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 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)
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)
“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)
“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)
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)
On September 8, 2015, the Department of Health and Human Services issued a Notice of Proposed Rule Making to revise the Federal Policy for the Protection of Human Subjects, widely known as the “Common Rule.” The NPRM proposes several changes to the current system, including a dramatic shift in the approach to secondary research using biospecimens and data. Under the current rules, it is relatively easy to use biospecimens and data for secondary research. This approach systematically facilitates secondary research with (...) biospecimens and data, maximizing the capacity for substantial public benefit. However, it has been criticized as insufficiently protective of the privacy and autonomy interests of biospecimen and data sources. Thus, the NPRM proposes a more restrictive regime, although more so for biospecimens than data. Both the status quo and the NPRM's proposal are critically flawed. (shrink)
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)
ABSTRACTA 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)
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)
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.
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)
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)
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 …. (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)
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)
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.
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)
