Ethical debate on human germ-line gene therapy is in a new stage. After an era when only individual convictions could be examined, technology is on a threshold of real possibilities. Germ-line gene therapy can conceivably be carried out in either of two practical ways: 1) insertion of a gene into a pre-embryo, which is the subject of this paper, or 2) insertion of a gene into the germ cells of an individual.

Transgenic animal research and pre-implantation embryo diagnosis have implications for human embryonic germ-line experiments to correct single gene disorders. When would such experiments be feasible and ethically acceptable? If further animal research supports it, we argue for a moral obligation to learn if human germ-line experiments are feasible and safe to attempt. The obligation is grounded in several social-ethical principles that lead society and researchers to set gods for studies that promisc to relieve and to prevent human suffering and premature death. These principles also shape the practices and restrictions of biomedical research.

“Public health legal preparedness” is a term born in the ferment, beginning in the late 1990s, that has led to unprecedented recognition of the essential role law plays in public health and, even more recently, in protecting the public from terrorism and other potentially catastrophic health threats.

The initial articulation of public health has not kept pace with rapid evolution in the concept and in practical development of public health preparedness itself. This poses the risk that legal preparedness may fall behind construction of general readiness in the public health system—and may, in fact, undercut achievement of comprehensive public health preparedness for massive threats to health in both the United States and world-wide. Inadvertent results might include both negative health impacts and infringement on individual rights.

Incidental research findings, as defined in this symposium’s consensus paper, are unexpected findings discovered in the course of research but “beyond the aims of the study.” These include findings generated by research methodology, such as imaging or genetic analysis, findings related to clinical screening for inclusion or exclusion, or direct observations of physical abnormalities or behavior. Decisions about managing incidental research findings involve important ethical considerations regarding a researcher’s obligations to provide care, minimize harms, and respect research participants’ wishes. When the research participant is a child, the triadic relationship between the researcher, child participant, and parent makes these considerations more complicated. (See Figure 1.)

The tension between economic policy and health policy is a longstanding dilemma, but one that was brought to the fore with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 1994. The pharmaceutical industry has long argued that intellectual property protection (IPP) is vital for innovation. At the same time, there are those who counter that strong IPP negatively impacts the affordability and availability of essential medicines in developing countries. However, actors on both sides of the debate were in agreement that something needed to be done to address the HIV/AIDS crisis, especially in developing countries. In response to sustained and significant pressure from civil society groups, members of the World Trade Organization agreed to the Declaration on the TRIPS Agreement and Public Health (the Doha Declaration) in 2001. The Declaration clarified that countries unable to manufacture the needed pharmaceuticals could obtain more affordable generics elsewhere if necessary.

Nearly 2.5 million Americans currently reside in nursing homes and assisted living facilities in the United States, accounting for approximately five percent of persons sixty-five and older. The aging of the “Baby Boomer” generation is expected to lead to an exponential growth in the need for some form of long-term care (LTC) for this segment of the population within the next twenty-five years. In light of these sobering demographic shifts, there is an urgency to address the profound concerns that exist about the quality-of-care (QoC) and quality-of-life (QoL) of this frailest segment of our population.

In China, there have been numerous reports that doctors or other health care workers have been attacked by patients or members of patient’s families. From 2000 to 2003, there were 502 reports of violence against health care workers in the city of Beijing, in which 90 health care workers were wounded or disabled. From January 1991 to July 2001, in Hubei Province, 568 attacks on health care facilities and workers were reported, and some health care workers were even killed. In Jiangsu Province, from 2000 to 2002, violent events against health care facilities and workers increased by 35% every year, with an average of 177 such events occurring each year. Those acts of violence have been attributed, in part, to the inadequacy of the legal system for handling medical disputes that was in effect prior to 2002.

In the theater the fictional Dr. Kelekian’s relief that he does not have to talk to family members about his patient’s cancer treatment draws uneasy laughter from the audience. Doctors, patients, and family members alike recognize the situation, even if hearing it so baldly expressed discomfits them.

Why do physicians and other health care professionals, including lawyers and bioethicists, so often view families as “trouble”? And why do families so often see medical professionals as uncaring and uncommunicative? Presumably everyone wants the same goal—recovery or the best possible outcome for the patient. And yet trouble clearly exists. We do not see the problem as one of “dysfunctional families” or “callous doctors,” although there are undoubtedly many of each.

“There's glory for you!”

“I don't know what you mean by ‘glory,’ ” Alice said.

Humpty Dumpty smiled contemptuously. “Of course, you dont—till I tell you. I meant ‘there's a nice knock-down argument.’”

“But ‘glory’ doesn't mean a ‘nice knock-down argument,” Alice objected.

