Individual research protections provided by bioethical principles can be extended to group protections, particularly for place-based (geographic) communities and cultural groups who may share a common harm or burden. In this article, an argument is made for the need to consider the group conditions of individual research subjects in the ethics of individual report-backs of human biomonitoring results. Human biomonitoring, the measuring of concentration of chemicals or their metabolites in blood, urine, breast milk, hair, and other biological samples, can provide an assessment of an individual's exposure to a chemical(s) and can integrate exposures from multiple pathways and sources. Biomonitoring studies have been increasing in the past decade for such purposes as measuring the levels of chemicals that are ingested by members of the general population and at what concentrations, to determine if exposure levels are higher in some groups vs. others, to track temporal trends to establish reference ranges for chemical exposures, and to investigate an association with health.

The Common Rule (45 CFR 46, subpart A) is a set of regulations for protecting human participants in research funded by the Department of Health and Human Services (DHHS), which has been adopted in part by 17 federal agencies. It includes four different subparts: Subpart A (general protections for human research participants), Subpart B (additional protections for pregnant women, fetuses, and neonates), Subpart C (additional protections for prisoners), and Subpart D (additional protections for children). The Common Rule has not been significantly revised since 1981 although some significant changes may be forthcoming. The Food and Drug Administration (FDA) has adopted its own regulations for the protection of human participants, which are similar to the Common Rule in many key areas, such as the structure and function of the Institutional Review Board (IRB), and the criteria for approving research.

The concept of vulnerability has been the topic of considerable discussion in research bioethics, largely because of dissatisfaction with early constructions of the concept that were based on subpopulations of research subjects. These subpopulations have attributes likely to undermine their capacity to provide autonomous informed consent: persons who are relatively or absolutely incapable of protecting their own interests through negotiations for informed consent. Several subpopulations were seen as requiring special protections, including children, pregnant women, prisoners, racial minorities, the economically disadvantaged, the very sick, and the institutionalized. Recent years have witnessed the identification of other subpopulations with attributes that could render them vulnerable, as well. For example, the Council for the International Organization of Medical Societies has named such potentially vulnerable groups as the homeless, nursing home residents, patients with incurable diseases, patients in the emergency department, employees, students, and members of communities who are unfamiliar with modern medicine.

The response many gay men took to the HIV epidemic in the United States was largely informal, especially given distant state and federal governments. The condom code, a set of informal norms that encouraged the use of condoms, is one instance of this informal response, which was wholly uncoordinated. Yet, it is not clear why these informal norms emerged or why they have since eroded. This paper explores how gay men in particular generated expectations and normative beliefs regarding condom usage, which helped to establish the condom code as an informal norm. Furthermore, the erosion of the condom code is viewed as a result of changing expectations, which change as bio-medical means of HIV treatment and prevention develop and as online and digital communities facilitate serosorting, all of which provide alternatives to condoms as a means of prevention and their associated informal norms. Future HIV prevention campaigns should recognize the extent to which informal norms coordinate and encourage preventative behavior, as well as how beliefs and expectations alter the informal norms people adopt.

The recent case of Baby M has brought surrogate motherhood to the forefront of American attention. ultimately, whether we permit or prohibit surrogacy depends on what we take to be good reasons for preventing people from acting as they wish. A growing number of people want to be, or hire, surrogates; are there legitimate reasons to prevent them? Apart from its intrinsic interest, the issue of surrogate motherhood provides us with an opportunity to examine different justifications for limiting individual freedom.

In the first section of this article, I examine the Baby M case and the lessons it offers. In the second section, I examine claims that surrogacy is ethically unacceptable because it is exploitive, inconsistent with human dignity, or harmful to the children born of such arrangements. I conclude that these reasons justify restrictions on surrogate contracts, rather than an outright ban.

