Do we have a legal and moral right to health care against others? There are international conventions and institutions that say emphatically yes, and they summarize this in the expression of “the right to health,” which is an established part of the international human rights canon. The International Covenant on Social and Economic Rights outlines this as “the right of everyone to the enjoyment of the highest attainable standard of physical and mental health,” but declarations such as this remain tragically unfulfilled. According to recent figures, roughly two billion people lack access to essential drugs or to primary health care. Millions are afflicted by infections and illnesses that are easily avoidable or treatable. In the developing world many children die or grow stunted and damaged for lack of available treatments. Tropical diseases receive little or no attention by the major pharmaceutical companies’ research departments. Is this a massive violation of the right to health? And if so, why does it attract so little attention? Is it because our supposed commitment to human rights and the rule of law is hypocritical and hollow? Or is it because the right to health is a special case of a right, so that these tragedies are no violation at all? Jennifer Prah Ruger summarized this puzzle when she wrote: “one would be hard pressed to find a more controversial or nebulous human right than the right to health.” In this essay I discuss three different theories of a right to health care. I conclude by offering my own reconstruction of one such theory.

In an explicit attempt to reduce physician paternalism and encourage patient participation in making health care decisions, the informed consent doctrine has become a foundational precept in medical ethics and health law. The underlying ethical principle on which informed consent rests — autonomy — embodies the idea that as rational moral agents, patients should be in command of decisions that relate to their bodies and lives. The corollary obligation of physicians to respect and facilitate patient autonomy is reflected in the rules that have been created to implement consent procedures, especially those requiring disclosure of relevant information.

However, there are many practical impediments to patient self-determination in health care decisionmaking. Well-meaning physicians often lack the time to live up to the ideal of facilitating genuine, informed deliberation with and by their patients, and many lack the motivation or skill to do so successfully.

Consider this hypothetical scenario involving a choice not to vaccinate a child. Ms. S has a niece who is autistic. The girl's parents are suspicious that there is some relationship between her autism and her Measles Mumps and Rubella (MMR) vaccination. They have shared their concerns with Ms. S. She then declines to have her own daughter, Jinny S., vaccinated with the MMR vaccine. To bypass the state's mandatory vaccination requirement, Ms. S claims a state-legislated philosophical exemption, whereby she simply attests to the fact that she is opposed to vaccinating her daughter due to a conscientiously held belief. At the age of four, Jinny goes on a trip by airplane to Germany with her mother. After returning to the United States, she attends daycare despite having some mild cold symptoms. Subsequently, she develops a classic measles rash, at which point her mother brings her to a pediatrician and keeps her home from daycare.

To find adequate answers to a changing reality heavily influenced by advances in technology, medical professionals have developed and adopted an array of terms that have brought new concepts into the profession. “Dignity,” “vegetative state,” “futility,” “double effect,” and “brain death” have become indispensable words in the medical setting. In the following discussion, the attention is on terminology. If we believe in phenomenology, the assumption is that we should closely reflect on the words we use in all spheres of life, especially in those that concern life and death. This article calls for a sincere discussion about these terms and concepts. The thesis put forward is that the language in the medical setting serves primarily the physicians, at times at the expense of the patients’ best interests. This language and the concepts it describes have generated an unhealthy atmosphere for patients, which might lead to undesirable actions at the end of patients’ lives.

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as a mechanism for harmonizing clinical research regulations. The intent of harmonization was to improve patients’ “access to new drugs, to prevent unnecessary global development delays and to avoid animal and human study duplications” through policy reconciliation.

FDA/EMA efforts at collaboration call for a reassessment of past harmonization efforts: to what extent are ICH member policies already synchronized and to what extent can they be harmonized in the future? This paper will focus on these questions through the lens of pediatric investigation.

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.

Since the first phase of the formal effort to sequence the human genome, geneticists, social scientists and other scholars of race and ethnicity have warned that new genetic technologies and knowledge could have negative social effects, from biologizing racial and ethnic categories to the emergence of dangerous forms of genetic discrimination. Early on in the Human Genome Project (HGP), population geneticists like Luigi Luca Cavalli-Sforza enthusiastically advocated for the collection of DNA samples from global indigenous populations in order to track the history of human ancestry, migration, and languages, while social scientists like Troy Duster insisted that the new genetics was in danger of ushering in insidious practices of eugenics. The Human Genome Diversity Project's 1991 proposal to archive human genetic variation around the world quickly came under intense scrutiny by indigenous peoples and advocacy groups who worried that such measures could exploit indigenous groups as research populations and even resurrect racist taxonomies from the nineteenth century.

