The ethical recruitment of participants with neurological disorders in clinical research requires obtaining initial and ongoing informed consent. The purpose of this study is to characterize barriers faced by research personnel in obtaining informed consent from research participants with neurological disorders and to identify strategies applied by researchers to overcome those barriers. This study was designed as a web-based survey of US researchers with an optional follow-up interview. A subset of participants who completed the survey were selected using a stratified (...) purposeful sampling strategy and invited to participate in an in-depth qualitative interview by phone or video conference. Data were analyzed using a mixed methods approach, including content analysis of survey responses and thematic analysis of interview responses. Over 1 year, 113 survey responses were received from US research personnel directly involved in obtaining informed consent from participants in neurological research. Frequently identified barriers to informed consent included: cognitive and communication impairments (e.g. aphasia), unrealistic expectations of research participants, mistrust of medical research, time constraints, literacy barriers, lack of available social support, and practical or resource-related constraints. Strategies to enhance informed consent included: involving close others to support participant understanding of study-related information, collaborating with more experienced research personnel to facilitate training in obtaining informed consent, encouraging participants to review consent forms in advance of consent discussions, and using printed materials and visual references. Beyond conveying study-related information, researchers included in this study endorsed ethical responsibilities to support deliberation necessary to informed consent in the context of misconceptions about research, unrealistic expectations, limited understanding, mistrust, and/or pressure from close others. Findings highlight the importance of training researchers involved in obtaining informed consent in neurological research to address disease-specific challenges and to support the decision-making processes of potential research participants and their close others. (shrink)

Growth of the Hispanic consumer population in America is changing the marketplace landscape. Due to their considerable buying power, a better understanding of Hispanic consumer behavior has become a necessity. The marketing literature has examined issues regarding religiosity and attitude toward business in regards to consumer ethical beliefs as well as research differentiating consumers on the basis of ethnicity due to their inherently different religious principles. Therefore, the present study contributes to the existing consumer ethics literature by examining the roles (...) of religiosity and attitude toward business in determining consumer ethical beliefs. Furthermore, this study compares the relationships among religiosity, attitude toward business, and ethical beliefs at the sub-cultural level (i.e., between Hispanic and Anglo-American consumers). Survey data compare a sample of 187 predominately Catholic Hispanic consumers with a sample of 127 predominately protestant Anglo consumers. Results suggest a positive relationship between intrinsic religiousness and beliefs that questionable consumer activities are unethical. However, extrinsic religiousness does not impact consumer views as to the ethicality of consumer practices. Hispanics exhibit higher levels of extrinsic religiousness than Anglos, but no difference in terms of their intrinsic religiousness. Results also suggest that Hispanics have a more negative attitude toward business than Anglos do. Implications of these results are discussed. (shrink)

The process of dehumanization, or thinking of others as less than human, is a phenomenon with significant societal implications. According to Haslam's model, two concepts of humanness derive from comparing humans with either animals or machines: individuals may be dehumanized by likening them to either animals or machines, or humanized by emphasizing differences from animals or machines. Recent work in cognitive neuroscience emphasizes understanding cognitive processes in terms of interactions between distributed cortical networks. It has been found that reasoning about (...) internal mental states is associated with activation of the default mode network and deactivation of the task positive network ; whereas reasoning about mechanical processes produces the opposite pattern. We conducted two neuroimaging studies. The first examined the neural bases of dehumanization and its relation to these two brain networks, using images and voice-over social narratives which either implicitly contrasted or implicitly likened humans to either animals or machines. The second study addressed a discrepancy between findings from the first study and prior work on the neural correlates of dehumanization: using a design similar to prior work we examined neural responses to pictures of humans, animals and machines, presented without any social context. In both studies, human and humanizing conditions were associated with relatively high activity in the DMN and relatively low activity in the TPN. However, the non-human and dehumanizing conditions deviated in different ways: they demonstrated more marked changes either in the DMN or in the TPN. Notably, differences between the animal dehumanizing and humanizing conditions were most evident in regions associated with mechanistic reasoning, not in the mentalizing network. Conjunction analysis of contrasts from both paradigms revealed that only one region was consistently more active when participants saw human, a medial parietal region regarded as the central hub of the DMN. These findings provide a neural basis for Haslam's distinction between two types of dehumanization, and suggest that the DMN and TPN play opposing roles in creating a sense of moral concern. (shrink)

