Cancer—and scientific research on cancer—raises a variety of compelling philosophical questions. This entry will focus on four topics, which philosophers of science have begun to explore and debate. First, scientific classifications of cancer have as yet failed to yield a unified taxonomy. There is a diversity of classificatory schemes for cancer, and while some are hierarchical, others appear to be “cross-cutting,” or non-nested. This literature thus raises a variety of questions about the nature of the disease and disease classification. Second, (...) philosophers of science have historically taken the aim of science to be arriving at true theories. However, scientists studying cancer come from a variety of disciplines, with different scientific as well as practical aims. Perhaps it is not surprising, then, that historians and philosophers of science do not seem to agree on how best to characterize the aim and structure of cancer research; it is far from clear whether the appropriate characterization of the aim is arriving at true theories, or even whether the proper units of analysis are “theories”, or instead, “models”, “explanatory frameworks”, “research programs”, “paradigms”, or perhaps, “experimental traditions”. With the rise of “big data” science—such as the Cancer Genome Atlas Project (or TCGA)—and “systems” approaches to the study of disease, both philosophers and historians of science are rethinking how best to describe and explain these distinctive kinds of scientific inquiry. -/- Third, cancer is in part a byproduct of our developmental and life history, as well as our evolutionary history. Cancer progression can be compared to a reversion of development, or, to the evolution of multicellularity. Thus, cancer raises intriguing questions about how we conceive of “functions”, “development”, and the role of our evolutionary history and particularly, selective trade-offs, in vulnerability to disease. -/- Last but not least, cancer research provides a case study for consideration of the roles of values at the science-policy interface. Epidemiological and toxicological research on cancer’s causes informs toxics law and regulatory policy, which raises a variety of questions about the nature of evidence and inductive risk in such contexts. (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)

This undergraduate textbook introduces some fundamental issues in philosophy of science for students of philosophy and science students. The book is divided into two parts. Part 1 deals with knowledge and values. Chap. 1 presents the classical conception of knowledge as initiated by the ancient Greeks and elaborated during the development of science, introducing the central concepts of truth, belief and justification. Aspects of the quest for objectivity are taken up in the following two chapters. Moral issues are broached in (...) Chap. 4, which discusses some aspects of the use and abuse of science, taking up the responsibilities of scientists in properly conducting their business and decision-makers in their concerns with the import of science for society. Part 2 contrasts the view of scientific progress as the rejecting of old hypotheses and theories and replacing them with new ones, represented by Karl Popper, with the conception of progress as accumulating knowledge, saving as much as possible from older theories, represented by Pierre Duhem. A concluding chapter defends the natural attitude of taking the theories of modern science to be literally true, i.e. realism, in the face of arguments drawn partly from the history of scientific progress in criticism of this stance. (shrink)

I examine the role of time-sensitivity in science by drawing on a discussion between Kevin Elliott and Daniel McKaughan and Daniel Steel, on the role of non-epistemic values in theory assessment and the epistemic status of speed of inference. I argue that: 1) speed supervenes on ease of use in the cases they discuss, 2) speed is an epistemic value, and 3) Steel’s account of values doesn’t successfully distinguish extrinsically epistemic from non-epistemic values. Finally, I propose an account of time-sensitivity.

Kevin Elliott and others separate two common arguments for the legitimacy of societal values in scientific reasoning as the gap and the error arguments. This article poses two questions: How are these two arguments related, and what can we learn from their interrelation? I contend that we can better understand the error argument as nested within the gap because the error is a limited case of the gap with narrower features. Furthermore, this nestedness provides philosophers with conceptual tools for analyzing (...) more robustly how values pervade science. (shrink)

Mechanistic information is used in the field of risk assessment in order to clarify two controversial methodological issues, the selection of inference guides and the definition of standards of evidence. In this paper we present an analysis of the concept of mechanistic information in risk assessment by recurring to previous philosophical analyses of mechanistic explanation. Our conclusion is that the conceptual analysis of mechanistic explanation facilitates a better characterization of the concept of mechanistic information. However, it also shows that the (...) use of this kind of information in risk assessment is heavily influenced by pragmatic factors, which have not been sufficiently taken into account in philosophical analysis. Mechanistic models are like hypothesis that have to be validated empirically. Due to their dependence on the standards of evidence, they are subject to the same pragmatic factors. Therefore, recurring to mechanistic information does not lead to closure of the methodological controversies in risk assessment. (shrink)

The Linda paradox is a key topic in current debates on the rationality of human reasoning and its limitations. We present a novel analysis of this paradox, based on the notion of verisimilitude as studied in the philosophy of science. The comparison with an alternative analysis based on probabilistic confirmation suggests how to overcome some problems of our account by introducing an adequately defined notion of verisimilitudinarian confirmation.

