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.

Community Voices and Whole-Genome Sequencing for Tuberculosis: Storytelling and the Importance of Listening.

One of the primary public health functions of a tuberculosis (TB) program is to arrest the spread of infection. Traditionally, TB programs have relied on epidemiological information, gathered through contact tracing, to infer that transmission has occurred between people. The ability of drawing such inferences is extensively context dependent. Where epidemiological information has been strong, such as 2 cases of TB occurring sequentially within a single household, confidence in such inferences is high; conversely, public health authorities have been less certain about the significance of TB cases merely occurring in the same wider social group or geographic area. Many current laboratory tests for TB used globally may be sufficient to confirm a diagnosis and guide appropriate therapy but still be insufficiently precise for distinguishing two strains reliably. In short, drawing inferences regarding a chain of transmissions has always been as much art as science.

Ethics and Health Security in the Australian COVID-19 Context: A Critical Interpretive Literature Review.

Background The concept of "health security" is often used to motivate public health responses, yet the ethical values that underpin this concept remain largely unexamined. The recent Australian responses to COVID-19 serve as an important case study by which we can analyse the pre-existing literature to see what ethical values shaped, and continue to shape, Australia's response. Methods We conducted a critical interpretive literature review of academic and grey literatures within key databases, resulting in 2,220 sources. After screening for duplicates and relevance, we analysed ninety-six sources. Results First, risk and uncertainty are a leading focus, with a heavy concentration on risks to life and health. Second, free movement, safety, and security were recurringly emphasized, albeit narrowly focused upon the safety of the population. Third, legitimacy was a recurring theme, and it is here that discussions of "health security" figured highly. Conclusion Discussions of harm from government and associated official bodies fail to adequately distinguish between various senses of harm. Moreover, while the literature often discusses the balancing of rights, the steps involved in the weighing of these rights is rarely adequately explained and defended. We suggest that decision-makers should endeavour to clearly identify and defend the values undergirding their decisions in the public sphere.

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.

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.

Effects of aerobic, resistance, and combined training on endothelial function and arterial stiffness in older adults: study protocol for a systematic review and meta-analysis.

INTRODUCTION: Aging is an independent risk factor for cardiovascular events. It promotes vascular dysfunction which is associated with risk factors for cardiovascular diseases (CVDs). Exercise can modulate vascular function parameters, but little is known about the effects of different modalities of training (aerobic, resistance, and combined) on endothelial function and arterial stiffness in older adults. METHODS: This systematic review study will include randomized controlled trials (RCTs) selected from the electronic databases MEDLINE (PubMed), Cochrane, LILACS, EMBASE, and Web of Science. We will follow the PRISMA guidelines and PICOS framework. Studies involving both male and female older adults (≥60 years old) with or without comorbidities undergoing aerobic, resistance, and/or combined training compared to a control group (no exercise) will be eligible. We will use the Cochrane Risk of Bias 2 (RoB 2) tool to evaluate the quality of individual studies and GRADE to assess the strength of evidence. Statistical analyses will be conducted with RStudio for Windows (v1.3.959) using R package meta. DISCUSSION: A systematic review and meta-analysis involving data from studies of older adults would deepen our understanding of vascular adaptations to exercise training in this population. It could provide new insights into how health providers can improve patient management and prevention of cardiovascular events in older adults. SYSTEMATIC REVIEW REGISTRATION: PROSPERO 42021275451.

R&D during public health emergencies: the value(s) of trust, governance and collaboration.

In January 2021, Dr Tedros Adhanom Ghebreyesus, director-general of the WHO, warned that the world was 'on the brink of a catastrophic moral failure [that] will be paid with lives and livelihoods in the world's poorest countries'. We are now past the brink. Many high-income countries have vaccinated their populations (which, in some cases, includes third and even fourth doses) and are loosening public health and social measures, while low-income and middle-income countries are struggling to secure enough supply of vaccines to administer first doses. While injustices abound in the deployment and allocation of COVID-19 vaccines, therapies and diagnostics, an area that has hitherto received inadequate ethical scrutiny concerns the upstream structures and mechanisms that govern and facilitate the research and development (R&D) associated with these novel therapies, vaccines and diagnostics. Much can be learnt by looking to past experiences with the rapid deployment of R&D in the context of public health emergencies. Yet, much of the 'learning' from past epidemics and outbreaks has largely focused on technical or technological innovations and overlooked the essential role of important normative developments; namely, the importance of fostering multiple levels of trust, strong and fair governance, and broad research collaborations. In this paper, we argue that normative lessons pertaining to the conduct of R&D during the 2014-2016 Ebola epidemic in West Africa provide important insights for how R&D ought to proceed to combat the current COVID-19 pandemic and future infectious disease threats.

