This paper discusses possible mechanisms that might lead to misinterpretations of collected data and makes new evidence‐based medicine (EBM) recommendations to oppose the previously accepted preventive measures, or treatment options. It is focused on the danger of the “red meat” consumption, and the question whether eating pungent food is good or bad for our health and finally whether the “bad luck” concept of getting several cancer types is valid or not. These three topics got and still have significant media (...) attention. Several mechanisms are proposed as possible causes of these apparent conflicts. Some of them have already been recognized but sadly remained less known to medical readers and also to the general population. Also see the video abstract here https://youtu.be/owjoRXrNShA. (shrink)

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)

There are widely held premises that suicide is almost exclusively the result of mental illness and there is “strong evidence for successfully detecting and managing suicidality in healthcare”. In this context, ‘zero-suicide’ policies have emerged, and suicide risk assessment tools have become a normative component of psychiatric practice. This essay discusses how suicide evolved from a moral to a medical problem and how, in an effort to reduce suicide, a paternalistic healthcare response emerged to predict those at high (...) class='Hi'>risk. The evidence for the premises is critiqued and shown to be problematic; and it is found that strong paternalistic interventions are being used more often than acknowledged. Using a Principles approach, the ethics of overriding autonomy in suicide prevention is considered. Ethical concerns are identified with the current approach which are potentially amplified by the use of these risk assessments. Furthermore, it is identified that the widespread use of risk assessments in health settings is equivalent to screening without regard to the ethical principles of screening. The essay concludes that this is unethical; that we should abandon the use of standardized suicide risk assessments and ‘zero-suicide’ policy; and that this may improve outcomes. (shrink)

Recent progress in synthetic biology has enabled the development of novel therapeutic opportunities for the treatment of human disease. In the near future, first-in-human trials will be indicated. FIH trials mark a key milestone in the translation of medical SynBio applications into clinical practice. Fostered by uncertainty of possible adverse events for trial participants, a variety of ethical concerns emerge with regards to SynBio FIH trials, including ‘risk’ minimization. These concerns are associated with any FIH trial, however, due to (...) the novelty of the approach, they become more pronounced for medical applications of emerging technologies like SynBio. To minimize potential harm for trial participants, scholars, guidelines, regulations and policy makers alike suggest using ‘risk assessment’ as evaluation tool for such trials. Conversely, in the context of emTech FIH trials, we believe it to be at least questionable to contextualize uncertainty of potential adverse events as ‘risk’ and apply traditional risk assessment methods. Hence, this issue needs to be discussed to enable alterations of the evaluation process before the translational phase of SynBio applications begins. In this paper, we will take the opportunity to start the debate and highlight how a misunderstanding of the concept of risk, and the possibilities and limitations of risk assessment, respectively, might impair decision-making by the relevant regulatory authorities and research ethics committees, and discuss possible solutions to tackle the issue. (shrink)

Quantitative health risk assessment is a procedure for estimating the likelihood that exposure to environmental contaminants will produce certain adverse health effects, most commonly cancer. One instance of its use has been a California air toxics public “right-to-know” law. This article examines the ways in which credible health risk measurements were produced and challenged during the implementation of the California public policy. Fieldwork and documentary analysis finds that stakeholders negotiated within the formal constraints of the (...) risk assessment procedures but still expressed their competing visions for the implementation of the risk communication policy. The abstract results of the method were contextualized according to different time frames and allocations of uncertainty. Furthermore, the article demonstrates that the political process privileged consistency of measurement over accuracy, revealing political negotiations at a fundamentally technical level. The struggle and variation in interpretations can be explained best by the demand to organize the program around the discordant values of democratic accountability and technical efficiency. (shrink)

The U.S. Food and Drug Administration (FDA) announced recently that food products derived from some animal clones and their offspring are safe for human consumption. In response to criticism that it had failed to engage with ethical, social, and economic concerns raised by livestock cloning, the FDA argued that addressing normative issues prior to issuing a final ruling on animal cloning is not part of its mission. In this article, the authors reject the FDA's claim that its mission to protect (...) and advance public health can be accomplished without considering ethical issues or without making value judgments. The authors offer two arguments in support of their position. First, the agency's mission statement presupposes significant normative commitments and judgments. Second, the FDA's risk assessment of food products from cloned animals and their offspring is itself clearly shaped by a variety of normative commitments. (shrink)

