Faculty Bibliography
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Abortion remains one of the most divisive controversies in the United States, and few states restrict the practice more than Alabama. In 2018, Alabama voters passed an amendment to the state’s constitution that “recognize[s] and support[s] the sanctity of unborn life and the rights of unborn children.” Kansas, Missouri, and Louisiana have enacted similar language into their constitutions. These clauses variously classify fertilized eggs, zygotes, embryos, and fetuses as “persons” entitled to unspecified legal protections from the moment of conception. They have the potential for sweeping consequences. It is unclear whether and how these measures would lead to criminal penalties against pregnant women for activities like drug use that risk harming the fetus, as well as prohibitions on in vitro fertilization (IVF), stem cell research, or other practices that involve the destruction of human embryos
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Transparency in Health and Health Care in the United States: Law and Ethics (Holly Fernandez Lynch, I. Glenn Cohen, Carmel Shachar & Barbara J. Evans eds., 2019).
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Transparency is a concept that is becoming increasingly lauded as a solution to a host of problems in the American health care system. Transparency initiatives show great promise, including empowering patients and other stakeholders to make more efficient decisions, improve resource allocation, and better regulate the health care industry. Nevertheless, transparency is not a cure-all for the problems facing the modern health care system. The authors of this volume present a nuanced view of transparency, exploring ways in which transparency has succeeded and ways in which transparency initiatives have room for improvement. Working at the intersection of law, medicine, ethics, and business, the book goes beyond the buzzwords to the heart of transparency's transformative potential, while interrogating its obstacles and downsides. It should be read by anyone looking for a better understanding of transparency in the health care context.
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The implications of scientific breakthroughs are rarely faced up to in advance of their realization. Stem cell-derived human gametes, a disruptive technology in waiting, are likely to recapitulate this historic pattern absent active intervention. Herein we call for the conduct of thoughtful ante hoc deliberations on the prospect of stem cell-derived human gametes with an eye toward minimizing potential untoward post hoc regulatory or statutory impositions.
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William M. Sage, I. Glenn Cohen & Allison K. Hoffman, Health Law and Ethics, in Health Systems Science (Susan Skochelak ed., 2d ed. 2019).
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Law and ethics are both essential attributes of a high-functioning health care system and powerful explainers of why the existing system is so difficult to improve. U.S. health law is not seamless; rather, it derives from multiple sources and is based on various theories that may be in tension with one another. There are state laws and federal laws, laws setting standards and laws providing funding, laws reinforcing professional prerogatives, laws furthering social goals, and laws promoting market competition. Complying with law is important, but health professionals also should understand that the legal and ethical constraints under which health systems operate must themselves adapt if health systems science is to advance.
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In its 1972 decision in Eisenstadt v. Baird, the US Supreme Court announced that: “it is the right of the individual, married or single, to be free from unwarranted governmental intrusion into matters so fundamentally affecting a person as the decision whether to bear or beget a child.” But, in fact, both within and outside the United States, this firm-sounding principle has often been honored in the breach. Both as to coital and assisted reproduction, but particularly the latter, the state has asserted significant control over reproductive decision-making. This chapter details various forms of reproductive regulation prevalent today in a variety of areas including: Sterilization, abstinence education, surrogacy, sperm and egg “donor” anonymity and paternity, insurance funding, cloning, and mitochondrial replacement therapy. More conceptually, it divides state regulation of reproduction along the axes of attempts to influence whether, when, with whom, and how we reproduce and the means by which the state intervenes. Finally, it examines variations on child welfare justifications the state has or might offer for such reproductive regulation, and raises some questions about those justifications.
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Mary Anne Bobinsky, David Orentlicher, I. Glenn Cohen & Mark A. Hall, Bioethics and Public Health Law (4th ed. 2018).
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The updated Fourth Edition includes recent cases and developments in biotechnology, including stem cell research and gene patents, and updates to HIPPA coverage, DNA research, and bio-banks.
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Effy Vayena and colleagues argue that machine learning in medicine must offer data protection, algorithmic transparency, and accountability to earn the trust of patients and clinicians.
