Background U.S. federal regulations require that certain ethical elements be followed to protect human research subjects. The location and clinical circumstances of a proposed research study can differ substantially and can have significant implications for these ethical considerations. Both the location and clinical circumstances are particularly relevant for research in intensive care units (ICUs), where patients are often unable to provide informed consent to participate in a proposed research intervention. Purpose Our goal is to elaborate on the updated 2013 U.S. (...) Food and Drug Administration (FDA) guidance document regarding an exemption from the requirement of obtaining informed consent from patients or their surrogates and to address certain elements within that document, thereby assisting clinicians in developing a framework for emergency research in accordance with the regulatory bodies at their own institutions and in the United States. Methods Review of the 2011 and updated FDA guidance document on exemption from informed consent. Results The current process of obtaining informed consent within ICUs needs to be revisited, especially for research in which timely informed consent is not likely. In particular, the process of obtaining informed consent may not be appropriate or even ethical for critically ill patients in extremis who require an intervention for which there is no current acceptable standard of care and clinical equipoise exists. We provide clinicians with a viewpoint that further elaborates on the FDA guidance document. Limitations The viewpoints provided herein are those of the authors and are therefore inherently limited by the personal views of a selected few. Other clinicians or researchers may not interpret the FDA guidelines in a similar manner. Moreover, the discussion of a guideline document is a limitation in and of itself. The guidelines set forth by the FDA are precisely that—guidelines. Therefore, they may not be followed as outlined in the guidance document within one’s own institution. Our goal is that, by elaborating on the guidelines for planned research involving human subjects in the ICU, institutional regulatory bodies may gain a better understanding in drafting their own document when faced with a clinician or a researcher who wishes to conduct planned research in an ICU. Conclusions We believe that the interpretations provided will allow clinicians to safely undertake planned research in ICUs without endangering the main tenets of ethical research involving human participants. This research is needed for the advancement of care in the critically ill. (shrink)

Based on the results of open ended interviews with managers in a variety of organizational positions, moral questions encountered in everyday managerial life are described. These involve transactions with employees, peers and superiors, customers, suppliers and other stakeholders. It is suggested that managers identify transactions as involving personal moral concern when they believe that a moral standard has a bearing on the situation and when they experience themselves as having the power to affect the transaction. This is the first in (...) a research series of three papers. (shrink)

The lack of concrete guidance provided by managerial moral standards and the ambiguity of the expectations they create are discussed in terms of the moral stress experienced by many managers. It is argued that requisite clarity and feelings of obligation with respect to moral standards derive ultimately from public discussion of moral issues within organizations and from shared public agreement about appropriate behavior. Suggestions are made about ways in which the moral dimension of an organization's culture can be more effectively (...) managed. This is the third in a research series of three papers. (shrink)

Based on analysis of interviews with managers about the ethical questions they face in their work, a typology of morally questionable managerial acts is developed. The typology distinguishes acts committed against-the-firm (non-role and role-failure acts) from those committed on-behalf-of-the-firm (role-distortion and role-as-sertion acts) and draws attention to the different nature of the four types of acts. The argument is made that senior management attention is typically focused on the types of acts which are least problematical for most managers, and that (...) the most troublesome types are relatively ignored. (shrink)

In Foundationalism, Coherentism, and the Levels Gambit, David Shatz argued that foundationalists must countenance a circular mediate justification of perceptual beliefs which the foundationalist holds are already immediately justified. Because the circularity of coherentist accounts of the justification of beliefs is a major basis of foundationalist criticism of coherentism, Shatz's claim is a serious challenge to foundationalism. In this paper, using a moderate foundationalism with a reliabilist conception of justification, I give an account of immediately and mediately justified beliefs which (...) shows that such a foundationalism need not accept such a circular justification (and in crucial cases cannot do so) and that Shatz's claim is therefore incorrect. (shrink)

This paper has two aims. The first is to criticize epistemological externalism in a way different from most other criticisms. Most criticisms claim externalism fails because it does not adequately explicate ordinary notions of knowledge and justification. Such criticisms are often unhelpful to the externalist because he may not even intend his theory to be such an explication. The criticism presented here avoids this difficulty. The other aim, achieved en route to this criticism, is to explode a dogma of contemporary (...) epistemology — that the primary end of epistemic endeavors is truth — and to bring to light the many other important goals there are for such endeavors in addition to truth. Several of these goals pertain to the power of knowledge in social contexts. The criticism ultimately made of externalism is that externalist knowledge is defective because it fails to achieve these extra-verific goals of epistemic endeavors. (shrink)

