The possibility for three‐parent children has prompted criticism from many corners. Critics have pointed to ethical issues including safety concerns and risks to children, genetic and germline engineering concerns, the potential exploitation of the third‐parent egg donor, donor anonymity and privacy, and objections to creating babies with three parents, which undermines natural and traditional conceptions of procreation. Additionally, developing the technology would involve experimenting on, manipulating, and disposing of embryos. Although the IOM report considers the ethical concerns about the value of the three‐parent IVF technology, the IOM failed to give due attention to an important objection to the development of this technology: three‐parent IVF lacks the social value necessary to make investment of public resources in it ethical. Unlike the other concerns, this objection is not based on conservativism about new reproductive technologies or default favoritism of the status quo. I argue that the technology does not meet a plausible social value standard to render public research investment into its development ethical. Proponents of three‐parent IVF make inaccurate and exaggerated claims that it will eradicate mitochondrial disease and save lives. Were these claims true, proponents would have a strong case for the social value of the technology. But three‐parent IVF alone will not eradicate mitochondrial disease, and it will not save lives. Rather, it can create healthy lives. As I discuss, the moral distinction is crucial. Most importantly, investment in three‐parent IVF comes at the opportunity cost of researching treatment for mitochondrial disease that would benefit actual, living disease sufferers.