In 2004, prenatal risk assessment (PRA) was implemented as a routine offer in Denmark, in order to give all pregnant women an informed choice about whether to undergo prenatal testing. PRA is a non-invasive intervention performed in the first trimester of pregnancy and measures the risk of a fetus having Down's syndrome or other chromosomal disorders. The risk figure provides the basis for action, i.e. the decision about whether or not to undergo invasive fetal testing via the (...) maternal route (amniocentesis or chorionic villus sampling), which, however, involves the risk of inducing a miscarriage. On the basis of ethnographic fieldwork in an ultrasound clinic in Denmark and interviews with pregnant women and their partners, this paper investigates how ideals such as autonomy and non-directiveness are practised in processes of decision-making. We view such ideals as forming social practice rather than neutral instruments to reach a certain goal. Focusing on one couple's trajectory through the clinical practices of PRA and the process through which a decision is reached, we call into question the assumption that more choice and more objective information is a source of empowerment and control. We make evident how decisions are made through a complicated process of meaning-making, which emerges through the relationship between professionals, the clinical setting and the social life of the couples. In the face of complex risk knowledge, PRA users are reluctant to make choices and seek to re-install authority in the health professionals. However, when assumptions about autonomy and self-determination are inscribed into the social practice of PRA, authority is transferred to the couple undergoing PRA and a new configuration of responsibility evolves between the couple and their relationship to the fetus. It is argued that PRA performs a form of government that works not through compulsion or persuasion but through choice. An ethic of a shared responsibility for PRA and its outcome between pregnant women and health professionals would be more in agreement with how decisions are actually made. (shrink)

A comprehensive assessment of a health technology requires that a wide variety of questions are addressed. These range from whether the use of a technology results in achievement of its intended effects at acceptable costs and without incurring undue risks to the patient, to whether its use may challenge existing social arrangements and values. Clearly, this is a major challenge, since it requires the use of quite different methods of inquiry. In the past decades, we have rarely witnessed (...) class='Hi'>assessments where both types of questions were addressed in a balanced way. Rather, a wide gap exists between inquiries with a strong empirical focus and an almost complete neglect of underlying normative issues, and inquiries which are largely discursive, but with a serious disregard of relevant empirical data. The complex interplay between normative frameworks and empirical data in the assessment of health technologies is illustrated in two case studies: the assessment of surgical management of children with glue ears, and the assessment of Extra Corporeal Membrane Oxygenation in neonates. (shrink)

In 2004 prenatal risk assessment was implemented as a routine offer to all pregnant women in Denmark. It was argued that primarily the new programme would give all pregnant women an informed choice about whether to undergo prenatal testing. On the basis of ethnographic fieldwork in an ultrasound clinic in Denmark and interviews with pregnant women and their partners, we call into question the assumption underlying the new guidelines that more choice and more objective information is a source of (...) empowerment and control. We focus on one couple's experience of PRA. This case makes it evident how supposed choices in the context of PRA may not be experienced as such. Rather, they are experienced as complicated processes of meaning-making in the relational space between the clinical setting, professional authority and the social life of the couples. PRA users are reluctant to make choices and abandon health professionals as authoritative experts in the face of complex risk knowledge. When assumptions about autonomy and self-determination are inscribed into the social practice of PRA, authority is transferred to the couple undergoing PRA and a new configuration of responsibility evolves between the couple and their relationship to the foetus. It is argued that al-though the new programme of prenatal testing in Denmark presents itself in opposition to quasi-eugenic and paternalistic forms of governing couples' decisions it represents another form of government that works through the notion of choice. An ethics of a shared responsibility of PRA and its outcome would be more in agreement with how decisions are actually made. (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)

Risk assessment is an evidence-based analytical framework used to evaluate research findings related to environmental and public health decision-making. Different routines have been adopted for assessing the potential risks posed by substances and products to human health. In general, the traditional paradigm is a hazard-driven approach, based on a monocausal toxicological perspective. Questions have been raised about the applicability of the general chemical risk assessment approach in the specific case of nanomaterials. Most scientists and stakeholders assume (...) that the current standard methods are in principle suitable, but point out that experimental aspects and practical guidelines need specific adaptations. Beyond this laboratory level, risk assessment of nanomaterials also faces a number of substantive and procedural limitations, which are intrinsically attributed to the general orthodoxy of the risk assessment concept. Moreover, the developed formalism used to organize scientific knowledge is closely interlinked with the underlying governance design and the mode of interaction between the two spheres of ‘science’ and ‘decisions’. This contribution will provide a closer look at the evolution of different institutional settings for risk assessment in the context of decision-making. Improved risk governance frameworks with different narratives, process designs and procedural elements will be compared. The question of a general principle of enhanced organization of risk assessment will be discussed taking account of the barriers of substantive and procedural limitations in the special case of nanomaterials. (shrink)

Apparently objective and value-free `scientific' assessments of health risks are often highly value-laden and incorporate contentious social assumptions. Mr Wynne exposes some of the complexities underlying attempts to compare the health risks of nuclear and other sources of energy.

The robustness of a health system can often be assessed by its response to unpredictable circumstances that demand resourcefulness and resilience. The ongoing COVID-19 pandemic has similarly challe...

