The routine use of chemical and physical restraints in nursing homes is bad care. Medical and nursing literature on the care of nursing home patients consistently criticizes the use of restraints when that use is unrelated to diagnosis and treatment considerations. Federal and state laws have included restrictions on the use of restraints for some time. The criticisms of inappropriate and indiscriminate use of chemical and physical restraints are not new. What, then, supports their continued misuse despite the ordinarily powerful combination of professional and governmental approbation?

The use of restraints responds to generally quite acceptable and desirable patient-oriented goals. Restraints are used in an attempt to protect the patient with physical or mental disabilities from avoidable injury caused by falling or wandering away from the facility. In the social context of nursing homes, restraints are also used to protect residents from injury by threatening, violent patients. When the rationale is measured against the known effects of restraints, however, the self-evident nature of the justification begins to break down.

There are deep divides over the use of racial and ethnic categories in biomedical research and its application in both medical and non-medical contexts. On one side of a roughly described dividing line are practitioners who need to use every piece of information at their disposal to solve pressing, realworld problems in real time, such as making clinical diagnoses or identifying perpetrators of crime. On the other side are scientists and policy makers committed to meeting a scientific and social need for accuracy and thus trying to avoid miscategorization.

As Jay Cohn describes in this issue, medical practitioners in particular have used racial and ethnic categories to “enhance diagnostic and therapeutic precision.” He argues for retaining this practice. The plea, motivated by genuine concern for patients, is to avoid “throwing the baby out with the bathwater.” However, Cohn and others mischaracterize the nature of the debate. The argument is not about whether differences among populations exist, or even whether differences among “races” exist.

The profession of medicine is predicated upon an ethical mandate: first do no harm. However, critics charge that the medical profession’s culture and its public health mission are being undermined by the pharmaceutical industry’s wide-ranging influence. In this article, we analyze how drug firms influence psychiatric taxonomy and treatment guidelines such that these resources may serve commercial rather than public health interests. Moving beyond a conflict-ofinterest model, we use the conceptual and normative framework of institutional corruption to examine how organized psychiatry’s dependence on drug firms has distorted science. We suggest that academic-industry relationships have led to the corruption of the evidence base upon which accurate diagnosis and sound treatment depend. We describe the current dependency corruption and argue that transparency alone is not a solution — and sometimes even produces iatrogenic effects. Furthermore, we argue that the corruption of the evidence base for diagnostic and practice guidelines renders obsolete the traditional informed consent process, and we offer suggestions for reforming this process.

The routine use of chemical and physical restraints in nursing homes is bad care. Medical and nursing literature on the care of nursing home patients consistently criticizes the use of restraints when that use is unrelated to diagnosis and treatment considerations. Federal and state laws have included restrictions on the use of restraints for some time. The criticisms of inappropriate and indiscriminate use of chemical and physical restraints are not new. What, then, supports their continued misuse despite the ordinarily powerful combination of professional and governmental approbation?

The use of restraints responds to generally quite acceptable and desirable patient-oriented goals. Restraints are used in an attempt to protect the patient with physical or mental disabilities from avoidable injury caused by falling or wandering away from the facility. In the social context of nursing homes, restraints are also used to protect residents from injury by threatening, violent patients. When the rationale is measured against the known effects of restraints, however, the self-evident nature of the justification begins to break down.

Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. The cases described were disturbing. They involved physicians engaged in excessive “enrollment activities” in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the safety of subjects and the validity of research results, referring their patients to research investigating treatments for conditions from which they did not suffer. One of the articles reports that physicians focusing exclusively on commercial research regularly divulge annual incomes upwards of $1,000,000 with profits in excess of $300,000. Two physicians accumulated well over $10,000,000 through clinical trials activities in less than a decade.

Approximately two billion people lack access to medicines globally. People living with HIV, cancer patients, those suffering from tuberculosis or malaria, and other populations in desperate need of life-saving medicines are increasingly unable to access existing preventative, curative, and life-prolonging treatments. In many cases, treatment may be unavailable or inaccessible for even some of the most common and readily treatable health concerns, such as hypertension. In the developing world, many of the factors that contribute to making the world’s most vulnerable and marginalized populations particularly susceptible to illness also operate to restrict their access to medicines. As a result of dramatic economic inequities and widespread poverty, it is not profitable for most originator pharmaceutical companies to develop new medicines for sale in developing markets or to lower the cost of existing drugs so that they are affordable for the majority of these populations.

