Policy Feedback and the Politics of Childhood Vaccine Mandates: Conflict and Change in California, 2012-2019.

CONTEXT: In 2012, California instituted a new requirement for parents to consult with a clinician before receiving a personal belief exemption to its school entry vaccine mandate. In 2015, the state removed this exemption altogether. In 2019, legislators cracked down on medical exemptions to address their misuse by vaccine refusers and supportive clinicians. This paper explores these political conflicts using 'policy feedback theory,' arguing that personal belief exemptions informed the emergence and approaches of two coalitions whose conflict reshaped California's vaccination policies. METHODS: We analysed legal, policy, academic and media documents; interviewed ten key informants; and deductively analysed transcripts using NVivo 20 transcription software. FINDINGS: California's long-standing vaccination policy inadvertently disseminated two fundamentally incompatible social norms: vaccination is a choice; vaccination is not a choice. Over time, the culture and number of vaccine refusers grew, at least in part because the policy state-sanctioned the norm of vaccine refusal. CONCLUSIONS: The long-term consequences of California's 'mandate + PBE' policy - visible, public, and socially sanctioned vaccine refusal - undermined support for it over time, generating well-defined losses for a large group of people (the vaccinating public) and specifically for the parent activists whose experiences of personal grievance drove their mobilisation for change.

Limits on Parental Discretion in Medical Decision-Making: pediatric intervention principles converge.

Pediatric intervention principles help clinicians and health-care institutions determine appropriate responses when parents' medical decisions place children at risk. Several intervention principles have been proposed and defended in the pediatric ethics literature. These principles may appear to provide conflicting guidance, but much of that conflict is superficial. First, seemingly different pediatric intervention principles sometimes converge on the same guidance. Second, these principles often aim to solve different problems in pediatrics or to operate in different background conditions. The potential for convergence between intervention principles-or at least an absence of conflict between them-matters for both the theory and practice of pediatric ethics. This article builds on the recent work of a diverse group of pediatric ethicists tasked with identifying consensus guidelines for pediatric decision-making.

Conscientious Objection to Aggressive Interventions for Patients in a Vegetative State.

Some physicians refuse to perform life-sustaining interventions, such as tracheostomy, on patients who are very likely to remain permanently unconscious. To explain their refusal, these clinicians often invoke the language of "futility", but this can be inaccurate and can mask problematic forms of clinical power. This paper explores whether such refusals should instead be framed as conscientious objections. We contend that the refusal to provide interventions for patients very likely to remain permanently unconscious meets widely recognized ethical standards for the exercise of conscience. We conclude that conscientious objection to tracheostomy and other life-sustaining interventions on such patients can be ethical because it does not necessarily constitute a form of invidious discrimination. Furthermore, when a physician frames their refusal as conscientious objection, it makes transparent the value-laden nature of their objection and can better facilitate patient access to the requested treatment.

Making salient ethics arguments about vaccine mandates: A California case study.

Vaccine mandates can take many forms, and different kinds of mandates can implicate an array of values in diverse ways. It follows that good ethics arguments about particular vaccine mandates will attend to the details of individual policies. Furthermore, attention to particular mandate policies-and to attributes of the communities they aim to govern-can also illuminate which ethics arguments may be more salient in particular contexts. If ethicists want their arguments to make a difference in policy, they should attend to these kinds of empirical considerations. This paper focuses on the most common and contentious vaccine mandate reform in the contemporary United States: the elimination of nonmedical exemptions (NMEs) to school and daycare vaccine mandates. It highlights, in particular, debates about California's Senate Bill 277 (SB277), which was the first successful recent effort to eliminate NMEs in that country. We use media, secondary sources, and original interviews with policymakers and activists to identify and evaluate three ethics arguments offered by critics of SB277: parental freedom, informed consent, and children's rights to care and education. We then turn to one ethics argument often offered by advocates of SB277: harm prevention. We note, however, that three arguments for mandates that are common in the immunization ethics literature-fairness/free-riding, children's rights to vaccination, and utilitarianism-did not play a role in debates about SB277.

It's Worth What You Can Sell It for: A Survey of Employment and Compensation Models for Clinical Ethicists.