BackgroundThe complexities of the workplace environment in the downstream oil and gas industry contain several safety-risk factors. In particular, instituting stringent safety standards and management procedures are considered insufficient to address workplace safety risks. Most accident cases attribute to unsafe actions and human behaviors on the job, which raises serious concerns for safety professionals from physical to psychological particularly when the world is facing a life-threatening Pandemic situation, i.e., COVID-19. It is imperative to re-examine the safety management of facilities (...) and employees’ well-being in the downstream oil and gas production sector to establish a sustainable governance system. Understanding the inherent factors better that contribute to safety behavior management could significantly improve workplace safety features.ObjectiveThis study investigates employees’ safety behavior management model for the downstream oil and gas industry to consolidate the safety, health and wellbeing of employees in times of COVID-19.MethodsNominal Group Technique was first employed to screen primary behavioral factors from 10 workplace health and safety experts from Malaysia’s downstream oil and gas industry. Consequently, 18 significant factors were identified for further inquiry. Next, the interpretive structural modeling technique was used to ascertain the complex interrelationships between these factors and proposed a Safety Behavioral Management Model for cleaner production.ResultsThis model shows that management commitment, employee knowledge and training, leadership, and regulations contribute significantly to several latent factors. Our findings support the Social Cognitive Theory, where employees, their environment, and their behaviors are related reciprocally.ConclusionIt is postulated that identifying safety factors and utilizing the proposed model guides various stakeholder groups in this industry, including practitioners and policymakers, for achieving long-term sustainability. (shrink)

A comprehensive assessment of a health technology requires that a wide variety of questions are addressed. These range from whether the use of a technology results in achievement of its intended effects (e.g., better tumour control, pain relief, improved mobility, etc.) at acceptable costs and without incurring undue risks to the patient, to whether its use may challenge existing social arrangements and values (e.g., individual responsibility for preserving good health, the value of human life, etc.). Clearly, this is (...) a major challenge, since it requires the use of quite different methods of inquiry. In the past decades, we have rarely witnessed assessments where both types of questions were addressed in a balanced way. Rather, a wide gap exists between inquiries with a strong empirical focus and an almost complete neglect of underlying normative issues, and inquiries which are largely discursive, but with a serious disregard of relevant empirical data. The complex interplay between normative frameworks and empirical data in the assessment of health technologies is illustrated in two case studies: the assessment of surgical management of children with glue ears, and the assessment of Extra Corporeal Membrane Oxygenation in neonates. (shrink)

Government agencies and private risk assessors use (quasi) scientific risk assessment procedures to try to estimate or predict risk to human health or the environment that might result from exposure to toxic substances in order to take steps to prevent such risks from arising or to eliminate the risks if they already exist. In this paper I discuss several ways in which the "science" of carcinogen risk assessment differs from ordinary scientific enterprises. I also consider (...) several ways in which normative policy considerations infect this regulatory science. Scientists, philosophers of science, moral philosophers and policy makers should address these issues forthrightly in order to serve better the aims of science and regulation. (shrink)

Governments and citizens of nearly every nation have been compelled to respond to COVID-19. Many measures have been adopted, including contact tracing and risk assessment algorithms, whereby citizen whereabouts are monitored to trace contact with other infectious individuals in order to generate a risk status via algorithmic evaluation. Based on 38 in-depth interviews, we investigate how people make sense of Health Code, the Chinese contact tracing and risk assessment algorithmic sociotechnical assemblage. We probe how people accept (...) or resist Health Code by examining their ongoing, dynamic, and relational interactions with it. Participants display a rich variety of attitudes toward privacy and surveillance, ranging from fatalism to the possibility of privacy to trade-offs for surveillance in exchange for public health, which is mediated by the perceived effectiveness of Health Code and changing views on the intentions of institutions who deploy it. We show how perceived competency varies not just on how well the technology works, but on the social and cultural enforcement of various non-technical aspects like quarantine, citizen data inputs, and cell reception. Furthermore, we illustrate how perceptions of Health Code are nested in people’s broader interpretations of disease control at the national and global level, and unexpectedly strengthen the Chinese authority’s legitimacy. None of the Chinese public, Health Code, or people’s perceptions toward Health Code are predetermined, fixed, or categorically consistent, but are co-constitutive and dynamic over time. We conclude with a theorization of a relational perception and methodological reflections to study algorithmic sociotechnical assemblages beyond COVID-19. (shrink)

Recently, oysters have been identified by the US Food and Drug Administration (USFDA) as a risky food to eat because they may or may not contain the pathogenic bacteria Vibrio parahaemolyticus. The USFDA's attempts to manage the risk manifest themselves in a “Quantitative Risk Assessment”, a report that attempts to quantify and predict the number of oyster eaters that will fall ill from Vibrio. In seeking to produce knowledge and eliminate uncertainty, the USFDA, through the use of a (...) discourse of quantification, does the opposite. Instead, we argue, documents such as risk assessments are best understood as kinds of rhetorical practice. According to this perspective, these documents are epistemologically and ontologically reductive, produce uncertainty, politicize the act of eating, and serve an ironic function. (shrink)

