Nudging Immunity: The Case for Vaccinating Children in School and Day Care by Default

Abstract

Many parents are hesitant about, or face motivational barriers to, vaccinating their children. In this paper, we propose a type of vaccination policy that could be implemented either in addition to coercive vaccination or as an alternative to it in order to increase paediatric vaccination uptake in a non-coercive way. We propose the use of vaccination nudges that exploit the very same decision biases that often undermine vaccination uptake. In particular, we propose a policy under which children would be vaccinated at school or day-care by default, without requiring parental authorization, but with parents retaining the right to opt their children out of vaccination. We show that such a policy is (1) likely to be effective, at least in cases in which non-vaccination is due to practical obstacles, rather than to strong beliefs about vaccines, (2) ethically acceptable and less controversial than some alternatives because it is not coercive and affects individual autonomy only in a morally unproblematic way, and (3) likely to receive support from the UK public, on the basis of original empirical research we have conducted on the lay public.

Implementation of Japan’s First Clinical Research Regulatory Law: Background, Overview, and Challenges

Abstract

In April 2018, Japan’s first law regulating clinical research went into effect. The law aimed to strengthen regulations on research integrity and conflicts of interest, which had been limited under existing administrative guidelines; the law also provided stipulations for legal penalties. The scope of the new regulations, however, is limited entirely to studies that evaluate unapproved drugs or the off-label use of approved drugs, and those that receive funding from companies. On the other hand, the law’s application brings numerous complications, including the establishment of new review committees, troublesome procedures for transitioning studies that are currently underway, and ambiguities about the scope of what constitutes best efforts. Thus, the change has led to substantial strain and confusion in the field. This paper offers an overview of the law and its background, and discusses its future prospects from the practical standpoint of managing ethics committees and providing research ethics support in the field.

Transformation of the Doctor–Patient Relationship: Big Data, Accountable Care, and Predictive Health Analytics

Abstract

The medical profession is steeped in traditions that guide its practice. These traditions were developed to preserve the well-being of patients. Transformations in science, technology, and society, while maintaining a self-governance structure that drives the goal of care provision, have remained hallmarks of the profession. The purpose of this paper is to examine ethical challenges in health care as it relates to Big Data, Accountable Care Organizations, and Health Care Predictive Analytics using the principles of biomedical ethics laid out by Beauchamp and Childress (autonomy, beneficence, non-maleficence, and justice). Among these are the use of Electronic Health Records within stipulations of the Health Insurance Portability and Accountability Act. Clinicians are well-positioned to impact health policy development to address ethical issues associated with the use of Big Data, Accountable Care, and Health Care Predictive Analytics as we work to transform the doctor–patient relationship towards improving population health outcomes and creating a healthier society.

The Place for Religious Content in Clinical Ethics Consultations: A Reply to Janet Malek

Abstract

Janet Malek (HEC Forum 31(2):91–102, 2019) argues that a “clinical ethics consultant’s religious worldview has no place in developing ethical recommendations or communicating about them with patients, surrogates, and clinicians.” She offers five types of arguments in support of this thesis: arguments from (i) consensus, (ii) clarity, (iii) availability, (iv) consistency, and (v) autonomy. This essay shows that there are serious problems for each of Malek’s arguments. None of them is sufficient to motivate her thesis (nor are they jointly sufficient). Thus, if it is true that the religious worldview of clinical ethics consultants (CECs) should play no role whatsoever in their work as consultants, this claim will need to be defended on some other ground.

Bills as Band-Aids: Hopes and Challenges of Expanding Pharmacists’ Prescriptive Authority to Include Contraceptives

Abstract

This paper critically examines the implications of state efforts to expand prescriptive authority of pharmacists, which will allow them to prescribe various types of hormonal contraceptives. With this expansion, women no longer need to see a physician before being prescribed such contraceptives, but instead, they must answer self-assessment questionnaires at the pharmacy to ensure that their chosen method is safe and appropriate. This paper argues that while these measures to expand pharmacists’ prescriptive authority will surely meet the stated goal to increase access to hormonal contraceptives, the measures may have detrimental consequences that have largely been downplayed. Studies consistently show that the OB-GYN is a significant primary care provider identified by young female patients, and some of the main reasons provided by these young women for going to the OB-GYN is to discuss, or obtain a prescription for, contraceptives. Through the expansion of pharmacists’ prescriptive authority, a likely consequence is that some women will relinquish going to the OB-GYN. However, the OB-GYN provides important services beyond contraceptives, such as preventive screenings for hypertension, cardiovascular diseases, alcohol abuse, mental health, etc., and there is evidence supporting both the effectiveness and cost–benefits of these interventions. By increasing access to contraceptives, the likely result is that many women will have less interaction with a physician and will receive fewer preventive screenings. I do not wish to suggest that these bills should not pass, nor that OB-GYNs should hold contraceptives hostage, only that there are consequences to expanded prescriptive authority that must be anticipated. Further, expanding prescriptive authority obscures the real problem: some individuals have trouble accessing the health care system, not merely trouble accessing hormonal contraceptives. The expansion of prescriptive authority to include contraceptives applies a Band-Aid to treat one aspect of this problem. What is needed is not merely expanded access to hormonal contraceptives, but better access to health care in general.