This article reports results of a survey about employment and compensation models for clinical ethics consultants working in the United States and discusses the relevance of these results for the professionalization of clinical ethics. This project uses self-reported data from healthcare ethics consultants to estimate compensation across different employment models. The average full-time annualized salary of respondents with a clinical doctorate is $188,310.08 (SD=$88,556.67), $146,134.85 (SD=$55,485.63) for those with a non-clinical doctorate, and $113,625.00 (SD=$35,872.96) for those with a masters as their highest degree. Pay differences across degree level and type were statistically significant (F = 3.43; p < .05). In a multivariate model, there is an average increase of $2,707.84 for every additional year of experience, controlling for having a clinical doctorate (ß=0.454; p < .01). Our results also show high variability in the backgrounds and experiences of healthcare ethics consultants and a wide variety of employment models. The significant variation in employment and compensation models is likely to pose a challenge for the professionalization of healthcare ethics consultation.

Pediatric Decision Making: Consensus Recommendations.

Despite apparent disagreement in the scholarly literature on standards of pediatric decision making, a recognition that similar norms underpin many of the dominant frameworks motivated a June 2022 symposium "Best Interests and Beyond: Standards of Decision Making in Pediatrics" in St Louis, MO. Over the course of this 3-day symposium, 17 expert scholars (see author list) deliberated on the question "In the context of US pediatric care, what moral precepts ought to guide parents and clinicians in medical decision making for children?" The symposium and subsequent discussion generated 6 consensus recommendations for pediatric decision making, constructed with the primary goals of accessibility, teachability, and feasibility for practicing clinicians, parents, and legal guardians. In this article, we summarize these recommendations, including their justification, limitations, and remaining concerns.

Eliminating nonmedical exemptions: a radical shift in how childhood vaccine mandates govern.

INTRODUCTION: Every state in the US has had school vaccine mandates for decades, and all except West Virginia and Mississippi offered nonmedical exemptions (NMEs) in addition to medical exemptions. Several states recently eliminated NMEs, and others have attempted to do so. These efforts are transforming America's immunization governance. AREAS COVERED: What we call the 'mandates & exemptions' regime of vaccination policy from the 1960s and 1970s functioned to orient parents toward vaccination, but did not coerce or punish them for not vaccinating. The article identifies how policy tweaks in the 2000s - including education requirements and other bureaucratic burdens - delivered enhancements to the 'mandates & exemptions' regime. Finally, the paper illustrates how the recent elimination of NMEs, first in California and then in other states, represents a radical transformation of America's vaccine mandates. EXPERT OPINION: Today's 'unencumbered vaccine mandates' (mandates without exemptions) directly govern and punish non-vaccination, unlike the 'mandates & exemption' regime that aimed to make it harder for parents to avoid vaccination. This kind of policy change introduces new problems for implementation and enforcement, especially within America's underfunded public health system, and in the context of post-COVID public health political conflicts.

Ethics of age de-escalation in pediatric vaccine trials: Attending to the case of COVID-19.

In the development of new vaccines, many trials use age de-escalation: after establishing safety and efficacy in adult populations, progressively younger cohorts are enrolled and studied. Age de-escalation promotes many values. The responsibility to protect children from potential risks of experimental vaccines is significant, not only given increased risks of adverse effects but also because parents and medical professionals have a moral responsibility to protect children from harms associated with novel, uncertain interventions. Further, given that young children cannot provide informed consent, acceptable risks for research requiring proxy consent are lower than for adults making decisions for themselves. Although age de-escalation approaches are widely used in vaccine trials, including notably in the recent development of pediatric COVID-19 vaccines, ethicists have not addressed the benefits and risks of these approaches. Their benefits are largely assumed and unstated, while their potential risks are usually overlooked. There are no official ethics guidelines for the use of age de-escalation in clinical research. In this paper, we provide a systematic account of key moral factors to consider when employing age de-escalation. Analyzing pediatric COVID-19 vaccine development as our key case study, we clarify the benefits, risks, and trade-offs involved in age de-escalation approaches and call for the development of evidence-based best practice guidelines to identify when age de-escalation is likely to be an ethical strategy in vaccine development.

School staff as vaccine advocates: Perspectives on vaccine mandates and the student registration process.

