Importance Informed consent is essential to ethical, rigorous research and is important to recruitment and retention in cancer trials.Objective To examine cancer clinical trial (CCT) participants’ perceptions of informed consent processes and variations in perceptions by cancer type.Design and Setting and Participants Cross-sectional survey from mixed-methods study at National Cancer Institute–designated Northeast comprehensive cancer center. Open-ended and forced-choice items addressed: (1) enrollment and informed consent experiences and (2) decision-making processes, including risk-benefit assessment. Eligibility: CCT participant with gastro-intestinal or genitourinary, (...) hematologic-lymphatic malignancies, lung cancer, and breast or gynecological cancer (N = 334).Main Outcome Measures Percentages satisfied with consent process and information provided; and assessing participation’s perceptions of risks/benefits. Multivariable logistic or ordinal regression examined differences by cancer type.Results Most patient-participants felt well informed by the consent process (more than 90% overall and by cancer type) and. most (87.4%) reported that the consent form provided all the information they wanted, although nearly half (44.8%) reported that they read the form somewhat carefully or less. More than half (57.9%) said that talking to research staff (i.e., the consent process) had a greater impact on participation decisions than reading the consent form (2.1%). A third (31.1%) were very sure of joining in research studies before the informed consent process (almost half of lung cancer patients did—47.1%). Most patients personally assessed the risks and benefits before consenting. However, trust in physicians played an important role in the decision to enroll in CCT.Conclusions and Relevance Cancer patients rely less on written features of the informed consent process than on information obtained from the research staff and their own physicians. Research should focus on information and communication strategies that support informed consent from referring physicians, researchers, and others to improve patient risk-benefit assessment and decision-making. (shrink)

Philosophers have long debated whether, if determinism is true, we should hold people morally responsible for their actions since in a deterministic universe, people are arguably not the ultimate source of their actions nor could they have done otherwise if initial conditions and the laws of nature are held fixed. To reveal how non-philosophers ordinarily reason about the conditions for free will, we conducted a cross-cultural and cross-linguistic survey (N = 5,268) spanning twenty countries and sixteen languages. Overall, (...) participants tended to ascribe moral responsibility whether the perpetrator lacked sourcehood or alternate possibilities. However, for American, European, and Middle Eastern participants, being the ultimate source of one’s actions promoted perceptions of free will and control as well as ascriptions of blame and punishment. By contrast, being the source of one’s actions was not particularly salient to Asian participants. Finally, across cultures, participants exhibiting greater cognitive reflection were more likely to view free will as incompatible with causal determinism. We discuss these findings in light of documented cultural differences in the tendency toward dispositional versus situational attributions. (shrink)

Recent developments in biotechnology allow for the generation of increasingly complex products out of human tissues, for example, human stem cell lines, synthetic embryo-like structures and organoids. These developments are coupled with growing commercial interests. Although commercialisation can spark the scientific and clinical promises, profit-making out of human tissues is ethically contentious and known to raise public concern. The traditional bioethical frames of gift versus market are inapt to capture the resulting practical and ethical complexities. Therefore, we propose an alternative (...) approach to identify, evaluate and deal with the ethical challenges that are raised by the increasing commercialisation of the exchange of sophisticated human tissue products. We use organoid technology, a cutting-edge stem cell technology that enables the cultivation of ‘mini-organs’ in a dish, as an example. First, we examine the moral value of organoids and recognise them as hybrids that relate to persons and their bodies as well as to technologies and markets in ambiguous ways. Second, we show that commercialisation of organoids is legitimised by a detachment of the instrumental and commercial value of organoids from their associations with persons and their bodies. This detachment is enacted in steps of disentanglement, among which consent and commodification. Third, we contend that far-reaching disentanglement is ethically challenging: (1) Societal interests could be put under pressure, because the rationale for commercialising organoid technology, that is, to stimulate biomedical innovation for the good of society, may not be fulfilled; (2) The interests of donors are made subordinate to those of third parties and the relational moral value of organoids may be insufficiently recognised. Fourth, we propose a ‘consent for governance’ model that contributes to responsible innovation and clinical translation in this exciting field. (shrink)

