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)

In the last several months, several major disciplines have started their initial reckoning with what ChatGPT and other Large Language Models (LLMs) mean for them – law, medicine, business among other professions. With a heavy dose of humility, given how fast the technology is moving and how uncertain its social implications are, this article attempts to give some early tentative thoughts on what ChatGPT might mean for bioethics. I will first argue that many bioethics issues raised by ChatGPT are similar (...) to those raised by current medical AI – built into devices, decision support tools, data analytics, etc. These include issues of data ownership, consent for data use, data representativeness and bias, and privacy. I describe how these familiar issues appear somewhat differently in the ChatGPT context, but much of the existing bioethical thinking on these issues provides a strong starting point. There are, however, a few “new-ish” issues I highlight – by new-ish I mean issues that while perhaps not truly new seem much more important for it than other forms of medical AI. These include issues about informed consent and the right to know we are dealing with an AI, the problem of medical deepfakes, the risk of oligopoly and inequitable access related to foundational models, environmental effects, and on the positive side opportunities for the democratization of knowledge and empowering patients. I also discuss how races towards dominance (between large companies and between the U.S. and geopolitical rivals like China) risk sidelining ethics. (shrink)

Originally edited by Timothy Stoltzfus Jost, this text examines how different countries around the world approach the same challenges in health care law and ethics: how to finance care for as many people as possible; how to ensure quality care; how to best secure patients' rights; how to regulate abortion, end of life decision making, and assisted reproduction; and how to manage infectious diseases, tobacco use, and human subject research. The new edition considers a broader array of countries, particularly from (...) Asia, Latin America, Africa, and the Middle East. (shrink)

In a study published in late April in Nature Communications, the authors were able to sustain 105- to 115-day-old premature lamb fetuses—whose level of development was comparable to that of a twenty-three-week-old human fetus—for four weeks in an artificial womb, enabling the lambs to develop in a way that paralleled age-matched controls. The oldest lamb of the set, more than a year old at the time the paper came out, appeared completely normal. This kind of research brings us one step (...) closer to providing excellent quality of life for premature newborns, but it also portends major legal and ethical questions, especially for abortion rights in America. (shrink)

“Medical Tourism” is the travel of residents of one country to another country for treatment. In this article I focus on travel abroad to purchase organs for transplant, what I will call “Transplant Tourism.” With the exception of Iran, organ sale is illegal across the globe, but many destination countries have thriving black markets, either due to their willful failure to police the practice or more good faith lack of resources to detect it. I focus on the sale of kidneys, (...) the most common subject of transplant tourism, though much of what I say could be applied to other organs as well. Part I briefly reviews some data on sellers, recipients, and brokers. Part II discusses the bioethical issues posed by the trade, and Part III focuses on potential regulation to deal with these issues. (shrink)

It is a pleasure to comment on Giulia Cavaliere’s ‘ Gestation, Equality and Freedom: Ectogenesis as a Political Perspective’ in what one might say is ‘enthusiastic disagreement’. The enthusiastic part is because the article is deserving of much praise for adding an important feminist and political theoretical perspective on ectogenesis. The disagreement may come more from disciplinary differences or disposition. As I understand her argument, Cavaliere intends to attack two common arguments in favour of research into ectogenesis—that is, gestation of (...) a human fetus outside the womb—one that sounds in the potential of the technology to promote equality, the other that it has the potential to promote liberty. On the first her critique is that the risks and burdens of gestation for women are most pronounced for the worst off, but ectogenesis is unlikely to be used by them. On the second her critique is, i nter alia, that treating ‘ectogenesis as a means to address workplace inequalities calls for solutions that change the way society reproduces itself rather than a labour market …. (shrink)

“Medical Tourism” is the travel of residents of one country to another country for treatment. In this article I focus on travel abroad to purchase organs for transplant, what I will call “Transplant Tourism.” With the exception of Iran, organ sale is illegal across the globe, but many destination countries have thriving black markets, either due to their willful failure to police the practice or more good faith lack of resources to detect it. I focus on the sale of kidneys, (...) the most common subject of transplant tourism, though much of what I say could be applied to other organs as well. Part I briefly reviews some data on sellers, recipients, and brokers. Part II discusses the bioethical issues posed by the trade, and Part III focuses on potential regulation to deal with these issues. (shrink)

Hastings Center Report, Volume 52, Issue 2, Page 10-14, March‐April 2022.