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A key aim of patient-centered outcomes research (PCOR) is to generate data that are important to patients by deliberately and extensively involving them in all aspects of research, from design to dissemination. However, certain elements of PCOR raise challenging and potentially novel ethical and regulatory issues for institutional review boards and oversight bodies. These challenges stem primarily from the engagement of patients in roles other than research subject, such as advisors, study personnel, and co-investigators, which gives rise to questions about appropriate levels of protection, training, and education, as well as identifying and managing conflicts of interest. This article presents and discusses recommendations from a Delphi expert panel that was convened to address these and other PCOR-related oversight challenges.
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As progress in the biosciences soldiers forth, new breakthroughs can often be swept up in a common narrative, that is, the narrative of science as a disruptive threat. Responding to perceived threats, policymakers the world over have frequently overreacted to these developments by enacting shortsighted legislation. These knee-jerk reactions often entail a ban or pause on the science to be explored, thereby foregoing a dialog or term-limited oversight. In this paper, we explore the history and transparency of such moratoria.
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Patient-centered outcomes research (PCOR) is becoming increasingly common. However, there is little evidence regarding what novel ethical challenges, if any, are posed by PCOR with relevance to institutional review board (IRB) oversight and human subjects protections. This article reports the results of a national survey of all IRB chairpersons from research-intensive institutions in the United States. Findings address the responsibilities of IRBs and the challenges associated with PCOR review and oversight. IRB chairpersons varied in their judgment of PCOR’s overall value to the scientific enterprise and to research at their institution. Furthermore, 27% of respondents considered patients serving in nontraditional roles to be research subjects even when they are not enrolled in research. There was also variation in the training and safeguards their IRBs require for patient partners. Our results suggest that guidance should be developed around ethical and regulatory issues associated with PCOR oversight.
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Medical Liability and Treatment Relationships (Mark A. Hall, David Orentlicher, Mary Anne Bobinski, Nicholas Bagley & I. Glenn Cohen eds., 4th ed. 2018).
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Includes cases and materials on Medical Malpractice not found in the parent book, including: Supreme Court decisions and notes on forensic medicine and epidemiological evidence. Problems on practice guidelines as proof of negligence.
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In ethics and political philosophy, it is not uncommon to distinguish the question of who is a moral agent (one who bears moral responsibility) from the question of who is a moral patient (one to whom moral obligations are owed). The two need not go together: one could be a moral patient but not have moral agency – infant children are a plausible example. In this draft chapter, I examine the allied notion of a human rights patient for the human right to health. I consider two particular questions. First, to what extent should a human right to health focus on identified lives, those whom we have identified as currently in need and who make claims on us, as opposed to statistical lives – the faceless masses who may also need our help just as much? This question sadly comes up all the time for ministries of health – whether to fund an expensive treatment for a sympathetic child who has come forward and demanded the treatment to save his or her life or to invest in programs that distribute less expensive, more quotidian benefits to hundreds of children in need. In particular, I will dwell on how countries like Colombia that have made a right to health justiciable may have tilted spending towards identified lives in a way that is potentially troubling. This discussion will occupy Section I of this chapter. In Section II I will go into even more murky territory and discuss whether a human right to health ought to encompass as its moral patients only those who currently exist, those who certainly will exist but do not yet exist, those whose existence may be contingent on the decisions we make, all of the above, or only some of the above. To give some tangible examples: How should a health care allocator, trying to fulfill a human right to health, make trade-offs between expending resources to prevent a very bad disability (say blindness) in an individual who currently exists versus implementing a program that works on asymptomatic adults but prevents them from transmitting the same bad disability to the children they are about to conceive? This is a trade-off between currently existing lives and lives that are certain to exist but do not yet exist. What if the way that “prevention” is accomplished is by having those women delay getting pregnant (think of the Zika virus) or choosing a sperm donor rather than their romantic partner who is a carrier of the disease? This form of prevention does not prevent a disease for those who do not currently exist but will certainly exist, instead it prevents the disease by changing who comes into existence – a different sperm meets the egg and a different child is born. Call this the question of contingent persons. Does the human right to health treat contingent persons as its moral patients?
