Pandemic diseases have a nasty history of racialization. COVID-19 is no exception. Beyond the obvious racist invocations of the "China virus" or the "Wuhan Flu" are subtler racializing dynamics that are often veiled in more benign motives but are nonetheless deeply problematic. The racialization of COVID-19 proceeded along two distinct trajectories each of which threatened to reinforce inaccurate biologized conceptions of race while diverting attention from the social, legal, and political forces historically structuring race-based health disparities. First, early on as significant racial disparities in disease incidence and mortality became evident, a frame of race-based genetic difference came to the fore as a possible explanation. Second, as vaccine development ramped up there came widespread calls for racially "diversifying" clinical trials for the vaccines being tested. The rationales for such diversification were varied but tended to reinforce genetic frames of racial difference. Most common was the assertion (without substantial evidence) that vaccines might work differently in Black or Brown bodies and so racial diversity in trials was imperative for reasons of safety and efficacy. Derrick Bell cautioned 20 years ago that "the concept of diversity … is a serious distraction in the ongoing efforts to achieve racial justice." (Derrick Bell, Diversity's Distractions, 103 Colum. L. Rev. 1622, 1622 (2003).) This article explores the dynamics of how the concept of "diversity" racialized responses to COVID-19 and considers their broader implications for understanding and responding to racial disparities in the face of pandemic emergencies and beyond. In the short term, vaccine developers did a decent job of enrolling minorities in their clinical trials and the vaccines have proven to have the same safety and efficacy across races. In the long term, diversity in the biomedical context of pandemic response not only distracts attention from important structural causes of health injustice, but it also focuses attention on the genetics of disparities in a manner that has the potential to reinforce pernicious and false ideas of essential biological difference among racial groups. This article argues that an uncritical embrace of the idea of diversity in analyzing and responding to emergent health crises has the potential to distract us from considering deeper historical and structural formations contributing to racial health disparities. It proceeds first by exploring the dynamics through which initial responses to racial disparities in COVID-19 became geneticized. It will then move on to unpack the rationales for such racialization, examine their merits (or lack thereof), and consider their implications for developing an equitable response to pandemic emergencies. The next section will examine the subsequent racialization of clinical trials for COVID-19 vaccines through the concept of "diversity." It then moves on to explore how the geneticization of COVID-19 racial disparities laid the foundations for a similar geneticization of race in vaccine development. It will argue that in failing to clearly distinguish social and biological rationales for diversity, such framings, while generally well-intentioned, are poorly supported and work in tandem with the geneticization of racial disparities in COVID-19 morbidity and mortality to locate the causes of disparities in the minds and bodies of minoritized populations; again this distracts attention from the historical and structural forces contributing to such disparities. The article concludes by recognizing a certain intractability to the problems of using race in biomedical research and practice, particularly in the context of public health emergencies. It offers modest suggestions for improvement that could have significant practical effects if taken to heart by researchers, clinicians, and policy makers.
The identification and arrest of the Golden State Killer using DNA uploaded to an ancestry database occurred shortly before recruitment for the National Institutes of Health's (NIH) All of Us Study commenced, with a goal of enrolling and collecting DNA, health, and lifestyle information from one million Americans. It also highlighted the need to ensure prospective research participants that their confidentiality will be protected and their materials used appropriately. But there are questions about how well current law protects against these privacy risks. This article is the first to consider comprehensively and simultaneously all the federal and state laws offering protections to participants in genomic research. The literature typically focuses on the federal laws in isolation, questioning the strengths of federal legal protections for genomic research participants provided in the Common Rule, the HIPAA Privacy Rule, or the Genetic Information Nondiscrimination Act. Nevertheless, we found significant numbers and surprising variety among state laws that provide greater protections than federal laws, often filling in federal gaps by broadening the applicability of privacy or nondiscrimination standards or by providing important remedies for individuals harmed by breaches. Identifying and explaining the protections these laws provide is significant both to allow prospective participants to accurately weigh the risks of enrolling in these studies and as models for how federal legal protections could be expanded to fill known gaps.
