In this paper, we assume that organ donation policy in the United States will continue to be based on an opt-in model, requiring express consent to donate, and that families will continue to have the prerogative to make donation decisions whenever the deceased person has not recorded his or her own preferences in advance. The limited question addressed here is what should be done when a potential donor dies unexpectedly, without any recorded expression of his or her wishes at hand, while a family decision is being sought.

As concerns about the negative health effects of unhealthy eating and overweight/obesity increase, so too do efforts to combat obesity. Both the federal government, as well as state and local governments, have proposed and implemented a variety of healthy eating and obesity prevention policies. Many of these policies are controversial, facing objections that range from the practical (e.g., the policy will not succeed at improving people's diets) to the ethical (e.g., the policy is paternalistic or inequitable). In this paper, we consider one such policy — restrictions on food assistance programs that are meant to improve participants’ diet — and one criticism of these policies, that they are inequitable. We take as our primary example the recent, unsuccessful effort by New York State to exclude sweetened beverages from the items eligible for purchase in New York City with Supplemental Nutrition Assistance Program (SNAP, also known as food stamps).

BPA Production and Associated Health Risks Bisphenol A (BPA) is a chemical agent found in many everyday products, including canned goods and plastic food containers. BPA exposure is linked to a variety of adverse health effects, such as obesity and diabetes. To protect the public's health — especially the health of vulnerable fetuses, infants, children, and pregnant women — BPA regulations should encompass products intended specifically for these populations. Even with tremendous public outcry against the use of BPA, current federal restrictions do not reach far enough. The U.S. Food and Drug Administration (FDA) recently banned the use of BPA in children's sippy cups and baby bottles, but failed to address its inclusion in canned infant formula or plastic tableware.

BPA production began in the 1950s to make epoxy resins and was later employed to create polycarbonate plastic products.

For a symposium in honor of Jay Katz, my teacher, advisor, friend, and ever-present source of help, it is an honor to be asked to write about disclosure and consent in pediatrics. From the time he began to think, write and teach about family law, Jay has advocated taking children and adolescents seriously. In our society such concern for their legal rights is unfortunately rare; the situation would be much worse were it not for Jay's writings and for his former students who have gone on to work for and with children. When he began to work in the areas of human subjects research and then informed consent, his concern for the rights of young people permeated this work as well.

Public health emergencies invariably entail difficult decisions among medical and emergency first responders about how to allocate essential, scarce resources (e.g., medicines, supplies, personnel). To the extent that these critical choices can profoundly impact community and individual health outcomes, achieving consistency in how these decisions are executed is valuable. Since the terrorist attacks on September 11, 2001, however, public and private sector allocation plans and decisions have followed uncertain paths. Lacking empirical evidence and national input, various entities and actors have proffered multifarious approaches on how best to allocate scarce resources to protect the public's health. Though beneficial in some jurisdictions, these approaches fail to clarify how the type and amount of care delivered in major emergencies might be curtailed. This is due, in part, to a lack of meaningful guidance on shifting standards of care in major emergencies.

To achieve lower medical spending with as little reduction as possible in good outcomes, practitioners and policy makers alike have been experimenting with the use of practice guidelines. These guidelines both recommend certain types of therapies and proscribe others in the treatment of patients with particular conditions. This paper explores the question of whether guidelines which do reduce total resource costs of medical care to a population will (1) be feasible and (2) produce “acceptable” results. The definition of acceptable is part of the policy problem, so it will be left open for a while, but the question of which outcomes match with which levels of resource cost will form the positive basis for the normative judgment of “acceptability.”

America is aging. But even more striking than the rise in the proportion of the population over age 65 is the unprecedented number of individuals who are living into their eighties and nineties. While many people remain robust well into advanced age, the dramatic increase in the number of the oldest old has brought with it an epidemic of Alzheimer’s disease and other dementias. Dementia is a highly prevalent condition — currently 5.4 million Americans have Alzheimer’s disease, a number which may rise to 16 million by 2050 if there is no breakthrough in the prevention or treatment of the disease — but it disproportionately affects those over age 85, striking between one-third and one-half of this cohort. Developing a reasonable approach to the medical care of older people with dementia will be essential in the coming decades.

The incorporation of exome and genome sequencing into research and clinical practice raises the possibility of providing a range of genomic results to relatives in the event of the death of the research participant or patient. Genomic data can be of direct relevance to the medical care of relatives. However, some test subjects (e.g., cancer patients) are at higher risk of dying before they receive their test results and thus may not be able to share useful information with family members. We created an Institutional Review Board (IRB)-approved document with talking points on the possibility of disclosure of results to family members after an individual’s death to discuss during the informed consent process for genomic testing with participants in a study of exome sequencing in the context of familial colorectal cancer/polyposis.

Though in existence for over thirty-five years, due to the increasing panoply of possible tests. Newborn screening programs are drawing public attention. Many jurisdictions have mandatory newborn screening programs for treatable disorders. Disorders are detected through tests on blood spots drawn from a newborn’s heel soon after birth and verified through a diagnostic test with follow-up. Unbeknownst to most parents, these blood spot cards are also stored thereafter. Indeed, while dried blood spots (DBSs) are primarily used for screening for health problems, experience demonstrates that they can be made useful in various contexts unrelated to screening.

