BackgroundThe U.S. Food and Drug Administration traditionally has kept confidential significant amounts of information relevant to the approval or non-approval of specific drugs, devices, and biologics and about the regulatory status of such medical products in FDA’s pipeline.ObjectiveTo develop practical recommendations for FDA to improve its transparency to the public that FDA could implement by rulemaking or other regulatory processes without further congressional authorization. These recommendations would build on the work of FDA’s Transparency Task Force in 2010.MethodsIn 2016-2017, we convened (...) a team of academic faculty from Harvard Medical School, Brigham and Women’s Hospital, Yale Medical School, Yale Law School, and Johns Hopkins Bloomberg School of Public Health to develop recommendations through an iterative process of reviewing FDA’s practices, considering the legal and policy constraints on FDA in expanding transparency, and obtaining insights from independent observers of FDA.ResultsThe team developed 18 specific recommendations for improving FDA’s transparency to the public. FDA could adopt all these recommendations without further congressional action.FundingThe development of the Blueprint for Transparency at the U.S. Food and Drug Administration was funded by the Laura and John Arnold Foundation. (shrink)

Method as Identity considers how social identity shapes methodological standpoints. With a refreshing hip hop sensibility, Miller and Driscoll reorient the contemporary academic study of religion toward recognition of the costs and benefits of manufacturing “critical” distance from our objects of study.

This paper presents a preliminary analysis of the first participatory budgeting experiment in the United States, in Chicago's 49th Ward. There are two avenues of inquiry: First, does participatory budgeting result in different budgetary priorities than standard practices? Second, do projects meet normative social justice outcomes? It is clear that allowing citizens to determine municipal budget projects results in very different outcomes than standard procedures. Importantly, citizens in the 49th Ward consistently choose projects that the research literature classifies as low (...) priority. The results are mixed, however, when it comes to social justice outcomes. While there is no clear pattern in which projects are located only in affluent sections of the ward, there is evidence of geographic clustering. Select areas are awarded projects like community gardens, dog parks, and playgrounds, while others are limited to street resurfacing, sidewalk repairs, bike racks, and bike lanes. Based on our findings, we offer suggestions for future programmatic changes. (shrink)

Critics of evolutionary psychology and sociobiology have advanced an adaptationists-as-right-wing-conspirators (ARC) hypothesis, suggesting that adaptationists use their research to support a right-wing political agenda. We report the first quantitative test of the ARC hypothesis based on an online survey of political and scientific attitudes among 168 US psychology Ph.D. students, 31 of whom self-identified as adaptationists and 137 others who identified with another non-adaptationist meta-theory. Results indicate that adaptationists are much less politically conservative than typical US citizens and no more (...) politically conservative than non-adaptationist graduate students. Also, contrary to the “adaptationists-as-pseudo-scientists” stereotype, adaptationists endorse more rigorous, progressive, quantitative scientific methods in the study of human behavior than non-adaptationists. (shrink)

The Rho GTPases—Rho, Rac and Cdc42—act as molecular switches, cycling between an active GTP‐bound state and an inactive GDP‐bound state, to regulate the actin cytoskeleton. It has recently become apparent that the Rho GTPases can be activated in subcellular zones that appear semi‐stable, yet are dynamically maintained. These Rho GTPase activity zones are associated with a variety of fundamental biological processes including symmetric and asymmetric cytokinesis and cellular wound repair. Here we review the basic features of Rho GTPase activity zones, (...) suggest that these zones represent a fundamental signaling mechanism, and discuss the implications of zone properties from the perspective of both their function and how they are likely to be controlled. BioEssays 28: 983–993, 2006. © 2006 Wiley Periodicals, Inc. (shrink)

This new translation of the first volume of Hegel's Lectures on the History of Philosophy is a welcome and valuable addition to the new translations of Hegel's works, and now appears in paperback for the first time. Hegel's History of Philosophy has been described as perhaps one of his greatest achievements, and also as the first systematic history of philosophy since Aristotle. The translation included material from lecture notes taken by Hegel's pupils in 1923-4, 1925-6, and 1927-8. This material was (...) not available to Haldane and Simson when they made their translation nearly 100 years ago. The present volume, which supersedes that earlier one, besides being indispensable for the professional student, will also introduce those unfamiliar with Hegel to his conception of philosophy. (shrink)

This is a pioneering study of how multiculturalism interacts with multinationalism. Focusing specifically on post-devolution Scotland, and based on statistical analysis of over 1500 interviews, Hussain and Miller critically examine the challenges of Scotland's largest visible and invisible minorities: ethnic Pakistanis and English immigrants.

