It is the researcher's responsibility to provide accurate, complete, and unbiased verbal and written information yet, as this essay discusses, challenges to meaningful research consent abound in the communication between researcher and subject. This discussion of these challenges is far from exhaustive, but it will flag some of the potholes that researchers must anticipate on the sometimes rocky road to eliciting meaningful consent. These include, but are not limited to, inadequate scientific literacy, poorly written consent forms, and even the deployment of scientific terms and seductive acronyms like CURE and MIRACL. Studies with acronyms, for example, enroll five times as many patients as those without, are more likely to be published by prestigious journals, and have higher Jadad methodologic quality scores although they are no more likely to conclude with positive findings. Other barriers to researcher-subject communication include: widely differing beliefs and customs, semiotics, socioeconomic status, iatrophobia, and dramatically different histories of treatment in the medical-research arena.

This Essay examines the elegantly simple idea that consent to medical treatment or participation in human research must be “informed” to be valid. It does so by using as a case study the controversial clinical research trial known as the Surfactant, Positive Pressure, and Oxygenation Randomized Trial (“SUPPORT”). The Essay begins by charting, through case law and the adoption of the common rule, the evolution of duties to secure fully informed consent in both research and treatment. The Essay then utilizes the SUPPORT study, which sought to pinpoint the level of saturated oxygen that should be provided to extremely low birth weight infants to demonstrate modern complexities and shortcomings of the duty to secure informed consent. This Essay shows how the duty is measured by foreseeability of risks and benefits in human research and why federal regulators believed the tradeoffs in risk and benefits from differing oxygen levels administered in the support study were foreseeable. It then explores the contours of the duty to secure informed consent when applied to researchers who also serve as treating physicians, highlighting how common law duties differ in jurisdictions that apply the professional standard and those that apply the patient-centered material risk standard. This Essay provides new insight into what the law must do to make real the notion that [e]very human being of adult years and sound mind has a right to determine what shall be done with his body.”

The COVID-19 pandemic laid bare systemic inequities shaped by social determinants of health (SDoH). Public health agencies, legislators, health systems, and community organizations took notice, and there is currently unprecedented interest in identifying and implementing programs to address SDoH. This special issue focuses on the role of medical-legal partnerships (MLPs) in addressing SDoH and racial and social inequities, as well as the need to support these efforts with evidence-based research, data, and meaningful partnerships and funding.

The payment of human subjects is an area where Institutional Review Boards (IRBs) have wide discretion. Although the “Common Rule” requires the provision of full information to human research participants to secure valid consent, the Rule is silent on the issue of payment. Still, some federal agencies offer guidance on the matter. For example, the National Science Foundation (NSF) cautions that high payments for risky research “may induce a needy participant to take a risk that they normally would prefer not to take.” For research under its purview, the Food and Drug Administration (FDA) guidance provides that “[a]dvertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.” One might read the FDA guidance to permit the advertisement for human subjects to state the specific amount of payment, as long as it is not emphasized.

During the early twentieth century, otologists began collaborating with organizers of the New York League for the Hard of Hearing to build a bridge to “adjust the economic ratio” of deafness and create new research avenues for alleviating or curing hearing loss. This collegiality not only defined the medical discourse surrounding hearing impairment, anchoring it in hearing tests and hearing aid prescription, but, in so doing, solidified the notion that deafness was a “problem” in dire need of a “solution.” Public health campaigns thus became pivotal for spreading this message on local and national levels. This paper focuses on how, from the 1920s to 1950s, as otologists became more involved with social projects for the deaf and hard of hearing — advocating lip-reading, community work, and welfare programs — at the same time, they also mandated for greater therapeutic regulation, control of hearing aid distribution, and standardization of hearing tests. The seemingly paradoxical nature of their roles continued to reinforce the stigmatization of deafness: with widespread availability of effective help, the hearing impaired were expected to seek out therapeutic or technological measures rather than live with their affliction.

