Genetic testing can be used to determine if unexplained fractures in children could have resulted from a predisposition to bone fractures, e.g., osteogenesis imperfecta. However, uncertainty is introduced if a variant of unknown significance (VUS) is identified. Proper interpretation of VUS in these situations is critical because of its influence on clinical care and in court rulings. This study sought to understand how VUS are interpreted and used by practitioners when there is a differential diagnosis including both osteogenesis imperfecta and non-accidental injury.

A 15-question survey was emailed to physicians who requested analysis of two genes, COL1A1 and COL1A2, from the University of Washington from 2005-2013 for patient cases involving suspicion of child abuse.

Among the 89 participants, responses differed about when genetic testing should be ordered for osteogenesis imperfecta, who should be consulted about utilization of VUS test results, follow-up procedures, and who should receive the VUS results.

There are no clear guidelines for how to interpret and follow up on VUS. In the legal setting, misinterpreted VUS could lead to unintended consequences and deleterious ramifications for family members. The need for better practice guidelines to help promote more equitable handling of these sensitive legal cases is clear.

On November 2, 2004, California voters approved Proposition 69, “The DNA Fingerprint, Unsolved Crime, and Innocence Protection Act” by a margin of approximately 60 to 40 percent. Given the limited amount of information provided to voters during the initiative process, it is unclear how many of the yea-sayers were apprised of the full implications of this measure. Indeed, by voting “yes” on Proposition 69, California has elected to house the most radical and costly state criminal DNA database in the country. This dangerous expansion of California's database poses tremendous threats to civil liberties and social justice while offering little, if anything, by way of increasing the safety of its citizens.

Prior to November 2, California law required the permanent retention of DNA samples from felons convicted of serious, violent crimes.

Over the last century, droughts have caused more deaths internationally than any other weather- or climate-related disaster. Like other natural disasters, droughts cause significant changes in the environment that can lead to negative health outcomes. As droughts are becoming more frequent and intense with climate change, public health systems need to address impacts associated with these events. Partnering with federal and local entities, we evaluated the state of knowledge of drought and health in the United States through a National Drought and Public Health Summit and a series of subsequent regional workshops. The intended outcome was to develop public health strategies for implementing activities to better support and prepare public health systems for future droughts. The information gathered from this work identified multiple policy and law options to address the public health issues associated with drought. These policy recommendations include the use of public health emergency declarations for drought events, increased usage of preparedness evaluations for drought emergencies, and engagement of drought and climate experts in state and local risk assessments. As drought events are projected to increase in frequency and magnitude with climate change, taking policy action now will help decrease the health impacts of drought and save lives.

Military physicians are often perceived to be in a position of ‘dual loyalty’ because they have responsibilities towards their patients but also towards their employer, the military institution. Further, they have to ascribe to and are bound by two distinct codes of ethics (i.e., medical and military), each with its own set of values and duties, that could at first glance be considered to be very different or even incompatible. How, then, can military physicians reconcile these two codes of ethics and their distinct professional/institutional values, and assume their responsibilities towards both their patients and the military institution? To clarify this situation, and to show how such a reconciliation might be possible, we compared the history and content of two national professional codes of ethics: the Defence Ethics of the Canadian Armed Forces and the Code of Ethics of the Canadian Medical Association. Interestingly, even if the medical code is more focused on duties and responsibility while the military code is more focused on core values and is supported by a comprehensive ethical training program, they also have many elements in common. Further, both are based on the same core values of loyalty and integrity, and they are broad in scope but are relatively flexible in application. While there are still important sources of tension between and limits within these two codes of ethics, there are fewer differences than may appear at first glance because the core values and principles of military and medical ethics are not so different.

Nanotechnology is a collection of different technologies and approaches dealing with manipulating matter with dimensions on the nanometer scale. The growth of nanotechnology has been rapid in recent years and encompasses a range of industries including pharmaceuticals, chemicals, robotics, medicine, agriculture, electronics, national defense, fiber optics, and energy. Nanoparticles with shapes, morphologies, and chemical compositions engineered for specific functions and applications are now common. While estimates of the numbers of new types of nanoparticles being produced in academic and industrial labs that combine these different characteristics are uncertain, it is likely that they run into the hundreds.

For decades, health information has been collected and shared for health care delivery and public health purposes. While the “primary use” of patient data for providing direct health care services is the cornerstone of health care practice, health departments rely on data sharing for research and analysis to support disease prevention and health promotion in the population. As the U.S. health system undergoes a digital revolution, health information that was previously captured in paper form now can be captured electronically. Electronic health information (EHI) has transformed the efficiency, capacity, and functions of the U.S. health system. For this reason, there is increased attention to the “secondary use” of electronic patient data for public health uses, including disease reporting and investigation, syndromic surveillance, and patient-specific or population-level communications about health conditions and their associated risk factors. Secondary uses may also encompass clinical research, licensure, and payment for services.

