Traditionally, fertility regulating methods were devised and offered in accord with the convenience of service providers and/or with their perceptions of the convenience of the population served. Generally, the focus was on a method's safety, efficacy, and affordability. It was not until a June 1972 planning meeting of the World Health Organization Human Reproduction Unit that the concept of acceptability was adopted as an additional criterion. The purpose was “to modify technology and programs to fit people, rather than modifying people to fit technology and programs.” A WHO Task Force on the Acceptability of Fertility Regulating Methods was established in January 1973 within what has now become the WHO Special Programme of Research, Development, and Research Training in Human Reproduction. Research conducted in the subsequent 17 years has had a profound effect on the field.

It is the purpose of this article to review the current status of early pregnancy interruption with mifepristone (RU 486) combined with a prostaglandin analogue from the standpoint of its acceptability to women.

The ability to determine genetic predisposition to cancer represents an opportunity to expand cancer control efforts in a manner that was previously unimaginable. This possibility also forces individual patients, families, health care professionals, and society to confront difficult questions about genetic knowledge. Although genetic testing or screening for cancer risk may hold promise of cancer control benefits, this prospect also raises significant ethical and legal concerns that must inform and shape policy decisions. In “Cancer Genetic Susceptibility Testing,” Benjamin Wilfond and the Cancer Genetic Screening Consortium (CGSC) present a status report and an ambitious agenda for future examination of ethical and policy issues in this embryonic field. The paper provides a provocative and timely discussion of some extremely vexing issues, but it also misses on several critical points.

All scientific activity involves some method of observation and some method of recording what is observed. These activities can be carried out in ways that involve little interaction between subject and object, as is the case when a telescope observes a far-away star. At the other end of the scale are experiments in modern high energy physics in which there is little distinction between the observer and the observed, and the process of observation materially affects the data that are recorded. In this regard, research on human phenomena resembles modern physics more than it does classical astronomy.

Research on human phenomena, however, differs from modern physics in the way in which it affects that which is observed. Both the procedures and the findings of research on human phenomena alter the modes of thinking and the self-awareness of the (human) objects of study.

The Task Force on Organ Transplantation was announced on September 26, 1983 by the Secretary of Human Services and the Commissioner of Public Health, and charged with “the development of standards and processes for evaluating the use of organ transplantation” in Massachusetts. It was asked to

• make recommendations concerning how organ transplantation should he introduced and financed, including mechanisms to assure equality of access;

• determine what priority should be placed by the state on extreme and expensive medical interventions;

• determine what criteria should be used in patient selection; and

• determine how and by whom decisions concerning transplantation availability and patient selection criteria should be made.

In 1990, the United States Supreme Court issued a decision in the Cruzan case, the first “right-to-die case” to reach that court. Prior to the Court's decision, there was widespread speculation as to what it would decide and what the impact of the decision would be. Speculation about the impact of the decision intensified after it was announced, with many suggesting that it would prove to be a serious setback to the consensus about the legality of terminating life-sustaining medical treatment that had evolved in the state courts since the Karen Quinlan case ushered in the era of right-to-die litigation in 1976.

This article examines a number of aspects of the legal consensus about forgoing life-sustaining treatment that emerged prior to Cruzan and discusses their viability in light both of what Cruzan did and did not decide and in light of subsequent judicial decisions in right-to-die cases. Two years after the Supreme Court's decision, it is apparent that the pre-Crtrzan legal consensus is stronger than ever.

The role of government in assuring population access to affordable and appropriate health care represents a central question for any nation. Of particular concern is access to prescription drug coverage, not only because of the vital role played by drugs in modern medicine, but also because of their high costs. This article examines the sharply contrasting prescription drug coverage and payment policies found in Australia and the U.S. – strong political allies and international trading partners – and describes how key U.S. interests have sought, through an aggressive trade agenda, to expand markets for U.S. goods and services, even when market expansions clash with other nations’ contrasting emphasis on social equity and fairness. Indeed, the nation’s bilateral free trade negotiations have brought the contours of this policy schism into sharp relief.

Bioinformatics, the integration of information technology and biotechnology, is the primary means to make medical sense out of the map of the human genome, and bioinformatics capabilities continue to expand exponentially. Consequently, the demand for access to human biological samples and medical information has never been greater. This demand is giving rise to ambitious biobanking initiatives - meaning the organized collection of samples and medical information from human population.

