Whether intended or not, conceptions of informed consent are often rooted in archetypal notions of the researcher and prospective study participant. The former is assumed problematically to be a disinterested yet humanitarian individual who is well trained to conduct robust science. The latter is often characterized as being motivated by some altruistic notions about the contribution to science and society they are making even as they seek some personal benefit from the research. Cast in a dyad, the researcher has the (...) responsibility to inform the participant thoroughly about the purpose of the research, the risks and benefits of participation, and any alternatives to research available, as well as the .. (shrink)

Phase I clinical trials are the first stage of testing new pharmaceuticals in humans. The majority of these studies are conducted under controlled, inpatient conditions using healthy volunteers who are paid for their participation. This article draws on an ethnographic study of six phase I clinics in the United States, including 268 semistructured interviews with research staff and healthy volunteers. In it, I argue that an institutional banalization of risk structures the perceptions of research staff and healthy volunteers participating in (...) the studies. For research staff, there are three mechanisms by which risk becomes banal: a perceived homogeneity of studies, Fordist work regimes, and data-centric discourse. For healthy volunteers, repeat study participation contributes to the institutional banalization of risk both through the process of desensitization to risk and the formation of trust in the clinics. I argue that the institutional banalization of risk also renders invisible ethical concerns about exploitation of underprivileged groups in pharmaceutical research. (shrink)

Volume 19, Issue 9, September 2019, Page 35-36.

: This paper provides a simultaneously reflexive and analytical framework to think about obstacles to truly informed consent in social science and biomedical research. To do so, it argues that informed consent often goes awry due to procedural misconceptions built into the research context. The concept of procedural misconception is introduced to describe how individuals respond to what is familiar in research settings and overlook what is different. In the context of biomedical research, procedural misconceptions can be seen to function (...) as root causes of therapeutic misconceptions. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and (...) long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others’ experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials. (shrink)

In this paper I explore the politics of trust in the clinical testing of pharmaceuticals in the US. Specifically, I analyze trust in terms of its institutional manifestations in the pharmaceutical clinical trials industry. In the process of testing new drugs, pharmaceutical companies must (1) protect their proprietary information from the clinicians who conduct their studies, and (2) find a way to ensure human subjects’ compliance to study protocols. Concern with these two critical issues leads drug companies to approach clinicians (...) and research subjects with an attitude of mistrust and the desire to exert control over their activities. This orientation results in an institutionalization of mistrust that structures the relationships and activities required for the clinical development of new pharmaceutical products. (shrink)

Background The ethical use both of human and non-human animals in research is predicated on the assumption that it is of a high quality and its projected benefits are more significant than the risks and harms imposed on subjects. Yet questions remain about whether and how IRBs and IACUCs should consider the scientific value of proposed research studies.Methods We draw upon 45 interviews with IRB and IACUC members and researchers with oversight experience about their perceptions of their own roles in (...) reviewing the quality and value of scientific protocols. Interview transcripts were memoed to highlight specific findings, which were then used to identify key themes through an iterative process.Results IRB and IACUC members expressed broad trust in the need for and value of research, and they often assumed that protocols had social value or that prior review, especially when associated with funding, affirmed both the rigor and merit of those protocols. Some oversight members also took an explicit stance against scientific review by stating that such review is not within the regulatory mandates governing their parts in the oversight system. Yet other interviewees expressed uneasiness about the current paradigm for evaluating the quality and overall value of science, suggesting that IRB and IACUC members perceive gaps in the oversight systems.Conclusions These findings reveal many similarities in how IRB and IACUC members understand the roles and limitations of their respective oversight committees. We conclude with a discussion of how the lack of a clear mandate regarding scientific review within US federal regulations may undermine ethical engagement of whether human and animal research is scientifically justified, resulting in a “mission lapse” wherein no organizational body is clearly responsible for ensuring that the research being conducted has the potential to advance science and benefit society. (shrink)

Clinical trials on healthy volunteers generate unique ethical challenges both because participants accept potential physical risks without the possibility of direct medical benefit and because participants’ financial motivations to enroll in trials could lead to their exploitation. Despite the large volume of published empirical studies and ethical analyses of healthy volunteer research, there has been little concerted effort to change how healthy‐volunteer research is overseen or regulated. A new collaborative effort to do so is the VolREthics (Volunteers in Research and (...) Ethics) Initiative. Launched in 2022, this initiative brings together an international community to engage questions about how healthy volunteers could best be protected from the risks of harm and exploitation while the validity of clinical trials is optimized. (shrink)