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Mutant mitochondrial DNA gives rise to a broad range of incurable inborn maladies. Prevention may now be possible by replacing the mutation-carrying mitochondria of zygotes or oocytes at risk with donated unaffected counterparts. However, mitochondrial replacement therapy is being held back by theological, ethical, and safety concerns over the loss of human zygotes and the involvement of a donor. These concerns make it plain that the identification, validation, and regulatory adjudication of novel embryo-sparing donor-independent technologies remains a pressing imperative. This Opinion highlights three emerging embryo-sparing donor-independent options that stand to markedly allay theological, ethical, and safety concerns raised by mitochondrial replacement therapy.
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The practice of paying research participants has received significant attention in the bioethics literature, but the focus has been almost exclusively on consideration of factors relevant to determining acceptable payment amounts. Surprisingly little attention has been paid to what happens once the payment amount is set. What are the ethical parameters around how offers of payment may be advertised to prospective participants? This article seeks to answer this question, focusing on the ethical and practical issues associated with disclosing information about payment, and payment amounts in particular, in recruitment materials. We argue that it is permissible—and indeed typically ethically desirable—for recruitment materials to disclose the amount that participants will be paid. Further, we seek to clarify the regulatory guidance on “emphasizing” payment in a way that can facilitate design and review of recruitment materials.
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When data from all aspects of our lives can be relevant to our health - from our habits at the grocery store and our Google searches to our FitBit data and our medical records - can we really differentiate between big data and health big data? Will health big data be used for good, such as to improve drug safety, or ill, as in insurance discrimination? Will it disrupt health care (and the health care system) as we know it? Will it be possible to protect our health privacy? What barriers will there be to collecting and utilizing health big data? What role should law play, and what ethical concerns may arise? This timely, groundbreaking volume explores these questions and more from a variety of perspectives, examining how law promotes or discourages the use of big data in the health care sphere, and also what we can learn from other sectors. This document contains the Introduction to the book, which also summarizes all the chapters in the volume.
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In a possible first, the heritable transmission of a fatal mitochondrial DNA disease (Leigh syndrome) may have been prevented by replacing the mutation-bearing mitochondria of oocytes with donated mutation-free counterparts. The procedure, carried out by a U.S.-led team, took place in Mexico in circumvention of a statutory U.S. moratorium on mitochondrial replacement. This development calls into question the regulatory utility of a national moratorium in a globalized world wherein cross-border care is increasingly prevalent. This development also calls to account the moral defensibility of a moratorium that acquiesces in the birth of gravely ill children whose afflictions could have been prevented. In this Current Commentary, we outline a potential path forward by analyzing the dual imprint of the moratorium, examining its legislative shortcomings, exploring its motivational roots, considering its national effect, and proposing its unlinking from the related yet distinct ban on editing the genome of the human embryo.
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When data from all aspects of our lives can be relevant to our health - from our habits at the grocery store and our Google searches to our FitBit data and our medical records - can we really differentiate between big data and health big data? Will health big data be used for good, such as to improve drug safety, or ill, as in insurance discrimination? Will it disrupt health care (and the health care system) as we know it? Will it be possible to protect our health privacy? What barriers will there be to collecting and utilizing health big data? What role should law play, and what ethical concerns may arise? This timely, groundbreaking volume explores these questions and more from a variety of perspectives, examining how law promotes or discourages the use of big data in the health care sphere, and also what we can learn from other sectors.
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Mark Hall, David Orentlicher, Mary Anne Bobinski, Nicholas Bagley & I. Glenn Cohen, Health Care Law and Ethics (Wolters Kluwer 9th ed. 2018).
