Research ethics review during the COVID-19 pandemic: An international study.

Research ethics review committees (ERCs) worldwide faced daunting challenges during the COVID-19 pandemic. There was a need to balance rapid turnaround with rigorous evaluation of high-risk research protocols in the context of considerable uncertainty. This study explored the experiences and performance of ERCs during the pandemic. We conducted an anonymous, cross-sectional, global online survey of chairs (or their delegates) of ERCs who were involved in the review of COVID-19-related research protocols after March 2020. The survey ran from October 2022 to February 2023 and consisted of 50 items, with opportunities for descriptive responses to open-ended questions. Two hundred and three participants [130 from high-income countries (HICs) and 73 from low- and middle-income countries (LMICs)] completed our survey. Respondents came from diverse entities and organizations from 48 countries (19 HICs and 29 LMICs) in all World Health Organization regions. Responses show little of the increased global funding for COVID-19 research was allotted to the operation of ERCs. Few ERCs had pre-existing internal policies to address operation during public health emergencies, but almost half used existing guidelines. Most ERCs modified existing procedures or designed and implemented new ones but had not evaluated the success of these changes. Participants overwhelmingly endorsed permanently implementing several of them. Few ERCs added new members but non-member experts were consulted; quorum was generally achieved. Collaboration among ERCs was infrequent, but reviews conducted by external ERCs were recognized and validated. Review volume increased during the pandemic, with COVID-19-related studies being prioritized. Most protocol reviews were reported as taking less than three weeks. One-third of respondents reported external pressure on their ERCs from different stakeholders to approve or reject specific COVID-19-related protocols. ERC members faced significant challenges to keep their committees functioning during the pandemic. Our findings can inform ERC approaches towards future public health emergencies. To our knowledge, this is the first international, COVID-19-related study of its kind.

"She was finally mine": the moral experience of families in the context of trisomy 13 and 18- a scoping review with thematic analysis.

INTRODUCTION: The value of a short life characterized by disability has been hotly debated in the literature on fetal and neonatal outcomes. METHODS: We conducted a scoping review to summarize the available empirical literature on the experiences of families in the context of trisomy 13 and 18 (T13/18) with subsequent thematic analysis of the 17 included articles. FINDINGS: Themes constructed include (1) Pride as Resistance, (2) Negotiating Normalcy and (3) The Significance of Time. INTERPRETATION: Our thematic analysis was guided by the moral experience framework conceived by Hunt and Carnevale (2011) in association with the VOICE (Views On Interdisciplinary Childhood Ethics) collaborative research group. RELEVANCE: This article will be of interest and value to healthcare professionals and bioethicists who support families navigating the medically and ethically complex landscape of T13/18.

Cause for coercion: cause for concern?

In his 2000 book, From Chaos to Coercion: Detention and the Control of Tuberculosis, Richard Coker makes a number of important observations and arguments regarding the use of coercive public health measures in response to infectious disease threats. In particular, Coker argues that we have a tendency to neglect public health threats and then demand immediate action, which can leave policymakers with fewer effective options and may require (or may be perceived as requiring) more aggressive, coercive measures to achieve public health goals. While Coker makes a convincing case as to why we should find it ethically problematic when governments find themselves in this position and resort to coercion, left outstanding is the question of whether this should preclude governments and health authorities from using coercion if and when they do find themselves in this position. In this paper, I argue that, while we should consider it ethically objectionable when governments resort to coercion because they have neglected a public health threat, its causes, and other possible responses to that threat, this should not then necessarily rule out the use of coercion in such circumstances; that there are ethically objectionable antecedents for why coercion is being considered should not necessarily or automatically cause us to think coercion in such cases cannot be justified. I address an objection to this argument and draw several conclusions about how governments' use of coercion in public health should be evaluated.

The ethics of firing unvaccinated employees.

