The primary responsibility of the US Food and Drug Administration is to protect public health by ensuring the safety of the food supply. To that end, it sometimes conducts risk assessments of novel food products, such as genetically modified food. The FDA describes its regulatory review of GM food as a purely scientific activity, untainted by any normative considerations. This paper provides evidence that the regulatory agency is not justified in making that claim. It is argued that the (...) FDA’s policy stance on GM food is shaped by neoliberal considerations. The agency’s review of a genetically engineered animal, the AquAdvantage salmon, is used as a case study to track the influence of neoliberalism on its regulatory review protocol. After that, an epistemic argument justifying public engagement in the risk assessment of new GM food is outlined. It is because risk evaluations involve normative judgments, in a democracy, layperson representatives of informal epistemic communities that could be affected by a new GM food should have the opportunity to decide the ethical, political or other normative questions that arise during the regulatory review of that entity. (shrink)

Biobanks act as the custodians for the access to and responsible use of human biological samples and related data that have been generously donated by individuals to serve the public interest and scientific advances in the health research realm. Risk assessment has become a daily practice for biobanks and has been discussed from different perspectives. This paper aims to provide a literature review on risk assessment in order to put together a comprehensive typology of diverse (...) risks biobanks could potentially face. Methodologically set as a typology, the conceptual approach used in this paper is based on the interdisciplinary analysis of scientific literature, the relevant ethical and legal instruments and practices in biobanking to identify how risks are assessed, considered and mitigated. Through an interdisciplinary mapping exercise, we have produced a typology of potential risks in biobanking, taking into consideration the perspectives of different stakeholders, such as institutional actors and publics, including participants and representative organizations. With this approach, we have identified the following risk types: economic, infrastructural, institutional, research community risks and participant’s risks. The paper concludes by highlighting the necessity of an adaptive risk governance as an integral part of good governance in biobanking. In this regard, it contributes to sustainability in biobanking by assisting in the design of relevant risk management practices, where they are not already in place or require an update. The typology is intended to be useful from the early stages of establishing such a complex and multileveled biomedical infrastructure as well as to provide a catalogue of risks for improving the risk management practices already in place. (shrink)

Objective: The aim of this study was to compare the cervical posture, sleep quality, and perceived health risk of technology-addicted adolescents, young adults and their controls. -/- Methods: Adolescents and young-adults participants (n=160) were divided into four groups as addicted and non-addicted according to their age and Technology Addiction Scale scores. Cervical posture assessments were obtained by photographic analysis. Craniovertebral (CVA), craniohorizontal (CHA) and sagittal shoulder angle (SSA) values were recorded. Sleep quality was assessed with the Pittsburg Sleep (...) Quality Scale. Participants' Perceived Health Risk was evaluated with a single-item, five-point Likert questionnaire. -/- Results: The addicted participants had worse CVA than both their controls (p=0.000). Participants' CHA and SSA angles were similar in addicted groups (p=0.710 and p=0.612, respectively). Addicted adolescents had worse sleep quality than addicted young-adults (p=0.005). Perceived Health Risk is low level in all groups and there were no significant differences (p=0.055). -/- Conclusion: Technology addiction affects the adolescent group more negatively than the young-adults. In the sample of adolescents and young-adults, individuals did not perceive excessive use of technological tools as a risk factor for their health. The degradation of CVA due to overuse of technological tools precedes the degradation of CHA and SSA. This can be explained by the fact that CVA is a more general angle that includes both the head- neck position and the vertebrae. It is necessary for public health and future health expenditures to educate and raise awareness of the more vulnerable adolescent group. (shrink)

Abstract: This research employs a Random Forest classification model to predict and assess obesity and cardiovascular disease (CVD) risk based on a comprehensive dataset collected from individuals in Mexico, Peru, and Colombia. The dataset comprises 17 attributes, including information on eating habits, physical condition, gender, age, height, and weight. The study focuses on classifying individuals into different health risk categories using machine learning algorithms. Our Random Forest model achieved remarkable performance with an accuracy, F1-score, recall, and precision (...) all reaching 97.23%. The model's success is attributed to its ability to effectively leverage attributes related to eating habits, physical condition, and demographic factors. Feature importance analysis reveals key factors contributing to accurate predictions. This paper contributes to the field of health analytics by demonstrating the effectiveness of Random Forest in predicting and categorizing health risks. The insights gained from this research have the potential to inform personalized health interventions and contribute to the advancement of precision health strategies. Furthermore, the study highlights the importance of leveraging machine learning techniques for health risk assessment in diverse populations. (shrink)

Common mental health disorders are rising globally, creating a strain on public healthcare systems. This has led to a renewed interest in the role that digital technologies may have for improving mental health outcomes. One result of this interest is the development and use of artificial intelligence for assessing, diagnosing, and treating mental health issues, which we refer to as ‘digital psychiatry’. This article focuses on the increasing use of digital psychiatry outside of clinical settings, in the (...) following sectors: education, employment, financial services, social media, and the digital well-being industry. We analyse the ethical risks of deploying digital psychiatry in these sectors, emphasising key problems and opportunities for public health, and offer recommendations for protecting and promoting public health and well-being in information societies. (shrink)

In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools. In August 2016, the US Food (...) and Drug Agency (FDA) approved the uncaged field trial of a GE Aedes aegypti mosquito in Key Haven, Florida. The FDA’s decision was based on its assessment of the risks of the proposed experimental public health research project. The FDA is considered a global regulatory standard setter. So, its approval of the uncaged field trial could be used by proponents of GE mosquitoes to urge countries in the global South to permit the use of those bio-technologies. -/- From a public health ethics perspective, this paper evaluates the FDA’s 2016 risk assessment of the proposed uncaged field trial of the GE mosquito to determine whether it qualified as a realistic risk evaluation. -/- The FDA’s risk assessment of the proposed uncaged field trial did not proximate the conditions under which the GE mosquitoes would be used in regions of the global South where there is a high prevalence of mosquito-borne diseases. -/- Given that health and disease have political-economic determinants, whether a risk assessment of a product is realistic or not particularly matters with respect to interventions meant for public health problems that disproportionately impact socio-economically marginalized populations. If ineffective public health interventions are adopted based on risk evaluations that do not closely mirror the conditions under which those products would actually be used, there could be public health and ethical costs for those populations. (shrink)

Over the past year, technology companies have made headlines claiming that their artificially intelligent (AI) products can outperform clinicians at diagnosing breast cancer, brain tumours, and diabetic retinopathy. Claims such as these have influenced policy makers, and AI now forms a key component of the national health strategies in England, the United States, and China. While it is positive to see healthcare systems embracing data analytics and machine learning, concerns remain about the efficacy, ethics, and safety of some commercial, (...) AI health solutions. This paper argues that improved regulation and guidance is urgently required to mitigate risks, ensure transparency and best practice, Without this, patients, clinicians, and other stakeholders cannot be assured of an app’s efficacy, and safety. (shrink)

