Faculty Bibliography

This chapter will examines places where law, religion, and reproductive technology conflict. It examines four particular intersections: The first involves religiously motivated denials of service, in particular as they pertain to single and gay and lesbian couples. The second involves embryo adoption, where the largest providers of the service in the United States are religious organizations. The third is a bit of a dog that didn’t bark (at least so far): the “personhood movement” and its attempts to gain state constitutional protection for zygotes, embryos, and fetuses. Finally, the chapter will close by discussing relatively new attempts by religious organizations to bring forward objections to embryo destruction in pre-embryo disposition disputes between private individuals, in particular a recent case in Missouri that is currently being litigated.

This comprehensive report, published as part of the Football Players Health Study at Harvard University, highlights areas in which the player health related policies and practices of the NFL could potentially be improved by considering steps taken by other professional sports leagues. While the report concludes that the NFL’s player health provisions are generally the most protective of player health among the relevant comparators, there are still important opportunities for improvement. The report is unprecedented both in scope and focus. This is the first comprehensive comparison of the health-related policies and practices of elite professional sports leagues: the National Football League (NFL); Major League Baseball (MLB); National Basketball Association (NBA); National Hockey League (NHL); Canadian Football League (CFL); and, Major League Soccer (MLS). After analyzing the leagues, the report compares each one to the NFL on the following health-related issues: (1) Club Medical Personnel (including discussion of conflicts of interest); (2) Injury Rates and Policies (including detailed comparisons of concussion rates); (3) Health-Related Benefits (including health insurance and retirement benefits for current and former players); (4) Drug and Performance-Enhancing Substance Policies; (5) Compensation (including guaranteed compensation); and, (6) Eligibility Rules (including discussion of the “readiness” of athletes for professional play). The areas in which the NFL can potentially learn from other leagues are: 1. Pre-season physicals performed by a neutral physician (CFL). 2. Concussion-specific short-term injury list (MLB). 3. Injury reporting policies that do not require disclosure of the location of a player’s injury (MLB, NHL, and CFL). 4. Health insurance to players for life (MLB, NBA, and NHL). 5. Retirement plan payments higher than the NFL (MLB, NBA, and NHL). 6. Players vested in pension plans on their first day in the league (MLB and NHL). 7. Treatment for players who violated performance-enhancing substance policies (NBA and CFL). 8. More guaranteed compensation than in the NFL (MLB, NBA, and NHL). 9. Less restrictive eligibility rules (MLB, NBA, NHL, and MLS).

We live in the age of globalization. In medicine, that globalization has brought many benefits such as the diffusion of technology and the spread of health care training, but it has also brought threats to biosecurity. This article examines how medical tourism and medical migration pose risks to biosecurity. It also argues that designing legal responses to these risks requires not only technical competence but also a theory of global justice to guide that design.

Ensuring that clinical trials, once launched, successfully complete and generate useful knowledge is an important and indeed ethically imperative goal, given the risks and burdens borne by research participants. Since there are insufficient willing research participants to power all the trials that are currently undertaken,1 addressing underenrolment will require prioritisation decisions that reduce the number of trials competing for participants. While there are multiple levels at which research priority-setting can and does take place, competition between trials often plays out in real time at the institutional or site level, where complex decisions must be made about how to manage overlapping trials in ways that balance different considerations, including the risk of non-completion. We sought to explore what research institutions in particular might ethically do to mitigate the risk that competition between trials will contribute to recruitment shortfalls. Against this backdrop, we appreciate the thoughtful replies to our article and are especially encouraged that all three respondents acknowledge the importance and indeed necessity of setting research priorities in ways that respect the rights and interests of various parties. The key question raised by the commentaries primarily concerns not whether research prioritisation should take place but rather how it is best accomplished. In what follows, we clarify our argument in the original article, and then focus on several points raised in the commentaries regarding the role of institutions in research priority-setting. Our approach is animated by the risk that competition between clinical trials for the same population of participants can be a cause of underenrolment when there are insufficient participants to meet the statistical needs of all open studies. In such situations, one or more of the competing studies will fail to meet recruitment targets, reducing their statistical ability to answer the research question. There are strong ethical reasons to avoid …