To understand the possible forms of extraterrestrial intelligence, we need not only astrobiology theories about how life evolves given habitable planets, but also evolutionary psychology theories about how intelligence emerges given life. Wherever intelligent organisms evolve, they are likely to face similar behavioral challenges in their physical and social worlds. The cognitive mechanisms that arise to meet these challenges may then be copied, repurposed, and shaped by further evolutionary selection to deal with more abstract, higher-level cognitive tasks such as conceptual (...) reasoning, symbolic communication, and technological innovation, while retaining traces of the earlier adaptations for solving physical and social problems. These traces of evolutionary pathways may be leveraged to gain insight into the likely cognitive processes of ETIs. We demonstrate such analysis in the domain of search strategies and show its application in the domains of emotional aversions and social/sexual signaling. Knowing the likely evolutionary pathways to intelligence will help us to better search for and process any alien signals from the search for ETIs and to assess the likely benefits, costs, and risks of humans actively messaging ETIs. (shrink)

Purpose This paper aims to formalize long-term trajectories of human civilization as a scientific and ethical field of study. The long-term trajectory of human civilization can be defined as the path that human civilization takes during the entire future time period in which human civilization could continue to exist. -/- Design/methodology/approach This paper focuses on four types of trajectories: status quo trajectories, in which human civilization persists in a state broadly similar to its current state into the distant future; catastrophe (...) trajectories, in which one or more events cause significant harm to human civilization; technological transformation trajectories, in which radical technological breakthroughs put human civilization on a fundamentally different course; and astronomical trajectories, in which human civilization expands beyond its home planet and into the accessible portions of the cosmos. -/- Findings Status quo trajectories appear unlikely to persist into the distant future, especially in light of long-term astronomical processes. Several catastrophe, technological transformation and astronomical trajectories appear possible. -/- Originality/value Some current actions may be able to affect the long-term trajectory. Whether these actions should be pursued depends on a mix of empirical and ethical factors. For some ethical frameworks, these actions may be especially important to pursue. (shrink)

Using Brehm's (1999) intensity of emotion paradigm, we investigated whether basic positive or negative affect operates like a motivational state. We focused on one of the most basic affects, the sensory affect experienced when eating food. Participants tasted a delicious chocolate truffle (Study 1) or some bitter chocolate (Study 2) and were exposed to either a weak, moderately strong, or a very strong reason for feeling an opposing-valence affect or to no reason. In line with the predictions, the affect that (...) participants reported in response to chocolate functioned like a motivational state as its intensity was a cubic function of the importance of the reason for feeling an opposing affect. We discussed the implications of these findings for the conceptualisation of affect and consider several applications for food advertising and consumer rating research. (shrink)

Importance Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials.Objective To examine cancer clinical trial (CCT) participants’ perceptions of informed consent processes and variations in perceptions by cancer type.Design and Setting and Participants Cross-sectional survey from mixed-methods study at National Cancer Institute–designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, hematologic-lymphatic (...) malignancies, lung cancer, and breast or gynecological cancer (N = 334).Main Outcome Measures Percentages satisfied with consent process and information provided; and assessing participation’s perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type.Results Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did—47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT.Conclusions and Relevance Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making. (shrink)

1 Strategic Sea Power By its very nature as an enabling agent sea power is a strategic force that can make a very positive difference in support of high ...

This is the third of four papers to be published in Research Ethics Review in 2009, that address methodological issues of relevance to research ethics committees. It focuses on three issues: the representativeness of study participants, the size of the study and data analysis. Differences between best practices in qualitative and quantitative research are highlighted. The paper argues that, while lack of representativeness may not be unethical, the ethical implications of unnecessary restrictions on eligibility should be considered by committees. Studies (...) that are either too small or too big can pose problems. Research teams need to have the necessary competence to enable an appropriate analysis focused on the main objectives and interpreted in the context of the limitations of the study design. (shrink)

First published in 2002. Routledge is an imprint of Taylor & Francis, an informa company.

It has been a common assumption that words are substances that instantiate or have properties. In this paper, I question the assumption that our ontology of words requires posting substances by outlining a bundle theory of words, wherein words are bundles of various sorts of properties (such as semantic, phonetic, orthographic, and grammatical properties). I argue that this view can better account for certain phenomena than substance theories, is ontologically more parsimonious, and coheres with claims in linguistics.

This is the second of four papers to be published in Research Ethics Review in 2009 that address methodological issues of relevance to research ethics committees. It focuses on three issues: the appropriateness of the research question, the different types of study design available, including both qualitative and quantitative, and the need for, and choice of, a control group. The paper argues that these issues are key to ethical consideration since inappropriate design may not be salvageable and can lead to (...) unusable data, in which case the risks and burdens to participants would be unjustified. (shrink)

The natural name theory, recently discussed by Johnson (2018), is proposed as an explanation of pure quotation where the quoted term(s) refers to a linguistic object such as in the sentence ‘In the above, ‘bank’ is ambiguous’. After outlining the theory, I raise a problem for the natural name theory. I argue that positing a resemblance relation between the name and the linguistic object it names does not allow us to rule out cases where the natural name fails to resemble (...) the linguistic object it names. I argue that to avoid this problem, we can combine the natural name theory with a type-realist metaphysics of language, and hold that the name is natural because the name is an instance of the kind that it names. I conclude by reflecting on the importance of the metaphysics of language for questions in the philosophy of language. (shrink)

