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 …

Evaluating For-Profit Public Benefit Corporations As An Additional Structure For Antibiotic Development And Commercialization, Kevin Outterson, John H. Rex

Faculty Scholarship

While antibiotics are a key infrastructure underpinning modern medicine, evolution will continue to undermine their effectiveness, requiring continuous investment to sustain antibiotic effectiveness. The antibiotic R&D ecosystem is in peril, moving towards collapse. Key stakeholders have identified pull incentives such as Market Entry Rewards or subscription models as the key long-term solution. If substantial Market Entry Rewards or other pull incentives become possible, there is every reason to expect that for-profit companies will return to the antibiotic field. However, the political and financial will to develop such Market Entry Rewards or other similar incentives may be difficult to muster in …

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 …

Gift Giving To Biobanks, Leonard H. Glantz, Patricia Roche, George J. Annas

Faculty Scholarship

We agree with Mark Rothstein's goal of giving tissue donors control over their donated tissues. But we think using the research model as the basis for attaining this goal, while widely employed and accepted, should be abandoned.

The research regulations were originally adopted to deal with interventions on living human beings, not on the tissue of human beings. The Nuremberg Code (a reaction to concentration camp experiments), the Willowbrook experiment, the Tuskegee syphilis experiment, and the other examples of the abuse of research subjects that provided the rationale for regulating research on human subjects clearly had nothing to do with …

Rules For Donations To Tissue Banks: What Next?, George J. Annas

Faculty Scholarship

Michael Crichton's Next is a fictional creation of multiple catastrophes emanating from the real-life case of John Moore, in which the California Supreme Court ruled in 1990 that Moore did not own his cells after they were removed from his body. As human tissue has become commercially useful, and as tissue banks storing and providing samples for research have flourished, the question of who owns the tissue has become more vital. Next got mixed reviews, but even many scientists, such as Michael Goldman, who reviewed the book in Nature, agree with Crichton that it is imperative that we “establish clear …

Bioterror And “Bioart”: A Plague O' Both Your Houses, George J. Annas

Faculty Scholarship

Since September 11, 2001, the threat of bioterrorism has caused Congress and the President to dramatically increase research funding for countermeasures, including funding for new biosecurity laboratories. The new kind of war against non-state actors who use terror to intimidate populations has also made the creation of new ethical and legal rules for researchers seem critical. New laws have been passed, and there have been proposals for new codes of ethics for bioterrorism-related research. Almost five years after September 11, however, the outcome of the development of new research rules remains uncertain.

Dna Testing, Banking, And Genetic Privacy, George J. Annas

Faculty Scholarship

"Who am I?” has always been a fundamental philosophical question that may require decades of reflection to answer. With the advent of DNA analysis, there is a growing public impression that the answer may be found in our genes. Various Internet sites offer descriptions of our ancestral history on the basis of our DNA, as well as testing for specific “disease genes” or general profiles that are used to recommend lifestyle changes, such as foods to be eaten or avoided. Researchers have even suggested that although the scientific evidence is speculative and at best probabilistic, many people will want to …

Politics, Morals And Embryos, George J. Annas

Faculty Scholarship

Bioethics in the United States reflects US culture and tends to be pragmatic, market-oriented and insular. Add embryo politics to this mix and, over the past few years, the result has been a bioethics that has become so narrow and selfabsorbed as to be virtually irrelevant to the rest of the world. Not all the blame for this can be placed on President George W. Bush’s political agenda for his President’s Council on Bioethics, now in its third year of operation, but much can. The council has made public bioethics the servant of politics by pursuing a narrow, embryo-centric agenda. …

Arbitrage, Bioethics, And Cloning: The Abcs Ofgestating A United National Cloning Convention, George J. Annas

Faculty Scholarship

America's inability to craft a regulatory ethics of abortion has led to a
wild west of unregulated research with human embryos and pregnant
women by our private infertility industry. Because of an "all or nothing"
research mentality, it is becoming increasingly impossible to suggest
outlandish and reckless reproductive research possibilities without seeing
them actually pursued. And if even the wild west seems a bit inhospitable
to particular research goals, such as cloning to produce the genetic duplicate
of an existing person, media darlings like Severino Antinori and Zavos
Panos, and even members of the Raelian cult, clone press conferences
(since …

