Just Compensation: A No-Fault Proposal for Research-Related Injuries

Biomedical research, no matter how well designed and ethically conducted, carries uncertainties and exposes participants to risk of injury. Research injuries can range from the relatively minor to those that result in hospitalization, permanent disability, or even death. Participants might also suffer a range of economic harms related to their injuries. Unlike the vast majority of developed countries, which have implemented no-fault compensation systems, the United States continues to rely on the tort system to compensate injured research participants—an approach that is no longer morally defensible. Despite decades of US advisory panels advocating for no-fault compensation, little progress has been made. Accordingly, this article proposes a novel and necessary no-fault compensation system, grounded in the ethical notion of compensatory justice. This first-of-its-kind concrete proposal aims to treat like cases alike, offer fair compensation, and disburse compensation with maximum efficiency and minimum administrative cost. It also harmonizes national and international approaches—an increasingly important goal as research becomes more globalized, multi-site trials grow in number, and institutions and sponsors in the United States move to single-IRB review

Deciphering Dignity

This commentary draws on dignity’s usage in law, ethics, and public policy to contemplate a narrow question about what the concept of dignity means in debates about human enhancement technologies. In particular, it considers arguments made by Fabrice Jotterand and other bioethicists who aim to repudiate the transhumanist claim that individuals can enhance their dignity through technological modification. The trouble with the positions on both sides of this debate is that it is extremely difficult to make normative comparisons about human and post-human dignity without first infusing dignity with particular metaphysical assumptions. To that end, the commentary offers a brief taxonomy of dignity to illustrate the various meanings of dignity that animate the debate between Jotterand and the transhumanists, and it demonstrates how the taxonomy can clarify and lend moral salience to the issues at hand

Book Review: Human Dignity and Bioethics: Essays Commissioned by the President\u27s Council on Bioethics

The President’s Council on Bioethics frequently invokes -- but never defines -- the notion of human dignity in its reports on caregiving, stem-cell research, cloning, assisted reproduction, and biomedical enhancement. This article argues that the Council employs the language of dignity so loosely in its policy recommendations that the word is often nothing more than a rhetorical trump card to reject policies at odds with the Bush administration’s perspective. This article examines how the Council uses the word dignity; explores competing philosophical, theological, and political understandings of the word; and suggests ways in which a more productive dialogue about dignity\u27s meaning can proceed

Revising the Common Rule: Prospects and Challenges

The annual Bioethics and Law Roundtable, jointly sponsored by the Law & Health Care Program at the University of Maryland Francis King Carey School of Law and the Johns Hopkins Berman Institute of Bioethics, convened in April 2012 to address Human Subjects Research Regulations: Proposals for Reform. This paper serves as the introduction to the seven papers presented at the symposium that discuss the prospects and challenges of revising the Common Rule

Moral Gridlock: Conceptual Barriers to No-Fault Compensation for Injured Research Subjects

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. In at least one critical way, however, the regulations have always fallen short of this promise: if a subject suffers a research-related injury, then neither the investigator nor the sponsor has any legal obligation under the regulations to care for or compensate the subject. Because very few subjects with research-related injuries can meet the financial or evidentiary requirements associated with a successful legal claim to recover the costs associated with their injuries, most injured subjects must shoulder the burden of those expenses alone. For 40 years, national advisory panels have concluded that this result is out of step with the Common Rule\u27s otherwise protectionist promise. When the Department of Health and Human Services released an Advance Notice of Proposed Rulemaking (ANPRM) in 2011, suggesting potential changes to the Common Rule, the time seemed ripe to address research-related injuries. The ANPRM, however, makes no mention of compensation for research-related injuries, and the federal government once again seems poised to stop short of addressing what has arguably become the most longstanding, frequent, and consistent plea for regulatory reform of research: protections for injured subjects. This article asks why, despite decades of federal-level panels recommending no-fault compensation for research-related injuries, the United States has so strongly resisted change. I suggest that a central reason for our current impasse is that, despite consensus among federal advisory committees that there is an obligation to compensate injured subjects, the committees have not coalesced around a moral justification for that duty. Although multiple justifications can support and even strengthen a single ethical obligation, the reverse has occurred in this context. I demonstrate that the committees\u27 articulation of multiple ethical principles—including humanitarianism, professional beneficence, and compensatory justice—results in incongruent obligations that favor different kinds of compensation systems. This outcome, which I call “moral gridlock,” makes it extremely difficult to determine what kind of compensation scheme to implement. Recognizing that each moral argument for compensation creates a slightly different trajectory is, however, an important first step in moving toward a more systematic approach to compensating injured research subjects