As states increasingly use algorithms to improve the legibility of society, particularly during the COVID-19 pandemic, it is common for concerns about the expanding power of the algorithm or the state to be raised in a deterministic manner. However, how are the algorithms for states’ legibility projects enacted, contested, and reconfigured? Drawing on interviews and media data, this study fills this gap by examining Health Code, the Chinese contact tracing and risk assessment algorithmic system that serves as the (...) COVID-19 health passport. I first explore the intensive and invisible work and infrastructures that enact and stabilize Health Code’s sociotechnical assemblage. I then show how this assemblage is frequently challenged and destabilized by errors, breakdowns, and exclusions. Facing unintended engagements from heterogeneous social actors, local interests, and power hierarchies, Health Code reassembles into multiple and contradictory assemblages at different periods and social localities. Finally, I examine how people game and bypass the algorithm’s surveillance with their agencies. Recognizing this messiness and heterogeneity contributes to a more nuanced and realistic understanding of states’ use of algorithms, including the risks. Doing so also urges us to rethink the politics of citizenship and inequality in the digital age beyond inclusion. (shrink)

In‐vitro fertilization clinics across the world currently use the body mass index (BMI) to assess risk for and determine access to in‐vitro fertilization (IVF); however, clinics vary widely in both setting specific BMI limits for access to IVF and articulating the reasons for their policies. Given that scholars have begun to question the usefulness of BMI for individual health risk assessment, it is striking that ethicists have not yet systematically evaluated the reasons given for using BMI in (...) assessing individuals' risk in IVF treatments. In this paper, I provide the first systematic analysis of the chief arguments currently offered by IVF programs for using BMI as a criterion for risk assessment. Specifically, I articulate empirical concerns about the success of IVF in high‐BMI patients, practical concerns about the ability of high‐BMI patients to safely undergo procedures associated with IVF, and ethical concerns about the risk‐to‐reward ratio for high‐BMI patients and their potential children. I advance a series of objections to those arguments, using empirical data regarding IVF procedures and analogies with other high‐risk conditions including systemic lupus erythematosus, and science regarding the diagnosis of BMI‐correlated comorbidities such as high blood pressure or diabetes to argue that BMI alone is not a reasonable criterion for risk assessment in IVF; moreover, the usage of BMI may involve unacceptable violations of the bioethical principles of justice and respect for autonomy. Instead, I hold that IVF programs should rely on more precise laboratory and clinical measurements to evaluate risk in IVF. (shrink)

I strongly endorse many of the suggestions made by the authors of the extremely useful reviews in this issue. In particular, the need to identify the complex causal mechanisms underlying the major health risk factors requires urgent attention of the research community. I suggest considering the important role of emotional disturbances as contributors to health risks given the empirically established comorbidity between mental and somatic illness. Better knowledge of these mechanisms is an essential prerequisite to develop tailored (...) personalized prevention and intervention programs, including reliable and valid assessment of deficits. (shrink)

The new field of quantitative health risk assessment owes its emergence much more to the 'market pull' of demand from societal decision-making processes than to dramatic advances in our ability to make the desired predictions. This paper discusses problems and opportunities in the current practice of quantitative risk estimation under three broad headings: Basic (Technical) Assessment Methodology, and Methods for Assessing Uncertainty; Conception of the Problem for Analysis, and Ways of Expressing Results; and Defining Appropriate Roles for (...) Expert Analysts in Social Decision Processes. Finally, borrowing from work of McMullin, the paper offers some criteria for judging risk assessment theories other than the generally unavailable 'goodness-of-fit' procedures. (shrink)

The problem of collecting, analyzing and evaluating evidence on adverse drug reactions (ADRs) is an example of the more general class of epistemological problems related to scientific inference and prediction, as well as a central problem of the health-care practice. Philosophical discussions have critically analysed the methodological pitfalls and epistemological implications of evidence assessment in medicine, however they have mainly focused on evidence of treatment efficacy. Most of this work is devoted to statistical methods of causal inference with a (...) special attention to the privileged role assigned to randomized controlled trials in Evidence Based Medicine. Regardless of whether the RCT’s privilege holds for efficacy assessment, it is nevertheless important to make a distinction between causal inference of intended and unintended effects, in that the unknowns at stake are heterogonous in the two contexts. This point has been emphasized by epidemiologists in the last decade. Their main focus is methodological, and regards the fact that bias and confounding do not affect studies on intended and unintended effects in the same way. However, deeper concerns ground the intuition for such a distinction; these are related to the constraints which we impose on evidence and their epistemological justification. My thesis is that such constraints ought to be understood to be different in the case of evidence for risk vs. benefit assessment. I present the recent debate on the causal association between acetaminophen and asthma in order to illustrate the point at issue. (shrink)