Newborn dried blood spots have taken on a new life as a result of developments in genetics and the increasing ability of bioinformatics to link DNA information with clinical data. Additionally, storage and secondary uses have been documented to occur without parental consent.

The federal government indirectly subsidizes the pharmaceutical industry by funding basic research, various tax credits and deductions, patent rules, grants of market exclusivity, and other means, in order to spur drug development, promote public health, and improve medical care. But today, the pharmaceutical industry often neglects these goals and sometimes even undermines them, due to what Lawrence Lessig refers to as institutional corruption — that is, widespread or systemic practices, usually legal, that undermine an institution’s objectives or integrity. A key source of institutional corruption is improper dependence by the institution or its key actors on the actions of third parties that have fundamentally different interests. It is the health care system’s improper dependency on pharmaceutical firms that allows them to displace some public policy goals and to compromise the attainment of others.

The Michigan Department of Community Health (MDCH) stores almost 4 million dried blood spot specimens (DBS) in the Michigan Neonatal Biobank. DBS are collected from newborns under a mandatory public health program to screen for serious conditions. At 24 to 36 hours of age, a few drops of blood are taken from the baby’s heel and placed on a filter paper card. The card is sent to the state public health laboratory for testing. After testing, MDCH retains the spots indefinitely for the personal use of the patient and also, pursuant to a 2000 law, for possible research.

The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided to largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary's Advisory Committee on Human Research Protections (SACHRP), and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation.

Opioid litigation continues a growing public health litigation trend in which governments seek to hold companies responsible for population harms related to their products. The litigation can serve to address gaps in regulatory and legislative policymaking and in market self-regulation pervasive in the prescription opioid domain. Moreover, prior opioid settlements have satisfied civil tort litigation objectives of obtaining compensation for injured parties, deterring harmful behavior, and holding certain opioid manufacturers, distributors and pharmacies accountable for their actions. In this way, opioid litigation represents progress over prior public health litigation campaigns involving tobacco, lead paint, and asbestos, which had more limited tort litigation effects. Although opioid litigation is not a comprehensive solution to the opioid crisis, it can complement other strategies and infuse much needed money, behavior changes, and public accountability for prescription opioid and related harms.

Stem cells derived from pluripotent cells offer the hope of new treatments for diseases for which current therapy is inadequate. Clinical trials are essential in developing effective and safe stem cell therapies and fulfilling this promise. However, such clinical trials raise ethical issues that are more complex than those raised in clinical trials using drugs, cord blood stem cells, or adult stem cells. Several clinical trials are now being carried out with stem cells derived from pluripotent cells, and many more can be expected in light of the rapid scientific progress in the field.

Degenerative neurological diseases are desirable targets for stem cell clinical trials. The FDA has approved Phase 1 clinical trials of neural stem cell transplantation for Batten Disease, Pelizaeus-Merzbacher Disease, and spinal cord injury. In Parkinson Disease (PD), stem cell transplantation could correct the primary pathophysiological defect — inadequate levels of the neurotransmitter dopamine. Current treatment is unsatisfactory in late-stage PD.

Every year thousands of patients suffer injury while attempting to make use of bathroom facilities. In addition to the suffering and protracted inpatient care that these incidents cause, hospitals have been faced with staggering costs in the form of increased insurance premiums arising directly out of an increased number of lawsuits. This problem has reached a proportion such that it clearly deserves careful and indepth industry study.

This article, while far from a comprehensive study, will attempt to draw certain conclusions and perhaps dispel certain myths based upon a study of 181 patient falls at a 200+-bed community hospital in the Northeastern United States.

In the not too distant past, hospitals could not generally be held legally responsible for failure to raise bedrails absent specific medical direction. Such was the case because few, if any, hospitals had guidelines or procedures for the placement of bedrails in the absence of a physician's order.

Federal funding of the National Nanotechnology Initiative (NNI) has averaged roughly $1 billion annually for the last three years, from 2004 to 2006. Society is poised to see more realistic nano-scale devices enter the marketplace, along with futuristic depictions of nanotechnology. For this reason, serious thought must be given to the societal impact of nanotechnology.

Inconsistency may well be the hallmark of the teenage years. Frequently, teenagers are serious and adult-like, yet just as often, they are callow and unpredictable. Generally, they are all of these things, in no particular order. They studiously observe the adults in their lives, adopting certain values and behaviors, while wholly rejecting others. Their moods shift without warning, leaving entire households with the sensation that they are living on a roller-coaster. As a result, it is not entirely surprising that the legal system has had difficulty deciding how to respond to them. The laws devised to govern teenagers are layered, reflecting society's alternating perceptions of teenagers as adult-like and child-like, and our accompanying impulses to respect as well as to protect this population. Read together, these laws defy any consistent description of adolescent capacity. We have lived with these inconsistencies for so long, though, that they have grown rather familiar to us, and that we hardly recognize the puzzle in the fact that we trust eighteen year olds enough to let them fight and die in the military, but not enough to let them drink alcoholic beverages.