Despite the growing body of literature on training in the responsible conduct of research, few studies have examined the effectiveness of delivery formats used in ethics courses. The present effort sought to address this gap in the literature through a meta-analytic review of 66 empirical studies, representing 106 ethics courses and 10,069 participants. The frequency and effectiveness of 67 instructional and process-based content areas were also assessed for each delivery format. Process-based contents were best delivered face-to-face, whereas contents delivered online (...) were most effective when restricted to compliance-based instructional contents. Overall, hybrid courses were found to be most effective, suggesting that ethics courses are best delivered using a blend of formats and content areas. Implications and recommendations for future development of ethics education courses in the sciences are discussed. (shrink)

BackgroundCommunity engagement within biomedical research is broadly defined as a collaborative relationship between a research team and a group of individuals targeted for research. A Community Advisory Board is one mechanism of engaging the community. Within genomics research CABs may be particularly relevant due to the potential implications of research findings drawn from individual participants on the larger communities they represent. Within such research, CABs seek to meet instrumental goals such as protecting research participants and their community from research-related risks, (...) as well as intrinsic goals such as promoting the respect of participants and their community. However, successful community engagement depends on the degree to which CABs legitimately represent and engage with communities targeted for research. Currently, there is little literature describing the use of CABs in genomics research taking place in developing countries, and even less in the field of genomics research relating to mental illness. The aim of this article is to describe and consider the contributions made by a researcher-driven, population-specific CAB in a genomics of schizophrenia research project taking place in South Africa, from the perspective of the research team.DiscussionFour broad discussion topics emerged during the CAB meetings namely: 1) informed consent procedures, 2) recruitment strategies, 3) patient illness beliefs and stigma experiences, and 4) specific ethical concerns relating to the project. The authors consider these discussions in terms of their contributions to instrumental and intrinsic goals of community engagement.SummaryThe CAB gave valuable input on the consent processes and materials, recruitment strategies and suggested ways of minimizing the potential for stigma and discrimination. All of these contributions were of an instrumental nature, and helped improve the way in which the research took place. In addition, and perhaps more importantly, the CAB made a unique and important contribution relating to intrinsic functions such as promoting the respect and dignity of research participants and their community. This was particularly evident in ensuring sensitivity and respect of the community’s traditional beliefs about schizophrenia and its treatment, and in this way promoting a respectful relationship between the research team and the participants. (shrink)

Cell line immortalisation is a growing component of African genomics research and biobanking. However, little is known about the factors influencing consent to cell line creation and immortalisation in African research settings. We contribute to addressing this gap by exploring three questions in a sample of Xhosa participants recruited for a South African psychiatric genomics study: First, what proportion of participants consented to cell line storage? Second, what were predictors of this consent? Third, what questions were raised by participants during (...) this consent process? 760 Xhose people with schizophrenia and 760 controls were matched to sex, age, level of education and recruitment region. We used descriptive statistics to determine the proportion of participants who consented to cell line creation and immortalization. Logistic regression methods were used to examine the predictors of consent. Reflections from study recruiters were elicited and discussed to identify key questions raised by participants about consent. Approximately 40% of participants consented to cell line storage. The recruiter who sought consent was a strong predictor of participant’s consent. Participants recruited from the South African Eastern Cape, and older participants, were more likely to consent; both these groups were more likely to hold traditional Xhosa values. Neither illness nor education were significant predictors of consent. Key questions raised by participants included two broad themes: clarification of what cell immortalisation means, and issues around individual and community benefit. These findings provide guidance on the proportion of participants likely to consent to cell line immortalisation in genomics research in Africa, and reinforce the important and influential role that study recruiters play during seeking of this consent. Our results reinforce the cultural and contextual factors underpinning consent choices, particularly around sharing and reciprocity. Finally, these results provide support for the growing literature challenging the stigmatizing perception that people with severe mental illness are overly vulnerable as a target group for heath research and specifically genomics studies. (shrink)

In our article, we share the lessons we have learned after creating and running a successful legal laboratory over the past seven years at Yale Law School. Our legal laboratory, which focuses on the intersection of law and severe brain injury, represents a unique pedagogical model for legal academia, and is closely influenced by the biomedical laboratory.

