Institutional Review Boards (IRBs) have substantial power and authority over research with human subjects, and in turn, their decisions have substantial implications for those subjects, investigators, and the public at large. However, there is little transparency about IRB processes and decisions. This article provides the first comprehensive taxonomy of what transparency means (or could mean) for IRBs — answering the questions “to whom, about what, and by what mechanisms?” It also explains why the status quo of nontransparency is problematic, and presents arguments for greater transparency from the perspective of a variety of stakeholders. IRB transparency will make boards more accountable, improve the quality of their decision-making, facilitate consistency in board decisions, permit empirical study of IRBs, promote research efficiency, and advance trust in the research enterprise, among a variety of other benefits. Regulators should promote IRB transparency, IRBs themselves should commit to sharing as much information as they can within the confines of confidentiality requirements, and investigators can endeavor to take matters into their own hands by sharing IRB correspondence and IRB-approved protocols and consent materials.

The human papillomavirus (HPV) is the most common sexually transmitted infection worldwide. In the United States, more than six million people are infected each year. Although most HPV infections are benign, two strains of HPV cause 70 percent of cervical cancer cases. Two other strains of HPV are associated with 90 percent of genital warts cases.

In June 2006, the Food and Drug Administration (FDA) approved the first vaccine against HPV. Sold as Gardasil, the quadrivalent vaccine is intended to prevent four strains of HPV associated with cervical cancer, precancerous genital lesions, and genital warts. Following FDA approval, the national Advisory Committee on Immunization Practices (ACIP) recommended routine vaccination for girls ages 11-12 with three doses of quadrivalent HPV vaccine. Thereafter, state legislatures around the country engaged in an intense effort to pass laws mandating vaccination of young girls against HPV. This activity was spurred in part by an intense lobbying campaign by Merck, the manufacturer of the vaccine.

Malpractice lawsuits serve as a great source of pain, consternation and loss for physicians and patients alike, usually leaving all parties involved in the process with a sense of betrayal. A significant number of physicians will be sued at least once in their career, especially if they practice in some of the more vulnerable specialties. In addition, there is some evidence that the threat of malpractice lawsuits changes the practice style of many physicians, leading to the practice of “defensive medicine” and raises the total cost of health care. Clearly, the prevention of medical malpractice is an issue that deserves considerable attention from physicians and from those who train them.

Empirical evidence suggests that medical negligence may play a relatively minor role in malpractice lawsuits. As demonstrated by Localio, et al., one in thirty-five cases of negligence or incompetence actually results in a lawsuit.

Researchers in the health sciences regularly discover information of potential health importance unrelated to their object of study in the course of their research. However, there appears to be little guidance available on what researchers should do with this information, known in the scientific literature as incidental findings (IFs). The study described here was designed to determine the extent of guidance available to researchers from public sources. This empirical study was part of a larger two-year project funded by the National Human Genome Research Institute (NHGRI) to generate guidance on how incidental findings should be managed in human subjects research, especially genetics, genomics, and imaging research. We generated empirical analysis of publicly available guidance and consent forms to help guide a multidisciplinary Working Group of experts in their formulation of normative recommendations reported in this symposium.

The foreskin is a complex structure that protects and moisturizes the head of the penis, and, being the most densely innervated and sensitive portion of the penis, is essential to providing the complete sexual response. Circumcision—the removal of this structure—is non-therapeutic, painful, irreversible surgery that also risks serious physical injury, psychological sequelae, and death. Men rarely volunteer for it, and increasingly circumcised men are expressing their resentment about it.

Circumcision is usually performed for religious, cultural and personal reasons. Early claims about its medical benefits have been proven false. The American Academy of Pediatrics and the Centers for Disease Prevention and Control have made many scientifically untenable claims promoting circumcision that run counter to the consensus of Western medical organizations.

Circumcision violates the cardinal principles of medical ethics, to respect autonomy (self-determination), to do good, to do no harm, and to be just. Without a clear medical indication, circumcision must be deferred until the child can provide his own fully informed consent.

In 2012, a German court held that circumcision constitutes criminal assault. Under existing United States law and international human rights declarations as well, circumcision already violates boys› absolute rights to equal protection, bodily integrity, autonomy, and freedom to choose their own religion. A physician has a legal duty to protect children from unnecessary interventions. Physicians who obtain parental permission through spurious claims or omissions, or rely on the American Academy of Pediatrics' position, also risk liability for misleading parents about circumcision.

