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)

In addressing thescientific study of consciousness, Crick and Koch state, It is probable that at any moment some active neuronal processes in your head correlate with consciousness, while others do not: what is the difference between them? (1998, p. 97). Evidence from electrophysiological and brain-imaging studies of binocular rivalry supports the premise of this statement and answers to some extent, the question posed. I discuss these recent developments and outline the rationale and experimental evidence for the interhemispheric switch hypothesis of (...) perceptual rivalry. According to this model, the perceptual alternations of rivalry reflect hemispheric alternations, suggesting that visual consciousness of rivalling stimuli may be unihemispheric at any one time (Miller et al., 2000). However, in this paper, I suggest that interhemispheric switching could involve alternating unihemispheric attentional selection of neuronal processes for access to visual consciousness. On this view, visual consciousness during rivalry could be bi hemispheric because the processes constitutive of attentional selection may be distinct from those constitutive of visual consciousness. This is a special case of the important distinction between the neuronal correlates and constitution of visual consciousness. (shrink)

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)

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.

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)

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)

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)

A twenty‐person working group convened to discuss the ethical and policy considerations of the controversial intervention called “growth attenuation,” and if possible to develop practical guidance for health professionals. A consensus proved elusive, but most of the members did reach a compromise.

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)

This report describes the rationale, approaches, organization, and resource development leading to a large-scale deletion bin map of the hexaploid wheat genome. Accompanying reports in this issue detail results from chromosome bin-mapping of expressed sequence tags representing genes onto the seven homoeologous chromosome groups and a global analysis of the entire mapped wheat EST data set. Among the resources developed were the first extensive public wheat EST collection. Described are protocols for sequencing, sequence processing, EST nomenclature, and the assembly of (...) ESTs into contigs. These contigs plus singletons were used for selection of distinct sequence motif unigenes. Selected ESTs were rearrayed, validated by 5′ and 3′ sequencing, and amplified for probing a series of wheat aneuploid and deletion stocks. Images and data for all Southern hybridizations were deposited in databases and were used by the coordinators for each of the seven homoeologous chromosome groups to validate the mapping results. Results from this project have established the foundation for future developments in wheat genomics. (shrink)

A twenty‐person working group convened to discuss the ethical and policy considerations of the controversial intervention called “growth attenuation,” and if possible to develop practical guidance for health professionals. A consensus proved elusive, but most of the members did reach a compromise.

Whole eye transplantation (WET) remains experimental. Long presumed impossible, recent scientific advances regarding WET suggest that it may become a clinical reality. However, the ethical implications of WET as an experimental therapeutic strategy remain largely unexplored. This article evaluates the ethical considerations surrounding WET as an emerging experimental treatment for vision loss. A thorough review of published literature pertaining to WET was performed; ethical issues were identified during review of the articles.

In this essay we argue that the current social and ethical structure in the Open Source Software Community stem from its roots in academia. The individual developers experience a level of autonomy similar to that of a faculty member. Furthermore, we assert that the Open Source Software Community’s social structure demands benevolent leadership. We argue that it is difficult to pass off low quality open source software as high quality software and that the Open Source development model offers strong accountability. (...) Finally, we argue that Open Source Software introduces ethical challenges for universities and the software development community. (shrink)

This book undertakes a multifaceted and integrated examination of biometric identification, including the current state of the technology, how it is being used, the key ethical issues, and the implications for law and regulation. The five chapters examine the main forms of contemporary biometrics–fingerprint recognition, facial recognition and DNA identification– as well the integration of biometric data with other forms of personal data, analyses key ethical concepts in play, including privacy, individual autonomy, collective responsibility, and joint ownership rights, and proposes (...) a raft of principles to guide the regulation of biometrics in liberal democracies. Biometric identification technology is developing rapidly and being implemented more widely, along with other forms of information technology. As products, services and communication moves online, digital identity and security is becoming more important. Biometric identification facilitates this transition. Citizens now use biometrics to access a smartphone or obtain a passport; law enforcement agencies use biometrics in association with CCTV to identify a terrorist in a crowd, or identify a suspect via their fingerprints or DNA; and companies use biometrics to identify their customers and employees. In some cases the use of biometrics is governed by law, in others the technology has developed and been implemented so quickly that, perhaps because it has been viewed as a valuable security enhancement, laws regulating its use have often not been updated to reflect new applications. However, the technology associated with biometrics raises significant ethical problems, including in relation to individual privacy, ownership of biometric data, dual use and, more generally, as is illustrated by the increasing use of biometrics in authoritarian states such as China, the potential for unregulated biometrics to undermine fundamental principles of liberal democracy. Resolving these ethical problems is a vital step towards more effective regulation. (shrink)

Combinatorial operations on sets are almost never well defined on Turing degrees, a fact so obvious that counterexamples are worth exhibiting. The case we focus on is the symmetric-difference operator; there are pairs of degrees for which the symmetric-difference operation is well defined. Some examples can be extracted from the literature, e.g. from the existence of nonzero degrees with strong minimal covers. We focus on the case of incomparable r.e. degrees for which the symmetric-difference operation is well defined.

"The Rules" are found in a collaborative document that states principles for responsibility when a computer artifact is designed, developed and deployed into a sociotechnical system. At this writing, over 50 people from nine countries have signed onto The Rules. Unlike codes of ethics, The Rules are not tied to any organization, and computer users as well as computing professionals are invited to sign onto The Rules. The emphasis in The Rules is that both users and professionals have responsibilities in (...) the production and use of computing artifacts. In this paper, we use The Rules to examine issues of trust. (shrink)

We contend that software developers have an ethical responsibility to strive for reliable software. We base that obligation on long standing engineering traditions that place the public good as a central tenant and on the professional relationship between a software developer and the users of the software developed.

