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)

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)

The study of alternatives to conventional industrial agricultural production has intensified in recent years. While many types of alternative production systems, and the motivations of individuals to participate in them, have been studied, there are significant gaps in the literature. One such dearth is research on those participating in self-provisioning activities. This study begins to fill the gap by looking at the self-provisioning activity of home gardening using data from the 2008 Ohio Survey of Food, Agriculture, and Environmental Issues. Discerning (...) who household gardeners are is important given the recent economic, cultural, and political climate of the United States. The results show that home gardening occurs throughout the state of Ohio at surprisingly high levels. Bivariate and multivariate analyses reveal several noteworthy associations between gardening and household characteristics, including spatial location, pro-environmental and economic hardship behaviors, and level of participation in localized food systems. (shrink)

The repercussions of unconscious priming on the neural correlates subsequent cognition have been explored previously. However, the neural dynamics during the unconscious processing remains largely uncharted. To assess both the complexity and temporal dynamics of unconscious cognition the present study contrasts the evoked response from classes of masked stimuli with three different levels of complexity; words, consonant strings, and blanks. The evoked response to masked word stimuli differed from both consonant strings and blanks, which did not differ from each other. (...) This response was qualitatively different to any evoked potential observed when stimuli were consciously visible and peaked at 140 ms, earlier than is usually associated with differences between words and strings and 100 ms earlier than word-consonant string differences in the visible condition. The evoked response demonstrates a qualitatively distinct signature of unconscious cognition and directly demonstrates the extraction of abstract information under subliminal conditions. (shrink)

Studies in the yeast Saccharomyces cerevisiae have validated the major features of the double‐strand break repair (DSBR) model as an accurate representation of the pathway through which meiotic crossovers (COs) are produced. This success has led to this model being invoked to explain double‐strand break (DSB) repair in other contexts. However, most non‐crossover (NCO) recombinants generated during S. cerevisiae meiosis do not arise via a DSBR pathway. Furthermore, it is becoming increasingly clear that DSBR is a minor pathway for recombinational (...) repair of DSBs that occur in mitotically‐proliferating cells and that the synthesis‐dependent strand annealing (SDSA) model appears to describe mitotic DSB repair more accurately. Fundamental dissimilarities between meiotic and mitotic recombination are not unexpected, since meiotic recombination serves a very different purpose (accurate chromosome segregation, which requires COs) than mitotic recombination (repair of DNA damage, which typically generates NCOs). (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)

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)

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)

The purpose of this study was to explore the views of members of the general public regarding ethical issues in adult predictive genetic testing. The literature pertaining to ethical issues regarding to adult predictive genetic testing is largely restricted to the views of ‘experts’ who have emphasized informed consent, patent issues, and insurance discrimination. Occasionally the views of patients who have undergone genetic counselling and testing have been elicited, adding psychosocial and family issues. However, the general public has not had (...) the opportunity to contribute. In order to explore theatre as a health policy research tool, 1,200 audience members attended the play ‘Sarah’s Daughters’ in seven Canadian cities, following which audience discussions were audiotaped. This study performed a secondary qualitative analysis of the data to identify the ethical issues of adult predictive genetic testing important to members of the general public. The identified issues were: (1) need for public education; (2) choice to undergo genetic counselling and testing; (3) access to genetic counselling and testing; and (4) obligations regarding the handling of genetic information. Audience members emphasized public education and access to information regarding potential choices, which was different from the emphasis on informed consent and other ethical issues prominent in the literature. Members of the general public emphasized ethical issues that were different than those identified by experts and patients. It is essential that members of the public be included in complex and controversial public policy decisions. (shrink)

A new temperament construct based on recent brain physiology literature has been investigated using the Fisher Temperament Inventory (FTI). Four collections of behaviors emerged, each associated with a specific neural system: the dopamine, serotonin, testosterone, and estrogen/oxytocin system. These four temperament suites have been designated: (1) Curious/Energetic, (2) Cautious/Social Norm Compliant, (3) Analytical/Tough-minded, and (4) Prosocial/Empathetic temperament dimensions. Two functional magnetic resonance imaging (fMRI) studies have suggested that the FTI can measure the influence of these neural systems. In this (...) paper, to further the behavioral validation and characterization of the four proposed temperament dimensions, we measured correlations with five variables: (1) gender; (2) level of education; (3) religious preference; (4) political orientation; (5) the degree to which an individual regards sex as essential to a successful relationship. Subjects were 39,913 anonymous members of a US Internet dating site and 70,000+ members in six other countries. Correlations with the five variables characterize the FTI and are consistent with mechanisms using the proposed neuromodulators. We also report on an analysis between the FTI and the NEO-Five Factor Inventory, using a college sample ( n = 215), which showed convergent validity. The results provide novel correlates not available in other questionnaires: religiosity, political orientation, and attitudes about sex in a relationship. Also, an Eigen analysis replicated the four clusters of co-varying items. The FTI, with its broad systems and non-pathologic factors complements existing personality questionnaires. It provides an index of some brain systems that contribute to temperament, and may be useful in psychotherapy, business, medicine, and the legal community. (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)

Throughout his writings, Karl Rahner remained open to the prospect that the process of cosmic evolution had yielded sentient life form in other galaxies. He argued against any theological veto on this notion, while also distinguishing the existential significance of such life forms from that of angles. Furthermore, the possibility of multiple incarnations is raised though not affirmed. With its Christological intensity, his theology seems to militate against any repetition of the incarnation. This essay examines some of the arguments for (...) and against the possibility of multiple incarnations, before assessing the current state of the extraterrestrial intelligence debate. In the light of inconclusive scientific findings, the cautionary position of Rahner is reaffirmed. (edited). (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)

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.

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)

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)

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)

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)

White matter tracts are known to be susceptible to injury following concussion. The objective of this study was to determine whether contact play in sport could alter white matter metabolite levels in female varsity athletes independent of changes induced by long-term exercise. Metabolite levels were measured by single voxel proton magnetic resonance spectroscopy in the prefrontal white matter at the beginning and end of season in contact and non-contact varsity athletes. Sedentary women were scanned once, at a time equivalent to (...) the Off-Season time point. Metabolite levels in non-contact athletes did not change over a season of play, or differ from age matched sedentary women except that non-contact athletes had a slightly lower myo-inositol level. The contact athletes had lower levels of myo-inositol and glutamate, and higher levels of glutamine compared to both sedentary women and non-contact athletes. Lower levels of myo-inositol in non-contact athletes compared to sedentary women indicates long-term exercise may alter glial cell profiles in these athletes. The metabolite differences observed between contact and non-contact athletes suggest that non-contact athletes should not be used as controls in studies of concussion in high-impact sports because repetitive impacts from physical contact can alter white matter metabolite level profiles. It is imperative to use athletes engaged in the same contact sport as controls to ensure a matched metabolite profile at baseline. (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.

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)