Beneath the Sword of Damocles: Moral Obligations of Physicians in a Post-Dobbs Landscape.

Since the U.S. Supreme Court's decision in Dobbs vs. Jackson Women's Health Organization, a growing web of state laws restricts access to abortion. Here we consider how, ethically, doctors should respond when terminating a pregnancy is clinically indicated but state law imposes restrictions on doing so. We offer a typology of cases in which the dilemma emerges and a brief sketch of the current state of legal prohibitions against providing such care. We examine the issue from the standpoints of conscience, professional ethics, and civil disobedience and conclude that it is almost always morally permissible and praiseworthy to break the law and that, in a subset of cases, it is morally obligatory to do so. We further argue that health care institutions that employ or credential physicians to provide reproductive health care have an ethical duty to provide a basic suite of practical supports for them as they work to ethically resolve the dilemmas before them.

'Staying in the lane' of public health? Boundary-work in the roles of state health officials and experts in COVID-19 policymaking.

The state-level COVID-19 response in the United States necessitated collaboration between governor' offices, health departments and numerous other departments and outside experts. To gain insight into how health officials and experts contributed to advising on COVID-19 policies, we conducted semi-structured interviews with 25 individuals with a health specialisation who were involved in COVID-19 policymaking, taking place between February and December 2022. We found two diverging understandings of the role of health officials and experts in COVID-19 policymaking: the role of 'staying in the lane' of public health in terms of the information that they collected, their advocacy for policies and their area of expertise and the role of engaging in the balancing of multiple considerations, such as public health, feasibility and competing objectives (such as the economy) in the crafting of pandemic policy. We draw on the concept of boundary-work to examine how these roles were constructed. We conclude by considering the appropriateness as well as the ethical implications of these two approaches to public health policymaking.

Predictors of student mask mandate policies in United States school districts during the COVID-19 pandemic.

Introduction: Although factors such as urbanicity, population demographics, and political affiliation have been linked with COVID-19 masking behavior and policy in community settings, little work has investigated factors associated with school mask policies. We sought to characterize United States state and school district student COVID-19 masking policies during the 2021-22 school year and determine predictors of these mandates at four time points, including before and after federal guidance relaxed school mask recommendations in February 2022. Methods: Student mask policies for US states and the District of Columbia, as well as a sample of 56 districts were categorized as prohibited, recommended, or required in September 2021, November 2021, January 2022, and March 2022 based on the Johns Hopkins eSchool+ Initiative School Reopening Tracker. Changes in policies over time were characterized. Generalized estimating equations and logistic regression were used to evaluate whether political affiliation of governor, urbanicity, economic disadvantage, and race/ethnic composition of district students, and county-level COVID-19 incidence predicted the presence of a district mask mandate at any time point and at all four time points. Results: State and district policies changed over time. Districts that implemented student mandates at any point were more likely to be in states with Democratic governors (AOR: 5.52; 95% CI: 2.23, 13.64) or in non-rural areas (AOR: 8.20; 95% CI: 2.63, 25.51). Districts that retained mask mandates at all four time points were more likely to have Democratic governors (AOR: 5.39; 95% CI: 2.69, 10.82) and serve a smaller proportion of economically disadvantaged students (AOR: 0.97; 95% CI: 0.95, 0.99). Districts serving a larger proportion of students from minoritized racial/ethnic groups were more likely to have mask mandates at any or all timepoints. Notably, county-level COVID-19 prevalence was not related to the presence of a mask mandate at any or all time points. By March 2022, no factors were significantly associated with district mask policy. Discussion: Political, geographic, and demographic characteristics predicted the likelihood of student mask mandates in the 2021-22 school year. Public health promotion messages and policy must account for variation in these factors, potentially through centralized and consistent messaging and unbiased, trustworthy communication.

The Value of Explicit, Deliberative, and Context-Specified Ethics Analysis for Health Technology Assessment: Evidence From a Novel Approach Piloted in South Africa.

OBJECTIVES: This article explores the perceived value, including associated strengths and challenges, of using a context-specified ethics framework to guide deliberative health technology appraisals. METHODS: The South African Values and Ethics for Universal Health Coverage (SAVE-UHC) approach, piloted in South Africa, consisted of 2 phases: (1) convening a national multistakeholder working group to develop a provisional ethics framework and (2) testing the provisional ethics framework through simulated health technology assessment appraisal committee meetings (SACs). Three SACs each reviewed 2 case studies of sample health interventions using the framework. Participants completed postappraisal questionnaires and engaged in focus group discussions. RESULTS: The SACs involved 27 participants across 3 provinces. Findings from the postappraisal questionnaires demonstrated general support for the SAVE-UHC approach and content of the framework, high levels of satisfaction with the recommendations produced, and general sentiment that participants were able to actively contribute to appraisals. Qualitative data showed participants perceived using a context-specified ethics framework in deliberative decision making: (1) supported wider consideration of and deliberation about morally relevant features of the health coverage decisions, thereby contributing to quality of appraisals; (2) could improve transparency; and (3) offered benefits to those directly involved in the priority-setting process. Participants also identified some challenges and concerns associated with the approach. CONCLUSIONS: The SAVE-UHC approach presents a novel way to develop and pilot a locally contextualized, explicit ethics framework for health priority setting. This work highlights how the combination of a context-specified ethics framework and structured deliberative appraisals can contribute to the quality of health technology appraisals and transparency of health priority setting.