The abandonment of Australians in India: an analysis of the right of entry as a security right in the age of COVID-19.

In May 2021, when the Delta variant of SARS-CoV2 was wreaking havoc in India, the Australian Federal Government banned its citizens and residents who were there from coming back to Australia for 14 days on penalty of fines or imprisonment. These measures were justified on the grounds of protecting the broader Australian public from potentially importing the Delta strain, which officials feared would then seed a local outbreak. Those Australians stranded in India, and their families and communities back home, claimed that they were abandoned by Prime Minister Scott Morrison's government. This case-along with other barriers used as part of border control measures in the name of public health-raises the following question: is it ever morally permissible for a state to ban its citizens and residents from entering their own country during a pandemic? I conclude that it's impermissible. I argue that persons have a right of entry that should be understood as a security right. This security right should be non-derogable because it's a foundational good that is necessary for life-planning purposes. Moreover, it is a right that people should be able to rely upon absolutely, even during pandemics. At the very least, should someone believe that there are rare exceptions to the right of entry on public health grounds, governments have a duty-grounded in the principle of reciprocity-to support those who are temporarily denied entry. In the case of Australians stranded in India, I will argue that the Australian Federal Government failed on all accounts.

Predictive Biomathematical Modeling Compared to Objective Sleep During COVID-19 Humanitarian Flights.

BACKGROUND: Biomathematical modeling software like the Sleep, Activity, Fatigue, and Task Effectiveness (SAFTE) model and Fatigue Avoidance Scheduling Tool (FAST) help carriers predict fatigue risk for planned rosters. The ability of a biomathematical model to accurately estimate fatigue risk during unprecedented operations, such as COVID-19 humanitarian ultra-long-range flights, is unknown. Azul Cargo Express organized and conducted five separate humanitarian missions to China between May and July 2020. Prior to conducting the missions, a sleep-prediction algorithm (AutoSleep) within SAFTE-FAST was used to predict in-flight sleep duration and pilot effectiveness. Here we compare AutoSleep predictions against pilots' sleep diary and a sleep-tracking actigraphy device (Zulu watch, Institutes for Behavior Resources) from Azul's COVID-19 humanitarian missions.METHODS: Pilots wore Zulu watches throughout the mission period and reported sleep duration for their in-flight rest periods using a sleep diary. Agreement between AutoSleep, diary, and Zulu watch measures was compared using intraclass correlation coefficients (ICC). Goodness-of-fit between predicted effectiveness distribution between scenarios was evaluated using the R² statistic.RESULTS: A total of 20 (N = 20) pilots flying across 5 humanitarian missions provided sleep diary and actigraphy data. ICC and R² values were >0.90, indicating excellent agreement between sleep measures and predicted effectiveness distribution, respectively.DISCUSSION: Biomathematical predictions of in-flight sleep during unprecedented humanitarian missions were in agreement with actual sleep patterns during flights. These findings indicate that biomathematical models may retain accuracy even under extreme circumstances. Pilots may overestimate the amount of sleep that they receive during extreme flight-duty periods, which could constitute a fatigue risk.Devine JK, Garcia CR, Simoes AS, Guelere MR, de Godoy B, Silva DS, Pacheco PC, Choynowski J, Hursh SR. Predictive biomathematical modeling compared to objective sleep during COVID-19 humanitarian flights. Aerosp Med Hum Perform. 2022; 93(1):4-12.

Ethical health security in the age of antimicrobial resistance.

OBJECTIVE: Owing to its potential human, social and economic costs, antimicrobial resistance (AMR) is frequently referred to as a threat to health security. Simultaneously, health security and the preservation of antimicrobials are often described as a global public good. However, how the term 'public good' is used in the context of health security, and the values that underpin it, remains ambiguous. Policymaking is never value-free, and a better examination of such values is critical to understanding how issues such as AMR are problematised and how policy decisions are informed. DESIGN: We used McDougall's version of critical interpretive synthesis to capture the recurring concepts and arguments within public policy, political science and applied ethics literature on AMR. Articles were analysed by identifying recurring ideas and developing themes across the literature. RESULTS: A total of 77 papers were included in our review. In the context of health security and AMR, the concept of 'public good' appears to be used interchangeably with 'common good', reflecting confusion, but sometimes meaningful differences, regarding how antimicrobials, as a good, are conceived. Main approaches to addressing AMR are statism, globalism and regionalism, which appeal to different values in guiding policymakers. Common justificatory values underpinning preservation of antimicrobials as a public good were prevention of harm, solidarity, justice and rights. CONCLUSION: The findings suggest that within the literature there is a lack of conceptual clarity as to whether antimicrobials constitute a public good or a common good. Moreover, the way in which antimicrobials are conceived and the approaches through which AMR as a threat to health security is addressed appear to be grounded in values that are often implicit. Being explicit about the values that underpin AMR and health security is not simply an intellectual exercise but has very real policy and programmatic implications.