This article argues that current data for the safety and efficacy of fecal microbiota transplants as a treatment for any indication, including recurrent Clostridioides difficile infection, is low-quality. It develops a governance proposal that encourages production of high-quality evidence by incentivizing well-designed RCTs of stool and stoolderived microbial products. The proposal would require that FDA change its current enforcement approach, but it would not require any change in statutes or regulations.

State and international laws have often been instruments of oppression against Indigenous peoples, enabling and casting a veil of legitimacy over state actions that dispossess, assimilate, and discriminate. In the contemporary setting such law has, at times, come to be harnessed to support or protect Indigenous interests, including addressing Indigenous health deficits and associated injustices.

Prostate cancer has become a major health concern of male Americans. It is now the most common nondermatologic cancer and the second leading cause of cancer death among men. The incidence of detected prostate cancer rose rapidly in recent years, partly because of prostate-specific antigen (PSA) testing; it is only now tapering off. Screening for prostate cancer with PSA is widespread in the United States, yet controversial: the American Urological Association recommends PSA screening and the American Cancer Society recommends offering screening; however, the United States Preventive Services Task Force (USPSTF) and the American College of Physicians (ACP) recommend against routine screening; and the American Academy of Family Physicians believes that the decision to screen should be left to the patient.

In the first reported judicial interpretation of modern nursing practice acts, Sermchief v. Gonzales, the Missouri Supreme Court has decided that “new functions for nurses delivering health services” may evolve without statutory constraints.’ The notion that nurses in expanded roles are practicing medicine without a license was cast aside, as the court specifically held that nurses may render diagnosis and treatment in accordance with standing orders and protocols. While directly affecting only nurses in Missouri, the court's recognition of nursing as a profession with its own prerogatives and responsibilities has important implications for the future of nursing.

At issue was Missouri's nursing practice act which had been drafted with the assistance of members of the Missouri Nurses Association and passed by the legislature in 1975.

This article argues in general support of the sIRB rule, but also draws on recent empirical research to highlight several residual weaknesses in the US regulatory structure for research ethics review, and suggests ways in which these weaknesses might be addressed in future regulatory reforms to improve upon the sIRB rule.

Taking notice of race is both risky and inevitable, in medicine no less than in other endeavors. The literature on race as a classifying tool in clinical research poses this core dilemma: On the one hand, race can be a useful stand-in for unstudied genetic and environmental factors that yield differences in disease expression and therapeutic response. On the other hand, racial distinctions have social meanings that are often pejorative or worse, especially when these distinctions are cast as culturally or biologically fixed. Our country's troubled past in this regard and the persistence of race-related disadvantage should keep us on notice about this hazard. Yet paying attention to race in order to ameliorate past wrongs sometimes supports the quest for social justice, as Dorothy Roberts points out in this issue. And at times, as Jay Cohn and Raj Bhopal note, attention to race can make a therapeutic difference, to the point of saving lives.

Not much work has been done on Hindu bioethics other than by a select few scholars and medical doctors. Professor Cromwell Crawford, author of Dilemmas of Life and Death: Hindu Ethics in a North American Context and Hindu Ethics for the Twenty-first Century, for example, is well known in the field of Hindu bioethics. Others scholars include Dr. Uma Mysorekar, who is a gynecologist as well as the president of the board of trustees of the Ganesha Temple of Flushing New York. She has published several short pieces on Hindu bioethics, and has even been interviewed by PBS for their “Religion and Ethics” program. Dr. H. L. Trivedi, director of the Institute of Kidney Diseases and Research Center at the Civil Hospital Campus in Ahmedabad, India, is also prominent. His pithy paragraph in Transplant Proceedings on Hinduism and organ transplantation is cited with enormous frequency on the Internet and elsewhere. These thinkers, however, are unequivocally wrong in their position that Hinduism supports organ transplantation, and, more importantly, that it offers any coherent or systematic bioethics whatsoever.

During the past two decades, several reports have documented substantial support from clinicians, policy-makers, and the general public for the use of advance directives, yet studies continue to find that only a minority of individuals (10 to 25 percent) have completed these legal documents. Advance directives are written instructions, such as living wills or durable powers of attorney for health care, which describe an individual's medical treatment wishes in the event that individual becomes incapacitated in the future. The completion and use of advance directives is one of several components of the broader activity of advance care planning, that is, the overall planning and communication of personal wishes concerning future medical care.

In December 1991, the federal Patient Self-Determination Act (PSDA) became effective. Promoted as a federal initiative to enhance an individual's control over medical treatment decision making and, therefore, patient autonomy and self-determination, PSDA placed several new requirements on health care organizations receiving Medicare or Medicaid payments.

