Inbar Cohen

Recently in Israel, a woman was mistakenly implanted with an embryo that is genetically related to another couple. Unfortunately, this case is not an isolated occurrence, as other cases of embryo mix-ups have been reported in several countries, including the USA, China, the UK and various other countries within the European Union. Cases of mixed-up embryos are ethically and legally complex: the woman who carried the pregnancy and the woman who is genetically related to the resulting child—both of whom endured emotionally and physically demanding infertility treatments—along with their partners, may be unwilling to relinquish parental rights over the child.This article explores four possible approaches, found in numerous common law jurisdictions, which can be used to address cases involving embryo mix-ups. Our analysis reveals several avenues through which legal parentage can be established. It can be done through gestation and the marital presumption, genetic connections, by adhering to the principle of the best interests of the child, or by recognising multiple individuals as legal parents. We review the advantages and disadvantages of each approach, but we have one clear recommendation: resolving embryo mix-up cases should be done proactively through the establishment of legislation and guidelines, rather than relying on post hoc individual court decisions. Such legislation and guidelines should guarantee the consistency of values throughout diverse reproductive contexts and mandate that fertility clinics and medical professionals provide individuals with comprehensive information regarding the potential risks associated with assisted reproductive treatments.

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.

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.

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.

Artificial Intelligence (AI), especially of the machine learning (ML) variety, is used by health care organizations to assist with a number of tasks, including diagnosing patients and optimizing operational workflows. AI products already proliferate the health care market, with usage increasing as the technology matures. Although AI may potentially revolutionize health care, the use of AI in health settings also leads to risks ranging from violating patient privacy to implementing a biased algorithm. This chapter begins with a broad overview of health care AI and how it is currently used. We then adopt a “lifecycle” approach to discussing issues with health care AI. We start by discussing the legal and ethical issues pertaining to how data to build AI are gathered in health care settings, focusing on privacy. Next, we turn to issues in algorithm development, especially algorithmic bias. We then discuss AI deployment to treat patients, focusing on informed consent. Finally, we will discuss existing oversight mechanisms for health AI in the United States: liability and regulation.

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.

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 …

“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 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

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.

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.