The main aim of this article is to reflect on the impact of biases related to artificial intelligence (AI) systems developed to tackle issues arising from the COVID-19 pandemic, with special focus on those developed for triage and risk prediction. A secondary aim is to review assessment tools that have been developed to prevent biases in AI systems. In addition, we provide a conceptual clarification for some terms related to biases in this particular context. We focus mainly on (...) nonracial biases that may be less considered when addressing biases in AI systems in the existing literature. In the manuscript, we found that the existence of bias in AI systems used for COVID-19 can result in algorithmic justice and that the legal frameworks and strategies developed to prevent the apparition of bias have failed to adequately consider social determinants of health. Finally, we make some recommendations on how to include more diverse professional profiles in order to develop AI systems that increase the epistemic diversity needed to tackle AI biases during the COVID-19 pandemic and beyond. (shrink)

Many healthcare practices expose people to risks of harmful outcomes. However, the major theories of moral philosophy struggle to assess whether, when and why it is ethically justifiable to expose individuals to risks, as opposed to actually harming them. Sven Ove Hansson has proposed an approach to the ethical assessment of risk imposition that encourages attention to factors including questions of justice in the distribution of advantage and risk, people’s acceptance or otherwise of risks, and the scope (...) individuals have to influence the practices that generate risk. This paper investigates the ethical justifiability of preventive healthcare practices that expose people to risks including overdiagnosis. We applied Hansson’s framework to three such practices: an ‘ideal’ breast screening service, a commercial personal genome testing service, and a guideline that lowers the diagnostic threshold for hypertension. The framework was challenging to apply, not least because healthcare has unclear boundaries and involves highly complex practices. Nonetheless, the framework encouraged attention to issues that would be widely recognised as morally pertinent. Our assessment supports the view that at least some preventive healthcare practices that impose risks including that of overdiagnosis are not ethically justifiable. Further work is however needed to develop and/or test refined assessment criteria and guidance for applying them. (shrink)

The Adverse Outcome Pathway (AOP) concept is a knowledge assembly and communication tool to facilitate the transparent translation of mechanistic information into outcomes meaningful to the regulatory assessment of chemicals. The AOP framework and associated knowledgebases (KBs) have received significant attention and use in the regulatory toxicology community. However, it is increasingly apparent that the potential stakeholder community for the AOP concept and AOP KBs is broader than scientists and regulators directly involved in chemical safety assessment. In this (...) paper we identify and describe those stakeholders who currently—or in the future—could benefit from the application of the AOP framework and knowledge to specific problems. We also summarize the challenges faced in implementing pathway-based approaches such as the AOP framework in biological sciences, and provide a series of recommendations to meet critical needs to ensure further progression of the framework as a useful, sustainable and dependable tool supporting assessments of both human health and the environment. Although the AOP concept has the potential to significantly impact the organization and interpretation of biological information in a variety of disciplines/applications, this promise can only be fully realized through the active engagement of, and input from multiple stakeholders, requiring multi-pronged substantive long-term planning and strategies. (shrink)

In this article we argue that the social value of health research should be conceptualized as a function of both the expected benefits of the research and the priority that the beneficiaries deserve. People deserve greater priority the worse off they are. This conception of social value can be applied for at least two important purposes: in health research priority setting when research funders, policy-makers, or researchers decide between alternative research projects; and in evaluating the ethics of proposed (...) research proposals when research ethics committees assess whether the social value of the research is sufficient to justify the risks and burdens to research participants and others. In assessing how far a proposed research project will advance the interests of people who are more disadvantaged, research priority setters and RECs should examine the diseases that the research targets and the type of research. Just as certain diseases impose a greater burden on people who are more disadvantaged, so certain types of intervention and forms of research are more likely to benefit people who are more disadvantaged. We outline which populations are likely to be representative of the global worst off and identify what types of health research, and which disease categories, are priorities for these populations. (shrink)

Audience segmentation is necessary in health communications to ensure equitable resource distribution. Peer crowds, which are macro-level teen subcultures, are effective psychographic segments for health communications because each crowd has unique mindsets, values, norms, and health behavior profiles. These mindsets affect behaviors, and can be used to develop targeted health communication campaigns to reach those in greatest need. Though peer crowd research is plentiful, no existing peer crowd measurement tool has been formally validated. As such, we (...) developed and validated Virginia's Mindset Lens Survey (V-MLS), a mindset-based teen peer crowd segmentation survey to support health communication efforts. Using an online convenience sample of teens (N = 1,113), we assessed convergent and discriminant validity by comparing the V-MLS against an existing, widely-used peer crowd survey (I-Base Survey®) utilizing a multi-trait multi-method matrix. (shrink)

In Western societies many immigrants live in difficult social and working conditions. Together with other factors, this state of affairs represents a risk for the well being of their children. This article will consider the principle risk factors for child psychopathology and/or distress, with a distinction between temporary and permanent factors and with a peculiar attention to the interplay between risk and protective factors. Risk factors can be ordered in cultural, social, familiar/parental and individual factors. Some (...) of these are general risk factors, applying to child and adolescent psychopathology and distress independently from the status of immigrants’ offspring. Other factors are specific of migration, some of them being related to: a) different ways of immigrated families to situate themselves within the host society ; b) cultural/familiar attitudes in child’s nurture and education; c) the family role of women as well as factors specific of the pregnancy period in immigrants; d) the ability of the school system to enhance and support children’s abilities to integrate within the new society; e) the political/bureaucratic facilitation/impediment to the regularization of VISA, with the consequent effect on the sense of identity/rejection within/from the host society. In conclusion, the programs for monitoring immigrants’ living and health conditions should also include: the assessment of parental skills, the dynamic indicators of risk and protection indexes, the assessment of living conditions and social school environment, with a careful attention to those early signs of discomfort that might precede possible later onset of psychopathology and/or social distress. (shrink)

