Inbar Cohen

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

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.

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.

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.

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 …

ABSTRACT 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.

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.

“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.

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.

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.

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.

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..