In recent decades, advances in information technology have given rise to a post-industrial society in which emphasis on the manufacture of material goods has been supplanted by the creation of intellectual property. Indeed, this new “knowledge economy” can be tracked by the exponential growth in patented products across a range of sectors since the 1980s (see Figure 1). According to the United States Patent and Trademark Office, the number of annual patent applications submitted grew from 112,379 to 520,277 over the past three decades, a 464% increase.

The transformation in the industrial markets has been accompanied by the rise of a new, global institution for coordinating intellectual property rights (IPRs): the World Trade Organization (WTO).

Is it futile to sustain biologic life when the patient will permanently require intensive medical care? Dr. Koch and Dr. Miles agree that such treatment would be futile; however, their concept of futility rests on no explicit standards and reflects no communal judgment. The authors view the lack of widely accepted medical standards as an impediment to answering this question definitively. Dr. Koch laments that patients and their families have seized too much power and have begun deciding that mere biologic life is worth sustaining. And Dr. Miles sees benefit to perceiving a decision not to sustain such life as “primarily biomedical” and “realistic.”

Here is where we disagree with these authors. We do not see the problem as a lack of standards that are medical. The question of prolonging a patient's life when the patient has no likelihood of regaining consciousness confronts moral, political, and economic issues.

The major challenge facing the American health care system today is to devise a strategy for achieving three primary objectives simultaneously: (1) high quality, or excellence in standards of care, (2) balance, or equitable access to that quality care, and (3) some reasonable semblance of cost control in providing that quality care to everyone. Following World War II, the weight of government was thrown solidly behind the access and quality portions of the equation, first with the enactment of the Hill-Burton capital financing program and its accompanying community service obligations, and accelerating in the midsixties through creation of Medicare, Medicaid, and other financing and delivery programs entitling categories of individuals to health care benefits.

Is it futile to sustain biologic life when the patient will permanently require intensive medical care? Dr. Koch and Dr. Miles agree that such treatment would be futile; however, their concept of futility rests on no explicit standards and reflects no communal judgment. The authors view the lack of widely accepted medical standards as an impediment to answering this question definitively. Dr. Koch laments that patients and their families have seized too much power and have begun deciding that mere biologic life is worth sustaining. And Dr. Miles sees benefit to perceiving a decision not to sustain such life as “primarily biomedical” and “realistic.”

Here is where we disagree with these authors. We do not see the problem as a lack of standards that are medical. The question of prolonging a patient's life when the patient has no likelihood of regaining consciousness confronts moral, political, and economic issues.

In 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research considered many aspects of fetal research. The Commission received some detailed ethical, legal, and scientific analyses, invited public testimony, and recommended guidelines for biomedical research involving the human fetus. One of the authors of the present article (KJR) chaired the Commission. Many of its recommendations became federal regulations on fetal research issued in 1975.

These regulations explicitly govern only research “conducted by the Department of Health and Human Services (DHHS) or funded in whole or in part by a Department grant, contract, cooperative agreement or fellowship.” However, as Baron pointed out in his legal review, they effectively cover all federally funded institutions, regardless of the source of the funds the institution may be using for fetal research.

Adult protective service systems in many of our states have been subjected to a good deal of public criticism. Much of this denunciation, particularly that emanating from civil libertarians who advocate on behalf of the legal and ethical rights of older citizens, centers on the legal aspects of protective services, and especially on the legal authority of the state to intervene unilaterally in the private life of an unwilling, protesting older individual.

Except in the most compelling of circumstances, society should avoid the coercive elements of protective services. Often overlooked, however, by commentators, policy-makers, and caregivers alike, is that protective services may be, and in the vast majority of instances are, accepted voluntarily (and gratefully) by the older recipient. A mentally competent individual may voluntarily give informed consent in the medical sphere, as well as in others, to the receipt of services that he or she currently needs. Additionally, legal mechanisms frequently enable a competent independent adult to foresee and prepare for the possibility that he or she might become incompetent and dependent, by providing for a substitute decisionmaking process of the individual's own choosing.

