Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health (NIH) doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now are as common in the private practice setting as in academia.

For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards (IRBs) that review the ethics of federally funded research.

Alyne da Silva Pimentel Teixeira died of postpartum hemorrhage (PPH) following the stillbirth of a 27-week-old fetus on November 16, 2002 in Rio de Janeiro, Brazil. Her death led in 2011 to the first decision of an international treaty body holding a government accountable for a preventable maternal death. The decision, Alyne da Silva Pimentel Teixeira (deceased) v. Brazil, was given by the Committee on the Elimination of Discrimination against Women (the Committee), established to monitor compliance by member states with the UN Convention on the Elimination of All Forms of Discrimination against Women (the Convention). The decision upheld a complaint, filed in 2007 against the state and government of Brazil, finding discrimination in the field of health care for Alyne’s avoidable maternal death, in breach of the Women’s Convention.

Mobile devices with health apps, direct-to-consumer genetic testing, crowd-sourced information, and other data sources have enabled research by new classes of researchers. Independent researchers, citizen scientists, patient-directed researchers, self-experimenters, and others are not covered by federal research regulations because they are not recipients of federal financial assistance or conducting research in anticipation of a submission to the FDA for approval of a new drug or medical device. This article addresses the difficult policy challenge of promoting the welfare and interests of research participants, as well as the public, in the absence of regulatory requirements and without discouraging independent, innovative scientific inquiry. The article recommends a series of measures, including education, consultation, transparency, self-governance, and regulation to strike the appropriate balance.

Five years ago, an article co-written by some of us (Joly and Simard) presented an emerging trend to disclose some individual genetic results to research participants within the international research community. At the time, ethical norms and scholarly publications on the return of results often did not distinguish between the return of research results in general and the return of unexpected results (also called incidental findings). Both technologies and research practices have evolved significantly. Today whole genome and exome sequencing are increasingly affordable and frequently used in genetic research. Because these techniques produce a vast amount of interpretable and non-interpretable data (i.e., data of unproven significance) about an individual, the issue of how to manage information generated by such technologies needs to be considered. However, the development of international ethical guidelines has not kept up with the rapid pace of technological progress. Indeed developments in genomic biobanking also challenge the duty to disclose research results.

Corporate social responsibility has become a potential path to legitimacy and improved public relations for both companies that produce mainstream products and those that sell vice, such as the tobacco industry. Since the early 1990s, the tobacco industry has sought to bridge the gap between the public perception it has earned as a merchant of death and its goal of gaining corporate legitimacy and normality by promoting programs, positions, and policies it hopes the general public will believe are aimed at preventing or mitigating some of the societal ills that smoking causes, such as youth smoking. There is, however, an intractable problem that corporate social responsibility efforts can mask but not resolve: the tobacco industry’s products are lethal when used as directed, and no amount of public relations or funding of ineffective youth smoking prevention programs can reconcile that fundamental contradiction with ethical corporate citizenship. The focus of this study is to better understand the tobacco industry’s corporate social responsibility efforts and to assess whether there has been any substantive change in the way it does business with regard to the issue of exposure to secondhand smoke.

One of the largest, oldest, and most interesting challenges in health care is the balancing act in which clinicians have generally uncontroversial duties both to individual patients and to communities. Physicians and nurses must — so we teach them — put patients first, and at the same time recognize that individuals are members of communities. Individuals affect the health of communities, and communities affect the health of individuals. Thus, the moral and professional duties that result are sometimes in conflict.

Moreover, the traditional, prosaic clinical encounter is evolving in an environment increasingly shaped (albeit too slowly according to some) by electronic health records, personal health records, pharmacogenomics and vast networks of data collection and storage for public health surveillance, human subjects research, health services evaluation, and comparative effectiveness research. Health information technology is changing everything. It would be perverse otherwise: imagine large amounts of data and information either ignored, missed, or collected and then ignored.

Since at least the mid-1970s, public health and law enforcement officials have conducted joint or parallel investigations of both health problems possibly associated with criminal intent and crimes having particular health dimensions. However, the anthrax and other terrorist attacks of fall 2001 have dramatically underscored the needs that public health and law enforcement officials have for a clear understanding of the goals and methods each discipline uses in investigating such problems, including and especially the potential use of biologic agents as weapons of mass destruction. Recognition of these needs has prompted some experts to call for the application of “forensic epidemiology” to such problems. Even before the attacks of fall 2001, other problems, such as the detection of the West Nile Virus in the United States and concerns that the emergence of this infectious agent was the consequence of a deliberate act, raised novel challenges to the combined interests of public health and criminal investigators.

