Michael R. Ulrich

The duty to rescue in genomic research.

Applying the duty to rescue to incidental findings in genomic research provides benefits over the ancillary care framework. A rescue model avoids conflating the return of genetic information with providing needed clinical care, it recognizes the ethical duties researchers have toward the research study and offers a mechanism for appropriately balancing these with obligations to individual subjects, and answers definitively that there is no duty to search for incidental findings.

Decreasing Smoking but Increasing Stigma? Anti-tobacco Campaigns, Public Health, and Cancer Care

Public health researchers, mental health clinicians, philosophers, and medical ethicists have questioned whether the public health benefits of large-scale anti-tobacco campaigns are justified in light of the potential for exacerbating stigma toward patients diagnosed with lung cancer. Although there is strong evidence for the public health benefits of anti-tobacco campaigns, there is a growing appreciation for the need to better attend to the unintended consequence of lung cancer stigma. We argue that there is an ethical burden for creators of public health campaigns to consider lung cancer stigma in the development and dissemination of hard-hitting anti-tobacco campaigns. We also contend that health care professionals have an ethical responsibility to try to mitigate stigmatizing messages of public health campaigns with empathic patient-clinician communication during clinical encounters.

Whither the “improvement standard”? Coverage for severe brain injury after Jimmo v. Sebelius

As improvements in neuroscience have enabled a better understanding of disorders of consciousness as well as methods to treat them, a hurdle that has become all too prevalent is the denial of coverage for treatment and rehabilitation services. In 2011, a settlement emerged from a Vermont District Court case, Jimmo v. Sebelius, which was brought to stop the use of an “improvement standard” that required tangible progress over an identifiable period of time for Medicare coverage of services. While the use of this standard can have deleterious effects on those with many chronic conditions, it is especially burdensome for those in the minimally conscious state (MCS), where improvements are unpredictable and often not manifested through repeatable overt behaviors. Though the focus of this paper is on the challenges of brain injury and the minimally conscious state, which an estimated 100,000 to 200,000 individuals suffer from in the United States, the post-Jimmo arguments presented can and should have a broad impact as envisioned by the plaintiffs who brought the case on behalf of multiple advocacy groups representing patients with a range of chronic care conditions.

Disorders of Consciousness, Agency, and Health Care Decision Making: Lessons From a Developmental Model

The health care decision-making framework applied to adolescents, a process that gives minors an increasing role in decision making as they mature, should be applied to patients recovering from disorders of consciousness. The flexibility afforded by this framework allows for participation to change over time in accordance with the patients evolution during the recovery process, unlike the rigid surrogate-focused model utilized for those with permanent incapacity. While the legal system may regard patients with disorders of consciousness and subsequent disability as incompetent to make decisions, respect for personhood and self-determination requires that the physician and surrogate involve the recovering patient in decision making to the maximal extent possible.

Guidance From Vaccination Jurisprudence

The lengthy history of case law covering compulsory vaccination policies state consistently that conscientious exemptions and evaluating their validity can be difficult, administratively cumbersome, and potentially unconstitutional.

Guardianship and Clinical Research Participation: The Case of Wards with Disorders of Consciousness

ABSTRACT:We review relevant federal law about research on human subjects and state laws on guardian authority to determine whether guardians can consent on behalf of their wards to participation in research. The Common Rule is silent on the issue as are most state guardianship laws. Our analysis shows significant variation in guardians’ decision-making authority in the states that do regulate wards’ participation in research.We consider how the appointment of guardians for patients with disorders of consciousness (DOC) impacts such patients’ access to research. We assert that it is important that such persons be permitted to participate in research, so that their conditions and potential medical interventions can be studied, and that those with similar conditions can benefit from the knowledge gained from these studies. We argue that state guardianship laws should be adapted to specifically give guardians the authority to consent to research on behalf of wards who may be able to regain decisional capacity.

Law and Politics, an Emerging Epidemic A Call for Evidence-Based Public Health Law

As Jacobson v. Massachusetts recognized in 1905, the basis of public health law, and its ability to limit constitutional rights, is the use of scientific data and empirical evidence. Far too often, this important fact is lost. Fear, misinformation, and politics frequently take center stage and drive the implementation of public health law. In the recent Ebola scare, political leaders passed unnecessary and unconstitutional quarantine measures that defied scientific understanding of the disease and caused many to have their rights needlessly constrained. Looking at HIV criminalization and exemptions to childhood vaccine requirements, it becomes clear that the blame cannot be placed on the hysteria that accompanies emergencies. Indeed, these examples merely illustrate an unfortunate array of examples where empirical evidence is ignored in the hopes of quelling paranoia. These policy approaches are not only constitutionally questionable, they generate their own risk to public health. The ability of the law to jeopardize public health approaches to infectious disease control can, and should, be limited through a renewed emphasis on science as the foundation of public health, coordination through all levels and branches of government, and through a serious commitment by the judiciary to provide oversight. Infectious disease creates public anxiety, but this cannot justify unwarranted dogmatic approaches as a response. If we as a society hope to ensure efficient, constitutional control over the spread of disease, it is imperative that science take its rightful place at the forefront of governmental decision-making and judicial review. Otherwise, the law becomes its own public health threat.

A federal compulsory vaccination plan

During oral arguments for the Patient Protection and Affordable Care Act, Justice Breyer on several occasions questioned whether the federal government could compel individuals to be vaccinated in the event of a national emergency where a highly contagious disease was sweeping through the country. This article does not seek to predict or analyze the legal implications of such an action; rather it argues that a national approach to such an emergency should be implemented. Recent concerns over the potential for H5N1, or “bird flu,” to become airborne illustrate the type of epidemic that Justice Breyer may have been envisioning. By broaching this subject now, instead of in the midst of an outbreak, adequate time is left to research appropriate solutions, allow for debate, and provide public education.While vaccination laws are typically promulgated on the state level under state police power, these compulsory laws are accompanied by exemptions that can undermine their effectiveness. For example, religious and philosophical exemptions have led to outbreaks of pertussis, or whooping cough, in multiple states. Considering the various state exemptions along with laws granting governors and health officials broad power to alter vaccination laws during emergencies, it is nearly impossible to predict how individual states will respond. Legally and ethically speaking, the rights of individuals are not absolute and cannot be utilized to subject others to harm.A federal compulsory vaccination law allows for balancing individual rights and public health, with the interests of the nation as a whole in mind.