Early in 1970, just as we were organizing The Hastings Center, we had to decide which issues on a long menu of possibilities should receive our early attention. At the top of our list was end-of-life care. Complaints about care for the dying had mounted during the 1960s, fueled by technological progress in sustaining life, by too many patients abandoned by physicians as they lay dying, by a lack of patient choice on how their lives should end, and by woefully inadequate pain management. After a few years of study, the care of the dying seemed to admit of a solution: giving patients more choice by the use of living wills or appointment of a surrogate, improving the training of physicians to better deal with death and discussion with patients, and creating a hospice movement and greatly enhanced palliative care.

Industry analysts estimate that Internet pharmacies will generate $1.4 billion in prescription drug sales by 2001 and over $15 billion by 2004. The recent rush by traditional brick and mortar pharmacies either to partner with existing Internet pharmacies or to create their own web counterparts illustrates the increasing importance of business on the Internet. Last summer, retail pharmacy giant CVS acquired the Internet pharmacy soma.com and changed its name to reflect the new ownership. Early this year, in another key industry move, Walgreen's launched an upgraded, full-service Internet pharmacy in order to compete more successfully in the pharmacy industry.

A powerful movement is afoot to create a national computerized system of health records. Advocates claim it could save the health delivery system billions of dollars and improve the quality of health services. According to Lawrence Gostin, a leading commentator on privacy and health records, this new infrastructure is “already under way and [has] an aura of inevitability.” When it is in place, almost any information that is viewed as relevant to a decision in the health care delivery system would be available to a large and yet undetermined number of individuals. The transformation of the collection and communication of health information from texts housed by health care providers and facilities to data electronically transmitted through networks of linked computers has significant implications for confidentiality and for data collection in scientific research. The best evidence clearly indicates that most people in the United States consider confidentiality for health information important and worry that the increased computerization of health records will result in inappropriate disclosure.

The AIDS (acquired immunodeficiency syndrome) crisis has aroused scientists to major research efforts and the public at times to near-hysteria. The media and their audience eagerly await the latest scientific reports, yet the public seems to respond selectively, embracing the most frightening interpretation of the data and discounting attempts to place those data in perspective. One might be tempted to conclude that questions of public health policy are best dealt with by expert judgment unsullied by lay opinion. Yet such an attitude supposes scientists to be governed by pure reason and to be beyond influence by narrow self-interest or by political or moralistic considerations, a self-serving assumption belied by an examination of the record. The erosion of public confidence in science has indeed bedeviled health authorities in their efforts to generate consensus on the policies they wish to implement, but the public response—including the response of scientists to AIDS—is a far more complex phenomenon.

Guardianship has traditionally been presented by courts and in the literature as a benevolent mechanism through which those who cannot protect themselves will be assisted through surrogate management of their assets, their persons, or both. While notice has been taken of the significant deprivation of property and liberty inherent in a total guardianship, authorities recognize the sad necessity of imposing plenary external control over some of us when sufficient need is shown. The power to do so is grounded in the state's police power and the traditional role of the state as parens patriae.

The question of how and when a novel medical procedure becomes accepted as standard practice has important legal implications. It may in certain situations be determinative of whether third-party reimbursement is available for such procedures. It may also affect the standard used in determining a physician’s liability for negligence. This article discusses several innovative medical procedures and the process of their acceptance by the medical community. It will be seen that none of these examples effectively delineates the process by which an innovative procedure becomes the accepted standard of care. Finally, the article suggests a system based upon consensus among recognized medical experts, and recommends that this system supplant the traditional cost-benefit analysis which is currently used to determine the accepted standard of care.

No formal mechanism currently exists for the introduction of innovative medical technologies, in contrast to the complicated procedures developed for the orderly introduction of new drugs into the marketplace.

As policy makers place great hope in health information technology (HIT) as a means to lower costs and achieve improvements in health care quality, safety, and efficiency, organizations at the forefront of building health information exchange (HIE) networks attempt to weave the concept and function of informed consent into an evolving information-driven health care system. The vast amount of information that will become available to both health professionals and patients in the new HIT-driven environment can reasonably be expected to affect the relationship between them in many ways, particularly in the area of informed consent. During this early stage of HIT adoption, it is critical that we engage in discussions regarding informed consent’s proper role in a heretofore unknown health care environment — one in which electronic information sharing holds primary (and possibly rightful) importance. The central and largely unexamined question of whether and how the legal and ethical underpinnings of informed consent will fit into the context of HITenabled treatment is critical to both public policy and clinical practice.

Until the mid-20th century, biomedical research centered on the study of specific diseases, concerned with short periods of time and small groups of living research participants. However, the growth of longitudinal population studies and long-term biobanking now forces the research community to examine the possibility of the death of their research participants.

The death of a research participant raises numerous ethical and legal issues, including the return of deceased individuals’ research results to related family members. As with the return of individual research results for living research participants, the question of the obligation to return a deceased person’s research results to family members has yet to be settled. This question is particularly acute in the context of genetic research since the research results from one individual may have health implications for all biological relatives.

A criminal offense requires two elements. First, it requires proof of misconduct that is specifically prohibited by law (actus reus). Second, it requires proof of sufficient intention or recklessness (mens rea) to warrant assignment of moral culpability for the act. For example, a person who kills another person intentionally is typically guilty of murder, while a person who kills recklessly or in the heat of passion in response to provocation may be guilty of manslaughter, and a person who kills accidentally is not guilty of any crime. Even if the elements of the offense have been proven by the prosecution, the actor may not be punishable if the defense proves that his conduct was either justified (e.g., self-defense) or excused (e.g., duress).

