While society debates whether and how to use public funds to support work on human embryonic stem cells (hESCs), many scientific groups and businesses debate a different question — the extent to which patents that cover such stem cells should be permitted to limit or to tax their research. The Wisconsin Alumni Research Foundation (WARF), a non-profit foundation that manages intellectual property generated by researchers at the University of Wisconsin at Madison, owns three patents that have been at the heart of the latter controversy. The story of WARF’s patents and the controversy they have fostered highlights not only continuing tensions between proprietary and nonproprietary approaches to developing science and technology, but also an at least partly reassuring capacity of public and private sectors to deal with those tensions in a way that can render them substantially manageable, and frequently more manageable as a technology matures.

For nearly twenty-five years, federal regulation of privacy issues in research involving human subjects was the primary province of the federal rule for Protection of Human Subjects (Common Rule). As of April 14, 2003, the compliance date for the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA), however, the Common Rule and the Privacy Rule jointly regulate research privacy. Although, in theory, the Privacy Rule is intended to complement the Common Rule, there are several areas in which the rules diverge. In some instances the inconsistencies result in gaps in privacy protection; in other instances the inconsistencies result in added burdens on researchers without additional privacy protections. In all instances, the lack of harmonization of these rules has created confusion, frustration, and misunderstanding by researchers, research subjects, and institutional review boards (IRBs). In this article, I review the major provisions of the Privacy Rule for research, explain the areas in which the Privacy Rule and Common Rule differ, and conclude that the two rules should be revised to promote consistency and maximize privacy protections while minimizing the burdens on research.

Existing data sources have tremendous potential to inform public health activities. However, a patchwork of data protection laws impede data sharing efforts. Nevertheless, a data-sharing initiative in Peoria, IL was able to overcome challenges to set up a cross-sectoral data system to coordinate mental health, law enforcement, and healthcare services.

The public safety, human services, health, and relief workers who comprise the first wave of a response to natural or man-made disasters play a critical role in emergency preparedness. These first responders provide care and services in the immediate aftermath of emergencies and may remain in affected communities for weeks or months. They often work long hours under stressful conditions, witnessing the human harms, physical destruction, and psychological devastation that can accompany disasters.

Parents, providers, policy makers, and the public need to talk about the implications of advances in genomic technologies for state run newborn metabolic screening programs. Technologies, such as highly multiplex testing and whole genome sequencing, are raising old issues with new urgency and are posing new challenges that threaten to overwhelm newborn screening programs.

Newborn screening programs in their current form were born in the late 1960s. Robert Guthrie developed a screening test for phenylketonuria (PKU) that could be performed on blood spots collected on filter cards that Guthrie also developed. States rapidly established newborn screening programs, which were almost always mandatory, in response to advocacy by geneticists and parents. Although the programs initially varied in form and experienced significant pushback from the medical community, by the early 1970s, all states had established programs with centralized laboratories, and the medical community had come on board.

On November 14, 1996, an in-depth report on the recruiting and testing practices of Lilly Pharmaceuticals appeared in the Wall Street Journal. Laurie Cohen reported that most pharmaceutical companies had difficulty recruiting healthy subjects to participate in testing of “untried and potentially dangerous” drugs. These companies often had to pay subjects up to $250 a day to ensure adequate enrollment, and some even gave referral bonuses to doctors who sent potential subjects their way. Cohen then exposed how Lilly was able to keep costs down: by recruiting homeless alcoholics to serve as research guinea pigs. “In many ways,” Cohen reported, “the practice is mutually beneficial. For Lilly, it is efficient and limits the risk that subjects will sue if harmed by an experiment or divulge particulars of a drug.” And the subjects “get several weeks or months of free room and board, and in interviews they express voluble gratitude for what they often call easy money.”

Genetics offers real opportunities for public health actors. Increased understanding of genetics will illuminate some of the factors that affect disease and, in many cases, will lead to more effective treatments. The recognition that phenylketonuria was caused by a metabolic defect that led to the accumulation of toxic levels of phenylalanine, an elevation that could largely be averted by adopting a low-phenylalanine diet, is an early example. Some cases of what was thought to be Sudden Infant Death Syndrome, a diagnosis used when no etiology is known, now appear to have been caused by metabolic defects in fatty acid oxidation and sodium channel defects. One of the tasks that has already been undertaken by the public health sector is to ensure that genomic information is incorporated into clinical care when the robusmess of findings and their clinical utility have been well defined.

