Les décisions politiques sur les risques environnementaux complexes font fréquemment intervenir des éléments scientifiques contestés. Il n’y a généralement pas de « faits » qui conduisent à une politique correcte unique. Les éléments de preuve qui sont intégrés dans les avis scientifiques destinés à une décision politique nécessitent une évaluation de leur qualité. En 2003, l’Agence néerlandaise d’évaluation environnementale a adopté une méthode standardisée, désignée sous le nom de « guide », dans le cadre de laquelle les principaux aspects de (...) la production et de l’utilisation des connaissances sont présentés grâce à une liste de contrôle visant à l’évaluation et à la communication des incertitudes. Dans cet article, nous présentons des résultats de l’application de ce guide à la controverse sur les risques des particules en suspension. La délibération active sur l’incertitude dans un contexte d’expertise entraîne un processus d’apprentissage commun entre les experts et les décideurs politiques, ce qui conduit à une meilleure prise de conscience du phénomène d’incertitude et de ses implications politiques.Policy decisions on complex environmental risks often involve disputed science. Typically, there are no “ facts” to support a single unequivocally correct policy. The evidence provided in scientific studies for policy-making decisions requires high-quality assessment. In 2003, the Netherlands Environmental Assessment Agency adopted a standardized method, referred to as “guidelines”, whereby key quality aspects of knowledge production and use are presented in the form of a checklist for uncertainty assessments and communication. In this article, we present the outcomes of applying the guidelines in controversies on the risks of ambient particulate matter. In the policy–advisory context, active deliberation on uncertainty produces a common learning process for advisors and policy makers, which leads to a deeper understanding and increased awareness of the phenomenon of uncertainty and its policy implications. (shrink)

In this paper we argue for a naturalistic solution to some of the methodological controversies in regulatory science, on the basis of two case studies: toxicology and health claim regulation. We analyze the debates related to the scientific evidence that is considered necessary for regulatory decision making in each of those two fields, with a particular attention to the interactions between scientific and regulatory aspects. This analysis allows us to identify two general stances in the debate: a) (...) one that argues for more permissive standards of evidence and for methodological pluralism, and b) an opposing one that not only defends strict evidence requirements but also stipulates the use of one particular scientific methodologies for data generation. We argue that the real-world outcomes produced by alternative regulatory options are a vital piece of information that allows for the empirical assessment of these two stances. In particular, this information on outcomes makes it possible to analyze which standards of evidence and scientific methods generate the most useful knowledge as input for regulatory decision making. Our conclusion is that instead of an a priori selection of methodologies and standards, such decisions ought to be based on empirical evidence related to real-world outcomes. (shrink)

The paper provides a deeper insight into institutionally given opportunities for and limitations to reflexive, dialogue-centered, and risk-sensitive knowledge exchange between scientific experts and agro-political decision makers, especially under the conditions of a significant degree of complexity, far-reaching uncertainties and potential impacts. It focuses on the practical orientations, guiding expectations and selection criteria shaping expertise in processes of science policy consulting. In doing so, two perspectives will be discussed: first the orientation of the knowledge production (...) process by different concepts of ‘‘usable knowledge.’’ Second, the influence of specific constellations on different stages of the political process, which shape the institutional conditions for the transfer and the use of scientific knowledge within the policy consulting process. Both perspectives help to come to a closer understanding of the demanding and very heterogeneous process of science policy consulting, which - if successful - leads to the interactive production of a very special form of ‘‘orientational knowledge.’’. (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)

The controversy over commercial releases of genetically modified crops demonstrates that there is a need for new approaches that are more broadly based, transparent and able to acknowledge the uncertainties involved. This article investigates whether new forms of knowledge production as prescribed in the concept of post-normal science can improve risk governance of GM crops. The GM science review carried out in the UK in 2003 serves as a case study and the focus is on how scientific (...) uncertainty and public concern was taken into account. Some recommendations are advanced for assessing scientific uncertainty, for accommodating scientific disputes and for integrating stakeholders' interests and perspectives in relations to GM crops. (shrink)

BackgroundHealth research funding agencies are placing a growing focus on knowledge translation (KT) plans, also known as dissemination and implementation (D&I) plans, in grant applications to decrease the gap between what we know from research and what we do in practice, policy, and further research. Historically, review panels have focused on the scientific excellence of applications to determine which should be funded; however, relevance to societal health priorities, the facilitation of evidence-informed practice and policy, or (...) realizing commercialization opportunities all require a different lens.DiscussionWhile experts in their respective fields, grant reviewers may lack the competencies to rigorously assess the KT components of applications. Funders of health research—including health charities, non-profit agencies, governments, and foundations—have an obligation to ensure that these components of funding applications are as rigorously evaluated as the scientific components. In this paper, we discuss the need for a more rigorous evaluation of knowledge translation potential by review panels and propose how this may be addressed.ConclusionWe propose that reviewer training supported in various ways including guidelines and KT expertise on review panels and modalities such as online and face-to-face training will result in the rigorous assessment of all components of funding applications, thus increasing the relevance and use of funded research evidence. An unintended but highly welcome consequence of such training could be higher quality D&I or KT plans in subsequent funding applications from trained reviewers. (shrink)

European and international regulation of human health research is typified by a morass of interconnecting laws, diverse and divergent ethical frameworks, and national and transnational standards. There is also a tendency for legislators to regulate in silos—that is, in discrete fields of scientific activity without due regard to the need to make new knowledge as generalisable as possible. There are myriad challenges for the stakeholders—researchers and regulators alike—who attempt to navigate these landscapes. This Delphi study was undertaken (...) in order to provide the first interdisciplinary and crosscutting analysis of health research regulation, as it is experienced by such stakeholders in the UK context. As well as reinforcing existing understandings of the regulatory environment, Delphi participants called for greater collaboration, and even co-production, of processes involved in health research regulation. On the basis of this research, we offer insights about how health research regulation can become a matter with which a wider range of stakeholders—including researchers, regulators, publics and research sponsors—can engage. The evidence supports the normative claim that health research regulation should continue to move away from strict, prescriptive rules-based approaches, and towards flexible principle-based regimes that allow researchers, regulators and publics to co-produce regulatory systems serving core principles. By unpacking thorny concepts and practices at the heart of health research regulation—including the public interest and public engagement—our results have the potential to situate and breathe life into them. The results also demonstrate that while proportionality is well-recognised as a crucial element of flexible regulatory systems, more must be done to operationalise this as an ethical assessment of the values and risks at stake at multiple junctures in the research trajectory. This is required if we are to move beyond proportionality as a mere risk-management tool. Compliance culture no longer accurately reflects the needs and expectations of researchers or regulators, nor does it necessarily produce the best research. Embracing uncertainty—both as a human practice and a regulatory objective—may represent the brighter future for health research. (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)

