Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) research (P = (...) 0.001), more sponsor‐country authors (P = 0.003), sponsor‐country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host‐country involved (P = 0.002), journals having sponsor‐country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor‐country editors and research being biomedical.Conclusions: One‐third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards. (shrink)

Objectives: We investigated how often journal articles reporting on human HIV research in four developing world countries mention any institutional review boards (IRBs) or research ethics committees (RECs), and what factors are involved.Methods: We examined all such articles published in 2007 from India, Nigeria, Thailand and Uganda, and coded these for several ethical and other characteristics.Results: Of 221 articles meeting inclusion criteria, 32.1% did not mention IRB approval. Mention of IRB approval was associated with: biomedical (versus psychosocial) research (P = (...) 0.001), more sponsor-country authors (P = 0.003), sponsor-country corresponding author (P = 0.047), mention of funding (P < 0.001), particular host-country involved (P = 0.002), journals having sponsor-country editors (P < 0.001), and journal stated compliance with International Committee of Medical Journal Editors (ICMJE) guidelines (P = 0.003). Logistic regression identified 3 significant factors: mention of funding, journal having sponsor-country editors and research being biomedical.Conclusions: One-third of articles still do not mention IRB approval. Mention varied by country, and was associated with biomedical research, and more sponsor country involvement. Recently, some journals have required mention of IRB approval, but allow authors to do so in cover letters to editors, not in the article itself. Instead, these data suggest, journals should require that articles document adherence to ethical standards. (shrink)

Several films, includingThree Identical Strangers, examined ethical problems in an experiment that involved identical siblings who were adopted as infants and separated into different families to examine the effects of nature versus nurture. The study was primarily designed and directed by Dr Peter Neubauer. The experiment, conducted in the 1960’s through 1980’s, serves as an important cautionary case study, raising several critical and ongoing ethical issues faced by researchers, universities and archives today. The organisation coordinating the study donated the research (...) records to Yale University under the condition that they remain sealed until 2065, and has impeded study participants’ full access to research material. This case raises questions of what investigators, their descendants, research ethics committees or institutional review boards (IRBs), universities and archives should do with study records when researchers retire or die—whether universities should accept researchers’ donations of archival records that may contain patient or participant data, and if so, under what conditions. This study also poses crucial issues for IRBs—for example, whether researchers themselves or their designates should control all access to study records, particularly if controversy or lawsuits ensue. These questions will become increasingly crucial since the amount of research has burgeoned over recent decades, and investigators, on retirement or death, may want to donate their archives to universities. This experiment thus highlights ethical questions to which researchers, IRBs, universities, healthcare institutions, archivists and libraries should attend. (shrink)

Increasingly, US-sponsored research is carried out in developing countries, but how US Institutional Review Boards (IRBs) approach the challenges they then face is unclear.METHODS: I conducted in-depth interviews of about 2 hours each, with 46 IRB chairs, directors, administrators and members. I contacted the leadership of 60 IRBs in the United States (US) (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding), and interviewed IRB leaders from 34 (55%).RESULTS: US IRBs face (...) ethical and logistical challenges in interpreting and applying principles and regulations in developing countries, given economic and health disparities, and limited contextual knowledge. These IRBs perceive wide variations in developing world IRBs/RECs' quality, resources and training; and health systems in some countries may have long-standing practices of corruption. These US IRBs often know little of local contexts, regulations and standards of care, and struggle with understandings of other cultures' differing views of autonomy, and risks and benefits of daily life. US IRBs thus face difficult decisions, including how to interpret principles, how much to pay subjects and how much sustainability to require from researchers. IRB responses and solutions include trying to maintain higher standards for developing world research, obtain cultural expertise, build IRB infrastructure abroad, communicate with foreign IRBs, and ‘negotiate’ for maximum benefits for participants and fearing ‘worst-case scenarios’.CONCLUSIONS: US and foreign IRBs confront a series of tensions and dilemmas in reviewing developing world research. These data have important implications for increased education of IRBs/RECs and researchers in the US and abroad, and for research and practice. (shrink)

While attention has focused in many states and countries on the initial acute phase of the COVID-19 pandemic and on lowering rates of infection and deaths, evidence suggests that among many survivo...