Some authors argue that the ethics of medical care and the ethics of research differ, and that it is a mistake to conflate the two. They propose “that medical research and medical treatment are two distinct forms of activities, governed by different ethical principles.” This raises the question of whether physicians who are also clinical investigators may separate their role as physician from that of researcher when they are involved in clinical trials, thereby avoiding the obligations required in the physician-patient relationship. Miller and Brody suggest that medical training is to blame for what they believe is the physicians’ tendency to confound the obligations of research and practice. “Physician-investigators, after all, went to medical school” they explain. They believe that considering research with patients outside the ethical framework of the physician-patient relationship may be “difficult and threatening” to physicians who have “psychological needs” to consider the ethical obligations flowing from their relationship with their patients.

Nanotechnology is the “next small thing” in technological innovation. Spanning a range of science and engineering disciplines, nanotechnology will dramatically alter products and processes upon which we currently rely and promises significant advances in technology. Federal agencies taking part in the National Nanotechnology Initiative (NNI) have attempted to articulate a suitable definition for nanotechnology. The NNI definition refers to “[r]esearch and technology development at the atomic scale, molecular or macromolecular levels, in the length scale of approximately 1-100 nanometer range[; creating] and using of structures, devices and systems that have novel properties and functions because of their small size and/or intermediate size[; and the ability] to control or manipulate at the atomic scale.” Nanotechnology thus refers to material engineered or altered at the nanoscale, in order to take advantage of unique properties that emerge at that scale.

In August 2001, the Maryland Court of Appeals harshly criticized the Kennedy Krieger Institute of Johns Hopkins University for knowingly exposing poor children to lead-based paint. The court’s decision made national news, and is worth examining because it raises several very important issues for research ethics.

The research conducted by the Institute was an attempt to understand how successful different lead abatement programs were in reducing continued lead exposure to children. Previously, Julian Chisolm and Mark Farfel, of John Hopkins University, had disclosed the dangers of traditional dust-generating deleading practices. In the current study, Dr. Farfel and colleagues sought to document the longevity of various lead-based paint abatement strategies.

The two questions, “What is public health law?” and “How can law improve the public’s health?”, are perennial ones for public health law scholars. They are ideological questions because perceptions about the proper boundaries of law’s role will shape perceptions of what law can do, in an operational sense, to improve health outcomes. They are also theoretical questions, in the sense that, without closing down debate about the limits of public health law, these questions can be addressed by mapping the range of perspectives on how law might “go to work” for the public’s health. Finally, these are immensely practical questions. On our ability to understand the roles that law can play in public health improvement rests our capacity, as a society, to use law strategically as a policy tool.

Public health is concerned with how to improve the population’s health. At times, though, actions to improve the community’s health may collide with individual civil rights. For example, a public health response to a bioterrorism attack, such as smallpox, may require relaxing an individual’s due process protections to prevent the smallpox from spreading. This tension lies at the heart of public health policy. It also must be considered in discussing the concept of human rights in health.

Proponents of incorporating the concept of human rights in health emphasize the importance of both individual rights and collective rights. They argue that observing human rights is not only consistent with broad public health goals, but necessary to their attainment. To many human rights advocates, the concept is not limited to protecting against governmental intrusion. Accordingly, they emphasize the government’s obligation to promote attainment of human rights by, for instance, providing adequate health care.

Open science has recently gained traction as establishment institutions have come on-side and thrown their weight behind the movement and initiatives aimed at creation of information commons. At the same time, the movement's traditional insistence on unrestricted dissemination and reuse of all information of scientific value has been challenged by the movement to strengthen protection of personal data. This article assesses tensions between open science and data protection, with a focus on the GDPR.

Circe directed Ulysses to fill the ears of his seamen with wax, so that they should not hear the strain [of the Sirens]; and to cause himself to be bound to the mast, and his people to he strictly enjoined, whatever be might say or do, by no means to release him till they should have passed the Sirens’ island. His men obeyed… . At the sound of the Sirens Ulysses struggled to get loose, and by cries and signs to his people begged to be released; but they, obedient to his previous orders, sprang forward and bound him still faster. They held on their course, and the music grew fainter till it ceased to be heard, when with joy, Ulysses gave his companions the signal to unseal their ears, and they relieved him from his bonds.