This essay discusses the new report, Heritable Human Genome Editing, by the National Academy of Medicine, the National Academy of Sciences, and the Royal Society. After summarizing the report, we argue that the report takes four quite bold steps away from prior reports, namely (1) rejecting an omnibus approach to heritable human genome editing (HHGE) in favor of a case‐by‐case analysis of possible uses of HHGE, accepting that HHGE is acceptable in some cases; (2) recognizing that the interest in having (...) children who are genetically related to both would‐be rearing parents is one that the regulation of HHGE should honor; (3) patterning a regulatory model for HHGE on the United Kingdom's approach to regulating mitochondrial replacement techniques; and (4) conveying skepticism that international regulation is possible while showing a strong preference for a default into national regulatory regimes for HHGE. (shrink)

This essay discusses the new report, Heritable Human Genome Editing, by the National Academy of Medicine, the National Academy of Sciences, and the Royal Society. After summarizing the report, we argue that the report takes four quite bold steps away from prior reports, namely (1) rejecting an omnibus approach to heritable human genome editing (HHGE) in favor of a case‐by‐case analysis of possible uses of HHGE, accepting that HHGE is acceptable in some cases; (2) recognizing that the interest in having (...) children who are genetically related to both would‐be rearing parents is one that the regulation of HHGE should honor; (3) patterning a regulatory model for HHGE on the United Kingdom's approach to regulating mitochondrial replacement techniques; and (4) conveying skepticism that international regulation is possible while showing a strong preference for a default into national regulatory regimes for HHGE. (shrink)

Politics, public discourse, and legislation restricting abortion has settled on a moderate orthodoxy: restrict abortion, but leave exceptions for pregnancies that result from rape and incest. I challenge that consensus and suggest it may be much harder to defend than those who support the compromise think. From both Pro-Life and Pro-Choice perspectives, there are good reasons to treat all abortions as equal.

As Professor Ziegler’s article and prior books show, the reversal of Roe v. Wade has been an overarching goal of the abortion-restrictive movement. With that goal approaching—indeed if the l...

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 and the Club Evaluation Doctor. 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. (shrink)

Should the law recognize an individual's right not to be a genetic parent when genetic parenthood does not carry with it legal or gestational parenthood? If so, should we allow individuals to waive that right in advance, either by contract or a less formal means? How should the law's treatment of gestational and legal parenthood inform these questions? Developments in reproductive technology have brought these questions to the fore, most prominently in the preembryo disposition cases a number of courts have (...) confronted - disputes over the use of stored frozen preembryos that couples have fertilized in the course of In Vitro Fertilization (IVF) - but other examples abound.In this Article, I argue that in analyzing these cases it is essential to unbundle the possible rights not to be a genetic, gestational, and legal parent, and to recognize that the three rights do not stand and fall together. I show that we cannot move from the discourse surrounding the rights not to be a gestational and legal parent to a justification for a right not to be a genetic parent. Instead, I argue that the normative mooring of the right not to be a genetic parent is best understood as a way of protecting individuals from what I call "attributional parenthood," a harm that stems from the social assignment of the status of parent to the provider of genetic material that persists notwithstanding the fact that the legal system has declared him or her a non-parent.Using this framework, I argue for the recognition of the right not to be a genetic parent. However, I reject the claim, common among courts and commentators, that this right should not be capable of advance waiver. I instead conclude that we should permit advance waiver of the right through contract, with several interventions aimed at improving contractual consent. In preembryo disposition disputes where the parties have not contracted, I argue for a general default rule of non-use, perhaps with a sub-rule permitting use when non-use would mean the impossibility of one party ever having any genetic children. (shrink)