Some organisations make vaccination a condition of employment. This means prospective employees must demonstrate they have been vaccinated (eg, against measles) to be hired. But it also means organisations must decide whether existing employees should be expected to meet newly introduced vaccination conditions (eg, against COVID-19). Unlike prospective employees who will not be hired if they do not meet vaccination conditions, existing employees who fail to meet new vaccination conditions risk being fired The latter seems worse than the former. Hence, objections to vaccination mandates commonly centre on the harms that will be visited on existing employees who are unwilling to be vaccinated. However, because this objection does not necessarily entail the claim that vaccination is unnecessary for the effective and safe performance of certain jobs, those making this objection should have less of an objection, or no objection at all (at least on these grounds), to introducing vaccination requirements in some cases for prospective employees. Yet, in this paper, I shall argue that if one has reason to believe vaccination requirements can be justified for prospective employees, one should also believe they are justified for existing employees despite any asymmetry in consequences experienced by the two groups. As a consequence, common objections made against vaccination mandates grounded solely in the harms that may be experienced by existing employees who are unwilling to be vaccinated should be considered unpersuasive.

Institutional trust is a distinct construct related to vaccine hesitancy and refusal.

BACKGROUND: Vaccine hesitancy is driven by a heterogeneous and changing set of psychological, social and historical phenomena, requiring multidisciplinary approaches to its study and intervention. Past research has brought to light instances of both interpersonal and institutional trust playing an important role in vaccine uptake. However, no comprehensive study to date has specifically assessed the relative importance of these two categories of trust as they relate to vaccine behaviors and attitudes. METHODS: In this paper, we examine the relationship between interpersonal and institutional trust and four measures related to COVID-19 vaccine hesitancy and one measure related to general vaccine hesitancy. We hypothesize that, across measures, individuals with vaccine hesitant attitudes and behaviors have lower trust-especially in institutions-than those who are not hesitant. We test this hypothesis in a sample of 1541 Canadians. RESULTS: A deficit in both interpersonal and institutional trust was associated with higher levels of vaccine hesitant attitudes and behaviors. However, institutional trust was significantly lower than interpersonal trust in those with high hesitancy scores, suggesting that the two types of trust can be thought of as distinct constructs in the context of vaccine hesitancy. CONCLUSIONS: Based on our findings, we suggest that diminished institutional trust plays a crucial role in vaccine hesitancy. We propose that this may contribute to a tendency to instead place trust in interpersonally propagated belief systems, which may be more strongly misaligned with mainstream evidence and thus support vaccine hesitancy attitudes. We offer strategies rooted in these observations for creating public health messages designed to enhance vaccine uptake.

Navigating the uncertainty: A novel taxonomy of vaccine hesitancy in the context of COVID-19.

Vaccine hesitancy remains a significant and evolving public health challenge. The COVID-19 pandemic has created a unique decision context with significant uncertainty caused by the novelty of the disease being targeted, unfamiliarity with the vaccines being offered, misinformation, and strong handed government measures. In an effort to extend our understanding of vaccine hesitancy to the high uncertainty decision environment presented by COVID-19, we present a novel taxonomy of the determinants of vaccine hesitancy, based on an inductive analysis of qualitative data gathered during the COVID-19 pandemic. We report on focus group data from a purposive sample of 18 Canadians with varying sociodemographic characteristics and COVID-19 vaccination attitudes. An inductive thematic analysis of this data reveals eight core themes related to vaccine hesitancy: values, trust, social environment, personal anecdotes, environmental fluctuation, prior knowledge, perceived risk & systems of care. We explore these core themes as well as 25 sub-themes, contrasting them with previous models of vaccine hesitancy and suggesting potential strategies for public health professionals.

Bridging ethics and epidemiology: Modelling ethical standards of health equity.