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)

Contemporary bioethics education has been developed predominately within Euro-American contexts, and now, other global regions are increasingly joining the field, leading to a richer global understanding. Nevertheless, many standard bioethics curriculum materials retain a narrow geographic focus. The purpose of this article is to use local cases from the Asia-Pacific region as examples for exploring questions such as ‘what makes a case or example truly local, and why?’, ‘what topics have we found to be best explained through local cases or (...) examples?’, and ‘how does one identify a relevant local case?’ Furthermore, we consider the global application of local cases to help extend the possible scope of the discussion, opening new avenues for the development of practical bioethics educational materials. We begin with a background description and discussion of why local cases enhance bioethics education, move to an overview of what is currently available and what is not for the region, and then outline a discussion of what it means to be local using example cases drawn from Hong Kong, Australia, Pakistan, and Malaysia. We are not creating a casebook but rather constructing by example a toolbox for designing active and dynamic learning cases using regional diversity as contextualised cases with generalised principles. (shrink)

Internet-based health research is increasing, and often offers financial incentives but fraudulent behavior by participants can result. Specifically, eligible or ineligible individuals may enter the study multiple times and receive undeserved financial compensation. We review past experiences and approaches to this problem and propose several new strategies. Researchers can detect and prevent Internet research fraud in four broad ways: through the questionnaire/instrument ; through participants' non-questionnaire data and seeking external validation through computer information,, and 4) through study design. These approaches (...) each have pros and cons, and raise ethical, legal, and logistical questions, given that ethical tensions can emerge between preserving the integrity of research vs. protecting the privacy and confidentiality of study respondents. While past discussions concerning the ethics of online research have tended to focus on the participants' ability to trust the researchers, needs now arise to examine researchers' abilities to trust the participants. This analysis has several critical implications for future practice, policy, and research. (shrink)

Most lymphocytes of the T cell lineage develop along the CD4/CD8 pathway and express antigen receptors on their surfaces consisting of clonotypic αβ chains associated with invariant CD3‐γδε components and ζ chains, collectively referred to as the T cell antigen receptor complex (TCR). Expression of the TCR complex is dynamically regulated during T cell development, with immature CD4+CD8+ thymocytes expressing only 10% of the number of αβ TCR complexes on their surfaces expressed by mature CD4+ and CD8+ T cells. Recent (...) evidence demonstrates that low surface TCR density on CD4+CD8+ thymocytes results from the limited survival of a single TCR component within the ER, the TCRα chain, which has a half life of only 15 minutes in immature thymocytes, compared to >75 minutes in mature T cells. Instability of TCRα proteins in immature CD4+CD8+ thymocytes represents a novel mechanism by which expression of the multisubunit TCR complex is quantitatively regulated during T cell development. In the current review we discuss our recent findings concerning the assembly, intracellular transport, and expression of αβ TCR complexes in CD4+CD8+ thymocytes and comment on the functional significance of TCRα instability during T cell development. (shrink)

We demonstrate that the key components of cognitive architectures (declarative and procedural memory) and their key capabilities (learning, memory retrieval, probability judgment, and utility estimation) can be implemented as algebraic operations on vectors and tensors in a high‐dimensional space using a distributional semantics model. High‐dimensional vector spaces underlie the success of modern machine learning techniques based on deep learning. However, while neural networks have an impressive ability to process data to find patterns, they do not typically model high‐level cognition, and (...) it is often unclear how they work. Symbolic cognitive architectures can capture the complexities of high‐level cognition and provide human‐readable, explainable models, but scale poorly to naturalistic, non‐symbolic, or big data. Vector‐symbolic architectures, where symbols are represented as vectors, bridge the gap between the two approaches. We posit that cognitive architectures, if implemented in a vector‐space model, represent a useful, explanatory model of the internal representations of otherwise opaque neural architectures. Our proposed model, Holographic Declarative Memory (HDM), is a vector‐space model based on distributional semantics. HDM accounts for primacy and recency effects in free recall, the fan effect in recognition, probability judgments, and human performance on an iterated decision task. HDM provides a flexible, scalable alternative to symbolic cognitive architectures at a level of description that bridges symbolic, quantum, and neural models of cognition. (shrink)

Reply to a commentary by Felicitas Holzer and Ignacio Mastroleoon “Models of Consent to Return of Incidental Findings in Genomic Research.”.

