Embryonic stem cell research is morally and politically controversial because the process of deriving the embryonic stem (ES) cells kills embryos. If embryos are, as some would claim, human beings like you and me, then ES cell research is clearly impermissible. If, on the other hand, the blastocysts from which embryonic stem cells are derived are not yet human beings, but rather microscopic balls of undifferentiated cells, as others maintain, then ES cell research is probably morally permissible. Whether the research can be justified depends on such issues as its cost, chance of success, and numbers likely to benefit. But this is an issue for any research project, not just ES cell research. What makes the debate over ES cell research controversial is that it, like the debate over abortion, raises “questions that politicians cannot settle: when does human life begin, and what is the moral status of the human embryo?” This paper looks at several theories of moral status and their implications for embryo research.

In September 2006, a small start-up company in Cambridge, MA called Sermo, Inc., launched a social networking site with an unusual twist: only physicians practicing medicine in the United States would be allowed to participate. Sermo, which means “conversation” in Latin, marketed its website as an online community exclusively for doctors that would allow them to talk openly (and anonymously) about a range of topics, from challenging and unusual medical cases to the relative merits of one treatment versus another. “Sermo enables the private and instant exchange of knowledge among MDs,” the company announced in its first press release. Even better, participation was free and the site carried no advertising.

We design an agent based Monte Carlo model of antibiotics research and development (R&D) to explore the effects of the policy intervention known as Market Entry Reward (MER) on the likelihood that an antibiotic entering pre-clinical development reaches the market. By means of sensitivity analysis we explore the interaction between the MER and four key parameters: projected net revenues, R&D costs, venture capitalists discount rates, and large pharmaceutical organizations' financial thresholds. We show that improving revenues may be more efficient than reducing costs, and thus confirm that this pull-based policy intervention effectively stimulates antibiotics R&D.

For more than 20 years, the Soviet Union has been charged with confining political and religious dissidents in psychiatric hospitals for other than medical reasons. The repressive use of psychiatric hospitalization has been primarily associated with the maximum security “special hospitals,” operated by the Ministry of Internal Affairs, to which dissidents have been committed after being found mentally nonresponsible for political crimes. In 1977, the World Psychiatric Association (WPA) condemned the Soviet Union for such abuses, and six years later the Soviet All-Union Society of Neuropathologists and Psychiatrists resigned from the WPA rather than face almost certain expulsion. Soviet psychiatric officials repeatedly denied these charges of political abuse and refused to permit international bodies or psychiatrists from other countries to see the patients and psychiatric hospitals in question.

In the spring of 1989, however, the Soviet government allowed an official delegation of psychiatrists and forensic experts from the United States to interview patients, selected by the delegation, in whose cases hospitalization was believed to have been politically motivated.

On August 2, 1988, 6-month-old Samuel Linares aspirated a balloon at a birthday party and was unconscious and blue when his father, Rudolfo, found him. Nine months later, his father used a gun to keep medical staff at bay while he disconnected the respirator keeping his comatose son alive. Mr. Linares ignited much soul-searching among pediatricians, lawyers, and ethicists about treatment decisions for profoundly damaged children.

Public discussion of the ethics of forgoing life support in pediatric care moves like a pendulum betweeen fear of inappropriately allowing children to die and fear of unrestrained life-supporting technology. In the early 1970s, physicians’ and theologians challenged accepted tenets of law and ethics by proposing that pediatricians should allow critically ill or severely disabled babies to die without the most aggressive use of technology. By 1982, Baby Doe caught the nation's moral imagination and raised the possibility that withholding or withdrawing life-sustaining procedures amounted to sanctioned infanticide. This concern led to restrictions on the right of parents and doctors to decide to discontinue treatment. Public sympathy for Mr. Linares suggests that the pendulum may be swinging back toward a less restrictive public policy about forgoing life-sustaining treatment in children.

In the 20th century, public health was responsible for most of the 30-year increase in average life expectancy in the United States.1 Most of the significant advances in public health (e.g., vaccinations, water fluoridation) required the combined effort of scientists and attorneys. Scientists identified public health threats and the means of controlling them, but attorneys and policymakers helped convert those scientific discoveries into laws that could change the behavior of industries or individuals at a population level. In tobacco control, public health scientists made the groundbreaking discovery that smoking caused lung cancer, but attorneys and policymakers developed and implemented the policies and litigation strategies that helped reduce smoking rates by more than half over the past 50 years.

