Pediatricians provided expert testimony that, in the case of Baby K, provision of ventilator support goes beyond accepted standards of care for anencephalic infants and so is medically futile. This argument, however reasonable, does not persuade those who believe in the absolute value of even a fraction of human life. In Baby K, court records indicate that Ms. H, Baby K's mother, persistently adheres to the sanctity-of-life principle on religious grounds.

While I think that quality-of-life considerations have a role in medical decision making, those who reject such considerations must be respected. This article makes the following claims, on behalf of religious dissenters: (1) the Baby K case should be interpreted in light of the freedom of religion guaranteed in the First Amendment (“Congress shall make no law respecting an establishment of a religion, or prohibiting the free exercise thereof”); (2) religious beliefs should not be trivialized in clinical ethics, even if reason, not belief, is the language of the public forum; (3) the time-honored free exercise clause (“or prohibiting the free exercise thereof ”) is essential to the American experiment in liberty and should not be overridden in the name of a concept as vague as futility; and (4) free exercise of religion deserves serious discussion in the futility debate, and significant religious accommodation must be included in any hospital or societal futility policies. In the concluding section, issues are raised regarding the balance between religious consideration and resource allocation.

Much of the focus of the published 2011 symposium that inspired this work focused on the question, “When have you reduced risk enough to move from bench/animal studies to ‘first in-human’ studies?” Building applied research ethics related to nanotherapeutics requires bench and clinical scientists to have a clear vision about how to test nanotherapeutic safety, and it is clear that there is still much to be considered at the steps before “in-human” assessment. Herein, the perspective of the bench scientist is brought to bear on using in vivo and in vitro models to assess the safety of nanotherapeutics. Much of this work falls under the purview of the field of nanotoxicology that aims to understand the toxicological impact of engineered nanoscale materials. Engineered nanomaterials include a wide variety of materials that are manipulated and controlled on the nanoscale level where, typically, the nanoparticle or nanomaterial has some dimension that is less than 100 nm.

Despite governmental and private antismoking initiatives, tobacco smoking remains a significant public health and economic challenge. The Centers for Disease Control and Prevention (CDC) estimates that for each year between 1997 and 2001, cigarette smoking and exposure to secondhand smoke caused approximately 438,000 U.S. residents to die prematurely, resulting in 5.5 million years of potential life lost, and in $92 billion dollars of lost productivity. Also, despite convincing scientific data that laws against indoor smoking protect people from the negative health effects of cigarette smoke, not all states have afforded their residents this protection. As of July 2007, 16 states neither restricted nor banned indoor smoking in restaurants, private worksites, or government worksites, and many state statutes only required separate rooms for smokers rather than eliminating all smoking inside buildings. In several states, local governments have attempted to fill this gap by adopting their own antismoking measures.

In my career as a primary care physician and as a palliative care consultant, I have assisted many patients to die with their full consent. None of them wanted to die, and all would have chosen other paths had their disease not been so severe and irreversible. To a person, none of these patients thought of themselves as “suicidal,” and they would have found that label preposterous and demeaning. In fact, the kind of personal disintegration that the label implies is just what is trying to be prevented by those choosing this possibility. So on behalf of patients who have chosen this option, I reject the title of this debate as it unnecessarily tars the discussion with the suggestion of mental illness. In my primary care practice, I have also met many patients who were “suicidal” in the mental health sense of the word, and rest assured I have assisted none of them to die. In fact, I have at times had them involuntarily hospitalized to prevent them from carrying out their wishes.

Multiple scholars and institutions have asked what distinguishes public health research from public health practice. Most often, they ask in order to have a clear definition of what one does in various public health settings to assess oversight and/or regulation of human subjects research. More importantly, however, whether something is considered public health research or public health practice has real ethical implications in terms of the general moral considerations at stake and the obligations of public health researchers/practitioners to the populations they serve or study.

Numerous examples in recent history of research ethics, including the Kennedy Krieger Lead Abatement Study and EPA’s Children’s Environmental Exposure Research Study (CHEERS), suggest that an exploration of the ethics of public health, or more generally population-based research, may be warranted. Although we acknowledge that there are important ethical issues to consider in the implementation of public health practice, we leave that discussion for other authors.

