In qualitative interviews with a diverse group of experts, the vast majority believed unregulated researchers should seek out independent oversight. Reasons included the need for objectivity, protecting app users from research risks, and consistency in standards for the ethical conduct of research. Concerns included burdening minimal risk research and limitations in current systems of oversight. Literature and analysis supports the use of IRBs even when not required by regulations, and the need for evidence-based improvements in IRB processes.

True revolutions turn the entire world upside down, in ways expected and surprising, profound and mundane. The revolution spawned by advances in molecular biology is no exception. Most of the attention has gone, deservedly, to the possible effects of these advances on medicine, on society, and on our understanding of what it means to be human. But the revolution has already had effects—large and small, good and bad—in other areas. This paper analyzes one aspect of the industry created by that revolution in molecular biology–biotechnology. Specifically, it surveys the various kinds of conflicting interests, both real and perceived, that develop among commercial enterprises, government, and institutions in biotechnology; and it examines the legal implications and public policy concerns of these conflicting interests.

The paper focuses on three different kinds of conflicting interests that confront private and public enterprises competing or collaborating in the biotechnology industry: (1) those among businesses involved within the industry; (2) those in relationships between industry and government; and (3) those in relationships between industry and universities. These types of conflicts raise very different issues, but each stems from circumstances unique to the young biotechnology industry.

Given the nature of scientific inquiry, biomedical and genomic researchers have forged innumerable ways to advance our understanding of human disease. In many cases, research requires the involvement of human subjects, and in a subset of these studies, the researcher may collect data and biospecimens from many participants, and even serially collect additional materials over time and across a number of geographically dispersed centers. The organized data and biospecimens are collectively known as research biobanks. Researchers have an obligation to disseminate findings from their research through publications and presentations to other professionals, and when possible, to the public. Sharing genomic data is increasingly being mandated; access to data can be obtained through collaborative or state-funded entities. For example, the database of Genotypes and Phenotypes (dbGAP) and the International Cancer Genome Consortium will grant approved research applicants access to de-identified individual level genomic data with accompanying demographic/clinical information.

Calls to abolish race as a proxy for biology or genetics in clinical care have reached a fever pitch in the latter half of 2020, including articles in the New England Journal of Medicine, and urgent letters from prominent Senators.

When a disaster occurs, adults over age 65 may be disproportionately impacted due to sensory deficits, chronic health conditions, diminished social support and isolation, and financial limitations. Although older adults comprised approximately 15 percent of the New Orleans population, they accounted for over 70 percent of the fatalities associated with Hurricane Katrina in 2005. Disasters can also impact older adults’ morbidity, as a disaster may disrupt established habits and routines (e.g., timing of medication administration) and result in removal from a familiar environment, promoting disorientation. This may raise particular challenges for older adults with mental and physical co-morbidities, and subsequently for their formal and informal caregivers.

While some older adults may need care for physical health problems following a disaster, mental health needs are often overlooked or unmet. One study of Hurricane Katrina survivors found that, compared to older adults, middle-aged individuals were twice as likely to have received mental health services in the eight months after the hurricane.

Immunization plays a crucial role in global health security, preventing public health emergencies of international concern and protecting individuals from infectious disease outbreaks, yet these critical public health benefits are dependent on immunization law. Where public health law has become central to preventing, detecting, and responding to infectious disease, public health law reform is seen as necessary to implement the Global Health Security Agenda (GHSA). This article examines national immunization laws as a basis to implement the GHSA and promote the public's health, analyzing the scope and content of these laws to prevent infectious disease across Sub-Saharan Africa. Undertaking policy surveillance of national immunization laws in 20 Sub-Saharan African countries, this study: (1) developed a legal framework to map the legal attributes relevant to immunization; (2) created an assessment tool to determine the presence of these attributes under national immunization law; and (3) applied this assessment tool to code national legal landscapes. An analysis of these coded laws highlights legal attributes that govern vaccine requirements, supply chains, vaccine administration standards, and medicines quality and manufacturer liability. Based upon this international policy surveillance, it will be crucial to undertake legal epidemiology research across countries, examining the influence of immunization law on vaccination rates and disease outbreaks.

Lost at times in the heat of debate about stem cell research, or any controversial advanced technology, is the need for precision in debate and discussion. The details matter a great deal, ranging from the need to use words that have precise definitions, to accurately quote colleagues and adversaries, and to cite scientific and medical results in a way that reflects the quality, rigor, and reliability of the work at issue. Regrettably, considerable inaccuracy has found its way into the debates about stem cells, on all sides, with consequent fogging of the issues.

A key detail that is often overlooked in the debates about the uses of human embryonic stem cells in research comes from the nature of in vitro fertilization (IVF) treatment for infertility. Specifically, there are many frozen human embryos (more precisely called blastocysts) that are in excess of reproductive needs of the couple who generated them, and that must be either frozen indefinitely, donated to another couple, or destroyed.

In this issue, Raphael Cohen-Almagor reviews some of the terms used in the discussion of bioethical issues at the end of a patient's life; he argues that they are “valueladen” and serve “primarily the physicians, at times at the expense of the patients’ best interest.” Each of the following terms comes under scrutiny: “death with dignity,” “persistent vegetative state,” “futility,” “double effect,” and “brain death.” He argues that these concepts, developed in recent decades, “have generated an unhealthy atmosphere for patients, which might lead to undesirable actions at the end of patients’ lives.” He issues a plea to discontinue the use of the term “persistent vegetative state” because it is dehumanizing, to explain “double effect” and “futility” in detail and with sincerity, and to clarify the motivation for using these terms and others. He warns physicians not to use terminology that is offensive to patients and loved ones or that weakens their patients’ will to live.

Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime.

Pandemics challenge the law and often highlight its strengths or expose its limits. The novel strain of influenza A (H1N1) virus that emerged in the spring of 2009 and rapidly spread around the globe was no exception. The H1N1 pandemic prompted the first significant application of a number of international legal and policy mechanisms that have been developed in the last decade to respond to this kind of event. Furthermore, it presented a considerable test for public health systems at all levels, from global to local.

Although initial predictions forecasting high morbidity and mortality from this virus overestimated its eventual impact, the human toll of the pandemic was nevertheless significant. The World Health Organization (WHO) reported approximately 1.5 million people were infected worldwide in 214 countries, resulting in over 25,000 confirmed deaths, but the actual health impact of the outbreak was certainly much higher.

In recent years, a number of prominent scholars have touted the use of litigation as an effective tool for making public health policy. For example, Stephen Teret and Michael Jacobs have asserted that product liability claims against car makers have played a significant role in reducing automobile-related injuries, Peter Jacobson and Kenneth Warner have argued that litigation against cigarette manufacturers has advanced the cause of tobacco control, and Phil Cook and Jens Ludwig have suggested that lawsuits against the firearms industry can reduce gun violence. Critics have attacked this use of litigation as doing more harm than good to public health and as a misuse of the courts. This debate involves two distinct controversies: one over whether the public health benefits of litigation outweigh its costs and the other over the proper role of courts within our system of government.

Biobank-based research in Mexico is mostly governed by research and data protection laws. There is no direct mention of biobanks in either statutory or regulatory law besides a requirement that the Federal Ministry of Health and a Mexican institution devoted to scientific research approve the transfer of biological materials outside of Mexico for population genetics research purposes. Such requirements are the basis of Genomic Sovereignty in Mexico, but such requirements have not prevented international collaboration. In addition, Mexican law singles out genetic research in informed consent provisions, but it does not specify whether all biobank-based research is genetic research. In order to facilitate international collaboration on biobank-based research, Mexico should directly address biobanking in its laws, building on the research framework and data protection framework already in place.

Even though health care provider reporting of diseases to public health authorities is common, often there is under-reporting by providers, including for notifiable diseases; frequently, under-reporting occurs by wide margins. Two causal factors for this under-reporting by providers have been that: (1) disclosing data may violate their patients’ privacy, and (2) disclosed data may be used to evaluate their performance. A reluctance to disclose information due to privacy concerns exists despite the U.S. Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule permitting disclosures of personal health information (PHI) for public health purposes without patient authorization. On the other hand, such patient privacy concerns are somewhat justified: there have been documented breaches of patient information from public health data custodians.

A common way to address this privacy issue is to de-identify patient data before it is disclosed to public health.

Despite historic efforts to enact the Patient Protection and Affordable Care Act (PPACA) in 2010, national health reform is threatened by multiple legal challenges grounded in constitutional law. Premier among these claims is the premise that PPACA’s “individual mandate” (requiring all individuals to obtain health insurance by 2014 or face civil penalties) is constitutionally infirm. Attorneys General in Virginia and Florida (joined by 25 other states) allege that Congress’ interstate commerce powers do not authorize federal imposition of the individual mandate because Congress lacks the power to regulate commercial “inactivity.” Stated simply, Congress cannot regulate individuals who choose not to obtain health insurance because they are not engaged in a commercial venture. Several courts initially considering this argument have rejected it, but two federal district courts in Virginia and Florida have concurred, leading to numerous appeals and the near promise of United States Supreme Court review.

This essay explores the long Western history of anxieties about feigned illness connected specifically to social policy. There is a remarkable consistency of such anxieties across time, as they appear in almost every major historical period in the West since the Middle Ages.

The fight for public health primacy in U.S. emergency preparedness and response to COVID-19 centers on which level of government — federal or state — should “call the shots” to quell national emergencies?

With the Nancy Cruzan decision, the post-Reagan Supreme Court continued recreating America's legal landscape by transferring traditional rights from its citizens to state legislatures and state officials. Attorneys Bopp and Marzen see Cruzan as a cause for celebration. The more common view is that it is a hollow acceptance of the technological imperative that requires all Americans to engage in extensive damage control. Given the composition of the Court, constituted by President Ronald Reagan to overrule Roe v. Wade, Bopp and Marzen correctly note that the result in Cruzan was “practically inevitable.” But its inevitability does not make its consequences any more desirable than the devastation caused by an inevitable tornado or tidal wave. This article summarizes the Cruzan case and suggests ways to contain its potentially destructive force.

To be a nurse involves the assumption of ethical responsibility in all areas of practice. Infection control practice is a nursing specialty which exemplifies two ethical issues: the nurse's duty or moral obligation for patient advocacy and the right of patients to safe care. Individual moral responsibility is an important issue for the nurse epidemiologist because epidemiologic fact-finding provides information that may present ethical problems as well as suggest solutions. This paper discusses ethical dilemmas arising in infection control practice, as illustrated by three actual situations.

In the course of practice, questions may arise concerning the ethical responsibilities of a nurse epidemiologist to provide facts that may be used in cases of dispute. This discussion shall be limited to institutionally acquired or nosocomial infections.