A One Health approach holds great promise for attenuating the risk and burdens of emerging infectious diseases (EIDs) in both human and animal populations. Because the course and costs of EID outbreaks are difficult to predict, One Health policies must deal with scientific uncertainty, whilst addressing the political, economic and ethical dimensions of communication and intervention strategies. Drawing on the outcomes of parallel Delphi surveys conducted with policymakers in Singapore and Australia, we explore the normative dimensions (...) of two different precautionary approaches to EID decision-making—which we call regimes of risk management and organizing uncertainty, respectively. The imperative to act cautiously can be seen as either an epistemic rule or as a decision rule, which has implications for how EID uncertainty is managed. The normative features of each regime, and their implications for One Health approaches to infectious disease risks and outbreaks, are described. As One Health attempts to move upstream to prevent rather than react to emergence of EIDs in humans, we show how the approaches to uncertainty, taken by experts and decision-makers, and their choices about the content and quality of evidence, have implications for who pays the price of precaution, and, thereby, social and global justice. (shrink)

This paper examines how the Harper Government of Canada shut down both debate about threats and research into environmental risk, a strategy that Canadian scientists characterized as the “death of evidence.” Based on interviews with scientists who research risks to the marine environment, we explore the shifting relationship between science and the Canadian government by tracing the change in the mode of risk calculation supported by the Harper administration and the impact of this change. Five themes emerged from (...) the interviews: erosion of science research capacity, resulting limitations in understanding risk, declining influence on policy and regulation, redirection of public science funds to support the private sector, and the need to broaden the science knowledge base. The Canadian death of evidence controversy represents a challenge to science and technology studies scholars who wish to maintain a critical and reflexive perspective on the scientific enterprise without supporting attacks on evidence. While subsequent Canadian governments may simply return science to an unreflexively privileged knowledge status, we view this as equally damaging to broad risk calculation and democratic science. We suggest instead that a broader gathering of matters of concern will always be essential to risk assessment. (shrink)

It can be argued that there is an ethical requirement to classify correctly what is known and what is unknown in decision situations, especially in the context of biomedicine when risks and benefits have to be assessed. This is because other methods for assessing potential harms and benefits, decision logics and/or ethical principles may apply depending on the kind or degree of uncertainty. However, it is necessary to identify and describe the various epistemic states of uncertainty relevant to such estimates (...) in the first place. Therefore, this paper aims to develop a category system of different epistemic states of uncertainty which, although not exclusively, is primarily intended to be applied to early clinical trials. It is formed on the basis—and various combinations—of three dimensions of uncertainty that represent certain parts of incomplete knowledge: outcome (type of event), probability (of outcome) and evaluation (assessment of outcome). Furthermore, it is argued that uncertainty can arise from three different sources (the structure of the object of research, the state of the evidence, or individual handling of the research and already existing knowledge). The categories developed are applied to actual examples from gene therapy and genome editing to illustrate that they can be helpful for a more precise definition of the respective uncertainties, especially in the context of risk–benefit assessment. The categories allow a differentiated perspective of decision-making situations from the point of view of incomplete knowledge in general, but particularly, for example, in early clinical research, and may thereby support a more acceptable ethical assessment of potential harms and benefits. (shrink)

Discussions of science and values in risk management have largely focused on how values enter into arguments about risks, that is, issues of acceptable risk. Instead this volume concentrates on how values enter into collecting, interpreting, communicating, and evaluating the evidence of risks, that is, issues of the acceptability of evidence of risk. By focusing on acceptable evidence, this volume avoids two barriers to progress. One barrier assumes that evidence of risk is largely a matter (...) of objective scientific data and therefore uncontroversial. The other assumes that evidence of risk, being "just" a matter of values, is not amenable to reasoned critique. Denying both extremes, this volume argues for a more constructive conclusion: understanding the interrelations of scientific and value issues enables a critical scrutiny of risk assessments and better public deliberation about social choices. The contributors, distinguished philosophers, policy analysts, and natural and social scientists, analyze environmental and medical controversies, and assumptions underlying views about risk assessment and the scientific and statistical models used in risk management. (shrink)

This edited volume looks at whether it is possible to be more transparent about uncertainty in scientific evidence without undermining public understanding and trust. With contributions from leading experts in the field, this book explores the communication of risk and decision-making in an increasingly post-truth world. Drawing on case studies from climate change to genetic testing, the authors argue for better quality evidence synthesis to cut through the noise and highlight the need for more structured public dialogue. (...) For uncertainty in scientific evidence to be communicated effectively, they conclude that trustworthiness is vital: the data and methods underlying statistics must be transparent, valid, and sound, and the numbers need to demonstrate practical utility and add social value to people's lives. Presenting a conceptual framework to help navigate the reader through the key social and scientific challenges of a post-truth era, this book will be of great relevance to students, scholars and policy makers with an interest in risk analysis and communication. (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)

Abstract.Mandatory risk assessment is intended to reassure concerned citizens and introduce reason into the heated European controversies on genetically modified crops and food. The authors, examining a case of risk assessment of genetically modified oilseed rape, claim that the new European legislation on risk assessment does nothing of the sort and is not likely to present an escape from the international deadlock on the use of genetic modification in agriculture and food production. The new legislation is likely (...) to stimulate the kind of emotive reactions it was intended to prevent. In risk assessment exercises, scientific uncertainty is turned into risk, expressed in facts and figures. Paradoxically, this conveys an impression of certainty, while value-disagreement and conflicts of interest remain hidden below the surface of factuality. Public dialogue and negotiation along these lines are rendered impossible. The only option left to critics is to resort to claims of fear and to call for new risk assessments to be performed, on and on again. Science is allowing itself to be abused by accepting the burden of proof in matters more suited to reflection and negotiation. The specific challenge to science would be to take care of itself – rethinking the role and the limitations of science in a social context, and, thereby gaining the strength to fulfill this role and to enter into dialogue with the rest of society. Scientific communities appear to be obvious candidates for prompting reflection and dialogue on this issue. (shrink)

Commercialization of genetically modified organisms (GMOs) have sparked profound controversies concerning adequate approaches to risk regulation. Scientific uncertainty and ambiguity, omitted research areas, and lack of basic knowledge crucial to risk assessmentshave become apparent. The objective of this article is to discuss the policy and practical implementation of the Precautionary Principle. A major conclusion is that the void in scientific understanding concerning risks posed by secondary effects and the complexity ofcause-effect relations warrant further research. (...) Initiatives to approach the acceptance or rejection of a number of risk-associated hypotheses is badly needed. Further, since scientific advice plays a key role in GMOregulations, scientists have a responsibility to address and communicate uncertainty to policy makers and the public. Hence, the acceptance of uncertainty is not only a scientific issue, but is related to public policy and involves an ethical dimension. (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)