COVID-19 vaccine policy development in a sample of 44 countries - Key findings from a December 2021 survey of National Immunization Technical Advisory Groups (NITAGs).

National Immunization Technical Advisory Committees (NITAGs) are tasked with the responsibility of guiding ministries of health and national immunization programmes in their policy development processes. Many NITAGs rely on evidence reviewed by the World Health Organization's (WHO) Strategic Group of Experts(SAGE) on immunization and aim to adapt WHO's recommendations to their respective contexts. This relationship took on exceptional importance since the onset of the COVID-19 pandemic, during which NITAGs have expressed a notable struggle to craft appropriate policies on population prioritization and vaccine utilization in the face of supply constraints and complex programmatic and delivery logistics. This online survey was conducted to assess the usefulness of the SAGE guidance documents for COVID-19 vaccine policies and to examine the persisting needs and challenges facing NITAGs. Results confirmed that SAGE recommendations concerning COVID-19 vaccines are easy to access, understand, and adapt. They have been found to be comprehensive and timely under the data and time constrained circumstances confronting SAGE. The Global NITAG Network (GNN) appears to be the most popular vehicle for addressing questions among high income countries, in contrast to lower income countries who favour WHO Country or Regional Offices. NITAGs place much value on interaction with other NITAGs, which requires facilitation and could benefit from increased opportunities, especially within regions. It is further noted that some NITAGs have had to tackle issues during the pandemic not typically considered by SAGE, such as supply chain logistics and vaccine demand. Learning from the COVID-19 experience offers opportunities to strengthen NITAGs and the pandemic recovery effort through the development of more concrete procedures and consideration of more varied types of data, including implementation effectiveness and uptake data. There is also an opportunity for an increasing involvement of Country Office WHO personnel to support NITAGs, while ensuring information and evidence needs of countries are adequately reflected in SAGE deliberations.

Clinical trials and pregnancy.

Traditionally, there has been a reluctance to involve pregnant people in clinical trials due to complex ethical issues surrounding the risk to unborn babies. However it is crucial that new interventions are safe and effective for all patients and ensuring this can be difficult to achieve in the absence of clinical trials.

Ethical and economic implications of the adoption of novel plant-based beef substitutes in the USA: a general equilibrium modelling study.

BACKGROUND: Slowing climate change is crucial to the future wellbeing of human societies and the greater environment. Current beef production systems in the USA are a major source of negative environmental impacts and raise various animal welfare concerns. Nevertheless, beef production provides a food source high in protein and many nutrients as well as providing employment and income to millions of people. Cattle farming also contributes to individual and community identities and regional food cultures. Novel plant-based meat alternatives have been promoted as technologies that could transform the food system by reducing negative environmental, animal welfare, and health effects of meat production and consumption. Recent studies have conducted static analyses of shifts in diets globally and in the USA, but have not considered how the whole food system would respond to these changes, nor the ethical implications of these responses. We aimed to better explore these dynamics within the US food system and contribute a multiple perspective ethical assessment of plant-based alternatives to beef. METHODS: In this national modelling analysis, we explored multiple ethical perspectives and the implications of the adoption of plant-based alternatives to beef in the USA. We developed USAGE-Food, a modified version of USAGE (a detailed computable general equilibrium model of the US economy), by improving the representation of sector interactions and dependencies, and consumer behaviour to better reflect resource use across the food system and the substitutability of foods within households. We further extended USAGE, by linking estimates of the environmental footprint of US agriculture, to estimate how changes across the agriculture sector could alter the environmental impact of primary food production across the whole sector, not only the beef sector. Using USAGE-Food, we simulated four beef replacement scenarios against a baseline of current beef demand in the USA: BEEF10, in which beef expenditure is replaced by other foods and three scenarios wherein 10%, 30%, or 60% of beef expenditure is replaced by plant-based alternatives. FINDINGS: The adoption of plant-based beef alternatives is likely to reduce the carbon footprint of US food production by 2·5-13·5%, by reducing the number of animals needed for beef production by 2-12 million. Impacts on other dimensions are more ambiguous, as the agricultural workforce and natural resources, such as water and cropland, are reallocated across the food system. The shifting allocation of resources should lead to a more efficient food system, but could facilitate the expansion of other animal value chains (eg, pork and poultry) and increased exports of agricultural products. In aggregate, these changes across the food system would have a small, potentially positive, impact on national gross domestic product. However, they would lead to substantial disruptions within the agricultural economy, with the cattle and beef processing sectors decreasing by 7-45%, challenging the livelihoods of the more than 1·5 million people currently employed in beef value chains (primary production and animal processing) in the USA. INTERPRETATION: Economic modelling suggests that the adoption of plant-based beef alternatives can contribute to reducing greenhouse gas emissions from the food system. Relocation of resources across the food system, simulated by our dynamic modelling approach, might mitigate gains across other environmental dimensions (ie, water or chemical use) and might facilitate the growth of other animal value chains. Although economic consequences at the country level are small, there would be concentrated losses within the beef value chain. Reduced carbon footprint and increased resource use efficiency of the food system are reasons for policy makers to encourage the continued development of these technologies. Despite this positive outcome, policy makers should recognise the ethical assessment of these transitions will be complex, and should remain vigilant to negative outcomes and be prepared to target policies to minimise the worst effects. FUNDING: The Stavros Niarchos Foundation, the Bill & Melinda Gates Foundation, Johns Hopkins University, the Commonwealth Scientific and Industrial Research Organisation, Cornell University, and Victoria University.