This article examines the complex relationship between power and the physical and social practices of tattooing in contemporary United States. Briefly tracing the history of tattooing from ancient Greece to contemporary America, I highlight the temporal and geographical changes in the practices and perceptions of tattooing. In addition to creating a historical narrative, I situate the sociocultural practice of tattooing the body for the tattooist and the `tattooee'. This investigation into body inscription serves as a means to elucidate the contemporary (...) practice of tattooing as one that is simultaneously physical and social, with multiple levels of constructed meaning. Finally, I will explore how tattooing, as a form of body modification, can be analyzed as a form of resistance to or a symptom of a culture that has commodified the body. (shrink)

The article "Picking and Choosing Among Phase I Trials", written by Jill A. Fisher, Torin Monahan and Rebecca L. Walker, was originally published Online First without Open Access. After publication in volume 16, issue 4, page 535-549 the author decided to opt for Open Choice and to make the article an Open Access publication.

In phase I clinical trials, healthy volunteers are dosed with investigational drugs and subjected to blood draws and other bodily monitoring procedures. In exchange, they are paid. Healthy volunteers are, in a very direct sense, selling access to their bodies for pharmaceutical companies and their associates to run drugs through. In his ethnographic study of socalled professional guinea pigs, Roberto Abadie writes, "Paid volunteers are well aware of the demand for an idealized, perfectly healthy volunteer. They also realize that their (...) body is a valued commodity in clinical trials research". It is perhaps surprising, then, that commodification is little discussed in the bioethics literature on phase I... (shrink)

While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of (...) the adverse events they experience during clinical trials. Drawing upon qualitative research, we find that participants largely minimize, deny, or re-attribute the cause of these AEs. We illustrate how participants' interpretations of AEs may be shaped both by the clinical trial environment and their economic motivation to participate. While these narratives are emblematic of the larger ambiguity surrounding harm in the context of clinical trial participation, we argue that these interpretations also problematically maintain the narrative of the safety of clinical trials, the ethics of testing investigational drugs on healthy people, and the rigor of data collected in the specter of such ambiguity. (shrink)

This article deploys sadomasochism as a framework for understanding medical practice on an institutional level. By examining the case of the factitious illness Munchausen syndrome, this article analyzes the operations of power in the doctor-patient relationship through the trope of role-playing. Because Munchausen syndrome causes a disruption to the dyadic relationship between physicians and patients, a lens of sadomasochism highlights dynamics of power in medical practice that are often obscured in everyday practice. Specifically, this article illustrates how classification and diagnosis (...) are concrete manifestations of the mobilization of medical power. (shrink)

Phase 1 healthy volunteer clinical trials—which financially compensate subjects in tests of drug toxicity levels and side effects—appear to place pressure on each joint of the moral framework justifying research. In this article, we review concerns about phase 1 trials as they have been framed in the bioethics literature, including undue inducement and coercion, unjust exploitation, and worries about compromised data validity. We then revisit these concerns in light of the lived experiences of serial participants who are income-dependent on phase (...) 1 trials. We show how participant experiences shift attention from discrete exchanges, behaviors, and events in the research enterprise to the ongoing and dynamic patterns of serial participation in which individual decision-making is embedded in collective social and economic conditions and shaped by institutional policies. We argue in particular for the ethical significance of structurally diminished voluntariness, routine powerlessness in setting the terms of exchange, and incentive structures that may promote pharmaceutical interests but encourage phase 1 healthy volunteers to skirt important rules. (shrink)

In the US, research payments are technically taxable income. This article argues that tax liability is a form of possible economic and legal risk of paid research participation. Findings are presented from empirical research on Phase I healthy volunteer trials. The article concludes by discussing the implications of these findings for the informed consent process, as well as for broader ethical issues in whether and how payments for research participation should be regulated.