Although a strict dichotomy between facts and values is no longer accepted, less attention has been paid to the roles values should play in our acceptance of factual statements, or scientific descriptive claims. This paper argues that values, whether cognitive or ethical, should never preclude or direct belief on their own. Our wanting something to be true will not make it so. Instead, values should only be used to consider whether the available evidence provides sufficient warrant for a claim. This (...) argument is made for all relevant values, including cognitive, ethical, and social values. The rational integrity of science depends not on excluding some values and including others in the reasoning process, but of constraining all values to their proper role in belief acceptance. (shrink)

The US Food and Drug Administration (FDA) is fraught with controversies over the role of values and politics in regulatory science, especially with drugs in the realm of reproductive health. Philosophers and science studies scholars have investigated the ways in which social context shapes medical knowledge through value judgments, and feminist scholars and activists have criticized sexism and injustice in reproductive medicine. Nonetheless, there has been no systematic study of values and gender norms in FDA drug regulation. I focus on (...) three questions about values in regulatory science. First, how have societal values and gender norms shaped the way that the FDA regulates drugs in the realm of reproductive health, specifically with drug labels? Second, what are the ethical, epistemic, and social consequences of these influences on regulation for women and other marginalized groups? Third, which societal values and gender norms ought to influence drug regulation about reproductive health, and how ought this happen? Integrating philosophical analysis with historical archival research and in-depth interviews, I conduct three case studies of drug labeling about reproductive health: (1) the “drug fact” about the mechanism of the morning-after pill; (2) the package inserts for patients about the health risks of oral contraceptives; and (3) the special physician labels made for prescribing drugs to pregnant women. I identify three challenges for the FDA and suggest ways to reduce the influence of sexist values and facilitate feminist alternatives. First, across these cases, I have found that there are many ways in which other concerns in reproductive medicine (such as zygotic life, fetal health, and population control) have devalued women’s health. Second, both knowledge and ignorance xvi about their reproductive health have contributed to women’s oppression, especially poor women and women of color. Finally, by avoiding the epistemic dimensions of ethics, powerful, mostly male parties in medicine (such as doctors, pharmaceutical companies, and religious institutions) have misused “informed consent,” “religious freedom,” and “paternalism” for unethical purposes. For improvement, I suggest extracting sexist values and gender norms from regulatory science that cause epistemic injustices, and I point to success stories for reforming sexism with feminism at the FDA. (shrink)

Various U.S. laws, such as the Clean Air Act and the Food Quality Protection Act, require additional protections for susceptible subpopulations who face greater environmental health risks. The main ethical rationale for providing these protections is to ensure that environmental health risks are distributed fairly. In this article, we (1) consider how several influential theories of justice deal with issues related to the distribution of environmental health risks; (2) show that these theories often fail to provide specific guidance concerning policy (...) choices; and (3) argue that an approach to public decision making known as accountability for reasonableness can complement theories of justice in establishing acceptable environmental health risks for the general population and susceptible subpopulations. Since accountability for reasonableness focuses on the fairness of the decision-making process, not the outcome, it does not guarantee that susceptible subpopulations will receive a maximum level of protection, regardless of costs or other morally relevant considerations. (shrink)

In the first part of the paper, three objections to the precautionary principle are outlined: the principle requires some account of how to balance risks of significant harms; the principle focuses on action and ignores the costs of inaction; and the principle threatens epistemic anarchy. I argue that these objections may overlook two distinctive features of precautionary thought: a suspicion of the value of “full scientific certainty”; and a desire to distinguish environmental doings from allowings. In Section 2, I argue (...) that any simple distinction between environmental doings and allowings is untenable. However, I argue that the appeal of such a distinction can be captured within a relational account of environmental equity. In Section 3 I show how the proposed account of environmental justice can generate a justification for distinctively “precautionary” policy-making. (shrink)

