Law Commons^™

The Shared Ethical Framework To Allocate Scarce Medical Resources: A Lesson From Covid-19, Ezekiel J. Emanuel, Govind C. Persad

Sturm College of Law: Faculty Scholarship

The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, …

Risk Tradeoffs And Equitable Decision-Making In The Covid-19 Pandemic, Lawrence O. Gostin, Sarah A. Wetter

Georgetown Law Faculty Publications and Other Works

Since the start of the Covid-19 pandemic, societies have faced agonizing decisions about whether to close schools, shutter businesses, delay nonemergency health care, restrict travel, and authorize the use of emergency Covid-19 countermeasures under limited scientific understanding. Measures to control the spread of COVID-19 have disrupted our health, educational, and economic systems, tarnished our mental health, and took away our cherished time with family and friends. Conflicting advice from health agencies on the utility of public health measures left us wondering, was it all worth it? We still do not have all the answers to guide us through difficult risk-risk …

Digital Health Passes In The Age Of Covid-19: Are “Vaccine Passports” Lawful And Ethical?, Lawrence O. Gostin, I. Glenn Cohen, Jana Shaw

Georgetown Law Faculty Publications and Other Works

As COVID-19 vaccination rates in high-income countries increase, governments are proposing or implementing digital health passes (DHPs) (vaccine “passports” or “certificates”). Israel uses a “green pass” smartphone application permitting vaccinated individuals’ access to public venues (eg, gyms, hotels, entertainment). The European Union plans a “Digital Green Certificate” enabling free travel within the bloc (see eTable in the Supplement). New York is piloting an IBM “Excelsior Pass,” confirming vaccination or negative SARS-CoV-2 test status through confidential data transfers to fast-track business reopenings. This paper examines the benefits of DHPs, scientific challenges, and whether they are lawful and ethical.

The Ethics Of Research That May Disadvantage Others, Christopher Robertson

Faculty Scholarship

In prospective interventional research, a treatment may provide an advantage for the recipient over other humans not receiving it. If the intervention proves successful, the treated are better able to compete for a scarce ventilator, a class grade, or a litigation outcome, potentially risking the deaths, jobs, or incomes of non-treated persons. The concerns for “bystanders” have typically focused on direct harms (e.g., infecting them with a virus), unlike the mere competition for rivalrous goods at issue here.

After broadly scoping this problem, analysis reveals several reasons that such research is typically permissible, notwithstanding the potential setbacks to the interests …

Equitable Allocation Of Covid-19 Vaccines: An Analysis Of The Initial Allocation Plans Of Cdc's Jurisdictions With Implications For Disparate Impact Monitoring, Harald Schmidt, Rebecca Weintraub, Michelle A. Williams, Alison Buttenheim, Emily Sadecki, Helen Wu, Lawrence O. Gostin, Angela A. Shen

Georgetown Law Faculty Publications and Other Works

Major global and national vaccine allocation guidelines urge planners to allocate vaccines in ways that recognize, and ideally reduce, existing societal inequities within countries. However, allocation plans of the US will be determined individually by each of the CDC’s 64 jurisdictions (states, the District of Columbia, five cities, and territories). We analyzed whether jurisdictions have incorporated novel approaches to reduce inequity, based on plans published by the CDC in early November 2020 (63 summaries [98% of all jurisdictions] and 47 full guidance documents [73% of all, including all 50 states]).

Eighteen states adopted a novel proposal to use a disadvantage …

Video; Health Law & Ethics 2020, Kathy Cerminara, Jonathan Kroner Law Office, Mcdermott Will & Emery Llp, Lubell & Rosen, Gerald M. Morris

NSU Law Seminar Series

This program will focus on the current climate of health law and the necessary steps used through federal practice to adjust to the ever-changing atmosphere of new legislation. Attendees will learn about the various paths within the practice, about emerging new laws, outreach and training, and how to become involved in the federal practice of health law. The presenters will explain what you need to get started, what different types of experiences and exposure might be helpful in entering the field and instruct you on maintaining ethics by knowing and following the Federal Rules of Civil Procedure and Model Rules …

Is It Lawful And Ethical To Prioritize Racial Minorities For Covid-19 Vaccines?, Harald Schmidt, Lawrence O. Gostin, Michelle A. Williams