Appraising public policies about using technoscientific innovations requires attending to the values reflected in the interests expected to be served by them. It also requires addressing questions about the efficacy of using the innovations, and about whether or not using them may occasion harmful effects ; moreover, judgments about these matters should be soundly backed by empirical evidence. Clearly, then, scientists have an important role to play in formulating and appraising these public policies. However, ethical and social values affect decisions (...) made about the criteria for identifying the range of risks, and of relevant empirical data needed for making judgments about them, that should be considered in public policy deliberations, and for determining how well claims concerning risks should be supported by the available data in order to warrant that they have a decisive role in the deliberations. Consider the case of public policies about using GMOs. Concerning the range of data: is it sufficient for risk assessment only to be informed by data relevant to investigating the risks of using GMOs that may be occasioned by way of physical/chemical/biological mechanisms directly triggered by events within their modified genomes? Or: should data pertaining to the full range of ecological and socioeconomic effects of using them, in the environments in which they are used and under the socioeconomic conditions of their use, also inform this assessment? Those interested in producing and using GMOs, in the light of their adhering to values of capital and the market, are likely to give a positive answer to the first question; those holding competing values, e.g., connected with respect for human rights and environmental sustainability, to the second. And, concerning the degree of support: the former – citing the ethical gravity of losses that would be incurred by failing to use GMOs on a wide scale – are likely to require less stringent standards of evidential appraisal than the latter. Scientists, qua scientists, however, do not have special authority in the realm of values. Thus, their judgments, about the evidential support that claims about risks have, may sometimes be reasonably contested partly on value-laden grounds – as they have been in the GMO case, where the contestation has generated considerable controversy, and continues to do so. It follows that, in the context of deliberations about public policy, unless scientists engage with representatives of all stakeholders in the outcomes of the policies – taking into account that their competing values may lead to making different decisions about what are the relevant data, as well as about the degree of support required for their claims about risks to gain the required credibility to inform the deliberations; and respecting "tempered equality" of participants in the dialogue – their trustworthiness is put into question and their authority diminished. (shrink)

In science policy, public controversy around synthetic biology has often been presented as a major risk because it could deter innovation. The following inter-related strategies for avoiding contestation have been observed: There have been attempts to close down debates by alluding to the importance and legitimacy of reliance on scientific evidence as input to regulatory processes. Scientific policy advice has stressed sufficiency of existing regulation, economic risks of additional regulation and/or suggestions for monitoring that are (...) limited in scope. Initiatives for self-governance have narrowed the scope of topics for consideration. Engagement with humanities, social sciences and arts has been co-opted for legitimisation and science communication. Although such agendas are of course not ubiquitous, in this paper, I criticise that instrumentally motivated engagement has been supported not only by the scientific community but also by policy institutions and funding bodies. I argue that it is good that this now seems to fuel controversy in the academic and policy realms. As synthetic biology is not the only technoscientific field to see such dynamics, this is also part of the broader context of debate about the governance of science, especially the concept of “responsible research and innovation” currently promoted in the EU. (shrink)

The way our decisions and actions can affect future generations is surrounded by uncertainty. This is evident in current discussions of environmental risks related to global climate change, biotechnology and the use and storage of nuclear energy. The aim of this paper is to consider more closely how uncertainty affects our moral responsibility to future generations, and to what extent moral agents can be held responsible for activities that inflict risks on future people. It is argued that our moral responsibility (...) to posterity is limited because our ability to foresee how present decisions and activities will affect future people is limited. The reason for this is primarily that we are in a situation of ignorance regarding the pace and direction of future scientific and technological development. This ignorance reduces our responsibility in a temporal dimension because in most areas it is impossible to predict the interests and resource needs of future generations. In one area, however, we have fairly reliable knowledge about future people. It is reasonable to assume that future human beings will have the same basic physiological (physical and biological) needs as we have. On this basis, it is argued that we can be held responsible for activities causing avoidable damage to critical resources that are necessary to provide for future physiological needs. Furthermore, it is suggested that it is prima facie immoral to impose risks upon future generations in cases where the following conditions are fulfilled: (1) the risk poses a threat to the ability of future generations to meet their physiological needs, and (2) the risk assessment is supported by scientifically based harm scenarios. (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)

Researchers doing welfare-related science frequently mischaracterize either situations of decision-theoretic mathematical/scientific uncertainty as situations of risk, or situations of risk as those of uncertainty. The paper outlines this epistemic/ethical problem ; surveys its often-deadly, welfare-related consequences in environmental-health sciences; and uses recent research on diesel particulate matter to reveal 7 specific methodological ways that scientists may mischaracterize lethal risks instead as situations of uncertainty, mainly by using methods and assumptions with false-negative biases. The article (...) closes by outlining two normative strategies for curbing misrepresentations of risk and uncertainty, especially in welfare-affecting science. (shrink)

Scientific knowledge has not stabilized in the current, early, phase of research and development of nanotechnologies creating a challenge to ‘upstream’ public engagement. Nevertheless, the idea that the public should be involved in deliberative discussions and assessments of emerging technologies at this early stage is widely shared among governmental and nongovernmental stakeholders. Many forums for public debate including focus groups, and citizen juries, have thus been organized to explore public opinions on nanotechnologies in a variety of countries over (...) the past few years. In Switzerland the Centre for Technology Assessment (TA-Swiss) organized such a citizen panel in fall 2006. Drawing from an ethnographic study of this panel called ‘publifocus on nanotechnologies, health, and environment’ this paper looks at the ways members of a stakeholder group deal with the epistemic uncertainty in their deliberation of nanotechnologies. By exploring the statements of the participants in the stakeholder discussion group, this paper reconstructs the narratives that constitute the epistemic foundations of the participants’ evaluations of nanotechnologies. (shrink)