A growing literature examines descriptive and normative questions about medical tourism such as: How does it operate? What are its effects? Are home country patients or their governments failing in moral duties by engaging in or permitting medical tourism?By contrast, much less has been written on the regulatory dimension: What might be done about medical tourism if we were convinced that it posed ethical issues and were motivated to act? I shall argue that this kind of regulatory analysis is essential (...) for bioethical analysis of medical tourism.This article focuses on these regulatory questions more directly, evaluating available methods, restrictions, costs, and benefits of home and destination country unilateral regulatory moves. This article also discusses more briefly multilateral treaty and private sector responses. (shrink)

In early 2010, the Nebraska state legislature passed a new abortion restricting law asserting a new, compelling state interest in preventing fetal pain. In this article, we review existing constitutional abortion doctrine and note difficulties presented by persistent legal attention to a socially derived viability construct. We then offer a substantive biological, ethical, and legal critique of the new fetal pain rationale.

On April 13, 2010, Nebraska enacted a new state ban on abortion in the Pain-Capable Unborn Child Protection Act that ha caught the attention of many on both sides of the abortion debate, and has inspired other states to attempt similar measures. The statute requires the referring or abortion-providing physician to make a “determination of the probable postfertilization age of the unborn child” and makes it illegal to induce or attempt to perform or induce an abortion upon a woman when (...) the “probable postfertilization age” of the fetus is “twenty or more weeks” unless the doctor determines in “reasonable medical judgment she has a condition which so complicates her medical condition as to necessitate the abortion of her pregnancy to avert her death or to avert serious risk of substantial and irreversible physical impairment of a major bodily function or it is necessary to preserve the life of an unborn child.”. (shrink)

When prospective parents use in vitro fertilization, many of them hope to generate more embryos than they intend to implant immediately. The technology often requires multiple attempts to reach a successful pregnancy, and couples can cryopreserve any excess embryos so that they have them on hand for later attempts. As part of obtaining informed consent for IVF or cryopreservation, clinics typically ask patients to specify their preferences for the embryos in the event of divorce or death, offering options such as (...) use of the embryos by a specified partner, donation to research, or discarding the remaining embryos. Still, many courts face a recurring problem: the partners dissolve their relationship, and one party wants to use the frozen embryos over the objections of the other. Courts and legislatures have struggled with how to handle these cases, which seem to pit one partner's right to procreate against the other's right not to procreate. In this essay, we use one of the most recent decisions in this line of cases—the Appellate Court of Illinois's decision in Szafranski v. Dunston—to explain the current state of the law and make recommendations for changes. The issue is ripe for revisiting because in the last year, embryo disputes have become a battlefront for larger conflagrations over the moral status of embryos. (shrink)

Medical crowdfunding has raised many ethical concerns, among them that it may undermine privacy, widen health inequities, and commodify health care. One motivation for medical crowdfunding has received particular attention among ethicists. Recent studies have shown that many individuals are using crowdfunding to finance access to scientifically unsupported medical treatments. Recently, GoFundMe prohibited campaigns for antivaccination groups on the grounds that they “promote misinformation about vaccines” and for treatment at a German clinic offering unproven cancer treatments due to “the need (...) to make sure people are equipped to make well‐informed decisions.” GoFundMe has not taken any additional actions to regulate the much larger presence of campaigns seeking to fund unproven medical interventions on the platform. In this article, we make the ethical case for intervention by GoFundMe and other crowdfunding platforms. (shrink)

It is a huge pleasure to engage with Prof. Shaw’s careful and close reading of my article. Though almost a decade old, many of the issues are becoming only more relevant as it seems that Roe v Wade will be overruled in the U.S. and travel for abortion will become a sad reality.1 I appreciate how deeply Prof. Shaw interacts with my article and am full of praise for his work, but given the small space allocated here I only focus (...) on our few places of disagreement. (shrink)

This commentary on Madeira's paper complicates the relationships between commodification, consumption, abortion, and assisted reproductive technologies she draws in two ways. First, I examine under what conditions the commodification of ARTs, gametes, and surrogacy lead to patients becoming consumers. Second, I show that there are some stark difference between applying commodification critiques to ART versus abortion.

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. (shrink)

Experts from different disciplines offer novel ideas for improving research oversight and protection of human subjects.