Georgetown Law Faculty Publications and Other Works

Coronavirus disease 2019 (COVID-19) has disproportionately affected racial minorities in the United States resulting in higher rates of infection, hospitalization, and death. With a limited supply after the initial approval of a safe and effective vaccine, difficult legal and ethical choices will have to be made on priority access for individuals. The National Academies of Sciences, Engineering, and Medicine (NASEM) has recommended prioritization of racial minorities who are “worse off” socioeconomically and epidemiologically. TheWorld Health Organization (WHO) similarly cautioned that “colorblind” allocation frameworks could perpetuate or exacerbate existing injustices. Both NASEM and WHO urge policy makers to allocate vaccines in …

Keeping The Patient At The Center Of Machine Learning In Healthcare, Jessica Findley, Andrew Woods, Christopher Robertson, Marvin J. Slepian

Faculty Scholarship

Char et al. (2020) aspire to provide "a systematic approach to identifying ... ethical concerns" around machine learning healthcare applications (ML-HCAs), which includes artificial intelligence and big data. Their approach, styled around the development "pipeline" for new technologies, has valuable insights, but we think it over-emphasizes technical design questions and under-emphasizes core ethical questions. There is little ethical debate about whether to maximize accuracy, evaluation, and oversight, at reasonable cost. Of course those goals should be pursued, but these are design challenges about feasibility more than ethical concerns.

Genome Editing 2020: Ethics And Human Rights In Germline Editing In Humans And Gene Drives In Mosquitoes, George J. Annas

Faculty Scholarship

The moon landing, now more than a half century in the past, has turned out to be the culmination of human space travel, rather than its beginning. Genetic engineering, especially applications of CRISPR, now presents the most publicly discussed engineering challenges—and not just technical, but ethical as well. In this article, I will use the two most controversial genomic engineering applications to help identify the ethics and human rights implications of these research projects. Each of these techniques directly modifies the mechanisms of evolution, threatens to alter our views of ourselves as humans and our planet as our home, and …

Setting Priorities Fairly In Response To Covid-19: Identifying Overlapping Consensus And Reasonable Disagreement, David Wasserman, Govind C. Persad, Joseph Millum

Sturm College of Law: Faculty Scholarship

Proposals for allocating scarce lifesaving resources in the face of the Covid-19 pandemic have aligned in some ways and conflicted in others. This paper attempts a kind of priority setting in addressing these conflicts. In the first part, we identify points on which we do not believe that reasonable people should differ—even if they do. These are (i) the inadequacy of traditional clinical ethics to address priority-setting in a pandemic; (ii) the relevance of saving lives; (iii) the flaws of first-come, first-served allocation; (iv) the relevance of post-episode survival; (v) the difference between age and other factors that affect life-expectancy; …

Regulating Care Robots, Valarie K. Blake

Law Faculty Scholarship

Care robots already assist the elderly in some nursing homes around the globe and could be in widespread use in hospitals and private homes sooner than we think. These robots promise great hope for patients: robots can provide increased independence, assistance with daily living, comfort and distraction during procedures, education, and companionship during vulnerable and lonely times in patients' lives. Despite these promising features, there are a number of concerns; care robots, designed with the aim of winning patient trust and affection, have unprecedented access to personal lives as well as recording and sensory capabilities beyond any human. They pose …

Why The Government Shouldn't Pay People To Get Vaccinated Against Covid-19, Ana Santos Rutschman

All Faculty Scholarship

As several pharmaceutical companies approach the Food and Drug Administration (FDA) seeking authorization to bring COVID-19 vaccines to market, concerns about vaccine mistrust cloud the prospects of imminent vaccination efforts across the globe. These concerns have prompted some commentators to suggest that governments may nudge vaccine uptake by paying people to get vaccinated against COVID-19. This post argues that, even if potentially viable, this idea is undesirable against the backdrop of a pandemic marked by the intertwined phenomena of health misinformation and mistrust in public health authorities. Even beyond the context of COVID-19, paying for vaccination is likely to remain …

The Personal Responsibility Pandemic: Centering Solidarity In Public Health And Employment Law, Lindsay F. Wiley, Samuel R. Bagenstos

