The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that (...) acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved. (shrink)

Voluntariness of consent to research has not been sufficiently explored through empirical research. The aims of this study were to develop a more comprehensive approach to assessing voluntariness and to generate preliminary data on the extent and correlates of limitations on voluntariness. We developed a questionnaire to evaluate subjects’ reported motivations and constraints on voluntariness. 88 subjects in five different areas of clinical research—substance abuse, cancer, HIV, interventional cardiology, and depression—were assessed. Subjects reported a variety of motivations for participation. Offers (...) of financial incentives were common but not influential, pressures from others were rare, and no threats were reported. However, certain financial incentives and—paradoxically—altruistic motivations led some subjects to feel more constrained. Consistent with previous studies, no one pattern of motivation was common to all research subjects. There was little evidence of constrained voluntariness, but some suggestion of areas of concern. Voluntariness appears to be susceptible to systematic empirical investigation. (shrink)

Institutional Review Boards are mandated to carry out the requirements of the Common Rule, and it is widely agreed that they are appropriate and necessary mechanisms to ensure the ethical conduct of human research. In this paper, we suggest that the changes proposed in ANPRM, although generally helpful, fail to take into consideration how IRBs actually review applications and therefore do not adequately address some of the problems that may be leading to ineffective human subject protection.

The federal Common Rule, which governs the conduct of research with human subjects, specifies the criteria and procedures by which Institutional Review Boards should review such research. Although there is wide agreement that IRBs, or Research Ethics Committees as they are called in most of the world, are essential to assuring that human subjects research meets common standards of ethics, IRBs have always come under considerable criticism. Some have critiqued IRBs for using important resources inefficiently, including the large amount of (...) time researchers put into submitting applications, modifications, and reports and delaying the start of data collection within the limited time that grants and contracts provide. Others have critiqued the inconsistency of review of multi-site projects. (shrink)

Institutional review boards are almost universally considered to be overworked and understaffed. They also require substantial commitments of time and resources from their members. Although some surveys report average IRB memberships of 15 people or more, federal regulations require only five. We present data on IRB meetings at eight of the top 25 academic medical centers in the United States funded by the National Institutes of Health. These data indicate substantial contributions from primary reviewers and chairs during protocol discussions but (...) little from other members, which implies that it may be possible for smaller IRBs to accomplish the same tasks with no reduction in the quality of review. (shrink)

Issues associated with consent to clinical trials have attracted considerable attention recently, spurred in part by controversies over alleged inadequacies in the consent process. Professor Jansen's interesting essay is unusual in two ways. First, it raises issues about the conceptualization of one set of problems in informed consent (which Jansen subsumes under the term “therapeutic error”) and, more critically, about the methods and the data used to assess them. Second, she is unique in using the findings of academic experimental psychology (...) to critique the empirical findings. This produces a thoughtful and original critique of the process of informed consent to research that, nonetheless, we believe, yields a model that does not reflect the reality of clinical research. (shrink)

: Responding to the paper by Miller and Joffe, we review the development of the concept of therapeutic misconception (TM). Our concerns about TM's impact on informed consent do not derive from the belief that research subjects have poorer outcomes than persons receiving ordinary clinical care. Rather, we believe that subjects with TM cannot give an adequate informed consent to research participation, which harms their dignitary interests and their abilities to make meaningful decisions. Ironically, Miller and Joffe's approach ends up (...) largely embracing the very position that they inaccurately attribute to us: the belief that, with some exceptions, it is only the prospect of poorer outcomes that should motivate efforts to dispel TM. In the absence of empirical studies on the steps required to dispel TM and the impact of such procedures on subject recruitment, it is premature to surrender to the belief that TM must be widely tolerated in clinical research. (shrink)

Depression is often diagnosed in patients nearing the end of their lives and medication or psychotherapy is prescribed. In many cases this is appropriate. However, it is widely agreed that a health care professional should treat sick persons so as to improve their condition as they define improvement. This raises questions about the contexts in which treatment of depression in late life is appropriate. This article reviews a problematic case concerning the appropriateness of treatment in light of the literature in (...) bioethics. Specific attention is paid to the concept of authenticity and the role of suffering. Suffering is often the result of a situation in which one's self is damaged. In some circumstances, this suffering should not be seen as a symptom of illness but as a reflection, in a difficult life context, of the individual's authentic nature. Assessment of depression in the elderly must go beyond a symptom list and must consider both the context of the individual's situation and his or her authentic self. When the symptoms reflect the individual's assessment of the situation in the context of the authentic self, they may be "appropriate." However, even when the symptoms are appropriate, if they interfere with life assessment and adjustment, treatment should be considered. (shrink)