The Jurisprudence of Dignity

Few words play a more central role in modern constitutional law without appearing in the Constitution than dignity. The term appears in nearly one thousand Supreme Court opinions, but despite its popularity, dignity is a concept in disarray. Its meaning and functions are commonly presupposed, but rarely articulated. The result is a cacophony of uses so confusing that some critics argue that word ought to be abandoned altogether. This Article fills a void in the literature by offering the first empirical study of Supreme Court opinions that invoke dignity, and then proposing a typology of dignity based on a Wittgensteinian analysis of those opinions. The dataset reveals three important findings. First, the Court’s reliance on dignity is increasing, and the Roberts Court is accelerating that trend. Second, in contrast to its past use, the more conservative Justices on the Court are now as likely to invoke dignity as their more liberal counterparts. Finally, the dataset demonstrates that dignity is not one concept, as other scholars have theorized, but rather that dignity admits of five related conceptions. The typology refers to these conceptions of dignity as: institutional status as dignity, liberty as dignity, equality as dignity, personal integrity as dignity, and collective virtue as dignity. This Article traces each type of dignity to its epistemic origins and describes the substantive dignitary interests each protects. Importantly, the typology offers more than a clarification of the conceptual chaos surrounding dignity. It provides tools to track the Court’s use of different types of dignity over time. This permits us to detect doctrinally transformative moments, in such areas as state sovereign immunity and abortion jurisprudence, which arise from shifting conceptions of dignity

Commerce Games and the Individual Mandate

While the Supreme Court declined an early invitation to resolve challenges to the Patient Protection and Affordable Care Act (“PPACA”), a recent split between the United States Courts of Appeals for the Sixth Circuit (sustaining the PPACA’s “individual mandate”) and the Eleventh Circuit (striking it down) virtually ensures that the Court will decide the fate of this centerpiece of the Obama Administration’s regulatory agenda. Whatever the Court’s decision, it will likely affect Commerce Clause doctrine- and related doctrines - for years or even decades to come. Litigants, judges, and academic commentators have focused on whether the Court’s “economic activity” tests, as set forth in Lopez v. United States, permits the individual mandate. This Article approaches the constitutionality of that provision from a novel perspective, one that proves essential in applying past Commerce Clause decisions, including Lopez, to the PPACA and in appreciating the real stakes involved in upending the individual mandate. By analyzing the Court’s Commerce Clause jurisprudence through the lens of game theory, we expose common features of games that have resulted in limiting state powers on the dormant side of the Commerce Clause doctrine, and of sustaining and restricting congressional powers on the affirmative side. Applying such games as the “prisoners’ dilemma,” and “the battle of the sexes,” yields critical insights about the nature and limits of state and federal regulatory powers. Our game theoretical analysis shows that while debates have centered on the role of the individual mandate in solving a micro-level separating game among low-risk individuals who do not purchase insurance and high-risk individuals who cannot afford it, a more compelling account focuses on the Act’s role in solving a macro-separating game played among the states. By comparing the PPACA to several important policy splits among states- public accommodations laws, abortion funding, the death penalty, civil remedies for violent crime against women, and same sex marriage- we demonstrate that the Act, including the individual mandate, fits well within those cases for which congressional commerce power is justified to avoid the risk that competing state policies will force other states into a problematic separating game thereby undermining the selected regulatory policy. Our analysis reconciles congressional power to implement the PPACA with the post-New Deal expansions and recent retrenchments of Congress’s Commerce Clause powers

Visionary Pragmatism and the Value of Privacy in the Twenty-First Century

Part I of our Review discusses the central premises of Understanding Privacy, with particular attention paid to Solove\u27s pragmatic methodology and his taxonomy of privacy. We introduce his pluralistic approach to conceptualizing privacy, which urges decision makers to assess privacy problems in context, and we explore his view that meaningful choices about privacy depend on an appreciation of how privacy benefits society as a whole. We also describe how Solove\u27s taxonomy aims to account for the variety of activities that threaten privacy. In Part II, we analyze the strengths of Solove\u27s pragmatism by demonstrating its functionality and flexibility in the face of evolving challenges like government-run fusion centers and the government\u27s use of social-media technologies to interact with the public. Part III contends that Solove\u27s pragmatic approach to balancing privacy against competing interests might benefit from more detailed instruction to policymakers. In this regard, we offer several suggestions to ensure the framework\u27s continued vitality