Michael Ruses Darwinian metaethics has come under just criticism from Peter Woolcock (1993). But with modification it remains defensible. Ruse (1986) holds that people ordinarily have a false belief that there are objective moral obligations. He argues that the evolutionary story should be taken as an error theory, i.e., as a theory which explains the belief that there are obligations as arising from non-rational causes, rather than from inference or evidential reasons. Woolcock quite rightly objects that this position entails moral (...) nihilism. However, I argue here that people generally have justified true beliefs about which acts promote their most coherent set of moral values, and hence, by definition, about which acts are right. What the evolutionary story explains is the existence of these values, but it is not an error theory for moral beliefs. Ordinary beliefs correspond to real moral properties, though these are not objective or absolute properties independent of anyones subjective states. On its best footing, therefore, a Darwinian metaethics of the type Ruse offers is not an error theory and does not entail moral nihilism. (shrink)

The practice of paying research subjects for participating inclinical trials has yet to receive an adequate moral analysis.Dickert and Grady argue for a wage payment model in whichresearch subjects are paid an hourly wage based on that ofunskilled laborers. If we accept this approach, what follows?Norms for just working conditions emerge from workplacelegislation and political theory. All workers, includingpaid research subjects under Dickert and Grady''s analysis,have a right to at least minimum wage, a standard work week,extra pay for overtime hours, (...) a safe workplace, no faultcompensation for work-related injury, and union organization.If we accept that paid research subjects are wage earners likeany other, then the implications for changes to current practiceare substantial. (shrink)

Notwithstanding requirements for scientific/social value and risk/benefit proportionality in major research ethics policies, there are no widely accepted standards for these judgments in Phase 1 trials. This paper examines whether the principle of clinical equipoise can be used as a standard for assessing the ratio of risk to direct-benefit presented by drugs administered in one category of Phase 1 study—first-in-human trials involving patients. On the basis of the supporting evidence for, and architecture of, Phase 1 studies, the articles offers two (...) provisional conclusions: (1) the risks of drug administration in such trials cannot generally be justified on therapeutic grounds but by appeal to the social value of the research; and (2) a framework for adjudicating the ratio of risk/social-value must be developed. (shrink)

Cells are cognitive entities possessing great computational power. DNA serves as a multivalent information storage medium for these computations at various time scales. Information is stored in sequences, epigenetic modifications, and rapidly changing nucleoprotein complexes. Because DNA must operate through complexes formed with other molecules in the cell, genome functions are inherently interactive and involve two-way communication with various cellular compartments. Both coding sequences and repetitive sequences contribute to the hierarchical systemic organization of the genome. By virtue of nucleoprotein complexes, (...) epigenetic modifications, and natural genetic engineering activities, the genome can serve as a read-write storage system. An interactive informatic conceptualization of the genome allows us to understand the functional importance of DNA that does not code for protein or RNA structure, clarifies the essential multidirectional and systemic nature of genomic information transfer, and emphasizes the need to investigate how cellular computation operates in reproduction and evolution. (shrink)

A notion of experimental series is developed, in which experiments or experimental sets are connected through experimental suggestions arising from previous experimental outcomes. To that end, the justification of Howard Temin’s DNA provirus hypothesis is examined. The hypothesis originated with evidence from two exploratory experimental sets on an oncogenic virus and was substantiated by including evidence from three additional experimental sets. Collectively these sets comprise an experimental series and the accumulative evidence from the series was adequate to justify the hypothesis (...) by persuading the virology community of its veracity. The notion of crucial experiment is also discussed in terms of experimental series. (shrink)

This article addresses the issue of moral compunction among a sample of senior managers set against the background of their routine organizational participation. In considering what factors influence their moral sensibilities these managers were interviewed using an approach designed to elicit their perceptions concerning both the ethical and commercially imperative dimensions of their working lives. The qualitative data resulting from this inquiry, while tentative, indicates the primacy of the normative appeal of shareholder value, conditioned by the exigencies of engagement in (...) corporate bureaucracies, including the maintenance of career and livelihood responsibilities. These conclusions indicate the magnitude of the obstacle that the normative business ethics project requires to overcome in order to fulfil its promise. (shrink)

