This symposium issue of the Journal of Law, Medicine & Ethics is about public health law, not health-care law. There is a difference. Most scholarly writing has examined the rich and textured field of health-care law or law and medicine. This field revolves around several broad themes related to the health-care system: delivery, financing, and research and innovation.

In studying health-care delivery, scholars have examined everything from the physician/patient relationship (e.g., consent and privacy) to systems of care (e.g., hospitals and managed care organizations). In studying financing, scholars have examined theories of competition and justice to ensure cost-efficient access to care. And in studying research and innovation, scholars have studied everything from human subject protection to intellectual property.

Two years ago, the Journal of Law, Medicine & Ethics published volume 28, number 4, devoted to a symposium entitled Human Subjects Research and the Role of Institutional Review Boards - Conflicts and Challenges. I had the good fortune to be asked to serve as editor of that issue. In her introduction to the symposium, the then editor-in-chief of the journal, Ellen Wright Clayton, observed that the country is currently undergoing a major reexamination of how biomedical research is conducted. While that reexamination has continued in the interim, some very recent events raise questions about the extent to which this will continue, at least in the short run, with equal vigor. The intervening years have witnessed a variety of new directions and events. The federal Office of Human Research Protections (OHRP), directed by Dr. Greg Koski, who wrote a brief commentary for the last symposium,L has taken a new direction, strongly stressing the need for institutions and their institutional review boards ORBS) to engage in extensive educational and quality improvement efforts with both researchers and their own member.

Thank you very much, Ladies and Gentleman. I am very honored by the invitation to give a keynote address at this very informative, national meeting, before such a distinguished audience.

If you made a list of the hundreds of different activities that go on during the day in a major medical center and tried to rank order them in terms of degree of difficulty, or judgment required, or risk of error, or damage that can result from an error of omission or an error of commission, at the top of the list one might consider the teaching of a surgical resident at the operating table by a senior experienced surgeon, hours on end, often emotionally draining.

Law is indispensable to the public's health. The twentieth century proved this true as law contributed to each of the century's ten great public health achievements: vaccination, healthier mothers and babies, family planning, safer and healthier foods, fluoridation of drinking water, the control of infectious diseases, the decline in death from heart disease and stroke, recognition of tobacco use as a health hazard, motor vehicle safety, and safer workplaces.

The readers of this journal can give examples of the relevant types of laws with ease: Jacobson v. Massachusetts, the 1905 U.S. Supreme Court case that upheld the constitutionality of compulsory vaccination; mandatory immunization for school admission; authorization of state prenatal care programs; mandatory fortification of foods; Title X of the Public Health Service Act; the Pure Food and Drugs Act of 1906; the Safe Drinking Water Act of 1974, and hundreds of state and local enactments regulating food; fluoridation ordinanceswater, and sanitation; the Surgeon General's warning notices on cigarette packs and restrictions on marketing tobacco; seat belt laws and mandated vehicle and highway design features; and laws like the federal Occupational Safety and Health Act of 1970 that regulate working conditions.

Few now question that population health is significantly shaped by social ecology. Power, wealth, and social status clearly matter: Their enactment in daily life makes them fundamental social determinants of health. Important as it is that we accept the broad importance of social factors in health, it is not enough. Our current grasp of the importance of social factors in health has to be strengthened by research that more precisely delineates the workings of social health through social processes, and the investment in research must in turn be vindicated by interventions that make a difference. The work presented in this issue of the Journal of Law, Medicine & Ethics is intended to advance the agenda for research and action.

An ecological theory puts health everywhere. Population health is shaped in the hierarchies of the workplace, the neighborhood, and the home.

Prominent among the arguments against the legalization of assisted suicide is the contention that legalization will have a disproportionately adverse, or “disparate,” impact on various vulnerable groups. There are many versions of this argument, with different advocates of this argument focusing on different vulnerable groups, and some advocates confusedly blending slippery slope and social justice concerns. Also, the weight placed on this argument by its various advocates is not uniform, with some including the argument in a list of multiple, apparently similarly persuasive, reasons for not legalizing assisted suicide, while others place significant reliance on it and yet others advance the argument without any clear indication of its importance. Nonetheless, the various versions share a common core: One reason assisted suicide should not be legalized is that members of certain vulnerable groups are more likely to be pressured into requesting it, whether directly by those hostile or indifferent to their interests, or indirectly by social circumstances, such as an inability to pursue other healthcare choices.

Public health is a dynamic field. Outbreaks of new diseases, as well as changing patterns of population growth, economic development, and lifestyle trends all may threaten public health and thus demand a public health response. As the practice of public health evolves, there is an ongoing need to reassess its scientific, ethical, legal, and social underpinnings. Such a reappraisal must consider the disagreement among public health officials, public health scholars, elected officials, and the public about the proper role of public health and the distinctions, for example, between public health and clinical care, and public health and health promotion.

