Law Commons^™

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 …

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 …

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 …

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 …

Reconsidering Constitutional Protection For Health Information Privacy, Wendy K. Mariner

Faculty Scholarship

What kinds of health information should be reported to government for civil purposes? Several competing trends encourage efforts to reassess the scope of constitutional protection for health information: the social and commercial value of health information; the amount of data held by third parties, from health care providers to internet servers; critiques of the third party doctrine exception to Fourth Amendment protection; and concerns about the loss of privacy. This article describes a variety of civil purposes for which health information is collected today. A close analysis of cases applying the third party doctrine, administrative search principles, and the special …

Enhancing The Fighting Force: Medical Research On American Soldiers, Catherine L. Annas, George J. Annas

Faculty Scholarship

During President Barack Obama's first primetime press conference, reporters asked primarily about the state of the economy and terrorism. Wedged between questions on these two vital issues was a query from the Washington Post's Michael Fletcher:

Question: What is your reaction to Alex Rodriguez's admission that he used steroids as a member of the Texas Rangers?

Obama: You know, I think it's depressing news.... And if you're a fan of Major League Baseball, I think it - it tarnishes an entire era, to some degree. And it's unfortunate, because I think there are a lot of ballplayers who played it …

Foreword: Phase Ii Of The Genetics Revolution: Sophisticated Issues For Home And Abroad, Frances H. Miller

Faculty Scholarship

The distinguished health law and policy scholars we invite to contribute to the American Journal of Law & Medicine's annual symposium issue are given carte blanche to write about any aspect of the designated topic that appeals to them. The authors in this year's genetics symposium, The Genetic Revolution: Conflicts, Challenges and Conundra, are already well known for their work in the field-in fact three of them have just co-authored the only casebook specifically dedicated to the law, policy and ethics of geneticsl-and we deliberately asked them for relatively short pieces on the theory that taken together their articles would …

Making Clinical Trials Safer For Human Subjects, Michael S. Baram

Faculty Scholarship

Clinical trials, in which new biotech and other medical products are tested on human subjects, provide much of the data used by the FDA to determine whether the products are suitable for routine use in health care. Thus, the trials are of obvious importance to medical progress and improvement of public health, and to those who have career and financial interests at stake. But clinical trials are also important to the human subjects involved because the products being tested on them may remedy their illnesses, but may also pose risks since the products have usually not been previously tested on …

The Empire Of Death: How Culture And Economics Affect Informed Consent In The U.S., The U.K., And Japan, George J. Annas, Frances H. Miller

Faculty Scholarship

Historically, most Americans have treated health care as a private commodity whose price, and therefore availability, is primarily determined by market forces. In such a context, the law not unsurprisingly places a high premium on information disclosure by physicians. Personal autonomy-an individual's power to choose among medical options-enjoys its most zealous protection under U.S. jurisprudence.⁷ The dominant U.S. version of informed consent is grounded on principles of patient/consumer autonomy, and seems to enhance market choice. But a strong theme of collectivism now runs through some discussions of U.S. health policy.⁸ President Clinton was elected at least in part …

The Politics Of Transplantation Of Human Fetal Tissue, George J. Annas

Faculty Scholarship

Research involving human fetal tissue has been the subject of intense political debate in this country for almost two decades, and the use of fetal tissues in transplantation continues this controversy in another forum. Since Roe v. Wade ,1 the landmark decision on abortion by the U.S. Supreme Court in 1973, the federal government has focused public attention on fetal research by creating panels of experts. "3 This conclusion was accepted on a vote of 15 to 2, and included recommendations that the decision to abort be kept independent of the decision to retrieve and use fetal tissue, that recipients …

Informed Consent In The Post-Modern Era, Wendy K. Mariner

Faculty Scholarship

The doctrine of informed consent' is intended to get physicians to talk to their patients so that patients can make reasonably knowledgeable choices about whether to undergo particular forms of medical care. Although the law has long prohibited treatment without the patient's consent,² physicians have resisted the idea that treatment decisions ultimately are for the patient to make. Only recently have physicians been willing to disclose information about the benefits and risks of recommended therapies. ³ Even with the best of intentions, however, the discussions that do take place are often far from the law's ideal of reasonable disclosure …

Trying To Live Forever, George J. Annas

Faculty Scholarship

Since the case of Karen Ann Quinlan, legal actions regarding the dying have become commonplace. Unfortunately, so has legal misinformation, misapplication, fantasy, and inhumanity. We seem to have frightfully underestimated the ability of lawyers to focus on trivia and self protection, and to ignore the basic human rights of dying persons. As the authors of the Hasting Center's Guidelines declare in the introduction:

Hospital legal counsel, lawyers serving other health care institutions, and legal advisors to individual health care professionals have a critical role to play in seeing that medicine is not driven by law, and health care professionals are …

Made In The U.S.A.: Legal And Ethical Issues In Artificial Heart Experimentation, George J. Annas

Faculty Scholarship

The death of William Schroeder in Louisville, Kentucky, on August 6, 1986, brought to a close a remarkable chapter in public human experimentation. Artificial heart implants represent the most public experiments in the history of the world. The manner in which they are conducted is a matter of utmost public and professional concern, since it graphically portrays the seriousness with which we take our laws and ethical rules regarding the protection of the rights and welfare of human subjects. Unfortunately, the brief history of artificial heart implants is neither a happy nor a proud one. Begun with high hopes and …