The seriousness of the COVID-19 pandemic requires a look into the implementation of drug registration rules for COVID-19 vaccines. Amidst the surrounding exigencies, vaccines being a biological product, require comprehensive and continuing pre and post registration rules to ensure their safety and efficacy. The study focuses on Malaysia which has rules on drug registration that have been successfully applied to vaccines. The study shows that the rules have been tailor-made to emergency situations. At the moment, special rules have been introduced (...) including to allow use of COVID-19 vaccines as unregistered product. Recognition of COVID-19 Vaccines Global Access (COVAX) facility and requirement for government sale only, are among the safety valves. The study shows that these however are temporary measures against the backdrops of possible entry of private players in the vaccination process. Therefore, regulatory responses to intellectual property (IP) related conditions underlying drug registration, and measures to ensure risk management involved in vaccine production, approval and administration are needed in the progressive rules pending further development of research in the area. (shrink)

Background: Shortage of donor organs is one of the major problems for liver transplant programmes. Living liver donation is a possible alternative, which could increase the amount of donor organs available in the short term.Objective: To assess the attitude towards living organ donation in the general population to have an overview of the overall attitude within Germany.Methods: A representative quota of people was evaluated by a mail questionnaire . This questionnaire had 24 questions assessing the willingness to be a living (...) liver donor for different potential recipients. Factors for and against living liver donation were assessed.Results: Donating a part of the liver was almost as accepted as donating a kidney. The readiness to donate was highest when participants were asked to donate for children. In an urgent life-threatening situation the will to donate was especially high, whereas it was lower in the case of recipient substance misuse. More women than men expressed a higher disposition to donate for their children. Sex, religion, state of health and age of the donor, however, did not influence other questions on the readiness to consider living organ donation. The will for postmortem organ donation positively correlated with the will to be a living organ donor.Conclusions: The motivation in different demographic subgroups to participate in living liver transplantation is described. Differences in donation readiness resulting from the situation of every donor and recipient are thoroughly outlined. The acceptance for a living liver donation was found to be high – and comparable to that of living kidney donation. (shrink)

The Patient Protection and Affordable Care Act, passed in 2010, is considered by many to be the most significant healthcare overhaul since the 1960s, but part of its promise — improvement of population health through requirements for non-profit hospitals to provide “community benefit” — has not been met. This paper examines the history of community benefit legislation, how community benefit dollars are allocated, and innovative practices by a few hospitals and communities that are addressing primarily non-medical factors that influence (...) health such as social disadvantage, attitudes, beliefs, risk exposure, and social inequalities. (shrink)

This article traces the different classifications of diesel emissions either as “safe” or as “hazardous” in the US and in West Germany between 1977 and 1995. It argues that the environmental regulation of diesel emissions was a political threshold. It contributes to our general understanding of how politicians, environmental lobbyists, scientists, and engineers constructed the standards and norms that defined the “safe” limit of environmental pollutants. After discussing how diesel emissions came under review as a potential carcinogen, I will show (...) that the coding as “safe” or as “hazardous” resulted from negotiations that were entirely dependent on the temporal, geographical, and intellectual contexts in which diesel technology, scientific research on their emissions, and political regulation were embedded. In particular, I trace the differences in German and US regulatory policy. While US regulation relied more on epidemiology that provided only weak data on the carcinogenicity of diesel particulates in the early 1980s, German government agencies tended to base their policy around the mid-1980s more on the results of animal tests and shortly afterwards also on epidemiology. Furthermore, the article reveals how US and German automakers tried to foster doubt on the carcinogenicity of diesel emissions and how their approaches differed and shifted. Thereby, it sheds light on the triangular relationship between technology, science, and politics in regulatory processes by analyzing the different roles of the state, automakers, scientists, and environmental agencies in Germany and in the United States. (shrink)

In prevention and health promotion interventions, screening methods and risk profile assessments are often used as tools for establishing the interventions’ effectiveness, for the selection and determination of the health status of participants. The role these instruments fulfil in the creation of effectiveness and the effects these instruments have themselves remain unexplored. In this paper, we have analysed the role screening methods and risk profile assessments fulfil as part of prevention and health promotion (...) programmes in the selection, enrolment and participation of participants. Our analysis showed, that screening methods and health risk assessments create effects as they objectify health risks and/or the health status of individuals, i.e., they select the individuals ‘at risk’ and indicate the lifestyle modifications these people are required to make in order to improve their health. Yet, these instruments also reduce the group of participants thereby decreasing the possible effect of interventions, as they provide the legitimisation for people to make choices to whether they enrol or not and what lifestyle changes they incorporate into their lives. In other words, they present a space of interaction, in which agency is distributed across the practice nurses, the participants and the instruments. Decisions were not just made upon the projection of the outcomes of these instruments; decisions that were made by both the patients and practice nurses were the resultant of their opinions on these outcomes that were formed in interaction with the instruments. (shrink)