The concept of brain death evolved because advancements in medical science permitted unprecedented artificial maintenance of vital body functions by external means. Although the concept of brain death is accepted clinically, ethically, and legally in the United States, there is no national standard for the determination of brain death. There is evidence that variability and inconsistency in the process of determining brain death exist both in clinical settings and in State statutes. Several studies demonstrate that medical personnel determine brain death in variable ways, and have variable understandings of the definition of brain death. The declaration of death has significant legal consequences such as probate proceedings and liability issues for wrongful death. Inconsistencies in the determination of death may therefore be medically, ethically, and legally problematic.

Can a country with a free press and a robust political debate provide its citizens with actionable information so that they can protect themselves from a threat to their health or safety? By actionable information, I mean accurate facts and reasonable interpretations of those facts upon which an individual should rely in making reason-based decisions. In the context of public health, this includes information that allows an individual to weigh the risk to one’s self, family, and community before deciding to act in an uncertain environment under threatening conditions. The recent H1N1 pandemic, and in particular the government’s campaign for public acceptance of the vaccine, highlights the challenges in ensuring that individuals receive accurate information and perceive that such information should be the basis on which to make potential life-saving decisions.

While the definitions employed by different governmental agencies and scientific societies differ somewhat, the term “nanotechnology” is generally understood to refer to the manufacturing, characterization, and use of man-made devices with dimensions on the order of 1-100 nanometers (1 nanometer [nm] = 1 billionth of a meter). Devices that comprise a fundamental functional element that is nanotechnological are also frequently comprised within nanotechnology, as are manufactured objects with dimensions less than one micrometer. The differences in definition lead to occasional paradoxes, such as the fact that the most widely used nanodrug (albumin nanoparticles of dimensions up to 300 nm, comprising the anticancer drug paclitaxel) is labeled a “nanopharmaceutical” by governments of European countries, Canada, and Australia, but it is not a nanotechnology for the U.S. Food and Drug Administration (FDA). It is also common in scientific domains to restrict the term “nanotechnology” to objects that possess special, “emerging” properties that only arise because of their nanoscale dimension.

Each year, millions of individuals in the United States are treated for a variety of serious medical conditions with prescription drugs whose therapeutic benefits are well known. The vast majority of these medications are used to treat medical and psychiatric illnesses. Generally, they are used as prescribed, and contribute to a better quality of life for persons suffering from debilitating or life-threatening disorders.

The fact that a small portion of these medications is diverted by those who seek their psychoactive effects raises the important policy issue: how to make drugs easily available for medical use while limiting access for purposes of abuse.

Such a responsibility poses challenges very different from those of the so-called “war” on illicit drugs, because this control must be achieved without impeding patients’ access to medical care. A rational public policy would attempt to achieve a balance between the need to minimize abuse and the need to provide relief.

In 1890 a man sold the rights to his body after death to the Royal Caroline Institute in Sweden for research purposes. Later, he tried to return the money and cancel the contract. In the subsequent lawsuit, the court held that he must turn his body over to the Institute and also ordered him to pay damages for diminishing the worth of his body by having two teeth removed.

Today, it would be an anathema for a person's body to be used against his wishes and for a research subject not to be allowed to withdraw from a study. In fact, the Uniform Anatomical Gift Act allows people to change their minds and withdraw a previous agreement to donate organs and tissue after their death and the federal research regulations allow people to withdraw from studies without penalty or loss of benefits.

States are rapidly modifying law and policy to increase access to the opioid antidote naloxone, and the provision of naloxone rescue kits (NRK) for use in the event of overdose is becoming increasingly common. As of late 2014 the majority of states had passed laws increasing naloxone access, and nearly as many have modified emergency responder scope of practice protocols to permit Emergency Medical Technicians (EMTs) and law enforcement officers to administer the medication. While the text of these laws is generally similar, their implementation varies among states.

This article outlines experiences and lessons learned from two diverse states, Massachusetts and North Carolina. In Massachusetts naloxone access initiatives were well underway before formal legislative action occurred, while in North Carolina the passage of a naloxone access law served as a catalyst for the creation of new programs and facilitated the scale-up of existing ones. In both states legislative action was necessary to permit the prescription and dispensing of naloxone to the friends and family members of people who use opioids, a key legal change.