In July 2011, the ACGME implemented new rules that limit interns to 16 hours of work in a row, but continue to allow 2nd-year and higher resident physicians to work for up to 28 consecutive hours. Whether the ACGME's 2011 work hour limits went too far or did not go far enough has been hotly debated. In this article, we do not seek to re-open the debate about whether these standards get matters exactly right. Instead, we wish to address the (...) issue of effective enforcement. That is, now that new work hour limits have been established, and given that the ACGME has been unable to enforce work hour limits effectively on its own, what is the best way to make sure the new limits are followed in order to reduce harm to residents, patients, and others due to sleep-deprived residents? We focus on three possible national approaches to the problem, one rooted in funding, one rooted in disclosure, and one rooted in tort law. (shrink)

Over the past decade, a series of studies have found that physicians-in-training who work extended shifts are at increased risk of experiencing motor vehicle crashes, needlestick injuries, and medical errors. In response to public concerns and a request from Congress, the Institute of Medicine conducted an inquiry into the issue and concluded in 2009 that resident physicians should not work for more than 16 consecutive hours without sleep. They further recommended that the Centers for Medicare & Medicaid Services and the (...) Joint Commission work with the Accreditation Council for Graduate Medical Education to ensure effective enforcement of new work hour standards.The IOM's concerns with enforcement stem from well-documented non-compliance with the ACGME's 2003 work hour rules, and the ACGME's history of non-enforcement. In a nationwide cohort study, 84% of interns were found to violate the ACGME's 2003 standards in the year following their introduction. (shrink)

Should anonymous sperm “donation”—a misnomer, since sperm is usually purchased—be permitted? A number of countries, including Sweden, Austria, Germany, Switzerland, the Netherlands, Norway, New Zealand, and several Australian states, have answered no.1 The United Kingdom recently joined this list, instituting a system whereby new sperm (and egg) donors must put information into a registry, and a donor-conceived child “is entitled to request and receive their donor’s name and last known address, once they reach the age of 18.”2 The arguments offered (...) by the legislators in these jurisdictions in favor of these measures, along with the arguments offered by scholarly proponents such as Naomi Cahn, focus on one major .. (shrink)

Professor Sparrow’s (2022) Target Article helpfully elucidates the question of when the ordinary person-affecting conception of harm and benefit should apply to discussions of germline genome editi...

When applied in the health sector, AI-based applications raise not only ethical but legal and safety concerns, where algorithms trained on data from majority populations can generate less accurate or reliable results for minorities and other disadvantaged groups.

Digital medicine is a medical treatment that combines technology with drug delivery. The promises of this combination are continuous and remote monitoring, better disease management, self-tracking, self-management of diseases, and improved treatment adherence. These devices pose ethical challenges for patients, providers, and the social practice of medicine. For patients, having both informed consent and a user agreement raises questions of understanding for autonomy and informed consent, therapeutic misconception, external influences on decision making, confidentiality and privacy, and device dependability. For providers, (...) digital medicine changes the relationship where trust can be verified, clinicians can be monitored, expectations must be managed, and new liability risks may be assumed. Other ethical questions include direct third-party monitoring of health treatment, affordability, and planning for adverse events in the case of device malfunction. This article seeks to lay out the ethical landscape for the implementation of such devices in patient care. (shrink)

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 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: the ethical significance of compliance with website “terms of use”; the ethics of recruiting from the online networks of research participants; and 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. (shrink)

It is not uncommon for multiple clinical trials at the same institution to recruit concurrently from the same patient population. When the relevant pool of patients is limited, as it often is, trials essentially compete for participants. There is evidence that such a competition is a predictor of low study accrual, with increased competition tied to increased recruitment shortfalls. But there is no consensus on what steps, if any, institutions should take to approach this issue. In this article, we argue (...) that an institutional policy that prioritises some trials for recruitment ahead of others is ethically permissible and indeed prima facie preferable to alternative means of addressing recruitment competition. We motivate this view by appeal to the ethical importance of minimising the number of studies that begin but do not complete, thereby exposing their participants to unnecessary risks and burdens in the process. We then argue that a policy of prioritisation can be fair to relevant stakeholders, including participants, investigators and funders. Finally, by way of encouraging and helping to frame future debate, we propose some questions that would need to be addressed when identifying substantive ethical criteria for prioritising between studies. (shrink)