Since the International Agency on Cancer Research’s monograph found glyphosate to be a likely carcinogen, the regulatory focus on the chemical has centred on this determinative criterion for regulatory action. Yet, other pertinent factors, such as the effects of glyphosate on fresh and ground water and ensuing effects on biodiversity, have received less attention as legitimate rationales for regulating the chemical. This underrepresentation prevents a wider policy discussion on the environmental and human health effects of the chemical and fails (...) to disrupt assumptions of path-dependently continuing on agriculture’s chemical treadmill. To avoid ad hoc post hoc chemical regulation, we assess four areas of chemical regulatory oversight in Europe with regard to glyphosate affecting water: (1) the undue emphasis on in laboratorio versus in situ testing; (2) assessing single chemicals (isolated glyphosate) versus admixtures (glyphosate plus surfactants and adjuvants) that are used in practice; (3) the tendency to downplay harms to non-human life; and (4) the lack of policy coherence in the existing regulatory framework. Focusing on European Union regulation of pesticide and water policy affecting aquatic environments, we conclude that issues of measurement and priority have become highly politicised in both science and policy, requiring preventative, precautionary frameworks utilising plural forms of measurement. (shrink)

At the beginning of the COVID-19 pandemic, high hopes were placed on digital contact tracing. Digital contact tracing apps can now be downloaded in many countries, but as further waves of COVID-19 tear through much of the northern hemisphere, these apps are playing a less important role in interrupting chains of infection than anticipated. We argue that one of the reasons for this is that most countries have opted for decentralised apps, which cannot provide a means of rapidly informing users (...) of likely infections while avoiding too many false positive reports. Centralised apps, in contrast, have the potential to do this. But policy making was influenced by public debates about the right app configuration, which have tended to focus heavily on privacy, and are driven by the assumption that decentralised apps are “privacy preserving by design”. We show that both types of apps are in fact vulnerable to privacy breaches, and, drawing on principles from safety engineering and risk analysis, compare the risks of centralised and decentralised systems along two dimensions, namely the probability of possible breaches and their severity. We conclude that a centralised app may in fact minimise overall ethical risk, and contend that we must reassess our approach to digital contact tracing, and should, more generally, be cautious about a myopic focus on privacy when conducting ethical assessments of data technologies. (shrink)

Background: Exposomics, the study of the exposome, is flourishing, but the field is not well defined. The term “exposome” refers to all environmental influences and associated biological responses throughout the lifespan. However, this definition is very similar to that of the term “environment”—the external elements and conditions that surround and affect the life and development of an organism. Consequently, the exposome seems to be nothing more than a synonym for the environment, and exposomics a synonym for environmental research. As a (...) result, some have rebranded their “standard” environmental health research with the neologistic exposome term, whereas others ignore or seek to abandon the seemingly redundant concept of the exposome. -/- Objectives: We argue that exposomics needs to sharpen its mission focus to counteract this apparent redundancy. Exposomics should be defined as a research program in environmental health aimed at enabling a comprehensive and discovery-driven approach to identifying environmental determinants of human health. Similar to the aim of the Human Genome Project, exposomics aims to analyze the complete complexity of exposures and their corresponding biological responses. Exposomics’ primary premise is that the existence of undiscovered, potentially interconnected, nongenetic (environmental) risk factors for health necessitates a comprehensive discovery-driven analysis approach. -/- Discussion: We argue that exposomics researchers should adopt our reconceptualization of exposomics and focus on the productiveness and integrity of their research program: its purpose and principles. We suggest that exposomics researchers should coordinate the writing of reviews that assess the program’s productiveness and integrity, as well as provide a platform for exposomics researchers to define their vision for the field. (shrink)

The dissemination of information in times of crisis or emergency is distinctive since the affected individuals may take, process, and act on information differently. As the Centers for Disease Control and Prevention noted “the right message at the right time from the right person can save lives.” This study elaborates on the principles of crisis and emergency risk communication (CERC) in the realistic narrative, and notes that a successful CERC should be prompt, accurate, veracious, empathetic, respectful, and promote meaningful (...) action. Since pandemics are not only biomedical but also social, political, economic, and cultural incidents, critical communication in the time of a pandemic is of crucial significance. Hence, the Coronavirus (COVID-19) pandemic is assessed as a recent and important case study. This pandemic had four chief challenges; including that since the disease is caused by the novel SARS-CoV-2 virus the assumptions about the disease have been revised numerously and rapidly. In addition, the cumulative scale and scope of COVID-19 which is in excess of 627 million confirmed cases, and approximately 6.58 million deaths worldwide remained a strain. Another concern was the overwhelming uncertainty and evolving trajectory of the pandemic about how and when it ends or enters the endemic stage of the outbreak. Finally, the overabundance of amplification and dissemination of both accurate and inaccurate information led to an infodemic. Long before the COVID-19 pandemic, many individuals used the internet as an important resource for seeking health-related information. However, the infodemic and the other aforementioned challenges made distinguishing up-to-date accurate information a more arduous task, and CERC and pandemic-related communication are even more crucial. Hence, a multi-dimensional set of skills is required to overcome these challenges whether amidst or after the pandemic. Therefore, a multi-stakeholder approach towards an overarching and comprehensive metaliteracy that “provides an integrated and inclusive framework to cultivate critical thinking and proficiency in comprehending data, information, visuals and the media” is essential. This study recommends and elaborates on how to incorporate metaliteracy into crisis and risk communication at governmental, organizational, and individual levels. (shrink)

Background Previous analyses of democracy and population health have focused on broad measures, such as life expectancy at birth and child and infant mortality, and have shown some contradictory results. We used a panel of data spanning 170 countries to assess the association between democracy and cause-specific mortality and explore the pathways connecting democratic rule to health gains. -/- Methods We extracted cause-specific mortality and HIV-free life expectancy estimates from the Global Burden of Diseases, Injuries, and Risk (...) Factors Study 2016 and information on regime type from the Varieties of Democracy project. These data cover 170 countries and 46 years. From the Financing Global Health database, we extracted gross domestic product (GDP) per capita, also covering 46 years, and Development Assistance for Health estimates starting from 1990 and domestic health spending estimates starting from 1995. We used a diverse set of empirical methods—synthetic control, within-country variance decomposition, structural equation models, and fixed-effects regression—which together provide a robust analysis of the association between democratisation and population health. -/- Findings HIV-free life expectancy at age 15 years improved significantly during the study period (1970–2015) in countries after they transitioned to democracy, on average by 3% after 10 years. Democratic experience explains 22·27% of the variance in mortality within a country from cardiovascular diseases, 16·53% for tuberculosis, and 17·78% for transport injuries, and a smaller percentage for other diseases included in the study. For cardiovascular diseases, transport injuries, cancers, cirrhosis, and other non-communicable diseases, democratic experience explains more of the variation in mortality than GDP. Over the past 20 years, the average country's increase in democratic experience had direct and indirect effects on reducing mortality from cardiovascular disease (−9·64%, 95% CI −6·38 to −12·90), other non-communicable diseases (−9·14%, −4·26 to −14·02), and tuberculosis (−8·93%, −2·08 to −15·77). Increases in a country's democratic experience were not correlated with GDP per capita between 1995 and 2015 (ρ=–0·1036; p=0·1826), but were correlated with declines in mortality from cardiovascular disease (ρ=–0·3873; p<0·0001) and increases in government health spending (ρ=0·4002; p<0·0001). Removal of free and fair elections from the democratic experience variable resulted in loss of association with age-standardised mortality from non-communicable diseases and injuries. -/- Interpretation When enforced by free and fair elections, democracies are more likely than autocracies to lead to health gains for causes of mortality (eg, cardiovascular diseases and transport injuries) that have not been heavily targeted by foreign aid and require health-care delivery infrastructure. International health agencies and donors might increasingly need to consider the implications of regime type in their efforts to maximise health gains, particularly in the context of ageing populations and the growing burden of non-communicable diseases. (shrink)