As a 2006 Institute of Medicine report highlights, surprisingly little empirical attention has been paid to how prisoners arrive at decisions to participate in modern research. With our study, we aimed to fill this gap by identifying a more comprehensive range of factors as reported by prisoners themselves during semistructured interviews. Our participants described a diverse range of motives, both favoring and opposing their eventual decision to join. Many are well-recognized considerations among nonincarcerated clinical research participants, including a desire for (...) various forms of personal benefit, altruism, and concern about study risks and inconveniences. However, a number of influences seem unique to prisoners. Participants did not report that they were not coerced into enrolling, and they have even been under pressure not to enroll. However, many sought to enroll in order to obtain access to better health care, raising a concern about whether they were unfairly exploited. (shrink)

Background: Therapeutic misconception, the misunderstanding of differences between research and clinical care, is widely prevalent among non-incarcerated trial participants. However, little attention has been paid to its presence among individuals who participate in research while incarcerated. Methods: This study examined the extent to which 72 incarcerated individuals may experience therapeutic misconception about their participation in one of six clinical trials, and its correlation with participant characteristics and potential influences on research participation. Results: On average, participants endorsed 70% of items suggestive (...) of therapeutic misconception. The tendency toward therapeutic misconception was significantly higher among African Americans and Latinos compared to Whites, among older and less educated participants, and among enrollment in a substance-abuse-related trial; it was also correlated with a belief that the trial was the only way to obtain needed treatment. Conclusions: Therapeutic misconception may be particularly high among select incarcerated individuals and is associated with a perceived lack of treatment options. Further examination of therapeutic misconception among incarcerated research participants is needed. (shrink)

Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB (...) process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials. (shrink)

In The Origin of Species (1859) Darwin challenged many of the most deeply-held beliefs of the Western world. Arguing for a material, not divine, origin of species, he showed that new species are achieved by "natural selection." The Origin communicates the enthusiasm of original thinking in an open, descriptive style, and Darwin's emphasis on the value of diversity speaks more strongly now than ever. As well as a stimulating introduction and detailed notes, this edition offers a register of the many (...) writers referred to by Darwin in the text. (shrink)

Discusses contemporary notions of the self, and examines their origins, development, and effects.

I will begin by considering how the social world appears to the scientific observer and ask the question of whether the world of scientific research, with all its categories of meaning interpretation and with all its conceptual schemes of action, is identical with the world in which the observed actor acts. Anticipating the result, I may state immediately that with the shift from one level to the other, all the conceptual schemes and all the terms of interpretation must be modified.Proceeding (...) in this direction, I encounter several problems overlapping with the problem of rational action and the “rational act unit” in Professor ParsonsParsons, Talcott’ sense. First: The conceptual scheme of rational action presupposes a more or less definite knowledge of, or orientation within, the world in which this action is performed. In this sense the term, “rationality”, is not specific to the conceptual scheme of action; it embraces the conceptual scheme of the world in general and is only one element in it. Therefore, we also must examine the problem of orientation in this world. Second: We ought to keep in mind that all interpretation of the social world has to start from the actor’s subjective point of view. Therefore, we cannot accept the term, “unit act”, as such, without trying to reduce it to its subjective meaning. Here I have to discuss in general terms why I insist on the subjective point of view. This is more than the whim of a few social scientists; social science cannot be built up except by taking cognizance of the subjective meaning the actor connects with his acting. Finally, I have to discuss the fact that there are social sciences operating on high theoretical levels that, like economics, apparently prefer to deal with statistical curves and mathematical formulae rather than with actions of human beings in the social world, yet they use the term, “rational action”, as an indispensable element of their systems. I will have to show what modification this term undergoes in these types of social sciences..). (shrink)

The present edition provides a detailed and accessible discussion ofhis theories and adds an account of the immediate responses to the book on publication.