Hipaa Regulations: A New Era Of Medical-Record Privacy?, George J. Annas

Faculty Scholarship

The new privacy regulations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) become effective April 14, 2003. This article outlines the implications of the new policy for practicing physicians. The regulations will affect virtually every physician, because they apply to any health care provider who conducts any business electronically, including billing. The regulations require health care providers to provide patients with a privacy notice that informs them who will have access to their records without their explicit consent and about patients' rights to inspect and amend their own records.

Symposium: Advances In Biomaterials And Devices, And Their Financing, Michael S. Baram, Ronald A. Cass, Steven Bauer, Joyce Wong, Martin Yarmush, Joshua Tolkoff, Rufus King

Faculty Scholarship

My name is Professor Michael Baram and I direct the Center for Law and Technology here at the law school. Today's meeting is the third annual Technology Law Symposium to be held here, sponsored by the high technology law firm of Testa, Hurwitz & Thibeault, LLP and the Center for Law and Technology.

Our meeting today is focused on an exciting area of research and product development. This area involves the use of conventional as well as new genetically engineered biomaterials in new medical device configurations for implantation and with the purpose of restoring bodily functions, regenerating tissue, bone, cartilage, …

Waste And Longing: The Legal Status Of Placental Blood Banking, George J. Annas

Faculty Scholarship

Waste is not always what it seems. In his Cold War novel Underworld, for example, Don DeLillo explores the multifaceted qualities of waste. “Waste,” he notes, “is the secret history, the underhistory, the way archaeologists dig out the history of early cultures, every sort of bone and broken tool, literally from under the ground.”1 And waste can also be transformed into money:

They are trading garbage in the commodity pits in Chicago. They are making synthetic feces in Dallas. You can sell your testicles to a firm in Russia that will give you four thousand dollars and then remove …

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Stem Cell Politics, Ethics And Medical Progress, George J. Annas

Faculty Scholarship

Controversy over how to fund and regulate stem cell research continues in the US and is unlikely to be resolved anytime soon. The National Institutes of Health (NIH) has announced that it is prepared to fund stem cell research under yet-to-be-specified guidelines. The National Bioethics Advisory Commission (NBAC) issued a report on stem cells in mid-September, recommending that Congress change the law to permit the derivation and use of stem cells from embryos no longer needed for reproduction purposes that are stored at in vitro fertilization (IVF) clinics. The NBAC also recommended that the Department of Health and Human Services …

The Politics Of Human-Embryo Research: Avoiding Ethical Gridlock, George J. Annas

Faculty Scholarship

[...]abortion is about more than politics; it is fundamentally about ethics, morals, equality, and religion, and how we think about abortion reveals much about how we are likely to think about other life-and-death issues in contemporary American medical practice. Because politics as currently practiced seems so unprincipled, there have been sporadic attempts to redefine abortion-related issues as ethical questions and to set up national panels and advisory groups to examine various practices and make recommendations about their ethics.

Report On The National Commission: Good As Gold, George J. Annas

Faculty Scholarship

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research ended its work by substantially endorsing the status quo which places primary reliance on local Institutional Review Boards for subject protection. This was predictable because of the Commission's researcher-dominated composition which permitted it to assume that (1) research is good; (2) experimentation is almost never harmful to subjects; and (3) researcher-dominated IRBs can adequately protect the Interests of human subjects. The successor Presidential Commission can learn much by reexamining these premises.

Scientific Research With Children: Legal Incapacity And Proxy Consent, Leonard H. Glantz, George J. Annas, Barbara Katz

Faculty Scholarship

Before an investigator can use any person as a subject in biomedical or behavioral research, he must obtain that person's informed consent. This consent must be voluntary, competent, and understanding.¹ There are two questions that arise in regard to experimentation on children. First, is a child legally capable of giving an informed and understanding consent? Second, do parents have the legal capacity to consent to the performance of research on their children? This article will attempt to answer both of these questions.