Susan Wolf, in an important article on hospital or institutional ethics committees (IECs) and due process, writes:

There are few data upon which to draw to disagree with Wolf's first claim about a due process “wasteland.” I suspect that it is mostly true, although one can observe, as I do, that Susan Wolf has omitted a great deal of evolution concerning ethics consultation in her article.

When 47-year-old Simba Abalo, an unemployed retired soldier in Lomé, Togo, found out that he had AIDS in September 2007, he was unable to receive government-supplied antiretroviral drugs: “CAMEG [the state’s central medicines purchasing organization],” he said, “told me they were not taking any new cases for six months because they had run out of drugs.

Stocks of antiretrovirals had become depleted after the Global Fund to Fight AIDS, Tuberculosis and Malaria suspended part of its grant to Togo in 2006 and failed to approve a new grant request in 2007, reportedly because of oversight irregularities. “Even if they had the drugs,” said Abalo, “I could not have paid more than US$4 a month since I had just lost my job as a security guard earning US$70 a month.”

No one who attended the 2010 national public health law conference hosted by the Public Health Law Association (PHLA) and the American Society of Law, Medicine & Ethics (ASLME) could miss the sense of excitement and momentum. The revival of this annual public health law meeting, with the support of the Robert Wood Johnson Foundation (RWJF), the energetic leadership of the PHLA president and board, ASLME’s expert guidance, and a rousing address by Dr. Tom Frieden, Director of the Centers for Disease Control and Prevention (CDC), symbolize the continued commitment of a wide range of important individuals and institutions to the proposition that law is of substantial importance to public health. But there is more than just symbolism to be excited about. CDC’s public health law program continues to champion efforts to promote the use and understanding of law as a public health tool.

The seemingly interminable debates about health care reform in the last few years have focused mainly on health care access, quality, and cost. Debates on the medical malpractice component of the issue have focused almost entirely on cost. The familiar arguments in favor of limiting liability include the financial and health costs of defensive medicine; decreased physician supply in certain specialties and geographic areas; excessive awards; and high transaction costs, including attorney and expert witness fees. The equally familiar arguments in favor of maintaining tort liability include the need to promote civil justice, deter substandard care, identify incompetent practitioners, and encourage systemic quality improvement.

Numerous studies have explored the possible effects of damage caps and other measures on malpractice premiums, health care costs, and other financial endpoints. One relatively under-examined aspect of the issue is how federal legislation expanding access to health care might alter the number of medical malpractice claims. With the enactment of the Patient Protection and Affordable Care Act of 2010 (PPACA), it is especially appropriate to consider what effect, if any, the new law will have on the rate of medical malpractice claims.

Entry into the practice of medicine is heavily regulated through scope of practice and licensing laws that make it illegal for nonlicensed individuals to perform many medical services. As institutions are structured at the beginning of the twenty-first century, most regulation takes place at the state level, through state departments of health that establish criteria for performing different types of medical activities, and that restrict allowable activities for various types of health care professionals. The regulations over the activities of physicians are more uniform across states than for other health care professionals because, although the regulation is done by individual state governments, the standards for physicians are set by the National Board of Medical Examiners, a group controlled by physicians themselves. The justification for this regulation is that it produces higher quality health care. Some would make an even stronger argument that regulation is necessary because patients do not have sufficient knowledge to distinguish effective practitioners from ineffective ones.

The dangers presented by antibiotic resistance (ABR) have now established themselves as a global health security issue. From an international policy perspective, three key pillars have been established: responsible access, conservation, and innovation. These pillars are intrinsically linked, meaning that any attempt to address one must take into account the implications for the other two.

An urgent need exists to address the innovation failure in ABR. In the field of anti-bacterials, the pipeline remains anemic in terms of therapeutics with novel mechanisms of action, new drug classes and strategies involving radically different, innovative approaches. The key reasons for this failure have already been well established. The slow development of new antibiotics is the result of a poor and uncertain commercial market and scientific challenges in research and development (R&D).

