Big data and Machine learning Techniques are reshaping the way in which food safety risk assessment is conducted. The ongoing ‘datafication’ of food safety risk assessment activities and the progressive deployment of probabilistic models in their practices requires a discussion on the advantages and disadvantages of these advances. In particular, the low level of trust in EU food safety risk assessment framework highlighted in 2019 by an EU-funded survey could be exacerbated by novel methods of analysis. The (...) variety of processed data raises unique questions regarding the interplay of multiple regulatory systems alongside food safety legislation. Provisions aiming to preserve the confidentiality of data and protect personal information are juxtaposed to norms prescribing the public disclosure of scientific information. This research is intended to provide guidance for data governance and data ownership issues that unfold from the ongoing transformation of the technical and legal domains of food safety risk assessment. Following the reconstruction of technological advances in data collection and analysis and the description of recent amendments to food safety legislation, emerging concerns are discussed in light of the individual, collective and social implications of the deployment of cutting-edge Big Data collection and analysis techniques. Then, a set of principle-based recommendations is proposed by adapting high-level principles enshrined in institutional documents about Artificial Intelligence to the realm of food safety risk assessment. The proposed set of recommendations adopts Safety, Accountability, Fairness, Explainability, Transparency as core principles (SAFETY), whereas Privacy and data protection are used as a meta-principle. (shrink)

The ‘Precautionary Principle’ provides a somewhat ill-defined guide, often of uncertain normative status, for those exercising administrative decision-making power in circumstances where that may create potential risks to human health or the environment. This paper seeks to explore to what extent the precautionary principle should have been and was in fact utilised by the Australian Therapeutic Goods Administration (TGA) in its decision to approve the marketing of sunscreens containing titanium dioxide (TiO2) and zinc oxide (ZnO) in nanoparticulate form. (...) In particular, this article assesses to what extent better application of that principle might have altered the TGA’s decision that TiO2 and ZnO ENPs in sunscreens do not require new safety testing, because they are considered to be functionally equivalent to their bulk counterparts. (shrink)

The safety conception of knowledge holds that a belief constitutes knowledge iff relevantly similar beliefs—its epistemic counterparts—are true. It promises an instructive account of why certain general principles of knowledge hold. We focus on two such principles that anyone should endorse: the closure principle that knowledge is downward closed under competent conjunction elimination, and the counter-closure principle that knowledge is upward closed under competent conjunction introduction. We argue that anyone endorsing the former must also endorse the latter (...) on pains of an unacceptable form of bootstrapping. We devise new formal models to identify necessary and sufficient conditions for these principles to hold on conceptions that construe knowledge in terms of true counterparts. These conditions state that counterparts of premise and conclusion beliefs are coordinated in certain ways whenever these beliefs stand in the relevant inferential relations. We show that the safety conception faces insuperable problems vindicating these coordination principles, because its epistemic counterpart relation is symmetric. We conclude that it thus proves unable to account for minimal closure properties of knowledge. More generally, our formal results establish parameters within which any conception must operate that construes knowledge in terms of true counterparts. (shrink)

The safety conception of knowledge holds that a belief constitutes knowledge iff relevantly similar beliefs—its epistemic counterparts—are true. It promises an instructive account of why certain general principles of knowledge hold. We focus on two such principles that anyone should endorse: the closure principle that knowledge is downward closed under competent conjunction elimination, and the counter-closure principle that knowledge is upward closed under competent conjunction introduction. We argue that anyone endorsing the former must also endorse the latter (...) on pains of an unacceptable form of bootstrapping. We devise new formal models to identify necessary and sufficient conditions for these principles to hold on conceptions that construe knowledge in terms of true counterparts. These conditions state that counterparts of premise and conclusion beliefs are coordinated in certain ways whenever these beliefs stand in the relevant inferential relations. We show that the safety conception faces insuperable problems vindicating these coordination principles, because its epistemic counterpart relation is symmetric. We conclude that it thus proves unable to account for minimal closure properties of knowledge. More generally, our formal results establish parameters within which any conception must operate that construes knowledge in terms of true counterparts. (shrink)

This article probes the advisability of regulating U.S. food and drug safety according to the precautionary principle. To do so, a precautionary regulatory regime is formulated on the basis of the beliefs that motivate most proponents of this initiative. That hypothetical regime is critically analyzed on the basis of an actual instantiation of a similarly stylized initiative. It will be argued that the precautionary principle entails regulatory constraints that are apt to violate basis tenets of political legitimacy. (...) The modifications that would change this finding would also change precautionary regulation to the point that it would be indistinguishable from orthodox safety protocols. It is concluded on the basis of its impoverished content that the precautionary principle should not be taken seriously as a formal approach to the regulation of U.S. food and drug safety. (shrink)

