In this article, we examine the legality and ethics of a controversial but widespread practice in clinical research: choice-masking nudges. A choice-masking nudge (CMN) exists when a research team explicitly obscures a meaningful choice from participants by presenting a default decision as the standard way forward. Even though an easy-to-use opt-out mechanism is available for participants who independently express concerns with the standard default, the fact that a default has been pre-selected is not made obvious to research participants. To opt out of the nudge, a participant must overtly request non-standard treatment. We argue that use of such nudges in medical research can be justified by their individual, collective, and social benefits, provided that they respect autonomy and satisfy our four further acceptability conditions. The structure of this Article is as follows. In Part II, we describe three controversial cases of CMNs in medical research. In Part III, we provide background on nudging and explain how our proposed CMNs fit into the existing literature on nudging and libertarian paternalism. In Part IV, we explain how the reasonable person standard as employed by United States research regulations can be used to support CMNs. In Part IV, we anticipate some of the strongest objections to CMNs by explaining how CMNs are compatible with a wide range of plausible accounts of autonomy. Finally, in Part VI, we discuss four additional core considerations an acceptable CMN must meet: legitimate policy goals; benefits outweighing harms; burdens distributed fairly; and absence of ethically superior feasible alternatives. We also analyze the three existing controversies explored in Part II and show how each would benefit from the conceptual clarity offered by our analytic framework. Medical research is complicated and can be difficult for participants to understand; thoughtfully designed CMNs can play an important role in gently guiding large numbers of research participants toward decision outcomes that really are best for them and their communities.
Vaccination benefits both individuals and communities. Vaccinated people gain protection against a disease. The community benefits, because each vaccinated individual is one fewer person who is spreading the disease. When a parent agrees to vaccinate a child, therefore, two things happen: the child is protected from contracting the disease, and the child’s community gains a measure of protection because the child doesn’t spread the disease. That community inevitably includes people who are too young or too fragile to be safely vaccinated and whose protection depends on a community of non-spreaders, a concept called “herd immunity.” Vaccination has been so successful in eliminating communicable diseases that it has been described as “one of the greatest achievements” of public health in the twentieth century. In a vanishingly small number of cases, a child may suffer long-term disability after receiving a vaccination. In part out of a recognition of the public need for herd immunity, Congress adopted the National Childhood Vaccine Injury Act of 1986 to ensure that people harmed after vaccination receive compensation. A gap exists in the scheme, however. When caring for the disabled child is incompatible with a parent’s market participation, the parent’s lost income is not covered. Instead of being celebrated for contributing to the public good, the parent, child and family suffer long-term financial harm. This article argues that the cases interpreting the Act as denying compensation for the efforts of parents to care for their sick child, while consistent, should be overturned. The argument has two parts. First, the cases wrongly refuse to interpret the word “expenses” to include compensation for a parent’s lost wages. Second, the narrow and unjustified interpretation of “expenses” should be rejected because the interpretation imposes and reinforces disadvantages experienced by children who experience a disability after a vaccination, by mothers and fathers who are meeting a child’s unusual levels of caregiving needs, and by low-income families who cannot afford to hire substitute caregivers. Strong public policy arguments with respect to each group demonstrate how the flawed interpretation of the Act is, quite simply, unfair.
Issues surrounding disclosure of pharmaceutical side effects are complicated. The literature abounds with pragm atic concerns regarding limited time or pharmacologic expertise in the clinic, patient nonadherence, and unintended nocebo effects, as well as philosophical arguments over the limits of autonomy, importance of shared decision-making, and the legal mandate to garner informed consent. Yet the actual thoughts and feelings of patients are largely missing from the literature. To investigate in greater depth and expand the debate to capture patients’ perspectives, we conducted a national survey exploring the gap between what patients want to be told about prescription drug risk and what they are actually told. Results from our research study indicate that many patients report having been “blind-sided” by previously undisclosed drug side effects and that a doctor’s failure to warn can result in considerable harm to both patient health and the doctor-patient relationship. Of real concern – and heretofore under-emphasized import – is the potential for erosion of the patient’s trust, which we argue offers a fresh evidentiary rationale to revisit the © 2021 Joshua E. Perry, Dena Cox, Anthony Cox, Dale B. Thompson Graf Family Professor and Chair, Department of Business Law & Ethics, Kelley School of Business, Indiana University. Professor Emerita, Kelley School of Business and IU School of Medicine, Indiana University. Professor Emeritus, Kelley School of Business and IU School of Medicine, Indiana University. Professor of Ethics & Business Law, Opus College of Business, University of St. Thomas. PERRY 02 (DO NOT DELETE) 3/16/2021 12:48 PM 28 JOURNAL OF HEALTH CARE LAW & POLICY [VOL. 24:1 legal standard for what constitutes adequate patient consent and the importance of securing it.
The inclusion of wellness programs that provide not just rewards but also penalties in private and public health coverage is problematic. Wellness incentives admittedly can further the principle of distributive justice by encouraging individuals to take more responsibility for their health. The punitive forms of these incentives, however, inappropriately elevate individual responsibility for health while ignoring the larger, systemic contributors to chronic diseases and conditions. This article examines these issues in the context of employer-sponsored wellness programs and Medicaid personal responsibility requirements. It first considers the history and increasing devolution of responsibility for health onto individuals through legal changes in employer-sponsored wellness programs and personal responsibility requirements in Medicaid programs. It then examines policy and ethical considerations regarding these changes. The article concludes that the degree to which we currently allocate responsibility for health onto individual behavior versus the government is ethically problematic and likely to lead to poor societal and financial outcomes. Individual choice has a role to play, but only in concert with collective legal action on larger policy issues.
The article discusses the policy of the Michigan-based Henry Ford Health System that protects healthcare professionals from the racist and biased demands of patients. Topics discussed include the obligation to treat all patients despite their personal characteristics under the Emergency Medical Treatment and Active Labor Act (EMTALA), the policy guidelines for operational leaders responding to requests to change assigned care providers, and effect of COVID-19 on the policy education rollout.
Responding to infectious disease emergencies is critically dependent upon the collection, analysis, and sharing of relevant data.1 These data include clinical, epidemiological, laboratory, surveillance, emergency response, geospatial, health facility data, knowledge, attitude and practices surveys, and pathogen genetic sequences.2 In contexts where the pathogen is unknown, or where there is no licensed biomedical intervention, relevant data also includes results from research into diagnostics, therapeutics, and vaccines.3 Recent infectious disease emergencies, including and perhaps especially the COVID-19 pandemic, have demonstrated that commercial and scientific proprietary claims have impeded critical data sharing.4 These claims are based on an incoherent patchwork of legal and ethical guidelines that often deteriorate in the face of infectious disease emergencies, creating major barriers to data sharing.5 These problems are exacerbated by some of the current incentives put in place by governments, funders, and medical journals.6 As we are witnessing today, climate change, urbanization and conflict are factors contributing to the emergence of novel pathogens that are likely to threaten human health security, it is crucial to identify the legal, social, and ethical barriers to data sharing and construct solutions to them now, before responders are in the midst of an infectious disease emergency.7