Accurate assessment and comprehension of smoking behavior are pivotal for elucidating associated health risks and formulating effective public health strategies. In this study, we introduce an innovative approach to predict and analyze smoking prevalence using an artificial neural network (ANN) model. Leveraging a comprehensive dataset spanning multiple years and geographic regions, our model incorporates various features, including demographic data, economic indicators, and tobacco control policies. This research investigates smoking trends with a specific focus on gender-based analyses. These (...) findings are pivotal for enhancing public health initiatives aimed at mitigating tobacco use, assessing associated health risks, and mitigating smoking-related diseases. (shrink)

The EU Artificial Intelligence Act (AIA) defines four risk categories for AI systems: unacceptable, high, limited, and minimal. However, it lacks a clear methodology for the assessment of these risks in concrete situations. Risks are broadly categorized based on the application areas of AI systems and ambiguous risk factors. This paper suggests a methodology for assessing AI risk magnitudes, focusing on the construction of real-world risk scenarios. To this scope, we propose to integrate the AIA (...) with a framework developed by the Intergovernmental Panel on Climate Change (IPCC) reports and related literature. This approach enables a nuanced analysis of AI risk by exploring the interplay between (a) risk determinants, (b) individual drivers of determinants, and (c) multiple risk types. We further refine the proposed methodology by applying a proportionality test to balance the competing values involved in AI risk assessment. Finally, we present three uses of this approach under the AIA: to implement the Regulation, to assess the significance of risks, and to develop internal risk management systems for AI deployers. (shrink)

Violence risk assessment tools are increasingly used within criminal justice and forensic psychiatry, however there is little relevant, reliable and unbiased data regarding their predictive accuracy. We argue that such data are needed to (i) prevent excessive reliance on risk assessment scores, (ii) allow matching of different risk assessment tools to different contexts of application, (iii) protect against problematic forms of discrimination and stigmatisation, and (iv) ensure that contentious demographic variables are not prematurely removed (...) from risk assessment tools. (shrink)

Abstract: Heart attacks, or myocardial infarctions, are a leading cause of mortality worldwide. Early prediction and accurate analysis of potential risk factors play a crucial role in preventing heart attacks and improving patient outcomes. In this study, we conduct a comprehensive review of datasets related to heart attack analysis and prediction. We begin by examining the various types of datasets available for heart attack research, encompassing clinical, demographic, and physiological data. These datasets originate from diverse sources, including hospitals, research (...) institutions, and public health agencies. Our analysis aims to identify common features, data quality, and potential biases in these datasets. Next, we explore the predictive modeling techniques employed in heart attack prediction. Machine learning algorithms, such as decision trees, support vector machines, and deep neural networks, have gained prominence in predicting heart attacks. We discuss the strengths and limitations of these methods and highlight recent advancements in predictive modeling. Furthermore, we delve into the critical risk factors associated with heart attacks. Factors such as age, gender, hypertension, diabetes, and cholesterol levels are examined for their significance in predicting cardiac events. We also investigate the role of lifestyle factors, including smoking, diet, and physical activity, in heart attack risk assessment. Additionally, this review addresses the importance of data preprocessing and feature engineering in improving prediction accuracy. Feature selection methods, missing data handling, and data scaling techniques are discussed to enhance the robustness of heart attack prediction models. In conclusion, this comprehensive dataset review provides valuable insights into the state of heart attack analysis and prediction. It serves as a resource for researchers and healthcare professionals seeking to better understand the datasets available for heart attack research and the methods employed for accurate prediction. Ultimately, our efforts in dataset analysis and predictive modeling contribute to the advancement of preventive cardiology and the reduction of heart attack-related morbidity and mortality. (shrink)

At the beginning of the COVID-19 pandemic, high hopes were put on digital contact tracing, using mobile phone apps to record and immediately notify contacts when a user reports as infected. Such apps can now be downloaded in many countries, but as second waves of COVID-19 are raging, these apps are playing a less important role than anticipated. We argue that this is because most countries have opted for app configurations that cannot provide a means of rapidly informing users of (...) likely infections while avoiding too many false positive reports. Mathematical modelling suggests that differently configured apps have the potential to do this. These require, however, that some pseudonymised data be stored on a central server, which privacy advocates have cautioned against. We contend that their influential arguments are subject to two fallacies. First, they have tended to one-sidedly focus on the risks that centralised data storage entails for privacy, while paying insufficient attention to the fact that inefficient contact tracing involves ethical risks too. Second, while the envisioned system does entail risks of breaches, such risks are also present in decentralised systems, which have been falsely presented as ‘privacy preserving by design’. When these points are understood, it becomes clear that we must rethink our approach to digital contact tracing in our fight against COVID-19. There are no data in this work. (shrink)

The dissertation, comprising a clinical intervention and three supporting studies, aimed to assess if it is possible to prevent nonsynostotic plagiocephaly while promoting safe infant sleeping practices. Five individuals were trained to assess cranial asymmetry and then reliability-tested; the interpreted results indicate substantial strength of rater-agreement. Intervention participants were allocated to group. Only intervention group nurses participated in the continuing education on plagiocephaly developed for nurses. A survey compared information intervention and control group parents received from nurses; intervention group parents (...) were significantly more aware of recommendations than the controls. Nurse education was evaluated by asking intervention and control group nurses and parents two open-ended questions; the intervention group reported new re-positioning strategies. The effect of the intervention on cranial shape was evaluated by assessing asymmetry at 2, 4, and 12 months (176 intervention group; 92 controls). It was nine times more common that cranial asymmetry at two months reversed by four months when parents were aware of written recommendations from their nurse (OR = 9.09 [0.02; 0.48], p = 0.004) when adjusted for group. An infant’s risk of asymmetry persisting until 12 months was significantly reduced in the intervention group (RR = 0.35 [0.13; 0.94], p = 0.03). Preventing brachycephaly was difficult. Conclusions: the assessors were considered reliable; educating nurses promoted the integration of new recommendations in practice; the intervention was associated with early reversal of nonsynostotic plagiocephaly. (shrink)

