Over the past two decades, we have seen an increase in the use of medical-legal partnerships (MLPs) in health-care and/or legal settings to address health disparities affecting vulnerable populations. MLPs increase medical teams' capacity to address social and environmental threats to patients' health, such as unsafe housing conditions, through partnership with legal professionals. Following the Preferred Reporting Items for Systematic Review and Meta-Analyses guidelines, we systematically reviewed observational studies published from January 1993-January 2016 to investigate the capacity of MLPs to address legal and health disparities. We identified 13 articles for qualitative analysis from an initial pool of 355 records. The resulting pool of 13 articles revealed more information regarding the capacity of MLPs to address legal outcomes than their capacity to address health outcomes; only 4 studies directly addressed the impact of MLP intervention on patient wellbeing and/or patient utilization of healthcare services. We call for further evaluation/longitudinal studies that specifically address MLPs' short and long term effects upon patient health disparities. Finally, given the demonstrated capacity of MLPs to address unmet legal needs, and their evident potential in regards to improving health outcomes, we present the MLP model as a framework to address HIV-related legal and health disparities.

There is a debate at the highest levels of government about how to classify the risks of research studies that evaluate therapies that are in widespread use. Should the risks of those therapies be considered as risks of research that is designed to evaluate those therapies? Or not? The Common Rule states, “In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research).” (CFR 46.111 (a)(2)). By contrast, the Office of Human Research Protections, in a proposed “guidance” states, “The reasonably foreseeable risks of research include already-identified risks of the standards of care being evaluated as a purpose of the research.” (emphasis added).

In this paper, I argue that the Common Rule got it right and OHRP got it wrong. When treatments are in widespread use, the risks of those treatments are ever-present for all patients. By enrolling in formal studies that use rigorous methods to compare one treatment with another and that carefully monitor outcomes and adverse events, patients are protected from the risks of idiosyncratic practice variation. Their risks are decreased, rather than increased.

If OHRP's approach becomes the law of the land, patients will be misinformed about the relative risks of treatment and research in ways that undermine autonomy rather than promoting it and that make truly informed consent impossible.

This piece explores legal, ethical, and policy arguments associated with using interventions that leverage feelings of shame and social exclusion to promote uptake of childhood immunizations by parents.

Informed consent is central to the law of the physicianpatient relationship, respecting patient autonomy. This paper addresses a conflict between law and medicine in defining informed consent. Additionally, it addresses the possibility that patients prefer not to be “informed“ and would defer decision-making to their physicians.

Fair competition law and public health law talk past each other when discussing pharmaceutical pricing and distribution. The former cannot agree on the relevant definition of consumer welfare. The latter does not fully comprehend the highly complex but inherently collective nature of pharmaceutical drug acquisition in the United States. This essay proposes to inject public health discourse into this debate to enrich it, focus it, and render it more accessible to those who must live by its outcome.

In 1968, the definition of death in the United States was expanded to include not just death by cardiopulmonary criteria, but also death by neurologic criteria. We explore the way the definition has been modified by the medical and legal communities over the past 50 years and address the medical, legal and ethical controversies associated with the definition at present, with a particular highlight on the Supreme Court of Nevada Case of Aden Hailu.

Stigma is a factor of diseases of craniofacial disfigurement, associated with negative health outcomes. Psychosocial interventions can improve the “illness” experience. The law can improve care by framing patients' rights, defining physicians' obligations to make psychological referrals, and fostering an activist orientation among patients.

Motorcycle helmet laws are perceived to infringe upon individual rights even though they reduce mortality and health care costs. We describe proposed helmet legislation that protects individual rights and provides incentives for helmet use through a differential motorcycle registration fee that requires higher fees for those who wish to ride without a helmet.

The random]ized clinical trial is widely accepted as the optimal approach to evaluating the safety and efficacy of medical treatments. Resistance to randomized treatment assignment arises regularly, most commonly in situations where the disease is life-threatening and treatments are either unavailable or unsatisfactory. Historical control designs, in which all participants receive the experimental treatment with results compared to a prior cohort, are advocated by some as more ethical in such circumstances; however, such studies are often highly biased in favor of the new treatment and frequently yield misleading results. Alternative controlled designs motivated by the desire to maximize the number of patients with the treatment ultimately determined to be superior have been proposed, but have been challenged on both methodological and ethical grounds. Debates about appropriate and ethical study designs recurred during the recent Ebola Virus Disease (EVD) epidemic in West Africa. Despite its devastating nature, the EVD epidemic showed the ongoing necessity of conducting randomized trials to obtain convincing evidence of the safety and efficacy of therapeutic interventions.