In 1996, President Clinton offered a promissory vision for human genetics when he said: “I think it won't be too many years before parents will be able to go home from the hospital with their newborn babies with a genetic map in their hands that will tell them, here's what your child's future will likely be like.”

The rapid evolution of genetic sequencing technologies has advanced that vision. In October 2006, the cost of sequencing an entire human genome was $10.4 million; by 2014 the cost had decreased a thousand fold. The term next generation sequencing (NGS) describes a variety of laboratory methods that allow efficient determination of the precise order of nucleotides in a DNA sequence. The papers in this issue of the Journal of Law, Medicine & Ethics focus on “clinical NGS,” which refers to rapid DNA sequencing using second-, third- and fourth-generation sequencing technologies to perform genome-wide sequencing of multiple genes or alleles for clinical prognostic, diagnostic, and therapeutic purposes.

Two contemporary strategies in cadaver organ transplantation, both with the potential to affect significantly expanding organ transplant waiting list sizes, have evolved: elective ventilation (EV) and use of nonheart-beating donors (NHBDs). Both are undergoing a period of critical review. It is not clear how widely EV is practiced around the world. In Great Britain, the Royal Devon and Exeter Hospital was the first hospital to develop an EV protocol (the Exeter Protocol), in 1988, after which other British hospitals followed suit. In the 1980s, new NHBD protocols of two distinct types were implemented worldwide, although both rely on death confirmed by traditional cardiopulmonary criteria. The first type involves the removal of organs immediately after death, the preeminent example being the University of Pittsburgh Medical Center Protocol (the Pittsburgh Protocol). The second involves the perfusion and cooling of kidneys immediately following death and subsequent organ removal. Protocols of this type have sprung up in Holland, Great Britain (for example, at Leicester General Hospital), Italy, France, Spain, Japan, and the United States (for example, the Regional Organ Bank of Illinois).

Hailed as the “foundation of the next industrial revolution,” nanotechnology is reshaping the landscape of technological innovation and creating hope around the world. Some believe that nanotechnology can address the critical needs of developing countries, but others are less optimistic. At one end of the spectrum, scientists predict that, among other accomplishments, nanotechnology can alleviate poverty, provide safe drinking water, and cure diseases. At the other end, skeptics warn that nanotechnology can further widen the gap between the rich and the poor, contributing to an already imbalanced global landscape. What can nanotechnology bring to the 21st century? How and in what ways should it intersect with law, public policy, and the plight of the developing world?

This article argues that the international community can harness nanotechnology to create sustainable development, particularly in the field of water remediation and treatment, but it must learn from its past missteps and adopt a strategy that combines two competing theories: instrumentalism and contextualism. Instrumentalism is the concept that technology is superb and stakeholders can easily transfer it from one application to another. In contrast, contextualism places technology in a socioeconomic context and conditions technological success on the stakeholders’ ability to meet local needs.

Among the many components of legal preparedness for public health emergencies is the assurance that the public health workforce and its private sector partners are competent to use the law to facilitate the performance of essential public health services and functions. This is a significant challenge. Multiple categories of emergencies, stemming from natural disasters to emerging infectious diseases, confront public health practitioners. Interpreting, assessing, and applying legal principles during emergencies are complicated by the changing legal environment and differences in governmental organization of emergency management functions. While law and legal competencies are essential to routine public health practices, once government declares a state of public health emergency or disaster, the legal landscape changes. Typical legal responses to protect the public's health may no longer be the norm. Public health practitioners, legal counsel, health care partners, and others need to be able to assess changing laws and policies and apply them in real-time.

Like all policies, contemporary human research policies are the product of their history. The scandals and traumas motivating their creation — the Nazi doctors trials, Tuskegee, the Milgram experiment on obedience — however different in their particulars, all share a common narrative: a scientist, pursuing valued social ends, runs roughshod over the personal interests of disadvantaged human subjects. From the Nuremberg code through the latest revisions of the Declaration of Helsinki, research ethics policies have sought to erect a sphere of protection around the latter.

