Do terminally ill patients who have exhausted all other available, government-approved treatment options have a constitutional right to experimental treatment that may prolong their lives? On May 2, 2006, a divided panel of the U.S. Court of Appeals for the District of Columbia, in a startling opinion, Abigail Alliance for Better Access to Developmental Drugs v. Von Eschenbach, held “Yes.” The plaintiffs, Abigail Alliance for Better Access to Developmental Drugs (Abigail Alliance) and Washington Legal Foundation, sought to enjoin the Food and Drug Administration (FDA) from refusing to allow the sale of investigational new drugs that had not yet received FDA approval. The terminally ill plaintiffs contended that they quite literally could not wait that long for the drugs. With no other treatment options available, the plaintiffs urged the court to recognize a fundamental, constitutional right to take potentially life-saving or life-prolonging drugs, even though the treatment had not been fully tested through human trials for safety and effectiveness and could not be legally marketed to the public.

In July 1990, the federal Centers for Disease Control (CDC) reported the first case of possible transmission of the Human Immunodeficiency Virus (HIV) to a patient from an HIV-infected health care worker. The transmission may have occurred during an invasive dental procedure performed on her by a dentist who had AIDS, and in January 1991, the CDC reported possible HIV transmission during dental procedures to two other patients of the same dentist. Further, the recent revelation that a respected surgeon at a major medical center performed many surgical procedures while infected with HIV created substantial public concern. These cases call into question the prudence of allowing infected workers to continue performing medical and dental procedures that involve some risk, however slight, of transmitting HIV infection to patients. Whether HIV-infected workers should be excluded from practice of their profession because of a remote risk to patients relates directly to levels of tolerable risk in health care delivery and in social policy.

On July 5, 1983. the Department of Health and Human Services (HHS) issued a revised version of its Proposed Rules for the so-called Infant Doe Regulations. The regulations are designed to prevent discriminatory denial of medical treatment to handicapped infants. An earlier version published last March had been struck down for procedural defects by Federal District Court Judge Gerhard Gesell. In the course of his opinion, Judge Gesell noted that the regulations touch upon one of the most difficult and sensitive medical and ethical problems facing society—the question of what, if any, life-sustaining medical treatment should be utilized to preserve the lives of severely mentally or physically defective newborn infants.

In his view not only were the original regulations procedurally flawed, but they also were substantively deficient. Arbitrary and capricious was Gesell's phrase to describe HHS's actions in establishing a toll-free 24-hour-a-day hotline on which anonymous tipsters could trigger an investigation of alleged nontreatment.

In the landmark case of Crzan v. Director, Missouri Department of Health; the United States Supreme Court went out of its way to emphasize that the state was paying for Nancy Cruzan's care. The court refused to allow removal of the artificial nutrition and hydration that was maintaining Nancy Cruzan in a persistent vegetative state (PVS). What if, instead of the state's paying for the care, the parents had to “spend down” in order to be eligible for Medicaid? Could the state opt for life and require the family to pay for the care? If not, do constitutional rights depend on who can or will pay the cost of care?

Now turn the facts of Cruzan around and assume that the parents want to keep the child alive. Could the parents force the state to bear the cost of keeping a PVS patient alive indefinitely? If not, why should the state, but not the parents, have a constitutional right to preserve life? Do constitutional rights boil down to dollars?

To understand the future of informed consent, we should pay attention to two ethical-legal sources in addition to the revised Common Rule. Physicians acting as investigators and patients serving as research subjects bring to that relationship a long history regarding consent to treatment, and everyone dealing with research ethics needs to be aware of the Nuremberg Code and other human-rights documents. These three streams make separate and distinctly different contributions to informed consent doctrine.

Futility has had a rough time in recent medical ethics literature. From about 1987 to 1996, various writers and groups tried to define futility within the context of medical treatment, but without success. Baruch Brody and Amir Halevy give an excellent summary of the morass in their 1995 article “Is Futility a Futile Concept?” where they argue that none of the then-proposed definitions succeed. While a smattering of other attempted definitions have appeared since then, for the most part writers about futility have found it more profitable to stop trying to define futility and instead move in a different direction, that of figuring out how to resolve disputes where patient families want more treatment which clinicians think is futile. This is, for example, the approach taken by the Texas Advance Directives Act (1999), which was the first futility legislation in North America and is often seen as an appropriate template. The idea embodied in this influential legislation is that our energies should be focused on creating a process which we can use to resolve difficult cases, and which everyone finds legitimate, rather than in trying to find a definition which everyone finds legitimate.

