Public “upstream engagement” and other approaches to the social control of technology are currently receiving international attention in policy discourses around emerging technologies such as nanotechnology. To the extent that such approaches hold implications for research and development (R&D) activities, the distinct participation of scientists and engineers is required. The capacity of technoscientists to broaden the influences on R&D activities, however, implies that they conduct R&D differently. This article discusses the possibility for more reflexive participation by scientists and engineers in (...) the internal governance of technology development. It reviews various historical attempts to govern technoscience and introduces the concept of midstream modulation, through which scientists and engineers, ideally in concert with others, bring societal considerations to bear on their work. (shrink)

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)

Little is known about the mechanisms by which psychology graduate programs transmit responsible conduct of research (RCR) values. A national sample of 968 current students and recent graduates of mission-diverse doctoral psychology programs completed a Web-based survey on their research ethics challenges, perceptions of RCR mentoring and department climate, whether they were prepared to conduct research responsibly, and whether they believed psychology as a discipline promotes scientific integrity. Research experience, mentor RCR instruction and modeling, and department RCR policies predicted student (...) RCR preparedness. Mentor RCR instruction, department RCR policies, and faculty modeling of RCR behaviors predicted confidence in the RCR integrity of the discipline. Implications for training are discussed. (shrink)

Drawing upon two independent national samples of 201 and 241 psychology graduate students, this article describes the development and psychometric evaluation of 4 Web-based student self-report scales tapping student socialization in the responsible conduct of research (RCR) with human participants. The Mentoring the Responsible Conduct of Research Scale (MRCR) is composed of 2 subscales assessing RCR instruction and modeling by research mentors. The 2 subscales of the RCR Department Climate Scale (RCR-DC) assess RCR department policies and faculty and student RCR (...) practices. The RCR Preparedness scale (RCR-P) and the RCR Field Integrity scale (RCR-FI) measure respectively students' confidence in their ability to conduct research responsibly and their belief in the RCR integrity of psychology as a discipline. Factor analysis, coefficient alphas, correlations, and multiple regression analyses demonstrated each of the scales had good internal consistency and concurrent and construct validity. (shrink)

Researchers have iterated that the future of synthetic biology and biotechnology lies in novel consumer applications of crossing biology with engineering. However, if the new biology’s future is to be sustainable, early and serious efforts must be made towards social sustainability. Therefore, the crux of new applications of synthetic biology and biotechnology is public understanding and acceptance. The RASVaccine is a novel recombinant design not found in nature that re-engineers a common bacteria to produce a strong immune response in humans. (...) Synthesis of the RASVaccine has the potential to improve public health as an inexpensive, non-injectable product. But how can scientists move forward to create a dialogue of creating a ‘common sense’ of this new technology in order to promote social sustainability? This paper delves into public issues raised around these novel technologies and uses the RASVaccine as an example of meeting the public with a common sense of its possibilities and limitations. (shrink)

Researchers have iterated that the future of synthetic biology and biotechnology lies in novel consumer applications of crossing biology with engineering. However, if the new biology’s future is to be sustainable, early and serious efforts must be made towards social sustainability. Therefore, the crux of new applications of synthetic biology and biotechnology is public understanding and acceptance. The RASVaccine is a novel recombinant design not found in nature that re-engineers a common bacteria to produce a strong immune response in humans. (...) Synthesis of the RASVaccine has the potential to improve public health as an inexpensive, non-injectable product. But how can scientists move forward to create a dialogue of creating a ‘common sense’ of this new technology in order to promote social sustainability? This paper delves into public issues raised around these novel technologies and uses the RASVaccine as an example of meeting the public with a common sense of its possibilities and limitations. (shrink)

Objective: To audit doctors’ knowledge of informed consent.Design: 10 consent scenarios with “true”, “false”, or “don’t know” answers were completed by doctors who care for children at a large district general hospital. These questions tested clinicians’ knowledge of who could give consent in different clinical situations.Setting: Royal United Hospital, Bath, UK.Results: 51 doctors participated . Paediatricians scored higher than other clinicians . Only 36% of paediatricians and 8% of other clinicians realised that the biological father of a child born before (...) 1 December 2003 needed a court order or a parental responsibility agreement to acquire parental responsibility, and thus be able to consent on behalf of his child, if he was not married to the child’s mother. Non-paediatric clinicians were unsure or incorrect when tested on situations where people with parental responsibility do not agree, or where young people , who are Fraser competent do not want to consult their parents. Most clinicians did not know that the parents of a 20-year-old man with severe learning difficulties are unable to consent to surgery on his behalf, and many non-paediatricians were unclear on who could give consent when a child lived with foster parents.Conclusion: Clinicians who obtain consent for the treatment of children need to increase their knowledge on who is able to give informed consent to ensure best practice. (shrink)

The first years of life mark a time of rapid development and dietary change, as children transition from an exclusive milk diet to a modified adult diet. During these early years, children's learning about food and eating plays a central role in shaping subsequent food choices, diet quality, and weight status. Parents play a powerful role in children's eating behavior, providing both genes and environment for children. For example, they influence children's developing preferences and eating behaviors by making some foods (...) available rather than others, and by acting as models of eating behavior. In addition, parents use feeding practices, which have evolved over thousands of years, to promote patterns of food intake necessary for children's growth and health. However in current eating environments, characterized by too much inexpensive palatable, energy dense food, these traditional feeding practices can promote overeating and weight gain. To meet the challenge of promoting healthy weight in children in the current eating environment, parents need guidance regarding alternatives to traditional feeding practices. (shrink)