Both researchers and clinicians are increasingly offering genomic testing for children and adolescents, a practice which parents have generally endorsed in numerous studies. By contrast, much less effort has been devoted to understanding what minors think about genetic and genomic testing. While a small number of investigators have shown that minors with or at risk for cancer generally concur with their parents and favor testing, other studies reveal that minors are less willing to participate in genomics research. Regardless, genetic and genomic testing of minors raises of host of potential legal questions. Key issues are: (1) To what extent can minors obtain genomic tests without involvement of parents or guardians? (2) To what extent can minors refuse genomic testing? and (3) To what extent can minors obtain their own results, keep their parents from getting access to them, and limit what their parents do with their genomic test results? While a number of authors have written about legal issues in genetic testing of minors, remarkably little has been written about the legal protections of minors’ choices about genomic analysis and return of results.

Until a few years ago, the prevailing view was that children should not be participants in clinical research trials because children were incapable of consenting to such nontherapeutic interventions and are particularly vulnerable to abuse. That view has undergone a significant shift in the last few years, particularly in the context of trials to test the safety and effectiveness of drugs. A number of events facilitated this change, including the widespread off-label distribution of drugs to children and developments in the AIDS epidemic. These social forces have shifted the core ethical question from whether children should be research subjects to when children should be research subjects.

The presumption in favor of including children as research subjects for drug trials has manifested itself primarily through two different reforms: a 1997 federal statute and a set of regulations promulgated by the Food and Drug Administration (FDA) that recently became effective. Together they reflect the view that children deserve the same access to safe and effective therapies as adults.

Alcohol and other drug-related stigma is a growing concern. Many organizations have called for a reduction in such stigma through law reform, but there is little sense of how, precisely, this might be achieved. This paper reports on a new method to examine the relationship between stigma and the law and establish a framework that can guide and inform future law reform efforts.

This article deals with a foreign policy question of extraordinary importance: what responsibilities do States have to provide economic and technical assistance to other States that have high levels of need affecting the health and life of their citizens? The question is important for a variety of reasons. There exist massive inequalities in health globally, with the result that poorer countries shoulder a disproportionate burden of disease and premature death. Average life expectancy in Africa is nearly 30 years shorter than in the Americas or Europe. In one year alone, an estimated 14 million of the poorest people in the world died, while only an estimated four million would have died if this population had the same death rate as the global rich.

There is perhaps no duty more fundamental to American government than the protection of the public's health, safety, and welfare. On September 11, 2001, this governmental duty was severely tested through a series of terrorist acts. The destruction of the World Trade Towers in New York City and a portion of the Pentagon in Washington, D.C., presented many Americans with a new, visible reality of the potential harms that terrorists can cause. The staggering loss of lives (estimated from 2,600 to 2,900) damaged the national psyche in ways far exceeding the physical scars to American institutions.

As horrific as the images of destruction and loss of human lives may be, events that unfolded after September 11 revealed another dreaded, and potentially more catastrophic, threat to Americans sense of security and public health: bioterrorism. Unlike terrorists that use bombs, explosives, or other tools for mass destruction, a bioterrorist's weapon is an infectious agent.

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.

In her opening address to the 2011 session of the World Health Organization's (WHO) governing body, the World Health Assembly, WHO's Director-General, Dr. Margaret Chan, noted that WHO's job was much more straightforward when it was dealing mainly with germs, hygiene, medicines, vaccines and sister sectors, like water supply and sanitation. Today, international public health governance is much more complex. It is not only about forging agreement around shared health problems, but also being concerned with health as an outcome of global policies in areas such as trade, intellectual property, and human rights and, nationally, as an outcome of work in other sectors such as education, agriculture and the environment. Global health governance is increasingly fragmented, and WHO is not the only health game in town.

Sugar consumption has long been linked with a host of chronic health problems, including obesity, diabetes, and cardiovascular disease. To reduce Americans’ intake, many have called for taxing sugary products or limiting access in certain environments like schools and workplaces. These sometimes controversial calls for new public policy to curb consumption may soon be eclipsed by newly emerging links between sugar and addiction.

Attaching the label “addictive” to a substance like sugar, which is necessary for human life, challenges widely held beliefs about addiction. But the extraordinary increase in sugar consumption during the past century, with related tripling of chronic diseases like obesity and diabetes, means our common understandings may be outdated.

Part I of this paper will define “addiction” — especially as it relates to what was once a naturally occurring food nutrient and now is a highly concentrated food additive — and present evidence of the addictive potential of sugar.

The concept of Health in All Policies aims to improve the health outcomes associated with policies in an attempt to mitigate health disparities and provide optimal environments for healthier living. This multidisciplinary framework seeks to improve health through effective assessment and reformation of policy for organizations of any level and stature. The importance of integrating health in policy assessment and decision making is a key concept in the growing field of Health Impact Assessment.