Though antiretroviral therapy is the standard of care for people living with HIV, its treatment limitations, burdens, stigma and costs lead to continued interest in HIV cure research. Early-phase cure trials, particularly those that include analytic treatment interruption, involve uncertain and potentially high risk, with minimal chance of clinical benefit. Some question whether such trials should be offered, given the risk/benefit imbalance, and whether those who choose to participate are acting rationally. We address these questions through a longitudinal decision-making study (...) nested in a Thai acute HIV research cohort. In-depth interviews revealed central themes about decisions to join. Participants felt they possessed an important identity as members of the acute cohort, viewing their bodies as uniquely suited to both testing and potentially benefiting from HIV cure approaches. While acknowledging risks of ATI, most perceived they were given an opportunity to interrupt treatment, to test their own bodies and increase normalcy in a safe, highly monitored circumstance. They were motivated by potential benefits to themselves, the investigators and larger acute cohort, and others with HIV. They believed their own trial experiences and being able to give back to the community were sufficient to offset participation risks. These decisions were driven by the specific circumstances experienced by our participants. Judging risk/benefit ratios without appreciating these lived experiences can lead to false determinations of irrational decision- making. While this does not minimise vital oversight considerations about risk reduction and protection from harm, it argues for inclusion of a more participant-centered approach. (shrink)

ABSTRACT:Re-establishing trust presents a complex challenge for a firm after it commits corporate misconduct. We introduce a new construct, moral salience, which we define as the extent to which the firm’s behavior is morally noticeable to the stakeholder. Moral salience is a function of both the moral intensity of the firm’s behavior and the relational intensity of the firm-stakeholder psychological contract. We apply this moral salience construct to firm misconduct to develop a model of trust repair that is based on (...) goodwill, and moderated by the firm’s stakeholder culture. (shrink)

ABSTRACT:Global multi-stakeholder initiatives are important instruments that have the potential to improve the social and environmental sustainability of global supply chains. However, they often fail to comprehensively address the needs and interests of various supply-chain participants. While voluntary in nature, MSIs have most often been implemented through coercive approaches, resulting in friction among their participants and in systemic problems with decoupling. Additionally, in those cases in which deliberation was constrained between and amongst participants, collaborative approaches have often failed to materialize. (...) Our framework focuses on two key aspects of these breakdowns: assumptions about the orientation of MSI participants, and the deliberation processes that participants use to engage with each other to create these initiatives and sustain them over time. Drawing from stakeholder and deliberation theories, we revisit the concept of MSIs and show how their deliberative capacity may be enhanced in order to encourage participants to collaborate voluntarily. (shrink)

This case study reviews a train crash that occurred in January 2005 when a Norfolk Southern freight train struck a parked train on the tracks near Graniteville, South Carolina. At issue is the safe transportation of hazardous materials, the assignment of responsibility, the stakeholder management of participants and the outcome to Avondale Mills, a local textile company that ended up closing its doors after the spill.

This paper develops and tests a model of fingerpointing behaviors that board members experience because of regulatory reforms. We present the partial results of a large study of 138 board members on 54 publicly traded boards in the United States. We found that recent governance reforms that mandate increased accountability of board members are associated with less board cohesion and thatlower board cohesion is associated with fingerpointing behaviors. These findings suggest that the stages of institutionalization following regulatory shock falter when (...) negative group behaviors develop under scrutiny. (shrink)

In this qualitative meta-analysis, I analyze corporate irresponsibility as an emergent organizational process. Organizations enacting irresponsible practices rely not only on a particular form of a process path, but on how this process path evolves within the organization. To achieve a better understanding of this process path, I conducted a qualitative meta-analysis drawn from 20 published cases of irresponsible organizations. I explore how and under which conditions irresponsible behavior of organizations arises, develops, and changes over time. The process path of (...) corporate irresponsibility relies on the interaction of multiple levels of analysis and its temporal occurrence, resulting in either path dependency or path creation. Based on the empirical findings of the evolving phenomena, this study focuses on three phases of corporate irresponsibility: institutionalization, problematization, and adaptation. The process of corporate irresponsibility can take two distinct paths, the reactive, and the proactive. This study contributes to the corporate irresponsibility literature by offering new insights into, first, a processual and more interactional approach to corporate irresponsibility that accounts for interdependencies on the different levels of each phase, and second, the self-reinforcing mechanisms and explanatory patterns of corporate irresponsibility leading to path dependency or path creation. (shrink)