As the term regenerative agriculture caught fire in public discourse around 2019, it was promptly labelled a buzzword. While the buzzword accusation tends to be regarded as negative, these widely used terms also reflect an important area of growing public interest. Exploring a buzzword can thus help us understand our current moment and offer insights to paths forward. In this study, we explored how and why different individuals and groups adopt certain key terms or buzzwords, in this case the term (...) “regenerative agriculture”. We used an interpretivist approach to understand how “regenerative agriculture” is being constructed, interpreted, understood, and employed, drawing from 19 semi-structured interviews conducted with farmers, researchers, private companies, and NGO/nonprofits. Several interviewees felt that regenerative agriculture is making an important societal shift in thinking towards addressing major issues like climate change and parity in our food and agricultural systems. However, farmers in particular felt that the term is being greenwashed, coopting the work they do, and even diluting the meaning. We also found that regenerative agriculture is being advanced as mobilizing “win-wins”—for farmers, for consumers, for society—but that this discourse may be veiling the political and economic agendas of the big companies using the term. Our findings further illustrated the debates over standardizing the term regenerative agriculture, with some contending that there should be room for “continuous improvement” but others felt it is meaningless without a definition. (shrink)

Objectives Disclosures of funding sources and conflicts of interests (COI) in published peer-reviewed journal articles have recently begun to receive some attention, but many critical questions remain, for example, how often such reporting occurs concerning research conducted in the developing world and what factors may be involved. Design Of all articles indexed in Medline reporting on human subject HIV research in 2007 conducted in four countries (India, Thailand, Nigeria and Uganda), this study explored how many disclosed a funding source and (...) COI, and what factors are involved. Results Of 221 articles that met the criteria, 67.9% (150) disclosed the presence or absence of a funding source, but only 20% (44) disclosed COI. Studies from Uganda were more likely, and those from Nigeria were less likely to mention a funding source (p<0.001). Of articles in journals that had adopted International Committee of Medical Journal Editors (ICMJE) guidelines, 56% did not disclose COI. Disclosure of funding was more likely when: ≥50% of the authors and the corresponding author were from the sponsoring country, the sponsor country was the USA, and the articles were published in journals in which more of the editors were from the sponsoring countries. Conclusions Of the published studies examined, over a third did not disclose funding source (ie, whether or not there was a funding source) and 80% did not disclose whether COI existed. Most articles in ICMJE-affiliated journals did not disclose COI. These data suggest the need to consider alteration of policies to require that published articles include funding and COI information, to allow readers to assess articles as fully as possible. (shrink)

The COVID-19 pandemic has raised a host of ethical challenges, but key among these has been the possibility that health care systems might need to ration scarce critical care resources. Rationing p...

Background Pediatric critical care physician attitudes about withdrawal of ventricular assist devices (VAD) and extracorporeal membrane oxygenation (ECMO) in cases of medical futility are poorly defined. Our aim was to define current attitudes regarding the withdrawal of these devices. Methods IRB-approved, cross-sectional observational survey conducted among pediatric critical care attending physicians and fellow physicians in the United States between 2016 and 2017. Data was collected anonymously and statistically analyzed. Results A total of 158 physicians responded with 67% being attending physicians. (...) Compared to a VAD, a higher percentage had taken care of a patient on ECMO where the device was turned off because care was believed to be futile (99% vs. 84%), including currently (95% vs. 57%). Nearly all reported that it can be ethically permissible to withdraw support from a patient with a VAD and on ECMO (97% vs. 99%), but varied opinions existed as to who should ultimately make this decision if the patient/their family disagrees. More respondents agreed that a patient/their family should agree to withdrawal of VAD or ECMO support prior to initiation if futility is later determined (60% vs. 58%) and that protocols should be created for VAD and ECMO withdrawal (77% vs. 76%). Conclusion Most pediatric critical care physicians felt that it can be ethically permissible to withdraw VAD and ECMO support. Our study indicates that pediatric VAD and ECMO withdrawal protocols are desired, but further investigation is needed to determine how to best design protocols that would incorporate multiple stakeholders. (shrink)

ABSTRACT:Despite widespread attention to corruption and organizational change in the literature, to our knowledge, no research has attempted to understand the linkages between these two powerful organizational phenomena. Accordingly, we draw on major theories in ethics, sociology, and management to develop a theoretical framework for understanding how organizational change can sometimes generate corruption. We extend anomie theory and ethical climate theory to articulate the deinstitutionalization of the normative control system and argue that, through this deinstitutionalization, organizations have the potential to (...) become incubators for corruption. We qualify this process by proposing conditions more ripe for anomie and under which this deinstitutionalization is more likely to occur, propounding moderating relationships that influence organizational reconfiguration. Examples of turbulence in the contemporary business environment that can trigger change highlight our discussion. We conclude with managerial implications, offering means by which the deleterious effects of corruption may be arrested or controlled. (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)

The extant marketing literature provides little guidance for theory development or practice with regard to questions of ethical conformity and the resulting market response. To begin to bridge this research gap, we advance a theoretical framework of ethical conformity in marketing, appealing to marketing ethics, management strategy, and sociological foundations. We set the stage for our theoretical arguments by considering the role of normative expectations related to marketing practices and behaviors held by societal constituents. Against this backdrop, we propose drivers (...) of conformity in marketing, including practices consistent with both overconformity and underconformity. The framework allows us to advance testable research propositions by which questions of ethical conformity may be explored. We conclude by suggesting additional future research needed to develop the domain, specifically in the form of empirical inquiries uncovering firm strategic decisions with ethical implications. (shrink)