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The George P. Smith Lecture. Medical Tourism” is the travel of patients from a home country to a destination country for the primary purpose of receiving health care. “Circumvention Tourism” is a sub-type of such travel where the motivation is circumventing a domestic prohibition on accessing a medical service. This Article focuses on such circumvention tourism for cutting-edge medicine. I use the recently reported case of travel to Mexico for Mitochondrial Replacement Therapy as a springboard for examining the legal and ethical issues raised by the practice and to discuss restrictive regulation in place in the United States.
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The year 2015 was a significant anniversary for global health: 15 years since the adoption of the Millennium Development Goals and the creation of the Global Alliance for Vaccines and Immunization, followed two years later by the Global Fund to Fight AIDS, TB and Malaria. 2015 was also the 10-year anniversary of the adoption of the International Health Regulations (May 2005) and the formal entering into force of the Framework Convention on the Tobacco Control (February 2005). The anniversary of these frameworks and institutions illustrates the growth and contribution of 'global' health diplomacy. Each initiative has also revealed on-going issues with compliance, sustainable funding and equitable attention in global health governance. In this paper, we present four thematic challenges that will continue to challenge prioritisation within global health governance into the future unless addressed: framing and prioritising within global health governance; identifying stakeholders of the global health community; understanding the relationship between health and behaviour; and the role of governance and regulation in supporting global health.
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This qualitative study examined how NFL players and their family members characterized the impact of an NFL career on the mental and emotional health of NFL players. We interviewed 25 NFL players (23 former and 2 current) and 27 family members (24 wives and 3 others) to elicit players’ experiences during and following their time in the NFL. While players experienced positive outcomes from their careers, they also described important mental health challenges including feelings of depression, loneliness, and stress. Many of their concerns during their careers were linked to anxiety about job performance and job security. Post-career concerns were linked to loss of social identify and connections. Players had difficulty finding help for their concerns. We conclude with eight recommendations, including improved resources, confidentiality, and support.
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The article reports on the Stakeholder Perspectives including investigators and institutional review boards (IRBs) and the Ethical and the Regulatory Oversight and to address technical and methodological challenges and Issues concerning the leading research institute in the United States for PCOR, Patient-Centered Outcomes Research Institute (PCORI).
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Just three days prior to the inauguration of Donald J. Trump as president of the United States, Rep. Jody B. Hice (R-GA) introduced the Sanctity of Human Life Act (H.R. 586), which, if enacted, would provide that the rights associated with legal personhood begin at fertilization. While often touted as a means to outlaw abortion, protecting the “lives” of single-celled zygotes may also have implications for the practice of reproductive medicine and research. Indeed, such personhood efforts stand apart and distinct from more incremental attempts to restrict abortion that target the abortion procedure and those who would perform it. While personhood efforts have not been successful to date at either the state or federal levels, abortion opponents may find a friend in President Trump and his Supreme Court nominees. What is more, because the recent decision by the Court in Whole Woman’s Health v. Hellerstedt makes it more difficult for states to impose incremental restrictions on the abortion procedure, restrictions focused on the status of the unborn may assume increasing importance. Personhood rhetoric is often seen in proceedings involving the disposition of unused embryos and in laws that restrict access to abortion on the basis of gender, race, or disability. Laws outlawing abortion on the basis of fetal pain are also on the rise. With so much uncertainty surrounding the political landscape, this essay places the personhood movement in historical context with other anti-abortion strategies. This essay further explores the theoretical underpinnings of the personhood movement and considers its future prospects with regard to abortion and other reproductive services.
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Stem cell therapies (hereinafter: SCT) hold tremendous promise for the treatment of a variety of diseases. Yet, alongside the medical potential, they pose significant risks. This article focuses on the phenomenon of B SCT travel and the regulatory challenges associated with it. Recent Findings Internet websites for clinics all around the world offer SCT for different medical conditions, such as degenerative and immunological conditions, as well as cosmetic indications. The demand for SCT is growing, despite their experimental nature, and an effective regulatory framework is urgently needed at both national and international levels. Summary A new regulatory framework aimed at reducing the risks associated with SCT travel and the provision of unproven SCT should be implemented. It should include professional guidelines, an accreditation system that would evaluate SCT being offered by clinics, enforcement mechanisms against fraud, reimbursement by insurers for approved SCT, and residency requirements.
