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Beyond the Pandemic: Historical Infrastructure, Funding, and Data Access Challenges in Indian Country
Get PDFThe COVID-19 pandemic has disproportionately impacted Tribal communities, in part, due to the historical inequities that Tribes have faced for centuries. As sovereign nations, Tribes have the authority to self-govern their people and land. However, the federal government has a special trust responsibility and treaty obligations to Tribes that it often has failed to fulfill. As a result, many Tribal communities live in inferior living conditions as compared to their non-Native counterparts. This Chapter builds on the prior report to explore the historical inequities Tribes experience and how they have been compounded by the pandemic. More specifically, it identifies persistent challenges with infrastructure in Indian Country. It also provides a legislative update on laws directly related to the pandemic as well as laws that have the potential to address some of the issues underlying the pandemic. It concludes by identifying additional recommendations to right these historic wrongs and build on the resiliency shown by Tribes during the pandemic. This paper was prepared as part of the COVID-19 Policy Playbook: Legal Recommendations for a Safer, More Equitable Future, a comprehensive report published by Public Health Law Watch in partnership with the de Beaumont Foundation and the American Public Health Association
Vaccine Clinical Trials and Data Infrastructure
Get PDFWe find ourselves at a momentous turn in the history of vaccines. The COVID-19 pandemic triggered a quasi-global vaccine race that not only compressed vaccine research and development (R&D) timelines, but also paved the way for the administration of a new type of vaccine technology – mRNA vaccines, which work in substantially different ways from the vaccines in use before the pandemic.
While the process of bringing emerging COVID-19 vaccines to market has taken place in an unusually short timeframe, it was largely predicated on the same scientific and regulatory processes that govern the development, approval and deployment of new vaccines. For decades, these processes have encompassed several phases of vaccine testing – first without and subsequently with the involvement of human subjects – followed by an analysis of the emerging data.
This Essay reflects on the evolution and status quo of the ways in which these data are gathered and disseminated within the context of the development of new vaccines. It treats information stemming from clinical trials as the initial building blocks of our vaccine data infrastructure, and surveys problems related to data collection and disclosure that have long been pervasive in the vaccine R&D ecosystem.
Part I of the Essay situates the discussion of vaccine clinical trial data within historical boundaries. Part I.A travels back in time to the polio vaccine trials of the 1950s in the United States, which were one of the main catalysts of the adoption of the clinical trial structure now in place throughout the world. Part I.B then charts the formalization of the modern vaccine clinical trial model through legislation adopted between the polio and the COVID-19 vaccine races.
Even though this formalization has resulted in a seemingly robust legal framework, there remain multiple problems that affect both the ways in which vaccine clinical trial data is actually generated and then utilized. Using examples from both past vaccine clinical trials and the COVID-19 vaccine race, Part II.A focuses on data collection issues, with an emphasis on the under-representation of minority populations in vaccine clinical trials. Part II.B then considers how imperfectly generated data meet further roadblocks in the form of delayed reporting or lack of reporting of clinical trial results, as well as restrictions to data sharing often attributable to agency interpretations of trade secrecy provisions that have long been disputed by several legal scholars.