Assessing social risks has proven difficult for IRBs. We undertook a novel effort to empirically investigate social risks before an HIV prevention trial among drug users in Thailand and China. The assessment investigated whether law, policies and enforcement strategies would place research subjects at significantly elevated risk of arrest, incarceration, physical harm, breach of confidentiality, or loss of access to health care relative to drug users not participating in the research. The study validated the investigator's concern that drug (...) users were subject to serious social risks in the site localities, but also suggested that participation in research posed little or no marginal increase in risk and might even have a protective effect. Our experience shows that it is feasible to inform IRB deliberations with actual data on social risks, but also raises the question of whether and when such research is an appropriate use of scare research resources. (shrink)

Dual-track assessment directs research ethics committees to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.Research guidelines around the world recognise that clinical research is ethical only when the risks to participants are (...) reasonable.1 Appropriate implementation of this requirement is vital to protecting research participants and allowing research to proceed when it poses acceptable risks. Unfortunately, as the US National Bioethics Advisory Commission notes: “current regulations do not further elaborate how risks and potential benefits are to be assessed, and little additional guidance is available to IRBs.”1The NBAC, as well as numerous commentators, recommend that research ethics committees , ethics review committees and institutional review boards should adopt what may be called dual-track risk assessment.2–5 Yet, dual-track assessment unnecessarily divides research interventions into two different categories before assessing their risks and relies on the unclear distinction between therapeutic and non-therapeutic interventions. As a result, dual-track assessment provides RECs with confusing guidance and has the potential to block valuable research that poses acceptable risks. This paper describes one alternative, the net risks test, and argues that this approach offers a better method for assessing research risks, one that puts RECs in a position to protect participants without blocking appropriate research studies.BACKGROUNDClinical research exposes participants to interventions and procedures to gather systematic data that may be used to improve overall health and well-being. To ensure that research is ethical, RECs must ensure that the risks and burdens to participants are not excessive and that …. (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)

The aim of this systematic review was to summarize and assess the quality of asthma intervention health economic studies from 2002 to 2007, compare the study findings with clinical management guidelines, and suggest avenues for future improvement of asthma health economic studies. Forty of the 177 studies met our inclusion criteria. We assessed the quality of studies using The Quality of Health Economic Studies validated instrument (total score range: 0-100). Six studies (15%) had quality category 2, 26 (...) studies (65%) achieved quality category 3, and the remaining eight (20%) studies were scored as the highest quality level, category 4. Overall, the findings from this review are in line with the Global Initiative for Asthma clinical guidelines. Many asthma health economic studies lacked appropriate long term time horizons to match the chronic nature of the disease and suffered from using effectiveness measures that did not capture all disease related risks and benefits. We recommend that new asthma simulation models: be flexible to allow for long term time horizons, focus on using levels of asthma control in their structure, and estimate both long term asthma specific outcomes like well-controlled time as well as generic outcomes such as quality adjusted survival. (shrink)

The healing and preventive powers of people's health resources and self-assessed knowledge have so far been grossly underestimated in medicine. In this article, we call attention to ethical and epistemological dilemmas related to knowledge, values, communication, and autonomy embedded in the prevailing risk-oriented epidemiology, and suggest a patient-centred salutogenetic approach to promote a better balance between resources and risks in medicine. Identification and intervention upon risk factors can provide hypotheses about origins of disease and predict and sometimes (...) prevent disease at a group level. However, there are several pitfalls related to this perspective concerning causal factors, group level based possibilities, adequate end points for intervention, informed consent, and medicalization, especially in the individualized context of the clinical encounter. By introducing a salutogenic perspective, we urge to shift the attention toward resources, agency and strength, which may counteract risk of disease and empower the patient. Talk can mediate oppression as well as empowerment. A communicative key question approach, and self-assessed health resources identified through this strategy, are briefly presented as examples of empowerment through dialogue. (shrink)

The ethics of health incentive research—a form of public health research—are not well developed, and concerns of justice have been least examined. In this paper, we explore what potential long term harms in relation to justice may occur as a result of such research and whether they should be considered as part of its ethical evaluation. ‘Long term harms’ are defined as harms that contribute to existing systematic patterns of disadvantage for groups. Their effects are experienced on a (...) long term basis, persisting even once an incentive research project ends. We will first establish that three categories of such harms potentially arise as a result of health incentive interventions. We then argue that the risk of these harms also constitutes a morally relevant consideration for health incentive research and suggest who may be responsible for assessing and mitigating these risks. We propose that responsibility should be assigned on the basis of who initiates health incentive research projects. Finally, we briefly describe possible strategies to prevent or mitigate the risk of long term harms to members of disadvantaged groups, which can be employed during the design, conduct and dissemination of research projects. (shrink)