In this paper, we distinguish between different sorts of assessments of algorithmic systems, describe our process of assessing such systems for ethical risk, and share some key challenges and lessons for future algorithm assessments and audits. Given the distinctive nature and function of a third-party audit, and the uncertain and shifting regulatory landscape, we suggest that second-party assessments are currently the primary mechanisms for analyzing the social impacts of systems that incorporate artificial intelligence. We then discuss two kinds of (...) as-sessments: an ethical risk assessment and a narrower, technical algo-rithmic bias assessment. We explain how the two assessments depend on each other, highlight the importance of situating the algorithm within its particular socio-technical context, and discuss a number of lessons and challenges for algorithm assessments and, potentially, for algorithm audits. The discussion builds on our team’s experience of advising and conducting ethical risk assessments for clients across dif-ferent industries in the last four years. Our main goal is to reflect on the key factors that are potentially ethically relevant in the use of algo-rithms, and draw lessons for the nascent algorithm assessment and audit industry, in the hope of helping all parties minimize the risk of harm from their use. (shrink)

Two general ethical problems in psychiatry are thrown into sharp relief by long term care. This article discusses each in turn, in the context of two anonymised case studies from actual clinical practice. First, previous mental health legislation soothed doubts about patients' refusal of consent by incorporating time limits on involuntary treatment. When these are absent, as in the provisions for long term care which have recently come into force, the justification for compulsory treatment and supervision becomes more obviously (...) problematic. Second, Anglo-American law does not normally allow the preventive detention of someone who may be dangerous but has not actually committed any crime. The justification for detaining a possibly dangerous user of mental health services without his or her consent can only be based on risk assessment, but this raises issues of moral luck. Is the psychiatrist who decides not to take out a supervision order for a possibly dangerous patient with an initial psychotic diagnosis morally at fault if that person harms someone in the community, or himself? Or is the psychiatrist merely unlucky? (shrink)

In Brazil, the social demand for veterinary expertise is growing. However, there is still a shortage of professionals trained in this area to apply specific knowledge to each case. Studies and research into forensic veterinary medicine are necessary for veterinary experts to assist in investigations and legal proceedings. Veterinary medicine has subjects on its curriculum that cover the knowledge needed to apply in the fields of animal health, public health and the environment. The interaction between human and veterinary (...) medicine, as well as other areas of health, is of great importance in the prevention and control of various diseases, both in animals and humans. Some cases of infectious bovine abortion have a major impact not only on cattle farming and animal health, but also on public and environmental health. The concept of "One Health" integrates human medicine and health professionals. In this context, knowledge of infectious abortive diseases that affect animal, human and environmental health is fundamental. Cattle are affected by specific infectious abortive diseases, caused by pathogens with different forms of presentation and transmission mechanisms. These include brucellosis, leptospirosis and listeriosis, which are potentially zoonotic diseases. Controlling these diseases can contribute to effective public health actions and reduce global health risks. In order to establish the diagnosis of these diseases, it is essential to properly collect specimens from live or dead animals under biosafety and biosecurity conditions, following the chain of custody for each case. These procedures allow for greater success in diagnosing the suspected agent and facilitate the investigation of other causes. Animal health standards for the prophylaxis and control of these diseases are established by specific legislation, including those of the Ministry of Agriculture, Livestock and Supply (MALS). This literature review was based on current knowledge on the Pubmed platform, Google Scholar, articles and textbooks. The aim of this article is to identify, understand and discuss the main infectious abortive diseases of cattle in the legal and forensic context, which have an impact on cattle farming, animal health, food safety, public and environmental health. -/- Referências bibliográficas Abdullah, N. M., Mohammad, W. M. Z. W., Shafei, M. N., Sukeri, S., Idris, Z., Arifin, W. N., Nozmi, N., Saudi, S. N. S., Samsudin, S., & Zainudin, A.-W. (2019). Leptospirosis and its prevention: knowledge, attitude and practice of urban community in Selangor, Malaysia. BMC Public Health, 19(1), 1–8. Agrimani, D. S. R., Rui, B. R., Cruz, I. V, Romano, R. M., & Lopes, H. C. (2011). 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Credit risk, also known as default risk, is the likelihood of a corporation losing money if a business partner defaults. If the liabilities are not met under the terms of the contract, the firm may default, resulting in the loss of the company. There is no clear way to distinguish between organizations that will default and those that will not prior to default. We can only make probabilistic estimations of the risk of default at best. There are (...) two types of credit risk default models in this regard: structural and reduced form models. Structural models are used to calculate the likelihood of a company defaulting based on its assets and liabilities. If the market worth of a company's assets is less than the debt it owes, it will default. Reduced form models often assume an external cause of default, such as a Poisson jump process, which is driven by a stochastic process. They model default as a random event with no regard for the balance sheet of the company. This paper provides a Review of credit risk default models. (shrink)

Call for Written evidence - Risk Assessment and Risk Planning.

Genetically engineered (GE) insects, such as the GE OX513A Aedes aegypti mosquitoes, have been designed to suppress their wild-type populations so as to reduce the transmission of vector-borne diseases in humans. Apart from the ecological and epidemiological uncertainties associated with this approach, such biotechnological approaches may be used by individual governments or the global community of nations to avoid addressing the underlying structural, systemic causes of those infections... We discuss here key ethical questions raised by the use of GE mosquitoes, (...) with the aim of fostering discussion between the public, researchers, policy makers, healthcare organizations, and regulatory agencies at the local, national, and international levels. We affect that goal by outlining a procedural approach to decision-making about the use of the “biotechnology” that goes beyond “community engagement.” The protocol we advocate for entails informed deliberations and decision-making at the community level. It is designed to ensure that the voices of the marginalized and vulnerable groups that would be disproportionately affected by the decision are heard during the community-wide discussions. Moreover, we make the case that the values embedded in the risk assessment should be identified so that the community can make an informed decision about the use of GE insects. In addition, we advocate for the involvement of a variety of actors whose responsibility would be to ensure that the community has the opportunity to make an informed decision based on deliberations about the use of the “biotechnology.”. (shrink)