Safety principles in epistemology are often hailed as providing us with an explanation of why we fail to have knowledge in Gettier cases and lottery examples, while at the same time allowing for the fact that we know the negations of sceptical hypotheses. In a recent paper, Sinhababu and Williams have produced an example—the Backward Clock—that is meant to spell trouble for safety accounts of knowledge. I argue that the Backward Clock case is, in fact, unproblematic for the (...) more sophisticated formulations of safety in the literature. However, I then proceed to construct two novel examples that turn out problematic for those formulations—one that provides us with a lottery-style case of safe ignorance and one that is a straightforward case of unsafe knowledge. If these examples succeed, then safety as it is usually conceived in the current debate cannot account for ignorance in all Gettier and lottery-style cases, and neither is it a necessary condition for knowledge. I conclude from these troublesome examples that modal epistemologists ought to embrace a much more simple and non-reductive version of safety, according to which the notion of similarity between possible worlds that determines in which worlds the subject must believe truly is an epistemic notion that cannot be defined or reduced to notions independent of knowledge. The resulting view is shown to also lead to desirable results with respect to lottery cases, certain quantum phenomena, and a puzzling case involving a cautious brain-in-a-vat. (shrink)

This paper considers, and rejects, three strategies aimed at showing that the KK-principle fails even in most favourable circumstances (all emerging from Williamson’s Knowledge and its Limits ). The case against the final strategy provides positive grounds for thinking that the principle should hold good in such situations.

Recent research has identified a tension between the Safety principle that knowledge is belief without risk of error, and the Closure principle that knowledge is preserved by competent deduction. Timothy Williamson reconciles Safety and Closure by proposing that when an agent deduces a conclusion from some premises, the agent’s method for believing the conclusion includes their method for believing each premise. We argue that this theory is untenable because it implies problematically easy epistemic access to one’s (...) methods. Several possible solutions are explored and rejected. (shrink)

The safety principle is the view that, roughly, if one knows that p, p could not easily have been false. It is common for safety theorists to relativize safety to belief-formation methods. In this paper, I argue that there is no fixed principle of method-individuation that can stand up to scrutiny. I examine various ways to individuate methods and argue that all of them are subject to serious counterexamples. In the end, I conclude by considering (...) some alternative ways to preserve the insight behind safety without invoking a fixed principle of method-individuation. (shrink)

Duncan Pritchard's version of the safety analysis of knowledge has it that for all contingent propositions, p, S knows that p iff S believes that p, p is true, and (the “safety principle”) in most nearby worlds in which S forms his belief in the same way as in the actual world, S believes that p only if p is true. Among the other virtues claimed by Pritchard for this view is its supposed ability to solve a (...) version of the lottery puzzle. In this paper, I argue that the safety analysis of knowledge in fact fails to solve the lottery puzzle. I also argue that a revised version of the safety principle recently put forward by Pritchard fares no better. (shrink)

This paper argues for several related theses. First, the epistemological position that knowledge requires safe belief can be motivated by views in the philosophy of science, according to which good explanations show that their explananda are robust. This motivation goes via the idea—recently defended on both conceptual and empirical grounds—that knowledge attributions play a crucial role in explaining successful action. Second, motivating the safety requirement in this way creates a choice point—depending on how we understand robustness, we'll end up (...) with different conceptions of safety in epistemology. Lastly, and most controversially, there's an attractive choice at this point that will not vindicate some of the most influential applications of the safety-theoretic framework in epistemology, e.g., Williamson's arguments against the KK principle, and luminosity. (shrink)

The lottery problem is the problem of explaining why mere reflection on the long odds that one will lose the lottery does not yield knowledge that one will lose. More generally, it is the problem of explaining why true beliefs merely formed on the basis of statistical evidence do not amount to knowledge. Some have thought that the lottery problem can be solved by appeal to a violation of the safety principle for knowledge, i.e., the principle that (...) if S knows that p, not easily would S have believed that p without p being the case. Against the standard safety‐based solution, I argue that understanding safe belief as belief that directly covaries with the truth of what is believed in a suitably defined set of possible worlds forces safety theorists to make a series of theoretical choices that ultimately prevent a satisfactory solution to the problem. In this way, I analyze several safety principles that result from such choices—the paper thus gives valuable insights into the nature of safety—and explain why none solves the lottery problem, including their inability to explain away Gettierized lottery cases. On a more positive note, I show that there is a viable solution in terms of safety if we get rid of the unquestioned assumption that safe beliefs directly track the truth. The alternative is a conception of safe belief according to which what safe beliefs directly track is the appropriateness of the circumstances and, indirectly, the truth. The resulting safety principle, I argue, explains why mere statistical evidence is not a safe source of knowledge. (shrink)

In “Knowledge Under Threat” (Philosophy and Phenomenological Research 2012), Tomas Bogardus proposes a counterexample to the safety condition for knowledge. Bogardus argues that the case demonstrates that unsafe knowledge is possible. I argue that the case just corroborates the well-known requirement that modal conditions like safety must be relativized to methods of belief formation. I explore several ways of relativizing safety to belief-forming methods and I argue that none is adequate: if methods were individuated in those ways, (...) safety would fail to explain several much-discussed cases. I then propose a plausible externalist principle of method individuation. On the one hand, relativizing safety to belief-forming methods in the way suggested allows the defender of safety to account for the cases. On the other hand, it shows that the target known belief of Bogardus’s example is safe. Finally, I offer a diagnosis of a common error about the kind of cases that are typically considered potential counterexamples to the necessity of the epistemic condition: proponents of the alleged counterexamples mistake a strong condition that I call super-safety for safety. (shrink)