The goal of this paper is to articulate and advocate for an enhanced role for philosophers of science in the domain of science policy as well as within the science curriculum. I argue that philosophy of science as a field can learn from the successes as well as the mistakes of bioethics and begin to develop a new model that includes robust contributions to the science classroom, research collaborations with scientists, and a role for public philosophy through involvement in science (...) policy development. Through an analysis of two case studies, I illustrate how philosophers of science can make effective and productive contributions to science education as well as to interdisciplinary scientific research, and argue for the essential role of philosophers of science in the realm of science policy. (shrink)

We argue that a responsible analysis of today's evidence-based risk assessments and risk debates in biology demands a critical or metascientific scrutiny of the uncertainties, assumptions, and threats of error along the manifold steps in risk analysis. Without an accompanying methodological critique, neither sensitivity to social and ethical values, nor conceptual clarification alone, suffices. In this view, restricting the invitation for philosophical involvement to those wearing a "bioethicist" label precludes the vitally important role philosophers of science may be able to (...) play as bioevidentialists. The goal of this paper is to give a brief and partial sketch of how a metascientific scrutiny of risk evidence might work. (shrink)

: Scientists are divided on the status of hypothesis H that low doses of ionizing radiation (under 20 rads) cause hormetic (or non-harmful) effects. Military and industrial scientists tend to accept H, while medical and environmental scientists tend to reject it. Proponents of the strong programme claim this debate shows that uncertain science can be clarified only by greater attention to the social values in(integral)uencing it. While they are in part correct, this paper argues that methodological analyses (not merely attention (...) to social values) also can help clarify uncertain science. The paper analyzes five measurement uncertainties, as well as seven methodological value judgments, relevant to H. Using criteria of internal and external consistency, as well as predictive power, it argues that metascience also helps resolve this debate. And if so, then value-laden, policy-relevant science may need, not only more attention to social values in order to resolve and to clarify disputes, but also more conceptual and methodological analyses of science. (This paper suggests what such methodological analyses might be like and uses the case of low-dose risks from radiation to illustrate its points, while a companion paper ("Chemical Hormesis, Conceptual Clarification, and the Warrant for Policy-Driven Science") in this same issue of POS suggests what such conceptual analyses might be like and uses the case of low-dose risks from chemicals to illustrate its points.) If this paper's thesis holds in the very politicized "hard case" of radiation hormesis, then it suggests that the metascientists may be right about what is also often necessary to clarify scientific disputes. (shrink)

In a recent paper, Gregor Betz has defended the value-free ideal: “the justification of scientific findings should not be based on non-epistemic values”against the methodological critique, by reference to the work of the International Panel on Climate Change . This paper argues that Betz’s defence is unsuccessful. First, Betz’s argument is sketched, and it is shown that the IPCC does not avoid the need to “translate” claims. In Section 2, it is argued that Betz mischaracterises the force of the methodological (...) critique. Section 3 shows why the methodological critique still applies to the work of the IPCC even on a refined version of Betz’s argument. Section 4 then considers an alternative way of defending the work of the IPCC which is in-line with, but does not clearly vindicate, the value-free ideal. (shrink)

Regulatory science, which generates knowledge relevant for regulatory decision?making, is different from standard academic science in that it is oriented mainly towards the attainment of non?epistemic (practical) aims. The role of uncertainty and the limits to the relevance of academic science are being recognized more and more explicitly in regulatory decision?making. This has led to the introduction of regulation?specific scientific methodologies in order to generate decision?relevant data. However, recent practical experience with such non?standard methodologies indicates that they, too, may be (...) subject to important limitations. We argue that the attainment of non?epistemic values and aims (like the protection of human health and the environment) requires not only control of the quality of the data and the methodologies, but also the selection of the level of regulation deemed adequate in each specific case (including a decision about which of the two, under?regulation or over?regulation, would be more acceptable). (shrink)

This paper examines how ethically significant assumptions and values are embedded not only in environmental policies but also in the language of the environmental sciences. It shows, based on three case studies associated with contemporary pollution research, how the choice of scientific categories and terms can have at least four ethically significant effects: influencing the future course of scientific research; altering public awareness or attention to environmental phenomena; affecting the attitudes or behavior of key decision makers; and changing the burdens (...) of proof required for taking action in response to environmental concerns. The paper argues that deliberative forums, research-ethics training, and conceptual work by environmental philosophers could all promote more ethically sensitive responses to these features of scientific language. (shrink)

