Explore the vast range of titles available.

Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion.

Background Despite increasing vaccine availability and evidence and expert recommendations to support administration, some countries maintained restrictive policies regarding COVID-19 vaccination in pregnancy throughout the pandemic. This global analysis explores the role of gender equity, country income level, and vaccine availability in predicting national policies on COVID-19 vaccine administration in pregnancy. Methods Policies were collected from May 2021 to January 2023 from 224 countries/territories using publicly available information posted on national public health authority web pages. Policies were categorized into 6 types, representing different levels of permissiveness, from recommended for some or all to not recommended, and changes in national policies were captured over time. Outcomes were defined as: 1) prevalence of restrictive policies at a specific time point; 2) country-level change from restrictive policy/no position at an earlier time point to a permissive policy at a later timepoint. Simple and multivariable logistic regressions were performed to explore the association between the outcomes and potential policy predictors, including income level, mRNA vaccine availability, and the Global Gender Gap Index (GGGI). Results Complete cross-sectional data were available for 114 countries as of June 2021, 137 countries as of October 2021, and 142 countries as of March 2022. The number of maternal immunization policies increased and became steadily more permissive between 2021 and 2022. Availability of mRNA vaccines and higher income level were associated with reduced odds of a restrictive policy at the 2021 timepoints, and higher GGGI scores were associated with reduced odds of restrictive policies at all timepoints. After adjusting for income level and mRNA vaccine availability, higher GGGI scores reduced the relative odds of a restrictive COVID-19 vaccine policy by 10% (aOR: 0.90, 95CI: 0.81, 0.99) in October 2021 and 14% (aOR: 0.86, 95%CI: 0.76, 0.97) in March 2021. Higher GGGI scores were also associated with increased odds of a policy switch from restrictive/no position in June 2021 to permissive in October 2021 (aOR: 1.12, 95%CI: 1.00, 1.24). Conclusions Gender inequity was associated with greater odds of a restrictive policy for use of COVID-19 vaccines in pregnancy, suggesting that gender biases may influence fair policymaking for pregnant people in pandemic preparedness and response.

IntroductionGaps 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.MethodsWe 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.ResultsAs 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.ConclusionOur 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.

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.

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.

ObjectivesWhile 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.MethodsThe 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.ResultsThe 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.ConclusionsThe 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.

The authors argue that in a learning health care system with ethically robust oversight policies, a streamlined consent process could replace formal written informed-consent procedures for many studies, and patient consent would not be required at all for some trials. Interest in learning health care systems and in comparative-effectiveness research (CER) is exploding. One major question is whether informed consent should always be required for randomized comparative-effectiveness studies, particularly studies conducted in a learning health care system. Our answer to this question is no. It will often be unethical to go forward with CER in which patients are randomly assigned to different interventions without their written, prospective, informed consent. However, in a mature learning health care system with ethically robust oversight policies and practices, some randomized CER studies may justifiably proceed with a streamlined consent process and others may not . . .

We analyzed trends in adult COVID-19 vaccine coverage over time based on COVID-19 vaccine hesitancy and social vulnerability. We found that each of these variables carries an independent association with disparities across counties in COVID-19 vaccine coverage. Counties that score high on both hesitancy and vulnerability are especially likely to have lower COVID-19 vaccination rates compared with the rest of the country.

Zika virus, influenza, and Ebola have called attention to the ways in which infectious disease outbreaks can severely – and at times uniquely – affect the health interests of pregnant women and their offspring. These examples also highlight the critical need to proactively consider pregnant women and their offspring in vaccine research and response efforts to combat emerging and re-emerging infectious diseases. Historically, pregnant women and their offspring have been largely excluded from research agendas and investment strategies for vaccines against epidemic threats, which in turn can lead to exclusion from future vaccine campaigns amidst outbreaks. This state of affairs is profoundly unjust to pregnant women and their offspring, and deeply problematic from the standpoint of public health. To ensure that the needs of pregnant women and their offspring are fairly addressed, new approaches to public health preparedness, vaccine research and development, and vaccine delivery are required. This Guidance offers 22 concrete recommendations that provide a roadmap for the ethically responsible, socially just, and respectful inclusion of the interests of pregnant women in the development and deployment of vaccines against emerging pathogens. The Guidance was developed by the Pregnancy Research Ethics for Vaccines, Epidemics, and New Technologies (PREVENT) Working Group – a multidisciplinary, international team of 17 experts specializing in bioethics, maternal immunization, maternal-fetal medicine, obstetrics, pediatrics, philosophy, public health, and vaccine research and policy – in consultation with a variety of external experts and stakeholders.

Public health ethics, like the field of public health it addresses, traditionally has focused more on practice and particular cases than on theory, with the result that some concepts, methods, and boundaries remain largely undefined. This paper attempts to provide a rough conceptual map of the terrain of public health ethics. We begin by briefly defining public health and identifying general features of the field that are particularly relevant for a discussion of public health ethics. Public health is primarily concerned with the health of the entire population, rather than the health of individuals. Its features include an emphasis on the promotion of health and the prevention of disease and disability; the collection and use of epidemiological data, population surveillance, and other forms of empirical quantitative assessment; a recognition of the multidimensional nature of the determinants of health; and a focus on the complex interactions of many factors—biological, behavioral, social, and environmental—in developing effective interventions.