Observational learning can enhance the acquisition and performance quality of complex motor skills. While an extensive body of research has focused on the benefits of synchronous (i.e., concurrent physical practice) and non-synchronous (i.e., delayed physical practice) observational learning strategies, the question remains as to whether these approaches differentially influence performance outcomes. Accordingly, we investigate the differential outcomes of synchronous and non-synchronous observational training contexts using a novel dance sequence. Using multidimensional cross-recurrence quantification analysis, movement time-series were recorded for novice (...) dancers who either synchronised with (n = 22) or observed and then imitated (n = 20) an expert dancer. Participants performed a 16-count choreographed dance sequence for 20 trials assisted by the expert, followed by one final, unassisted performance trial. Although end-state performance did not significantly differ between synchronous and non-synchronous learners, a significant decline in performance quality from imitation to independent replication was shown for synchronous learners. A non-significant positive trend in performance accuracy was shown for non-synchronous learners. For all participants, better imitative performance across training trials led to better end-state performance, but only for the accuracy (and not timing) of movement reproduction. Collectively, the results suggest that synchronous learners came to rely on a realtime mapping process between visual input from the expert and their own visual and proprioceptive intrinsic feedback, to the detriment of learning. Thus, the act of synchronising alone does not ensure an appropriate training context for advanced sequence learning. (shrink)

Farm to institution programs represent alternative supply chains that aim to organize the activities of local producers with institutions that feed the local community. The current study demonstrates the value of structuration theory :75–80, 1983; The constitution of society: outline of the theory of structuration. University of California Press, Berkeley, 1984) for conceptualizing how FTI agents create, maintain, and change organizational structures associated with FTI and traditional supply chains. Based on interviews with supply chain agents participating in FTI programs, we (...) found that infrastructure, relationships, and pricing were seen as important factors that enabled and constrained FTI organizing. Additionally, we describe how FTI organizing serves to simultaneously reinforce and challenge the practices associated with traditional supply chains. Theoretical and practical implications are discussed as well as directions for future research. (shrink)

Spatial experience in childhood is a factor in the development of spatial abilities. In this study, we assessed whether American and Faroese participants’ (N = 246, Mage = 19.31 years, 151 females) early spatial experience and adult spatial outcomes differed by gender and culture, and if early experience was related to adult performance and behavior. Participants completed retrospective reports on their childhood spatial experience, both large-scale (permitted childhood range size) and small-scale (Lego play). They also completed assessments of their current (...) large-scale spatial behavior (navigational strategy) and small-scale ability (mental rotation task, MRT). We replicated earlier results showing better MRT performance among males and more reliance by males on orientation navigational strategies, although males and females reported similar ranges as children. However, there were cross-cultural differences, with Faroese having larger childhood ranges, less reliance on route strategies, better MRT scores, and a smaller gender difference in MRT. Larger permitted childhood ranges were associated with reduced use of route strategies for navigation in adulthood, and greater Lego play in childhood predicted better MRT performance as adults. There was also some evidence supporting relationships across spatial scales, with more Lego play predicting an orientation style of navigation and larger childhood ranges predicting better performance on the MRT, although the latter was not independent of country. In sum, we observed an association in both cultures between large-scale childhood experience and large-scale behavior in adulthood, small-scale experience in childhood and adult small-scale performance, and some associations between experience and behavior across spatial scales. (shrink)