The safety condition on knowledge, in the spirit of anti-luck epistemology, has become one of the most popular approaches to the Gettier problem. In the first part of this essay, I intend to show one of the reasons the anti-luck epistemologist presents for thinking that the safety theory, and not the sensitivity theory, offers the proper anti-luck condition on knowledge. In the second part of this essay, I intend to show that the anti-luck epistemologist does not succeed, because (...) the safety theory fails to capture a necessary requirement for the possession of knowledge. I will attack safety on two fronts. First, I will raise doubts about whether there is any principled safety condition capable of handling a kind of case, involving inductive knowledge, that it was designed to handle. Second, I will consider two cases in which the safety condition is not met but the protagonist seems to have knowledge nonetheless, and I will vindicate my intuitions for thinking that those are in fact cases of knowledge by contrasting them with traditional, well-known Gettier cases. I want to conclude, finally, that safety failures do not necessarily prevent one from acquiring knowledge. (shrink)

The safety analysis of knowledge, due to Duncan Pritchard, has it that for all contingent propositions, p, S knows that p iff S believes that p, p is true, and (the “safety principle”) in most nearby worlds in which S forms his belief in the same way as in the actual world, S believes that p only if p is true. Among the other virtues claimed by Pritchard for this view is its supposed ability to solve a (...) version of the lottery puzzle. In this paper, I argue that the safety analysis of knowledge in fact fails to solve the lottery puzzle. I also argue that a revised version of the safety principle recently put forward by Pritchard fares no better. (shrink)

This study will be of interest to anyone concerned with a critical appraisal of mental health service users’ and carers’ participation in research collaboration and with the potential of the postcolonial paradigm of cultural safety to contribute to the service user research (SUR) movement. The history and nature of the mental health field and its relationship to colonial processes provokes a consideration of whether cultural safety could focus attention on diversity, power imbalance, cultural dominance and structural inequality, identified (...) as barriers and tensions in SUR. We consider these issues in the context of state‐driven approaches towards SUR in planning and evaluation and the concurrent rise of the SUR movement in the UK and Australia, societies with an intimate involvement in processes of colonisation. We consider the principles and motivations underlying cultural safety and SUR in the context of the policy agenda informing SUR. We conclude that while both cultural safety and SUR are underpinned by social constructionism constituting similarities in principles and intent, cultural safety has additional dimensions. Hence, we call on researchers to use the explicitly political and self‐reflective process of cultural safety to think about and address issues of diversity, power and social justice in research collaboration. (shrink)

Laboratory safety regulations have been traditionally viewed by its learners and practitioners as a matter of law and policy, which simply requires compliance. A compliance mindset tends be passive and dissociates individuals (or even institutions) from the important reasons and principles underlying the safety rules and regulations, leading to disinterestedness and disdain. I posit that laboratory safety regulations would need to be crafted, presented and taught in a manner that is coupled to, or at least with an (...) emphasis on, research ethics. Learners and practitioners of laboratory safety must be led to fully grasp the ethical underpinnings of the rules and regulations, however perceivably cumbersome or inconvenient the latter may seem. In extended definitions beyond the classical fabrication, falsification and plagiarism, laboratory safety violation (LSV) should indeed be considered a form of research misconduct (RM). A full appreciation of the ethical principles underlying laboratory safety regulations would intuitively make LSVs morally impermissible, and as such defiance would be morally unacceptable. Importantly, LSVs framed as moral transgressions would be equally applied to all perpetrators in terms of culpability regardless of one’s endowment and power status. LSV perpetrators should thus also be punishable in accordance with the federal or institutional laws or bylaws of research ethics and integrity. Pedagogical and content modifications to laboratory safety education to adequately reflect a research ethics emphasis, as well as promotion of epistemic acuity in this regard, would be desirable. (shrink)

Publication date: 21 March 2019 Source: Author: Viktoriia Varenyk Budget safety, as a component of financial security, depends on the results of the implementation of an effective state financial and economic policy as the basis for the achievement of national interests. Effective using of the budget, namely, effective management of the state's cash flows, should ensure the regulation of economic and social processes in the interests of society, and create stable conditions for economic development of the country. Budget policy (...) is an integral part of the state's financial policy and as one of the driving forces of Ukraine's development implies further stabilization of public finances, ensuring economic growth and raising standards of living for the maintenance of balanced development of the state. In today's conditions of development, the state faces the task of ensuring the balance and stability of the state budget against adverse external influences, establishing effective management of the country's cash flows, establishing effective budget and monetary policy, as well as long-term fiscal sustainability and stability. In recent years, to overcome this task, control over the activities of financial institutions has intensified, as a result they guided by the principles of responsible management of public finances, aimed at introducing the principles of medium-term financial planning, the availability of a system of forecasting budget parameters, ensuring the feasibility of economic forecasts, and creating and maintaining necessary financial reserves. (shrink)

In several areas of Mathematical Logic and Computer Science one would ideally like to use the set F orm(L) of all formulas of some first-order language L for some goal, but this cannot be done safely. In such a case it is necessary to select a subset of F orm(L) that can safely be used. Three main examples of this phenomenon are: • The main principle of naive set theory is the comprehension schema: ∃Z(∀x.x ∈ Z ⇔ A).