Defining the ethical considerations surrounding kidney transplantation for frail and cognitively impaired patients: a Delphi study of geriatric transplant experts.

BACKGROUND: Among adult kidney transplant (KT) candidates, 21% are frail and 55% have cognitive impairment, increasing the risk of pre- and post-KT mortality. Centers often assess frailty status and cognitive function during transplant evaluation to help identify appropriate candidate. Yet, there are no ethical guidelines regarding the use of frailty and cognitive function during this evaluation. We seek to develop a clinical consensus on balancing utility and justice in access to KT for frail and cognitively impaired patients. METHODS: Twenty-seven experts caring for ESRD patients completed a two-round Delphi panel designed to facilitate consensus (> 80% agreement). RESULTS: Experts believed that denying patients transplantation based solely on expected patient survival was inequitable to frail or cognitively impaired candidates; 100% agreed that frailty and cognitive impairment are important factors to consider during KT evaluation. There was consensus that health related quality of life and social support are important to consider before waitlisting frail or cognitively impaired patients. Experts identified important factors to consider before waitlisting frail (likely to benefit from KT, frailty reversibility, age, and medical contraindications) and cognitively impaired (degree of impairment and medication adherence) patients. CONCLUSIONS: Clinical experts believed it was ethically unacceptable to allocate organs solely based on patients' expected survival; frailty and cognitive impairment should be measured at evaluation when weighed against other clinical factors. Ethical guidelines regarding the use of frailty and cognitive function during KT evaluation ought to be developed.

Moral Reasons for Individuals in High-Income Countries to Limit Beef Consumption.

This paper argues that individuals in many high-income countries typically have moral reasons to limit their beef consumption and consume plant-based protein instead, given the negative effects of beef production and consumption. Beef production is a significant source of agricultural greenhouse gas emissions and other environmental impacts, high levels of beef consumption are associated with health risks, and some cattle production systems raise animal welfare concerns. These negative effects matter, from a variety of moral perspectives, and give us collective moral reasons to reduce beef production and consumption. But, as some ethicists have argued, we cannot draw a straight line from the ethics of production to the ethics of consumption: even if a production system is morally impermissible, this does not mean that any given individual has moral reasons to stop consuming the products of that system, given how miniscule one individual's contributions are. This paper considers how to connect those dots. We consider three distinct lines of argument in support of the conclusion that individuals have moral reasons to limit their beef consumption and shift to plant-based protein, and we consider objections to each argument. This argument applies to individuals in high beef-consuming and high greenhouse gas-emitting high-income countries, though we make this argument with a specific focus on the United States. Supplementary Information: The online version contains supplementary material available at 10.1007/s41055-022-00100-8.

Learning Health Care and the Obligation to Participate in Research.

This commentary responds to the article "Compulsory Research in Learning Health Care: Against a Minimal Risk Limit," by Robert Steel. Steel acknowledges that our ethics framework for a learning health care system, published in the 2013 special report Ethical Oversight of Learning Health Care Systems , includes an obligation on the part of patients to participate in learning activities, but he argues that this obligation does not go far enough. Steel, who provides an interesting justification for compulsory research participation in learning health care, claims that our obligation is limited to only minimal risk research. We take exception to that characterization insofar as it detracts from what we believe is most relevant for assessing learning activities, which is how much additional risk and burden a learning activity poses compared to clinical care alone. We also clarify that the level of additional risk is not the only morally relevant consideration in determining if a learning activity should be compulsory. Also important is whether the learning activity includes interventions or choices that engage values of importance to patients.