To foster understanding in the psychopathology of patients with anorexia nervosa at the psychological and physiological level, standardized experimental studies on reliable biomarkers are needed, especially due to the lack of disorder-specific samples. To this end, the autonomic nervous system response to a psychosocial stressor was investigated in n = 19 PAN, age, and gender-matched to n = 19 healthy controls. For this purpose, heart rate and heart rate variability parameters were assessed in a cross-sectional study design under two (...) experimental conditions: rest and stress. In addition, psychological indicators of stress were assessed. An 2 × 2 × 8 ANOVA demonstrated similar HR and HRV patterns between PAN and HC at rest. Under stress, PAN demonstrated a blunted HR [condition*time*group: F = 9.326, p = 0.000, η2 = 0.206] and an attenuated HRV response. Significant effects of stress appraisal and BMI on HRV-reactivity were revealed. SA on SDNN = Condition*time*SA = F = 2.676, p = 0.033, η2 = 0.073. BMI on LF/HF-Ratio = Condition*time*BMI = F = 3.339, p = 0.019, η2 = 0.164. Psychological indices suggested higher levels of chronic and appraised stress in PAN relative to HC. Additional analyses demonstrated that ED-symptoms are highly correlated with the latter constructs, as well as with psychological burden, but not with weight. Further, it was shown that abnormalities in reactivity persisted despite normalized ANS activity. Overall, we suggested that besides weight recovery, improvement in stress appraisal could be beneficial for cardiac health. In this light, a combination of therapy and biofeedback training may improve treatment outcomes and regulate stress reactivity. (shrink)

Around fifteen years before the chemical substance alumina could be decomposed in the laboratory, it was identified as a compound and predicted to contain a new element called ‘aluminium’. Using this episode from early nineteenth-century chemistry as a case study for the use of analogical reasoning in science, this paper examines how chemists relied on chemical classifications for the prediction of aluminium. I argue that chemists supplemented direct evidence of chemical decomposition with analogical inferences in order to evaluate the composition (...) of substances. Since they were established on the basis of relevant similarities in chemical properties, classifications were taken to reflect so-called ‘chemical analogies’ between substances. In combination with the knowledge that analogous properties indicated similarities in composition, this enabled chemists to infer the composition of experimentally indecomposable substances by analogy. The trust in such analogical inferences, even if they could not be confirmed through experiment, was justified by pragmatic considerations. Whereas the possibility of decomposing a substance depended on the available laboratory techniques, chemical analogies were thought to last independently of internal composition. It was therefore more practical to keep well-established classes of substances together rather than separate them on the basis of experimental results that might evolve as new techniques were developed. Besides highlighting the links between analogical reasoning and classification, this paper also illustrates the importance of analogy in the evaluation of elementary nature in the early nineteenth century. (shrink)

Human Research Ethics Committee (HREC) reviewers often provide similar feedback across applications, which suggests that the problem lies in researcher awareness of key issues rather than novel, unsolvable challenges. If common problems can be addressed before lodgement by applicants referencing clear evidence-based supports (e.g., FAQs on common application shortcomings), it would improve efficiency for HREC members and expedite approvals. We aim to inform such supports by analysing the patterns in the most frequent feedback made by HREC members during review processes. (...) We collected every instance (N = 4,195) of feedback made on N = 197 ‘low-risk’ protocols by all HREC staff (N = 16) at one institution over the course of a full year (2019). Reflexive thematic analysis to identify themes (and content analysis to determine relative frequency) revealed that the top three themes are consistent with existing literature: Consent, Administrative, and Methodological concerns. However, we identified important new themes that are not captured in previous research, including ‘Risk to Researchers’, ‘Commercial benefit, scope and scale’, ‘Diversity’ (covering issues of cultural sensitivity, language and accessibility), as well as fair right to a complaints process. Our thorough exploration of information-rich primary data marks an important methodological improvement over previous studies and offers a theoretical contribution to understanding themes that have heretofore been overlooked in the ethics review process. By identifying the common challenges experienced in HREC review we can better inform tailored supports to applicants (by extension reducing workload burdens on HREC systems) and reduce their perceived barriers to engaging in challenging but meaningful research. (shrink)