When the evidence leaves us with a choice among hypotheses of unequal strength, how is the choice to be made?Caution would counsel us to choose the weakest, the hypothesis that asserts the least, since it is the least likely to fail us later. But the principle of maximum safety quickly reduces to absurdity; for it always dictates the choice of a hypothesis that does not go beyond the evidence at all.

The safety analysis of knowledge, due to Duncan Pritchard, has it that for all contingent propositions, p, S knows that p iff S believes that p, p is true, and (the “safety principle”) in most nearby worlds in which S forms his belief in the same way as in the actual world, S believes that p only if p is true. Among the other virtues claimed by Pritchard for this view is its supposed ability to solve a (...) version of the lottery puzzle. In this paper, I argue that the safety analysis of knowledge in fact fails to solve the lottery puzzle. I also argue that a revised version of the safety principle recently put forward by Pritchard fares no better. (shrink)

The safety analysis of knowledge, due to Duncan Pritchard, has it that for all contingent propositions, p, S knows that p iff S believes that p, p is true, and (the “safety principle”) in most nearby worlds in which S forms his belief in the same way as in the actual world, S believes that p only if p is true. Among the other virtues claimed by Pritchard for this view is its supposed ability to solve a (...) version of the lottery puzzle. In this paper, I argue that the safety analysis of knowledge in fact fails to solve the lottery puzzle. I also argue that a revised version of the safety principle recently put forward by Pritchard fares no better. (shrink)

In this paper, I first seek a relatively plausible formulation of the safety principle. To this end, I refute a recent form of safety by Duncan Pritchard and then defend another weaker form of safe...

: Duncan Pritchard has recently highlighted the problem of veritic epistemic luck and claimed that a safety‐based account of knowledge succeeds in eliminating veritic luck where virtue‐based accounts and process reliabilism fail. He then claims that if one accepts a safety‐based account, there is no longer a motivation for retaining a commitment to reliabilism. In this article, I delineate several distinct safety principles, and I argue that those that eliminate veritic luck do so only if at least (...) implicitly committed to reliabilism. (shrink)

Safety is an important topic for a wide range of disciplines, such as engineering, economics, sociology, psychology, political science and philosophy, and plays a central role in risk analysis and risk management. The aim of this thesis is to develop a concept of safety that is relevant for decision-making, and to elucidate its consequences for risk and safety research and practices. Essay I provides a conceptual analysis of safety in the context of societal decision-making, focusing on (...) some fundamental distinctions and aspects, and argues for a more complex notion than what is commonly given. This concept of safety explicitly includes epistemic uncertainty, the degree to which we are uncertain of our knowledge of the situation at hand. It is discussed the extent to which such a concept may be considered an objective concept, and concluded that it is better seen as an intersubjective concept. Some formal versions of a comparative safety concept are also proposed. Essay II explores some consequences of epistemic uncertainty. It is commonly claimed that the public is irrational in its acceptance of risks. An underlying presumption in such a claim is that the public should follow the experts’ advice in recommending an activity whenever the experts have better knowledge of the risk involved. This position is criticised based on considerations from epistemic uncertainty and the goal of safety. Furthermore, it is shown that the scope of the objection covers the entire field of risk research, risk assessment as well as risk management. Essay III analyses the role of epistemic uncertainty for principles of achieving safety in an engineering context. The aim is to show that to account for common engineering principles we need the understanding of safety that has been argued for in Essays I-II. Several important principles in engineering safety are analysed, and it is argued that we cannot fully account for them on a narrow interpretation of safety as the reduction of risk. An adequate concept of safety must include not only the reduction of risk but also the reduction of uncertainty. (shrink)

Both sensitivity and safety theorists concur that their accounts should be relativized to the same method that one employs in the actual world. However, properly individuating methods has proven to be a tricky matter. In this regard, Nozick (Philosophical Explanations, Harvard University Press, Cambridge, 1981) proposes a Same-Experience-Same-Method Principle: if the experiences associated with two method tokens are the same, they are of the same type of method. This principle, however, has been widely rejected by recent (...) class='Hi'>safety and sensitivity theorists. In this paper, I raise an argument in favor of Nozick: not endorsing the principle leads to some rather implausible consequences when certain skeptical scenarios are considered—i.e., scenarios in which skeptical possibilities are ‘close’. Additionally, this argument reveals some important lessons about skepticism in general and the place of modal accounts of knowledge in the internalism/externalism debate. (shrink)

Food safety is a preoccupation of the European Commission, but there are major shortcomings in its governance. Reviewing legislation and practice, this paper explores the background of EU food safety institutions, and develops recommendations to make the EU decision process more transparent, accountable, and democratic.