For years, Jehovah's Witnesses have posed a challenge to the medical profession. Bound by religious belief to refuse blood and blood products, they can frustrate physicians who, since World War II, have utilized transfusions when indicated in the course of treatment.

The mission of public health is to assure the conditions in which people can be healthy and to reduce the occurrence of death and disability attributable to disease and injury. From the distinctive perspective of public health, the target is the health of the population as a whole, with a particular concern for vulnerable populations within the whole. Although public health is grounded in science, the mission and perspective of the field are shaped by the ever-evolving values of the society. Ethics and law are therefore constituent disciplines of public health policy and practice. One of the major challenges confronting contemporary practitioners of public health is the need to broaden and deepen their understanding of legal and ethical aspects of their work. This special issue of the Joumal of Law, Medicine & Ethics responds to this challenge. This article describes how the mission of public health has come to encompass the prevention and treatment of injury and highlights some of the political and ethical controversies now confronting the field.

Biomedical research using data from participants’ mobile devices borrows heavily from the ethos of the “citizen science” movement, by delegating data collection and transmission to its volunteer subjects. This engagement gives volunteers the opportunity to feel like partners in the research and retain a reassuring sense of control over their participation. These virtues, in turn, give both grass-roots citizen science initiatives and institutionally sponsored mHealth studies appealing features to flag in recruiting participants from the public. But while grass-roots citizen science projects are often community-based, mHealth research ultimately depends on the individuals who own and use mobile devices. This inflects the ethos of mHealth research towards a celebration of individual autonomy and empowerment, at the expense of its implications for the communities or groups to which its individual participants belong. But the prospects of group harms — and benefits — from mHealth research are as vivid as they are in other forms of data-intensive “precision health” research, and will be important to consider in the design of any studies using this approach.

Many observers have argued that the US health care system could be more efficient, and achieve better outcomes if providers focused more on improving the community's health, not just the welfare of individual patients. The passage of the Affordable Care Act (ACA) in 2010 seemed to herald the promise of such reforms, and greater integration of the health care and public systems. In this article, we reassess the quest for integration, a quest we call the “integration project.” After examining the modest steps taken so far toward integration, we consider some conceptual barriers to integration as well as some of the risks it might portend for the public health system. Our assessment contributes to wide-ranging debates among public health advocates, practitioners, and policymakers as to the health care system's role in protecting public health, and how the public health system can best be organized to meet expected population health challenges.

Health care depends on people. It is the health workforce — doctors, nurses, pharmacists, lab technicians, and nursing assistants, to mention a few — that, in large measure, determine the quality and effectiveness of any health enterprise. The nature of the health workforce was integral to the health care reform debates of the early 1990s and will surely be central in proposals to improve the quality, accessibility, and cost of U.S. health care in the future. Therefore, as we enter a new period of health reform deliberations and as we face the inevitability of an aging population, it is important to consider the problems and potential remediation necessary for the health workforce of the future. This article focuses particularly on physicians and nurses while recognizing the importance and frequently parallel concerns that arise across all health care disciplines. Understanding how the composition, capacity, and activities of a health care workforce must change as part of health reform requires an understanding of the context in which health professionals practice. What are the factors that govern health care today, and what are their impact on the health workforce?

Current discussions of so-called “enhancement” technologies immediately involve matters of definition, because the distinctions between enhancement and therapy invite ambiguity. Therapy is generally defined as the prevention or cure of disease, or as the restoration or approximation of return to normal physiological function. Enhancement is defined as the alteration of individual (or group) characteristics, traits, and abilities (both health- and non-health-related) beyond a measurable baseline of normal function. Both notions rely on shared understandings of disease and illness, which depend in turn on the ways that we conceptualize and operationalize judgments of normalcy. Both notions have therefore generated significant controversy among philosophers of medicine, with the result that blanket distinctions between therapy and enhancement appear unlikely to convince everyone.