In this article I will attempt to characterize the main points of contention as well as offer my own views regarding the proper scope of public health. Greater clarity and consensus on the meaning of public health are likely to lead to more efficient and effective public health interventions as well as increased public and political support for public health activities.

An issue of ongoing concern to clinical investigators, medical ethicists, and institutional review board (IRB) members is the problem of obtaining informed consent in research that involves people with mental illness as research participants. Although the presence of a mental disorder per se does not render a person incapable of giving informed consent, some individuals afflicted with significant cognitive impairment, formal thought disorder, substantial anxiety or depression, or a variety of other symptoms may be impaired in their capacity to comprehend consent disclosures and therefore to exercise consent to research participation in a competent manner.

The stakes surrounding this informed consent issue are significant. On the one hand, the inclusion in research of participants who are not capable of giving informed consent may result in their exposure to unwarranted risks and significant harm. These concerns may be exacerbated in certain clinical trials in which patients are required to discontinue their medications during “washout periods” at the onset of a study, or are randomly assigned to a placebo treatment and remain off medication for (potentially) extended periods.

In “Should We Impose Quotas? Evaluating the ‘Disparate Impact’ Argument Against Legalization of Assisted Suicide,” Ronald Lindsay argues that it should make no difference to the debate over legalizing assisted suicide whether the risks associated with legalization would fall disproportionately on the poor, people with disabilities, racial minorities, or any other especially vulnerable social group. Even assuming such an inequitable distribution of risks would occur, he maintains, attempting to avoid such an outcome is not a good reason to deny assisted suicide to “competent persons who truly voluntarily choose it.”

Those of us who worry that legalization will differentially burden already disadvantaged segments of society have generally taken it for granted that the possibility of such disparities raises significant public policy concerns. By insisting on an explanation of this assumption — and, in so doing, making explicit the tension between autonomy and equality that underlies the assisted suicide debate — Lindsay has significantly advanced the ongoing conversation. While I disagree with his analysis, I commend him for a thoughtful, provocative, and important contribution to the literature.

Greetings from faraway Australia. We used to think that we were separated from the world’s problems—at once victims and beneficiaries of the tyranny of distance. As recent events have shown, we are all liked together—all are vulnerable. Vulnerable to HIV/AIDS. To global warming. To nuclear catastrophe. To terrorism.

In another September, also in dangerous times, the poet WH. Auden wrote in New York a message for our times. His words have been remembered in recent days. This is what he wrote:

Serious concerns about pervasive, persistent, and unjustified social inequalities have prompted a small—but growing—number of academic commentators to raise some hard and troubling questions for those who would like to legalize physician-assisted suicide. In various ways, these commentators have asked: In light of existing social inequalities—inequalities that operate, for example, along sometimes intersecting lines of race, class, age, sex (including sexual orientation), and disability—how persuasive are autonomy-based arguments in favor of legalization of assisted suicide when those arguments depend (as they typically do) on a conception of autonomy that either presupposes social equality or does not expressly account for its absence? How compelling are arguments that we ought to legalize assisted suicide out of feelings of mercy for the sick and dying, when such affective expressions may actually be the socially acceptable manifestation of private ambivalence that includes merciless discrimination?

Clinical research employing the randomized clinical trial has, traditionally, been understood to pose an ethical dilemma. On the one hand, each patient ought to get the treatment that best meets her needs, as judged by the patient in consultation with her doctor. On the other hand, the method most helpful to advancing our understanding about what treatments are indeed best able to meet patient needs is the randomized trial, which necessitates that each patient's care is decided not by physician judgment or patient choice but instead by random assignment. The tension can be described as a conflict between the interests of individual patients who are sick today, and the interests of the group of people who will become sick in the future and would benefit from advances in medical understanding. How one ought to balance these important and often competing interests is an important ethical question that resists easy resolution.

This symposium issue of the Journal of Law, Medicine & Ethics indicates that interest in public health law in the United States is enjoying a renaissance. The focus of the articles reflects this renaissance, as they explore the state of public health law in various contexts within the United States. Additionally, all but one of the symposium authors plies his or her trade at a university, institution, or government agency in the United States. My task here is different: I focus on public health law within the context of international relations.

Analyzing public health law with an international perspective proves no easy assignment. Examining the role of public health law in the proverbial global village takes the analysis out of the familiar territory of law operating within a single sovereign state. The analysis could take two forms. One could compare different national systems of public health law on specific issues. Such a comparative law approach would be interested in, for example, how the public health laws of the United States and South Africa differ in connection with regulating tobacco consumption.