An important question in epistemology is whether the KK principle is true, i.e., whether an agent who knows that p is also thereby in a position to know that she knows that p. We explain how a “transparency” account of self-knowledge, which maintains that we learn about our attitudes towards a proposition by reflecting not on ourselves but rather on that very proposition, supports an affirmative answer. In particular, we show that such an account allows us to reconcile a (...) version of the KK principle with an “externalist” or “reliabilist” conception of knowledge commonly thought to make that principle particularly problematic. (shrink)

In this article, the important but neglected link between workplace safety-enhancing behavior and ethics is explored. Using data from 237 employees from five manufacturing plants in the Midwest, we investigated how specific local ethical climate types are linked to incidences of injuries and two types of safety-enhancing behaviors: safety compliance and safety participation. It was hypothesized that egoist climates are positively related to injuries and negatively related to safety-enhancing behaviors. In contrast, it is proposed that (...) both benevolent and principled climates have negative relationships with injuries and positive relationships with safety-enhancing behaviors. Results provided support only for our principled climate types while benevolence has the desired negative relationship with injuries. Egoism and benevolence are not related to safety-enhancing behaviors. Theoretical and practical implications of findings are discussed. (shrink)

Many epistemologists hold that the Zebra Deduction fails to transmit knowledge to its conclusion, but there is little agreement concerning why it has this defect. A natural idea is, roughly, that it fails to transmit because it fails to improve the safety of its conclusion. In his ‘Transmission Failure Explained’, Martin Smith defends a transmission principle which is supposed to underwrite this natural idea. There are two problems with Smith's account. First, Smith's argument for his transmission principle (...) relies on a dubious premise. Second, even if his transmission principle is true, Smith shows neither that it prevents the Zebra Deduction from transmitting knowledge to its conclusion, nor that it secures the natural idea. I suspect that the failures of Smith's account will be instructive for anyone who wants to connect transmission failure with a failure to enhance the safety, reliability or probability of one's conclusion.Send article to KindleTo send this article to your Kindle, first ensure [email protected] is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about sending to your Kindle. Find out more about sending to your Kindle. Note you can select to send to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be sent to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply. Find out more about the Kindle Personal Document Service.THE DANGERS OF USING SAFETY TO EXPLAIN TRANSMISSION FAILURE: A REPLY TO MARTIN SMITHVolume 9, Issue 4Chris TuckerDOI: https://doi.org/10.1017/epi.2012.24Your Kindle email address Please provide your Kindle [email protected]@kindle.com Available formats PDF Please select a format to send. By using this service, you agree that you will only keep articles for personal use, and will not openly distribute them via Dropbox, Google Drive or other file sharing services. Please confirm that you accept the terms of use. Cancel Send ×Send article to Dropbox To send this article to your Dropbox account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about sending content to Dropbox. THE DANGERS OF USING SAFETY TO EXPLAIN TRANSMISSION FAILURE: A REPLY TO MARTIN SMITHVolume 9, Issue 4Chris TuckerDOI: https://doi.org/10.1017/epi.2012.24Available formats PDF Please select a format to send. By using this service, you agree that you will only keep articles for personal use, and will not openly distribute them via Dropbox, Google Drive or other file sharing services. Please confirm that you accept the terms of use. Cancel Send ×Send article to Google Drive To send this article to your Google Drive account, please select one or more formats and confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about sending content to Google Drive. THE DANGERS OF USING SAFETY TO EXPLAIN TRANSMISSION FAILURE: A REPLY TO MARTIN SMITHVolume 9, Issue 4Chris TuckerDOI: https://doi.org/10.1017/epi.2012.24Available formats PDF Please select a format to send. By using this service, you agree that you will only keep articles for personal use, and will not openly distribute them via Dropbox, Google Drive or other file sharing services. Please confirm that you accept the terms of use. Cancel Send ×Export citation Request permission. (shrink)

The purpose of this article is to discuss the ethical issues impacting the phenomenon of patient safety and to present implications for nursing management. Previous knowledge of this perspective is fragmented. In this discussion, the main drivers are identified and formulated in ‘the ethical imperative’ of patient safety. Underlying values and principles are considered, with the aim of increasing their visibility for nurse managers’ decision-making. The contradictory nature of individual and utilitarian safety is identified as a challenge (...) in nurse management practice, together with the context of shared responsibility and identification of future challenges. As a conclusion, nurse managers play a strategic role in patient safety. Their role is to incorporate ethical values of patient safety into decision-making at all levels in an organization, and also to encourage clinical nurses to consider values in the provision of care to patients. Patient safety that is sensitive to ethics provides sustainable practice where the humanity and dignity of all stakeholders are respected. (shrink)

