In the March 2010 edition of Mayo Clinic Proceedings, Drs. Rose and Curry declared that resident physicians have an ethical duty to reduce error during periods of fatigue. Problematically, however, they argued this means ingesting a stimulant for performance enhancement and sleep avoidance (hereinafter “PESA”) during a shift when a resident physician is experiencing fatigue as the more ethical choice than forgoing ingesting a stimulant. Rather than accepting enhancement as an unstoppable technological imperative, this article will examine the underlying motivations for enhancement embedded in our culture and the corresponding legal framework relating to stimulant drugs. Although our society seems to be engaged in a pharmacological arms race of efficiency, competition, and self “betterment,” the FDA has not approved stimulant drugs such as modafinil for PESA. As a result, the off-label use of modafinil for PESA means these individuals are part of a large-scale experiment that poses serious immediate and long-term side effects to the individual user as well as society.

Domestic litigation has become a principal strategy for realizing international treaty obligations for the human right to health, providing causes of action for the public’s health and empowering individuals to raise human rights claims for HIV prevention, treatment, and care. In the past 15 years, advocates have laid the groundwork on which a rapidly expanding enforcement paradigm has arisen at the intersection of human rights litigation and HIV/AIDS policy. As this enforcement develops across multiple countries, human rights are translated from principle to practice in the global response to HIV/AIDS, transforming aspirational declarations into justiciable obligations and implementing human rights through national policies and programs.

Institutional Review Boards (IRBs) can play vital roles in observing, monitoring, and responding to research integrity (RI) issues among researchers, yet many questions remain concerning whether, when, and in what ways these boards in fact adopt these roles. Increasingly, RI is being challenged due to many factors, yet the extent of violations, and institutional responses to these, remain unknown. As the amount and complexity of experiments on human participants, often funded by for-profit industry, mushrooms, scandals have occurred, posing dilemmas concerning how to best oversee research to protect these participants from harm.

For over 15 years, many institutions have been developing research compliance programs that monitor misconduct and conflict of interest (COI), and may interact with IRBs. In 2002, the Institute of Medicine (IOM) report, “Responsible Research: A Systems Approach to Protecting Research Participants,” called for increased assessment of the overall human research protections system, and oversight of research.

In 2007, there were 182,479 injury-related deaths in the United States — including homicides, suicides, and unintentional injuries – making injuries the leading cause of death for persons under age 45. Also in 2007, nearly 30 million Americans suffered a non-fatal injury serious enough to warrant hospital treatment. The lifetime cost of fatal and non-fatal injuries occurring in 2000 is estimated to exceed $400 billion.

Efforts to prevent injuries have often focused on changes to the built environment or potentially dangerous products to reduce risks. Building safety into a product or environment — especially in ways that require little or no user action to confer protection — is often more effective than trying to change consumer behavior. For example, improving the crashworthiness of cars through design changes such as air bags, fire-resistant fuel systems, or electronic stability programs, is more effective than simply trying to teach operators to become safer drivers.

How should the definition of “minimal risk” in the federal research regulations be interpreted in regard to pregnant women and fetuses? Surprisingly, there has been little discussion of this question. There is, after all, a substantial amount of published work addressing the question of how “minimal risk” should be interpreted. Similarly, there is a large body of literature on the ethics of research involving pregnant women and fetuses, particularly maternal-fetal surgery. However, in neither of these bodies of work can one find an analysis of minimal risk in regard to fetuses or pregnant women.

The concept of minimal risk is defined in the regulations as follows:

A growing number of cities and counties have emerged as leaders in the fight against obesity in the United States and have enacted innovative policies to address this epidemic. Much of this local strategy focuses on how retail food establishments — namely, chain restaurants, corner stores, supermarkets, farmers markets, and mobile vendors – affect public health. Recognizing the enormous influence a community’s food environment has on the quality and quantity of what people eat, cities and counties have sought to encourage food retail establishments to promote healthier options through regulations and incentives.

The general consensus is that reform of medical malpractice law should be part of the health care system's overhaul. Medical malpractice litigation results in the expenditure of tens of billions annually, largely paid out of health care insurance funds and mostly (roughly two-thirds) paid to defendants' and plaintiffs' lawyers. By all accounts, this tort law regime ill serves the basic deterrence and compensation goals of civil liability. The causes and magnitude of these failings are disputed, and many typical reform proposals sidestep the basic problems and may do more harm than good. In contrast, we advance a straightforward way to improve both deterrence and compensation. Essentially, the proposal is to remove current legal limitations on the scope of insurance subrogation that bar private and public health care insurers from “buying” the whole of their insureds' potential medical malpractice claims in exchange for lower premiums and taxes and expanded insurance coverage. Our proposal’s benefits accrue regardless of the cause and magnitude of the failings of malpractice law or the further reforms that might be adopted.

Health equity can be defined as the absence of disadvantage to individuals and communities in health outcomes, access to health care, and quality of health care regardless of one’s race, gender, nationality, age, ethnicity, religion, and socioeconomic status. Health equity concerns those disparities in public health that can be traced to unequal, systemic economic, and social conditions. Despite significant improvements in the health of the overall population, health inequities in America persist. Racial and ethnic minorities continue to experience higher rates of morbidity and mortality than non-minorities across a range of health issues. For example, African-American children with asthma have a seven times greater mortality rate than Non-Hispanic white children with the illness. While cancer is the second leading cause of death among all populations in the U.S., ethnic minorities are especially burdened with the disease.

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.”

Recently, an agonizing twist intersecting predictive genetic tests and surrogacy contracts made news headlines in Canada. The intended parents, a couple from British Columbia, instructed the surrogate mother with whom they were working to undergo First Trimester Screening and Chorionic Villi Sampling (CVS), which revealed the fetus likely had Down syndrome. The parents directed the surrogate to terminate the fetus or they would abdicate their parental claim upon birth. This story raised numerous legal and ethical questions relating to the transferability of decision making for prenatal screening, diagnostic tests, and the connected decision of termination when additional interested parties – the intended parents – are involved in the medical decision-making relationship. First, although the surrogate is the patient, what are the implications when the intended parents' wishes influence or even dictate the relationship between her and her obstetrician and genetic counselor? Second, if the intended parents' level of authority reaches explicit demands, may the intended parents ethically and legally require the surrogate to waive her right to informed consent for prenatal screening and diagnosis?

The Michigan Department of Community Health (MDCH) stores almost 4 million dried blood spot specimens (DBS) in the Michigan Neonatal Biobank. DBS are collected from newborns under a mandatory public health program to screen for serious conditions. At 24 to 36 hours of age, a few drops of blood are taken from the baby’s heel and placed on a filter paper card. The card is sent to the state public health laboratory for testing. After testing, MDCH retains the spots indefinitely for the personal use of the patient and also, pursuant to a 2000 law, for possible research.

Physicians’ resistance to implementing innovative medical procedures due to a perceived risk of liability can adversely affect the public’s health. This resistance prevents public access to procedures that could better treat communicable or chronic diseases. Innovative procedures, for the purpose of this article, are medical practices that require physicians to modify current clinical approaches to treating or diagnosing a patient’s condition and incorporate: (1) newly developed tests, treatments, drugs or devices (e.g., genetic screening to identify drug sensitivities to reduce adverse drug reactions); or (2) novel methods not commonly used by a majority of physicians (e.g., partner delivered therapy to treat an intimate partner for a communicable disease or advanced prescription of naloxone to patients prone to an opioid overdose). Innovative procedures do not include treatments provided during clinical research or those beyond a physician’s scope of practice.