Protecting the public's health has recently regained prominence in political and public discussions. Threats of bioterrorism following September 11, 2001 and the deliberate dissemination of anthrax later that fall, the reemergence of novel or resurgent infectious diseases, (such as the West Nile Virus, SARS, influenza, avian flu) and rapid increases in diseases associated with sedentary lifestyles, poor diets, and smoking (e.g., heart disease, diabetes, cancer) have all raised the profile of public health. The U.S. government has responded with increased funding, reorganization, and new policies for the population's health, safety, and security. Politicians and the public more clearly understand the importance of law in improving the public's health. Recognizing that many public health laws have not been meaningfully reformed in decades, law- and policy-makers and public health practitioners have focused on the legal foundations for public health. Laws provide the mission, functions, and powers of public health agencies, set standards for their (and their partners’) actions, and safeguard individual rights.

Most contributors to the debate about brain death, including Dr. James Bernat, share certain assumptions. They believe that the concept of death is univocal, that death is a biological phenomenon, that it is necessarily irreversible, that it is paradigmatically something that happens to organisms, that we are human organisms, and therefore that our deaths will be deaths of organisms. These claims are supposed to have moral significance. It is, for example, only when a person dies that it is permissible to extract her organs for transplantation.

It is also commonly held that our univocal notion of death is the permanent cessation of integrated functioning in an organism and that the criterion for determining when this has occurred in animals with brains is the death of the brain as a whole – that is, brain death. The reason most commonly given for this is that the brain is the irreplaceable master control of the organism's integration.

This article seeks to document the latest danger in the opioid crisis: fentanyl and related synthetic opioids. Fifty times more potent than pure heroin, cheaper to manufacture in laboratories worldwide, and easily distributed by mail and couriers, fentanyl is flooding the illicit opioid markets throughout the country.

The success of fecal microbiota transplantation (FMT) as a treatment for Clostrioides difficile infection (CDI) has stirred excitement about the potential for microbiota transplantation as a therapy for a wide range of diseases and conditions. In this article, we discuss vaginal microbiota transplantation (VMT) as “the next frontier” in microbiota transplantation and identify the medical, regulatory, and ethical challenges related to this nascent field. We further discuss what we anticipate will be the first context for testing VMT in clinical trials, prevention of the recurrence of a condition referred to as bacterial vaginosis (BV). We also compare clinical aspects of VMT with FMT and comment on how VMT may be similar to or different from FMT in ways that may affect research design and regulatory decisions.

The evidence linking tobacco product advertising to adolescent smoking initiation and resulting long-term addiction, premature death, and disability is well established. Each link in the causal chain has been substantiated: children and adolescents are especially vulnerable to advertising; point-of-sale advertising comprises 92.1% of cigarette advertising and marketing expenditures by manufacturers and 71.3% of smokeless tobacco advertising; tobacco companies have targeted youth through advertising; advertising exposure causes adolescents to start and to continue smoking; among adults who become daily smokers, nearly all first use of cigarettes occurs by 18 years of age; adolescents who smoke are at high risk for long-term addiction because their brains are still developing; and long-term addiction results in the tremendous personal, social and financial costs of tobacco-related illnesses.

Terminally ill elderly and long-term disabled persons under our system of health care are eligible for Medicare and may qualify for the hospice care benefit. Despite such provisions, research shows that individuals still frequently do not receive the health care they need. But, as inadequate as end-of-life care can be for the general population, these inadequacies are exacerbated for individuals incarcerated in U.S. prisons and jails. Although inmates are guaranteed a basic level of health care under the Eighth Amendment and Due Process Clause, they lack the mobility or freedom to choose their health care coverage, and they are dependent on an institutional system for such care. Inside prison, security and access issues affect the care inmates receive. Further, the availability of adequate clinical resources, especially for high-cost procedures, may be problematic in some jurisdictions.

In addition to the practical, institutional, and legal barriers to providing and improving general end-of-life care, efforts to improve end-of-life care for prisoners may also encounter a lack of public sympathy.

Are clinical practice guidelines a means for improving the quality of health care? For saving money in the health care system? For solving the malpractice problem? For making the health care system work better for all? Or, are they a recipe for disaster? This overview sets out conceptual, definitional, and practical aspects of clinical practice guidelines as a broad framework for reflecting on the issue of what guidelines are and why they count. It draws mainly on work done since 1990 at the Institute of Medicine (IOM) and focuses on five questions. First, what are guidelines, and who develops them? Second, what criteria or principles should be used to create good guidelines? Third, what problems or pitfalls exist in developing and disseminating guidelines? Fourth, in what ways can guidelines help improve medical care, and in what ways will they not be as practical or useful, particularly with respect to quality of care? Finally, what ethical context might guide deliberations on this topic?