Decision-making by a Data and Safety Monitoring Board (DSMB) regarding clinical trial conduct and termination is intricate and largely limited by cases and rules. Decision-making by legal jury is also intricate and largely constrained by cases and rules. In this paper, I argue by analogy that legal decision-making, which strives for a balance between competing demands of conservatism and innovation, supplies a good basis to the logic behind DSMB decision-making. Using the doctrine of precedents in legal reasoning as my (...) central analog will lead us to a decision-theoretic analogy for much more systematic documentation of decisions in clinical trials. My conclusion is twofold: every DSMB decision should articulate a clear general principle (a ratio decidendi) that gives reason for the decision; and all such decisions should be made public. I use Bartha’s (2010) theory of analogical arguments to both frame and assess my argument by analogy. (shrink)

The issues and problems of mandatory vaccination policy and roll out in First Nations communities are unique and do not concern the safety and effectiveness of vaccines. These issues are also independent of more specific arguments of mandatory vaccination of healthcare workers as a condition of employment. As important as these issues are, they do not consider the complex politics of ongoing settler colonialism and First Nations community relations. In this paper, we also set aside the very real problems (...) of disinformation, hesitancy, scientific and health illiteracy, and other concerns that drive vaccine hesitancy and refusal. These affect all communities, including First Nations communities. We, instead describe the dominant arguments in favour of mandatory vaccination and critique them in terms of the disputed legitimacy of Settler-Colonial decision-making as it impacts First Nations communities. We contend cultural responsiveness and safety—not state compulsion—must remain the first principles of any engagement—including vaccination—with First Nations Peoples, families, and communities. (shrink)

Dunn has recently argued that the logic R-Mingle (or RM) is a good, and good enough, choice for many purposes in relevant and paraconsistent logic. This includes an argument that the validity of Safety principle, according to which one may infer an arbitrary instance of the law of excluded middle from an arbitrary contradiction, in RM is not a problem because it doesn’t allow one to infer anything new from a contradiction. In this paper, I argue that while (...) Dunn’s claim holds for the logic, there is a good reason to think that it’s not the case for (prime) theories closed under the logic, and that this should give relevantists, and some paraconsistentists, pause when considering whether RM is adequate for their purposes. (shrink)

The paper challenges Williamson’s safety based explanation for why we cannot know the cut-off point of vague expressions. We assume throughout (most of) the paper that Williamson is correct in saying that vague expressions have sharp cut-off points, but we argue that Williamson’s explanation for why we do not and cannot know these cut-off points is unsatisfactory. -/- In sect 2 we present Williamson's position in some detail. In particular, we note that Williamson's explanation relies on taking a particular (...) safety principle ('Meta-linguistic belief safety' or 'MBS') as a necessary condition on knowledge. In section 3, we show that even if MBS were a necessary condition on knowledge, that would not be sufficient to show that we cannot know the cut-off points of vague expressions. In section 4, we present our main case against Williamson's explanation: we argue that MBS is not a necessary condition on knowledge, by presenting a series of cases where one's belief violates MBS but nevertheless constitutes knowledge. In section 5, we present and respond to an objection to our view. And in section 6, we briefly discuss the possible directions a theory of vagueness can take, if our objection to Williamson's theory is taken on board. (shrink)

In A Virtue Epistemology, Ernest Sosa defines the notions of safety and aptness of beliefs and uses them to characterize two kinds of knowledge, animal and reflective. This paper tries to bring out what I take as an incoherence in Sosa's views concerning how safety and aptness relate to knowledge and to each other. I discuss an apparent counterexample Sosa gives to his final view that aptness suffices for animal knowledge and argue that in fact the principle (...) on which Sosa responds to the counterexample does not permit the response he offers. The principle in question is problematic for Sosa's epistemology in a deeper way: it doesn't seem to cohere with Sosa's view that only aptness, not safety, is required for animal knowledge. En A Virtue Epistemology, Ernesto Sosa define las nociones de seguridad y aptitud de las creencias y las usa para caracterizar dos clases de conocimiento, el animal y el reflexivo. En este artículo discuto lo que parece una incoherencia en las tesis de Sosa acerca de cómo se relacionan la seguridad y la aptitud con el conocimiento y entre sí. Examino un aparente contraejemplo que Sosa plantea a su tesis final de que la aptitud es suficiente para el conocimiento animal, y argumento que el principio que él usa para responder al contraejemplo de hecho no permite dar esa respuesta. El principio en cuestión es problemático para la epistemología de Sosa de una manera más profunda: no parece ser coherente con su tesis central de que sólo la aptitud, no la seguridad, es necesaria para el conocimiento animal. (shrink)