As a consequence of this history, all major policies start with a well-rehearsed model of human investigations. Clinical research is viewed as an encounter between investigators and volunteers. The clinical investigator is given certain duties. The human volunteer has certain moral entitlements. What is ethically at stake in human investigations inheres in the nature and quality of the interactions between investigators and volunteers. These interactions involve an asymmetry because the investigator has privileged knowledge and influence.

Medical technologies, including nanomedicine products, are intended to improve health but in many cases may also create their own health risks. Medical products that create their own health risks differ from most other risk-creating technologies in that the very purpose of the medical technology is to prevent or treat health risks. This paradox of technologies intended to reduce existing risks that may have the effect of creating new risks has two conflicting implications. On one hand, we may be more tolerant of health risks from medical technologies because these products are intended to, and often (but not always) do, reduce overall health risks and improve our health. The health benefits of a medical technology may outweigh the unavoidable adverse effects of that same technology in an individual patient or in the overall treated population.

There has been a growing concern over establishing norms that ensure the ethically acceptable and scientifically sound conduct of clinical trials. Among the leading norms internationally are the World Medical Association's Declaration of Helsinki, guidelines by the Council for International Organizations of Medical Sciences (CIOMS), the International Conference on Harmonization's standards for industry (ICH), and the CONSORT group's reporting norms (Consolidated Standards of Reporting Trials), in addition to the influential U.S. Federal Common Rule, Food and Drug Administration's (FDA) body of regulations, and information sheets by the Department of Health and Human Services. There are also many norms published at more local levels by official agencies and professional groups.

Any account of international standards should cover both scientific and ethical norms at once – the two are conceptually intertwined. Recent sources recognize that “[s]cientifically unsound research on human subjects is unethical in that it exposes research subjects to risks without possible benefit.”

Throughout the post-World War II decades, the United States has wrestled in its own unique style with a problem that is shared by all modern societies: how to achieve a reasonably equitable distribution of health care, without losing control of total spending on health care, and without suffocating the delivery system with controls and regulations that inhibit technical progress.

Because an equitable distribution of health care inevitably requires at least some government regulation, and because government regulations tend to impose rigidity on any system, it is widely believed in the United States (and elsewhere) that a trade-off actually exists between fairness in the distribution of care and the health system’s ability to innovate. This troublesome trade-off bedevils American policy makers to this day.

Imagine a study in which HIV-infected pregnant women are given antiretroviral treatment (ART) to determine how effectively it will prevent HIV transmission during childbirth. Each mother’s involvement in this study ends with the birth of her child, at which time her access to antiretrovirals provided by the study also ceases. At the outset of the study, the investigator and sponsor agree that after the child’s birth, they will refer mothers who require treatment for their HIV to a national program that provides antiretroviral treatment and care. Assuming the Institutional Review Board (IRB) raises no objections to this plan, should the research team consider their ethical obligations to participants fulfilled? If the investigator and sponsor were to consult the Common Rule, they would find little to suggest that there are any further ethical issues to address.

Many ideas grow better when transplanted into another mind than the one where they sprang up.

This article argues that state government actors concerned about gun violence prevention should prioritize enactment of robust firearm purchaser regimes at the state level. First, the article outlines the empirical evidence base for purchaser licensing. Then, the article describes how state governments can design this policy. Next, the article assesses the likelihood that purchaser licensing legislation will continue to be upheld by federal courts. Finally, the article addresses the implications of this policy, aimed at curbing gun deaths, for equally important racial justice priorities. Taken together, these various considerations indicate that purchaser licensing policies are among the most effective firearm-focused laws state governments can enact to reduce gun deaths within the existing federal legislative and legal frameworks.

A recent case report described a 62-year-old woman who had suffered a stroke and subsequently had global aphasia, hemiplegia, and could not respond consistently to yes-no questions. She remained hospitalized for four years and throughout this period was irritable, uncooperative, and often refused food. Her care providers considered it very likely that she was depressed and treated her with antidepressant medication, but these drugs did not have beneficial effect.

Her situation subsequently deteriorated. She refused food and water to a greater extent and lost 22 pounds over one month. At that time electroconvulsive therapy was instituted. Thereafter, presumably responding to electroconvulsive therapy, she became pleasant and cooperative and drank and ate heartily.