When are we responsible for addressing the acute deprivations of others beyond state borders? One widely held view is that we are responsible for addressing or preventing acute deprivations insofar as we have contributed to them or are contributing to bringing them about. But how should agents who endorse this “contribution principle” of allocating responsibility yet are uncertain whether or how much they have contributed to some problem conceive of their responsibilities with respect to it? Legal systems adopt formal norms (...) that set the burden of proof, the standard of proof, and the constraints on admissible evidence, which help courts to apply liability rules in cases where there are significant evidential uncertainties. Applying principles for determining ethical responsibilities, too, require such norms. Their content, however, should be much different from that found in criminal and even civil legal settings, where the moral costs of falsely holding those responsible for bringing about some harm are more worrisome. Instead of demanding that an agent be shown to have contributed to some deprivation “beyond a reasonable doubt,” we should express a willingness to err in favor of the acutely deprived subjects, demanding that even those agents who merely suspect that they may have substantially contributed to these deprivations undertake efforts to address them. (shrink)

A general criterion for distinguishing between epistemic and non-epistemic values is that the former promotes the attainment of truth whereas the latter does not. Daniel Steel is a proponent of this criterion, although it was initially proposed by McMullin. There are at least two consequences of this criterion; it always prioritizes epistemic values over non-epistemic values in scientific research, and it overlooks the diverse aims of science, especially the aims of regulatory or policy-oriented science. This criterion assumes the lexical priority (...) of truth or lexical priority of evidence. This paper attempts to show a few inadequacies of this assumption. The paper also demonstrates why epistemic priority over non-epistemic values is a problematic stance and how constraining the role of non-epistemic values as ‘tiebreakers’ may undermine the diverse aims of science. (shrink)

Biology incorporated into other disciplines is often distorted, alarmingly so in some areas of medicine. Together with other forms of bias, this may have detrimental effects for patients depending on medical research for their health. A case study concerning omeprazole (Losec), one of the acid-suppressive drugs against gastric ulcers, and NSAIDs, non-steroid anti-inflammatory drugs, confirms that distorted biology together with biased health care policies foster disasters in current biomedicine and medical practice. In our country, The Netherlands, omeprazole is presumably the (...) most commonly used medication. NSAIDs are also used in large quantities, increasingly since they have become available as analgesic over-the-counter drugs. Unofficial and official sources tend to inform the general public that the drugs promote human health. We argue that their being used on a massive scale is actually a medical disaster. The health of many patients would be served better if the drugs they take were replaced by proper forms of diet, but the pharmaceutical industry, the most potent force affecting medication policies, appears to prevent a shift in the balance from over-medicalization towards healthy life styles. The shift should come from government agencies responsible for regulation in the medication market. Policies of these agencies are now a dismal failure. (shrink)

The function and legitimacy of values in decision making is a critically important issue in the contemporary analysis of science. It is particularly relevant for some of the more application-oriented areas of science, specifically decision-oriented science in the field of regulation of technological risks. Our main objective in this paper is to assess the diversity of roles that non-cognitive values related to decision making can adopt in the kinds of scientific activity that underlie risk regulation. We start out, first, by (...) analyzing the issue of values with the help of a framework taken from the wider philosophical debate on science and values. Second, we study the principal conceptualizations used by scholars who have applied them to numerous case studies. Third, we appraise the links between those conceptualizations and learning processes in decision-oriented science. In this, we recur to the concept of methodological learning, i.e., learning about the best methodologies for generating knowledge that is useful for science-based regulatory decisions. The main result of our analysis is that non-cognitive values can contribute to methodological improvements in science in three principal ways: as basis for critical analysis, for contextualizing methodologies, and for establishing the burden of proof. (shrink)