Recently, several states in the US have made it more difficult to receive nonmedical exemptions to school vaccine mandates in the hope of better orienting parents towards vaccination. However, little is known about how public-facing school staff implement and enforce mandate policies, including why or how often they steer parents towards nonmedical exemptions. This study focused on Michigan, which has recently added an additional burden for families seeking nonmedical exemptions. We used an anonymous online survey to assess Michigan public-school employees (n = 157) about their knowledge, attitudes, and behaviors regarding Michigan's school enrollment vaccine mandate policy. Our main conclusions are that frontline school staff are generally knowledgeable about vaccines and immunization policy, but are at best ambivalent about their role in immunization governance, believing that other agents should be responsible for ensuring that children are vaccinated. Furthermore, some respondents indicated low vaccine confidence, which was associated with increased ambivalence about, or opposition to, their role in immunization governance. As more jurisdictions within and beyond the US consider introducing or tightening childhood vaccine mandates, it is increasingly important to understand how these policies can be improved by attending to the attitudes and roles of relevant frontline actors.

COVID-19 Vaccination Concerns and Reasons for Acceptance Among US Health Care Personnel.

OBJECTIVES: Because health care personnel (HCP) are potentially at increased risk of contracting COVID-19, high vaccination rates in this population are essential. The objective of this study was to assess vaccination status, barriers to vaccination, reasons for vaccine acceptance, and concerns about COVID-19 vaccination among HCP. METHODS: We conducted an anonymous online survey at a large US health care system from April 9 through May 4, 2021, to assess COVID-19 vaccination status and endorsement of reasons for acceptance and concerns related to vaccination (based on selections from a provided list). RESULTS: A total of 4603 HCP (12.2% response rate) completed the survey, 3947 (85.7%) had received at least 1 dose of a COVID-19 vaccine at the time of the survey, and 550 (11.9%) reported no plans to receive the vaccine. Unvaccinated HCP were 30 times more likely than vaccinated HCP to endorse religious or personal beliefs as a vaccine concern (odds ratio = 30.95; 95% CI, 21.06-45.48) and 15 times more likely to believe that personal vaccination is not needed if enough others are vaccinated (odds ratio = 14.99; 95% CI, 10.84-20.72). The more reasons endorsed for vaccination (ß = 0.60; P < .001), the higher the likelihood of having received the vaccine. However, the number of concerns about COVID-19 vaccine was not related to vaccination status (ß = 1.01; P = .64). CONCLUSIONS: Our findings suggest that reasons for vaccination acceptance and concerns about vaccination need to be considered to better understand behavioral choices related to COVID-19 vaccination among HCP, because these beliefs may affect vaccination advocacy, responses to vaccine mandates, and promotion of COVID-19 vaccine boosters.

COVID-19 Vaccine Hesitancy Among Healthcare Personnel Who Generally Accept Vaccines.

To identify psychological antecedents of COVID-19 vaccine hesitancy among healthcare personnel (HCP). We surveyed 4603 HCP to assess psychological antecedents of their vaccination decisions (the '5 Cs') for vaccines in general and for COVID-19 vaccines. Most HCP accept vaccines, but many expressed hesitancy about COVID-19 vaccines for the psychological antecedents of vaccination: confidence (vaccines are effective), complacency (vaccines are unnecessary), constraints (difficult to access), calculation (risks/benefits), collective responsibility (need for vaccination when others vaccinate). HCP who were hesitant only about COVID-19 vaccines differed from HCP who were consistently hesitant: those with lower confidence were more likely to be younger and women, higher constraints were more likely to have clinical positions, higher complacency were more likely to have recently cared for COVID-19 patients, and lesser collective responsibility were more likely to be non-white. These results can inform interventions to encourage uptake of COVID-19 vaccines in HCP.

Three Kinds of Decision-Making Capacity for Refusing Medical Interventions.

According to a standard account of patient decision-making capacity (DMC), patients can provide ethically valid consent or refusal only if they are able to understand and appreciate their medical condition and can comparatively evaluate all offered treatment options. We argue instead that some patient refusals can be capacitated, and therefore ethically authoritative, without meeting the strict criteria of this standard account-what we call comparative DMC. We describe how patients may possess burdens-based DMC for refusal if they have an overriding objection to at least one burden associated with each treatment option or goals-based DMC for refusal if they have an overriding goal that is inconsistent with treatment. The overridingness of a patient's objections to burdens, or of their commitment to a goal, can justify the moral authority of their refusal, even when a patient lacks some of the cognitive capacities that standard accounts of DMC involve.