Over the past decade we have witnessed a remarkable change in the courts, and presumably in societys, attitude toward the care of the terminally ill patient. In a series of court decisions, judges have consistently ruled that the terminally ill patient's autonomy must be respected, even if that means limiting the patient's care when that is the patient's wish. Moreover, courts have allowed the incompetent patient's family and doctors, when they agree, to make substituted decisions to limit care, that is, decisions which attempt to replicate the choices that the patient would have made about his own treatment were he able to do so. Courts have not, however, offered guidance on those situations in which the incompetent patient's family and physicians disagree with respect to their recommendations concerning the course of therapy the patient would choose. Most importantly, courts have failed to establish clear limits on professional authority in situations where disagreements occur.

In a recent issue of the Hastings Center Report, Paul and Marilyn Bridge discuss the difficulties and frustrations they encountered with the physicians and hospital concerning a proposal to withhold treatment from their severely defective newborn son, Christopher. Born some three months prematurely, he had signs of viral encephalitis. His long-term outlook was quite dim: he had severe mental retardation, and would possibly suffer from uncontrollable convulsions, deafness, blindness, and quadraplegia. Brain damage was extensive, and was thought to extend to the cortex. While Christopher was not terminally ill nor in any immediate danger of dying, the pediatrician suggested that there would be situations in the future which perhaps ought not be treated, such as infection or the aspiration of food. The family rejected that option, and insisted on treatment until Christopher, on his 75th day of life, suffered cardiac arrest. After three days of ventilator support, the parents agreed to discontinue the heroic means supporting their son whom they now believed to be terminally ill and approaching brain death.

In 1785, George Washington described a “knowing farmer” as “one who can convert every thing he touches into manure, as the first transmutation towards Gold.” With these words, Washington linked the “knowing farmer” to the alchemist who endeavored to transform base metals into gold with the aid of a philosopher's stone. In each instance, the challenge was to convert raw materials into something new and precious.

Today, the “knowing bioethicist” is in a similar position. American bioethics harbors a variety of ethical methods that emphasize different ethical factors, including principles, circumstances, character, interpersonal needs, and personal meaning. Each method reflects an important aspect of ethical experience, adds to the others, and enriches the ethical imagination.

When the HPV vaccine was released over a decade ago, there was intense opposition to mandating the vaccine, including among bioethics and legal scholars. Some of the original concerns are now obsolete, while other objections continue to present an obstacle to mandating the vaccine. This essay responds to earlier critiques of mandatory HPV vaccination and offers a series of arguments in support of a vaccine mandate. The first section briefly addresses initial concerns that are no longer relevant. The second section makes the ethical case for mandating HPV vaccination, based on three principles: 1) the best interests of children, 2) solidarity, and 3) health equity. The final section addresses concerns related to implementation of the vaccine, including the validity of linking vaccination to school entry. The essay concludes that we have a moral imperative to protect children from the leading cause of cervical cancer, and that mandating HPV vaccination is the best way to ensure that children of all backgrounds receive the vaccine before they have been exposed to the virus.

Selective reduction, also known as multifetal pregnancy reduction (MFPR), is the practice of terminating one or more fetuses to reduce a multiple pregnancy, e.g., from quadruplets to twins or a singleton. Selective reduction and abortion both involve the destruction of fetal life, but they are classified by different designations to underscore the notion that they are regarded as fundamentally different medical procedures: the two are performed using distinct techniques by different types of physicians, upon women under very different circumstances, in order to further dramatically different objectives. For these reasons, the two procedures appear to call for a distinct moral calculus, and they have traditionally evoked contradictory reactions from society — sympathetic responses towards selective reduction, which is perceived as a difficult but “responsible” choice vs. stigmatizing or even punitive approaches towards abortion, which is deemed an immoral action.

The new NIH data sharing policy, effective January 2023, requires researchers to submit a data management and data sharing plan in their grant application. Expanded data sharing, encouraged by NIH to facilitate secondary research, will require informed consent documents to explain data sharing plans, limitations, and procedures.

Population genomics seeks to better understand genomic diversity and variation at the level of populations. Numerous ethical questions are raised by large studies of human genomic diversity. First, at the level of ethical means, the confidentiality of the genetic data obtained and its handing (data banks, access, involvement of private sector, etc.) are challenging. Second, at the more fundamental level of ethical goals or ends, we find questions concerning the meaning and the interpretation of genetic knowledge. What shall we do with this knowledge? Who will decide research orientation and priorities? Ethical questions raised by population genomics imply those of “classical genomics,” but they have the additional ethical complexity of research done on populations. How should we take this particular aspect into account?