Ethics courses are most commonly evaluated using reaction measures. However, little is known about the specific types of reaction data being collected and how these reaction data relate to improvements in trainee performance. Using a sample of 381 ethics training sessions, major reaction data categories were identified. Content and course satisfaction were the most frequently collected types of reaction criteria. Furthermore, content relevance and course satisfaction showed strong, positive relationships with performance criteria, whereas content satisfaction demonstrated a moderate, negative relationship. (...) These results and future directions for ethics training evaluation are discussed. (shrink)

Background The rise in genomic and biobanking research worldwide has led to the development of different informed consent models for use in such research. This study analyses consent documents used by investigators in the H3Africa (Human Heredity and Health in Africa) Consortium. Methods A qualitative method for text analysis was used to analyse consent documents used in the collection of samples and data in H3Africa projects. Thematic domains included type of consent model, explanations of genetics/genomics, data sharing and feedback of (...) test results. Results Informed consent documents for 13 of the 19 H3Africa projects were analysed. Seven projects used broad consent, five projects used tiered consent and one used specific consent. Genetics was mostly explained in terms of inherited characteristics, heredity and health, genes and disease causation, or disease susceptibility. Only one project made provisions for the feedback of individual genetic results. Conclusion H3Africa research makes use of three consent models—specific, tiered and broad consent. We outlined different strategies used by H3Africa investigators to explain concepts in genomics to potential research participants. To further ensure that the decision to participate in genomic research is informed and meaningful, we recommend that innovative approaches to the informed consent process be developed, preferably in consultation with research participants, research ethics committees and researchers in Africa. (shrink)

Background Informed consent is an integral component of good medical practice. Many researchers have investigated measures to improve the quality of informed consent, but it is not clear which techniques work best and why. To address this problem, we propose developing a core outcome set to evaluate interventions designed to improve the consent process for surgery in adult patients with capacity. Part of this process involves reviewing existing research that has reported what is important to patients and doctors in the (...) informed consent process. Methods This qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies. Results Searches of bibliographic databases returned 11,073 titles. Of these, 16 studies met the inclusion criteria. Studies were published between 1996 and 2016 and included a total of 367 patients and 74 health care providers. Thirteen studies collected data using in-depth interviews and constant comparison was the most common means of qualitative analysis. A total of 94 findings were extracted from the primary papers and divided into 17 categories and ultimately 6 synthesised findings related to: patient characteristics, knowledge, communication, the model patient, trust and decision making. Conclusions This qualitative meta-aggregation is the first to examine the issue of informed consent for surgery. It has revealed several outcomes deemed important to capture by patients and clinicians when evaluating the quality of a consent process. Some of these outcomes have not been examined previously in research comparing methods for informed consent. This review is an important step in the development of a COS to evaluate interventions designed to improve the consent process for surgery. Registration The study protocol was registered on the international prospective register for systematic reviews. (shrink)

BackgroundMulti-centre studies generally cost more than single-centre studies because of larger sample sizes and the need for multiple ethical approvals. Multi-centre studies include clinical trials, clinical quality registries, observational studies and implementation studies. We examined the costs of two large Australian multi-centre studies in obtaining ethical and site-specific approvals.MethodsWe collected data on staff time spent on approvals and expressed the overall cost as a percent of the total budget.ResultsThe total costs of gaining approval were 38 % of the budget for (...) a study of 50 centres (mean cost AUD $6960 per site) and 2 % for a study of 11 centres (mean cost AUD $2300 per site). Seventy-five and 90 % of time was spent on repeated tasks, respectively, and many time-consuming tasks, such as reformatting documents, did nothing to improve the study design or participant safety.ConclusionsImprovements have been made to the ethical approval application system, but more gains could be made without increasing risks of harm to research participants. We propose that ethical review bodies and individual sites publish statistics on how long they take to process approvals which could then be nationally benchmarked. (shrink)