These problems affect both the transparency and accountability of vaccine innovation processes, and pose significant hurdles to follow-on R&D. Moreover, and relatedly, they can impair public trust on vaccine innovation processes at a time in which vaccine misinformation is quickly eroding overall levels of trust in vaccination as a public health tool. Part III concludes the Essay by pointing towards emerging ways to enrich the existing vaccine clinical trial data infrastructure. Specifically, it provides a short case study on the COVID-19 data sharing policy implemented in the European Union by its counterpart to the U.S. Food and Drug Administration, the European Medicines Agency. This ad hoc policy quickly expanded the disclosure of information about emerging COVID-19 drugs and vaccines in response to mounting pressure for more transparency about the drug and vaccine approval process. As such, it may be used as a blueprint by regulators elsewhere, as well as by proponents of a more robust system for the disclosure and sharing of clinical trial data
Certificates of Confidentiality: Mind the Gap
Get PDFCertificates of Confidentiality (“Certificates”) are a federal mechanism designed to protect sensitive, identifiable research data from compelled disclosure in any legal proceeding. The 21st Century Cures Act revised the authorizing statute to address criticisms raised about the Certificates’ coverage and protections. Despite many changes that expanded the scope and reinforced the protection of Certificates, questions remain concerning the robustness of the protection Certificates afford. Here, we briefly review the legal evolution of Certificates and then examine the gaps in protections that remain and their implications. We conclude with recommendations for areas of clarification and future research
Conservation Easements and the Proceeds Regulation
Get PDFThis article provides an in-depth look at Treasury Regulation § 1.170A-14(g)(6)(ii), known as the proceeds regulation. The proceeds regulation is intended to protect the public investment in conservation if a perpetual conservation easement that was the subject of a charitable deduction under Internal Revenue Code § 170(h) is later extinguished. A proper understanding of the proceeds regulation is critical because the public investment in deductible easements is significant—billions of dollars are being invested in such easements annually—and the regulation has recently been subject to challenges regarding its interpretation and validity. This article examines the history and operation of the proceeds regulation as well as possible alternatives. It explains that the proceeds regulation provides a simple and easy-to-implement rule that avoids a host of future valuation difficulties. It demonstrates that the proceeds regulation is neither irrational nor inherently unfair to donors or subsequent property owners, and serves to temper the perverse incentive that property owners may have to seek to extinguish easements. This article concludes that the proceeds regulation provides a reasonable solution to the difficult problem of ensuring that the conservation purpose of a contribution will be protected in perpetuity as required by § 170(h)(5)(A)
Sexual Harassment is Not a Crime: Aligning the Uniform Code of Military Justice with Title VII
Get PDFSexual harassment and sexual assault are ongoing problems in the military. The Department of Defense responded in 2019 with sweeping changes in how the military handles sexual misconduct, including a proposal to criminalize sexual harassment in the Uniform Code of Military Justice (UCMJ). This Article, co-authored by an expert on workplace sex discrimination and a former military officer, responds to this proposal. We argue that sexual harassment, however reprehensible, is not criminal conduct. Moreover, criminalization is likely to undermine the military’s efforts to prevent and punish sexual harassment by raising the stakes for the involved service members, thereby deterring reporting, and by imposing a high evidentiary standard. Building on these insights, we propose a set of reforms to the UCMJ aimed at aligning the military justice system with civil employment discrimination law. These proposals include assigning independent authority to investigate and discipline sexual harassment outside the chain of command, using administrative actions that employ a civil burden of proof to adjudicate sexual harassment complaints, and making compensatory damages available to service members for economic and psychological injuries caused by sexual harassment. The military maintains that preserving good order and discipline justifies its independence from the reach of civil courts and law. Federal courts have obliged by holding that Title VII does not cover uniformed military personnel. In exchange for this independence, the military justice system must provide the basic protections of the civilian justice system
Textualism and the Indian Canons of Statutory Construction