“When I use a word,” Humpty Dumpty said, in rather a scornful tone, “it means just what I choose it to mean—neither more nor less.”

“The question is,” said Alice, “whether you can make words mean so many different things.”

“The question is,” said Humpty Dumpty, “which is to be master, that's all.”

When applied bioethics confronts the topic of futility, the question of who is to be master turns out to be central. Indeed, much of the literature on futility has focused on exactly this question: who gets to define the terms of the debate? Who gets to decide that treatment is “futile” and therefore allowably withheld or withdrawn?

On August 28, 2008, Michael Marmot, Chair of the Commission on Social Determinants of Health, formally handed over the Commission’s Final Report to Margaret Chan, the Director-General of the World Health Organization, at the Palais des Nations in Geneva. It was a significant moment. Dr. Chan addressed a hall packed with representatives of the world’s communications media in a speech that was remarkably direct. Dr. Chan reiterated the Commission’s position that to improve health and health equity action needs to be taken not just across the health sector but across all social and economic policy areas, and stated, “Social deprivation is not a matter of fate. It is a marker of policy failure.” This was a bold statement from one of the world’s leading diplomats. Policy failure! The phrase echoes the Commission’s assertion that “a toxic combination of poor social policies, unfair economic arrangements and bad politics is killing people on a grand scale.” The Commission’s messages are far reaching.

Antibiotic resistance presents a classic example of the “tragedy of the commons.” In this eponymous tragedy, the commons — shared, public access lands — are overgrazed because farmers can send their livestock onto the land at a zero price. The “tragedy” occurs because overgrazing destroys the land and reduces its ability to provide fodder. The application to antibiotics is obvious: the use of antibiotics creates selection pressure leading to increased proportions of resistant bacteria in the patient and the environment. The increase in frequency of resistant organisms diminishes the effectiveness of antibiotics in treating future infections; thus, the long-term value of the antimicrobial resource is reduced.

Genetic privacy and confidentiality have both intrinsic and consequential value. Although general agreement exists about the need to protect privacy and confidentiality in the abstract, most of the concern has focused on preventing the harmful uses of this sensitive information. I hope to demonstrate in this article that the reason why genetic privacy and confidentiality are so difficult to protect is that any effort to protect them inevitably implicates broader and extremely contentious issues, such as the right of access to health care. Moreover, the tentative legislative and policy steps undertaken and proposed thus far have been, for the most part, misguided, simplistic, and ineffective.

In June 2012, New York City Mayor Michael Bloomberg announced his plans for a ban on the sale of sugary beverages in containers larger than 16 ounces. Shortly thereafter, the Center for Consumer Freedom took out a full-page ad in the New York Times featuring Bloomberg photo-shopped into a matronly dress with the tag line “New Yorkers need a Mayor, not a Nanny.” On television, the CATO Institute's Michael Cannon declared, “This is the most ridiculous sort of nanny state-ism; [i]t’s none of the mayor's business how much soda people are drinking.” And in newspapers around the country, editorial pages featured headlines such as “Gulp! Yet Another Intrusion of the Nanny State.” Just like that, the public debate about this measure became focused on government overreach, while the public health problem of obesity (and of overconsumption of soda in particular) faded into the background.

Of the many global health challenges facing the world today, only a small number require global collective action. Most health challenges can be fully addressed through action at local, regional or national levels.

What kind of actions must be taken to address the global threat of antibiotic resistance (ABR)? What legal, political and economic tools might be needed to achieve this level of action?

In March 2015 the Dag Hammarskjöld Foundation convened a workshop in Uppsala, Sweden to address these questions in partnership with the Global Strategy Lab, the Journal of Law, Medicine & Ethics (JLME), the Norwegian Institute of Public Health, and ReAct — Action on Antibiotic Resistance. Eleven concise articles were commissioned to explore whether ABR depended on global collective action, and if so, what tools could help states and non-state actors to achieve it.

In 2000, researchers from the Human Genome Project (HGP) proclaimed that the initial sequencing of the human genome definitively proved, among other things, that there was no genetic basis for race. The genetic fact that most humans were 99.9% the same at the level of their DNA was widely heralded and circulated in the English-speaking press, especially in the United States. This pronouncement seemed proof that long-term antiracist efforts to de-biologize race were legitimized by scientific findings. Yet, despite the seemingly widespread acceptance of the social construction of race, post-HGP genetic science has seen a substantial shift toward the use of race variables in genetic research and, according to a number of prominent scholars, is re-invoking the specter of earlier forms of racial science in some rather discomfiting ways. During the past seven years, the main thrust of human genetic research, especially in the realm of biomedicine, has shifted from a concern with the 99.9% of the shared genome — what is thought to make humans alike — towards an explicit focus on the 0.1% that constitutes human genetic variation. Here I briefly explore some of the potential implications of the conceptualization and practice of early 21st century genetic variation research, especially as it relates to questions of race.