The rise of precision medicine has led to an unprecedented focus on human biological material in biomedical research. In addition, rapid advances in stem cell technology, regenerative medicine and synthetic biology are leading to more complex human tissue structures and new applications with tremendous potential for medicine. While promising, these developments also raise several ethical and practical challenges which have been the subject of extensive academic debate. These debates have led to increasing calls for longitudinal governance arrangements between tissue providers (...) and biobanks that go beyond the initial moment of obtaining consent, such as closer involvement of tissue providers in what happens to their tissue, and more active participatory approaches to the governance of biobanks. However, in spite of these calls, such measures are being adopted slowly in practice, and there remains a strong tendency to focus on the consent procedure as the tool for addressing the ethical challenges of contemporary biobanking. In this paper, we argue that one of the barriers to this transition is the dominant language pervading the field of human tissue research, in which the provision of tissue is phrased as a ‘donation’ or ‘gift’, and tissue providers are referred to as ‘donors’. Because of the performative qualities of language, the effect of using ‘donation’ and ‘donor’ shapes a professional culture in which biobank participants are perceived as passive providers of tissue free from further considerations or entitlements. This hampers the kind of participatory approaches to governance that are deemed necessary to adequately address the ethical challenges currently faced in human tissue research. Rather than reinforcing this idea through language, we need to pave the way for the kind of participatory approaches to governance that are being extensively argued for by starting with the appropriate terminology. (shrink)

Volume 19, Issue 5, May 2019, Page 43-45.

Alexithymia is a dimensional trait characterized by difficulties identifying and describing feelings and an externally oriented thinking (EOT) style. Here, we explored interrelationships between alexithymia and measures assessing how individuals process and regulate their responses to environmental and body-based cues. Young adults (N= 201) completed self-report questionnaires assessing alexithymia, sensory processing sensitivity (SPS), interoceptive accuracy (IA), sensory processing styles, and current levels of depression, anxiety, and stress. Whereas EOT was related to low orienting sensitivity, problems with emotional appraisal (difficulties identifying (...) feelings/difficulties describing feelings) were related to heightened sensory sensitivity. In addition, features of SPS improved the prediction of alexithymia above and beyond that accounted for by IA. We suggest that EOT is linked to problems maintaining a representation of one’s emotions in working memory and that low IA and problems with emotional appraisal are linked to atypicalities in sensory processing that may impact embodiment. A latent profile analysis revealed five classes of individuals distinguished by the relative strength of different alexithymic traits and by differences in IA and sensory processing styles. The classes identified included two lexithymic, one modal, and two alexithymic groups, showing different susceptibilities to SPS. Overall, our findings lend support to the view that alexithymia is associated with atypicalities in both bottom–up and top–down processes that impact emotion processing and regulation. They also raise the possibility that individuals with different alexithymia subtypes may differ with regard to a range of factors, including not only SPS but also early life experiences, mental health outcomes, and susceptibility to various personality disorders. (shrink)

Bringing the 12.8% of children with special healthcare needs into the national response to the childhood obesity epidemic will require new information, a view of health promotion beyond that which occurs within healthcare systems, and services and supports in addition to the multi-sectoral strategies presently designed for children overall. These efforts are necessary to protect the health of the nation's 9.4 million children with special health care needs now and long-term.

Although the obesity epidemic appears to have affected all segments of the U.S. population, its impact on children with special health care needs has received little attention. “Children with special health care needs” is a term used in the U.S. to describe children who come to the attention of health care providers and policy makers because they need different services and supports than other children. Government, at both the federal and state levels, has long felt a particular responsibility for safeguarding (...) the health of children with special needs. The definition “children with special health care needs,” in fact, was developed by a work group established by the U.S. Maternal and Child Health Bureau to assist states in their efforts to develop community systems of services for children with complex medical and behavioral conditions. (shrink)

Visuomotor adaptation to novel environments can occur via non-physical means, such as observation. Observation does not appear to activate the same implicit learning processes as physical practice, rather it appears to be more strategic in nature. However, there is evidence that interspersing observational practice with physical practice can benefit performance and memory consolidation either through the combined benefits of separate processes or through a change in processes activated during observation trials. To test these ideas, we asked people to practice aiming (...) to targets with visually rotated cursor feedback or engage in a combined practice schedule comprising physical practice and observation of projected videos showing successful aiming. Ninety-three participants were randomly assigned to one of five groups: massed physical practice, distributed physical practice, or one of 3 types of combined practice: alternating blocks, or all observation before or after blocked physical practice. Participants received 100 practice trials. All groups improved in adaptation trials and showed savings across the 24-h retention interval relative to initial practice. There was some forgetting for all groups, but the magnitudes were larger for physical practice groups. The Act and Obs_During groups were most accurate in retention and did not differ, suggesting that observation can serve as a replacement for physical practice if supplied intermittently and offers advantages above just resting. However, after-effects associated with combined practice were smaller than those for physical practice control groups, suggesting that beneficial learning effects as a result of observation were not due to activation of implicit learning processes. Reaction time, variable error, and post-test rotation drawings supported this conclusion that adaptation for observation groups was promoted by explicit/strategic processes. (shrink)