Metaphysical presuppositions are important for guiding scientific practices and research. The success of twentieth-century biology, for instance, is largely attributable to presupposing that complex biological processes are reducible to elementary components. However, some biologists have challenged the sufficiency of reductionism for investigating complex biological phenomena and have proposed alternative presuppositions like organicism. In this article, contemporary cancer research is used as a case study to explore the importance of metaphysical presuppositions for guiding research. The predominant paradigm directing cancer research is (...) the somatic mutation theory, in which mutated genes are presumed to be ultimately responsible for explaining carcinogenesis. This reductionistic approach to cancer has been criticised recently, and an organistic approach has been proposed. The article concludes with a discussion of the reciprocal interaction of metaphysical presuppositions and scientific practices for investigating cancer's complex nature. (shrink)

Evidence that confirms a scientific hypothesis is said to be ‘novel’ if it is not discovered until after the hypothesis isconstructed. The philosophical issues surrounding novel confirmation have been well summarized by Campbell and Vinci [1983]. They write that philosophers of science generally agree that when observational evidence supports a theory, the confirmation is much stronger when the evidence is ‘novel’... There are, nevertheless, reasons to be skeptical of this tradition... The notion of novel confirmation is beset with a theoretical (...) puzzle about how the degree of confirmation can change without any change in the evidence, hypothesis, or auxiliary assumptions... There have not yet appeared any obviously satisfactory solutions to these problems Much of the literature on novel confirmation relies on the Bayesian analysis of conditional probabilities. Let H represent a hypothesis, E an event that confirms the hypothesis, and B some relevant background information. Denote by Pr the conditional probability of x given y. There are various plausible measures of the degree of support that E lends to H. Among these are: Degree of support = Pr Degree of support = Pr – Pr Degree of support = Pr – Pr Degree of support = Pr – Pt In the work cited, Campbell and Vinci offer a somewhat more involved Bayesian interpretation. Formula is discussed by Gardner [1981] who points out that under this formulation there can be no role for novelty. 'The function Pr contains no third slot in which to insert a temporal relation between the invention of H and the inventor's learning E. Obviously, then, this relation could not possibly affect E's support of H.' Formula, on the other hand, suggests a role for novelty. Bayes's Theorem allows us to rewrite the formula as Degree of support = Pr x [Pr – 1] We can use 1/Pr as a measure of the novelty of E. Then shows that the degree of support increases with novelty of E. In the paper already cited, Campbell and Vinci discuss shortcomings of this analysis. Formula expresses an alternative offered by Howson [1984]. In that formula, Pr represents the probability of H assuming that only B – {E} is known. This allows for the possibility of non-novel facts generating support for hypotheses. Niiniluoto [1984] argues for a variant along the lines of, in which we account for the possibility that the theorist was unaware that his hypothesis entails E. One problem in deciding among these approaches is that the choice of a definition for the degree of support appears arbitrary. What kind of argument could justify the choice of one definition over another? It is our position that there can be no basis for addressing this question in the absence of an explicit model of the process by which hypotheses are generated. Only in the presence of such a model can the various conditional probabilities be given meaningful interpretations. We provide such models in Sections 1, 2 and 4. The simple model of Section 1, incorporating strong assumptions, yields the conclusion that novelty is irrelevant. When these assumptions are relaxed in the later sections, novelty becomes relevant for a variety of reasons. It is at least potentially the case that scientists have more information about their own abilities than is publicly available, and this information might influence their decisions about whether even to attempt novel prediction. If this is so, then it should be incorporated into the model of hypothesis generation. This requires an explicit discussion of how scientists respond to incentives and how the incentives themselves evolve, which in turn takes us into the realm of economic theory. We have addressed these issues in another paper, written for an audience of economists. The results of this research are summarized in Section 3. (shrink)

As scientists target communities for research into the etiology, especially the genetic determinants of common diseases, there have been calls for the protection of communities. This paper identifies the distinct characteristics of aboriginal communities and their implications for research in these communities. It also contends that the framework in the Belmont Report is inadequate in this context and suggests a fourth principle of respect for communities. To explore how such a principle might be specified and operationalized, it reviews existing guidelines (...) for protecting aboriginal communities and points out problems with these guidelines and areas for further work. (shrink)

The Yijing/Binary System Episode involved Leibniz' discovery of a de facto representation of the binary number system in the sixty-four-hexagram Fu Xi "Yijing." Scholars have left the match unexplained, since they have found no evidence of a forgotten binary number system in ancient China. The interesting similarities and differences are discussed between the thought of Leibniz and that of Shao Yong, both of whom, it is argued, understood and recognized the importance of the double geometric progression in the diagram.