The use of social media as a recruitment tool for research with humans is increasing, and likely to continue to grow. Despite this, to date there has been no specific regulatory guidance and there has been little in the bioethics literature to guide investigators and institutional review boards (IRBs) faced with navigating the ethical issues such use raises. We begin to fill this gap by first defending a nonexceptionalist methodology for assessing social media recruitment; second, examining respect for privacy and investigator transparency as key norms governing social media recruitment; and, finally, analyzing three relatively novel aspects of social media recruitment: (i) the ethical significance of compliance with website "terms of use"; (ii) the ethics of recruiting from the online networks of research participants; and (iii) the ethical implications of online communication from and between participants. Two checklists aimed at guiding investigators and IRBs through the ethical issues are included as appendices.

This book addresses key historical, scientific, legal, and philosophical issues surrounding euthanasia and assisted suicide in the United States as well as in other countries and cultures. • Addresses the extended history of debates ...

This Article follows the path of a hypothetical college football player with aspirations to play in the National Football League, explaining from a legal and ethical perspective the health and performance evaluations he will likely face throughout his career. Some of these evaluations are commonplace and familiar, while others are more futuristic — and potentially of unproven value. How much information about themselves should aspiring and current professional players be expected to provide in the employment context? What are the current legal standards for employers collecting and acting on an individual’s health- and performance-related information? Drawing on disability law, privacy law, and the law governing genetic testing, this Article seeks to answer those questions, as well as to provide recommendations to better protect the health and privacy of professional football players. The upshot of our analysis is that it appears that some of the existing evaluations of players, both at the NFL Scouting Combine (Combine) and once drafted and playing for a club, seem to violate existing federal employment discrimination laws. Specifically, (1) the medical examinations at the Combine potentially violate the Americans with Disabilities Act’s (ADA) prohibitions on pre-employment medical exams; (2) post-offer medical examinations that are made public potentially violate the ADA’s confidentiality provisions; (3) post-offer medical examinations that reveal a disability and result in discrimination — e.g., the rescission of a contract offer — potentially violate the ADA provided the player can still perform the essential job functions; (4) Combine medical examinations that include a request for a player’s family medical history potentially violate the Genetic Information Nondiscrimination Act (GINA); and (5) the preseason physical’s requirement that a player disclose his family medical history potentially violates GINA. We believe all employers — including the NFL and its clubs — should comply fully with the current law. To that end, our recommendations center around four “C”s: compliance, clarity, circumvention, and changes to existing statutory schemes as applied to the NFL (and perhaps other professional sports).

In vitro gametogenesis raises new possibilities for reproductive and regenerative medicine as well as vexing policy challenges.

“Big data” has become the ubiquitous watchword of this decade. Predictive analytics, which is something we want to do with big data -- to use of electronic algorithms to forecast future events in real time. Predictive analytics is interfacing with the law in a myriad of settings: how votes are counted and voter rolls revised, the targeting of taxpayers for auditing, the selection of travelers for more intensive searching, pharmacovigilance, the creation of new drugs and diagnostics, etc. In this paper, written for the symposium “Future Proofing the Law,” we want to engage in a bit of legal arbitrage; that is, we want to examine which insights from legal analysis of predictive analytics in better-trodden ground — predictive policing — can be useful for understanding relatively newer ground for legal scholars — the use of predictive analytics in health care. To the degree lessons can be learned from this dialogue, we think they go in both directions.