Health inequities are differences in health that are 'unjust'. Yet, despite competing ethical views about what counts as an 'unjust difference in health', theoretical insights from ethics have not been systematically integrated into epidemiological research. Using diabetes as an example, we explore the impact of adopting different ethical standards of health equity on population health outcomes. Specifically, we explore how the implementation of population-level weight-loss interventions using different ethical standards of equity impacts the intervention's implementation and resultant population health outcomes. We conducted a risk prediction modelling study using the nationally representative 2015-16 Canadian Community Health Survey (n = 75,044, 54% women). We used the Diabetes Population Risk Tool (DPoRT) to calculate individual-level 10-year diabetes risk. Hypothetical weight-loss interventions were modelled in individuals with overweight or obesity based on each ethical standard: 1) health sufficiency (reduce DPoRT risk below a high-risk threshold (16.5%); 2) health equality (equalize DPoRT risk to the low risk group (5%)); 3) social-health sufficiency (reduce DPoRT risk <16.5 in individuals with lower education); 4) social-health equality (equalize DPoRT risk to the level of individuals with high education). For each scenario, we calculated intervention impacts, diabetes cases prevented or delayed, and relative and absolute educational inequities in diabetes. Overall, we estimated that achieving health sufficiency (i.e., all individuals below the diabetes risk threshold) was more feasible than achieving health equality (i.e., diabetes risk equalized for all individuals), requiring smaller initial investments and fewer interventions; however, fewer diabetes cases were prevented or delayed. Further, targeting only diabetes inequalities related to education reduced the target population size and number of interventions required, but consequently resulted in even fewer diabetes cases prevented or delayed. Using diabetes as an example, we found that an explicit, ethically-informed definition of health equity is essential to guide population-level interventions that aim to reduce health inequities.

Artificial intelligence and the work-health interface: A research agenda for a technologically transforming world of work.

The labor market is undergoing a rapid artificial intelligence (AI) revolution. There is currently limited empirical scholarship that focuses on how AI adoption affects employment opportunities and work environments in ways that shape worker health, safety, well-being and equity. In this article, we present an agenda to guide research examining the implications of AI on the intersection between work and health. To build the agenda, a full day meeting was organized and attended by 50 participants including researchers from diverse disciplines and applied stakeholders. Facilitated meeting discussions aimed to set research priorities related to workplace AI applications and its impact on the health of workers, including critical research questions, methodological approaches, data needs, and resource requirements. Discussions also aimed to identify groups of workers and working contexts that may benefit from AI adoption as well as those that may be disadvantaged by AI. Discussions were synthesized into four research agenda areas: (1) examining the impact of stronger AI on human workers; (2) advancing responsible and healthy AI; (3) informing AI policy for worker health, safety, well-being, and equitable employment; and (4) understanding and addressing worker and employer knowledge needs regarding AI applications. The agenda provides a roadmap for researchers to build a critical evidence base on the impact of AI on workers and workplaces, and will ensure that worker health, safety, well-being, and equity are at the forefront of workplace AI system design and adoption.

Data Sharing During Pandemics: Reciprocity, Solidarity, and Limits to Obligations.

South Africa shared with the world the warning of a new strain of SARS-CoV2, Omicron, in November 2021. As a result, many high-income countries (HICs) instituted complete travel bans on persons leaving South Africa and other neighbouring countries. These bans were unnecessary from a scientific standpoint, and they ran counter to the International Health Regulations. In short, South Africa was penalized for sharing data. Data sharing during pandemics is commonly justified by appeals to solidarity. In this paper, we argue that solidarity is, at best, an aspirational ideal to work toward but that it cannot ground an obligation to share data. Instead, low-and-middle income countries (LIMCs) should be guided by the principle of reciprocity, which states that we ought to return good for good received. Reciprocity is necessarily a conditional principle. LMICs, we argue, should only share data during future pandemics on the condition that HICs provide enforceable assurances that the benefits of data sharing will be equitably distributed and that LMICs won't be penalized for sharing information.

The importance of getting the ethics right in a pandemic treaty.