About 6,000 individuals participate in the U.S. transplant system as a living organ donor each year. Organ donation (most commonly a kidney or part of liver) by living individuals is a unique procedure, where healthy patients undergo a major surgical operation without any direct functional benefit to themselves. In this article, the authors explore how the ideal of informed consent guides education and evaluation for living organ donation. The authors posit that informed consent for living organ donation is a process. Though the steps in this process are partially standardized through national health policy, they can be improved through institutional structures at the local, transplant center-level. Effective structures and practices aimed at supporting and promoting comprehensive informed consent provide more opportunities for candidates to ask questions about the risks and benefits of living donation and to opt out voluntarily Additionally, these practices could enable new ways of measuring knowledge and improving the consent process.

The United States federal government anticipates that nanotechnology will be the platform for the next technological and industrial revolution. The vision of its ongoing National Nanotechnology Initiative (NNI) is “a future in which the ability to understand and control matter on the nanoscale leads to a revolution in technology and industry.” The idea that nanotechnology is revolutionary has reached the public. In one public survey, over three-quarters of respondents answered correctly that “experts consider nanotechnology to be the next industrial revolution of the U.S. Economy.”

Labeling nanotechnology as “revolutionary” promotes a general attitude towards nanotechnology by trading on a common line of reasoning: technological revolutions are constituted by significant technological progress; technological progress enables comfort, ease, health, longevity, security and wealth; therefore, technological revolutions are social goods. Thus, to claim that nanotechnology is revolutionary invites a positive socio-ethical evaluation of it, not just a positive scientific or technological one.

In this article, the author reviews the ways that the microaggressions framework has been taken up with regard to weight stigma by academics and activists and offers insight into its value for conceptualizing and challenging weight stigma.

Over the past several years, the most widely publicized issue in capital litigation has been the constitutional status of states’ lethal injection protocols. Death row inmates have not challenged the constitutionality of lethal injection itself, but rather execution protocols and their potential for maladministration. The inmates’ concern is due to the three-drug protocol used in the vast majority of capital jurisdictions: if the anesthetic, which is administered first, is ineffectively delivered, then the second and third drugs — the paralytic and heartbeat-ceasing agents — will cause torturous pain and suffering in violation of the Eight Amendment. Inmates have argued that the participation of anesthesiologists or other highly trained medical professionals is constitutionally required to minimize the risk of unnecessary suffering. This litigation, in conjunction with evidence that some executed inmates suffered torturous pain, has reinvigorated the ethical debate about physician participation in executions. Even though the United States Supreme Court has signaled that physician participation is not constitutionally required, lawmakers in death penalty states must consider the ethics of physician involvement.

Over fifteen years after first reporting to the State of New York, the Harvard Medical Practice Study (HMPS) continues to have a significant impact in medical malpractice policy debates. In those debates the HMPS has come to stand for four main propositions. First, “medical injury… accounts for more deaths than all other kinds of accidents combined” and “more than a quarter of those were caused by substandard care.” Second, the vast majority of people who are injured as result of substandard care do not file a claim. Third, “a substantial majority of malpractice claims filed are not based on provider carelessness or even iatrogenic injury.” Fourth, “whether negligence or a medical injury had occurred… bore little relation to the outcome of the claims.”

Medical malpractice researchers have long known that the HMPS provides far stronger support for the first two of these propositions than for the last two; the HMPS was not designed or powered to reach strong conclusions about the validity of medical malpractice claims.

Twenty-four U.S. states have enacted HIV exposure laws that prohibit HIV-positive persons from engaging in sexual activities with partners to whom they have not disclosed their HIV-status. From a public health perspective, HIV serostatus exposure laws can be viewed as structural interventions that seek to limit the spread of HIV by acting at the policy level. A central premise of these laws is that informed partners are more likely to protect themselves by declining sex, by substituting less risky activities for higher-risk ones, or by using condoms, than are uninformed partners. However, the effectiveness of these laws at preventing HIV transmission is not known.

There is little standardization among existing HIV exposure laws, which vary substantially with respect to the sexual activities that are prohibited without prior serostatus disclosure. Among the strictest laws are those in Arkansas, Michigan, New Jersey, and Ohio which mandate disclosure prior to almost any type of sexual contact.

We first heard about this case from nurses in one of our intensive care units (ICUs) while we were conducting an inservice. When the session was over, we discussed it between ourselves, and decided that it must have been misrepresented. The case had been presented as one of a teenager who was brain dead, had been so for six months, yet had been brought into the ICU for treatment. We have run into this before, we thought: medical professionals confusing brain death with persistent vegetative state (PVS). But, of course, we reasoned, no one can be brain dead for six months. To us, as it would to many, the case sounded like a clinical and ethical impossibility.