Developing and piloting a context-specified ethics framework for health technology assessment: the South African Values and Ethics for Universal Health Coverage approach.

OBJECTIVES: While ethics has been identified as a core component of health technology assessment (HTA), there are few examples of practical, systematic inclusion of ethics analysis in HTA. Some attribute the scarcity of ethics analysis in HTA to debates about appropriate methodology and the need for ethics frameworks that are relevant to local social values. The "South African Values and Ethics for Universal Health Coverage" (SAVE-UHC) project models an approach that countries can use to develop HTA ethics frameworks that are specific to their national contexts. METHODS: The SAVE-UHC approach consisted of two phases. In Phase I, the research team convened and facilitated a national multistakeholder working group to develop a provisional ethics framework through a collaborative, engagement-driven process. In Phase II, the research team refined the model framework by piloting it through three simulated HTA appraisal committee meetings. Each simulated committee reviewed two case studies of sample health interventions: opioid substitution therapy and either a novel contraceptive implant or seasonal influenza immunization for children under five. RESULTS: The methodology was fit-for-purpose, resulting in a context-specified ethics framework and producing relevant findings to inform application of the framework for the given HTA context. CONCLUSIONS: The SAVE-UHC approach provides a model for developing, piloting, and refining an ethics framework for health priority-setting that is responsive to national social values. This approach also helps identify key facilitators and challenges for integrating ethics analysis into HTA processes.

WHO guidance on COVID-19 vaccine trial designs in the context of authorized COVID-19 vaccines and expanding global access: Ethical considerations.

While the degree of COVID-19 vaccine accessibility and uptake varies at both national and global levels, increasing vaccination coverage raises questions regarding the standard of prevention that ought to apply to different settings where COVID-19 vaccine trials are hosted. A WHO Expert Group has developed guidance on the ethical implications of conducting placebo-controlled trials in the context of expanding global COVID-19 vaccine coverage. The guidance also considers alternative trial designs to placebo controlled trials in the context of prototype vaccines, modified vaccines, and next generation vaccines.

Streamlined versus traditional consent for low-risk comparative effectiveness trials: a randomized experimental study to measure patients' and public attitudes.

Aim: Streamlining consent for low-risk comparative effectiveness research (CER) could facilitate research, while safeguarding patients' rights. Materials & methods: 2618 adults were randomized to one of seven consent approaches (six streamlined and one traditional) for a hypothetical, low-risk CER study. A survey measured understanding, voluntariness, and feelings of respect. Results: Participants in all arms had a high understanding of the trial and positive attitudes toward the consent interaction. Highest satisfaction was with a streamlined approach showing a video before the medical appointment. Participants in streamlined were more likely to mistakenly think a signature was required. Conclusion: Streamlined consent was no less acceptable than traditional, signed consent. Streamlined and traditional approaches achieved similar levels of understanding, voluntariness and a feeling that the doctor-patient interaction was respectful.

Global disparities in public health guidance for the use of COVID-19 vaccines in pregnancy.

INTRODUCTION: Gaps in information about the safety and efficacy of COVID-19 vaccines in pregnancy have led to substantial global variation in public health guidance regarding the use of COVID-19 vaccines in pregnancy over the course of the pandemic. METHODS: We conducted systematic screenings of public health authorities' websites across 224 countries and territories every 3 weeks to track the development of policies on COVID-19 vaccine use in pregnancy. Policies were categorised using a 1-5 permissiveness scale, with 1 indicating policies that recommended use, and 5 indicating policies that recommended against use. RESULTS: As of 30 September 2021, 176 countries/territories had issued explicit guidance on COVID-19 vaccine use in pregnancy, with 38% recommending use, 28% permitting use, 15% permitting use with qualifications, 2% not recommending but with exceptions, and 17% not recommending use whatsoever. This represented a significant shift from May 2021, when only 6% of countries/territories with such policies recommended the use of COVID-19 vaccines in pregnancy (p<0.001). However, no policy positions could be found for 21% of all countries and territories, the vast majority being low and middle income. Policy positions also varied widely by vaccine product, with Pfizer/BioNTech and Moderna vaccines being most commonly recommended or permitted. CONCLUSION: Our study highlights the evolution of policies regarding COVID-19 vaccine use in pregnancy over a 5-month period in 2021, the role of pregnancy-specific data in shaping these policies and how inequities in access for pregnant people persist, both within countries and globally.