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)

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)

There is a growing literature on the concept of e-trust and on the feasibility and advisability of “trusting” artificial agents. In this paper we present an object-oriented model for thinking about trust in both face-to-face and digitally mediated environments. We review important recent contributions to this literature regarding e-trust in conjunction with presenting our model. We identify three important types of trust interactions and examine trust from the perspective of a software developer. Too often, the primary focus of research in (...) this area has been on the artificial agents and the humans they may encounter after they are deployed. We contend that the humans who design, implement, and deploy the artificial agents are crucial to any discussion of e-trust and to understanding the distinctions among the concepts of trust, e-trust and face-to-face trust. (shrink)

Background Nurses experienced intense ethical and moral challenges during the COVID-19 pandemic. Our 2020 qualitative parent study of frontline nurses’ experiences during the COVID-19 pandemic identified ethics as a cross-cutting theme with six subthemes: moral dilemmas, moral uncertainty, moral distress, moral injury, moral outrage, and moral courage. We re-analyzed ethics-related findings in light of refined definitions of ethics concepts. Research aim To analyze frontline U.S. nurses’ experiences of ethics during the COVID-19 pandemic. Research design Qualitative analysis using a directed content (...) methodology. Participants and research context The study included 43 nurses from three major metropolitan academic medical centers and one community hospital in the northeastern, mid-Atlantic, midwestern, and western United States. Ethical considerations Participant privacy and data confidentiality were addressed. Findings Moral dilemmas arose from many situations, most frequently related to balancing safety and patient care. Moral uncertainty commonly arose from lacking health information or evidence about options. Moral distress occurred when nurses knew the right thing to do, but were prevented from doing so, including with end-of-life issues. Moral injury (accompanied by suffering, shame, or guilt) occurred after doing, seeing, or experiencing wrongdoing, often involving authority figures. Nurses expressed moral outrage at events and people within and outside healthcare. Despite difficult ethical situations, some nurses exemplified moral courage, sometimes by resisting policies they perceived as preventing compassionate care, guided by thinking about what was best for patients. Discussion This content analysis of ethics-related subthemes revealed conceptual characteristics and clarified distinctions with corresponding exemplars. Conceptual clarity may inform responses and interventions to address ethical quandaries in nursing practice. Conclusions Ethics education in nursing must address the moral dilemmas of pandemics, disasters, and other crises. Nurses need time and resources to heal from trying to provide the best care when no ideal option was available. (shrink)

This collection seeks to excavate the tradition of radical liberal class analysis, which predated and inspired Marx's reflections on class. Liberal class theory is distinctive because it regards relationship with the state as constitutive rather than just indicative of social class membership. Along with an introduction that frames the discussion historically and conceptually, Social Class and State Power provides readers with easy access to provocative texts from the early modern period to the present.

University human research ethics application procedures can be complicated and daunting, especially for international students unfamiliar with the process and the language. We conducted focus groups and interviews with four research higher degree and 21 Master’s coursework international students at an Australian university to gain their views on the human ethics application process. We found the most important influences on their experience were: the time it took to do an application; support from supervisors, peers and others; their own language skills; (...) and their lack of familiarity with research ethics procedures. To improve the experience of international students undertaking research involving human research ethics applications, we recommend universities provide guidance on institutional ethics review processes, concepts and terminology, with translations in a range of languages, together with guidance on how to conduct research ethically within and outside the students’ own countries. We also recommend curricula be developed to further students’ understanding of the importance of ethical research practice, and that these curricula be embedded in undergraduate and postgraduate degree programs and reflected in course learning outcomes. (shrink)

Aristotle's Politics is widely recognized as one of the classics of the history of political philosophy, and like every other such masterpiece, it is a work about which there is deep division.

Primary progressive aphasia is a clinical syndrome in which patients progressively lose speech and language abilities. Three variants are recognized: logopenic, associated with phonology and/or short-term verbal memory deficits accompanied by left temporo-parietal atrophy; semantic, associated with semantic deficits and anterior temporal lobe atrophy; non-fluent associated with grammar and/or speech-motor deficits and inferior frontal gyrus atrophy. Here, we set out to investigate whether the three variants of PPA can be dissociated based on error patterns in a single language task. We (...) recruited 21 lvPPA, 28 svPPA, and 24 nfvPPA patients, together with 31 healthy controls, and analyzed their performance on an auditory noun-to-verb generation task, which requires auditory analysis of the input, access to and selection of relevant lexical and semantic knowledge, as well as preparation and execution of speech. Task accuracy differed across the three variants and controls, with lvPPA and nfvPPA having the lowest and highest accuracy, respectively. Critically, machine learning analysis of the different error types yielded above-chance classification of patients into their corresponding group. An analysis of the error types revealed clear variant-specific effects: lvPPA patients produced the highest percentage of “not-a-verb” responses and the highest number of semantically related nouns ; in contrast, svPPA patients produced the highest percentage of “unrelated verb” responses and the highest number of light verbs. Taken together, our findings indicate that error patterns in an auditory verb generation task are associated with the breakdown of different neurocognitive mechanisms across PPA variants. Specifically, they corroborate the link between temporo-parietal regions with lexical processing, as well as ATL with semantic processes. These findings illustrate how the analysis of pattern of responses can help PPA phenotyping and heighten diagnostic sensitivity, while providing insights on the neural correlates of different components of language. (shrink)