A prefrontal control system that is less mature than the limbic reward system in adolescence is thought to impede self-regulatory abilities, which could contribute to poor dietary choices and obesity. We, therefore, aimed to examine whether structural morphology of the prefrontal cortex and the amygdala are associated with dietary decisions and obesity in children and adolescents. Seventy-one individuals between the ages of 8–22 years participated in this study; each participant completed a computer-based food choice task and a T1- and T2-weighted (...) structural brain scans. Two indices of obesity were assessed, including age- and sex-specific body mass index and waist-to-height ratio. The behavioral task included rating 60 food stimuli for tastiness, healthiness, and liking. Based on each participant’s self-ratings, 100 binary food choices were then made utilizing a computer mouse. Dietary “self-control” was calculated as the proportion of trials where the individual chose the healthier food item over the total number of trials. Cortical thickness and amygdala subnuclei volumes were quantified using FreeSurfer 6.0 and CIT168 atlas, respectively. We found that WHtR was negatively associated with the thickness of bilateral superior frontal, left superior temporal, right insula, and right inferior temporal regions. We also found WHtR to be positively associated with the volume of the central nucleus region of the amygdala, after adjusting for the hemisphere, age, sex, and intracranial volumes. A similar data pattern was observed when BMIz was used. Moreover, we found that across all participants, thinner right superior frontal cortex and larger left CEN volumes predicted lower dietary self-control. These results suggest that differential development of the PFC and amygdala relate to obesity and dietary self-control. Further longitudinal studies are merited to determine causal relationships among altered PFC to amygdala neural circuitry, dietary self-control, and obesity. (shrink)

People consistently act in ways that harm the environment, even when believing their actions are environmentally friendly. A case in point is a biased judgment termed the negative footprint illusion, which arises when people believe that the addition of “eco-friendly” items to conventional items, reduces the total carbon footprint of the whole item-set, whereas the carbon footprint is, in fact, increased because eco-friendly items still contribute to the overall carbon footprint. Previous research suggests this illusion is the manifestation of an (...) “averaging-bias.” We present two studies that explore whether people’s susceptibility to the negative footprint illusion is associated with individual differences in: environment-specific reasoning dispositions measured in terms of compensatory green beliefs and environmental concerns; or general analytic reasoning dispositions measured in terms of actively open-minded thinking, avoidance of impulsivity and reflective reasoning. A negative footprint illusion was demonstrated when participants rated the carbon footprint of conventional buildings combined with eco-friendly buildings and conventional cars combined with eco-friendly cars. However, the illusion was not identified in participants’ ratings of the carbon footprint of apples. In Studies 1 and 2, environment-specific dispositions were found to be unrelated to the negative footprint illusion. Regarding reflective thinking dispositions, reduced susceptibility to the negative footprint illusion was only associated with actively open-minded thinking measured on a 7-item scale and 17-item scale. Our findings provide partial support for the existence of a negative footprint illusion and reveal a role of individual variation in reflective reasoning dispositions in accounting for a limited element of differential susceptibility to this illusion. (shrink)

1 Evidence-based policy requires researchers to provide the answers to ecological questions that are of interest to policy makers. To find out what those questions are in the UK, representatives from 28 organizations involved in policy, together with scientists from 10 academic institutions, were asked to generate a list of questions from their organizations. 2 During a 2-day workshop the initial list of 1003 questions generated from consulting at least 654 policy makers and academics was used as a basis for (...) generating a short list of 100 questions of significant policy relevance. Short-listing was decided on the basis of the preferences of the representatives from the policy-led organizations. 3 The areas covered included most major issues of environmental concern in the UK, including agriculture, marine fisheries, climate change, ecosystem function and land management. 4 The most striking outcome was the preference for general questions rather than narrow ones. The reason is that policy is driven by broad issues rather than specific ones. In contrast, scientists are frequently best equipped to answer specific questions. This means that it may be necessary to extract the underpinning specific question before researchers can proceed. 5 Synthesis and applications. Greater communication between policy makers and scientists is required in order to ensure that applied ecologists are dealing with issues in a way that can feed into policy. It is particularly important that applied ecologists emphasize the generic value of their work wherever possible. (shrink)

