In the post-genome world of biomedical research, an increasingly common research strategy is to focus on large repositories of biological specimens. There are now several well-known efforts to compile vast collections of biological materials, reanalyze extant samples, collect new ones, and link the samples to medical records. The significant issues of law, ethics, and policy raised by these research activities usually are heightened when commercial enterprises play a leading role in accumulating and distributing the samples. Emerging companies are not only compiling repositories for their own use, but some companies are positioning themselves to act as intermediaries, developing vast biobanks for sale to a wide range of other researchers.

Shifting laws and regulations increasingly displace the centrality of women’s needs in the provision of abortion services. Lawmakers and judges contribute to this environment in two ways: by protecting the right of “Crisis Pregnancy Centers” (CPCs) to give false and misleading information about abortion and by supporting legislation mandating that abortion providers give misleading and unnecessary information for the purposes of informed consent. Litigation on informed consent is further complicated through the mobilization of facts — such as the gestational age or sonogram of the fetus — delivered with the intent to dissuade women from accessing abortion. In other words, factual information utilized for ideological purpose.

First Amendment litigation has done little to help prioritize women’s access to appropriate information about abortion that is calibrated to their needs.

The term therapeutic misconception was coined by Paul Appelbaum and his colleagues to describe the tendency of patients enrolled in clinical trials to confuse research participation with the personal clinical attention characteristic of medical care. It has not been recognized that an analogous therapeutic misconception pervades ethical thinking about clinical research with patient-subjects. Investigators and bioethicists often judge the ethics of clinical research based on ethical standards appropriate to the physician-patient relationship in therapeutic medicine. This ethical approach to clinical research constitutes a misconception because it fails to appreciate the ethically significant differences between clinical research and clinical care.

In this article I argue that the assumption that the ethical principles governing the practice of therapeutic medicine should also apply to clinical research with patient- subjects produces incoherence in research ethics and erroneous guidance concerning certain controversial research designs.

Using mobile health (mHealth) research as an extended example, this article provides an overview of when the Common Rule “applies” to a variety of activities, what might be meant when one says that the Common Rule does or does not “apply,” the extent to which these different meanings of “apply” matter, and, when the Common Rule does apply (however that term is defined), how it applies.

Several lines of evidence suggest that children born via Cesarean section (C-section) are at greater risk for adverse health outcomes including allergies, asthma and obesity. Vaginal seeding is a medical procedure in which infants born by C-section are swabbed immediately after birth with vaginal secretions from the mother. This procedure has been proposed as a way to transfer the mother's vaginal microbiome to the child, thereby restoring the natural exposure that occurs during vaginal birth that is interrupted in the case of babies born via C-section. Preliminary evidence indicates partial restoration of microbes. However, there is insufficient evidence to determine the health benefits of the procedure. Several studies, including trial, are currently underway. At the same time, in the clinic setting, doctors are increasingly being asked to by expectant mothers to have their babies seeded. This article reports on the current research on this procedure and the issues it raises for regulators, researchers, physicians, and patients.

Many transgender people need specific medical services to affirm their gender. Gender-affirming health care services may include mental health support, hormone therapy, and reconstructive surgeries. Scant information is available about the utilization or costs of these services among transgender people, which hinders the ability of insurance regulators, health plans, and other health care organizations to plan and budget for the health care needs of this population and to ensure that transgender people can access medically necessary gender-affirming care. This study used almost three decades of commercial insurance claims from a proprietary database containing data on more than 200 million people to identify temporal trends in the provision of gender-affirming hormone therapy and surgeries and to quantify the costs of these services.

Human genomics is a translational field spanning research, clinical care, public health, and direct-to-consumer testing. However, law differs across these domains on issues including liability, consent, promoting quality of analysis and interpretation, and safeguarding privacy. Genomic activities crossing domains can thus encounter confusion and conflicts among these approaches. This paper suggests how to resolve these conflicts while protecting the rights and interests of individuals sequenced. Translational genomics requires this more translational approach to law.

