There are compelling medical, ethical, and legal arguments that support mandating use of a central institutional review board (CIRB) for the review of clinical trials performed at multiple institutional sites. Progress against serious diseases depends on this.

Work requirements are the centerpiece of HHS's Trump Administration strategy to undo the ACA expansion for low income working age adults. This article examines the June 29, 2018 trial court opinion in Stewart v. Azar which held that HHS's approval of Kentucky's Section 1115 work demonstration was “arbitrary and capricious.” The purpose of Medicaid is to provide health coverage and HHS may not ignore the loss of coverage that will result from a work requirement.

Firearm injury in the United States is a public health crisis in which physicians are uniquely situated to intervene. However, their ability to mitigate harm is limited by a complex array of laws and regulations that shape their role in firearm injury prevention. This piece uses four clinical scenarios to illustrate how these laws and regulations impact physician practice, including patient counseling, injury reporting, and the use of court orders and involuntary holds. Unintended consequences on clinical practice of laws intended to reduce firearm injury are also discussed. Lessons drawn from these cases suggest that physicians require more nuanced education on this topic, and that policymakers should consult front-line healthcare providers when designing firearm policies.

A key feature of unregulated mHealth research is the diversity of participants in this space. Applying an approach drawn from user experience design, we describe a set of archetypal unregulated mHealth researcher “personas,” which range from individuals who seek empowerment or have philanthropic objectives to those who are primarily motivated by financial gain or have misanthropic objectives. These descriptions are useful for evaluating policies applicable to mHealth to understand how they will impact various stakeholders.

Over the past decades, anti-cancer treatments have evolved rapidly from cytotoxic chemotherapies to targeted therapies including oral targeted medications and injectable immunooncology and cell therapies. New anti-cancer medications come to markets at increasingly high prices, and health insurance coverage is crucial for patient access to these therapies. State laws are intended to facilitate insurance coverage of anti-cancer therapies.

Using Massachusetts as a case study, we identified five current cancer coverage state laws and interviewed experts on their perceptions of the relevance of the laws and how well they meet the current needs of cancer care given rapid changes in therapies. Interviewees emphasized that cancer therapies, as compared to many other therapeutic areas, are unique because insurance legislation targets their coverage. They identified the oral chemotherapy parity law as contributing to increasing treatment costs in commercial insurance. For commercial insurers, coverage mandates combined with the realities of new cancer medications — including high prices and often limited evidence of efficacy at approval — compound a difficult situation. Respondents recommended policy approaches to address this challenging coverage environment, including the implementation of closed formularies, the use of cost-effectiveness studies to guide coverage decisions, and the application of value-based pricing concepts. Given the evolution of cancer therapeutics, it may be time to evaluate the benefits and challenges of cancer coverage mandates.

There is a stark difference between American and British policy on embryo science and research cloning. The following survey of the discourse offered both in support of and in opposition to research cloning and embryo science in the United States and Great Britain will show that the same arguments were made in both countries. The fact that similar ethical argumentation occurred in environments where different policy was set is an indicator that current frames for ethical discourse on embryonic stem cell research and human cloning do not effectively capture the debate in the form that politicians and possible consumers of services to be derived from embryo science face.

The ethics surrounding embryo research and human cloning have been presented from virtually every possible viewpoint in all forms of medium. It is impossible to reprise every argument made on embryo science and research cloning; therefore, this survey will focus on some of the arguments made during the time leading up to the enactment of Great Britain's Human Fertilisation and Embryology Act of 1990 and the Human Fertilisation and Embryology regulations added to it in 2001.

This article reviews existing state laws related to autonomous vehicle (AV) safety, equity, and automobile insurance. Thirty states were identified with relevant legislation. Of these, most states had one or two relevant laws in place. Many of these laws were related to safety and insurance requirements. Data are needed to evaluate the effectiveness of these laws in order to guide further policy development.

This article discusses the relationship between stress, physical health, and well-being in cultural context, offers examples of laws, policies, and programs to promote mental health and well-being, and examines how collective impact supports mental health and well-being.