This article deals with scientific advice to the public where the relevant science is subject to public attention and uncertainty of knowledge. It focuses on a tension in the management and presentation of scientific uncertainty between the uncertain nature of science and the expectation that scientific advisers will provide clear public guidance. In the first part of the paper the tension is illustrated by the presentation of results from a recent interview study with nutrition scientists in (...) Denmark. According to the study, nutrition scientists feel their roles as ‘‘public advisers’’ and ‘‘scientists’’ differ in that the former involves an expectation that they will provide unambiguous advice of the kind that might relegate scientific uncertainty to the background. In the second, more general, part of the paper we provide a normative analysis of different strategies of dealing with the tension. The analysis is structured around the extremes of either total concealment or full openness regarding scientific uncertainty. The result of analysis is that scientific advisers should not simply ‘‘feed’’ scientific conclusions to the public. They should rather attempt to promote the ability and willingness of the public to assess and scrutinize scientific knowledge by displaying uncertainties in the scientific basis of advice. On the other hand, scientific advisers must accommodate the public’s need for guidance. Such guidance should be restricted by careful consideration of what it is relevant for the public to know in order to evaluate scientific advice in practical terms. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:“What Is Actually Being Measured?”: Causality and Underlying Scientific Thinking Process in the Assessment of DepressionGreta Kaluzeviciute-Moreton, PhD (bio)Depression is a complex mental health phenomenon due to its multifaceted nature. For one, depression is thought to have a significant genetic component, with studies suggesting that heritability is a significant factor in the development of the disorder (Sullivan, Neale, Kendler, 2000). In clinical psychology, environmental factors such as (...) childhood trauma, chronic stress, social isolation and negative life events (e.g., the loss of a loved one) have been documented as significant risk factors for the development of depression or as trigger events for depressive episodes (Fu & Parahoo, 2009; Kendler, Kuhn, & Prescott, 2004; Neitzke, 2016). Despite this, causal theories of mental health conditions are often tricky and/or scarcely reflected in both diagnostic and rating scales. For instance, the Diagnostic and Statistical Manual of Mental Disorders classifies mental health disorders primarily based on observable symptoms and behaviors, rather than on the underlying psychological and neurobiological processes that may contribute to these symptoms (Kendler, 2006).Similarly, rating scales for depression are typically designed to assess the severity of symptoms, rather than their underlying causes, that is, most rating scales are used as screening tools to identify individuals who may require further evaluation and treatment. Some rating scales may include items related to causal factors, such as the Beck Depression Inventory-II (BDI-II) includes an item that asks about “loss of interest in sex,” which could be related to either biological or psychological factors. Several rating scales include items assessing risk factors for depression, such as family history of depression or personal history of trauma. This may be indicative of both genetic and environmental risk factors, such as the Patient Health [End Page 255] Questionnaire-9, includes an item that asks about family history of depression. However, while risk and causal factors are related, they are distinct in the assessment of depression. Risk factors refer to factors that increase the likelihood of developing depression, while causal factors refer to factors that directly contribute to the development of the condition. The presence of a risk factor does not necessarily mean that an individual will develop depression (Peterson & Seligman, 1984). However, the two are frequently blurred and equated in psychotherapy research (Westen & Bradley, 2005).As such, the historical issues of rating and diagnostic scales, aptly depicted by the Le Moigne (2023) as full of “composite, if not contradictory, heritage, weaving together the classificatory and discontinuous tradition of psychiatry, on the one hand, and the psychometric and continuous tradition of psychology, on the other” (p. XX ), suffer from an epistemological oversight when it comes to the assessment of causal factors in complex mental health conditions, such as depression. In turn, this contributes to a wider psychometric issue: what is actually being measured? Le Moigne’s detailed overview predominantly focuses on “superficial” symptomatology of depression (which contributed to two distinct forms of evaluation: hetero- and self-evaluation), and its subsequent impact on the classification and taxonomy of depression throughout history. However, the overarching conceptualization of depression (including a more detailed consideration of causal factors and their assessment) and the usefulness of rating scales in applied research (such as psychotherapy) remain in the background.The question of “what is actually being measured” is obviously not new in psychometrics. However, it is important to continuously revisit this issue, given that rating scales (such as the BDI) are considered to be universally applicable “evidence-based” tools (Rogers, Adler, Bungay, & Wilson, 2005) as well as a common and well-accepted form of scientific thinking in psychotherapy research (Kaluzeviciute & Willemsen, 2020). From an epistemological point of view, a scientific thinking style entails not only cognitive operations common to methodology, but also practices of generating, sharing, assimilating and transforming knowledge(Hacking, 2012).Therefore, it is important to acknowledge that any scientific tool, including rating scales, encompasses not just what but also how researchers find out about their studied phenomena (i.e., a scientific thinking style conveys a performative quality) (Kaluzeviciute & Willemsen, 2020). As identified by Le Moigne (2023), taxonomy leads toward a category-based logic in that it considers the examined phenomenon to be shared by only a... (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Kennedy Institute of Ethics Journal 12.4 (2002) 389-390 [Access article in PDF] IOM Report on the System for Protecting Human Research Participants Tom L. Beauchamp* In response to society's concerns about the use of human subjects in research, the Department of Health and Human Services commissioned the Institute of Medicine to perform a comprehensive assessment of current systems of research participant protection in the U.S., including recommendations for (...) reform (Committee 2002). Although the committee declared its frustration over the lack of data, it found ample evidence to indicate that there are pivotal weaknesses in the current system. First, it discovered dissatisfaction with the current system from virtually every quarter and at virtually every level. Second, it found evidence that IRBs are under severe strain and performing inadequately. Third, it found that the existing regulatory framework—the IRB system and the Common Rule—has not and probably now cannot react adequately to the constantly evolving research environment. Some of these problems might be handled through federal agencies, but the committee holds that the problems are more extensive and will require additional institutional support and professional attention.The committee found that federal protection requirements should be extended to every research project—private, public, or otherwise. Subjects should be, in this respect, equally protected in privately sponsored research.The committee found that the IRB system is in important respects a failure, especially when it alone is relied upon for ethics reviews in institutions. One set of problems concerns the proper education of IRB members. The committee recommends that all members henceforth be given a specialized knowledge of human research ethics. It finds that IRB deliberations commonly have been dominated by scientists, who often marginalize the perspectives of nonscientist members. It therefore recommends that unaffiliated members, nonscientists, local community representatives, and those representing the participant-perspective comprise at least 25 percent of the membership. It also recommends that no protocol be approved without three-quarters of the voting members concurring. [End Page 389]The committee recommends that institutions distinguish review aimed at (1) scientific merit, (2) conflict of interest, and (3) general Ethics Review. The distinction should more evenly distribute the work of institutional ethics review. The IRB should not conduct the initial scientific review nor should it be spending the bulk of its time purely in examining either scientific merit—as many IRBs now do—or conflict of interest. Instead, the conclusions of the scientific review should be submitted to the IRB for ethics-focused deliberations. Problems of both financial and nonfinancial conflicts of interest should be handled similarly, preferably by a committee properly distanced from the institution's interests.The committee underscores that consent must be understood on the model of an interactive dialogue between research staff and participants and not merely as a signed form or single-disclosure event. Conversations between the participant and the research staff should begin even prior to the point of enrollment and should be reinforced during each stage of the research. The committee finds that informed consent conversations and documents too often are being conceived as risk management tasks gauged to protect the institution from liability.The committee also believes that the system of protections established by a research program should be open to the public in order to foster and maintain the community's trust. Open communication should occur among all relevant stakeholders. The committee notes that currently no centralized system exists for the dissemination of information about clinical trials and other research activities.It urges reconsideration of present policies regarding compensation, finding that many research organizations provide at least short-term medical care for those who are injured, but that few organizations cover all potential risks and that many organizations have no effective policy of compensation. The report holds that providing reasonable compensation for bona fide instances of research harm is the only just system and is necessary to avoid diminished public trust.The committee holds that establishing the appropriate culture in research institutions will require sustained efforts to educate researchers, research administrators, IRB members, and... (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)