Making Medical Decisions for Incapacitated Patients Without Proxies: Part II

Abstract

In the United States, there is no consensus about who should make decisions in acute but non-emergent situations for incapacitated patients who lack surrogates. For more than a decade, our academic medical center has utilized community volunteers from the hospital ethics committee to engage in shared decision-making with the medical providers for these patients. In order to add a different point of view and minimize conflict of interest, the volunteers are non-clinicians who are not employed by the hospital. Using case examples and interviews with the community members, this paper describes how the protocol has translated into practice over the years since its inception. Members reported comfort with the role as well as satisfaction with the thoroughness of their discussions with the medical team. They acknowledged feelings of moral uncertainty, but expressed confidence in the process. Questions raised by the experience are discussed. Overall, the protocol has provided oversight, transparency, and protection from conflict of interest to the decision-making process for this vulnerable patient population.

Making Medical Decisions for Incapacitated Patients Without Proxies: Part I

Abstract

To date no one has identified or described the population of incapacitated patients being treated in an inpatient setting who lack proxy decision-makers. Nor, despite repeated calls for protocols to be developed for decision-making, has any institution reported on the utilization of such a protocol. In 2005, our urban tertiary care hospital instituted a protocol utilizing community members of the ethics committee to meet with the medical providers and engage in shared decision-making for patients without proxies (PWPs). We conducted a retrospective chart review and in this paper describe nearly 200 patients who were identified and treated according to the protocol over a 12 year period. After an aggressive search, family members were located for a surprising number of patients, leaving 80 patients who needed decisions to be made utilizing the PWP committee. We review the decisions required, the results of the shared decision-making meetings, and the patient outcomes. Our experience has shown that a protocol involving community volunteers to make decisions for PWPs in a timely manner is feasible and ethically defensible. The protocol has been accepted by physicians and utilized with increasing frequency. Because it was possible to gather at least minimal information on most patients, a standard of “informed best interest” was used to make decisions. PWP committee recommendations varied, but in all cases agreement was reached with the attending physicians.

Clinical Ethics Needs Assessment: Adapting Clinical Ethics to a Population Health Program

Abstract

The clinical encounter between providers and patients is insufficient: most factors influencing health outcomes occur outside the clinic. Community Health Needs Assessments address this insufficiency via collaboration between hospitals and the communities they serve to address systemic sociological-economic variables impacting health outcomes. Considering this, why are Health Care Ethics Consultation (HCEC) services limited to the clinical setting? We can cultivate better ethics outcomes by addressing systemic sociological-economic factors that cause recurring ethics issues in the hospital. In this article, I argue for the need for a Community Ethics Needs Assessment (CENA). CENA is a novel concept; thus, this article is exploratory. I argue for the necessity of a CENA and, more importantly, outline what methodology a CENA would use to both identify and address an ethics need.

Rural Bioethics: The Alaska Context

Abstract

With by far the lowest population density in the United States, myriad challenges attach to healthcare delivery in Alaska. In the “Size, Population, and (In)Accessibility” section, we characterize this geographic context, including how it is exacerbated by lack of infrastructure. In the “Distributing Healthcare” section, we turn to healthcare economics and staffing, showing how these bear on delivery—and are exacerbated by geography. In the “Health Care in Rural Alaska” section, we turn to rural care, exploring in more depth what healthcare delivery looks like outside of Alaska’s major cities. This discussion continues in the “Alaska’s Native Villages” section, which specifically analyzes healthcare in Alaska’s indigenous villages, some of the smallest and most isolated communities in the United States. Though many of the ways we could improve Alaskan health care for Alaskan residents are limited by its unique features, the “Justice and Healthcare Delivery” and “Technology and Telemedicine” sections consider ways in which certain policies and technology—including telemedicine—could mitigate the challenges developed in previous sections.