Drinking water is an important health behavior to support overall child health. Research indicates that children are consuming too little water and too many sugary drinks. Overconsumption of sugary drinks increases child risk for the epidemics of obesity and diet-related chronic diseases like type-II diabetes, stroke, and heart disease. Increasing access to appealing, low-cost drinking water in schools and childcare where children spend much of their time supports efforts to reduce sugary drink consumption. Drinking water infrastructure is key to water access in childcare and schools. In 2012-2013, almost one-third of permanent U.S. school buildings had plumbing systems in fair or poor condition, and almost 40 percent had major renovations or repairs planned.3 Basic plumbing standards for new construction and major renovations or repairs are contained in state and local plumbing codes, and many of these codes are derived from model codes established by private organizations. This article describes the model code process and intervention points where the public health community can work to improve plumbing standards in school buildings and childcare centers.

Quality health care relies upon communication in a patient's preferred language. Language access in health care occurs when individuals are: (1) Welcomed by providers regardless of language ability; and (2) Offered quality language services as part of their care. Federal law generally requires access to health care and quality language services for deaf and Limited English Proficient (LEP) patients in health care settings, but these patients still find it hard to access health care and quality language services.

Meanwhile, several states are implementing Medicaid Accountable Care Organization (ACO) initiatives to reduce health care costs and improve health care quality. Alternative payment methods used in these initiatives can give Accountable Care Organizations more flexibility to design linguistically accessible care, but they can also put ACOs at increased financial risk for the cost of care. If these new payment methods do not account for differences in patient language needs, ACO initiatives could have the unintended consequence of rewarding ACOs who do not reach out to deaf and LEP communities or offer quality language services.

We reviewed public documents related to Medicaid ACO initiatives in six states. Some of these documents address language access. More could be done, however, to pay for language access efforts. This article describes Medicaid ACO initiatives and explores how different payment tools could be leveraged to reward ACOs for increased access to care and quality language services. We find that a combination of payment tools might be helpful to encourage both access and quality.

A significant body of evidence shows that law schools and many elite colleges use large admissions preferences based on race, and other evidence strongly suggests that large preferences can undermine student achievement in law school and undergraduate science majors, thus producing highly counterproductive effects. This article draws on available evidence to examine the use of racial preferences in medical school admissions, and finds strong reasons for concern about the effects and effectiveness of current affirmative action efforts. The author calls for better data and careful investigation of several identified patterns.

The FDA's new table of surrogate endpoints used for drug approvals is an important step forward for overseeing the use of biomarkers in clinical trials. Nevertheless, we present several ways in which the table can be improved.

In 2008, Susan L. Smith published “Mustard Gas and American Race-Based Human Experimentation in World War II.” Research, undertaken by the US Army, attempted to quantify the effect of mustard gas (actually a volitile liquid) and othe chemical agents on people from different racial groups. This was based on the idea that different races would respond differently to the toxins, and in particular that this would be evident through dermal reaction. In other words, different skin color might mean different skin constitution. Some of the testing seemed reasonable, since new chemicals and equipment had been developed since 1919, and the racial issue added another dimension to the research. On closer examination, the testing was primarily based on old chemical agents such as mustard gas, Lewisite and phosgene, and thus the extent of the testing seemed scientifically and medically unnecessary. The chemical agents had been developed, tested, used in battle, the wounded treated and the dead subjected to detailed pathological study. The major combatants in World War I had all committed extensive scientific resources to the study of these agents looking at both offensive and defensive aspects of their use, including toxicity testing. The U.S. Chemical Warfare Service (CWS) had been formed in 1918 to specifically deal with issues such as toxicity tests, so why was the U.S. Army revisiting the subject of chemical weapons testing during World War II?

Knowledge of the law and its impact on health outcomes is increasingly important in public health practice. The CDC's Public Health Law Academy helps satisfy this need by providing online trainings, facilitator toolkits, and legal epidemiology tools to aid practitioners in learning about the law's role in promoting public health.

This interdisciplinary course, which included students from medicine, public health, law, and public policy, explored the concept of “prevention” and the role of law and public policy preventing disease and injury and improving population health. In addition to interdisciplinary course content, students worked in interdisciplinary teams on public health law and policy projects at community organizations and agencies.

Competition cannot stem the rise of health care expenditures because it leaves agency diffuse and transferred in part to the institutions of advanced capitalism, which excel in generating demand for their services. The United States should turn to state rate setting to concentrate purchasing power.