BackgroundCritical Incident Reporting Systems (CIRS) provide a well-proven method to identify clinical risks in hospitals. All professions can report critical incidents anonymously, low-threshold, and without sanctions. Reported cases are processed to preventive measures that improve patient and staff safety. Clinical ethics consultations offer support for ethical conflicts but are dependent on the interaction with staff and management to be effective. The aim of this study was to investigate the rationale of integrating an ethical focus into CIRS.MethodsA six-step approach combined (...) the analysis of CIRS databases, potential cases, literature on clinical and organizational ethics, cases from ethics consultations, and experts’ experience to construct a framework for CIRS cases with ethical relevance and map the categories with principles of biomedical ethics.ResultsFour main categories of critical incidents with ethical relevance were derived: (1) patient-related communication; (2) consent, autonomy, and patient interest; (3) conflicting economic and medical interests; (4) staff communication and corporate culture. Each category was refined with different subcategories and mapped with case examples and exemplary related ethical principles to demonstrate ethical relevance.ConclusionThe developed framework for CIRS cases with its ethical dimensions demonstrates the relevance of integrating ethics into the concept of risk-, quality-, and organizational management. It may also support clinical ethics consultations’ presence and effectiveness. The proposed enhancement could contribute to hospitals’ ethical infrastructure and may increase ethical behavior, patient safety, and employee satisfaction. (shrink)

Research on quantum gravity has historically relied on appeals to guiding principles. This essay frames three such principles within the context of the condensed matter approach to QG. I first identify two distinct versions of this approach, and then consider the extent to which the principles of asymptotic safety, relative locality, and holography are supported by these versions. The general hope is that a focus on distinct versions of a single approach may provide insight into the conceptual and foundational (...) significance of these principles. (shrink)

Sensitivity is a modal epistemic principle. Modal knowledge accounts are externalist in nature and claim that the knowledge yielding connection between a true belief and the truthmaker must be spelled out in modal terms. The sensitivity condition was introduced by Robert Nozick. He suggests that if S knows that p, then S’s belief that p tracks truth. Nozick argues that this truth-tracking relation can be captured by subjunctive conditionals. As a first approximation, he provides the following modal analysis of (...) knowledge: S knows that p iff (1) p is true; (2) S believes that p; (3) if p were false, S wouldn’t believe that p and (4) if p were true, S would believe that p. The dominant terminology in the literature, also adopted here, is to call condition (3) the sensitivity condition and condition (4) the adherence condition. The sensitivity condition is intuitively appealing since it states that a subject does not know that p if she would believe that p even if p were false. Nozick used the sensitivity condition to accomplish two major tasks. First, he provided a solution to the Gettier problem by arguing that in Gettier cases subjects do not know since the sensitivity condition is violated. Second, he presented a controversial solution to the skeptical problem according to which we have external world knowledge but do not know that the skeptical hypothesis is false. This solution is available because sensitivity is not closed under known entailment. Quickly, criticism of the sensitivity condition emerged. First, most epistemologists regarded the price of abandoning knowledge closure as a price too high to pay. Second, it was noted that sensitivity leads to the counterintuitive consequence of precluding us from inductive knowledge since induction typically yields insensitive beliefs. The most dominant reaction to these problems was to replace sensitivity by the modal principle of safety, nowadays the most popular modal principle. However, sensitivity is not only important as a starting point of modal epistemology. Because of its intuitive attractiveness, many authors aimed at refining the original sensitivity account in order to avoid well-known problems. This has led to a second wave of sensitivity accounts. As of today, various sensitivity-based theories are on the market, including accounts that avoid closure failure, probabilistic interpretations of sensitivity and adherence, and contextualist approaches. There is thus a vivid and ongoing debate about the sensitivity principle in epistemology. (shrink)

My purpose in this paper is to defend safety as a necessary condition on knowledge. First, I introduce Ernest Sosa’s safety condition. Second,I set up and grapple with Juan Comesaña’s recent putative counterexample to safety as a necessary condition on knowledge; Comesaña’s case forces us to consider Sosa’s updated safety condition. From such grappling a principled modification to Sosa’s safety condition emerges. Safety is safe from this, and like, attacks.

Contemporary regulation of food safety incorporates principles of quality management and systemic performance objectives that used to characterize private standards. Conversely, private standards are covering ground that used to be the realm of regulation. The nature of the two is becoming increasingly indistinguishable. The case study of the Ugandan fish export industry highlights how management methods borrowed from private standards can be applied to public regulation to achieve seemingly conflicting objectives. In the late 1990s, the EU imposed repeated bans (...) on fish imported from Uganda on the basis of food safety concerns. However, the EU did not provide scientific proof that the fish were actually “unsafe.” Rather, the poor performance of Uganda’s regulatory and monitoring system was used as justification. Only by fixing “the system” and performing the ritual of laboratory testing for all consignments for export to the EU did the Ugandan industry regain its status as a “safe” source of fish. Yet, gaps and inconsistencies abound in the current Ugandan fish safety management system. Some operations are by necessity carried out as “rituals of verification.” Given the importance of microbiological tests and laboratories in the compliance system, “alchemic rituals” provide an appropriate metaphor. These rituals are part and parcel of a model that reassures the EU fish-eating public that all is under control in Uganda from boat to point of export. As a consequence, actual non-compliance from boat to landing site allows the fishery to survive as an artisanal operation. (shrink)