Using the case of Ebola Virus Disease as an example, this paper shows why patients at high risk for death have a defensible moral claim to access unregistered medical interventions (UMI), without having to enrol in randomized placebo controlled trials.

A number of jurisdictions permit and facilitate such access under emergency circumstances. One controversial question is whether patients should only be permitted access to UMI after trials investigating the interventions are fully recruited. It is argued that regulatory regimes should not prioritise trial recruitment over patient access, even if this results in drug research and development delays.

We describe how the moral duty to rescue impacts on others' duties to oblige patients seeking emergency access to unregistered medical interventions. The view that eligible patients are owed the provision of access to UMI regardless of their willingness to enrol in a randomised controlled trial (RCT) is defended.

Immigration poses numerous challenges for health professionals and public health lawyers. This article reviews these challenges. We begin by offering some background on immigration and health and then explain some of the reasons why immigrants are less likely than natives to have health insurance. Next we turn to a discussion of some of the particular challenges relating to the health care of refugees. We conclude by analyzing and rejecting some of the arguments that are made for discriminating against immigrants with respect to the provision of public health benefits and services.

Alcohol and other drug-related stigma is a growing concern. Many organizations have called for a reduction in such stigma through law reform, but there is little sense of how, precisely, this might be achieved. This paper reports on a new method to examine the relationship between stigma and the law and establish a framework that can guide and inform future law reform efforts.

With developed country governments and high resource institutions engaging in research in low- and middle-income countries (LMIC), we argue that these entities have a moral obligation to help build and strengthen research infrastructure and capacity so local scientists and institutions can adequately conduct studies to understand and resolve the health burdens in low and middle income countries. We explore the moral justifications and motivations behind engaging in research capacity strengthening in the health sector in LMIC at multiple levels. In highlighting these issues, this paper aims to initiate a global discourse around why capacity development in LMIC has a moral basis at the individual, institutional and system levels.

Proposed changes to the Common Rule would require publicly funded researchers to disclose whether a subject's biospecimens could be used for commercial profit and whether the subject will share in those proceeds. Disclosing commercial interests will inform research participants that their tissue may have commercial value, a possibility that those individuals might not have previously considered. The proposed changes may then provide people with an opportunity to negotiate commercial rights in their biospecimens despite the well-accepted legal precedent that individuals maintain no interests in their excised tissue.

This article introduces and defines the Health in All Policies (HiAP) concept and examines existing state legislation, with a focus on California. The article starts with an overview of HiAP and then analyzes the status of HiAP legislation, specifically addressing variations across states. Finally, the article describes California's HiAP approach and discusses how communities can apply a HiAP framework not only to improve health outcomes and advance health equity, but also to counteract existing laws and policies that contribute to health inequities.

In this paper, we claim that we can only seek to eradicate the stigma associated with the contemporary opioid overdose epidemic when we understand how opioid stigma and the epidemic have co-evolved. Rather than conceptualizing stigma as a parallel social process alongside the epidemiologically and physiologically defined harms of the epidemic, we argue that the stigmatized history of opioids and their use defines the epidemic. We conclude by offering recommendations for disrupting the burden of opioid stigma.

The Health in All Policies (HiAP) approach aims to integrate health into decisions across sectors to address the social determinants of health and enhance health equity. Jurisdictions interested in implementing this approach may seek clarification about how to operationalize it. Public health legal preparedness provides useful lessons for HiAP. While there are important differences between these two areas, there are also critical similarities. These similarities are particularly important because HiAP and public health preparedness are complementary. Law has been essential in advancing public health preparedness by helping to: (1) prioritize planning; (2) allocate responsibility; (3) enhance collaboration and coordination; (4) establish responsive funding; and (5) emphasize the needs of vulnerable populations. Law can be used similarly to advance HiAP.