Articles

Our nation’s response to the coronavirus pandemic has revealed fundamental flaws in our legal regimes governing both public health and employment. Public health orders have called on individuals to make sacrifices to protect society as a whole. Simple fairness dictates that the burdens should be shared as widely as the benefits. And the case for burden-sharing does not rest on fairness alone. Public health measures are more likely to succeed when those who are subject to them understand them as fair1 and when their cooperation is supported. 2 Predictably, our pandemic response has placed disproportionate burdens on those who are …

“Unusual Care”: Groupthink And Willful Blindness In The Support Study, George J. Annas, Catherine L. Annas

Faculty Scholarship

The SUPPORT study of extremely premature newborns seems likely to go down as one of the most controversial studies of the 21st century (SUPPORT Study Group Citation2010). We previously suggested that the researchers in SUPPORT were “legally blind” in failing to understand that the “standard” that defines the content of informed consent is set by law, including the federal regulations, not by what physicians “usually” do or don’t do (Annas and Annas Citation2013). Macklin and Natanson, also early critics of the SUPPORT study’s failure to disclose the increased risk of death posed by the study, (Macklin et al. …

The Two Most Important Questions For Ethical Public Health, John Coggon, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

Public health ethics is a distinct and established field, and it is important that its approaches and rationales are understood widely in the public health community. Such understanding includes the capacity to identify and combine principled and practical concerns in public health. In this paper, we present a background to the ideas that motivate public health ethics as a field of research and practice, and rationalize these through a critical ethico-legal approach to analysis. Two essential points of inquiry are identified and formulated to allow philosophical and practical agendas regarding public health to be combined. These come through asking the …

Mid-Atlantic Ethics Committee Newsletter, Summer 2019

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Legalization Of Physician-Assisted Suicide For Increased Patient Autonomy, Morgan Mcenroe

Religion: Student Scholarship & Creative Works

This essay features an assessment of the various factors which play into the argument for legalization of physician-assisted suicide (PAS) in the United States for increased patient autonomy. Arguments for legalization of PAS as a means of end-of-life care remain separate from voluntary euthanasia. National legalization of PAS, for this fundamental principle of hospice care, is necessary to allow a choice to those in their final stages of life of how they wish to leave. If the values of PAS advocates are maximization of autonomy and minimization of suffering, then it follows that the chronically depressed, as well as patients …

Informed Consent And The Role Of The Treating Physician, Eric Feldman, Holly Fernandez Lynch, Steven Joffe

All Faculty Scholarship

In the century since Justice Benjamin N. Cardozo famously declared that “[e]very human being of adult years and sound mind has a right to determine what shall be done with his own body,” informed consent has become a central feature of American medical practice. In an increasingly team-based and technology-driven system, however, who is — or ought to be — responsible for obtaining a patient’s consent? Must the treating physician personally provide all the necessary disclosures, or can the consent process, like other aspects of modern medicine, take advantage of specialization and division of labor? Analysis of Shinal v. Toms, …

Mid-Atlantic Ethics Committee Newsletter, Spring 2018

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Template Policy Re: Access To Medical Assistance In Dying In Publicly-Funded Institutions, Jocelyn Downie

Articles, Book Chapters, & Popular Press

Patients are being denied access to assessments for, and provision of, medical assistance in dying (MAiD) in publicly-funded institutions in Canada. Health authorities should implement policies that prohibit forced transfer for MAiD (assessments and provision) unless it can be achieved without undue delay or harm to the patient (as determined by the MAiD Program, not the institution). This is a template policy that health authorities could adopt to ensure access to a legal health service in all publicly-funded institutions (including faith-based institutions) under their authority.