The desire to have healthy and happy children is the most basic parental instinct. A parent's moral obligation to care for the child extends before the moment of birth back to the point of conception. In classical Jewish tradition, the Talmud itself offers pregnant women advice on how to improve the well-being of their offspring, such as eating parsley in order to have handsome children, drinking wine in order to bear healthy children, or eating coriander to have especially plump children. We stand on the cusp of a new era today because an explosion of genetic knowledge in recent years has provided us the ability to pursue certain health and wellness advantages even before pregnancy has begun. Technology called preimplantation genetic diagnosis (PGD) allows parents to screen the DNA of embryos fertilized in vitro and to implant only those embryos that match the parents' desired genetic makeup. This may include selecting only embryos guaranteed not to have a particular genetic disease, only embryos of one particular gender, or eventually even only embryos with a predisposition for certain traits such as height, eye color, or enhanced memory.

How should the definition of “minimal risk” in the federal research regulations be interpreted in regard to pregnant women and fetuses? Surprisingly, there has been little discussion of this question. There is, after all, a substantial amount of published work addressing the question of how “minimal risk” should be interpreted. Similarly, there is a large body of literature on the ethics of research involving pregnant women and fetuses, particularly maternal-fetal surgery. However, in neither of these bodies of work can one find an analysis of minimal risk in regard to fetuses or pregnant women.

The concept of minimal risk is defined in the regulations as follows:

Since the anthrax attacks of 2001 and the severe acute respiratory syndrome (SARS) outbreak of 2003, significant efforts have been made to develop and revise a range of legal tools designed to strengthen public health emergency responses. The 2009 H1N1 pandemic provided an unprecedented opportunity to implement and exercise many of these mechanisms. At the global level, the World Health Organization (WHO) declared a public health emergency of international concern (PHEIC) pursuant to the revised International Health Regulations [IHR (2005)], and many governments declared national or regional emergencies. At the U.S. federal level, the Secretary of Health and Human Services (HHS) made public health emergency and Public Readiness and Emergency Preparedness (PREP) Act declarations. In addition, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) (to allow the emergency use of certain antiviral medications, diagnostic tests, and respirators during the pandemic), and President Obama declared a National Emergency (to authorize the use of temporary waivers or modifications of certain federal requirements related to health care facility responses). Select state and local governments also declared emergencies.

In this paper, we outline the policy implications of mobile health research conducted at the international level. We describe the manner in which such research may have an international dimension and argue that it is not likely to be excluded from conventionally applicable international regulatory tools. We suggest that closer policy attention is needed for this rapidly proliferating approach to health research.

The question of legalizing physician-assisted suicide (PAS) has become a serious public debate. Growing interest in assisted suicide reflects a public increasingly fearful of the process of dying, particularly the prospect of dying a painful, protracted, or undignified death. PAS has been proposed as a compassionate response to unrelievable suffering, designed to give terminally or incurably ill individuals direct control over the timing, manner, and circumstances of their death. Although the American Medical Association remains firmly opposed to legalizing PAS, many physicians have begun to express support for the practice, and some have acknowledged that they have helped patients commit suicide despite the existing legal ban.

As support for PAS grows, it becomes increasingly likely that the practice will be legalized in at least some states in the not-too-distant future. In 1994, Oregon voters approved a referendum legalizing PAS for competent, terminally ill patients; a federal court injunction preventing the referendum from going into effect is currently on appeal, and it is widely expected that the injunction will be lifted.

Several methods have been reported for extracting sperm from a man after he dies or enters a persistent vegetative state (PVS). Although such sperm retrieval could be performed for nonprocreative purposes, such as research, in this paper I focus on cases involving procreative intent. Since 1980, more than ninety cases have occurred in which family members requested sperm retrieval from patients who died or were irreversibly unconscious, with the intent that a wife, girlfriend, or other woman would be inseminated. Recently, the first report of pregnancy and birth following postmortem sperm retrieval appeared in the media.

In these cases, death or PVS typically is caused by anoxic injuries, trauma, or rapidly progressing infections.