Multiteam systems are complex organizational forms comprising interdependent teams that work towards their own proximal goals within and across teams to also accomplish a shared superordinate goal. MTSs operate within high-stakes, dangerous contexts with high consequences for suboptimal performance. We answer calls for nuanced exploration and cross-context comparison of MTSs “in the wild” by leveraging the MTS action sub-phase behavioral taxonomy to determine where and how MTS failures occur. To our knowledge, this is the first study to also examine how (...) key MTS attributes influence MTS processes and performance. We conducted historiometric analysis on 40 cases of failed MTS performance across various contexts to uncover patterns of within- and between-team behaviors of failing MTSs, resulting in four themes. First, component teams of failing MTSs over-engaged in within-team alignment behaviors by enacting acting, monitoring, and recalibrating behaviors more often within than between teams. Second, failing MTSs over-focused on acting behaviors and tended to not fully enact the action sub-phase cycle. Third and fourth, boundary status and goal type exacerbated these behavioral patterns, as external and physical MTSs were less likely to enact sufficient between-team behaviors or fully enact the action sub-phase cycle compared to internal and intellectual MTSs. We propose entrainment as a mechanism for facilitating MTS performance wherein specific, cyclical behavioral patterns enacted by teams align to facilitate goal achievement via three multilevel behavioral cycles. We argue that the degree to which these cycles are aligned both between teams and with the overarching MTS goal determines whether and how an MTS fails. Our findings add nuance beyond single-context MTS studies by showing that the identified behavioral patterns hold both across contexts and almost all types of MTS action-phase behaviors. We show that these patterns vary by MTS boundary status and goal type. Our findings inform MTS training best practices, which should be structured to integrate all component teams and tailored to both MTS attributes and situation type. (shrink)

Background: Omalizumab, an anti-immunoglobulin E antibody, reduces exacerbations and symptoms in uncontrolled allergic asthma. The study objective was to estimate the costs and consequences of omalizumab compared to usual care from a US payer perspective. Methods: We estimated payer costs, quality-adjusted survival (QALYs), and the incremental cost-effectiveness ratio (ICER) of omalizumab compared to usual care using a state-transition simulation model that included sensitivity analyses. Every 2 weeks, patients could transition between chronic asthma and exacerbation health states. The best available evidence (...) informed the clinical and cost input estimates. Five years of omalizumab treatment followed by usual care was assumed to estimate a lifetime horizon. Omalizumab responders (60.5% of treated) were modeled as a separate scenario where nonresponders reverted back to usual care after 16 weeks of active treatment. Results: The mean lifetime discounted costs and QALYs were $83 400 and 13.87 for usual care and $174 500 and 14.19 for omalizumab plus usual care resulting in $287 200/QALY (95% interval: $219 300, $557 900). The ICER was $172 300/QALY when comparing omalizumab to usual care in the responder scenario. One-way sensitivity analyses indicated that the results were sensitive to the difference in treatment-specific utilities for the chronic state, exacerbation-associated mortality, omalizumab price, exacerbation rates, and response definition. Conclusions: The results suggest that adding omalizumab to usual care improves QALYs at an increase in direct medical costs. The cost-effectiveness of omalizumab is similar to other chronic disease biologics. The value increases when omalizumab response is used to guide long-term treatment. (shrink)

The aim of this systematic review was to summarize and assess the quality of asthma intervention health economic studies from 2002 to 2007, compare the study findings with clinical management guidelines, and suggest avenues for future improvement of asthma health economic studies. Forty of the 177 studies met our inclusion criteria. We assessed the quality of studies using The Quality of Health Economic Studies validated instrument (total score range: 0-100). Six studies (15%) had quality category 2, 26 studies (65%) achieved (...) quality category 3, and the remaining eight (20%) studies were scored as the highest quality level, category 4. Overall, the findings from this review are in line with the Global Initiative for Asthma clinical guidelines. Many asthma health economic studies lacked appropriate long term time horizons to match the chronic nature of the disease and suffered from using effectiveness measures that did not capture all disease related risks and benefits. We recommend that new asthma simulation models: be flexible to allow for long term time horizons, focus on using levels of asthma control in their structure, and estimate both long term asthma specific outcomes like well-controlled time as well as generic outcomes such as quality adjusted survival. (shrink)