Get PDFWhen interpreting statutes enacted for the benefit or regulation of Indians or construing treaties signed with Indian Nations, courts are supposed to apply any of five specific canons of construction relating to the field of Indian Affairs. Through an examination of the Supreme Court’s cases involving statutory or treaty interpretation relating to Indian nations since 1987, this Article demonstrates that the Court has generally been faithful in applying canons relating to treaty interpretation or abrogation. The Court has also respected the canon requiring unequivocal expression of congressional intent before finding an abrogation of tribal sovereign immunity. However, there are two other canons that the Court almost never applies. One requires clear intent to interfere with tribal sovereign rights, the other requires statutes to be construed liberally with ambiguities resolved to the benefit of Indians. After reviewing the possible reasons why textualist jurists might be opposed to the use of substantive canons, this Article makes two arguments to remedy any reluctance to use these two canons: First, these canons have constitutional roots and as such even textualists on the Court should not be reluctant to use them. Secondly, the canon applicable to abrogation of tribal sovereign immunity should also be applied to statutes interfering with tribal sovereign rights. There are no normative reasons to treat abrogation of sovereign immunity differently than other statutory interference with tribal sovereignty
Public Compensation for Public Enforcement
Get PDFPublic enforcement actions frequently result in the distribution of money to people affected by violation of market protection laws. This “public compensation” returns billions of dollars to consumers, investors, and others each year. The law of public compensation appears confusing at first impression because of inconsistent use of nomenclature and conceptual confusion, but courts have developed a discernible set of principles that allow for presumptions and loosened proof standards in awarding this relief. This doctrine held for decades despite repeated challenges by business defendants. The Supreme Court’s decision in Liu v. SEC in June 2020, followed by its grant of certiorari in July 2020 to review enforcement actions brought by the Federal Trade Commission, have unsettled the law.This paper offers two contributions to the development of the law of public compensation. First, we analyze decades of judicial decisions across federal and state public enforcement agencies and identify consensus legal principles for awarding two different forms of public compensation—disgorgement and public restitution. We extend the less developed doctrine of public restitution by suggesting a proportionality test to provide guidance for more difficult cases. Second, we propose legislation to create uniform statutory authority for public enforcers that would reverse restrictions that have been or may be imposed on public compensation by recent and pending Supreme Court decisions. The doctrine and the proposed legislation are grounded in the unique position and authority of public enforcers, including discretion to select between civil penalties and public compensation as monetary remedies, and the deterrence rationale of public enforcement. An appendix includes the model legislation Congress could adopt to clarify and restore enforcement agencies’ public compensation authority
Do You See What I See? The Science Behind Utah Rule of Evidence 617
Get PDFEyewitness identifications play a key role in many investigations and are often central to a prosecutor’s case. At the same time, eyewitness identifications can be tainted, accidentally or purposely, thus tainting the justice system as well. There are myriad reasons for this phenomenon, but the primary responsibility lies not with the witness, but rather a system that fails to recognize, and often amplifies, mistakes and assumptions in the identification process
“Corruptly” Continues Consistently Confounding Courts: A New Look at “Corruptly Persuades” in 18 U.S.C. § 1512(b) Obstruction of Justice
Get PDFThe word “corruptly” presents significant interpretation problems to courts construing the word in statutes. This word has created a circuit split between the Second and Third Circuits over 18 U.S.C. § 1512(b), which forbids corruptly persuading witnesses not to cooperate with federal authorities. The Second Circuit requires defendants to have an improper purpose for persuading a witness not to cooperate. The Third Circuit requires defendants to know they have a corrupt motive behind their persuasion. Rather than declare one approach superior to the other, this Note instead contends that both Circuits achieve the same outcome for two reasons. First, both circuits rely on equivalent connotations for interpreting “corruptly.” Second, both circuits recognize that some motives for persuading a witness are not corrupt, and thus should not be prosecuted under § 1512(b). Even though the Third Circuit better clarifies that persuasion undertaken for innocent purposes should not be prosecuted, this Note demonstrates that the circuit split over § 1512(b) is not as drastic as other analyses claim
Shenanigans (Internet Takedown Edition)
Get PDFProtecting one’s own reputation and livelihood—whether protecting it against lies, against opinions, or against the truth—is likely high on many people’s willing-to-lie-for lists. Making money is, too. Yet though I don’t think of myself as naïve on this score, the sheer magnitude and brazenness of these schemes surprised me. My sense is that it surprised many of my colleagues. Perhaps it surprised you. And this reminder of just how common fraud can be might help keep us alert to shenanigans in many other fields as well— and might help us design systems that deal better with such risks