"While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious beliefs to patients? How should we think about institutional conscience in the health care setting? How should health care providers deal with families with religious objections to withdrawing treatment? In this timely book, experts from a variety of perspectives and disciplines offer insight on these and other pressing questions, describing what the public discourse gets right and wrong, how policymakers might respond, and what potential conflicts may arise in the future. It should be read by academics, policymakers, and anyone else - patient or physician, secular or devout - interested in how US law interacts with health care and religion." -- Publisher

At the federal level in the United States, development of regulations is governed by the Administrative Procedure Act (APA), the statute by which Congress authorized various federal agencies to develop rules with the force of law, under a process called “notice and comment rulemaking.” In 2011, the Department of Health and Human Services (HHS) published in the Federal Register an “Advanced Notice of Proposed Rule Making” (ANPRM) to begin the first public discussion in decades about amending the Federal Policy for the Protection of Human Subjects, also known as the “Common Rule.” Over 1,100 public comments were submitted. In 2015, HHS along with several other federal agencies issued a “Notice of Proposed Rule Making” (NPRM), the second step in the process toward revising the Common Rule. This time, the agencies received nearly 2,200 public comments. Courts have interpreted the APA to require that agencies consider public comments with an “open mind” susceptible to persuasion, although this does not require an agency to actually change what has been proposed. Given the relatively lax legal standard for engaging with public comments, it seems clear that despite widespread opposition to several key changes that have been proposed to the Common Rule, the agencies are free to finalize the rule essentially as set forth in the NPRM. In our view, this would be an extremely worrisome outcome, but one offering little to no legal recourse—and given the pace of change to the Common Rule over the past several decades, not one likely to be corrected any time soon.

Advances in medicine often depend on the effective collection, storage, research use, and sharing of human biological specimens and associated data. But what about the sources of such specimens? When a blood specimen is drawn from a vein in your arm, is that specimen still you? Is it your property, intellectual or otherwise? Should you be allowed not only to consent to its use in research but also to specify under what circumstances it may be used? These and other questions are at the center of a vigorous debate over the use of human biospecimens in research. In this book, experts offer legal, regulatory, and ethical perspectives on balancing social benefit and human autonomy in biospecimen research. After discussing the background to current debates as well as several influential cases, including that of Henrietta Lacks, the contributors consider the rights, obligations, risks, and privacy of the specimen source; different types of informed consent under consideration (broad, blanket, and specific); implications for special patient and researcher communities; and the governance of biospecimen repositories and the responsibilities of investigators.

This chapter explores the way bioethics is taught as part of U.S. health law. It begins with an overview of changes in several major textbooks in the field that cover bioethics and the law, in terms of their content and the way they organize the field. It then considers the problem of translation and, more specifically, the ways in which the ethical discourse gets translated into a much more formalist legal discourse, by discussing a number of recent court cases, including Sherley v. Sebelius and Isaacson v. Horne. It proceeds by assessing where the field is going, with emphasis on the increased interest in population-level bioethics and the law, including the increased recognition of intellectual property and drug development as topics for both disciplines. The chapter also examines the rise of libertarian bioethics in litigation by focusing on two circuit court cases: Abigail Alliance v. Eschenbach and Flynn v. Holder.

This online publication includes two documents published in a Hastings Center Special Report – NFL Player Health: The Role of Club Doctors. The Special Report was published as part of the Football Players Health Study at Harvard University. The first document is the main article for the Special Report, entitled A Proposal to Address NFL Club Doctors’ Conflicts of Interest and to Promote Player Trust. This article focuses on the principal recommendation of our report, “Protecting and Promoting the Health of NFL Players: Legal and Ethical Analysis and Recommendations,” for addressing the conflicts of interest inherent in the current structure of NFL player healthcare, in which club medical staff provide services to both the club and players. The article proposes to “resolve the problem of dual loyalty by largely severing the club doctor’s ties with the club and refashioning that role into one of singular loyalty to the player-patient.” Specifically, club physicians would be replaced by two sets of medical professionals: the players’ medical staff, with exclusive loyalty to the player, and the club evaluation doctor, with exclusive loyalty to the club. Existing ethical codes and legal requirements are not adequate to ensure that players receive health care that is trustworthy and as free of conflicts of interest as is realistically possible, the article says, making structural change necessary. “This structure – which is flawed even in the absence of ethical lapses by any individual club doctor – may substantially contribute to player health concerns,” it concludes. The Special Report also included commentaries from a diverse and highly-qualified group of experts, including: · Arthur L. Caplan, Lee H. Igel, and Brendan Parent, New York University, · Richard Diana, former NFL player and current sports medicine specialist, · Laurent Duvernay-Tardif, current NFL player and offseason medical student, · Ross McKinney, Association of American Medical Colleges and NFLPA consultant, · National Football League Physicians Society, · Mark A. Rothstein, University of Louisville, · Marvin Washington, former NFL player. The commentaries can be found on the Wiley Online Library. This online publication includes our response to the commentaries.