Americans who are afraid of living for many years with Alzheimer's might seek a way to end their lives early, when their dementia has just entered the moderate phase. There is no legal process for doing so. In this paper I argue that advance directives, in particular, are not a legal solution for those who prefer to die rather than suffer years of dementia. The problem is that an advance directive only works to hasten death when there is a life-threatening illness for which one can refuse treatment; more often than not, Alzheimer's kills the self long before it kills the body.

According to Congressional Budget Office projections, the Patient Protection and Affordable Care Act (Affordable Care Act or Act) — assuming it survives the pending legal challenges and is fully implemented — will provide health insurance to 34 million additional Americans by 2021. This will increase the percentage of non-elderly Americans with health insurance from the current rate of 83 percent to 95 percent. Although enactment of the Affordable Care Act constitutes a historic step forward in the nearly century-long effort to ensure universal health insurance coverage, relatively little in the Act focused on the potentially transformative impact of public health efforts that prevent disease. Chronic diseases such as heart disease, cancer, stroke, and diabetes are now responsible for more than 75 percent of health care costs, and reducing the incidence of these diseases — which are often entirely preventable — could dramatically improve the nation’s physical and fiscal health.

Is it futile to sustain biologic life when the patient will permanently require intensive medical care? Dr. Koch and Dr. Miles agree that such treatment would be futile; however, their concept of futility rests on no explicit standards and reflects no communal judgment. The authors view the lack of widely accepted medical standards as an impediment to answering this question definitively. Dr. Koch laments that patients and their families have seized too much power and have begun deciding that mere biologic life is worth sustaining. And Dr. Miles sees benefit to perceiving a decision not to sustain such life as “primarily biomedical” and “realistic.”

Here is where we disagree with these authors. We do not see the problem as a lack of standards that are medical. The question of prolonging a patient's life when the patient has no likelihood of regaining consciousness confronts moral, political, and economic issues.

The major challenge facing the American health care system today is to devise a strategy for achieving three primary objectives simultaneously: (1) high quality, or excellence in standards of care, (2) balance, or equitable access to that quality care, and (3) some reasonable semblance of cost control in providing that quality care to everyone. Following World War II, the weight of government was thrown solidly behind the access and quality portions of the equation, first with the enactment of the Hill-Burton capital financing program and its accompanying community service obligations, and accelerating in the midsixties through creation of Medicare, Medicaid, and other financing and delivery programs entitling categories of individuals to health care benefits.

Is it futile to sustain biologic life when the patient will permanently require intensive medical care? Dr. Koch and Dr. Miles agree that such treatment would be futile; however, their concept of futility rests on no explicit standards and reflects no communal judgment. The authors view the lack of widely accepted medical standards as an impediment to answering this question definitively. Dr. Koch laments that patients and their families have seized too much power and have begun deciding that mere biologic life is worth sustaining. And Dr. Miles sees benefit to perceiving a decision not to sustain such life as “primarily biomedical” and “realistic.”

Here is where we disagree with these authors. We do not see the problem as a lack of standards that are medical. The question of prolonging a patient's life when the patient has no likelihood of regaining consciousness confronts moral, political, and economic issues.

In 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research considered many aspects of fetal research. The Commission received some detailed ethical, legal, and scientific analyses, invited public testimony, and recommended guidelines for biomedical research involving the human fetus. One of the authors of the present article (KJR) chaired the Commission. Many of its recommendations became federal regulations on fetal research issued in 1975.

These regulations explicitly govern only research “conducted by the Department of Health and Human Services (DHHS) or funded in whole or in part by a Department grant, contract, cooperative agreement or fellowship.” However, as Baron pointed out in his legal review, they effectively cover all federally funded institutions, regardless of the source of the funds the institution may be using for fetal research.

Adult protective service systems in many of our states have been subjected to a good deal of public criticism. Much of this denunciation, particularly that emanating from civil libertarians who advocate on behalf of the legal and ethical rights of older citizens, centers on the legal aspects of protective services, and especially on the legal authority of the state to intervene unilaterally in the private life of an unwilling, protesting older individual.

Except in the most compelling of circumstances, society should avoid the coercive elements of protective services. Often overlooked, however, by commentators, policy-makers, and caregivers alike, is that protective services may be, and in the vast majority of instances are, accepted voluntarily (and gratefully) by the older recipient. A mentally competent individual may voluntarily give informed consent in the medical sphere, as well as in others, to the receipt of services that he or she currently needs. Additionally, legal mechanisms frequently enable a competent independent adult to foresee and prepare for the possibility that he or she might become incompetent and dependent, by providing for a substitute decisionmaking process of the individual's own choosing.