Communicable diseases, especially those that are readily contagious, are on the rise as evidenced by the emergence of viruses like severe acute respiratory syndrome (SARS), the global resurgence of resistant forms of ancient mycobacteria such as extensively drug resistant tuberculosis (XDR TB), and the 2009 swine flu outbreak in Mexico. Moreover, each of us, no matter who we are or where we live, is just as likely to transmit contagious diseases to others as we are to contract such diseases from others. As cogently described in the title of a recent book by Margaret Battin et al., we are all potential “victims and vectors.”

Just as contagious diseases are readily passed person to person, so too can they readily be passed across local and national boundaries. We therefore all have a stake in the development of effective infectious disease control policies on a national scale, with “effective” being the operative term: regulations and statutes that are neither enforceable nor likely to be complied with may do more harm than good.

This article proposes a novel strategy, one that draws on insights from antidiscrimination law, for addressing a persistent challenge in medical ethics and the philosophy of disability: whether health systems can consider quality of life without unjustly discriminating against individuals with disabilities. It argues that rather than uniformly considering or ignoring quality of life, health systems should take a more nuanced approach. Under the article's proposal, health systems should treat cases where (1) quality of life suffers because of disability-focused exclusion or injustice differently from cases where (2) lower quality of life results from laws of nature, resource scarcity, or appropriate tradeoffs. Decisionmakers should ignore quality-of-life losses that result from injustice or exclusion when ignoring them would improve the prospects of individuals with disabilities; in contrast, they should consider quality-of-life losses that are unavoidable or stem from resource scarcity or permissible tradeoffs. On this proposal, while health systems should not amplify existing injustice against individuals with disabilities, they are not required to altogether ignore the potential effects of disability on quality of life.

Planning of effective responses to the recent resurgence of tuberculosis in the United States, and particularly in New York City, requires review of our knowledge of (1) the factors that led to the decline of tuberculosis in the U.S. and other countries during the nineteenth and the first three-quarters of the twentieth century, and (2) the recent changes in these same factors and the rise of new factors that have contributed to its resurgence. Because the analysis of the impact of all of these factors in both the remote and the recent past is controversial, it is important to use a well-defined framework to organize the analysis. The framework we will use is shown in Table 1. To the classic epidemiologic triad of Agent, Host and Environment it adds the category of Health Services. In this paper we redefine both the classic and new categories using current disciplines and concepts applicable to tuberculosis.

Early announcements of this special journal issue solicited authors interested in contributing articles on the subject of “costs at the end of life.” Those who replied were then informed the title was being changed, on the basis of early subscriber interest (or, perhaps disinterest), in “rational end-of-life treatment.” Because that seemed a still inadequate reflection of the authorial concerns of responding potential contributors, the editors again changed the title, two months later, to “Making Treatments More Rational and Compassionate for the Chronically Critically Ill.” At that point the editors gave up and decided this issue’s final title would be determined only after the papers were submitted and reviewed.

This paper evaluates the existing research on Stand Your Ground (SYG) laws in terms of the extent to which it has accounted for gender. In particular, we address (a) what the available evidence suggests are the gender-based impacts of SYG laws and (b) where, how, and why considerations of gender may be missing in available studies.

Disparities exist in the health, livelihood, and opportunities for the 46-60 million people living in America’s rural communities. Rural communities across the United States need a new energy and focus concentrated around health and health care that allows for the designing capturing, and spreading of existing and new innovations. This paper aims to provide a framework for policy solutions to build a healthier rural America describing both the current state of rural health policy and the policies and practices in states that could be used as a national model for positive change.

Gene therapies to treat sickle cell disease are in development and are expected to have high costs. The large eligible population size — by far, the largest for a gene therapy — poses daunting budget challenges and threatens to exacerbate health disparities for Black patients, who make up the vast majority of American sickle cell patients.