US Senate is considering legislation designed to immunize small businesses from lawsuits brought by customers alleging to have been infected with COVID-19 while on the premises. The legislation seeks to subsidize reopening small businesses by reducing their vulnerability to liability. I argue that the legislation produces worse public health outcomes than existing liability regimes, obliterates claims to redress supported by corrective justice, and unfairly burdens victims by forcing them to become de facto insurers of their injurers. In the US, (...) where health insurance is inextricably linked with employment, and during the pandemic with the consequent loss of employment, the legislation is cruel in addition to being ineffective, unjust, unfair and inappropriate. Since I first uploaded this manuscript to Philpapers, Senate Republicans have in fact introduced specific legislation that is marginally different than the one I discuss in the manuscript. Instead of offering blanket immunity, the current Republican proposal offers a series of substantial barriers both to filing lawsuits and to securing a successful verdict at trial. I discuss these as an addendum to the main paper. In short, though the changes impact some features of my argument, they do not alter any of the conclusions. The current proposal produces worse public health outcomes than would existing tort regime; it leaves the vast majority of those with legitimate claims to repair in corrective justice without a remedy, when providing the opportunity to secure a remedy for wrongs is in large measure, the essential nature of tort liability. Worse still, it continues to render victims the de facto insurers of those who have wronged them; it imposes the burden of spreading risks on victims who are considerably less efficient risk spreaders than are businesses and hospitals; it constitutes an inappropriate response to the challenge it seeks to address, i.e. subsidizing various sectors of the economy by reducing their overall costs; and given the fact that in the US health insurance is too closely linked to employment, it shifts the costs of the pandemic to those who are most at risk of losing their health insurance, rendering the proposal cruel in addition to inefficient, unjust, unfair and inappropriate. For those interested, I am considering a short op-ed piece assessing the particular legislative proposal. If I follow through I will let the readership know where that can be found. (shrink)

In this essay, we advocate that the issue of health data ethics should no longer be considered on the level of individual scientists or research labs, but rather as a problem involving all stakeholders, from publishers, funders, ethical committees to governments, for the sake of research integrity.

The foundations of research ethics are riven with fault lines emanating from a fear that if research is too closely connected to weighty social purposes an imperative to advance the common good through research will justify abrogating the rights and welfare of study participants. The result is an impoverished conception of the nature of research, an incomplete focus on actors who bear important moral responsibilities, and a system of ethics and oversight highly attuned to the dangers of research but largely (...) silent about threats of ineffective, inefficient, and inequitable medical practices and health systems. -/- In For the Common Good: Philosophical Foundations of Research Ethics, Alex John London defends a conception of the common good that grounds a moral imperative with two requirements. The first is to promote research that generates the information necessary to enable key social institutions to effectively, efficiently, and equitably safeguard the basic interests of individuals. The second is to ensure that research is organized as a voluntary scheme of social cooperation that respects its various contributors' moral claims to be treated as free and equal. Connecting research to the goals of a just social order grounds a framework for assessing and managing research risk that reconciles these requirements and justifies key oversight practices in non-paternalistic terms. Reconceiving research ethics as resolving coordination problems and providing credible assurance that these requirements are being met expands the issues and actors that fall within the purview of the field and provides the foundation for a more unified and coherent approach to domestic and international research. -/- This is an open access title available under the terms of a CC BY-NC-ND 4.0 license. It is free to read at Oxford Scholarship Online and offered as a free PDF download from OUP and selected open access locations. (shrink)

Risk is an intrinsic part of our lives. In the future, the development and growth of the Internet of things allows getting a huge amount of data. Considering this evolution, our research focuses on developing a novel concept, namely Holistic Risk Assessment (HRA), that takes into consideration elements outside the direct influence of the individual to provide a highly personalized risk assessment. The HRA implies developing a methodology and a model. This paper is related to (...) the epistemological positioning of this research. We consider this research as an artificial science under the constructivism paradigm. We also introduce the positioning of this research in the complexity science paradigm. We end this paper by presenting a methodology based on an adapted Design Thinking Model. (shrink)

Background: Use of patients’ medical data for secondary purposes such as health research, audit, and service planning is well established in the UK. However, the governance environment, as well as public understanding about this work, have lagged behind. We aimed to systematically review the literature on UK and Irish public views of patient data used in research, critically analysing such views though an established biomedical ethics framework, to draw out potential strategies for future good practice guidance and inform ethical (...) and privacy debates. Methods: We searched three databases using terms such as patient, public, opinion, and electronic health records. Empirical studies were eligible for inclusion if they surveyed healthcare users, patients or the public in UK and Ireland and examined attitudes, opinions or beliefs about the use of patient data for medical research. Results were synthesised into broad themes using a framework analysis. Results: Out of 13,492 papers and reports screened, 20 papers or reports were eligible. While there was a widespread willingness to share patient data for research for the common good, this very rarely led to unqualified support. The public expressed two generalised concerns about the potential risks to their privacy. The first of these concerns related to a party’s competence in keeping data secure, while the second was associated with the motivation a party might have to use the data. Conclusions: The public evaluates trustworthiness of research organisations by assessing their competence in data-handling and motivation for accessing the data. Public attitudes around data-sharing exemplified several principles which are also widely accepted in biomedical ethics. This provides a framework for understanding public attitudes, which should be considered in the development in any guidance for regulators and data custodians. We propose four salient questions which decision makers should address when evaluating proposals for the secondary use of data. (shrink)

The EU proposal for the Artificial Intelligence Act (AIA) defines four risk categories: unacceptable, high, limited, and minimal. However, as these categories statically depend on broad fields of application of AI, the risk magnitude may be wrongly estimated, and the AIA may not be enforced effectively. This problem is particularly challenging when it comes to regulating general-purpose AI (GPAI), which has versatile and often unpredictable applications. Recent amendments to the compromise text, though introducing context-specific assessments, remain insufficient. To (...) address this, we propose applying the risk categories to specific AI scenarios, rather than solely to fields of application, using a risk assessment model that integrates the AIA with the risk approach arising from the Intergovernmental Panel on Climate Change (IPCC) and related literature. This model enables the estimation of the magnitude of AI risk by considering the interaction between (a) risk determinants, (b) individual drivers of determinants, and (c) multiple risk types. We use large language models (LLMs) as an example. (shrink)