This introductory chapter to the edited volume "Nudging Health: Health Law and Behavioral Economics" (I. Glenn Cohen, Holly Fernandez Lynch, Christopher T. Robertson, eds.) introduces the potential benefits, drawbacks, and possibilities for using the tools of behavioral economics - and particularly behavioral law and policy - to improve human health, exploring the policy alternatives to traditional "carrots and sticks" that may be utilized in the health sector. It also provides brief summaries of each chapter in the volume, along with a complete Table of Contents. From the book jacket: Behavioral nudges are everywhere: calorie counts on menus, automated text reminders to encourage medication adherence, a reminder bell when a driver’s seatbelt isn’t fastened. Designed to help people make better health choices, these reminders have become so commonplace that they often go unnoticed. In Nudging Health, forty-five experts in behavioral science and health policy from across academia, government, and private industry come together to explore whether and how these tools are effective in improving health outcomes. Behavioral science has swept the fields of economics and law through the study of nudges, cognitive biases, and decisional heuristics — but it has only recently begun to impact the conversation on health care. Nudging Health wrestles with some of the thorny philosophical issues, legal limits, and conceptual questions raised by behavioral science as applied to health law and policy. The volume frames the fundamental issues surrounding health nudges by addressing ethical questions. Does cost-sharing for health expenditures cause patients to make poor decisions? Is it right to make it difficult for people to opt out of having their organs harvested for donation when they die? Are behavioral nudges paternalistic? The contributors examine specific applications of behavioral science, including efforts to address health care costs, improve vaccination rates, and encourage better decision-making by physicians. They wrestle with questions regarding the doctor-patient relationship and defaults in healthcare while engaging with larger, timely questions of healthcare reform. Nudging Health is the first multi-voiced assessment of behavioral economics and health law to span such a wide array of issues — from the Affordable Care Act to prescription drugs.

Behavioral nudges are everywhere: calorie counts on menus, automated text reminders to encourage medication adherence, a reminder bell when a driver's seatbelt isn't fastened. Designed to help people make better health choices, these reminders have become so commonplace that they often go unnoticed. In Nudging Health, forty-five experts in behavioral science and health policy from across academia, government, and private industry come together to explore whether and how these tools are effective in improving health outcomes. Behavioral science has swept the fields of economics and law through the study of nudges, cognitive biases, and decisional heuristics-but it has only recently begun to impact the conversation on health care. Nudging Health wrestles with some of the thorny philosophical issues, legal limits, and conceptual questions raised by behavioral science as applied to health law and policy. The volume frames the fundamental issues surrounding health nudges by addressing ethical questions. Does cost-sharing for health expenditures cause patients to make poor decisions?Is it right to make it difficult for people to opt out of having their organs harvested for donation when they die? Are behavioral nudges paternalistic? The contributors examine specific applications of behavioral science, including efforts to address health care costs, improve vaccination rates, and encourage better decision-making by physicians.