Familiarity with Charles Darwin's treatise on evolution is essential to every well-educated individual. One of the most important books ever published--and a continuing source of controversy, a century and a half later--this classic of science is reproduced in a facsimile of the critically acclaimed first edition.

Should engineering ethics be taught? Despite the obvious truism that we all want our students to be moral engineers who practice virtuous professional behavior, I argue, in this article that the question itself obscures several ambiguities that prompt preliminary resolution. Upon clarification of these ambiguities, and an attempt to delineate key issues that make the question a philosophically interesting one, I conclude that engineering ethics not only should not, but cannot, be taught if we understand “teaching engineering ethics” to mean (...) training engineers to be moral individuals (as some advocates seem to have proposed). However, I also conclude that there is a justification to teaching engineering ethics, insofar as we are able to clearly identify the most desirable and efficacious pedagogical approach to the subject area, which I propose to be a case study-based format that utilizes the principle of human cognitive pattern recognition. (shrink)

Quantifiers are a test case for an interface between psychological questions, which attempt to specify the numerical content that supports the semantics of quantifiers, and linguistic questions, which uncover the range of possible quantifier meanings allowable within the constraints of the syntax. Here we explore the development of comprehension of most in English, of particular interest as it calls on precise numerical content that, in adults, requires an understanding of large exact numerosities (e.g., 23 blue dots and 17 yellow is (...) an instance of “most of the dots are blue”). In a sample of 100 children 2 to 5 years of age we find that (a) successful most comprehension in cases with two salient subsets is achieved at 3 years, 7 months of age, and (b) most comprehension is independent of knowledge of large exact number words; that is, knowledge of large exact number words is neither necessary, as evidenced by children who understand “most” but not “four,” nor sufficient, as evidenced by children who understand “nine” but not “most.”. (shrink)

How do children learn the meanings of propositional attitude verbs? We argue that children use information contained in both syntactic distribution and pragmatic function to zero in on the appropriate meanings. Specifically, we identify a potentially universal link between semantic subclasses of attitude verbs, their syntactic distribution and the kinds of indirect speech acts they can be used to perform. As a result, children can use the syntax as evidence about the meaning, which in turn constrains the kinds of pragmatic (...) enrichments they do and do not make in understanding these verbs in conversation. (shrink)

The essays collected in this volume all explore the problem of the relation between moral philosophy and modernity. Charles Larmore addresses this problem by attempting to define the way distinctive forms of modern experience should orientate our moral thinking. Charles Larmore wonders whether the dominant forms of modern philosophy have not become blind to important dimensions of the moral life. The book argues against recent attempts to return to the virtue-centered perspective of ancient Greek ethics. As well as (...) exploring the differences between ancient and modern ethics, the author examines such topics as the roles of reason and history in our moral understanding, the inadequacy of philsophical naturalism, and the foundations of modern liberalism. There are also extended discussions of a number of leading contemporary philosophers: Rawls, Habermas, Williams and Rorty. (shrink)

This book proposes a new paradigm for the interpretation of Plato's early and middle dialogues. Rejecting the usual assumption of a distinct 'Socratic' period in the development of Plato's thought, this view regards the earlier works as deliberate preparation for the exposition of Plato's mature philosophy. Differences between the dialogues do not represent different stages in Plato's own thinking but rather different aspects and moments in the presentation of a new and unfamiliar view of reality. Once the fictional character of (...) the Socratic genre is recognised, there is no reason to regard Plato's early dialogues as representing the philosophy of the historical Socrates. The result is a unified interpretation of all of the dialogues down to the Republic and the Phaedrus. (shrink)

"This is a marvelous book, full of subtle, thoughtful, and original argument.

This paper proposes an Interface Transparency Thesis concerning how linguistic meanings are related to the cognitive systems that are used to evaluate sentences for truth/falsity: a declarative sentence S is semantically associated with a canonical procedure for determining whether S is true; while this procedure need not be used as a verification strategy, competent speakers are biased towards strategies that directly reflect canonical specifications of truth conditions. Evidence in favor of this hypothesis comes from a psycholinguistic experiment examining adult judgments (...) concerning ‘Most of the dots are blue’. This sentence is true if and only if the number of blue dots exceeds the number of nonblue dots. But this leaves unsettled, e.g., how the second cardinality is specified for purposes of understanding and/or verification: via the nonblue things, given a restriction to the dots, as in ‘|{x: Dot(x) & ~Blue(x)}|’; via the blue things, given the same restriction, and subtraction from the number of dots, as in ‘|{x: Dot(x)}| – |{x: Dot(x) & Blue(x)}|’; or in some other way. Psycholinguistic evidence and psychophysical modeling support the second hypothesis. (shrink)

Darwin discusses why different muscles are brought into action under different emotions and how particular animals have adapted for association with man.