Poor working conditions remain a serious problem in supplier facilities in developing countries. While previous research has explored this from the developed buyers’ side, we examine this phenomenon from the perspective of developing countries’ suppliers and subcontractors. Utilizing qualitative data from a major knitwear exporting cluster in India and a stakeholder management lens, we develop a framework that shows how the assumptions of conventional, buyer-driven voluntary governance break down in the dilution of buyer power and in the web of factors (...) rooted in suppliers’ traditions, beliefs, local demands and resource dependency. We reveal out how success in governing collaborative global supply chains often falls short within the subcontracting stage, where a stakeholder management mindset is elusive to most participants. We suggest that success in governing collaborative global supply chains is dependent on concepts of stakeholder utility and the presence of shared value that is often at odds with the realities of power, information asymmetry and compliance/reward systems inherent in the non-market coordination of global supply chains. Our findings offer important insights for delineating the concepts of value creation from CSR concepts and practices, and for modifying the basic assumptions of conventional supply chain governance. (shrink)

This article leverages insights from the body of Adam Smith’s work, including two lesser-known manuscripts—the Theory of Moral Sentiments and Lectures in Jurisprudence —to help answer the question as to how companies should morally prioritize corporate social responsibility (CSR) initiatives and stakeholder claims. Smith makes philosophical distinctions between justice and beneficence and perfect and imperfect rights, and we leverage those distinctions to speak to contemporary CSR and stakeholder management theories. We address the often-neglected question as to how far a company (...) should be expected to go in pursuit of CSR initiatives and we offer a fresh perspective as to the role of business in relation to stakeholders and to society as a whole. Smith’s moral insights help us to propose a practical framework of legitimacy in stakeholder claims that can help managers select appropriate and responsible CSR activities. (shrink)

Multinational corporations dominate the global business arena, but new expectations for MNC boards call to question how they might effectively manage global stakeholder relationships in this new era of accountability. Uniting political behavior theory, which describes a board’s international political orientation, and global operating governance systems outlining a set of board behaviors, we develop a typology of four types of boards. We then provide recommendations for the development of an integrative governance structure, taking into account the mechanisms, structure, endorsements, and (...) codes of conduct that MNCs can use to promote ethical behavior across MNC horizons. (shrink)

Drawing on a conception of scientists and community members as partners in the construction of ethically responsible research practices, this article urges investigators to seek the perspectives of teenagers and parents in evaluating the personal and political costs and benefits of research on adolescent risk behaviors. Content analysis of focus group discussions involving over 100 parents and teenagers from diverse ethnic and socioeconomic backgrounds revealed community opinions regarding the scientific merit, social value, racial bias, and participant and group harms and (...) benefits associated with surveys, informant reports, intervention studies, blood sampling, and genetic research on youth problems. Participant comments highlight new directions for socially responsible research. (shrink)

Two experiments examined false recall for lists of semantically and phonologically associated words as a function of presentation duration. Veridical recall increased with long exposure durations for all lists. For semantically associated lists, false recall increased from 20–250 ms, then decreased. There was a high level of false recall with 20 ms durations for phonologically associated lists , which declined as duration increased. In Experiment 2, for lists presented at 20 and 50 ms rates, false recall given zero correct recall (...) was observed frequently, suggesting that conscious recollection of studied words was not necessary for phonological false memory. Differences between phonologically and semantically associated lists were consistent with a feature integration model based on automatic initial processing of phonetic features of words. (shrink)

Here we present and develop the hypothesis that the derepression of endogenous retrotransposable elements (RTEs) – “genomic parasites” – is an important and hitherto under‐unexplored molecular aging process that can potentially occur in most tissues. We further envision that the activation and continued presence of retrotransposition contribute to age‐associated tissue degeneration and pathology. Chromatin is a complex and dynamic structure that needs to be maintained in a functional state throughout our lifetime. Studies of diverse species have revealed that chromatin undergoes (...) extensive rearrangements during aging. Cellular senescence, an important component of mammalian aging, has recently been associated with decreased heterochromatinization of normally silenced regions of the genome. These changes lead to the expression of RTEs, culminating in their transposition. RTEs are common in all kingdoms of life, and comprise close to 50% of mammalian genomes. They are tightly controlled, as their activity is highly destabilizing and mutagenic to their resident genomes. (shrink)