Imagine that you are a teenager and have cancer. You undergo a year of chemotherapy and after a brief return to normal life, you have a relapse. Your physician says that chemotherapy and radiation therapy could be tried, but a bone marrow transplant (BMT) is your only chance of a real cure. He tells you and your parents that you could die as a result of complications from the transplant, but without it you would only be expected to live one year. You and your family discuss the alternatives and decide to have the transplant. You ask what will happen if the BMT fails, but both your physician and your family tell you that right now you must fight to get better and not think negative thoughts. You do not ask any more questions.

The surge in genetic research and technology, fuelled in large part by the Human Genome Project, has resulted in the continuing expansion of the range of genetic tests and other genetic information available to physicians, insurance companies, employers, and the general public.’ Genetic tests can provide presymptomatic medical information about an individual, including information about an individual's increased risk of future disease, disability, or early death. These tests can reveal information about an individual's carrier status, that is, the likelihood of parents passing on to their children a genetic condition, and about the health of the individual's family members. Although genetic information provides the promise of early detection and treatment of certain illnesses and disorders, it also poses risks. As a result of the increase in genetic testing and information, legal issues regarding employment discrimination on the basis of genetic information are emerging.

The Early Care and Education (ECE) track presentations from CDC’s Weight of the Nation (WON) 2012 conference showcased innovative national, state, and community obesity prevention efforts. The track was organized around CDC’s “Spectrum of Opportunities” for obesity prevention in ECE (the Spectrum; Table 1), which outlines a common set of opportunities that can enhance the ECE environment with respect to nutrition, breastfeeding support, physical activity, and screen time — all important areas for obesity prevention targeting young children. Participants discussed the opportunities on the spectrum that had been pursued, the obesity prevention standards and best practices that had been the emphasis of their efforts, and common steps for developing, implementing, and evaluating initiatives. This paper provides background information on why ECE is an important component of any jurisdiction’s obesity prevention efforts, references for the primary national reports offering standards and best practice recommendations, an introduction to the Spectrum, and brief summaries of the WON ECE track presentations.

The U.S. has the tools to end the HIV epidemic, but progress has stagnated. A major gap in U.S. efforts to address HIV is the under-utilization of medications that can virtually eliminate acquisition of the virus, known as pre-exposure prophylaxis (PrEP). This document proposes a financing and delivery system to unlock broad access to PrEP for those most vulnerable to HIV acquisition and bring an end to the HIV epidemic.

Childhood obesity is a national public health problem. Regardless of gender, race, socioeconomic status, or geographic location, children are “gaining weight to a dangerous degree and at an alarming rate.” Since 1980, the number of overweight children has doubled; among adolescents the number has almost tripled. Today, among children who are more than six years old, about nine million are obese. Many of the factors that contribute to obesity occur at a societal level, prompting the Surgeon General to conclude that preventing obesity is a “community responsibility.”

Childhood obesity is, in many important respects, a result of legal policy. Law shapes the situational and environmental influences that drive both dietary intake and physical activity. Government, public health advocates, and the food industry all use the law to alter these influences in furtherance of their respective goals. Public interest advocates attempt to persuade government and corporations to act in the interest of public health while the industry focuses on profit.

Screening for prostate cancer with the prostate-specific antigen (PSA) blood test is controversial, as evidence to date has not demonstrated such screening does more good than harm. While the potential benefit of PSA screening on reducing prostate cancer mortality has not been documented in randomized trials, many risks of PSA screening have been well documented. These risks include a substantially higher risk of a prostate cancer diagnosis over a screenee’s lifetime, false-positive and false-negative test results, possible complications from biopsies done in response to suspicious test results, and substantial risks of side effects from subsequent prostate cancer treatments. Nevertheless, PSA screening is widespread in the United States, and many physicians in a national survey reported supporting routine PSA screening as well as getting PSA tests themselves, despite the lack of evidence.

Public health ethics is emerging as a new field of inquiry, distinct not only from public health law, but also from traditional medical ethics and research ethics. Public health professional and scholarly attention is focusing on ways that ethical analysis and a new public health code of ethics can be a resource for health professionals working in the field. This article provides a preliminary exploration of the ethical issues faced by public health professionals in day-to-day practice and of the type of ethics education and support they believe may be helpful.

In March, 1989, 12 physicians published an article on the provision of care to hopelessly ill patients. Unfortunately, many of the substantive points in that article received insufficient attention from readers because the authors call for appropriate, continually adjusted care for terminally ill patients was overshadowed by a portion of the document in which ten of the authors agreed that “it is not immoral for a physician to assist in the rational suicide of a terminally ill person.”