The COVID-19 pandemic has helped to clarify the fair and equitable allocation of scarce medical resources, both within and among countries. The ethical allocation of such resources entails a three-step process: (1) elucidating the fundamental ethical values for allocation, (2) using these values to delineate priority tiers for scarce resources, and (3) implementing the prioritisation to faithfully realise the fundamental values. Myriad reports and assessments have elucidated five core substantive values for ethical allocation: maximising benefits and minimising harms, mitigating unfair (...) disadvantage, equal moral concern, reciprocity, and instrumental value. These values are universal. None of the values are sufficient alone, and their relative weight and application will vary by context. In addition, there are procedural principles such as transparency, engagement, and evidence-responsiveness. Prioritising instrumental value and minimising harms during the COVID-19 pandemic led to widespread agreement on priority tiers to include health-care workers, first responders, people living in congregate housing, and people with an increased risk of death, such as older adults and individuals with medical conditions. However, the pandemic also revealed problems with the implementation of these values and priority tiers, such as allocation on the basis of population rather than COVID-19 burden, and passive allocation that exacerbated disparities by requiring recipients to spend time booking and travelling to appointments. This ethical framework should be the starting point for the allocation of scarce medical resources in future pandemics and other public health conditions. For instance, allocation of the new malaria vaccine among sub-Saharan African countries should be based not on reciprocity to countries that participated in research, but on maximally reducing serious illness and deaths, especially among infants and children. (shrink)

In this article, I show why it is necessary to abolish the use of predictive algorithms in the US criminal justice system at sentencing. After presenting the functioning of these algorithms in their context of emergence, I offer three arguments to demonstrate why their abolition is imperative. First, I show that sentencing based on predictive algorithms induces a process of rewriting the temporality of the judged individual, flattening their life into a present inescapably doomed by its past. Second, I demonstrate (...) that recursive processes, comprising predictive algorithms and the decisions based on their predictions, systematically suppress outliers and progressively transform reality to match predictions. In my third and final argument, I show that decisions made on the basis of predictive algorithms actively perform a biopolitical understanding of justice as management and modulation of risks. In such a framework, justice becomes a means to maintain a perverse social homeostasis that systematically exposes disenfranchised Black and Brown populations to risk. (shrink)

Exposome research is put forward as a major tool for solving the nature-versus-nurture debate because the exposome is said to represent “the nature of nurture.” Against this influential idea, we argue that the adoption of the nature-versus-nurture debate into the exposome research program is a mistake that needs to be undone to allow for a proper bioethical assessment of exposome research. We first argue that this adoption is originally based on an equivocation between the traditional nature-versus-nurture debate and a (...) debate about disease prediction/etiology. Second, due to this mistake, exposome research is pushed to adopt a limited conception of agential control that is harmful to one's thinking about the good that exposome research can do for human health and wellbeing. To fully excise the nature-versus-nurture debate from exposome research, we argue that exposome researchers and bioethicists need to think about the exposome afresh from the perspective of actionability. We define the concept of actionability and related concepts and show how these can be used to analyze the ethical aspects of the exposome. In particular, we focus on refuting the popular “gun analogy” in exposome research, returning results to study participants and risk-taking in the context of a well-lived life. (shrink)

This project has been supported by the Australian Government through the Australian Research Council (project number CS170100008); the Department of Industry, Innovation and Science; and the Department of Prime Minister and Cabinet. ACOLA collaborates with the Australian Academy of Health and Medical Sciences and the New Zealand Royal Society Te Apārangi to deliver the interdisciplinary Horizon Scanning reports to government. The aims of the project which produced this report are: 1. Examine the transformative role that artificial intelligence may play (...) in different sectors of the economy, including the opportunities, risks and challenges that advancement presents. 2. Examine the ethical, legal and social considerations and frameworks required to enable and support broad development and uptake of artificial intelligence. 3. Assess the future education, skills and infrastructure requirements to manage workforce transition and support thriving and internationally competitive artificial intelligence industries. (shrink)

Metaphors for describing the introduction, impacts, and management of non-native species are numerous and often quite outspoken. Policy-makers have adopted increasingly disputed metaphorical terms from scientific discourse. We performed a critical analysis of the use of strong metaphors in reporting scientific findings to policy-makers. Our analysis shows that perceptions of harm, invasiveness or nativeness are dynamic and inevitably display multiple narratives in science, policy or management. Improving our awareness of multiple expert and stakeholder narratives that exist in the context of (...) non-native species management, as well as metaphorical alternatives, is critical. (shrink)

Local participation is always beneficial for sustainable action and environmental problems resulting from urban implementation due to the failure of social and institutional change necessary for a successful transformation of rural life to urban life ahead of the rapid movement of the population. Despite good legal practice and comprehensive guidelines, evidence suggests that Environmental Impact Assessment (EIA) or more broadly Environmental, Social and Health Impact Assessment (ESHIA) have not yet been found satisfactory in Nigeria, as the current (...) system amounts to duplication of efforts and cost. However, ESHIA has been developed and integrated to help manage project activities, facilities, and operations sustainably, so that both economic and ecological profits are accrued (sustainable development) or ensure that any development project does not result in excessive deterioration of and/or the irreversible adverse effect on any component of the environment – a recite for sustainable development. A literature review was done by using a variety of search engines including Research Gate, Google Scholar, Academia, Mendeley, SSRN search strategy to retrieve research publications, “grey literature” and expert working group reports. The thrust of this study is to evaluate the potential benefits of ESHIA as a tool for sustainable environmental development. The evaluation and implementation of EIA are one of the strengths of these tools. Indeed, EIA is the first and foremost management tool employed to help mitigate adverse, potential, and associated impacts of proposed major developments in our environment. EIA is a regulatory requirement that is efficiently used to improve performance, project design, enhancing decision-making, and facilitating policy programs in a sustainable environment. An evaluation of the EIA systems reveals several weaknesses of the EIA system. These include the inadequate capacity of EIA approval authorities, deficiencies in screening and scoping, poor EIA quality, insufficient public participation, and weak monitoring, and erratic government policies. Overall, most EIA study rarely meets the objectives of being a project planning tool to contribute to achieving sustainable development and mitigate the impact of the development project. The study recommends some directions for the future to ensure that entire content of the EIA are religiously implemented, review the existing EIA act, increase the expertise of EIA consultants, create a liaison office with an international organisation and with sister agency, ESHIA must enjoy Improved budgetary provision, time latitude, spatial contexts and methodological improvements for outcome measures to achieve results that are relevant to sustainable development by improving project design, enhancing decision making and facilitating policy programs. (shrink)

Drink driving causes great suffering and material destruction. The alcohol interlock promises to eradicate this problem by technological design. Traditional counter-measures to drink driving such as policing and punishment and information campaigns have proven insufficient. Extensive policing is expensive and intrusive. Severe punishment is disproportionate to the risks created in most single cases. If the interlock becomes inexpensive and convenient enough, and if there are no convincing moral objections to the device, it may prove the only feasible as well as (...) the only justifiable solution to the problem of drink driving. A policy of universal alcohol interlocks, in all cars, has been proposed by several political parties in Sweden and is supported by the National Road Administration and the 2006 Alcohol Interlock Commission. This article assesses two possible moral objections to a policy of universal interlocks: (i) that it displaces the responsibility of individual drivers and (ii) that it constitutes a paternalistic interference with drivers. The first objection is found unconvincing, while the second has only limited bite and may be neutralized if paternalism is accepted for the sake of greater net liberty. Given the expected technological development, the proposed policy seems a commendable health promotion measure for the near future. (shrink)