When Congress passed the 19th Amendment in 1919 granting women voting rights, 13 western states had already adopted woman suffrage. Only 2 states outside the West had done so. Using event history analysis, the authors investigate why woman suffrage came early to the western states. Alan Grimes's hypotheses, that native-born, western men were willing to give women the vote to remedy western social problems and to increase the number of women in the region, receive little support in our analysis. Rather, (...) this study finds that woman suffrage came to the West because of the mobilization of the western suffrage movements and because of political and gendered opportunities existing in that region. (shrink)

Incapacitated adults with a legally appointed guardian or conservator may be recruited for or involved with medical, behavioral, or social science research. Much of the research in which such persons participate is aimed at evaluating medical interventions for them, or contributing to general knowledge about disorders from which they may suffer. In this paper we will consider how the appointment of guardians for patients with disorders of consciousness —severe brain injuries that affect a patient’s level of arousal and ability to (...) interact —impacts such patients’ access to research.Such persons may be under guardianship because they have lost decisional capacity (i.e., those in a coma or... (shrink)

The philosopher John J. McDermott comes out of the long American tradition that takes the aim of philosophical inquiry to be interpretation of the open meanings of experience, so that we might all live fuller and richer lives. Here, the authors of these nine essays explore his highly original interpretations of philosophy's various questions about our shared existence. How are we to understand the nature of American culture and to carry forward its important contributions? What is the personal importance of (...) embodiment, of living in the realization of death? How does our physical and personal environment nourish bodies and spirits? What does the deliberate pursuit of a morality offer us? How can we carry forward the fundamental tasks of education to enable those who follow us to use our shared past to address their civic and spiritual problems? What are the possibilities for community? Together, these essays offer a clear, multi-layered understanding of the compelling vision that McDermott has presented over the years. In an Afterword, McDermott responds to the authors' queries and concerns, offering a restatement of his understanding of the American philosopher's task. These essays indicate, and McDermott's response confirms, that for him philosophy is not a purely cerebral activity. Philosophy is, rather, an intellectual means of exploring the fullness of human experience, and it functions best when it operates in the context of the broad sweep of the humanities. Similarly, for McDermott the self is no given substantial entity. On the contrary, it is relational, rooted geographically and socially in its place and its fellows, and damaged when these life-giving processes fail. Further, McDermott does not accept any ultimate canopy of meaning. The human journey is a personal project within which provisional meanings must be created to sustain our advance. (shrink)

The philosopher John J. McDermott comes out of the long American tradition that takes the aim of philosophical inquiry to be interpretation of the open meanings of experience, so that we might all live fuller and richer lives. Here, the authors of these nine essays explore his highly original interpretations of philosophy's various questions about our shared existence. How are we to understand the nature of American culture and to carry forward its important contributions? What is the personal importance of (...) embodiment, of living in the realization of death? How does our physical and personal environment nourish bodies and spirits? What does the deliberate pursuit of a morality offer us? How can we carry forward the fundamental tasks of education to enable those who follow us to use our shared past to address their civic and spiritual problems? What are the possibilities for community? Together, these essays offer a clear, multi-layered understanding of the compelling vision that McDermott has presented over the years. In an Afterword, McDermott responds to the authors' queries and concerns, offering a restatement of his understanding of the American philosopher's task. These essays indicate, and McDermott's response confirms, that for him philosophy is not a purely cerebral activity. Philosophy is, rather, an intellectual means of exploring the fullness of human experience, and it functions best when it operates in the context of the broad sweep of the humanities. Similarly, for McDermott the self is no given substantial entity. On the contrary, it is relational, rooted geographically and socially in its place and its fellows, and damaged when these life-giving processes fail. Further, McDermott does not accept any ultimate canopy of meaning. The human journey is a personal project within which provisional meanings must be created to sustain our advance. (shrink)