Methodology: Literature Review and medico-legal commentary. Results: Fatal one-punch assaults have been reported extensively in the media. This article provides a commentary on recent policy developments and legislative amendments in Australia regarding so called ‘one-punch’ assaults. Comparisons are made with the situation in other jurisdictions including the UK, US, and Europe. The clinical forensic medical aspect of fist strikes to the head and face is examined in the context of the recent media attention and public interest these cases have attracted. The increased recognition of the risk of harm and death inherent in these types of assaultive behavior is reflected in the policy and legislative changes that have taken place in some jurisdictions. Conclusion: One punch strikes may result in a range of injuries that can include permanent neurological impairment and death. Recent media and community concern regarding these cases and the need for stronger deterrence has resulted in a change in public policy and consequent legislative amendments.

Regulatory policy for genomic testing may be subject to biases that favor reliance on existing regulatory frameworks even when those frameworks carry unintended legal consequences or may be poorly tailored to the challenges genomic testing presents. This article explores three examples drawn from genetic privacy regulation, oversight of clinical uses of genomic information, and regulation of genomic software. Overreliance on expedient regulatory approaches has a potential to undercut complete and durable solutions.

Whether, and to what degree, do patents granted on human genes cast a shadow of uncertainty over genomics and its applications? Will owners of patents on individual genes or clusters of genes sue those performing whole-genome analyses on human samples for patent infringement? These are related questions that have haunted molecular diagnostics companies and services, coloring scientific, clinical, and business decisions. Can the profusion of whole-genome analysis methods proceed without fear of patent infringement liability?

Whole-genome sequencing (WGS) is proceeding apace. Academic centers have been performing whole-genome and -exome sequencing (WES) in research for at least five years, and academic clinical laboratories with national reach have been doing sequencing for clinical applications for almost as long. Companies have also been offering WGS and WES as a clinical service for a few years now. So far as we know, no one has been sued for infringement of “gene patents” for performing WGS.

Although the first human embryonic stem cells (hESCs) were produced in 1998, the direction of U.S. policy on stem cell research was set nearly 20 years earlier when the recommendations of a congressionally established Ethics Advisory Board were ignored by the Reagan administration. Thus began an unprecedented and unparalleled 30-year-long history of political intrusions in an area of scientific and biomedical research that has measurable impacts on the health of Americans. Driving these intrusions were religiously informed public policy positions that have usually escaped critical ethical analysis. Here I record my own encounters with this history of intrusions and the thinking behind them.

My most abrupt encounter with the politics of stem cell research occurred on September 6, 2006, at a hearing of the Senate Subcommittee on Labor, Health and Human Services and Related Agencies, chaired by Senator Arlen Specter. Just a week before, scientists at Advanced Cell Technology (ACT), a small Massachusetts biotech company, had published a paper in the journal Nature in which they described a method for extracting stem cells from early human embryos while leaving the embryos intact and viable. As head of ACT’s Ethics Advisory Board, I had supported this research.

Post-traumatic stress disorder (PTSD) is a “young” disorder formally recognized in the early 1980s, although the symptoms have been noted for centuries particularly in relation to military conflicts. PTSD may develop after a serious traumatic experience that induces feelings of intense fear, helplessness or horror. It is currently characterized by three key classes of symptoms which must cause clinically significant distress or impairment of functioning: (1) persistent and distressing re-experiencing of the trauma; (2) persistent avoidance of stimuli associated with the trauma and numbing of general responsiveness; and (3) persistent symptoms of hyper-arousal. One of the possible symptoms within the second class is difficulty in remembering an important aspect of the traumatic event.

PTSD is not an uncommon condition, with an estimated lifetime prevalence of about 7-9% based on studies conducted in the United States and Canada, with women at higher risk than men. While not everyone who experiences a significant trauma will go on to develop PTSD, about a third will do so. Sexual assault, along with other forms of assaultive violence, pose a comparatively high risk of PTSD.

Many advances in public health and medical technology have contributed to the improved wellbeing and overall longevity of Americans. Such benefits, however, have been offset by a change in the nature and prolongation of the dying process. Daniel Callahan offers a challenge to caregivers in his observation of violent death by technological attenuation, and he sets an agenda to identify a more appropriate approach to the needs of the dying.

Over the past quarter century, hospice has increasingly been used as a resource for care at the end of life. However, according to 1995 estimates by the National Hospice Organization (NHO), hospice care presently accounts for only about 15 percent of the care of terminally ill patients in the United States. We will review issues of access and use of hospice services and examine the various institutional, professional, societal, and cultural barriers to hospice principles of care, and consider various options to promote optimal care at the end of life.