The objective of the paper is to analyze whether that the pharmaceutical companies producing HIV drugs have moral obligation(s) towards the HIV victims in developing countries who don‟t have access to get drug to reduce their risks. The primary assessment is that the pharmaceutical companies have minimum moral obligation(s) to the HIV patients especially in developing countries. It is because they are human beings and hence they are the subject of moral considerations. The paper argues that from the sense (...) of benevolence, there may be an obligation that will tend pharmaceutical companies to make an opportunity of the concerned HIV patients of developing countries to get drugs. The discussion will be made from the utilitarian point of view. Though it is assumed that, utilitarianism is too demanding, I will show that the too demanding ness of utilitarianism can be minimized and it will not be contradictory with the main theme of utilitarian morality. In this respect the counter examples and arguments will also be analyzed to make the claim stronger. The paper also argues that though the primary aim of the pharmaceutical companies is to make money, the actions that might be taken by the pharmaceutical companies for the welfare of HIV victims will not hamper them in making money for which they are deployed. (shrink)

An axiom of medical research ethics is that a protocol is moral only if it has a “favorable risk-benefit ratio”. This axiom is usually interpreted in the following way: a medical research protocol is moral only if it has a positive expected value -- that is, if it is likely to do more good (to both subjects and society) than harm. I argue that, thus interpreted, the axiom has two problems. First, it is unusable, because it requires us to (...) know more about the potential outcomes of research than we ever could. Second, it is false, because it conflicts with the so-called “soft paternalist” principles of liberal democracy. In place of this flawed rule I propose a new way of making risk-benefit assessments, one that does comport with the principles of liberalism. I argue that a protocol is moral only if it would be entered into by competent subjects who are informed about the protocol. The new rule this eschews all pseudo-utilitarian calculation about the protocol’s likely harms and benefits. (shrink)

Physical activity levels of people with chronic neurological disorders are lower than those of healthy people. Problems in neurological disorders, including gait abnormalities, muscle weakness/loss of strength, spasticity, tremor, fatigue, balance disorder, and incontinence, results in lower physical activity level. After determining the situations that are contraindicated for physical activity, the patients should be evaluated by physiotherapists, and possible risks that may occur should be determined. Many studies have demonstrated that physical activity significantly reduces mortality and morbidity, increases community participation, (...) and improves health-related quality of life. These benefits show that increased physical activity and exercise should be part of the standard management of neurological disorders. In these patients, physical activity programs should be structured individually by providing appropriate environmental conditions and safety, following the assessment of the functional status and severity of the disease. The duration, intensity, and type of planned physical activity should be adjusted individually; Appropriate rest intervals should be given during the activity, and termination criteria should be determined according to individual tolerance. This literature review aims to provide an up-to-date overview of physical activity recommendations for individuals with chronic neurological disorders. (shrink)

What role should legislation or policy play in avoiding the complications of in-vitro fertilization? In this article, we focus on single versus double embryo transfer, and assess three arguments in favour of mandatory single embryo transfer: risks to the mother, risks to resultant children, and costs to society. We highlight significant ethical concerns about each of these. Reproductive autonomy and non-paternalism are strong enough to outweigh the health concerns for the woman. Complications due to non-identity cast doubt on the (...) extent to which children are harmed. Twinning may offer an overall benefit rather than burden to society. Finally, including the future health costs for children in reproductive policy is inconsistent with other decisions. We conclude that mandatory single embryo transfer is not justified and that a number of countries should reconsider their current embryo transfer policy. (shrink)

A large proportion of the total global burden of disease is caused by emergency medical conditions. Emergency care research is essential to improving emergency medicine but this research can raise some distinctive ethical challenges, especially with regard to (1) standard of care and risk–benefit assessment; (2) blurring of the roles of clinician and researcher; (3) enrolment of populations with intersecting vulnerabilities; (4) fair participant selection; (5) quality of consent; and (6) community engagement. Despite the importance of research to (...) improve emergency care in low-income and middle-income countries (LMICs) and the widely acknowledged ethical challenges, very little has been written on the ethics of emergency care research in LMICs. This paper examines the ethical and regulatory challenges to conducting emergency care research with human participants in LMICs. We outline key challenges, present potential solutions or frameworks for addressing these challenges, and identify gaps. Despite the ethical and regulatory challenges, conducting high-quality, ethical emergency care research in LMICs is possible and it is essential for global health. (shrink)

Risk assessment is one of the prerequisites for understanding its causes and possible consequences. We base our risk assessment on the principles described in the European standard EN 31000 - Risk Management Process. This standard comprehensively describes the continuous activities that are necessary in managing risks and minimizing their possible adverse effects on the operation of the system under investigation. In this activity, it is necessary to first identify the existing risks, then analyze and evaluate (...) the identified risks. In the analysis of existing risks, it is possible to use both qualitative and quantitative analytical methods, or combine them. We use qualitative methods in cases where we do not have a sufficient amount of input information, these are more subjective. Quantitative methods are more accurate, but also more demanding on input information and time. The choice of a suitable analytical method is a basic prerequisite for knowledge of risks and their evaluation. The values of individual risks obtained in this way are the basis for determining the measures that are ecessary to minimize them, i.e., to adjust them to an acceptable level. The draft measures are always based on the value of the individual components used to calculate the risk number, as well as on the value of the asset , which needs to be protected. Appropriately chosen analytical methods are one of the basic prerequisites for the consistent application of the principles of risk management, as a continuous process aimed at increasing the overall security of the system under study. In the article, the author describes the procedures used in risk assessment, as well as specific analytical methods that can be used in working with risks. The aim of identifying risk factors is to create a list of events that could cause undesirable disruption to ongoing processes. At this stage, we define all the risks that will be subsequently analyzed and evaluated. When identifying, we can use methods such as, e.g. SWOT, PHA (Preliminary Hazard Analysis) or CA (Checklist Analysis). Methods suitable for determining the causes and creating scenarios for the course of a risk event are ETA (Event Tree Analysis) or FTA (Fault Tree Analysis). The basic analysis of the system can be performed using the FMEA method (Failure Mode and Effect Analysis), which provides a numerical risk assessment. By comparison with the numerical value of the risk that we are willing to accept, we obtain 2 groups of risks. Acceptable, which will be given regular attention and unacceptable, which we will focus on in risk management and we will try to minimize its negative affect on the functioning of the system under study. (shrink)