In lieu of an abstract, here is a brief excerpt of the content:Credibility, Persuasiveness, and EffectivenessPatricia A. King (bio)Since the early 1970s, complex ethical, social, legal, and scientific controversies generated by biomedicine have been referred to governmentally created commissions, committees, boards, and panels that are commonly referred to as “ethics” committees. The Advisory Committee on Human Radiation Experiments is the most recent example of such a group. Although it is too early to know the full impact of the Committee’s (...) work, it is important to reflect on aspects of its deliberations that shed light on the public policy role of ethics bodies. Specifically, I will reflect on matters that go to the credibility, persuasiveness, and effectiveness of these committees.The point should be made at the outset that these ethics committees are, first and foremost, public policy groups. Governmentally created bodies of all types, including ethics committees, are established to provide pragmatic advice to governments about specific problems and controversies or to complete specified tasks on behalf of governments. What distinguishes ethics committees from other advisory groups is that the issues assigned to them are presumed to be primarily ethical, as opposed to, say, economic, in nature. It is expected that ethical analyses and premises will play a significant, albeit not exclusive, role in the committee’s deliberations. 1 As with other advisory groups, the primary responsibility of ethics committees is to respond to the branches of government that were instrumental in their creation as well as to the public at large. Since political concerns undoubtedly play a role in the creation of these groups, it is understandable that political concerns have some impact on the committee’s work. Thus, ethics committees are generally cognizant of the need to ensure that their processes and substantive conclusions are credible, persuasive, and effective.In my experience, members of ethics commissions understand the need to offer principled arguments that are factually accurate to justify their recommendations and conclusions. They also appreciate the need for consensus and rightly worry about disagreement among members. I believe, however, that committee members are less attentive than they should be to the social and political contexts in which they operate. This is not surprising. Members of these committees, and often their staffs as well, are typically experts drawn from the academy. [End Page 313] Scholars traditionally offer advice or influence policy through articles and scholarly work undertaken individually or in cooperation with like-minded individuals who do not need to be persuaded about the merits of a specific position. Moreover, scholarly articles are often pitched at a level of abstraction that may be of limited utility in the context of concrete decision making.Scholarly efforts are important. Particularly in bioethics, these scholarly efforts often have furnished the conceptual frameworks that are critical to the efforts of those who grapple with complex matters, the appropriate resolution of which pose moral disagreement and genuine perplexity. Policy formulation by its very nature, however, requires more. Attention must be paid to competing moral and social frameworks. Logical, rational arguments and risk/benefit assessments are important, but emotion, passion and values grounded in experience also demand consideration. Policy formulation as a result can be a quite messy process.Members of the academy are often uncomfortable in this environment. Pursuing the messy details can be threatening and at times at odds with values that academics prize highly. I believe this discomfort was evident in the reluctance of several Advisory Committee members to obtain security clearances that were required in order to see classified material related to the Committee’s work. Secrecy may have seemed at odds with cherished values of openness. As a result the perusal of classified materials was left to those with clearances. Fortunately, the Committee was successful in having relevant information declassified so all committee members read and deliberated about the same information. Committees needing to see more contemporaneous classified information might not be so fortunate.Ethics commission members correctly worry about disagreement. The ability to reach consensus helps to give recommendations a compelling quality. Morris Abram, chairman of the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, makes this point powerfully. He states that “a commission requires agreement that is as... (shrink)

“I urge that we turn Kuhn on his head and demonstrate that a paradigm is nothing more than an arrested social development.” Notwithstanding the long debate to which The Structure of Scientific Revolutions has given rise since its publication in 1962, this quote from Steve Fuller’s assessment of its author’s legacy suggests an original if controversial project: may a better understanding of science arise from the ashes of idealist historicism! Yet rather than furnish the Marx to Kuhn’s Hegel, Fuller (...) but manages a pastiche of Proudhon, as it were, which calls for another inversion of titles as rejoinder in turn. There can be no doubt that some very important issues are raised in this book, but just as this reader’s expectations were dashed in its course, so the issues end.up curiously diminished; given the significance of the subject matter, it is of interest to find out why. (shrink)

In C.S. Lewis's science fiction parable Perelandra was a planet which had no solid ground. At all times the floating landscape was continually swirling and moving, chasms would appear where a minute before there had been safe standing. The rational beings who lived there hopped nimbly on to another little island when the one on which they stood disappeared under their feet. They were used to it and took it for granted that nothing was certain. The visitor from our planet (...) had to learn a completely new way of existence. But where did he get his idea of certainty in a fixed environment? It is more plausible that uncertainty is normal and the whole idea of certainty an illusion. Today gives an opportunity to reflect on how people deal with skepticism, doubt and uncertainty.The questions apply to a current debate in the UK on risk. Opinion polls constantly reveal that the public lacks trust in government, and particularly it does not trust the government to reveal the information needed to assess important risks. From which the risk analysts conclude that the government should grant access to information more freely and encourage enquiry. They believe that openness would foster a better understanding on the part of the public which at present does not know what to believe. More information would create certainty, more certainty and the public would trust its spokesmen, unreasonable fears would be calmed. This is the advice of an expert enquiry.Certainty is not a mood, or a feeling, it is an institution: this is my thesis. Certainty is only possible because doubt is blocked institutionally: most individual decisions about risk are taken under pressure from institutions. If we recognize more uncertainty now, it will be because of things that have happened to the institutional underpinning of our beliefs. And that is what we ought to be studying. In my student days the hottest controversies in anthropology were about why `other people' — that is people not living in advanced capitalist society — had certainty about their absurd beliefs.When trying to explain their misfortunes, why did they neglect the physical and scientific evidence, and draw instead on their beliefs in spirits, magic, and taboos? How could they be so obstinate in error? Anthropologists spent their energies on defending the allegedly irrational beliefs of other people, and I shall continue the tradition. (shrink)

Global health emergencies such as the COVID-19 pandemic are contexts in which it is critical to draw upon learning from prior research and to conduct novel research to inform real-time decision-making and pandemic responses. While research is vitally important, however, emergencies are radically non-ideal contexts for its conduct, due to exceptional uncertainty, urgency, disruption, health needs, and strain on existing health systems, amongst other challenges. This generates novel ethical challenges and a broader conception of research ethics is (...) necessary to effectively address the complexity of pandemic research contexts. Going beyond traditional approaches to research ethics centring on the design of specific studies, this broader conception requires consideration of fundamental questions relating to the exercise of power and influence throughout research pathways, and a broader attention to both salient ethical issues, and the ethical responsibilities of stakeholders. These include important questions about responsibilities to gather evidence and generate knowledge systematically during emergencies, to implement policy responses in ways that are amenable to evaluation, and even potential moral obligations to participate in research. In situations of heightened uncertainty, additional questions arise about what constitutes sufficient evidence to justify the development and implementation of policy responses, and the responsibilities of scientific and social science researchers involved in policy-making processes. The four cases in this chapter prompt reflection on evolving and at times competing values and responsibilities of policy-makers, regulators, health authorities and researchers during the design and conduct of research, and proposed early implementation of research findings. These cases highlight issues arising when conducting research of national importance in a pandemic, where researchers are required to liaise with authorities responsible for pandemic responses and address complex ethical issues, including protecting the interests of participants and publics when tensions arise between prioritising the completion of research and accelerating the rollout of novel health interventions. This chapter invites reflection on the practical ethical implications of commitments to undertake research during emergencies, including the nature and scope of the relevant responsibilities of a range of stakeholders. (shrink)