As a matter of respect for the person, it is considered an ethical duty to offer to return research results to participants where appropriate. Nevertheless, the return of individual research results to participants raises many socio-ethical issues and greater challenges when the participant is a child. This discrepancy arises partly because the return of individual pediatric research results entails a tripartite relationship between researcher, child, and parent(s) and is embroiled in numerous considerations (e.g., acting in the best interest of the child, respect for the person, and respect for the autonomy of the parents/child).

Extra caution is required in the pediatric research context because children cannot generally decide (consent) whether they want to be informed of their own research results or whether the results should be disclosed to parents. Children have long been considered a special and vulnerable group, and their parents, as guardians, play a critical role in the consent process. However, with regards to the return of individual research results, this might pose a potential conflict of interest between the current or future desires of the child and those of the parents.

U.S. approaches to oversight of research and technological products have developed over time in an effort to ensure safety to humans, animals, and the environment and to control use in a social context. In modern times, regulatory and oversight tools have evolved to include diverse approaches such as performance standards, tradable allowances, consultations between government and industry, and pre-market safety and efficacy reviews. The decision whether to impose an oversight system, the oversight elements, the level of oversight (for example, federal, state, local), the choice of approach (for example, mandatory or voluntary), and its execution can profoundly affect technological development, individual and collective interests, and public confidence in technological products. Oversight is conducted by a range of institutions with various capabilities, cultures, and motives. Avenues for disputing oversight decisions are also important, and some argue that the U.S. operates in an adversarial regulatory culture in which Congress, the media, and stakeholders regularly contest the decisions of federal agencies.

Scientific reports about clinical research appear objective and straightforward. They describe a study's findings, methods, subject population, number of subjects, and contribution to existing knowledge. The overall picture is pristine: the research team establishes the requirements of study participation and subjects conform to these requirements. Readers are left with the impression that everything was done correctly, by the book.

In other places, however, one finds a different and messier picture of clinical research. In this picture, research subjects deviate from the prescribed plan. One author contrasted the “tidy graphics” and “crisp prose” of the New England Journal of Medicine's HIV/AIDS trial publications with reports that subjects shared medications and broke other trial rules. Awareness of this behavior, he wrote, could lead insiders to “conclude that knowledge was resting on something rather less solid than bedrock.”

Male to male unprotected anal sex is the main route of HIV transmission in Australia. The Australian Study of Health and Relationships, a large, representative population survey of sexual health behaviors, found that six percent of males in the general population have engaged in homosexual activity. These findings were consistent with studies in Europeand North America. Condoms have been shown to reduce the transmission of HIV in the community. Barriers to the use of condoms include access,stigma,and cost? Nevertheless, increased condom use has been reported among homosexual males, sex workers and injecting drug users although recent declines in condom use among homosexuals has presented new challenges in HIV prevention.

The prevalence of male to male sexual activity may be higher in prison than in the general population. Sexual activity in prison can be consensual and non-consensual involving both homosexual / bisexual and heterosexual men.

Discussions about the role of practice guidelines and the strength of the evidence on which they are based should begin with a set of more basic questions: What is the function of such guidelines and what forces shape their use?

At least two forces can be seen behind the press for guidelines. On the one hand, guidelines can be used to improve the quality of care by raising the general level of practice to meet at least the standards set by experts. At the other, they become vehicles for cost containment.

By international standards, the United States spends a disproportionate share of its gross domestic product on health care. The majority of spending increases are traceable to the growth in technology. Whether couched as a concern that resources could be better used to provide other parts of the population with more effective health care or as a general concern that money spent on health might be better used for other social goods, a notion exists that less is better.

A significant amount of discussion in the bioethics community has been devoted to the question of whether individuals performing ethics consultations in healthcare institutions have any special expertise. In addition, articles in the lay press have questioned the “added value” that bioethicists bring to ethical dilemmas. Those at the forefront of the bioethics community have argued repeatedly that those doing ethics consults cannot simply be well-intentioned individuals, that some training in bioethics, group process, and facilitation is necessary to competently execute a consult. As one bioethicist commented:

if you approach any endeavor as an amateur activity, you will get, in the end, an amateurish version of the activity. Without a sufficient commitment of personnel, time, support, and financial resources, a healthcare organization will get the ‘ethics’ program … it set out to create: an inept, unskilled, inefficient, and highly risky ‘program’ in healthcare ethics and bioethics.