Few things seem more a part of the material world than biological specimens. Yet the processes by which collections of specimens are assembled, translated into information, combined with more information, and distributed are taking research repositories into the virtual realm.

The term “virtual” has a number of meanings, and so a research repository can qualify as virtual in a variety of ways. The term would seem to apply, for example, to (1) constructing a repository by forming a network among institutions; (2) using the Internet or the World Wide Web to solicit specimens and information; (3) integrating web-based technology into the operation of the bank; (4) using the Internet or web-based technology to manage relationships with donors or collection sites and recipients; and (5) digitizing specimens. The all-digital repository would seem the most virtual of all possible repositories, a true cyberbank.

On December 30, 2003, the FDA announced that it will publish a rule banning sales of ephedra - a dietary supplement often utilized for weight loss, increased energy, and enhanced athletic performance - because it poses an unreasonable health risk.The ban will be issued under the auspices of the Federal Food, Drug, and Cosmetic Act and the Dietary Supplement Health and Education Act of 1994 (DSHEA), in response to a process that began in June of 1997, when the FDA first proposed a mandatory warning statement on dietary supplements containing ephedra. FDAs analysis of the scientific evidence has led it to conclude that dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury and are therefore adulterated under Section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act?

Since the beginning of the AIDS epidemic, the proportion of AIDS cases among women has continued to rise. Women constituted 23 percent of the AIDS cases reported to the Centers for Disease Control and Prevention (CDC) in 1995, and 81 percent of these women were of childbearing age (13 to 44 years). It was not until 1991, however, that epidemiological studies of women were initiated. By comparison, the representation of HIV-infected women in clinical trials gradually has grown. Undoubtedly, a consequence of the increased numbers of women in clinical and epidemiological research is the earlier identification of and more appropriate treatments for HIV-related syndromes when women present in the clinical setting. Despite this expanded focus on women, however, clear information to guide the treatment of HIV-infected women who are pregnant is still lagging behind.

It is axiomatic that the first responsibility of researchers, whether they are working in the developed or the developing world, is to (strive to) do no harm to those who participate in their studies or trials. However, on neither side of the Atlantic is there any such settled view with regard to the responsibility of researchers to attend to the ancillary-care needs of their participants – that is, a responsibility to advise or assist participants who have medical condition X in circumstances where the research concerns medical condition Y, and the research did not contribute to the presence of condition X in participants, nor did the having of condition X contribute to the research. Consider, for example, the following hypothetical posed by Leah Belsky and Henry Richardson:

In the trauma surrounding mass disasters, the need to identify victims accurately and as soon as possible is critical. DNA identification testing is increasingly used to identify human bodies and remains where the deceased cannot be identified by traditional means. This form of testing compares DNA taken from the body of the deceased with DNA taken from their personal items (e.g. hairbrush, toothbrush etc.) or from close biological relatives. DNA identification testing was used to identify the victims of the terrorist attack on the World Trade Center in New York on September 11, 2001, and of the victims of the Tsunami that hit Asia on December 26, 2004. Shortly after the 9/11 attack, police investigators asked the victims' families for personal items belonging to the missing, and for DNA samples from family members themselves. The New York medical examiner's office coordinated the DNA identification testing program; however, some of the identification work was contracted out to private laboratories.

Wolf et al. define an incidental finding (IF) as “... a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of the study...” Wolf et al. also propose that researchers “... should consider what kinds of IFs the protocol may produce and how rapidly the identification and evaluation process needs to proceed to provide timely information to the research participant and avoid harm.”

Recently, the U.S. Presidential Commission for the Study of Bioethical Issues considered the matter of IFs. In the Commission's December 2013 report on this topic, “Anticipate and Communicate–Ethical Management of Incidental and Secondary Findings in the Clinical, Research, and Direct-to-Consumer Contexts,” the panel further defines two categories of IFs, anticipatable and un-anticipatable, as well as introduces the concept of secondary findings. The commission recommends that researchers should develop plans to manage anticipatable IFs, and should consider to actively look for secondary findings.