A medical information commons (MIC) is a networked data environment utilized for research and clinical applications. At three deliberations across the U.S., we engaged 75 adults in two-day facilitated discussions on the ethical and social issues inherent to sharing data with an MIC. Deliberants made recommendations regarding opt-in consent, transparent data policies, public representation on MIC governing boards, and strict data security and privacy protection. Community engagement is critical to earning the public's trust.

There is a growing concern in our society about the proper application of life-sustaining medical treatments. This concern has been stimulated by both the explosion in medical technology and the increasing emphasis on patients’ rights and autonomy in clinical decisionmaking. Technological progress enables us to prolong or sustain life, even when its “value” or “quality” is questionable. There is also increased concern, both within and outside the medical community, about the optimal process for making decisions to withhold or withdraw treatment.

Hospital ethics committees have been suggested as a possible solution to this problem. Although few hospitals have actually adopted ethics committees, and little is known about the way that they function or their effectiveness, there have been some recent efforts to study these issues. Despite the increasing recognition of patients’ wishes to know more about and to influence their medical care, there have been no reports about patients’ attitudes toward the role of ethics committees in decisionmaking.

The same concerns that have led society to consider euthanasia as an option for relieving the suffering of the dying led to the development of the hospice movement. How effectively has hospice care met these needs, and is there still a need for euthanasia? Is the hospice approach to death an alternative to euthanasia, compatible with euthanasia, or euthanasia in another form? Do those health care workers who are drawn to providing hospice care favor or oppose euthanasia?

Hospice care developed out of a sense of frustration with the treatment of the dying, and as a reaction against the abuses of an impersonal high-technology approach to patients. There was institutional denial of death which made it impossible to integrate death into the lives of people. Due to neglect, many patients were under-treated with little attention paid to relieving pain or dealing with their or their families’ psychosocial needs.

As the millennium approaches, the United States is on the verge of major health care reform. While swallowing scarce national resources, our health care system produces unenviable results and major inconsistencies. In 1992, $838.5 billion were spent on health care, biting more than 14 percent out of our gross national product. From 35 to 37 million Americans, or approximately 14 percent of the populationn, are uninsured. Our health care system is inherently inconsistent: We have the highest birthweight-specific survival rate of any country in the world, yet we rank 19th worldwide in infant mortality rate, i.e., state-of-the-art medical technology allows us to save a 500-gram infant, yet the mother of that infant may not have had access to basic, minimal prenatal care.

Good decision-making requires reliable information. In medicine, relevant information comes from clinical trials and other forms of scientific research. In business, one source is in corporate annual financial statements. As for-profit, publicly traded companies whose business is discovering, manufacturing, and marketing drugs, pharmaceutical companies sit at the nexus of these two fields. Determining the safety and efficacy of a pharmaceutical product and determining the profitability of a complex enterprise are similarly difficult tasks: each is fraught with deeply ambiguous information that requires sophisticated judgment to interpret reasonably.

What are the Differences between Public Health Practice and Research? This perplexing question constantly arises in the planning and performance of public health activities involving the acquisition and use of identifiable health information. Public health agencies collect and analyze significant identifiable health data from health care providers, insurers, other agencies, or individuals to perform an array of public health activities. These activities include surveillance (e.g., reporting requirements, disease registries, sentinel networks), epidemiological investigations (e.g., to investigate disease outbreaks), and evaluation and monitoring (e.g., public health program development and analysis, oversight functions). Few debate that these essential public health activities, often specifically authorized by law, are classifiable as public health practice.

Other public health activities in which identifiable health data are acquired or used, however, can resemble, include, or constitute human subjects research. “Human subjects research” is legally defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” that involves living human subjects (or their identifiable, private data).

The Consensus Statement of the Third International Congress on Concussion in Sport in November 2008 defined concussion as a “complex pathophysiologic process affecting the brain, induced by traumatic biochemical forces.” Definitions of concussion vary slightly between various professional organizations of neurosurgeons, neurologists, and orthopedic surgeons, but all share the common characteristics of trauma affecting the head or body resulting in transient neurologic deficits or symptoms. Underlying the symptoms of concussion is a complex pathophysiologic process at the cellular level. While concussion is typically thought of as resulting from a direct impact to the head, a concussion can also be sustained as a result of an impact to the body causing the force of the impact to be transmitted to and absorbed by the brain.