Over the past decade we have witnessed a remarkable change in the courts, and presumably in societys, attitude toward the care of the terminally ill patient. In a series of court decisions, judges have consistently ruled that the terminally ill patient's autonomy must be respected, even if that means limiting the patient's care when that is the patient's wish. Moreover, courts have allowed the incompetent patient's family and doctors, when they agree, to make substituted decisions to limit care, that is, decisions which attempt to replicate the choices that the patient would have made about his own treatment were he able to do so. Courts have not, however, offered guidance on those situations in which the incompetent patient's family and physicians disagree with respect to their recommendations concerning the course of therapy the patient would choose. Most importantly, courts have failed to establish clear limits on professional authority in situations where disagreements occur.

In a recent issue of the Hastings Center Report, Paul and Marilyn Bridge discuss the difficulties and frustrations they encountered with the physicians and hospital concerning a proposal to withhold treatment from their severely defective newborn son, Christopher. Born some three months prematurely, he had signs of viral encephalitis. His long-term outlook was quite dim: he had severe mental retardation, and would possibly suffer from uncontrollable convulsions, deafness, blindness, and quadraplegia. Brain damage was extensive, and was thought to extend to the cortex. While Christopher was not terminally ill nor in any immediate danger of dying, the pediatrician suggested that there would be situations in the future which perhaps ought not be treated, such as infection or the aspiration of food. The family rejected that option, and insisted on treatment until Christopher, on his 75th day of life, suffered cardiac arrest. After three days of ventilator support, the parents agreed to discontinue the heroic means supporting their son whom they now believed to be terminally ill and approaching brain death.

Both the European Union and the Council of Europe have a bearing on privacy in genomic databases and biobanking. In terms of legislation, the processing of personal data as it relates to the right to privacy is currently largely regulated in Europe by Directive 95/46/EC, which requires that processing be “fair and lawful” and follow a set of principles, meaning that the data be processed only for stated purposes, be sufficient for the purposes of the processing, be kept only for so long as is necessary to achieve those purposes, and be kept securely and only in an identifiable state for such time as is necessary for the processing. The European privacy regime does not require the de-identification (anonymization) of personal data used in genomic databases or biobanks, and alongside this practice informed consent as well as governance and oversight mechanisms provide for the protection of genomic data.

On January 25, 2013, the Federal Register published the Department of Health and Human Services (HHS) omnibus amendments to the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security, Enforcement, and Breach Notification Rules. These modifications also include the final versions of the HIPAA regulation amendments mandated by the Health Information Technology for Economic and Clinical Health Act (HITECH Act) and the Genetic Information Nondiscrimination Act (GINA). Although the amended rules were effective on March 26, 2013, covered entities and their business associates (which now have direct liability for violations of the regulations) have a compliance date of September 23, 2013.

It has been 10 years since the April 14, 2003 compliance date for the original HIPAA Privacy Rule. Despite HHS’ clarification of some issues by posting answers to frequently asked questions (FAQs), there have been no significant amendments to the Privacy Rule since 2003.

Over two hundred years ago, Thomas Jefferson suggested the need for a broader legal curriculum. As the twenty-first century begins, the practice of law will increasingly demand interdisciplinary knowledge and collaboration — between those trained in law and a broad range of scientific and technical fields, including engineering, biology, genetics, ethics, and the social sciences. The practice of public health law provides a model for both the substantive integration of law with science, and for the way its practitioners work. In addition, public health law also provides a model for interdisciphuy and integrative teaching.

Sickle cell disease (SCD) is an autosomal recessive hemoglobinopathy found mainly in populations of African and Mediterranean descent, including approximately 100,000 Americans. It is also very common in Spanish-speaking regions of Central America, South America, and parts of the Caribbean, in Saudi Arabia, and in India and Sri Lanka. The disorder is characterized most commonly by lifelong recurrent unpredictable vaso-occlusive pain that may be disabling, and by chronic tissue damage and organ dysfunction. There are several genotypes of the disease. Although SCD pain frequency generally varies between genotypes, it also varies between subjects even within genotype. It may worsen from childhood to adulthood. It may vary by gender. Its location, timing, and severity may be unpredictable.

Until recently, pain in SCD had been characterized as episodes that were acute, periodic, and relatively rare. Crises were viewed as usually associated with hospitalization. Many patients utilized hospital or emergency care for pain once per year or less, so painful episodes in SCD were called vaso-occlusive “crises.”

This article provides practical guidance for researchers who wish to enroll and collect data from pediatric research participants through online and mobile platforms, with a focus on the involvement of both children and their parents in the decision to participate.