Children in North America, some as young as eleven or twelve, routinely don helmets and pads and are trained to move at high-speed for the purpose of engaging in repeated full-body collisions with each other. The evidence suggests that the forces generated by such impacts are sufficient to cause traumatic brain injury among children. Moreover, there is only limited evidence supporting the efficacy of interventions typically used to reduce the risks of such hazards. What kind of risk assessment enables (...) such activities to be a relatively common feature of childhood in Canadian and American society?In order to understand this state of affairs, we must examine the particular risk frame under which such hazards are commonly assumed. Risk assessments are embedded in the cultures in which they are situated and must be evaluated in their social contexts. (shrink)

IntroductionHigh healthcare costs make illness precarious for both patients and their families’ economic situation. Despite the recent focus on the interconnection between health and financial risk at the systemic level, the ethical conflict between concerns for potential health benefits and financial risk protection at the household level in a low-income setting is less understood.MethodsUsing a seven-step ethical analysis, we examine a real-life dilemma faced by families and health workers at the micro level in Ethiopia and (...) analyse the acceptability of limiting treatment for an ill newborn to protect against financial risk. We assess available evidence and ethical issues at stake and discuss the dilemma with respect to three priority setting criteria: health maximisation, priority to the worse-off and financial risk protection.ResultsGiving priority to health maximisation and extra priority to the worse-off suggests, in this particular case, that limiting treatment is not acceptable even if the total well-being gain from reduced financial risk is taken into account. Our conclusion depends on the facts of the case and the relative weight assigned to these criteria. However, there are problematic aspects with the premise of this dilemma. The most affected parties—the newborn, family members and health worker—cannot make free choices about whether to limit treatment or not, and we thereby accept deprivations of people’s substantive freedoms.ConclusionIn settings where healthcare is financed largely out-of-pocket, families and health workers face tragic trade-offs. As countries move towards universal health coverage, financial risk protection for high-priority services is necessary to promote fairness, improve health and reduce poverty. (shrink)

BackgroundData processing of health research databases often requires a Data Protection Impact Assessment to evaluate the severity of the risk and the appropriateness of measures taken to comply with the European Union General Data Protection Regulation. We aimed to define and apply a comprehensive method for the evaluation of privacy, data governance and ethics among research networks involved in the EU Project Bridge Health.MethodsComputerised survey among associated partners of main EU Consortia, using a targeted instrument designed by (...) the principal investigator and progressively refined in collaboration with an international advisory panel. Descriptive measures using the percentage of adoption of privacy, data governance and ethical principles as main endpoints were used for the analysis and interpretation of the results.ResultsA total of 15 centres provided relevant information on the processing of sensitive data from 10 European countries. Major areas of concern were noted for: data linkage, access and accuracy of personal data and anonymisation procedures. A high variability was noted in the application of privacy principles.ConclusionsA comprehensive methodology of Privacy and Ethics Impact and Performance Assessment was successfully applied at international level. The method can help implementing the GDPR and expanding the scope of Data Protection Impact Assessment, so that the public benefit of the secondary use of health data could be well balanced with the respect of personal privacy. (shrink)

In 2022, students at North American universities with third-dose COVID-19 vaccine mandates risk disenrolment if unvaccinated. To assess the appropriateness of booster mandates in this age group, we combine empirical risk-benefit assessment and ethical analysis. To prevent one COVID-19 hospitalisation over a 6-month period, we estimate that 31 207–42 836 young adults aged 18–29 years must receive a third mRNA vaccine. Booster mandates in young adults are expected to cause a net harm: per COVID-19 hospitalisation prevented, we anticipate (...) at least 18.5 serious adverse events from mRNA vaccines, including 1.5–4.6 booster-associated myopericarditis cases in males (typically requiring hospitalisation). We also anticipate 1430–4626 cases of grade ≥3 reactogenicity interfering with daily activities (although typically not requiring hospitalisation). University booster mandates are unethical because they: (1) are not based on an updated (Omicron era) stratified risk-benefit assessment for this age group; (2) may result in a net harm to healthy young adults; (3) are not proportionate: expected harms are not outweighed by public health benefits given modest and transient effectiveness of vaccines against transmission; (4) violate the reciprocity principle because serious vaccine-related harms are not reliably compensated due to gaps in vaccine injury schemes; and (5) may result in wider social harms. We consider counterarguments including efforts to increase safety on campus but find these are fraught with limitations and little scientific support. Finally, we discuss the policy relevance of our analysis for primary series COVID-19 vaccine mandates. (shrink)