Research on social influences often distinguishes between social and quality incentives to ascribe meaning to the value that popularity conveys. This study examines the neural correlates of those incentives through which popularity influences preferences. This research reports an functional magnetic resonance imaging experiment and a behavioral task in which respondents evaluated popular products with three focus perspectives; unspecified focus, focus on social aspects, and focus on quality. The results show that value derived with a social focus reflects inferences of approval (...) and reward value, and positively affects preferences. Value derived with a quality focus reflects inferences of quality and negatively affects preferences. This study provides evidence of two distinct inferential routes on both a neurological level, represented by different regions in the brain, and a behavioral level. These results provide the first evidence that a single popularity cue can in different ways influence the value derived from product popularity. (shrink)

In the foundational piece in this issue of the journal, “Integrating Law and Social Epidemiology,” Burris, Kawachi, and Sarat present a model for understanding the relationship between law and health. This article uses the case of a specific health condition, the human immunodeficiency virus infection, as an opportunity to flesh out this schema and to test how the model “fits” the world of the HIV pandemic. In applying the model to this communicable disease, we hope to illustrate the multitude of (...) ways that laws affect the course of the pandemic as well as the course of an individual’s vulnerability or resilience to the disease, and how the complexities of an individual’s life dealing with the virus interface with the world of laws and legal institutions. (shrink)

A standard objection to act utilitarian theories is that they are not helpful in deciding what it is morally permissible for us to do when we actually have to make a choice between alternatives. That is, such theories are worthless as decision procedures. A standard reply to this objection is that act utilitarian theories can be evaluated solely as theories about right-making characteristics and, when so evaluated, their inadequacy as decision procedures is irrelevant. Even if somewhat unappealing, this is an (...) effective reply to the standard objection. (shrink)

The United States has the fastest growing prison population in the world, and elevated incarceration rates, substance use, and human immunodeficiency virus (HIV) prevalence are fueling each other. Yet without a national guideline mandated for HIV care within the prison system, standards for state and federal prisons vary greatly.

With this issue we initiate the policy of expanding the scope of Tulane Studies in Philosophy to include, in addition to the work of members of the department, contributions from philosophers who have earned advanced degrees from Tulane and who are now teaching in other colleges and universities. The Editor THE LOGIC OF OUR LANGUAGE ROBERT L. ARRINGTON Wittgenstein wrote in the Tractatus that "logic is not a body of doctrine, but a mirror-image of the world. " 1 In (...) line with his suggestion that a proposition is a 'picture', Wittgenstein argued that propositions 'show' the logical structure of the real. He was insistent, however, that "the apparent logical form of a proposition need not be its real one. " 2 As a result of this we can misunderstand the structure of fact. Philosophical problems arise just when "the logic of our language is mis understood. " 3 It is common knowledge that much of this view of logic was rejected by Wittgenstein himself in the Philosophical Investi gations. There we are told that language has no ideal or sublime 4 logic which mirrors the structure of the extra-linguistic world. Consequently, inferences from the structure of language to the structure of that extra-linguistic world are invalid. Reality can be 'cut up' in any of a number of ways by language. Wittgenstein adopted a view of philosophy which would render that discipline a non-explanatory, non-critical study of the multiple ways in which language can be used. (shrink)

An invited collection of prominent scholars examining normative issues raised by the role of coaching, the ethics of competition, coaching youth sports, and coaching relating to the law.

Use of the concept of `areasonable person and his or her expectations'is widely found in legal reasoning. This legalconstruct is employed in the present article toexamine privacy questions associated withcontemporary information technology, especiallythe internet. In particular, reasonableexpectations of privacy while browsing theworld-wide-web and while sending and receivinge-mail are analyzed.

This paper presents a representational theory of derived physical measurements. The theory proceeds from a formal definition of a class of similar systems. It is shown that such a class of systems possesses a natural proportionality structure. A derived measure of a class of systems is defined to be a proportionality-preserving representation whose values are n-tuples of positive real numbers. Therefore, the derived measures are measures of entire physical systems. The theory provides an interpretation of the dimensional parameters in a (...) large class of physical laws, and it accounts for the monomial dimensions of these parameters. It is also shown that a class of similar systems obeys a dimensionally invariant law, which one may safely subject to a dimensional analysis. (shrink)