The COVID-19 pandemic revealed numerous weaknesses in pandemic preparedness and response, including underfunding, inadequate surveillance, and inequitable distribution of countermeasures. To overcome these weaknesses for future pandemics, WHO released a zero draft of a pandemic treaty in February, 2023, and subsequently a revised bureau's text in May, 2023. COVID-19 made clear that pandemic prevention, preparedness, and response reflect choices and value judgements. These decisions are therefore not a purely scientific or technical exercise, but are fundamentally grounded in ethics. The latest treaty draft reflects these ethical considerations by including a section entitled Guiding Principles and Approaches. Most of these principles are ethical-they establish core values that undergird the treaty. Unfortunately, the treaty draft's set of principles are numerous, overlapping, and show inadequate coherence and consistency. We propose two improvements to this section of the draft pandemic treaty. First, key guiding ethical principles should be clearer and more precise than they currently are. Second, the link between ethical principles and policy implementation should be clearly established and define boundaries on acceptable interpretation, ensuring that signatories abide by these principles.

Use of digital technologies for public health surveillance during the COVID-19 pandemic: A scoping review.

Throughout the COVID-19 pandemic, a variety of digital technologies have been leveraged for public health surveillance worldwide. However, concerns remain around the rapid development and deployment of digital technologies, how these technologies have been used, and their efficacy in supporting public health goals. Following the five-stage scoping review framework, we conducted a scoping review of the peer-reviewed and grey literature to identify the types and nature of digital technologies used for surveillance during the COVID-19 pandemic and the success of these measures. We conducted a search of the peer-reviewed and grey literature published between 1 December 2019 and 31 December 2020 to provide a snapshot of questions, concerns, discussions, and findings emerging at this pivotal time. A total of 147 peer-reviewed and 79 grey literature publications reporting on digital technology use for surveillance across 90 countries and regions were retained for analysis. The most frequently used technologies included mobile phone devices and applications, location tracking technologies, drones, temperature scanning technologies, and wearable devices. The utility of digital technologies for public health surveillance was impacted by factors including uptake of digital technologies across targeted populations, technological capacity and errors, scope, validity and accuracy of data, guiding legal frameworks, and infrastructure to support technology use. Our findings raise important questions around the value of digital surveillance for public health and how to ensure successful use of technologies while mitigating potential harms not only in the context of the COVID-19 pandemic, but also during other infectious disease outbreaks, epidemics, and pandemics.

Complexities and benefits of adopting next-generation sequencing-based tuberculosis diagnostics: a qualitative study among stakeholders in low and high-income countries.

OBJECTIVES: To clarify perceived benefits, barriers and facilitators of Mycobacterium tuberculosis next-generation sequencing implementation in Madagascar and Canada, towards informing implementation of this diagnostic technology in public health agencies and clinical settings in and beyond these settings. DESIGN: This qualitative study involved conducting semistructured interviews with key stakeholders engaged with next-generation sequencing implementation in Madagascar and Canada. Team-based descriptive analysis supported by Nvivo V.12.0 was used to identify key themes. SETTING: The study was conducted with participants involved at the clinical, diagnostic and surveillance levels of tuberculosis (TB) management from Madagascar and Canada. PARTICIPANTS: Eighteen participants were interviewed (nine Madagascar and nine Canada) and included individuals purposively sampled based on involvement with TB surveillance, laboratory diagnosis and clinical management. RESULTS: The following five themes emerged in the analysis of Malagasy and Canadian interviews: (1) heterogeneity in experience with established TB diagnostics, (2) variable understanding of new sequencing-based diagnostics potential; (3) further evidence as being key to expand adoption; (4) ethical arguments and concerns; (5) operational and system-level considerations. CONCLUSION: There persists important lack of familiarity with TB next-generation sequencing (TB NGS) applications among stakeholders in Canada and Madagascar. This translates into skepticism on the evidence underlying its use and its true potential value added within global public health systems. If deployed, TB NGS testing should be integrated with clinical and surveillance programmes. Although this is perceived as a priority, leadership and funding responsibilities for this integration to happen remains unclear to clinical, laboratory and public health stakeholders.