Wind turbines generate low-frequency sounds that affect the ear. The ear is superficially similar to a microphone, converting mechanical sound waves into electrical signals, but does this by complex physiologic processes. Serious misconceptions about low-frequency sound and the ear have resulted from a failure to consider in detail how the ear works. Although the cells that provide hearing are insensitive to infrasound, other sensory cells in the ear are much more sensitive, which can be demonstrated by electrical recordings. Responses to (...) infrasound reach the brain through pathways that do not involve conscious hearing but instead may produce sensations of fullness, pressure or tinnitus, or have no sensation. Activation of subconscious pathways by infrasound could disturb sleep. Based on our current knowledge of how the ear works, it is quite possible that low-frequency sounds at the levels generated by wind turbines could affect those living nearby. (shrink)

In this article I distinguish a type of justification that is "epistemic" in pertaining to the grounds of one's belief, and "practical" in its connection to what act(s) one may undertake, based on that belief. Such justification, on the proposed account, depends mainly on the proportioning of "inner epistemic virtue" to the "outer risks" implied by one's act. The resulting conception strikes a balance between the unduly moralistic conception of William Clifford and contemporary naturalist virtue theories.

My account begins with Strawson’s celebrated “Freedom and Resentment” lecture. Here by making the “reactive emotions” partly constitutive of holding someone responsible, Strawson offered a deep analysis of what was wrong with the forward-looking, behavior-affecting view of responsibility often espoused by determinists, while apparently avoiding the metaphysical baggage carried by libertarianism. Yet, for all the promise of such a view, there remained the question of what a carefully worked-out, Strawsonian conception of responsibility would actually look like. In this study I (...) examine the thoughtful version of such a theory R. Jay Wallace offers in Responsibility and the Moral Sentiments. (shrink)

This article argues that we can and should recognize the mind dependence, epistemic dependence, and social dependence of theories of mind-independent reality, as opposed to Rorty, who thinks not even a constructivist theory of mind-independent reality can be had. It accuses Rorty of creating an equivocation or "dualism of scheme and content" between causation and justification based on various "Davidsonian" irrelevancies, not to be confused with the actual Davidson. These include the 'principle of charity', the attack against conceptual schemes, the (...) linguistification of social practice, intersubjectivism, and causal naturalism. It follows that realists and constructivists need neither follow Rorty's mischaracterizations nor succumb to his internal paradoxes. (shrink)

This paper continues a debate about the relation between Christian philosophers and theologians begun by Gordon Kaufman, who argued that Christian theologians need not be interested in “evidentialism.” In particular it replies to a paper by William Hasker charging that an earlier defense of Kaufman’s position introduced tensions because it required judgments about the merits of “evidentialism” which could be defended only by using the evidentialist arguments whose importance Kaufman denied. This reply denies that there are the tensions Hasker claims (...) and argues that the judgments need not rest on a detailed assessment of evidentialist arguments. (shrink)

Approaches to the analysis of theory choice in science studies often focus either on objective criteria or subjective values for evaluating theories or on critical experiments for testing theories. In the present article a historical case study in the biomedical sciences is reconstructed, in which experimentation was performed to choose between two competing theories of blood coagulation. Analysis of this case study reveals that experimentation exhibits a particular structure, composed of design, execution, and results, and specific characteristics, consisting of controllability, (...) reproducibility, plasticity, and fecundity. Although this structure and these characteristics are not used to replace objective criteria or subjective values of theory evaluation or to define critical experiments, they are instrumental for analyzing and understanding theory choice. (shrink)

This paper provides an answer to this question: is the Christian of today rationally justified in using the views expressed in the Bible as a (or the) standard for what she should accept for her own beliefs and practices. I argue against trying to answer this question on thebasis of some alleged character of the biblical writings (e.g., their inerrancy or inspiredness). Such a thesis would itself have to be rationally justified, as would the interpretations and applications of biblical writings (...) made by a Christian of today who held the thesis. Instead she should seek to understand how the writers’ faith was expressed in their views and use that understanding to guide her as she constructs (or adopts) a set of beliefs by which to express her faith today. I argue that using the Bible in this way and the conclusions reached in doing so are rationally justified. (shrink)

Why do bad things happen, even to good people? If there is a God, why aren't God's existence and God's will for humans more apparent? And if God really does miracles for some people, why not for others? This book examines these three problems of evil - suffering, divine hiddenness, and unfairness if miracles happen as believers claim - to explore how different ideas of God's power relate to the problem of evil.