This is an important time to focus on the question of insurance discrimination based on health status. The nation once again is poised to embark on a major health care reform debate. Even as the number of uninsured stands at some 45 million persons, millions more may be poised to lose coverage during the worst economic downturn in generations. In addition, a large number of persons may be seriously under-insured, with coverage falling significantly below the cost of necessary health care. In recent years, the proportion of insured persons who are underinsured has grown by 60% since 2003, reaching an estimated 25 million persons in 2007. Health care costs experienced by insured persons now account for more than 75% of all personal bankruptcies related to medical care. Underlying these figures is a national approach to health care financing for the non-elderly that effectively increases the odds that those who are in poor health status will be uninsured or underinsured.

The highly publicized deaths of research participants Ellen Roche and Jesse Gelsinger are stark reminders that risk is inherent in medical research and while untoward outcomes are infrequent when compared to individual and societal benefits, injury and even death will happen. Who is responsible for the welfare of research subjects and what are they owed? Why were they put at risk to begin with? Are obligations, if any, to research subjects dependent on the type of study in which they participate, in recognition that there may be personal benefit from participation in some studies?

The issue of injury resulting from participation in research and answers to questions such as those just posed were last considered in depth nearly 20 years ago by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.

Current methods of forensic DNA profiling (known also as DNA fingerprinting and DNA typing), based on Polymerase Chain Reaction (PCR) amplifications of a varying number of Short Tandem Repeat (STR) loci found at different locations on the human genome, are regularly described as constituting the “gold standard for identification” in contemporary society. At a time when criminal justice systems in Europe and North America increasingly seek to utilize the epistemic authority of a variety of sciences in support of the apprehension and prosecution of suspects and offenders, genetic science and recombinant DNA technology are often singled out for particular approbation. Indeed, the development and application of DNA profiling has been widely described as the “greatest breakthrough in forensic science since fingerprinting.”

This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Throughout, assessments employing both the multiple criteria and a method of expert elicitation are combined with the existing literature, case law, and regulations providing an integrative historical case study approach. The goal is to provide useful information from multiple disciplines and perspectives to guide discussions regarding appropriate oversight frameworks for nanobiotechnology applications under the FDA’s purview.

In Grimes v. Kennedy Krieger Institute, the Maryland Court of Appeals (Maryland’s highest court) considered whether it is possible for investigators or research entities to have a special relationship with subjects, thereby creating a duty of care that could, if breached, give rise to an action in negligence. The research under review, the Lead Abatement and Repair & Maintenance Study, was conducted from 1993 to 1996 by investigators at the Kennedy Krieger Institute (KKI), an affiliate of Johns Hopkins University.

After briefly discussing the case at the center of this ruling, I consider how ambiguities within the federal research regulations at 45 C.F.R. § 46 contribute to disagreements among reasonable and informed people of good will about what studies should be approved. I argue that Grimes may be understood as placing restrictions on how these regulations may be interpreted and used.

Until very recently, the lack of health insurance has been viewed primarily as a problem of financial risk for uninsured individuals. This article documents far broader adverse effects, drawn from the work of the Institute of Medicine (IOM) Committee on the Consequences of Uninsurance. It also synthesizes the Committee’s key findings, conclusions, and recommendations.

In early 2004, following 3½ years of study, the IOM Committee on the Consequences of Uninsurance recommended that “...the President and Congress develop a strategy to achieve universal insurance coverage and establish a firm and explicit schedule to reach this goal by 2010.” The Committee presented 5 principles to be used to assess various proposals for extending coverage or to guide the design of a new strategy, specifying that health care coverage should be universal, continuous, affordable to individuals and families, and affordable and sustainable for society.

Complementary and alternative medicine (CAM) is used by many in hopes of achieving important health-related goals. Survey data indicate that 42 percent of the U.S. population uses CAM, accounting for 629 million “office” visits a year and expenditures of 27 billion dollars. This high prevalence of use calls for a careful evaluation of CAM so as to ensure the well-being of those using its modalities. Such an evaluation would obviously include assessments of the safety and efficacy of particular approaches, the training and integrity of practitioners, and the appropriateness of modalities for different conditions or uses. Given the lack of published data concerning many of these aspects of CAM, the likely unfamiliarity of its practitioners to the approaches available to clinicians practicing modern scientific medcine, and the need to respect the unique preferences of persons seeking assistance with achieving health-related goals, it is also important to assess the potential roles of informed consent for the use of CAM. Examining such roles is the central task of this paper.

This piece explores legal, ethical, and policy arguments associated with using interventions that leverage feelings of shame and social exclusion to promote uptake of childhood immunizations by parents.

Despite clear legislative and judicial support, a well established ethical consensus, and increased efforts at information dissemination and education, proxy decision making for incapacitated patients continues to produce moral muddle and poor resolutions in end-of-life care.

In her analysis of the proxy-doctor relationship, Nancy Dubler spells out the institutionalized patterns that keep the promise of proxy directives so often unrealized. Facing medically complex care of an incapacitated patient, health care teams are apt to view the proxy as a potentially indecisive or unrealistically demanding decision-maker, less a stand-in for the patient than an interloper whose improper, misguided, or self-interested decisions will work against the patient's best interests. So perceived, proxies are routinely relegated to the edges of care planning discussions, left relatively uninformed and unconsulted, and then suddenly thrust center stage to face decisions they find overwhelming. Confronting such decisions, proxies need support and compassion. What they often find is isolation and distrust, a web of professional and institutional practices that trammel their efforts to understand and execute their role.