Precision medicine research involving human biological material is becoming an increasingly central component of healthcare, and its potential is quickly growing due to rapid technological progress...

Farm to institution (FTI) efforts aim to increase the amount of locally produced foods, typically fruits and vegetables, served by institutions such as schools, colleges, hospitals, senior meal sites, and correctional facilities. Scholars have cited these efforts as contributing to public health and community-based food systems goals. Prior research has found that relationships based on shared values have played a critical role in motivating and sustaining FTI efforts. We review previous studies, discussing values that motivate participation, and affect practices and (...) relationships in FTI supply chains. We use semi-structured interviews to better understand supply chain actors’ values and motivations and how they affect behaviors, with the aim of informing efforts to increase the scope and effectiveness of FTI efforts. All participants are currently engaged in FTI efforts. We find a mix of social and economic values were present for farmers, distributors, and buyers. Our implications focus on the importance of shared values and relationships, the benefit of local food for businesses along the supply chain, and the potential of non-school institution markets as entry points for farmers. (shrink)

Deprescribing is the term used to describe the process of withdrawal of an inappropriate medication supervised by a clinician. This article presents a discussion of how the Four Principles of biomedical ethics that may guide medical practitioners’ prescribing practices apply to deprescribing medications in older adults. The view of deprescribing as an act creates stronger moral duties than if viewed as an omission. This may explain the fear of negative outcomes which has been reported by prescribers as a barrier to (...) deprescribing. Respecting the autonomy of older adults is complex as they may not wish to be active in the decision-making process; they may also have reduced cognitive function and family members may therefore have to step in as surrogate decision-makers. Informed consent is intended as a process of information giving and reflection, where consent can be withdrawn at any time. However, people are rarely updated on the altered risks and benefits of their long-term medications as they age. Cessation of inappropriate medication use has a large financial benefit to the individual and the community. However, the principle of justice also dictates equal rights to treatment regardless of age. (shrink)

Parental refusal of a recommended treatment is not an uncommon scenario in the neonatal intensive care unit. These refusals may be based upon the parents’ perceptions of their child’s projected quality of life. The inherent subjectivity of quality of life assessments, however, can exacerbate disagreement between parents and healthcare providers. We present a case of parental refusal of surgical intervention for necrotizing enterocolitis in an infant with Bartter syndrome and develop an ethical framework in which to consider the appropriateness of (...) parental refusal based upon an infant’s projected quality of life. (shrink)

Research shows that early scientific interest is associated with science degree completion and career selection. However, little is known about the conditions that support early scientific interest. Using a “funds of knowledge” theoretical framework, this study examined the role of parents, family, and extended social networks in fostering early interest in science. Using interview narratives from 116 scientists (physicists and chemists) in the United States, we conducted a qualitative thematic content analysis. Findings suggest that children who become scientists in adulthood (...) often received early, informal opportunities to use and manipulate material objects and discover how the world works. Second, families used a wide variety of scientific terms at home and encouraged children to pursue their interests whether in science or other fields. Third, these future scientists were often networked with extended family members or friends to observe and do science when they were quite young. Collectively, these findings highlight the specific ways in which families fostered early scientific interest and aided in supporting a student-directed learning environment. (shrink)