The relevance of scientific knowledge for science and technology policy and regulation has led to a growing debate about the role of values. This article contributes to the clarification of what specific functions cognitive and noncognitive values adopt in knowledge generation and decisions, and what consequences the operation of values has for policy making and regulation. For our analysis, we differentiate between three different types of decision approaches, each of which shows a particular constellation of cognitive and noncognitive values. Our (...) objectives are to present a structured analysis of the varying functions that different kinds of values can adopt, as well as the value-related tensions and trade-offs they give rise to. We argue that the operation of noncognitive values in scientific knowledge generation, policy, and regulatory decision making can be understood as an enabling factor, rather than a limiting one. (shrink)

This article critically examines a recent philosophical debate on the role of values in climate change forecasts, such as those found in assessment reports of the Intergovernmental Panel on Climate Change. On one side, several philosophers insist that the argument from inductive risk, as developed by Rudner and Douglas among others, applies to this case. AIR aims to show that ethical value judgments should influence decisions about what is sufficient evidence for accepting scientific hypotheses that have implications for policy issues. (...) Advocates of extending AIR to climate science claim that values are deeply... (shrink)

Philosophy of epidemiology has recently emerged as a distinct branch of philosophy. The field will surely benefit from pluralism, reflected in the broad range of topics and perspectives in this special issue. Here, I argue that a healthy pluralistic field of philosophy of epidemiology has social responsibilities that require the field as a whole to engage actively with research on social determinants of health and health disparities. Practicing epidemiologists and the broader community of public health scientists have gradually acknowledged that (...) much of their attention ought to be paid to these, i.e. inequitable between-population health variations that largely reflect the world’s inequitable distribution of resources and social conditions. The paper illustrates how and why health disparities and social determinants of health, through no ill will, become de facto secondary concerns in Alex Broadbent’s field-defining Philosophy of Epidemiology, showing the ease with which these topics can be incidentally sidelined. As means for philosophy of epidemiology to meet its social responsibility obligations, I suggest philosophy of epidemiology expand its attention to two particular lines research. First, the paper discusses Geoffrey Rose’s concept of “causes of incidence”—causes of disparities between populations—and argues for the importance of engaging with these causes. Second, the paper argues for the value of engaging with Bruce Link and Jo Phelan’s “fundamental causes” model of how flexible social resources serve as buffers from harms, generating a plethora of shifting and locally-contingent health effects. (shrink)

There is currently great controversy over the contribution antimicrobial use in animal agriculture has made to antimicrobial resistance in pathogenic bacteria with negative consequences for human health. In light of this, the approval process for antimicrobials used in US animal agriculture, known as New Animal Drug Application or NADA, is currently being revised by the federal government. We explore the public deliberations over the development of these new policies focusing our attention on the interaction between pharmaceutical companies and the U.S. (...) Food and Drug Administration. What appears to be an antagonistic public discourse is examined in terms of its ability to simultaneously legitimate the roles of the Food and Drug Administration as the official arbiter of policy on antimicrobial use in animal agriculture and as a protector of the public welfare, as well as the role of pharmaceutical companies as the producers of safe and effective products necessary for the protection of public well-being. (shrink)

The aim of this thesis is to characterize and discuss two kinds of influences on the outcome of a toxicological risk assessment. One kind of influence has to do with values and the role played by value-based judgment. Currently, many toxicological risk assessments are characterized by scientific uncertainties. When this is the case, risk assessors are to some extent dependent on assumptions and judgment, and this has consequences for the outcome of the assessment. Another other kind of influence comes from (...) the quality and accuracy of the empirical studies that risk assessments are based on. If toxicological research and testing are affected by systematic errors, this will influence the ensuing risk assessment. In order to improve toxicological risk assessments work must be done both on understanding and dealing with the impact of values and on getting better and more efficient methods for gathering facts. The two papers that make up this licentiate thesis may be seen as a contribution to each of these objectives. Article 1: Values in science and risk assessment It is a widely accepted claim that scientific practice contains valuejudgments, i.e. decisions made on the basis of values. This paper clarifies the concepts involved in this claim and explains its implications for risk assessment. It is explained why values are necessarily a part of science and of risk assessment. A certain type of values that contribute to the aim of science, so-called epistemic values, are identified as rationally justified as basis for judgment in science. It is argued that the aims of pure science and risk assessment differ in some aspects and that consequently pure science’s epistemic values are not sufficient for risk assessment. I suggest how the epistemic values may be supplemented in order to align better with the aim of risk assessment. Article 2: Bias in toxicology In this article, the potential for bias in toxicological research and in the performance of standardized toxicological testing in discussed. Due to the lack of empirical studies of bias in toxicology, very little is known aboutits prevalence and impact. Areas to consider for such studies are pointed out, and it is suggested that such investigations should be given priority. (shrink)

