Investigator and institutional financial conflicts of interest have raised concerns about both the integrity of clinical research and protecting the rights and welfare of research participants. In response, professional groups and governmental bodies have issued guidance for managing conflicts of interest to minimize their potential untoward effects. Although a variety of approaches have been offered, a common protection is to disclose financial interests in research to potential research participants as part of the recruitment and informed consent process. This approach reinforces a basic norm of candor, ideally allowing potential research participants to evaluate whether financial interests should affect their decision to participate in research. Disclosure to potential research participants is viewed as an alternative to having regulators or research institutions limit or prohibit all financial interests in research, assuming that not all such interests are unacceptable.

Digital Health Technologies (DHTs) are currently the subject of much debate both in terms of their technological frontiers as well as their ethical, legal and societal implications (ELSI). Regulation of such technologies as medical devices currently lacks behind their level of adoption. Digital Twins are the next evolution step of such DHTs and provide an opportunity to anticipate and act on ELSI before adoption again leaps before the necessary review. This paper introduces the concept and use cases of digital twins in medicine, then frames the debate through the lens of related technologies, machine learning and personalized medicine, and maps ethical challenges stemming from those. Finally, we lay out how digital twins may change and challenge the future practice of medicine.

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.”

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.

Many commentators have expressed concern that large investments in biomedical research over the past two decades have not been translated effectively into clinical applications. In its Critical Path Report, the Food and Drug Administration (FDA) characterized the problem as a “technological disconnect between discovery and the product development process,” and documented that the number of investigational new drugs (INDs) submitted to the agency had declined “significantly” since 2000. Along a similar vein, another study found that only five of 101 basic science studies showing significant therapeutic promise were successfully translated into clinical applications.

This perceived translational lag is stimulating a shift toward human testing of study interventions earlier in the drug development process. One indication of this trend is a recent guidance encouraging sponsors to pursue human “exploratory” studies before embarking on phase I trials.

Magnetic resonance imaging (MRI) and functional MRI (fMRI) are important tools for neuroscience research because of their capability for investigating both the structure and function of the brain. The fMRI image extends traditional anatomical imaging of the MRI to include maps of human brain function. The ability to observe brain function opens an array of opportunities to research brain organization, neurological status, and neurosurgical risk. Neurological research is, thus, burgeoning. For example, Columbia University currently has several ongoing protocols investigating fMRI’s future role in neurosurgical planning, pain management, and understanding the physiological basis for neurological disorders as well as cognitive and perceptual events. One can imagine research proposals, both important and trivial, on such topics as whether brain imaging can shed light on the nature of dreams, memory, speech development, love, anger, or addiction.

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.

Laws in the 20 jurisdictions studied for this project display many similar approaches to protecting privacy in biobank research. Although few have enacted biobank-specific legislation, many countries address biobanking within other laws. All provide for some oversight mechanisms for biobank research, even though the nature of that oversight varies between jurisdictions. Most have some sort of controlled access system in place for research with biobank specimens. While broad consent models facilitate biobanking, countries without national or federated biobanks have been slow to adopt broad consent. International guidelines have facilitated sharing and generally take a proportional risk approach, but many countries have provisions guiding international sharing and a few even limit international sharing. Although privacy laws may not prohibit international collaborations, the multi-prong approach to privacy unique to each jurisdiction can complicate international sharing. These symposium issues can serve as a resource for explaining the sometimes intricate privacy laws in each studied jurisdiction, outlining the key issues with regards to privacy and biobanking, and serving to describe a framework for the process of harmonization of privacy laws.

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.

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.

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.

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.

Every day, students from marginalized communities disproportionately face adversity and trauma. It is well documented that exposure to adverse childhood experiences (ACEs) can impact children's ability to focus, learn, and even regulate their emotions. Many schools, rather than providing multi-tiered systems of support to address the root causes of behavior, place these students at greater risk of experiencing health disparities through the use of exclusionary school discipline (ESD) practices. ESDs not only deny students important educational opportunities, but also can compound existing social, economic, and health inequities. Thus, ESD practices must be understood as more than simply impacting what happens in the classroom. Instead, they should be conceptualized as public health policies with far-reaching impacts on a child's lifelong health and well-being. Even though school discipline has largely been overlooked by the public health community, current reform efforts are one aspect of a holistic health justice framework.

This article seeks to begin to bridge current gaps in the literature and public discourse by identifying key linkages between ESD practices and health. It then presents evidence-based design principles to ensure education policy is aligned with a health justice framework. And finally, it explores a specific school-based intervention, restorative justice.

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.

Cannabis use in some individuals can meaningfully introduce de novo risk for the initiation of opioid use and development of opioid use disorder. These risks may be particularly high during adolescence when cannabis use may disrupt critical periods of neurodevelopment. Current research studying the combination of genetic and environmental factors involved in substance use disorders is poorly understood. More research is needed, particularly to identify which adolescents are most at risk and to develop effective interventions addressing contributing factors such as trauma and psychiatric comorbidity.

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.

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?

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.