Several features of the existing occupational licensing system impede access to health care without providing appreciable protections for patients. Licensing restrictions prevent health care providers from offering services to the full extent of their competency, obstruct the adoption of telehealth, and deter foreign-trained providers from practicing in the United States. Scholars and policymakers have proposed a number of reforms to this system over the years, but these proposals have had a limited impact for political and institutional reasons. Still, there are grounds for optimism. In recent years, the federal government has taken a range of initial steps to reform licensing requirements for health care providers, and these steps have the potential to improve access to health care. Together, they illustrate a federalist approach to licensing reform, in which the federal government encourages the states to reform their licensing regimes, while largely preserving states’ control over the system. These steps include: (1) easing federal licensing restrictions for health care providers in certain areas where the federal government possesses regulatory authority; (2) creating incentives for states and professional bodies to experiment with reforms; (3) intensifying the Federal Trade Commission’s focus on licensing boards’ anti-competitive conduct; and (4) generating additional pressure for state-level reforms through expanding health insurance and promoting delivery system reforms under the Affordable Care Act. This article argues that a federalist approach represents the most promising path toward reforming occupational licensing in health care. Federal intervention in licensing is necessary, due to states’ lack of incentives to experiment with licensing reforms, the externalities of their licensing regimes, and their inability to resolve their own collective action problems. Nevertheless, large-scale federal preemption of state licensing laws is unlikely, due to a combination of interest group politics, Congress’s tendency toward incrementalism, and its reliance on the states to administer federal policies. A federalist approach also has functional advantages over outright federal preemption: it allows for more experimentation in constructing new licensing regimes, and it enables the federal government to take advantage of states’ institutional expertise in regulating occupations. Finally, this approach presents a model for how the federal government can play a constructive role in occupational licensing in other fields besides health care, and in other areas of state regulatory policy.
Globalization provides new potential for the scope and reach of reproductive service markets through the expansion of cross-border surrogacy and egg markets. As the technology advances in both contexts, gestational surrogacy and egg markets, new cases are emerging in the media and the courts, exposing questionable business practices, and raising obvious needs for regulation. Surprisingly, while there are many calls for global regulation of cross-border surrogacy markets, the parallel call to regulate egg markets is not as prevalent, reflecting a difference in how egg retrieval and surrogacy are viewed. This article probes the question of why the surrogacy market garners so much more attention than the egg market. It specifically considers whether there is a reason to differentiate the egg and surrogacy markets, or whether they are similar in terms of motives for regulation. The article offers two levels of analysis. First, whether to legitimize either one of the markets. Second, if allowed, or at least not forbidden, how to regulate market failures. Within each one of these analyses, the article asks whether the answer should be different when applied to the egg and surrogacy markets. Part I shows that many of the rationales, either to allow or to forbid each market, apply to both the egg and surrogacy contexts similarly. However, the paper claims that there is no justification to completely prohibit either market. Given that some sort of commodification will have to be acknowledged, Part II reviews the conduct of both cross-border markets and the main failures that raise the need for regulation in each market. The paper emphasizes that for both egg and surrogacy markets similar market failures are relevant, raising the need for regulation. In light of the international calling for regulation of cross-border surrogacy markets, Part III explains why initiatives focus more on surrogacy rather than on the egg market. It asks why only the surrogacy market has taken the initiative to regulate the market, although in both egg and surrogacy markets the protection of should be one of the motives for regulation. Since motives for regulation are similar in both markets, it concludes that the protection of assisting women is not the main motive fueling such regulation. Part IV considers two possible regulative approaches: a minimalistic and a pro-active approach. The article applies both to the two markets. The paper supports a pro-active legal approach not only because it gives the same protections as the minimalistic approach, which provides for safety and basic human rights safeguards, but also because it addresses the social structure and class differentiation when it aims to ameliorate women's expectation for recognition. Nevertheless, either of these approaches requires the adoption of a single regulative framework for both egg and surrogacy markets.
Genetic testing is becoming more frequent and the results more complex. Not infrequently, genetic testing that is conducted for one purpose reveals information about other features of the genome that may be of clinical significance. These unintended findings have been referred to as “incidental” or “secondary.” In 2013, the American College of Medical Genetics (ACMG) recommended that clinical laboratories inform people if their genetic analyses indicate that they have certain secondary mutations. These mutations were selected because they probably cause a serious disease, which is treatable, and may go undetected. The ACMG’s recommendations galvanized critical responses by the genetics and ethics community. One of the most important open questions concerns the scope of negligence liability for clinical laboratories if they failed to provide any of these SFs to patients who never requested them. To answer this question, this article argues that while there might be an ethical or professional obligation to share knowledge about these specific genetic mutations, laboratories should not be subject to tort liability for failure to share secondary findings directly with patients. The paper analyzes traditional common law doctrines surrounding the duty to warn to explain why the harm is not foreseeable enough and the burden is too great.