Aggressive medical and surgical interventions have not been clearly demonstrated to improve survival in neonates with trisomy 18; there are no data that demonstrates improved quality of life for these children after these interventions; and these interventions are clearly associated with significant morbidity, resource allocation, and cost.

If the evolution of American health policy (in both its purposeful and its accidental forms) is compared to the children’s game of Crack the Whip, then there is no question that the Medicaid program is the tail of the line. When those at the head of the line (e.g., employer-based insurance, Medicare, managed care plans, and pharmaceutical companies) start to move. Medicaid receives whatever shocks and unintended consequences result, and when the line “begins to run wildly in any direction,” it receives them faster and harder than the players at the center.

Shocks also come from other sources. When the economy slumps, an epidemic arises, or a path in another part of the system becomes a cul-de-sac, new twists and turns occur, with Medicaid absorbing much of the change.

Institutional ethics committees remain largely absent from the literature on error reduction and patient safety. This paper attempts to fill the gap. Healthcare professionals are on the front lines in the defense against medical error, but the changes that are needed to reduce medical errors and enhance patient safety are cultural and systemic in nature. As noted in the Hastings Centers recent report, Promoting Patient Safety, the occurrence of medical error involves a complex web of multiple factors. Human misstep is certainly one such factor, but not the only one. In this paper, I build on the Hasting Centers report on patient safety (HCR) in arguing that institutional ethics committees ought to play an integral role in the transformation of a culture of blame to a culture of safety in healthcare delivery.

The genetic testing and screening of children has been fraught with controversy since Robert Guthrie developed the bacterial inhibition assay to test for phenylketonuria and advocated for rapid uptake of universal newborn screening in the early 1960s. Today with fast and affordable mass screening of the whole genome on the horizon, the debate about when and in what scenarios children should undergo genetic testing and screening has gained renewed attention. United States (US) professional guidelines — both the American College of Medical Genetics (ACMG)/American Society of Human Genetics (ASHG) statement (1995) and the American Academy of Pediatrics (AAP) Statement on the genetic testing of children (2001) and the new AAP and ACMG joint policy statement (2013) and technical report (2013) — as well as the old UK guidelines by the Working Part of the Clinical Genetics Society (1994) and the new United Kingdom (UK) guidelines by the British Society of Human Genetics (BSHG) (2010) all give the same answer: genetic testing and screening should only be done if it is in the child’s best interest.

In the past few years, medical practices surrounding the decision to resuscitate marginally viable newborns have received a fair amount of attention. Baroness Warnock, of the UK Nuffield Council on Bioethics, has recently suggested that Britain follow the recommended practice in Holland of setting a gestational age limit below which marginally viable newborns should not be routinely resuscitated, despite reported statistical probabilities of raw survival approaching twenty percent. In the US, a highly publicized case from Texas came to a controversial legal conclusion, permitting physicians to disregard parental preference for palliative care and unilaterally initiate resuscitation when faced with the birth of an extremely premature baby.

In spring 2013 the American College of Medical Genetics and Genomics (ACMG) Working Group on Incidental Findings in Clinical Exome and Genome Sequencing (hereafter “Working Group”) released a report of “Recommendations for Reporting of Incidental Findings in Clinical Exome and Genome Sequencing,” the culmination of a three-year long consensus project. The Working Group recommended that a number of incidental findings, which they define as “the results of a deliberate search for pathogenic or likely pathogenic alterations in genes that are not apparently relevant to a diagnostic indication for which the sequencing test was ordered,” be returned to clinicians (and patients) independent of patient preferences. The Working Group recognized that their recommendations may violate existing ethical norms, but believe this is justified by a fiduciary duty on the part of clinicians and laboratory personnel to prevent harm by warning patients about certain findings, a duty they claim “supersedes concerns about autonomy.”