U.S. immigration policies and enforcement can make immigrants fearful of accessing healthcare. Although current immigration policies restrict enforcement in “sensitive locations” including healthcare facilities, there are reports of enforcement actions in such settings.

In the “olden days,” only a few years ago, physicians were free to order virtually any service they believed their patients needed, confident that virtually everything would be paid for. Reimbursernent was retrospective, fee-for-service and generous, essentially a cost-plus system in which insurers only rarely challenged medical decisions. That system is now gone. Uncontrolled escalations in the cost of health care have prompted those who pay its costs—primarily governments, businesses, and insurers—to initiate a broad array of cost controls in hopes of at least restraining the rise of their expenditures, even if not actually reducing them. Among the most prominent cost-containment mechanisms is utilization review (UR).

Insurers have always engaged in retrospective review, denying payment for services that are not medically necessary, or not covered by the patient's policy, or not documented in the patient's records. Recently, however, payers have added prospective review, in which physician and patient must secure advance payer approval for certain interventions if they wish to ensure reimbursement.

Traditionally, hospitals have been liable for the acts of their employees or agents under the doctrine of respondeat superior, but have not been considered liable for the actions of those whom they did not employ or over whom they had no control. Accordingly, hospitals and their insurers were able to avoid legal responsibility for the acts of medical malpractice committed by physicians on their medical staffs. Although elements of a new and distinct theory of hospital corporate responsibility unrelated to respondeat superior had emerged before, the widely discussed opinion of the Illinois Supreme Court in Darling v. Charleston Community Hospital is generally considered the hallmark of a change in judicial thinking in respect to a hospital's duty to monitor the quality of care rendered within its walls. However, Darling was not a forerunner of a spate of similar holdings, and, in fact, has never been specifically relied upon even in Illinois. Only in the last several years have significant additional strides been taken in developing this theory. Two recent intermediate appellate decisions in Wisconsin and North Carolina seem to reflect the trend of the law and the affirmative duty of a hospital to monitor the quality of care rendered by its medical staff.

This article examines emergency restrictions imposed by state-level public officials on firearms during the COVID-19 pandemic. It surveys the litigation challenging each of the relatively few restrictions that were imposed, considers when and whether courts should apply the deferential Jacobson standard, the Heller Second Amendment analysis, or both, and explores the possibility that the unsettled nature of Second Amendment jurisprudence makes it likely that challenges to emergency firearms restrictions could result in dramatic developments in what the Second Amendment protects.

Today's hospitals and health care facilities are being increasingly subjected to pressures to monitor the quality of the health care provided in their institution. One vehicle is the courts which, utilizing the doctrine of hospital corporate liability, have imposed a duty upon the hospital to use reasonable care in the selection and maintenance of physicians on its medical staff. This article will discuss three different approaches from three different states.

The first case is Johnson v. Misericordia Community Hospital, decided by the Wisconsin Supreme Court in January 1981. In its decision, the court sought to answer two questions: “Does a hospital owe a duty to its patients to use due care in the selection of its medical staffand the granting of specialized surgical (orthopedic) privileges?;” and second, “What is the standard of care that a hospital must exercise in the discharge of this duty to its patients…?”

After I was named Chief Judge of New York State, a position previously occupied by one of the noblest of jurists, Benjamin Cardozo, I went up to look at my new chambers and there was my new desk—the desk that had been used by Benjamin Cardozo. And I said to a friend of mine, “Just think of it, I will be seated and be using and will have Benjamin Cardozo's desk.” And he said, “Yes, but remember, 50 years from today, it will still be Benjamin Cardozo's desk.” We have through the likes of Benjamin Cardozo inherited a jurisprudential history in New York State.

The question that we now grapple with is a question which many states have had to face and the decisions from the state courts are diverse and often controversial. We were all waiting for the United States Supreme Court, that fountain of wisdom, to set the guidelines, so that we would have a standard to which we would look and adhere.