More than a decade ago, Solomon Benatar and Peter Singer argued that “a new, proactive research ethics…must ultimately be concerned with reducing inequities in global health and achieving justice in health research and health care.” Towards this objective, a limited amount of recent scholarship has started to consider whether a theoretical basis exists for the position that international research should help promote global health equity and, if so, what the implications are for its conduct. Theories of justice from political philosophy establish obligations for parties in high-income countries to improve the health of parties in low- and middle-income countries (LMICs). These theories have been shown to provide grounds for the claim that international research should be conducted to advance justice in global health. What this means for research actors from high-income countries is the focus of a recently proposed ethical framework: “research for health justice.”

The United Nations Convention on the Rights of Persons with Disabilities (the CRPD or the Convention), adopted on December 13, 2006, and entered into force on May 3, 2008, constitutes a key landmark in the emerging field of global health law and a critical milestone in the development of international law on the rights of persons with disabilities. At the time of its adoption, the U.N. High Commissioner for Human Rights heralded the CRPD as a rejection of the understanding of persons with disabilities “as objects of charity, medical treatment and social protection” and an embrace of disabled people as “subjects of rights.”

The text of the Convention itself, and the highly participatory process by which it was negotiated, signal a definitive break from previous international approaches that focused on disability within a medical model framework. In contrast to traditional approaches, the CRPD embraces a social model of disability, concentrating the disability experience not in individual deficiency, but in the socially constructed environment and the barriers that impede the participation of persons with disabilities in society.

Stem cell tourism is a form of medical tourism in which patients travel to receive unproven or untested stem cell-based interventions for many different diseases and conditions. A few studies indicate that patients and the public have several reasons for seeking these treatments for themselves or for their loved ones. Among these are the feeling of not having any other clinical options left, distrust of or frustration with their home country’s health care system, and a perception that their home country has a burdensome or sluggish regulatory system for the approval of novel stem cell therapies. These last two viewpoints may contribute to a certain sense of distrust of regulatory agencies governing the conduct of clinical research, and perhaps the perception of a health care system that seems unresponsive to the needs of patients suffering from severe conditions.

The past dozen years have witnessed an astounding rise in costs relating to the prevention and management of medical malpractice claims. Not surprisingly, a crisis of trust has also been building over the same period. Public interest in alternatives to traditional health care has increased as has the plethora of defensive medical procedures in hospitals. In addition, the past decade has seen the rise of such hospital professions as risk management, patient representation, quality assurance, and utilization review. The current high interest in “patient services” and “patient relations” is just that-current: a reflection of low priority until gathering crises made such interests relevant.

The cost crisis has led to both reactive and preventive behaviors on the part of hospital personnel. Reactive behaviors are those designed to respond to errors and claims after they occur. Examples are incident investigation, adjustment decisions, and insurance reserve manipulation. Preventive behaviors are designed to head off incidents before they occur, by identifying and reducing sources of clinical error, legal liability, and patient aggravation.

Emerging fields of science often create new challenges for ethics and law. In assessing the broader societal implications of scientific discoveries, a reasonable analytical starting point is determining how the discoveries compare with existing science. If the new field is substantially similar to an established one, then the ethical and legal analyses are likely to be comparable. On the other hand, if the new scientific developments are extraordinary in kind or degree, then a new analytical framework and new approaches to ethics and law may be necessary.

The increased competition for a share of the market of insured patients, which arose in the wake of failed comprehensive health care reform, has provoked questions about what, if any, standards will govern new “competitive” health care organizations. Managed care arrangements, which typically shift to providers and patients some or all of the financial risk for patient care, are of special concern because they can create incentives to withhold beneficial care from patients. Of course, fee-for-service (FFS) medical practice creates incentives to provide unnecessary services, and managed care can avoid that type of harm. Still, as Edmund Pellegrino has noted, “managed care, by its nature, places the good of the patient into conflict with … (1) the good of all the other patients served by the plan; (2) the good of the plan and the organization, themselves…; and (3) the self-interest of the physician.

Clinical gene transfer research (GTR) has both a unique history and a complex and layered system of research oversight, featuring a unique review body, the Recombinant DNA Advisory Committee (RAC). This paper briefly describes the process of decision-making about clinical GTR, considers whether the questions, problems, and issues raised in clinical GTR are unique, and concludes by examining whether the RAC's oversight is a useful model that should be reproduced for other similar areas of clinical research.