Most sperm donation that occurs in the USA proceeds through anonymous donation. While some clinics make the identity of the sperm donor available to a donor-conceived child at age 18 as part of ‘open identification’ or ‘identity release programs,’ no US law requires clinics to do so, and the majority of individuals do not use these programs. By contrast, in many parts of the world, there have been significant legislative initiatives requiring that sperm donor identities be made available to children after a certain age (typically when the child turns 18). One major concern with prohibiting anonymous sperm donation has been that the number of willing sperm donors will decrease leading to shortages, as have been experienced in some of the countries that have prohibited sperm donor anonymity. One possible solution, suggested by prior work, would be to pay current anonymous sperm donors more per donation to continue to donate when their anonymity is removed. Using a unique sample of current anonymous and open identity sperm donors from a large sperm bank in the USA, we test that approach. As far as we know, this is the first attempt to examine what would happen if the USA adopted a prohibition on anonymous sperm donation that used the most ecologically valid population, current sperm donors. We find that 29% of current anonymous sperm donors in the sample would refuse to donate if the law changed such that they were required to put their names in a registry available to donor-conceived children at age 18. When we look at the remaining sperm donors who would be willing to participate, we find that they would demand an additional $60 per donation (using our preferred specification). We also discuss the ramifications for the industry.

How can we ensure that players in the National Football League receive excellent health care they can trust from providers who are as free from conflicts of interest as realistically possible? NFL players typically receive care from the club's own medical staff. Club doctors are clearly important stakeholders in player health. They diagnose and treat players for a variety of ailments, physical and mental, while making recommendations to the player concerning those ailments. At the same time, club doctors have obligations to the club, namely to inform and advise clubs about the health status of players. While players and clubs share an interest in player health—both of them want players to be healthy so they can play at peak performance—there are several areas where their interests can diverge, and the divergence presents legal and ethical challenges. The current structure forces club doctors to have obligations to two parties—the club and the player—and to make difficult judgments about when one party's interests must yield to another's. None of the three parties involved should prefer this conflicted approach. We propose to resolve the problem of dual loyalty by largely severing the club doctor's ties with the club and refashioning that role into one of singular loyalty to the player-patient. The main idea is to separate the roles of serving the player and serving the club and replace them with two distinct sets of medical professionals: the Players' Medical Staff (with exclusive loyalty to the player) and the Club Evaluation Doctor (with exclusive loyalty to the club). We begin by explaining the broad ethical principles that guide us and that help shape our recommendation. We then provide a description of the role of the club doctor in the current system. After explaining the concern about the current NFL player health care structure, we provide a recommendation for improving this structure. We then discuss how the club medical staff fits into the broader microenvironment affecting player health.

Our article “NFL Player Health Care: Addressing Club Doctors’ Conflicts of Interests and Promoting Player Trust” focused on an inherent structural conflict that faces club doctors in the National Football League. The conflict stems from club doctors’ dual role of providing medical care to players and providing strategic advice to clubs. We recommended assigning these roles to different individuals, with the medical staff members who are responsible for providing player care being chosen and subject to review and termination by a committee of medical experts selected equally by the NFL and the NFL Players Association. Recognizing that the problem of structural conflict of interest is deeply entrenched and that our recommendation is a significant departure from the status quo, we invited comment from a diverse and highly qualified group of experts. There is considerable common ground among the commentators. All but one agreed with us that, despite the best intentions of upstanding professionals, there is a structural conflict of interest in the club doctors’ relationship with players, and the commentaries were generally supportive of our recommendation for change. There are also meaningful disagreements, however. Some commentators think that the proposal is on the right track but does not go far enough to reduce the structural conflict of interest, and one commentary wholly disagrees with our analysis and recommendations.

A potentially renewable provision of the Consolidated Appropriation Act of 2016 forestalling the prospect of human germline modification was signed into law on 18 December 2015 (1). The provision, also known as a rider (an amendment extraneous to the main purpose of the bill to which it is attached), stipulates that “none of the funds made available by this Act [to the FDA] may be used to review or approve an application for an exemption for investigational use of a drug or biological product… in which a human embryo is intentionally created or modified to include a heritable genetic modification” (1). Destined to expire at the conclusion of this fiscal year (30 September 2016), the rider has since been incorporated yet again into the House and Senate appropriation bills for the fiscal year ending 30 September 2017 (2, 3). Subject to ongoing annual renewal, this congressionally legislated ban undermines ongoing conversations on the possibility of human germline modification, its likely distant time horizon notwithstanding (4). Also affected are ongoing efforts of the FDA to review the prevention of mitochondrial DNA diseases through germline modification of human zygotes or oocytes at risk (5).