Although the obesity epidemic appears to have affected all segments of the U.S. population, its impact on children with special health care needs (SHCN) has received little attention. “Children with special health care needs” is a term used in the U.S. to describe children who come to the attention of health care providers and policy makers because they need different services and supports than other children. Government, at both the federal and state levels, has long felt a particular responsibility for safeguarding the health of children with special needs. The definition “children with special health care needs,” in fact, was developed by a work group established by the U.S. Maternal and Child Health Bureau (MCHB) to assist states in their efforts to develop community systems of services for children with complex medical and behavioral conditions.

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health (NIH) doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now are as common in the private practice setting as in academia.

For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards (IRBs) that review the ethics of federally funded research.

In the last few decades, great progress has been made in both genetic and genomic research. The development of the Human Genome Project has increased our knowledge of the genetic basis of diseases and has given a tremendous momentum to the development of new technologies that make widespread genetic testing possible and has increased the availability of previously inaccessible genetic information. Two examples of this exponential evolution are the increasing implementation of next-generation sequencing technologies in the clinical context and the expanding commercial offer of genetic tests directly-to-consumers.

Firstly, the rapid development of next generation sequencing technologies (i.e., high-throughput and massively parallel DNA sequencing technologies) has substantially reduced both the cost and the time required to sequence an entire human genome. These technologies are increasingly being used in the clinical setting with the goal of diagnosing conditions of presumed genetic origin that cannot be explained by targeted sequencing approaches.

Alyne da Silva Pimentel Teixeira died of postpartum hemorrhage (PPH) following the stillbirth of a 27-week-old fetus on November 16, 2002 in Rio de Janeiro, Brazil. Her death led in 2011 to the first decision of an international treaty body holding a government accountable for a preventable maternal death. The decision, Alyne da Silva Pimentel Teixeira (deceased) v. Brazil, was given by the Committee on the Elimination of Discrimination against Women (the Committee), established to monitor compliance by member states with the UN Convention on the Elimination of All Forms of Discrimination against Women (the Convention). The decision upheld a complaint, filed in 2007 against the state and government of Brazil, finding discrimination in the field of health care for Alyne’s avoidable maternal death, in breach of the Women’s Convention.

Five years ago, an article co-written by some of us (Joly and Simard) presented an emerging trend to disclose some individual genetic results to research participants within the international research community. At the time, ethical norms and scholarly publications on the return of results often did not distinguish between the return of research results in general and the return of unexpected results (also called incidental findings). Both technologies and research practices have evolved significantly. Today whole genome and exome sequencing are increasingly affordable and frequently used in genetic research. Because these techniques produce a vast amount of interpretable and non-interpretable data (i.e., data of unproven significance) about an individual, the issue of how to manage information generated by such technologies needs to be considered. However, the development of international ethical guidelines has not kept up with the rapid pace of technological progress. Indeed developments in genomic biobanking also challenge the duty to disclose research results.

Concerns about the influence of financial interests on research have increased, along with research dollars from pharmaceutical and other for-profit companies. Researchers’ financial ties to industry sponsors of research have also increased. Financial interests in biomedical research could influence research design, conduct, or reporting, and could compromise data integrity, participant safety, or both. Investigators’ financial ties with for-profit companies may influence reported scientific results, and may have compromised research participant safety.

Disclosure is one commonly accepted method of managing financial relationships in order to minimize possible threats to scientific objectivity, the safety of research participants, or public trust in the integrity of clinical research. Disclosure is presumed useful to the extent that “it gives those who would be affected, or who are otherwise in a good position to assess the risks, information they need to make their own decision.”

Since at least the mid-1970s, public health and law enforcement officials have conducted joint or parallel investigations of both health problems possibly associated with criminal intent and crimes having particular health dimensions. However, the anthrax and other terrorist attacks of fall 2001 have dramatically underscored the needs that public health and law enforcement officials have for a clear understanding of the goals and methods each discipline uses in investigating such problems, including and especially the potential use of biologic agents as weapons of mass destruction. Recognition of these needs has prompted some experts to call for the application of “forensic epidemiology” to such problems. Even before the attacks of fall 2001, other problems, such as the detection of the West Nile Virus in the United States and concerns that the emergence of this infectious agent was the consequence of a deliberate act, raised novel challenges to the combined interests of public health and criminal investigators.