Neurologic Physiology after Removal of Therapy (NeuPaRT) study: study protocol of a multicentre, prospective, observational, pilot feasibility study of neurophysiology after withdrawal of life-sustaining measures.

INTRODUCTION: In donation after circulatory determination of death, death is declared 5 min after circulatory arrest. This practice assumes, but does not explicitly confirm, permanent loss of brain activity. While this assumption is rooted a strong physiological rationale, paucity of direct human data regarding temporal relationship between cessation of brain activity and circulatory arrest during the dying process threatens public and healthcare provider trust in deceased organ donation. METHODS AND ANALYSIS: In this cohort study, we will prospectively record cerebral and brainstem electrical activity, cerebral blood flow velocity and arterial blood pressure using electroencephalography (EEG), brainstem evoked potentials, transcranial doppler and bedside haemodynamic monitors in adult patients undergoing planned withdrawal of life sustaining measures in the intensive care units at five hospital sites for 18 months. We will use MATLAB to synchronise waveform data and compute the time of cessation of each signal relative to circulatory arrest. Our primary outcome is the feasibility of patient accrual, while secondary outcomes are (a) proportion of patients with complete waveform recordings and data transfer to coordinating site and (b) time difference between cessation of neurophysiological signals and circulatory arrest. We expect to accrue 1 patient/site/month for a total of 90 patients. ETHICS AND DISSEMINATION: We have ethics approval from Clinical Trials Ontario (protocol #3862, version 1.0, date 19 January 2022.) and the relevant Research Ethics Board for each site. We will obtain written informed consent from legal substitute decision makers. We will present study results at research conferences including donor family partner forum and in peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05306327.

Is the Cure Worse than the Disease? The Ethics of Imposing Risk in Public Health.

Efforts to improve public health, both in the context of infectious diseases and non-communicable diseases, will often consist of measures that confer risk on some persons to bring about benefits to those same people or others. Still, it is unclear what exactly justifies implementing such measures that impose risk on some people and not others in the context of public health. Herein, we build on existing autonomy-based accounts of ethical risk imposition by arguing that considerations of imposing risk in public health should be centered on a relational autonomy and relational justice approach. Doing so better captures what makes some risk permissible and others not by exploring the importance of power and context in such deliberations. We conclude the paper by applying a relational account of risk imposition in the cases of (a) COVID-19 measures and (b) the regulation of sugar-sweetened beverages to illustrate its explanatory power.

COVID-19 vaccination certificates and lifting public health and social measures: ethical considerations.

Background: To reopen society, various countries are planning or have implemented differential public health and social measures (PHSMs) for COVID-19-vaccinated individuals, by exempting these individuals from some of the measures. Aims: To examine the ethical considerations raised by differential PHSMs by differrnt countries based on individual vaccination status verified by vaccination certificates. Discussion: Decisions on whether and when measures should be lifted specifically for vaccinated individuals should be guided by scientific and ethical considerations. These considerations include the public health risks of differential lifting, particularly in a context where a substantial portion of society is not vaccinated; mitigation of inequities and unfair disadvantages for unvaccinated individuals; and whether to permit other health certificates or credentials besides proof of vaccination as alternative options to access specific activities or services, as a way to balance public health and freedom of movement. Conclusion: Vaccination certificates may undermine a population-based approach to COVID-19 vaccination to achieve and accelerate universal lifting of PHSMs, result in unfair and inequitable health and social outcomes, and generate social divisions at a time when solidarity within (and between) countries is necessary to navigate the pandemic and its burdens. Further research on the ethical acceptability and impact of COVID-19 vaccine certificates in countries that have implemented them should be carried out to inform future ethical considerations on this issue.