Eating behaviors evolve during the first years of life as biological and behavioral processes directed towards meeting requirements for health and growth. For the vast majority of human history, food scarcity has constituted a major threat to survival, and human eating behavior and child feeding practices have evolved in response to this threat. Because infants are born into a wide variety of cultures and cuisines, they come equipped as young omnivores with a set of behavioral predispositions that allow them to (...) learn to accept the foods made available to them. During historical conditions of scarcity, family life and resources were devoted to the procurement and preparation of foods, which are often low in energy, nutrients, and palatability. In sharp contrast, today in non-Third World countries children's eating habits develop under unprecedented conditions of dietary abundance, where palatable, inexpensive, ready-to-eat foods are readily available. (shrink)

Against the backdrop of a global pandemic, this study investigates how U.S. higher education leaders have centered their crisis management on values and guiding ethical principles. We conducted 55 in-depth interviews with leaders from 30 U.S. higher education institutions, with most leaders participating in two interviews. We found that crisis plans created prior to the COVID-19 pandemic were inadequate due to the long duration and highly uncertain nature of the crisis. Instead, higher education leaders applied guiding principles on the fly (...) to support their decision-making. If colleges and universities infuse shared values into their future crisis plans, they will not have to develop a moral compass on the fly for the next pandemic. This paper suggests the following somewhat universal shared values: engage in accuracy, transparency, and accountability; foster deliberative dialog; prioritize safety; support justice, fairness, and equity; and engage in an ethic of care. To navigate ethics tensions, leaders need to possess crisis-relevant expertise or ensure that such expertise is present among crisis management team members. Standing up formal ethics committees composed of diverse stakeholders also is instrumental in navigating tensions inherent in crises. The next pandemic is already on the horizon according to experts. Through infusing values into future crisis plans, higher education leaders can be confident that their responses will be grounded in their communities’ shared values. (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)

The COVID-19 pandemic has necessitated innovations in data collection protocols, including use of virtual or remote visits. Although developmental scientists used virtual visits prior to COVID-19, validation of virtual assessments of infant socioemotional and language development are lacking. We aimed to fill this gap by validating a virtual visit protocol that assesses mother and infant behavior during the Still Face Paradigm and infant receptive and expressive communication using the Bayley-III Screening Test. Validation was accomplished through comparisons of data collected during (...) in-person laboratory visits and virtual visits conducted via Zoom. Of the 119 mother-infant dyads who participated, 73 participated in lab visits only, 13 participated in virtual visits only, and 33 dyads participated in a combination of lab and virtual visits across four time points. Maternal perspectives of, and preferences for, virtual visits were also assessed. Proportions of missing data were higher during virtual visits, particularly for assessments of infant receptive communication. Nonetheless, comparisons of virtual and laboratory visits within a given time point indicated that mothers and infants showed similar proportions of facial expressions, vocalizations and directions of gaze during the SFP and infants showed similar and expected patterns of behavioral change across SFP episodes. Infants also demonstrated comparable expressive and receptive communicative abilities across virtual and laboratory assessments. Maternal reports of ease and preference for virtual visits varied by infant age, with mothers of 12-month-old infants reporting, on average, less ease of virtual visits and a preference for in-person visits. Results are discussed in terms of feasibility and validity of virtual visits for assessing infant socioemotional and language development, and broader advantages and disadvantages of virtual visits are also considered. (shrink)

This provocative book paved the way for nursing research informed by f eminist scholarship, critical theory, and post-modern thought. Controv ersial then, relevant today.

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)

This interview with media anthropologist, Rebecca L. Stein, conducted by Noa Levin and Andrew Fisher in Spring 2023, takes her recent book Screenshots: State Violence on Camera in Israel and Palestine (2021) as its starting point in order to explore issues of state violence and the militarization of social media in Israel/Palestine. This book marks the culmination of a decade-long research project into the camera dreams introduced by digital imaging technologies and the fraught histories of their disillusionment. Stein discusses (...) the way her research has critically conceptualized the recent history of hopes invested in the digital image in this geopolitical context, by the occupier as much as the occupied, and charts the failures and mistakes, obstructions and appropriations that characterize the conflicted visual cultures of Israel/Palestine. (shrink)

In The Art Instinct, Denis Dutton promoted a theoretical framework that “has more validity, more power, and more possibilities than the hermetic discourse that deadens so much of the humanities.”1 This framework is Charles Darwin’s theory of evolution by natural and sexual selection. Dutton proposed to seek “human universals that underlie the vast cacophony of cultural differences and across the globe” (AI, p. 39), based on a shared, evolved human nature.This contrasts with the relativistic presumptions of those falling under the (...) shadow of Margaret Mead and Clifford Geertz, or “the dogmas of Freud, the speculations of Jung, the sterile formulations of behaviorism, all variously empty or misleading” (p. 37). Also .. (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)