The World Health Organization defines Health Impact Assessment (HIA) as “a combination of procedures, methods, and tools by which a policy, program, or project may be judged as to its potential effects on the health of a population, and the distribution of those effects within the population.” HIA provides a mechanism for collaboration between various sectors and disciplines bridging the gap between research, policymaking, and implementation of policies, programs, and projects affecting health outcomes. In the United States, while some HIA efforts have focused on proposed public policies, HIA has been used primarily to analyze the health effects of proposed development projects and plans related to community design and transportation.

The issue of how race and genetics should interrelate goes to the heart of an unfinished discussion about race and racism in both the United States and around the world. The category of race is still powerful and dangerous, especially in scientific work. Addressing this issue is all the more important given the fact that race is still frequently essentialized and treated as biologically real. This tendency continues even as social and natural scientists such as Troy Duster and Charles Mills largely agree that race is a social construction. Mills sees this racial construction as deeply rooted in the legal and constitutional orders of American society. Race is a modern category invented by white male scientists in the “era of modernity” and instantiated globally in the consciousness, social practices, and institutional interstices of Western European cultures, among countless others worldwide. Indeed, the pseudoscience of the period was highly informed by tales of difference brought back by explorers.

In past decades, biomedical technology has created such advances that many health care professionals and consumers are overwhelmed by the apparently unlimited choices in treatment decisions. Problems in human reproduction, preservation of life, research on human subjects, and allocation of scarce resources are just a few of the categories of concerns that we now face. These dilemmas are complex both from conceptual and ethical perspectives. Thus, it becomes more and more difficult to define such important concepts as “human life” or ‘extraordinary treatment,” and to apply these concepts to clinical situations. It has become almost impossible to objectively interpret and apply ethical principles which should guide actions of health care providers.

A 2011 National Academies of Sciences report called for an “Information Commons” and a “Knowledge Network” to revolutionize biomedical research and clinical care. We interviewed 41 expert stakeholders to examine governance, access, data collection, and privacy in the context of a medical information commons. Stakeholders' attitudes about MICs align with the NAS vision of an Information Commons; however, differences of opinion regarding clinical use and access warrant further research to explore policy and technological solutions.

Last July 26, amidst much fanfare, President Bush signed the Americans with Disabilities Act of 1990 (the “ADA”). The Act, which President Bush aptly called “the world's first comprehensive declaration of equality for people with disabilities,” breaks new ground. Seeking to ensure the dignity and legal equality of an estimated 43 million disabled Americans, the Act is both broad and visionary. Regulating areas as diverse as transportation, employment, communications, health care and public accommodations, it suggests a new understanding on the part of Congress about the nature of discrimination. It also both answers and raises numerous questions about the role of law in the face of disease and disability.

The ADA is modeled upon many prior laws, most especially the Rehabilitation Act of 1973. Included in the Rehabilitation Act are several provisions ancestral to the ADA. Secs. 501 and 503 of the Rehabilitation Act place affirmative obligations on the federal government and its contractors to employ the disab1ed.

Debate over return of results and incidental findings to participants in genetic and genomic research has exploded over the last decade. At this point, there is wide agreement that investigators have a responsibility to anticipate discovery of findings that may warrant return, to incorporate in protocols a plan for evaluating such findings, and to offer at least some of these results to participants consenting to such return. However, the issue of how to handle questions from a participant’s genetic relatives about their own risk, or whether investigators should alert relatives to a genetic risk they may share, has garnered much less attention. Only recently has the genomic research community begun to debate these questions and offer recommendations.

Discourse about the use of animals in biomedical research usually focuses on two issues. The first, which I will refer to as the “necessity issue,” is empirical and asks whether the use of nonhumans in experiments is required in order to gather statistically valid information that will contribute in a significant way to improving human health. The second, which I will refer to as the “justification issue,” is moral and asks whether the use of nonhumans in biomedical research, if necessary as an empirical matter, can be defended as a matter of ethical theory.

If it is not necessary as an empirical matter to use animals in research, then there is no need to inquire about moral justification. Therefore, I examine the necessity issue first. The argument that it is necessary to use nonhumans in biomedical research, though flawed, is at least plausible, unlike our necessity arguments for other animal uses. I then discuss the justification issue and conclude that we cannot morally justify using nonhuman animals in research.