ObjectiveTo apply a socioecological approach to identify risk and protective factors across levels of the “sports-ecosystem,” which are associated with mental health outcomes among athletes in para-sports and non-para sports. A further aim is to determine whether para athletes have unique risks and protective factor profiles compared to non-para athletes.MethodsA cross-sectional, anonymous online-survey was provided to all categorized athletes aged 16 years and older, registered with the Australian Institute of Sport. Mental health outcomes included mental health (...) symptoms, general psychological distress, risky alcohol consumption and eating disorder risk. Risk and protective factors across multiple levels of the socioecological model, including individual, microsystem, exosystem and macrosystem level factors were assessed via self-report.ResultsA total of 427 elite athletes participated in the study. No significant differences in the rates of mental health problems were observed between para and non-para athletes. Both differences and similarities in risk and protective factor profiles were found across the multiple levels of the sports-ecosystem. Weak evidence was also found to support the hypothesis that certain risk factors, including experiencing two or more adverse life events in the past year, sports related concussion, high self-stigma, inadequate social support and low psychological safety conferred a greater risk for poorer mental health outcomes for para athletes in particular.ConclusionRisk factors occurring across various levels of the sports ecosystem, including individual, interpersonal and organizational level risk factors were found to be associated with a range of poorer mental health outcomes. The association between mental ill-health and certain risk factors, particularly those at the individual and microsystem level, appear to be greater for para athletes. These findings have important implications for policy and mental health service provision in elite sports settings, highlighting the need for more nuanced approaches to subpopulations, and the delivery of mental health interventions across all levels of the sports ecosystem. (shrink)

Increasing rates of psychiatric problems like depression and anxiety among Swedish youth, predominantly among females, are considered a serious public mental health concern. Multiple studies confirm that psychological as well as existential vulnerability manifest in different ways for youths in Sweden. This multi-method study aimed at assessing existential worldview function by three factors: 1) existential worldview, 2) ontological security, and 3) self-concept, attempting to identify possible protective and risk factors for mental ill-health among female youths at (...) class='Hi'>risk for depression and anxiety. The sample comprised ten females on the waiting list at an outpatient psychotherapy clinic for teens and young adults. Results indicated that both functional and dysfunctional factors related to mental health were present, where the quality and availability of significant interpersonal relations seemed to have an important influence. Examples of both an impaired worldview function and a lack of an operating existential worldview were found. Psychotherapeutic implications are discussed. (shrink)

With more than half of individuals incarcerated having serious mental health concerns, correctional settings offer excellent opportunities for epidemiological, prevention, and intervention research. However, due to unique ethical and structural challenges, these settings create risks and vulnerabilities for participants not typically encountered in research populations. We surveyed 1,224 researchers, Institutional Review Board members, and IRB prisoner representatives to assess their perceptions of risks and vulnerabilities associated with mental health research conducted in correctional settings. Highest ranked risks were related (...) to privacy, stigma, and confidentiality; lowest ranked risks were related to prisoners’ loss of privileges or becoming targets of violence due to having participated in research. Cognitive impairment, mental illness, lack of autonomy, and limited access to services emerged as the greatest sources of vulnerability; being male, being female, being older than age 60, being a minority, and being pregnant were the lowest ranked sources of vulnerability. Researchers with corrections experience perceived lower risks and vulnerabilities than all other groups, raising the question whether these researchers accurately appraise risk and vulnerability based on experience, or if their lower risk and vulnerability perceptions reflect potential bias due to their vested interests. By identifying areas of particular risk and vulnerability, this study provides important information for researchers and research reviewers alike. (shrink)

BackgroundIncreasingly, hospitals and research institutes are developing technical solutions for sharing patient data in a privacy preserving manner. Two of these technical solutions are homomorphic encryption and distributed ledger technology. Homomorphic encryption allows computations to be performed on data without this data ever being decrypted. Therefore, homomorphic encryption represents a potential solution for conducting feasibility studies on cohorts of sensitive patient data stored in distributed locations. Distributed ledger technology provides a permanent record on all transfers and processing of patient data, (...) allowing data custodians to audit access. A significant portion of the current literature has examined how these technologies might comply with data protection and research ethics frameworks. In the Swiss context, these instruments include the Federal Act on Data Protection and the Human Research Act. There are also institutional frameworks that govern the processing of health related and genetic data at different universities and hospitals. Given Switzerland’s geographical proximity to European Union (EU) member states, the General Data Protection Regulation (GDPR) may impose additional obligations.MethodsTo conduct this assessment, we carried out a series of qualitative interviews with key stakeholders at Swiss hospitals and research institutions. These included legal and clinical data management staff, as well as clinical and research ethics experts. These interviews were carried out with two series of vignettes that focused on data discovery using homomorphic encryption and data erasure from a distributed ledger platform.ResultsFor our first set of vignettes, interviewees were prepared to allow data discovery requests if patients had provided general consent or ethics committee approval, depending on the types of data made available. Our interviewees highlighted the importance of protecting against the risk of reidentification given different types of data. For our second set, there was disagreement amongst interviewees on whether they would delete patient data locally, or delete data linked to a ledger with cryptographic hashes. Our interviewees were also willing to delete data locally or on the ledger, subject to local legislation.ConclusionOur findings can help guide the deployment of these technologies, as well as determine ethics and legal requirements for such technologies. (shrink)