Practising what we preach: clinical ethicists' professional perspectives and personal use of advance directives.

The field of clinical bioethics strongly advocates for the use of advance directives to promote patient autonomy, particularly at the end of life. This paper reports a study of clinical bioethicists' perceptions of the professional consensus about advance directives, as well as their personal advance care planning practices. We find that clinical bioethicists are often sceptical about the value of advance directives, and their personal choices about advance directives often deviate from what clinical ethicists acknowledge to be their profession's recommendations. Moreover, our respondents identified a pluralistic set of justifications for completing treatment directives and designating surrogates, even while the consensus view focuses on patient autonomy. Our results suggest important revisions to academic discussion and public-facing advocacy about advance care planning.

Imperfect Immunization Communication on School District Websites: A Mixed-Methods Review.

Schools and school districts are key to U.S. vaccination policies: They communicate immunization enrollment requirements and enforce them during registration. This article presents a mixed-methods study of how Michigan's 537 districts communicate about vaccine mandates through public-facing websites. It reports the results of a qualitative analysis (n = 50) of websites from Southeast Michigan and a quantitative analysis of all (n = 537) Michigan's district websites. School district websites engage in diverse health promotion practices surrounding immunization, from encouraging vaccination to neutral messaging and to encouraging exemptions. Most provide scant immunization information and few promote the importance of immunization for individual and community health. We recommend that school nurses, district staff, and health authorities collaborate to ensure that school district communication promotes immunization and does not promote nonmedical exemptions. This can lead schools to embrace immunization as an essential activity for their own functioning rather than as an unwelcome requirement imposed by outside agents.

The capacity to designate a surrogate is distinct from decisional capacity: normative and empirical considerations.

The capacity to designate a surrogate (CDS) is not simply another kind of medical decision-making capacity (DMC). A patient with DMC can express a preference, understand information relevant to that choice, appreciate the significance of that information for their clinical condition, and reason about their choice in light of their goals and values. In contrast, a patient can possess the CDS even if they cannot appreciate their condition or reason about the relative risks and benefits of their options. Patients who lack DMC for many or most kinds of medical choices may nonetheless possess the CDS, particularly since the complex means-ends reasoning required by DMC is one of the first capacities to be lost in progressive cognitive diseases (eg, Alzheimer's disease). That is, patients with significant cognitive decline or mental illness may still understand what a surrogate does, express a preference about a potential surrogate, and be able to provide some kind of justification for that selection. Moreover, there are many legitimate and relevant rationales for surrogate selection that are inconsistent with the reasoning criterion of DMC. Unfortunately, many patients are prevented from designating a surrogate if they are judged to lack DMC. When such patients possess the CDS, this practice is ethically wrong, legally dubious and imposes avoidable burdens on healthcare institutions.

School staff and immunization governance: Missed opportunities for public health promotion.

BACKGROUND: In US states, childhood immunization mandates are enforced for school registration by front-line school staff, usually secretaries. Despite substantial changes to mandate policies in several states and many countries, little attention has been paid to the people who enforce them. This qualitative pilot study aimed to uncover beliefs, attitudes, and practices regarding immunization governance of Michigan school staff. METHOD: Front-line administrative workers from Michigan schools and district offices were solicited by email. Sixteen were interviewed remotely. RESULTS: Front-line school staff believed in vaccines, but did not advocate for vaccination while registering children. Instead, they sought low-friction bureaucratic transactions, privileging the collection of data over the promotion of public health goals. This revealed a mismatch between the goals of the front-line staff who enforce vaccine mandates in schools and the goals of the policymakers who created school vaccine mandates. CONCLUSIONS: This study found low mobilization of front-line enforcers of mandates in public-facing school administration roles, a problem likely to afflict the majority of American states with the 'mandates + exemptions' model of immunization governance. Schools would have stronger incentives to promote vaccination if state funding were better tied to immunization compliance. Front-line staff could better enforce vaccine mandates if they were provided with resources and training about vaccine promotion.