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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.
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A review of the article "Untangling the Promise of Human Genome Editing" by Professor K. Drabiak, which appears in the same issue of the journal, is presented, and it mentions germline gene editing, Mitochondrial Replacement Therapy, and an appropriations-related U.S. Congressional Rider.
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The athletes who participate in professional football call themselves (and the public calls them) football “players,” not football “workers,” reflecting the reality that as exhausting and high-pressure as their efforts are, they are ultimately playing a sport. Nevertheless, we should not forget that these athletes indeed are workers; they have trained extensively to perform their roles, they do intense physical labor as part of their jobs, they are salaried employees of National Football League (“NFL”) clubs, and they are represented by a labor union, the National Football League Players Association (“NFLPA”). This Article is the first to explore in depth what might happen if our society treated professional football like a workplace, subject to government regulation, public–private cooperation or other “soft law” mechanisms, or required information disclosure to facilitate more informed understanding of the variety of safety and health risks these workers face to provide fans with entertainment. Specifically, it examines how recognizing the NFL as a workplace, governed by the U.S. Occupational Safety and Health Administration (“OSHA”) and the law surrounding occupational health and safety, can transform our understanding of the NFL and player safety. This topic has gained considerable and growing public attention, particularly regarding the recent and controversial concerns over the possible long-term risks of neurological damage in these workers. The Article explains that OSHA clearly has the authority to regulate the NFL. Nevertheless, there is little to no precedent or guidance for OSHA to insert itself into the on-the-field aspects of professional sports. We discuss in detail the small body of case law that bears on OSHA’s authority in entertainment and sports, which opens some doors for OSHA to issue standards but also sets limits on its ability to alter the nature of the entertainment or sport. But more importantly, there are a host of political and practical reasons we discuss, which make it very unlikely that OSHA will attempt to regulate the NFL. Nevertheless, there are a wide variety of ways for OSHA to intervene or involve itself without regulating, as discussed at length in the Article. Adding a public institution like OSHA as a party to existing labor-management discussions concerning health and safety may be the best natural evolution of the issue. Many in the public seem to believe that football must become safer to thrive and hope that it will. Regulations or “soft law” approaches have sometimes worked well even in complicated, uncertain, and fraught issues. OSHA understands evidence from a public health lens, and it is the institution empowered by Congress and the courts to help balance the competing goals of worker protection versus cost and liberty in an open setting. So we place the onus on OSHA in this Article: the agency should be more willing to step up to this challenge and less conflicted about offering to participate in an issue where it has expertise complementary to that which the NFL and NFLPA bring, as well as a unique opportunity to help bring about constructive change.
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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.
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Among the core missions of the U.S. Food and Drug Administration (FDA) are protecting public health by assuring the safety and efficacy of drugs, biologics, and medical devices and advancing public health by promoting scientific research and medical innovation (1). According to its mandate, the decisions made by the FDA in fulfilling these missions should be guided by scientific considerations, not economic or political ones. However, several recent, high-profile episodes have highlighted the fact that the FDA is buffeted by many external influences (2, 3). Such controversies require us to distinguish between legitimate influences that would improve the FDA or enhance its regulatory mission, illegitimate influences that seek to corrupt or undermine the agency, and influences that may be legitimate but nevertheless harm public health or patient outcomes. We present a decision framework to assist regulators, policy-makers, judges, physicians, and the public in evaluating the legitimacy and value of external influences on the FDA.
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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.
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On December 18, 2015, President Obama signed into law a policy rider forestalling the therapeutic modification of the human germ line. The rider, motivated by the science’s potential unethical ends, is only the most recent instance in which the legislature cut short the ongoing national conversation on the acceptability of a developing science. This essay offers historical perspective on what bills were proposed and passed surrounding four other then-developing scientific breakthroughs—Recombinant DNA, in vitro fertilization, Cloning, Stem Cells—to better analyze how Congress is, and should, regulate this exciting and promising science.