Bill C-14 was introduced by the government of Canada in the aftermath of the Supreme Court’s decision which legalized physician-assisted dying in Canada. This article compares the Bill with the decision of the Supreme Court (Carter v. Canada (Attorney General)) and tracks some of the important ways that the proposed Bill departs from the Carter decision. The Article also explores the ways in which the regime proposed under the Bill is both more and less restrictive than the U.S. states that have adopted regimes for assistance in dying. The article also analyzes the approach the Bill has taken to exclude non-citizen non-residents from using assistance in dying in Canada and whether this exclusion is in tension with the spirit of Carter. Finally, the article examines potential constitutional challenges should the Bill become law.

After an appreciation of the contribution of the main text to the clarification and deepening of the utility and dilemmas of randomized clinical trials (RCTs) in medicine, this chapter notes the present ubiquity of RCTs in, for instance, social welfare programs, labor economics, education, political science, sociology, and law, several of which are discussed in detail. The chapter notes ways in which these are and are not like RCTs in the context of medical care. In several of the law examples, such as randomizing bail conditions and assigning lawyers to meet legal needs of low-income individuals, none of the subjects of the research are (yet) in a client relationship similar to that of a patient, and so there is no analogous duty on the part of the experimenters. It is an allocation of scarce resources in part carried out in a way that may yield more reliable knowledge.

The recent explosion in available electronic health record (EHR) data is motivating a rapid expansion of electronic health care predictive analytic (e-HPA) applications, defined as the use of electronic algorithms that forecast clinical events in real time with the intent to improve patient outcomes and reduce costs. There is an urgent need for a systematic framework to guide the development and application of e-HPA to ensure that the field develops in a scientifically sound, ethical, and efficient manner.

Gamete donor anonymity has become an increasingly active area of legislative, bioethical, and empirical interest over the last decade or so. This chapter begins by detailing the very different status of gamete donor anonymity, contrasting the United States (where the law does not prohibit it) with the rest of the world (where it has been largely prohibited by law) and examining the effects of these policies. The chapter then examines the major arguments that have been offered in favor of and against mandating nonanonymous gamete donation. In particular, it focuses on the effects of removing anonymity on supply and arguments in favor of ending sperm donor anonymity based on the welfare of donor-conceived children or rights claims by them. The chapter also more briefly considers ethical and legal issues related to donor compensation, accidental incest, information reciprocity between donors and recipients, and reproductive tourism.

"he Oxford Handbook of U.S. Health Law covers the breadth and depth of health law, with contributions from the most eminent scholars in the field. The Handbook paints with broad thematic strokes the major features of American healthcare law and policy, its recent reforms including the Affordable Care Act, its relationship to medical ethics and constitutional principles, and how it compares to the experience of other countries. It explores the legal framework for the patient experience, from access through treatment, to recourse (if treatment fails), and examines emerging issues involving healthcare information, the changing nature of healthcare regulation, immigration, globalization, aging, and the social determinants of health. This Handbook provides valuable content, accessible to readers new to the subject, as well as to those who write, teach, practice, or make policy in health law." --Publisher

Enabled by globalizing processes such as trade liberalization, medical tourism is a practice that involves patients’ intentional travel to privately obtain medical care in another country. Empirical legal research on this issue is limited and seldom based on the perspectives of destination countries receiving medical tourists. We consulted with diverse lawyers from across Barbados to explore their views on the prospective legal and regulatory implications of the developing medical tourism industry in the country.