Research on the influence of industry on chemical regulation has mostly been conducted within the framework of the production of ignorance. This special issue extends this research by looking at how industry asserts its interests––not just in the scientific sphere but also at other stages of policy-making and regulatory process––with a specific focus on the types of tools or instruments industry has used. Bringing together sociologists and historians specialized in Science and Technology Studies, the articles of the special issue study (...) the arenas in which instruments and practical guidelines for public policy are negotiated or used. The aim is to observe the devices in the making or in action, from the selection of actors to the production of thresholds, criteria, and other technical regulations. The introduction highlights how industry influence on expertise and regulation is undoubtedly far more pervasive and multifarious than has been conceptualized to date by social scientists. Putting this issue back at the heart of both the STS and social sciences research agendas is increasingly urgent and could lead to new inquiries able to highlight these logics even more widely, using fresh empirical examples. (shrink)

This article examines the relationship between the precautionary principle and the well-known Hill criteria of causation. Some have charged that the Hill criteria are anti-precautionary because the...

Composed of scientific and technical experts and lay members, thousands of research ethics committees—Institutional Review Boards in the United States—must identify and assess the potential risks to human research subjects, and balance those risks against the potential benefits of the research. IRBs handle risk and its uncertainty by adopting a version of the precautionary principle. To assess scientific merit, IRBs use a tacit ``sanguinity principle,'' which treats uncertainty as inevitable, even desirable, in scientific progress. In balancing human subjects risks and (...) scientific benefits, IRBs use uncertainty as a boundary-ordering device that allows the mediation of the science and ethics aspects of their decisions. One effect is the entangling of methodological and ethical review. Some have suggested these should be more clearly separated, but decisions by research ethics committees depend in part on the negotiating space created by incommensurable approaches to uncertainty. (shrink)

The standard of proof in criminal trials should require that the evidence presented by the prosecution is robust. This requirement of robustness says that it must be unlikely that additional information would change the probability that the defendant is guilty. Robustness is difficult for a judge to estimate, as it requires the judge to assess the possible effect of information that the he or she does not have. This article is concerned with expert witnesses and proposes a method for reviewing (...) the robustness of expert testimony. According to the proposed method, the robustness of expert testimony is estimated with regard to competence, motivation, external strength, internal strength and relevance. The danger of trusting non-robust expert testimony is illustrated with an analysis of the Thomas Quick Case, a Swedish legal scandal where a patient at a mental institution was wrongfully convicted for eight murders. (shrink)

In this paper the coherence of the precautionary principle as a guide to public health policy is considered. Two conditions that any account of the principle must meet are outlined, a condition of practicality and a condition of publicity. The principle is interpreted in terms of a tripartite division of the outcomes of action . Such a division of outcomes can be justified on either “consequentialist” or “deontological” grounds. In the second half of the paper, it is argued that the (...) precautionary principle is not necessarily opposed to risk–cost–benefit analysis, but, rather, should be interpreted as suggesting a lowering of our epistemic standards for assessing evidence that there is a link between some policy and “special bad” outcomes. This suggestion is defended against the claim that it mistakes the nature of statistical testing and against the charge that it is unscientific or antiscientific, and therefore irrational. (shrink)

Is there such a thing as a “best scientific methodology” in regulatory science? By examining cases from varying regulatory processes, we argue that there is no best scientific method for generating decision-relevant data. In addition, in regulatory science, the most suitable methodologies often differ from what is considered best practice in knowledge-oriented science. In data generation for regulatory purposes, we are faced with a wide spectrum of preferred methodologies as well as controversy as to methodological choice. What goes by the (...) most adequate scientific method can and will—justifiably and rationally—vary significantly according to context and use. In order to make this argument, we analyze four case studies, two from risk assessment and two from benefit assessment. Our analysis shows that it is the noncognitive objectives of a particular regulatory process that determine what counts as the most appropriate scientific method. We use the concept of bounded rationality to indicate that those methodological choices, despite being context-dependent, can be interpreted as rational. (shrink)