BackgroundComorbidity between diabetes mellitus and depression is highly prevalent. The risk of depression in a person with diabetes is approximately twice that of a person without this disease. Depression has a major impact on patient well-being and control of diabetes. However, despite the availability of effective and specific therapeutic interventions for the treatment of depression in people with diabetes, 50% of patients do not receive psychological treatment due to insufficient and difficult accessibility to psychological therapies in health systems. (...) The use of information and communication technologies has therefore been proposed as a useful tool for the delivery of psychological interventions, but it continues to be a field in which scientific evidence is recent and controversial. This systematic review aims to update the available information on the efficacy of psychological interventions delivered through ICTs to improve depressive symptomatology in patients with diabetes.MethodsA systematic review of the literature was performed following the PRISMA guidelines and using MEDLINE, Embase, PubMed, Web of Science, PsycINFO, Scopus, and Cochrane Library databases to search for randomized clinical trials of eHealth treatments for patients with diabetes and comorbid depression from 1995 through 2020. In addition, studies related to follow-up appointments were identified. Inclusion criteria were as follows: randomized clinical trials ; patients with type 1 and type 2 diabetes; adult population over 18 years of age; presence of depressive symptomatology assessed with standardized instruments; treatments for depression based on established psychotherapeutic techniques and principles; delivered through eHealth technologies. We did not limit severity of depressive symptomatology, delivery setting or comparison group. Two coauthors independently reviewed the publications identified for inclusion and extracted data from the included studies. A third reviewer was involved to discuss discrepancies found. The PEDro scale was used to assess the quality of the RCTs. No meta-analysis of the results was performed. The protocol used for this review is available in PROSPERO.ResultsThe initial search identified 427 relevant scientific publications. After removing duplicates and ineligible citations, a total of 201 articles were analyzed in full text. Ten articles met the criteria of this review and were included, obtaining very good scientific quality after evaluation with the PEDro scale. The main results show that the eHealth psychological intervention for depression in patients with diabetes showed beneficial effects both at the end of treatment and in the short and long term for the improvement of depressive symptomatology. The methodology used was very heterogeneous. However, all studies were based on cognitive-behavioral tools and used standardized assessment instruments to evaluate depressive symptomatology or diagnosis of MDD. Glycemic control was assessed by glycosylated hemoglobin, but no benefits were found in improving glycemic control. Only four studies included psychoeducational content on diabetes and depression, but none used tools to improve or enhance adherence to medical prescriptions or diabetes self-care.ConclusionsICT-based psychological interventions for the treatment of depression in people with diabetes appear to be effective in reducing depressive symptomatology but do not appear to provide significant results with regard to glycemic control. Nonetheless, the scientific evidence reported to date is still very limited and the methodology very diverse. In addition, no studies have implemented these systems in routine clinical practice, and no studies are available on the economic analysis of these interventions. Future research should focus on studying and including new tools to ensure improvements in diabetes outcomes and not only on psychological well-being in order to advance knowledge about these treatments. Economic evaluations should also be undertaken to analyze whether these treatment programs implemented using eHealth technologies are cost-effective. (shrink)

Medical, scientific and societal progress has been such that, in a universalist humanist perspective such as the WHO’s, it has become an ethical imperative for the primary endpoints in evidence based health care research to be expressed in e.g. Quality Adjusted Life Years (QALYs). The classical endpoints of discrete health‐related functions and duration of survival are increasingly perceived as unacceptably reductionistic. The major problem in ‘felicitometrics’ is the measurement of the ‘quality’ term in QALYs. That (...) the mental, physical and social domains, each containing many dimensions and items, all contribute to QOL is uncontroversial. What is controversial, is the weight of the different dimensions in overall QOL. It has been shown to be very different between different patient populations. In human individuals, assuredly complex systems, the many dimensions and items of QOL observably interact, probably sometimes also in chaotic ways. In these conditions, the weights of isolated items in individuals become for all practical purposes meaningless. Therefore, the much used multi‐item questionnaires at best describe, but do not evaluate QOL, neither in individuals, nor in populations. For example, allergic patients treated with cetirizine scored better than those a placebo on all dimensions of the SF‐36, a standard QOL questionnaire. Here there is no serious doubt that the treatment improved QOL, because it is highly unlikely that any important dimension on which the patient groups would have scored otherwise is missing in the SF‐36. However, whether piracetam treatment of acute stroke, which improved the surrogate endpoints neurological and functional scores, also improved QOL is plausible, but will be proven only when comprehensive QOL measurement will have been done. And suppose in randomised populations of end‐stage metastatic solid cancer patients, one would compare palliative last‐line chemotherapy with only palliative care, and one would, as can be expected, find no significant differences in average survival, and chemotherapy superior for the mental domain, but inferior for the physical comfort domain: we would not know which treatment, on aggregate, would be the better. The problem is that QOL is an individual and emergent construct, the resultant of a great many intractions, and of a different order than its contributing components. Overall QOL can therefore best be captured only as the Gestalt of a global self‐assessment. Just as people in everyday life, while acting under uncertainty, make global assessments all the time, so they can seriously answer the serious question: ‘How have you been?’ A solemn, practical, non peer‐relativistic, non‐cultural, experiential, and well tolerated way to obtain such responses is Anamnestic Comparative Self Assessment (ACSA), in which the subjects' memories of the best and the worst times in their life experience define their individual scale of QOL. ACSA is thus both exquisitely idiosyncratic, and yet can in a universalist humanistic perspective be considered generic. Using both a multi‐item questionnaire and a global assessment allows by one logistic regression, to estimate the weights of the dimensions and items in populations, and thus identify those whose improvement would most contribute to the QOL of the greatest number. A combined approach to measurement of QOL is necessary to maximise the utility of QOL interventions. (shrink)

The commercial introduction of genetically modified organisms (GMOs) has revealed a broad range of views among scientists and other stakeholders on perspectives of genetic engineering (GE) and if and how GMOs should be regulated. Within this controversy, the precautionary principle has become a contentious issue with high support from skeptical groups but resisted by GMO advocates. How to handle lack of scientific understanding and scientific disagreement are core issues within these debates. This article examines some of the key (...) issues affecting precaution as a legal standard and as an approach to the use of science in decision-making processes. It is pointed out that there is a need for reflection over the level of scientific evidence required for applying the precautionary principle as well as who should have the burden of proof when there are uncertainties. Further, an awareness of the broader scientific uncertainties found in GMO risk assessment implies that a precautionary approach must be elaborated: both for acknowledging uncertainties and for identification of scientific responses. Since precaution is an important issue within the sustainable development framework, it is suggested that sustainability can provide a normative standard that can help to reveal the influence and negotiate the importance of the various forms of uncertainty. Wise management of uncertainties and inclusion of normative aspects in risk assessment and management may help to ensure sustainable and socially robust GMO innovations at present and in the future. (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)