Compared to other health care professions such as medicine, nursing and pharmacy, few studies have been conducted to examine the nature of practice errors in occupational and physical therapy. In an ongoing study to determine root causes, typographies and impact of occupational and physical therapy error on patients, focus group interviews have been conducted across the United States. A substantial number of harmful practice errors and/or other patient safety events (deviations or accidents) have been identified. Often these events have (...) had moral dimensions that troubled the therapist involved. In this article, six of these transcribed cases are analyzed, using predominant bioethical theories, ethical principles and professional codes of ethics. The cases and their analyses are intended to be exemplary, improving the readers’ ability to discern and critically address similar such events. Several patient safety strategies are suggested that might have prevented the events described in these cases. (shrink)

Large organisations are especially advised to consider the possibility of an Ethics Helpdesk in which all employees and managers can report with all suspected cases of unethical conduct, critical comments, dilemmas and advice for which there is insufficient room within the organisational hierarchy. A helpdesk is a central contact point where it is decided who the most appropriate person is to dealing with a given case. The helpdesk model is characterised by low barriers in its easy accessibility, positive approach and (...) the simple procedures employees need to follow. It offers employees consistent support while relying on the responsibilities of the individual employee as much as possible and it facilitates adequate monitoring and reporting. A helpdesk increases the chances of detecting unethical conduct which enables management to take adequate and timely measures against improper conduct. This article formulates principles, discusses critical factors and considers three models for adopting a sound and integrated ethics safety net. It also presents a case study and shows why organisational openness needs to be institutionalised. (shrink)

Transgenic plants are now being used to develop pharmaceutical and industrial products in addition to their use in crop improvement. Using confinement requirements, these transgenic plants are grown and processed under conditions that prevent intermixing with commodity crops. Regulatory agencies in the United States have provided guidance of zero tolerance of these new industrial crops with commodity crops. While this is a worthy goal, it is theoretically unattainable. In spite of the best containment practices, there is a potential risk using (...) any system of production due to unforeseen incidences including natural disasters or exposure to workers. The precautionary principle has been used for numerous regulated articles in addressing the potential risks of new products and technology based on a risk assessment in similar situations. We present here a risk assessment model that could be used as a start to develop an accepted model for the industry. The model is based on current risk models used for other regulated articles, but adapted for these types of products. This could be used to determine action levels in the event of an unintended exposure or to ensure that detection or confinement methods are adequate to avoid risks. As an example, aprotinin, a therapeutic protein now being produced in maize, was evaluated for potential risk to humans using this model. (shrink)

This article examines how scientists and regulators distribute the benefit of the doubt about drug safety under conditions of scientific uncertainty. The focus of the empirical research is the regulatory controversy over the hepatorenal toxicity of benoxaprofen in the United Kingdom and the United States. By scrutinizing the technical coherence of the arguments put forward by industrial and government scientists, it is concluded that these scientists are willing to award the commercial interests of the pharmaceutical industry an enormous benefit (...) of the sccentific doubt, which is not consistent with the best interests of patients. Interpretative flexibility, the burden of proof falling on regulators and their trust in, and dependence on, industrial scientists facilitates that distribution of the benefit of the scientific doubt. However, regulatory authorities' need for viability and the rationality common to opposing scientific views suggest that it is possible, in principle, to alter this dominant trend. To achieve adequate patient protection, drug regulation in the United Kingdom and the United States requires extensive reform. Some preliminary policy changes are sketched. (shrink)

This paper discusses two paradigms of risk communication that guide strategies for communicating food safety issues. Built on the principles of social utility and paternalism, the first paradigm heavily relies on science and technical experts to determine food safety regulations and policies. Risk communication, in this context, is a unidirectional process by which experts from the industry or government regulatory agencies inform or alert potentially affected publics about the hazards they face and the protective actions they can take. (...) However, public trust and confidence in government and industry have considerably declined. Experts are being questioned about the objectivity of their assessments of risks. Policy makers are being challenged on such risk management decisions as tolerance guidelines, food labeling laws, and emergency warning systems. Concomitantly, some segments of the public, especially consumer advocates and environmental groups, are demanding increased input into the decision making process as they call for the recognition of lay perceptions and interpretations of risk as a legitimate counterpart to technically-assessed risk. Hence, instead of the linear, persuasion-oriented communication process, there are evolving efforts to shape risk communication into a more dialogical, interactive, and democratic exchange of information among different stakeholders (i.e., technical experts, government policy makers, industry, interest groups, and the general public). Reflecting a more Jeffersonian approach, this second paradigm argues that decisions about food safety are so complex and multi-dimensional that they must not be left to experts alone.However, both paradigms present ethical dilemmas. Determining the risks and relative safety of foods is not a totally objective and concise process. Since it involves social, economic, political, and personal values, how can the public not be involved in the exchange of ideas and information concerning food risks and safety? On the other hand, can we afford to let public opinion govern decisions pertaining to food risks and safety without consideration for the merits of scientific risk assessment? This paper raises questions regarding some assumptions of these two risk communication paradigms, and explores and discusses some of the salient ethical questions inherent in each framework. (shrink)