I delineate four problems of evil encountered by Christian traditional theists (those who believe that God is all good, all knowing, and all powerful), and I present reasons for thinking that they have no good responses to these problems. Then I delineate important features of process metaphysics and discuss how this metaphysics solves the problems of evil. As conceived by process theists, God is all‐good and all‐knowing and has the greatest power any one being could have, but is not all‐powerful. (...) This God is related to the universe in such a way that the features of the world that generate the problems of evil are features to be expected rather than anomalies that require explanation, as they are for traditional theists. I also point out other features of the world that are anomalies for Christian traditional theists, but entirely to be expected by process theists. (shrink)

Ethics research in Accounting has not proceeded beyond the descriptive level while, at the same time, ethics is a vital part of accounting decisions to the point where professional codes of etherics are necessary. A theoretical model is offered using cognitive and contingency (field) theories to gain insight into how ethical considerations enter into accounting decisions. Propositions are generated so that the use of ethics in accounting decisions can be predicted.

Western civilization has experienced the birth of many philosophical movements. Most of these have had their origin in a particular geographical area. One usually refers to the "Continental Rationalists." the "British Empiricists." and the "American Pragmatists." Just as "Rationalism" is said to have been created in Great Britain, it is usually said that "Pragmatism" was born in America. One speaks of pragmatism as "characteristically American." The date of birth of pragmatism in America has been pin-pointed. Its genesis came about during (...) the early part of "The Classical Period in American Philosophy," a period extending from about 1870 to 1910. Both Perry and Wiener 2 have stated that in the United States the movement arose during the 1870's due in part to conversations held by James, Peirce, Wright, Holmes, Fiske, and others at the meetings in Cambridge of an organization called "The Metaphysical Club." At these gatherings the main scientific and philosophical ideas of the day were discussed, and these men produced "American Pragmatism," in part from these discussions, and in part from independent work. Although the birth of pragmatism in America has been quite thoroughly examined, the genesis of pragmatism in Europe has been only sparsely written about. There were many writers in Europe who were associated with the pragmatic movement. In Italy there were... (shrink)

Biology as a scientific discipline has relied heavily upon advances in chemistry and physics. An inherent danger in this relationship is the reduction of living phenomena to physico-chemical terms. Whitehead's Philosophy of Organism is utilized to examine current methodologies within biology and to evaluate their appropriateness for future research. Hemostatic regulation is employed to illustrate the applications of organistic concepts to biological research. It is concluded that understanding of living entities and their properties as well as possibly life itself will (...) require synthesis of the many analytical elements as informational structures. (shrink)

Philosophers of science have used various formulations of the "random mutation--natural selection" scheme to explain the development of scientific knowledge. But the uncritical acceptance of this evolutionary model has led to substantive problems concerning the relation between fact and theory. The primary difficulty lies in the fact that those who adopt this model (Popper and Kuhn, for example) are led to claim that theories arise chiefly through the processes of relatively random change. Systems theory constitutes a general criticism of this (...) model insofar as it demonstrates the necessity of supplementing this mechanism with the non-random influences exercised by the internal organization of a system on its own development. (shrink)

In his adoption of the Maimonidean guidelines for extreme humility, the king acts as the supreme existential model for imitatio dei. Imperial governance, when filtered through the prism of Maimonidean humility, results in a regime that most closely resembles a divine one. Using those who occupy the very bottom of the social and political hierarchy (slaves and orphans) as models, the king projects his own sense of "lowliness" to the people. The king thereby promotes their sense of autonomy, and inhibits (...) any anthropocentrism that would be fostered if he were to be viewed as an autocrat. His administration of the royal office is limited by the ethical and philosophical dictates of humility, thereby offering a window into the distinction between its common (anivut) and extreme (shefal ruah) manifestations. Maimonides does in fact define the parameters of this extraordinary humility, but he chooses to do so within the context of a distinct and concrete personality--that of the king. (shrink)

Michael Ruse‘s Darwinian metaethics has come under just criticism from Peter Woolcock (1993). But with modification it remains defensible. Ruse (1986) holds that people ordinarily have a false belief that there are objective moral obligations. He argues that the evolutionary story should be taken as an error theory, i.e., as a theory which explains the belief that there are obligations as arising from non-rational causes, rather than from inference or evidential reasons. Woolcock quite rightly objects that this position entails moral (...) nihilism. However, I argue here that people generally have justified true beliefs about which acts promote their most coherent set of moral values, and hence, by definition, about which acts are right. What the evolutionary story explains is the existence of these values, but it is not an error theory for moral beliefs. Ordinary beliefs correspond to real moral properties, though these are not objective or absolute properties independent of anyone‘s subjective states. On its best footing, therefore, a Darwinian metaethics of the type Ruse offers is not an error theory and does not entail moral nihilism. (shrink)