Perhaps the most readable and accessible of the great works of scientific imagination, The Origin of Species sold out on the day it was published in 1859. Theologians quickly labeled Charles Darwin the most dangerous man in England, and, as the Saturday Review noted, the uproar over the book quickly "passed beyond the bounds of the study and lecture-room into the drawing-room and the public street." Yet, after reading it, Darwin's friend and colleague T. H. Huxley had a different (...) reaction: "How extremely stupid not to have thought of that." Based largely on Darwin's experience as a naturalist while on a five-year voyage aboard H.M.S. Beagle, The Origin of Species set forth a theory of evolution and natural selection that challenged contemporary beliefs about divine providence and the immutability of species. A landmark contribution to philosophical and scientific thought, this edition also includes an introductory historical sketch and a glossary Darwin later added to the original text. Charles Darwin grew up considered, by his own account, "a very ordinary boy, rather below the common standard of intellect." A quirk of fate kept him from the career his father had deemed appropriate--that of a country parson--when a botanist recommended Darwin for an appointment as a naturalist aboard H.M.S. Beagle from 1831 to 1836. Darwin is also the author of the five-volume work Zoology of the Voyage of the Beagle (1839) and The Descent of Man (1871). (shrink)

The propensity interpretation of fitness (PIF) is commonly taken to be subject to a set of simple counterexamples. We argue that three of the most important of these are not counterexamples to the PIF itself, but only to the traditional mathematical model of this propensity: fitness as expected number of offspring. They fail to demonstrate that a new mathematical model of the PIF could not succeed where this older model fails. We then propose a new formalization of the PIF that (...) avoids these (and other) counterexamples. By producing a counterexample-free model of the PIF, we call into question one of the primary motivations for adopting the statisticalist interpretation of fitness. In addition, this new model has the benefit of being more closely allied with contemporary mathematical biology than the traditional model of the PIF. (shrink)

The meaning of 'most' can be described in many ways. We offer a framework for distinguishing semantic descriptions, interpreted as psychological hypotheses that go beyond claims about sentential truth conditions, and an experiment that tells against an attractive idea: 'most' is understood in terms of one-to-one correspondence. Adults evaluated 'Most of the dots are yellow', as true or false, on many trials in which yellow dots and blue dots were displayed for 200 ms. Displays manipulated the ease of using a (...) 'one-to-one with remainder' strategy, and a strategy of using the Approximate Number System to compare of (approximations of) cardinalities. Interpreting such data requires care in thinking about how meaning is related to verification. But the results suggest that 'most' is understood in terms of cardinality comparison, even when counting is impossible. (shrink)

Charles Mills makes visible in the world of mainstream philosophy some of the crucial issues of the black experience.

Nearly everyone has wronged another. Who among us has not longed to be forgiven? Who has not struggled to forgive? Charles Griswold has written the first comprehensive philosophical book on forgiveness in both its interpersonal and political contexts, as well as its relation to reconciliation. Having examined the place of forgiveness in ancient philosophy and in modern thought, he discusses what forgiveness is, what conditions the parties to it must meet, its relation to revenge and hatred, when it is (...) permissible and whether it is obligatory, and why it is a virtue. Griswold argues that forgiveness is inappropriate in politics, and analyzes the nature and limits of political apology with reference to historical examples. The book concludes with an examination of the relation between memory, narrative, and truth. (shrink)

David Charles presents a major new study of Aristotle's views on meaning, essence, necessity, and related topics. These interconnected views are central to Aristotle's metaphysics, philosophy of language, and philosophy of science, and are also highly relevant to current philosophical debates. Charles aims to reach a clear understanding of Aristotle's claims and arguments, to assess their truth, and to evaluate their importance to ancient and modern philosophy.