The increasing success of the evidence-based policy movement is raising the demand of empirically informed decision making. As arguably any policy decision happens under conditions of uncertainty, following our best available evidence to reduce the uncertainty seems a requirement of good decision making. However, not all the uncertainty faced by decision makers can be resolved by evidence. In this paper, we build on a philosophical analysis of uncertainty to identify the boundaries of scientific advice in policy (...) decision making. We start by introducing a distinction between empirical and non-empirical types of uncertainty, and we explore the role of two non-empirical uncertainties in the context of policy making. We argue that the authority of scientific advisors is limited to empirical uncertainty and cannot extend beyond it. While the appeal of evidence-based policy rests on a view of scientific advice as limited to empirical uncertainty, in practice there is a risk of over reliance on experts beyond the legitimate scope of their authority. We conclude by applying our framework to a real-world case of evidence-based policy, where experts have overstepped their boundaries by ignoring non-empirical types of uncertainty. (shrink)

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)

In climate science, observational gridded climate datasets that are based on in situ measurements serve as evidence for scientific claims and they are used to both calibrate and evaluate models. However, datasets only represent selected aspects of the real world, so when they are used for a specific purpose they can be a source of uncertainty. Here, we present a framework for understanding this uncertainty of observational datasets which distinguishes three general sources of uncertainty: (1) uncertainty that arises during (...) the generation of the dataset; (2) uncertainty due to biased samples; and (3) uncertainty that arises due to the choice of abstract properties, such as resolution and metric. Based on this framework, we identify four different types of dataset ensembles — parametric, structural, resampling, and property ensembles—as tools to understand and assess uncertainties arising from the use of datasets for a specific purpose. We advocate for a more systematic generation of dataset ensembles by using these sorts of tools. Finally, we discuss the use of dataset ensembles in climate model evaluation. We argue that a more systematic understanding and assessment of dataset uncertainty is needed to allow for a more reliable uncertainty assessment in the context of model evaluation. The more systematic use of such a framework would be beneficial for both scientific reasoning and scientific policy advice based on climate datasets. (shrink)

Global consumption of antibiotics has accelerated the evolution of bacterial antimicrobial resistance. Yet, the risks from increasing bacterial antimicrobial resistance are not restricted to human populations: transmission of antimicrobial resistant bacteria occurs between humans, farms, the environment and other reservoirs. Policies that take a ‘One Health’ approach deal with this cross-reservoir spread, but are often more restrictive concerning human actions than policies that focus on a single reservoir. As such, the burden of justification lies with these more restrictive policies. (...) We argue that an ethical justification for preferring One Health policies over less restrictive alternatives relies on empirical evidence as well as theory. The ethical justification for these policies is based on two arguments: (i) comparatively greater effectiveness, and (ii) comparatively better tracking of moral responsibility. Yet the empirical assumptions on which these claims rest are limited by existing empirical knowledge. Using livestock farming as an example, we suggest that scientific research into characterising antimicrobial resistance and linking practices to outcomes ought to be guided (at least in part) by the imperative to supply the context-specific data needed to ethically justify preferring a One Health policy over less restrictive alternatives. (shrink)

Scholars in philosophy, law, economics and other fields have widely debated how science, environmental precaution, and economic interests should be balanced in urgent contemporary problems, such as climate change. One controversial focus of these discussions is the precautionary principle, according to which scientific uncertainty should not be a reason for delay in the face of serious threats to the environment or health. While the precautionary principle has been very influential, no generally accepted definition of it exists and critics (...) charge that it is incoherent or hopelessly vague. This book presents and defends an interpretation of the precautionary principle from the perspective of philosophy of science, looking particularly at how it connects to decisions, scientific procedures, and evidence. Through careful analysis of numerous case studies, it shows how this interpretation leads to important insights on scientific uncertainty, intergenerational justice, and the relationship between values and policy-relevant science. (shrink)

Mitochondrial replacement therapy (MRT) utilises nuclear transfer technology to replace defective mitochondria with healthy ones and thereby minimise the risk of a mitochondrial disease passing from a mother to her child. It promises much but comes with ethical controversy, significant risk of harm and many unknowns. Forming a position on MRT requires accurate information about the current state of knowledge, and an appreciation of the ethical issues at stake. Ethical deliberations will vary depending on the framework used. (...) There are in principle objections to MRT on the grounds of direct harm to human embryos and germline genetic modification. But even without these objections MRT can be weighed in terms of the balance between risks and benefits, alternatives and uncertainties. This paper explores the evidence and lays out the relevant issues to assist such a deliberation. (shrink)

Post-Normal Science as a theory links epistemology and governance. It not only focuses on problem situations where facts are uncertain, values in dispute, stakes high and decisions urgent, but also tries to develop epistemic approaches that allow for sound scientific answers. The following article addresses major epistemological challenges within a typical ‘‘wicked-problem situation’’, i.e., risk assessment of emerging technologies. Such challenges include epistemological problems intrinsic to the task of proving the absence of risk, problems related to the (...) multi-sited production of evidence and the multitude of epistemic cultures involved, the incompatibility of the various implicit objectives and the complex actor-constellations, that shape not only the way scientific knowledge is translated into action, but also which kind of knowledge is produced and which experts are listened to. To illustrate and discuss these characteristics, the article draws on an empirical study of risk research in the fields of agri-biotechnology and telecommunication technology in Germany. It concludes that although some aspects of PNS are already part of current epistemic practices in these fields, a state of ‘‘functional post-normality’’ depends upon a meaningful co-evolution between post-normal science and post-normal governance that has not yet been achieved. (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)

Scientific risk evaluations are constructed by specific evidence, value judgements and biological background assumptions. The latter are the framework-setting suppositions we apply in order to understand some new phenomenon. That background assumptions co-determine choice of methodology, data interpretation, and choice of relevant evidence is an uncontroversial claim in modern basic science. Furthermore, it is commonly accepted that, unless explicated, disagreements in background assumptions can lead to misunderstanding as well as miscommunication. Here, we extend the discussion on background assumptions (...) from basic science to the debate over genetically modified (GM) plants risk assessment. In this realm, while the different political, social and economic values are often mentioned, the identity and role of background assumptions at play are rarely examined. We use an example from the debate over risk assessment of stacked genetically modified plants (GM stacks), obtained by applying conventional breeding techniques to GM plants. There are two main regulatory practices of GM stacks: (i) regulate as conventional hybrids and (ii) regulate as new GM plants. We analyzed eight papers representative of these positions and found that, in all cases, additional premises are needed to reach the stated conclusions. We suggest that these premises play the role of biological background assumptions and argue that the most effective way toward a unified framework for risk analysis and regulation of GM stacks is by explicating and examining the biological background assumptions of each position. Once explicated, it is possible to either evaluate which background assumptions best reflect contemporary biological knowledge, or to apply Douglas' 'inductive risk' argument. (shrink)