Pilot of a Training Format for Clinicians' Continuing Professional Development: Open House With Rotating Short Segments.

INTRODUCTION: Access to continuing professional development offered at lunchtime is limited by hospital scheduling that has staff members taking their lunch breaks at different times. To overcome this barrier, we developed a three-part training format with (1) a focus group segment soliciting participants' opinions on the training's target behavior, (2) a didactic segment introducing tools to support the behavior, and (3) a question-and-answer segment about the session topic. We rotated through these segments, each 15 minutes long, over 3 hours. Participants could join at any segment and experience the full curriculum after 45 minutes. METHODS: We piloted this training format five times at three hospitals. Our training aimed to encourage clinicians to consistently inform involuntary patients about their Mental Health Act rights. We gauged the effect of the training and participants' opinions of the session using the Continuing Professional Development Reaction questionnaire and a session evaluation, respectively. RESULTS: Continuing Professional Development-Reaction results (n = 80) showed a detectable increase in clinicians' intent to consistently give involuntary patients rights advice. Participants reported finding the training organized, informative, and valuable. DISCUSSION: The open house with rotating short segments is a feasible and adaptable training format to engage clinicians in voluntary continuing professional development.

To kill or not to kill: A systematic literature review of high-stakes moral decision-making measures and their psychometric properties.

Introduction: The present systematic review investigates the psychological tools available for capturing high-stakes decisions involving life-death content and their psychometric properties. Valid measurement of these individual differences will provide crucial information in the personnel selection and training in fields where high-stakes moral issues exist (e.g., military, medicine). To our knowledge, this is the first systematic examination of such instruments. Methods: Systematic searches of 6 electronic databases were conducted according to the PRISMA guidelines. An appraisal tool evaluated the quality of identified measures. Twenty studies met pre-determined inclusion criteria. Moral decision-making was assessed with either a self-report scale (n = 3) or moral dilemmas (n = 17). Results: The findings identified two measures, the Defining Issues Test and the Oxford Utilitarianism Scale as psychometrically sound measures of moral decision-making. However, they are unlikely to be considered "gold standard" measures due to their theoretically specific, but limited, scope. Overall, the findings suggest that research in the area has been scattered. There is a lack of consensus on the definition of moral decision-making, and a lack of cross-validation on how different measures of moral decision-making relate to each other. This presents a gap between theory and empirical measurement in moral decision-making. Further work is needed for a unified conceptualization of moral decision-making to pave the way to both theory development and the development of well-validated measurement tools, and this review provides a critical foundation for both.

Between rules and resistance: moving public health emergency responses beyond fear, racism and greed.

In times of a public health emergency, lawyers and ethicists play a key role in ensuring that government responses, such as travel restrictions, are both legally and ethically justified. However, when travel bans were imposed in a broadly discriminatory manner against southern African countries in response to the Omicron SARS-CoV-2 variant in late 2021, considerations of law, ethics or science did not appear to guide politicians' decisions. Rather, these bans appeared to be driven by fear of contagion and electoral blowback, economic motivations and inherently racist assumptions about low-income and middle-income countries (LMICs). With a new pandemic treaty and amendments to the WHO's International Health Regulations (IHR) on the near-term horizon, ethics and international law are at a key inflection point in global health governance. Drawing on examples of bordering practices to contain contagion in the current pandemic and in the distant past, we argue that the current IHR is not adequately constructed for a just and equitable international response to pandemics. Countries impose travel restrictions irrespective of their need or of the health and economic impact of such measures on LMICs. While the strengthening and reform of international laws and norms are worthy pursuits, we remain apprehensive about the transformative potential of such initiatives in the absence of collective political will, and suggest that in the interim, LMICs are justified in seeking strategic opportunities to play the same stark self-interested hardball as powerful states.

Pilot Sleep Behavior across Time during Ultra-Long-Range Flights.