Clinical GTR is governed by the same oversight system as most clinical trials, with a significant addition: the RAC. Like other research with human subjects, GTR, if it is affiliated with a federally funded institution, must be approved by an institutional review board (IRB) whose activities are governed by the common rule, that is, the federal regulations for protection of human subjects in research. Like other research intended to produce a drug, device, or biologic to be marketed in the United States, GTR is also overseen by the Food and Drug Administration (FDA).

As our world becomes increasingly interconnected, threats to global public health continue to proliferate. New and novel risks to health have emerged consistently over the past 30 years. Moreover, our shrinking world now allows health threats to spread more quickly than ever before. Given these realities, efforts to protect and improve global health must be expansive, flexible, and able to take into account the variety of circumstances that may imperil good health. These efforts also must consider the multiple levels and varying contexts in which laws, policies, and other factors govern global health and affect health outcomes.

Whole genome and exome sequencing (WGS/WES) techniques raise hope for a new scale of diagnosis, prevention, and prediction of genetic conditions, and improved care for children. For these hopes to materialize, extensive genomic research with children will be needed. However, the use of WGS/WES in pediatric research settings raises considerable challenges for families, researchers, and policy development. In particular, the possibility that these techniques will generate genetic findings unrelated to the primary goal of sequencing has stirred intense debate about whether, which, how, and when these secondary or incidental findings (SFs) should be returned to parents and minors. The debate is even more pronounced when the subjects are adolescents, for whom decisions about return of SFs may have particular implications. In this paper, we consider the rise of “genomic citizenship” and the main challenges that arise for these stakeholders: adolescents' involvement in decisions relating to return of genomic SFs, the types of SFs that should be offered, privacy protections, and communication between researchers and adolescents about SFs. We argue that adolescents' involvement in genomic SF-related decisions acknowledges their status as valuable stakeholders without detracting from broader familial interests, and promotes more informed genomic citizens.

In an era of unrivalled sequencing, computation and networking capability, international sharing of genomic samples and data is becoming a modus operandi for modern medical research. Researchers are collaborating to establish large collections with global scale. Having never before set foot outside the cell, the molecules that shape us are being digitized and launched across the globe. Protecting individual privacy interests in this information is a central challenge of the genomic research era.

This article reviews international privacy norms governing human genomic biobanks and databases. It will not directly consider biobanks established for other health-related purposes, such as screening or therapy. A genomic biobank is “a hybrid infrastructure,” an organized collection of human biological material combined with associated health information: physical measurements, outcome data in medical records, and epidemiological information, as well as genomic data derived from the samples.

Over the past two decades, we have seen an increase in the use of medical-legal partnerships (MLPs) in health-care and/or legal settings to address health disparities affecting vulnerable populations. MLPs increase medical teams' capacity to address social and environmental threats to patients' health, such as unsafe housing conditions, through partnership with legal professionals. Following the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines, we systematically reviewed observational studies published from January 1993-January 2016 to investigate the capacity of MLPs to address legal and health disparities. We identified 13 articles for qualitative analysis from an initial pool of 355 records. The resulting pool of 13 articles revealed more information regarding the capacity of MLPs to address legal outcomes than their capacity to address health outcomes; only 4 studies directly addressed the impact of MLP intervention on patient wellbeing and/or patient utilization of healthcare services. We call for further evaluation/longitudinal studies that specifically address MLPs' short and long term effects upon patient health disparities. Finally, given the demonstrated capacity of MLPs to address unmet legal needs, and their evident potential in regards to improving health outcomes, we present the MLP model as a framework to address HIV-related legal and health disparities.

Answering important public health questions often requires collection of sensitive information about individuals. For example, our understanding of how HIV is transmitted and how to prevent it only came about with people's willingness to share information about their sexual and drug-using behaviors. Given the scientific need for sensitive, personal information, researchers have a corresponding ethical and legal obligation to maintain the confidentiality of data they collect and typically promise in consent forms to restrict access to it and not to publish identifying data.

The interests of others, however, can threaten researchers' promises of confidentiality when legal demands are made to access research data (e.g., through subpoena). In some cases, the subject of the litigation is tightly connected to the research questions, and litigants' interest in the data is not surprising. Researchers conducting studies on tobacco or occupational or other chemical exposures, for example, are relatively frequent targets of subpoenas.