This paper provides an analysis of the evolution of thinking and talking about the role of scientific knowledge and expertise in food safety policy-making, and in risk policy-making more generally from the late 19th century to the present day. It highlights the defining characteristics of several models that have been used to represent and interpret the relations between policy-makers and expert scientific advisors and between scientific and political considerations. Both conceptual and empirical (...) strengths and weaknesses of those models are identified, focusing in particular on the ways in which they deal with scientific uncertainties and social choices. By drawing on both empirical evidence and conceptual analysis, a novel and more realistic model is provided along with an account of some conditions for food safety policy-making achieving both scientific and democratic legitimacy. (shrink)

Quality of democratic arrangements does matter. This kind of conceptual breakthrough has been made through painfully engagement with the nonphilosophical area of inquiry arisen by the COVID-19 pandemic. The pandemic has dramatically emphasized that health is a highly political domain. No surprise then that it made possible to challenge common thought about democratic procedures in political theory that considers procedure-independent standards suspicious. Therefore it is fair to state that the COVID-19 pandemic has taken the quality of (...) democratic outcomes back on center stage in the debate in political theory, which has been dominated by fair proceduralism’s claim not to refer to any procedure-independent standards of good political decisions. Procedural values have traditionally been seen as a defining element of fair deliberation and essential for democracy. They have been extolled in social choice theory that claims that democracy does not exhibit any particular disposition to lead to good or just political arrangements. They are the focus of attention in Jürgen Habermas’ procedural rationality, though philosophers are now more skeptical about the divorce between procedures and substantive standards. Overall, issues surrounding the topic of ensuring citizens’ health make the topic politically central and philosophically interesting for epistemic theories and impartial proceduralism theories of democracy alike. The aim of this paper is to justify the legitimacy and authority of public health policies on the basis of arguments that do not simply are a matter of their being democratic. In the first part, I want to display and criticize the idea that proceduralism’s not getting one’s hands dirty with the substance of decisions and remaining neutrally adherent only to procedures is untenable in the present case. Having criticized democratic theories that want to restrict themselves to purely procedural values, in the second part I will focus on the idea of knowledge and make explicit its characters of being practical and shared. Eventually, it will help to have one example. M-Health will show that many valuable insights would be incompatible with the restrictions of the proceduralism. Philosophical consideration of health will combine epistemic issues with political ones triggered by technology and sharpened by the COVID-19 pandemic. (shrink)

The judiciary is a key policy actor that is involved in deciding health rights and policy by intervening in the policy process through a variety of judicial mechanisms, yet the appropriate extent of its involvement remains contentious. Taking the competence objection seriously requires understanding it as an epistemic problem about how courts assess empirical and scientific evidence in order to competently adjudicate controversial health claims. This paper examines recent advances in social epistemology to develop (...) insights for the epistemic competence of the judiciary from a system‐oriented approach. I outline three epistemic features that set the judiciary and the judicial decision‐making process apart from other types of decision‐makers in health policy: the distribution of epistemic power, the epistemic authority of a justified believer, and the principle of disinterestedness. Finally, I relate these insights back to the judicial decision‐making process with a specific focus on recent court decisions in health rights and health policy in Chile. (shrink)

We are facing uncertainties regarding climate change and its impacts. To conceptualize and communicate these uncertainties to policy makers, the Intergovernmental Panel on Climate Change (IPCC) has introduced an uncertainty framework. In this paper, I assess the latest, most developed, version of this framework. First, I provide an interpretation of this framework, which draws from supporting documents and the practice of its users. Second, I argue that even a charitable interpretation exhibits three substantial conceptual problems. These problems point towards (...) untenable assumptions regarding evidence aggregation in the context of climate scientific findings. Third, I put forward a tentative roadmap for improving the uncertainty framework. (shrink)

We are facing uncertainties regarding climate change and its impacts. To conceptualize and communicate these uncertainties to policy makers, the Intergovernmental Panel on Climate Change (IPCC) has introduced an uncertainty framework. In this paper, I assess the latest, most developed, version of this framework. First, I provide an interpretation of this framework, which draws from supporting documents and the practice of its users. Second, I argue that even a charitable interpretation exhibits three substantial conceptual problems. These problems point towards (...) untenable assumptions regarding evidence aggregation in the context of climate scientific findings. Third, I put forward a tentative roadmap for improving the uncertainty framework. (shrink)

Biobanks are precariously situated at the intersection of science, genetics, genomics, society, ethics, the law and politics. This multi-disciplinarity has given rise to a new discourse in health research involving diverse stakeholders. Each stakeholder is embedded in a unique context and articulates his/her biobanking activities differently. To researchers, biobanks carry enormous transformative potential in terms of advancing scientific discovery and knowledge. However, in the context of power asymmetries in Africa and a distrust in science born out of (...) historical exploitation, researchers must balance the scientific imperative of collecting, storing and sharing high quality biological samples with obligations to donors/participants, communities, international collaborators, regulatory and ethics authorities. To date, researcher perspectives on biobanking in South Africa have not been explored and documented. In-depth qualitative interviews were conducted with a purposive sample of 21 researchers – 8 in the Western Cape, 3 in Gauteng and 10 in Kwa-Zulu Natal. Interviews lasted approximately 40–60 min and were audiotaped with consent. Thematic analysis of the transcribed interviews was conducted by the co-authors. Researchers articulated serious concerns over standardised regulatory approaches that failed to consider the heterogeneity of biobanks. Given that biobanks differ considerably, guidelines and RECs need to stratify risk accordingly and governance processes and structures must be flexible. While RECs were regarded as an important component of the governance structure researchers expressed concern about their expertise in biobanking. Operational management of biobanks was regarded as an ethical imperative and a pre-requisite to building trust during consent processes. While broad general consent was preferred, tiered consent was thought to be more consistent with respect for autonomy and building trust. Material Transfer Agreements were often lacking when biosamples were exported and this was perceived to impact negatively on trust. On the other hand, researchers believed that authentic community engagement would help to build trust. Building trust will best be achieved via a system of governance structures and processes that precede the establishment of a biobank and monitor progress from the point of sample collection through to future use, including export. Such governance structures must be robust and must include comprehensive national legislation, policy and contextualised guidelines. Currently such governance infrastructure appears to be lacking in many African countries including South Africa. Capacity development of all stakeholders including REC members will enhance expeditious and efficient review of biobanking protocols which in turn will reinforce trust in the researcher-donor relationship. Science translation and community engagement in biobanking is integral to the success of biobanking in South Africa. (shrink)