A week later, we were called by an attending physician from another ICU, at the urging of that unit's nursing staff. They had a patient who was brain dead, whose presence was causing distress among the staff. Ronald Chamberlain, a fifteen-year-old boy, had been a patient at a nearby longterm rehabilitation facility that is equipped to care for ventilator-dependent patients.

Developers and vendors of large language models (“LLMs”) — such as ChatGPT, Google Bard, and Microsoft’s Bing at the forefront—can be subject to Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) when they process protected health information (“PHI”) on behalf of the HIPAA covered entities. In doing so, they become business associates or subcontractors of a business associate under HIPAA.

Despite advances in medical knowledge regarding pain management, pain continues to be significantly undertreated in the United States. There are many drug and nondrug treatments, but the use of controlled substances, particularly the opioid analgesics, is universally accepted for the treatment of pain from cancer. Although opioid analgesics are safe and effective in treating chronic pain, there is continued research and discussion about patient selection and long-term effects. A number of barriers in the health care and drug regulatory systems account for the gap between what is known about pain management and what is practiced. Among the barriers are physicians’ fears of being disciplined by state regulatory boards for inappropriate prescribing.

State medical boards are in a unique position not only to address physicians’ concerns about being investigated, but also to encourage pain management. Prior to 1989, a few state medical boards had policies relating to controlled substances or pain. Subsequently, state medical boards began adopting policies regarding the prescribing of opioids for the treatment of pain; many of these specifically addressed physicians’ fear of regulatory scrutiny.

Since the first draft of the human genome was published in 2001, DNA sequencing technology has advanced at a remarkable pace. Launched in 1990, the Human Genome Project sought to sequence all three billion base pairs of the haploid human genome, an endeavor that took more than a decade and cost nearly three billion dollars. The subsequent development of so-called “next generation” sequencing (NGS) methods has raised the possibility that real-time, affordable genome sequencing will soon be widely available. Currently, NGS methods can be used to sequence up to 60 billion base pairs per day. Whole-genome sequencing costs an estimated $5,000-10,000, with that number predicted to fall to $1000 in the near future.

In the past few years, the availability of high-throughput NGS methods has led to a proliferation of potential and actual clinical applications for NGS. NGS therefore has the potential to usher in the long-awaited era of personalized medicine.

The successes of the Human Genome Project and the continuing advances of DNA technology have ushered in a new era of genomic science. Investigators around the world are using genomic technologies to advance our fundamental understanding of biologic and physiologic mechanisms in humans and other species. The ability to sequence the entire human genome exponentially expands our ability to identify the contribution of genetic variation to disease risk and other phenotypic differences within the population. Information derived from this research has the potential to contribute to disease prevention, disease prediction, and personalized treatment. These scientific advances, however, raise several ethical, legal, and social challenges. Many of these challenges, including personal and societal benefits and risks, and privacy and confidentiality, are mirrored in the current professional and public debate about the perceived conflict between personal autonomy, privacy, and confidentiality, and the potential value of sharing genomic information within the family.

With improved diagnostic capability and accuracy, the fields of medicine, neuroscience, psychiatry, and psychology have benefitted remarkably from the dramatic advancements in neuroimaging technology. Not only can surface and subsurface structures of the brain be mapped with incredible anatomical detail (with magnetic resonance imaging), now neural activity can be imaged across time as the brain responds to different stimuli (with functional magnetic resonance imaging). These sophisticated techniques have been a vital element in the recent increase in neuroimaging-based research. This increase, while producing new diagnostic techniques and improved treatment mechanisms for neurological disease, has also led to a new dilemma for human subjects researchers: how should incidental findings be managed? An incidental finding (IF) is a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of this study.

The term “nursing ethics” is controversial. Some insist that nursing ethics is a unique field posing issues that cannot be understood fully by adapting the professional ethics of physicians. They insist that the term “nursing ethics” connotes the uniqueness of the moral problems that nurses face in the health care setting.

On the other hand, others argue against the term. Some suggest that it is demeaning and has somewhat the connotation of watered-down ethics —the flavor of such textbook titles as anatomy for nurses or pharmacology for nurses Others critical of the term “nursing ethics” argue that there is really very little that is morally unique to nursing. The same ethical principles and the same moral issues emerge in the health care setting whether one is a physician, nurse or patient. This article puts forth the view that nursing ethics is a legitimate, if very limited, term referring to a field that is a sub-category of medical ethics.