Fatigue risk to the pilot has been a deterrent for conducting direct flights longer than 12 h under normal conditions, but such flights were a necessity during the COVID-19 pandemic. Twenty (N = 20) pilots flying across five humanitarian missions between Brazil and China wore a sleep-tracking device (the Zulu watch), which has been validated for the estimation of sleep timing (sleep onset and offset), duration, efficiency, and sleep score (wake, interrupted, light, or deep Sleep) throughout the mission period. Pilots also reported sleep timing, duration, and subjective quality of their in-flight rest periods using a sleep diary. To our knowledge, this is the first report of commercial pilot sleep behavior during ultra-long-range operations under COVID-19 pandemic conditions. Moreover, these analyses provide an estimate of sleep score during in-flight sleep, which has not been reported previously in the literature.

Ethics Guidance for Environmental Scientists Engaged in Surveillance of Wastewater for SARS-CoV-2.

The COVID-19 pandemic has given rise to rapid and widespread international pursuit of wastewater surveillance for genetic signals of SARS-CoV-2, the virus causing the pandemic. Environmental scientists and engineers familiar with the techniques required for this endeavor have responded. Many of the environmental scientists engaged in these investigations have not necessarily had experience with the ethical obligations associated with generating and handling human health data. The Canadian Water Network facilitated adoption of these surveillance methods by creating a national coalition, which included a public health advisory group that recognized a need for ethics guidance for the wastewater approach to public health surveillance. This Policy Analysis addresses that need and is based on a review of relevant ethics literature tightly focused on ethics applicable to public health surveillance. That review revealed that classical health bioethics governing clinical practice and general public health ethics guidance did not adequately address key issues in wastewater surveillance. The 2017 World Health Organization guidelines, directly based on a systematic literature review, specifically addressed ethical issues in public health surveillance. The application of relevant ethical guidance to wastewater surveillance is analyzed and summarized for environmental scientists.

A qualitative study of clinicians' perspectives on independent rights advice for involuntary psychiatric patients in British Columbia, Canada.

BACKGROUND: In British Columbia (BC), Canada, clinicians are responsible for giving involuntary psychiatric patients rights information upon admission. Yet an investigation by the BC Office of the Ombudsperson found that clinicians are not always fulfilling this responsibility. The Ombudsperson recommended that the provincial government fund an independent body to give rights advice to patients. METHODS: To understand how clinicians feel about this recommendation, focus groups of clinicians who may give psychiatric patients rights information (n = 81) were conducted in Vancouver, BC, to probe their attitudes toward independent rights advisors. The focus group transcripts were thematically analyzed. RESULTS: Most clinicians believe that giving rights information is within their scope of practice, although some acknowledge that it poses a conflict of interest when the patient wishes to challenge the treatment team's decisions. Participants' chief concerns about an independent rights-advice service were that (a) patients may experience a delay in receiving their rights information, (b) integrating rights advisors into the workflow would complicate an already chaotic admission process, and (c) more patients would be counselled to challenge their hospitalization, leading to an increased administrative workload for clinical staff. However, many participants believed that independent rights advisors would be a positive addition to the admission process, both allowing clinicians to focus on treatment and serving as a source of rights-related information. CONCLUSIONS: Participants were generally amenable to an independent rights-advice service, suggesting that the introduction of rights advisors need not result in an adversarial relationship between treatment team and patient, as opponents of the proposal fear. Clearly distinguishing between basic rights information and in-depth rights advice could address several of the clinicians' concerns about the role that independent rights advisors would play in the involuntary admission process. Clinicians' and other stakeholders' concerns should be considered as the province develops its rights-advice service.

Ethical challenges in the treatment of non-refugee migrants with tuberculosis in Canada.

While attention to the ethical issues that migrants face in accessing tuberculosis care has increased in the last few years, most of the attention has focused on challenges that refugees face when emigrating. Less attention has been given to ethical challenges that arise in the context of providing tuberculosis treatment and care to non-refugee migrants in high-income countries (HIC), particularly those that do not face immediate danger or violence. In this paper, we analyze some of the ethical challenges associated with treating migrants with tuberculosis in the Canadian context. In particular, we will discuss (i) inter- and intra-jurisdictional issues that challenge quotidian public health governance structures, and (ii) the ethical imperative for the Canadian government and its provinces to clearly differentiate access to healthcare from a person's immigration status to help overcome power imbalances that may exist between public health workers and their clients. The arguments presented herein could potentially apply to other HIC with some form of universal health coverage.