Many research ethics guidelines now oblige researchers to offer research participants the results of research in which they participated. This practice is intended to uphold respect for persons and ensure that participants are not treated as mere means to an end. Yet some scholars have begun to question a generalised duty to disclose research results, highlighting the potential harms arising from disclosure and questioning the ethical justification for a duty to disclose, especially with respect to individual results. In support of (...) this view, we argue that current rationales for a duty of disclosure do not form an adequate basis for an ethical imperative. We review policy guidance and scholarly commentary regarding the duty to communicate the results of biomedical, epidemiological and genetic research to research participants and show that there is wide variation in opinion regarding what should be disclosed and under what circumstance. Moreover, we argue that there is fundamental confusion about the notion of “research results,” specifically regarding three core concepts: the distinction between aggregate and individual results, amongst different types of research, and across different degrees of result veracity. Even where policy guidance and scholarly commentary have been most forceful in support of an ethical imperative to disclose research results, ambiguity regarding what is to be disclosed confounds ethical action. (shrink)

In this paper we examine the case of Tay, the Microsoft AI chatbot that was launched in March, 2016. After less than 24 hours, Microsoft shut down the experiment because the chatbot was generating tweets that were judged to be inappropriate since they included racist, sexist, and anti-Semitic language. We contend that the case of Tay illustrates a problem with the very nature of learning software that interacts directly with the public, and the developer's role and responsibility associated with it. (...) We make the case that when LS interacts directly with people or indirectly via social media, the developer has additional ethical responsibilities beyond those of standard software. There is an additional burden of care. (shrink)

In the past, hypothesis testing in medicine has employed the paradigm of the repeatable experiment. In statistical hypothesis testing, an unbiased sample is drawn from a larger source population, and a calculated statistic is compared to a preassigned critical region, on the assumption that the comparison could be repeated an indefinite number of times. However, repeated experiments often cannot be performed on human beings, due to ethical or economic constraints. We describe a new paradigm for hypothesis testing which uses only (...) rearrangements of data present within the observed data set. The token swap test, based on this new paradigm, is applied to three data sets from cardiovascular pathology, and computational experiments suggest that the token swap test satisfies the Neyman Pearson condition. (shrink)

ABSTRACT The idea that two words can be instances of the same word is a central intuition in our conception of language. This fact underlies many of the claims that we make about how we communicate, and how we understand each other. Given this, irrespective of what we think words are, it is common to think that any putative ontology of words, must be able to explain this feature of language. That is, we need to provide criteria of identity for (...) word-types which allow us to individuate words such that it can be the case that two particular word-instances are instances of the same word-type. One solution, recently further developed by Irmak, holds that words are individuated by their history. In this paper, I argue that this view either fails to account for our intuitions about word identity, or is too vague to be a plausible answer to the problem of word individuation. (shrink)

The tropomyosins are a family of actin filament binding proteins. In multicellular animals, they exhibit extensive cell type specific isoform diversity. In this essay we discuss the genetic mechanisms by which this diversity is generated and its possible significance to cellular function.

To many who develop and use free software, the GNU General Public License represents an embodiment of the meaning of free software. In this paper we examine the definition and meaning of free software in the context of three events surrounding the GNU General Public License. We use a case involving the GPU software project to establish the importance of Freedom 0 in the meaning of free software. We analyze version 3 of the GNU General Public License and conclude that (...) although a credible case can be made that the added restrictions are consistent with the definition of free software, the case requires subtle arguments. Strong arguments against the added restrictions are less subtle, and may therefore be more convincing to many users and developers. We also analyze the Affero General Public License and conclude that it is inconsistent with the definition of free software. (shrink)

This paper reviews the experience of an integrated approach to CSR in the U.S. electric utility sector. The authors report on the results of Southern Company’s historical definition of CSR as a dynamic model, balancing stakeholder needs through shifting pressures to assure long-term shareholder value, superior customer, price performance, and sustainable economic development. Using financial and utility sector measures, the paper assesses the company’s “balancing” approach to addressing CSR, which weights corporate, environmental, community, and economic factors in driving successful and (...) sustained financial, social, and environmental performance. The paper concludes by suggesting that CSR success in this sector requires, first, that the global warming issue be governed by the same balancing considerations to which all stakeholders and their legitimate interests are subject, and second, an energy policy that embraces both atechnology policy and appropriate regulatory incentives. (shrink)

It has been widely argued that words are analogous to species such that words, like species, are natural kinds. In this paper, I consider the metaphysics of word-kinds. After arguing against an essentialist approach, I argue that word-kinds are homeostatic property clusters, in line with the dominant approach to other biological and psychological kinds.

lecting statistics about missing bindings and macros, and other errors. This guides debugging and development efforts, leading to iterative improvements in both the tools and the quality of the converted corpus. The build system thus serves as both a production conversion engine and software test harness. We have now processed the complete arχiv collection through 2006 consisting of more than 400,000 documents (a complete run is a processor-yearsize undertaking), continuously improving our success rate. We are now able to convert more (...) than 90% of these documents to XHTML+MathML. We consider over 60% to be successes, converted with no or minor warnings. While the remaining 30% can also be converted, their quality is doubtful, due to unsupported macros or conversion errors. (shrink)