In June, 1970, Jack Kevorkian, a retired pathologist in Michigan, gained international media attention by enabling Janet Adkins, a woman in the early stage of Alzheimer's disease, to terminate her life with the help of his “suicide machine.” The features of the case were so unusual that physicians, ethicists, and attorneys in health law who were interviewed by journalists were unanimous in judging this particular act of physician-assisted suicide deplorable.

The several articles in this special issue on organ donation after circulatory determination of death or, as it is often put, donation after cardiac death (DCD), draw lessons from different kinds of experience in order to guide efforts in the U.S. to develop or refine policies for DCD. One lesson comes from a major and, by many measures, successful experimental DCD program in Washington, D.C. in the 1990s. Another lesson comes from European countries that have adopted presumed-consent legislation, a form of “opt out” that facilitates DCD as well as donation after neurological determination of death (DND). Another lesson, from the perspective of critical care medicine in Canada, attends to the implications of viewing a dying patient, undergoing resuscitative procedures, as a potential organ donor. A final lesson sketches implications of legislation and court cases in the U.S., often involving DND, for initiating temporary organ preservation (TOP) in DCD programs before consent has been obtained for organ donation. Some of these lessons are optimistic about the prospects for DCD, especially if certain steps are taken, while others are more cautious, particularly because of the costs and risks involved in DCD.

The 2009 pandemic of influenza A (H1N1) was relatively mild, but a subsequent outbreak of pandemic influenza could be much worse. According to projections from the Department of Health and Human Services, the potential health consequences of a severe (1918-like) influenza pandemic in the United States could be literally overwhelming: up to 1.9 million deaths; 90 million people sick; 45 million people needing outpatient care; 9.9 million people hospitalized, of whom 1.485 million would need treatment in an intensive care unit (ICU); and 742,500 patients needing mechanical ventilators. Even a less cataclysmic, moderate pandemic (like 1958 or 1968) would result in 209,000 deaths; 90 million people sick; 45 million people needing outpatient care; 865,000 people hospitalized, of whom 128,750 would need treatment in an ICU; and 64,875 patients needing mechanical ventilators.

Nanotechnology is the latest in a growing list of emerging technologies that includes nuclear technologies, genetics, reproductive biology, biotechnology, information technology, robotics, communication technologies, surveillance technologies, synthetic biology, and neuroscience. As was the case for many of the technologies that came before, a key question facing nanotechnology is what type of regulatory oversight is appropriate for this emerging technology. As two of us wrote several years ago, the question facing nanotechnology is not whether it will be regulated, but when and how.

Yet, appropriate regulation of nanotechnology will be challenging. The term “nanotechnology” incorporates a broad, diverse range of materials, technologies, and products, with an even greater spectrum of potential risks and benefits. This technology slashes across the jurisdiction of many existing regulatory statutes and regulatory agencies, and does so across the globe. Nanotechnology is developing at an enormously rapid rate, perhaps surpassing the capability of any potential regulatory framework to keep pace. Finally, the risks of nanotechnology remain largely unknown, both because of the multitude of variations in the technology and because of the limited applicability of traditional toxicological approaches such as structure-activity relationship (SAR) to nanotechnology products.

The family of a patient who is unconscious and respirator-dependent has made a decision to discontinue medical treatment. The patient had signed a donor card. The family wants to respect this decision, and agrees to non-heart-beating organ donation. Consequently, as the patient is weaned from the ventilator, he is prepped for organ explantation. Two minutes after the patient goes into cardiac arrest, he is declared dead and the transplant team arrives to begin organ procurement. At the time retrieval begins, it is not certain that the patient's brain is dead or that cardiac function cannot be restored. Procurement follows uneventfully, and two transplantable kidneys are retrieved.

Many people now consider such cases of non-heart-beating organ donation to be ethically permissible. However, widespread disagreement persists as to how such practices are to be justified and whether such practices are compatible with the Uniform Declaration of Death Act (UDDA). In this paper, I argue that non-heart-beating organ donation can be ethically justified, that in the justified cases the patients are in fact dead, and that the early declarations of death required for such donation do comply with the UDDA.

Policy arguments in support of stem cell research often use economic benefit as a key rationale for permissive policies and increased government funding. Economic growth, job creation, improved productivity, and a reduction in the burden of disease are all worthy goals and, as such, can be used as powerful rhetorical tools in efforts to sway voters, politicians, and funding agencies. However, declarations of economic and commercial benefit — which can be found in policy reports, the scientific literature, public funding policies, and the popular press — have arguably created a great deal of expectation. Can stem cell research deliver on the economic promise? And what are the implications of this economic ethos for the researchers who must work under its shadow?