In both academic literature and the media, financial conflicts of interest in human subjects research have come center-stage. The cover of a recent edition of Time magazine features a research subject in a cage with the caption human guinea pigs, signifying perhaps that human research subjects are no more protected from research abuses than are laboratory animals. That magazine issue highlights three well-publicized cases of human subjects research violations that occurred at the University of Oklahoma, the University of Pennsylvania, and Johns Hopkins University.

At St. John Medical Center in Tulsa, Oklahoma, a study that was co-sponsored by the University of Oklahoma Health Sciences Center investigated an experimental vaccine for malignant melanoma. In that case, the chair of the university's institutional review board (IRB) — the committee within each medical institution charged with ethics review of human research projects undertaken at that institution — and the dean of the University's College of Medicine allegedly concealed from both the IRB and the United States Food and Drug Administration (FDA) a report by an outside consulting firm that had found severe deficiencies with the melanoma vaccine study being conducted at the medical center.

In the opening years of the 21st century, it became fashionable to describe the human genome as belonging to the common heritage of humanity. The United Nations, in its Universal Declaration on the Human Genome and Human Rights, now identifies the human genome as part of the common heritage, as does the international Human Genome Organization (HUGO) and the Council of Europe. The common heritage concept has played a prominent role in arguments against patenting the human genome or portions thereof. This essay considers whether the common heritage designation will advance the political and legal goals of its proponents.

A number of recent reports and overviews on the ethical and societal problems of nanotechnology present a public that is polarized about nanotechnology. Very little responsible analysis can be found between those poles for two reasons. First, the debate about the highly controversial notion of molecular manufacturing introduced by Eric Drexler shaped much of the early discussion. Second, the polarization can be seen as a consequence of uncertainty about nanotechnology compounded by cognitive barriers. A reporter to UNESCO acknowledges that “…Assessments of nanotechnology tend to radically diverge…These radically diverging assessments that have thus far dominated the debate on nanotechnology seem to be due to a lack of common ground.” The “lack of common ground” is not unprecedented in the history of technology, and scientists rightfully fear a new “GMO debacle.”

Nanotechnology represents, in part, a technological revolution in the sense that it allows highly innovative applications of various areas of the physical and life sciences. The development of nanotechnology and nanoscience, however, intensifies challenges to the traditional understanding of how to pursue scientific and technological knowledge. Science (in its broad meaning) can no longer be construed simply as the ideal of the quest for truth (i.e., “pure science”). Science, through its technological applications, has become the source of economic power and, by extension, political power. Science, with its political implications, has entered what John Ziman calls the era of “post-academic science.”

In this paper, I argue that nanotechnology is a cardinal exemplar of this politicization, that is, the convergence of science, technology, politics, and economics for social and governmental purposes. At the same time, I assert that this new scientific ethos offers the possibility of a better integration of ethical and philosophical reflections at the core of scientific and technological development.

Despite increased general awareness of suicide in U.S. adult correctional facilities as well as the availability of research and correctional standards that advocate increased attention and services to potentially suicidal inmates, prevention efforts within correctional facilities remain piecemeal and inmate suicide continues to be a serious public health problem. A robotic state of mind excuse, that inmate suicide is not preventable, impedes prevention efforts. In the following discussion, the key ingredients to comprehensive suicide prevention programming are offered to dispel these obstacles.

Suicide is a leading cause of death in jails across the United States, with well over 400 inmates taking their lives each year. In some urban jail facilities, deaths related to acquired immune deficiency syndrome (AIDS) slightly outnumber deaths by suicide. The rate of suicide in county jails is estimated to be approximately nine times greater than that of the general population. Overall, most jail suicide victims are young white males who have been arrested for nonviolent offenses and were intoxicated when arrested.

A main objective of this study is to assess the opinions of 50 behavioral health patients on selective control over their behavioral and physical health information. We explored patients' preferences regarding current consent models, what health information should be shared for care and research and whether these preferences vary based on the sensitivity of health information and/or the type of provider involved. The other objective of this study was to solicit opinions of 8 behavioral health providers on patient-driven granular control of health information and potential impact on care.

Electronic surveys were implemented at an outpatient Behavioral Health facility that provides care for behavioral health patients with non-serious mental illnesses. The Patient Survey included questions regarding patients' demographics and about their concerns and preferences for data sharing for care and research. The Provider Survey included questions about their view on the current consent process and perceptions on barriers and facilitators to implement patient-controlled granular consent models.

This novel study provides valuable preliminary data that can help guide future studies to better understand privacy choices of this underrepresented patient group.