‘Medical tourism’ (to use the most common term, though ‘cross-border health care’ or ‘medical travel’ could also be used), is the travel of patients from their home country to a foreign country for the primary purpose of receiving health care services. There is no doubt that the existing market is significant, even though there are considerable disputes about its exact size. This chapter concerns legal and ethical issues related only to medical tourism for services that are legal in the patient’s home and destination country and will cover issues faced by all three populations of medical tourists engaged in it: patients paying out of pocket, private insurer prompted and government prompted medical tourists. I put to one side medical tourism for services illegal in the home or destination country, which I have dealt with elsewhere. First, I will discuss the question of how tourist patients can determine the quality of foreign facilities, the possibility of state interventions and the ability and the provision of patient safety information and the challenges in securing that information are discussed, including comparisons to domestic initiatives. Second, and especially as to medical tourists coming from the US, I discuss the question of whether medical tourists can recover for medical malpractice committed abroad and possible regulatory salves. Third, I turn to private insurer prompted medical tourism, focusing on its existing (and potential) regulation in the US health care system. Finally, I discuss government-prompted medical tourism in the form of the EU rules regarding reimbursement of cross-border health care. Because of the large numbers of topics covered here, my treatment of each will be brief, but I have written on each in-depth in other work.

It seems fair to say that human rights law takes the human as given. Human beings are particular kinds of entities with particular kinds of psychologies and propensities, and it is the job of human rights law and human rights enforcement to govern that kind of entity, be it through sanctions, education, incentives, or other mechanisms. More specifically, human rights law takes human brains as given. If humans were different kinds of beings, both the mechanisms of getting compliance and possibly the very rules themselves would be different. The purpose of this essay is to very tentatively start to tie together thinking in neuroscience, bioethics, and human rights law to ask whether human rights law should take the nature of human beings, and more specifically, human brains, as given. I sketch the alternative possibility and examine it from a normative and (to a lesser extent) scientific perspective: instead of merely crafting laws and setting up structures that get human beings such as they are to respect human rights, that the human rights approach should also consider embracing attempts to remake human beings (and more specifically human brains) into the kinds of things that are more respectful of human rights law. This is currently science fiction, but there is some scientific evidence that moral enhancement may one day be possible. I call the alternative “moral enhancement to respect human rights law.” To put the aim of the essay in its mildest form it is to answer the following question: if it becomes possible to use enhancement to increase respect for human rights and fidelity to human rights law (whatever you think is constitutive of those categories), and in particular in a way that reduces serious human rights violations, is it worth “looking into?” Or, by contrast, are the immediate objections to such an endeavor so powerful or hard to refute that going in this direction should be forbidden.

Mutant mitochondrial DNA (mtDNA) gives rise to a broad range of heritable clinical syndromes (1). A cure for those affected remains out of reach (1). However, recently developed mitochondrial replacement therapy (MRT) has raised the prospect of disease-free progeny for women carriers (2–4). Moreover, the feasibility of replacing mutant oocytic or zygotic mtDNA with a donated wild-type counterpart in humans has now been firmly established (2–4). In the United Kingdom, legislation regulating the clinical application of MRT, now 10 years in the making, has recently been approved by the House of Commons (5) and the House of Lords (6). The regulatory vetting of MRT in the United States, under way for a year, remains a work in progress (7). Here, we compare and contrast the regulatory history of MRT in the United Kingdom and the United States and examine potential lessons learned.

On January 20, 2015, Michael J. Davidson, MD, a cardiothoracic surgeon, was fatally shot on the premises of the Brigham and Women’s Hospital in Boston, Massachusetts. In the year leading up to this tragic day, a total of 14 active shooter incidents occurred in hospitals throughout the United States, leaving 15 fatalities in their wake. This reality and its potential amplification by copycats has reignited the debate over the adequacy of current and future hospital security arrangements. In this Viewpoint, we discuss the evolving frequency of hospital-based active shooter incidents, the relevant legal framework, and the role of hospitals and physicians in countering this threat.

Human beings show a greater inclination to assist (and avoid harming) persons and groups identified as those at high risk of great harm than to assist (and avoid harming) persons and groups who will suffer (or already suffer) similar harm but are not identified (as yet). The problem touches almost every aspect of human life and politics: health, the environment, the law. This volume is the first book to tackle the effect from all necessary perspectives.