The authors conducted a baseline survey of baccalaureate and graduate degree health humanities programs in the United States and Canada. The object of the survey was to formally assess the current state of the field, to gauge what kind of resources individual programs are receiving, and to assess their self-identified needs to become or remain programmatically sustainable, including their views on the potential benefits of program accreditation. A 56-question baseline survey was sent to 111 institutions with baccalaureate programs and 20 (...) institutions with graduate programs. Respondents were asked about three areas: (1) program administration (managing unit, paid director, faculty lines, paid staff, funding sources); (2) educational program (curricular structure, CIP code usage, completion rates); and (3) views on accreditation for the field. A clear majority of respondents agreed that some form of accreditation or consultation service could address resource and sustainability issues. Overall, the survey responses to staffing, curricular structure, and support suggest the need for developing a sustainable infrastructure for health humanities. (shrink)

"The fixed person for fixed duties, who in older societies was such a godsend, in the future ill be a public danger." Twenty years ago, a single legal metaphor accurately captured the role that American society accorded to physicians. The physician was "c- tain of the ship." Physicians were in charge of the clinic, the Operating room, and the health care team, responsible - and held accountabl- for all that happened within the scope of their supervision. This grant of responsibility (...) carried with it a corresponding grant of authority; like the ship's captain, the physician was answerable to no one regarding the practice of his art. However compelling the metaphor, few would disagree that the mandate accorded to the medical profession by society is changing. As a result of pressures from a number of diverse directions - including technological advances, the development of new health professionals, changes in health care financing and delivery, the recent emphasis on consumer choice and patients' rights - what our society expects phy- cians to do and to be is different now. The purpose of this volume is to examine and evaluate the conceptual foundations and the moral imp- cations of that difference. Each of the twelve essays of this volume assesses the current and future validity of the "captain of the ship" metaphor from a different perspective. The essays are grouped into four sections. In Section I, Russell Maulitz explores the physician's role historically. (shrink)

Research suggests political identity has strong influence over individuals’ attitudes and beliefs, which in turn can affect their behavior. Likewise, firsthand experience with an issue can also affect attitudes and beliefs. A large survey of Americans was analyzed to investigate the effects of both political identity and personal impact on individuals’ reactions to the COVID-19 pandemic. Results show that political identity and personal impact influenced the American public’s attitudes about and response to COVID-19. Consistent with prior research, political identity exerted (...) a strong influence on self-reports of emotional distress, threat perception, discomfort with exposure, support for restrictions, and perception of under/overreaction by individuals and institutions. The difference between Democrats and Republican responses were consistent with their normative value differences and with the contemporary partisan messaging. Personal impact exerted a comparatively weaker influence on reported emotional distress and threat perception. Both factors had a weak influence on appraisal of individual and government responses. The dominating influence of political identity carried over into the bivariate relations among these self-reported attitudes and responses. In particular, the appraisal of government response divided along party lines, tied to opposing views of whether there has been over- or under-reaction to the pandemic. The dominance of political identity has important implications for crisis management and reflects the influence of normative value differences between the parties, partisan messaging on the pandemic, and polarization in American politics. (shrink)

One of the convictions in religious studies and elsewhere is about the role dialogues play: by fulfilling the need for understanding, dialogues reduce violence. In this paper, we analyze two examples from Hinduism studies to show that precisely the opposite is true: dialogue about Hinduism has become the harbinger of violence. This is not because ‘outsiders’ have studied Hinduism or because the Hindu participants are religious ‘fundamentalists’ but because of the logical requirements of such a dialogue. Generalizing the structure of (...) this situation, we argue that, in certain dialogical situations, the requirements of reason conflict with the requirements of morality. (shrink)

Bullying often results in negative coping in victims, including an increased consumption of alcohol. Recently, however, an increase in alcohol use has also been reported among perpetrators of bullying. The factors triggering this pattern are still unclear. We investigated the role of empathy in the interaction between bullying and alcohol use in an adolescent sample (IMAGEN) at age 13.97 (±0.53) years (baseline (BL), N = 2165, 50.9% female) and age 16.51 (±0.61) years (follow-up 1 (FU1), N = 1185, 54.9% female). (...) General empathic distress served as a significant moderator of alcohol use in perpetrators (F9, 493 = 17.978, p < 0.01), which was specific for males and FU1. Male perpetrators, who are generally less sensitive to distress, might thus be more vulnerable to alcohol abuse. (shrink)