An Alternative To Medical Assistance In Dying? The Legal Status Of Voluntary Stopping Eating And Drinking (Vsed), Jocelyn Downie

Articles, Book Chapters, & Popular Press

Medical assistance in dying (MAiD) has received considerable attention from many in the field of bioethics. Philosophers, theologians, lawyers, and clinicians of all sorts have engaged with many challenging aspects of this issue. Public debate, public policy, and the law have been enhanced by the varied disciplinary analyses. With the legalization of MAiD in Canada, some attention is now being turned to issues that have historically been overshadowed by the debate about whether to permit MAiD. One such issue is voluntary stopping eating and drinking (VSED) as an alternative to MAiD. In this paper, I will apply a legal lens …

Can Rationing Through Inconvenience Be Ethical?, Nir Eyal, Paul Romain, Christopher Robertson

Faculty Scholarship

In this article, we provide a comprehensive analysis and a normative assessment of rationing through inconvenience as a form of rationing. By “rationing through inconvenience” in the health sphere, we refer to a non-financial burden (the inconvenience) that is either intended to cause or has the effect of causing patients or clinicians to choose an option for health‐related consumption that is preferred by the health system for its fairness, efficiency, or other distributive desiderata beyond assisting the immediate patient. We argue that under certain conditions, rationing through inconvenience may turn out to serve as a legitimate and, compared to direct …

Mid-Atlantic Ethics Committee Newsletter, Fall 2017

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Mid-Atlantic Ethics Committee Newsletter, Summer 2017

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Patenting Frankenstein's Monster: Exploring The Patentability Of Artificial Organ Systems And Methodologies, Jordana Goodman

Faculty Scholarship

The conception of Frankenstein’s monster bridges the ever-narrowing divide between man and machine. Long before Congress codified Section 33(a) of the America Invents Act (“AIA”), Mary Shelley’s vague description of the monster’s creation has left people wondering: what defines a human organism? Through an analysis of patent law and scientific progress in the development of artificial organ systems, this paper explores the boundaries of patentable subject matter in the United States and attempts to clarify Congress’s determination that “no patent may issue on a claim directed to or encompassing a human organism.” Though patent law should incentivize development of artificial …

Frontiers In Precision Medicine Ii: Cancer, Big Data And The Public, Emily Coonrod, Jorge L. Contreras, Willard Dere, Jeffrey Botkin, Leslie Francis, Jim Tabery

Utah Law Faculty Scholarship

Precision medicine is being developed within a complex landscape of public policy, science, economics, law, and regulation. In these and other policy areas, the goal of developing individually-tailored therapies poses novel challenges for health care research, delivery and policy. In this symposium, a range of experts in genetics, medicine, bioinformatics, intellectual property, health economics and bioethics identified and discussed many of the pressing questions raised by the development and practice of precision medicine. These and other issues will need to be taken into account as precision medicine moves ahead and becomes the standard of medical practice and care in the …

The Rise Of Ethical License, Christi Guerrini, Margaret Curnette, Jacob S. Sherkow, Christopher Scott

Other Publications

The Broad Institute's recent licensing of its gene editing patent portfolio demonstrates how licenses can be used to restrict controversial applications of emerging technologies while society deliberates their implications.

Mid-Atlantic Ethics Committee Newsletter, Fall 2016

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.

Is The United States Prepared For A Major Zika Virus Outbreak?, Lawrence O. Gostin, James G. Hodge Jr.

Georgetown Law Faculty Publications and Other Works

Zika virus has emerged as a global public health crisis with active transmission in the Americas and Caribbean. The World Health Organization (WHO) declared a Public Health Emergency of International Concern (PHEIC), and recently WHO reported there is a scientific consensus that Zika is a cause of microcephaly and Guillain-Barré syndrome (GBS). In the U.S. the Centers for Disease Control and Prevention (CDC) activated its emergency operations center at its highest capacity. President Obama requested $1.86 billion in emergency funding. Shamefully, Congress has yet to appropriate the funding needed for Zika preparedness, and the President has had to reallocate Ebola …

Heredity In The Epigenetic Era: Are We Facing A Politics Of Reproductive Obligations?, Michael J. Crawford

Biological Sciences Publications

Recent research in the emerging field of epigenetics has implications with the potential to re-ignite acrimony in the discourse of reproductive rights, medical ethics, and the role of the state in our homes and in our lives. For scientists, epigenetics has profoundly realigned our understanding of heredity: epigenetics provides a mechanism through which the environmental challenges met in one generation can be inscribed and transmitted to future offspring. Although both genetic parents have the potential to transmit heritable epigenetic changes to their offspring, mothers have a particularly potent effect because nutrition in the uterine environment can exert a supplemental effect …