We report the identification of a recurrent, 520-kb 16p12.1 microdeletion associated with childhood developmental delay. The microdeletion was detected in 20 of 11,873 cases compared with 2 of 8,540 controls and replicated in a second series of 22 of 9,254 cases compared with 6 of 6,299 controls. Most deletions were inherited, with carrier parents likely to manifest neuropsychiatric phenotypes compared to non-carrier parents. Probands were more likely to carry an additional large copy-number variant when compared to matched controls. The clinical (...) features of individuals with two mutations were distinct from and/or more severe than those of individuals carrying only the co-occurring mutation. Our data support a two-hit model in which the 16p12.1 microdeletion both predisposes to neuropsychiatric phenotypes as a single event and exacerbates neurodevelopmental phenotypes in association with other large deletions or duplications. Analysis of other microdeletions with variable expressivity indicates that this two-hit model might be more generally applicable to neuropsychiatric disease. © 2010 Nature America, Inc. All rights reserved. (shrink)

Mood affects social cognition and “theory of mind”, such that people in a persistent negative mood (i.e., dysphoria) have enhanced abilities at making subtle judgements about others’ mental states. Theorists have argued that this hypersensitivity to subtle social cues may have adaptive significance in terms of solving interpersonal problems and/or minimising social risk. We tested whether increasing the social salience of a theory of mind task would preferentially increase dyspshoric individuals’ performance on the task. Forty-four dysphoric and 51 non-dysphoric undergraduate (...) women participated in a theory of mind decoding task following one of three motivational manipulations: (i) social motivation (ii) monetary motivation, or (iii) no motivation. Social motivation was associated with the greatest accuracy of mental state decoding for the dysphoric group, whereas the non-dysphoric group showed the highest accuracy in the monetary motivation condition. These results suggest that dysphoric individuals may be especially, and preferentially, motivated to understand the mental states of others. (shrink)

Trope theory is a leading metaphysical theory in analytic ontology. One of its classic statements is found in the work of Donald C. Williams who argued that tropes qua abstract particulars are the very alphabet of being. The concept of an abstract particular has been repeatedly attacked in the literature. Opponents and proponents of trope theory alike have levelled their criticisms at the abstractness of tropes and the associated act of abstraction. In this paper I defend the concept of a (...) trope qua abstract particular by rejecting arguments that purport to show that tropes should not be understood as abstract and by arguing that the abstractness of tropes plays an indispensable role in one of our more promising trope-theoretic analyses of universals and of concrete objects. (shrink)

Individual studies have contributed to our knowledge of corporate philanthropy, but to date they remain fragmented. We proposed to extricate the conceptual and empirical work in corporate social responsibility from the conceptual and empirical work on corporate philanthropy, limiting our review to works that specifically refer to corporate philanthropy, as well as works that are labeled as corporate social responsibility but actually operationalize it as philanthropy. We will present an integrative model of corporate philanthropy research that draws on research from (...) a variety of perspectives and shows how the antecedents, processes, and outcomes of philanthropic process have been studied. We will recommend an agenda for future research that highlights research foci that are understudied, argues for greater theoretical and disciplinary diversity in the study of philanthropy, and points out new opportunities for better understanding the philanthropic process. (shrink)

Is there a link between how a firm manages its internal and external stakeholders? More specifically, are firms that give employees stock ownership and more say in running the enterprise more likely to engage with external stakeholders? This study seeks to answer these questions by elaborating on mechanisms that link employees to external stakeholders, such as the community, suppliers, and the environment. It tests these relationships using a sample of 347 private, mostly small-to-medium size firms, which completed a stakeholder impact (...) assessment organized by the non-profit B Lab. The results support the hypotheses that both employee ownership and employee involvement are positively associated with external stakeholder engagement. Further, we found that certification plays a role, as employee ownership contributes to external stakeholder engagement only in certified B Corporations, and not in firms that merely completed the B Lab Impact assessment. Our findings have import for stakeholder engagement frameworks, as we show that there is interplay between internal employee stakeholders and external stakeholders that may be important to overall firm–stakeholder management. (shrink)