No consensus yet exists on how to handle incidental fnd-ings in human subjects research. Yet empirical studies document IFs in a wide range of research studies, where IFs are fndings beyond the aims of the study that are of potential health or reproductive importance to the individual research participant. This paper reports recommendations of a two-year project group funded by NIH to study how to manage IFs in genetic and genomic research, as well as imaging research. We conclude that researchers (...) have an obligation to address the possibility of discovering IFs in their protocol and communications with the IRB, and in their consent forms and communications with research participants. Researchers should establish a pathway for handling IFs and communicate that to the IRB and research participants. We recommend a pathway and categorize IFs into those that must be disclosed to research participants, those that may be disclosed, and those that should not be disclosed. (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)

The spiders Cupiennius salei and Achaearanea tepidariorum are firmly established laboratory models that have already contributed greatly to answering evolutionary developmental questions. Here we appraise why these animals are such useful models from phylogeny, natural history and embryogenesis to the tools available for their manipulation. We then review recent studies of axis formation, segmentation, appendage development and neurogenesis in these spiders and how this has contributed to understanding the evolution of these processes. Furthermore, we discuss the potential of comparisons of (...) silk production between Cupiennius and Achaearanea to investigate the origins and diversification of this evolutionary innovation. We suggest that further comparisons between these two spiders and other chelicerates will prove useful for understanding the evolution of development in metazoans. BioEssays 30:487–498, 2008. © 2008 Wiley Periodicals, Inc. (shrink)

We investigate the index sets associated with the degree structures of computable sets under the parameterized reducibilities introduced by the authors. We solve a question of Peter Cholakand the first author by proving the fundamental index sets associated with a computable set A, {e : W e ≤ q u A} for q∈ {m, T} are Σ4 0 complete. We also show hat FPT(≤ q n ), that is {e : W e computable and ≡ q n ?}, is Σ4 (...) 0 complete. We also look at computable presentability of these classes. (shrink)

Deep brain stimulation is a well-established therapy for the motor symptoms of Parkinson’s disease, but there remains an opportunity to improve symptom relief. The temporal pattern of stimulation is a new parameter to consider in DBS therapy, and we compared the effectiveness of Temporally Optimized Patterned Stimulation to standard DBS at reducing the motor symptoms of PD. Twenty-six subjects with DBS for PD received three different patterns of stimulation while on medication and using stimulation parameters optimized for standard DBS. Side (...) effects and motor symptoms were assessed after 30 min of stimulation with each pattern. Subjects experienced similar types of side effects with TOPS and standard DBS, and TOPS were well-tolerated by a majority of the subjects. On average, the most effective TOPS was as effective as standard DBS at reducing the motor symptoms of PD. In some subjects a TOPS pattern was the most effective pattern. Finally, the TOPS pattern with low average frequency was found to be as effective or more effective in about half the subjects while substantially reducing estimated stimulation energy use. TOPS DBS may provide a new programing option to improve DBS therapy for PD by improving symptom reduction and/or increasing energy efficiency. Optimizing stimulation parameters specifically for TOPS DBS may demonstrate further clinical benefit of TOPS DBS in treating the motor symptoms of Parkinson’s disease. (shrink)

We evaluate several significant objections to the possibility of group belief. These incredulity objections urge that the very concept of group belief is suspect or incoherent. Although many other...

Is there really an ethical crisis? We propose that the situation is not as bad as many would have us believe. We have attempted to present an alternative explanation for some earlier reports of an ethical crisis. This has resulted in a number of research propositions. We are optimistic that there are, in spite of reports to the contrary, an overwhelming majority of ethical people populating our business community.

We consider Sussman et al. 's suggestion that auditory biases for processing low-noise relationships among pairs of acoustic variables is a preadaptation for human speech processing. Data from other animal communication systems, especially those involving sexual selection, also suggest that neural biases in the receiver system can generate strong selection on the form of communication signals.

Scientific knowledge and technological expertise continue to evolve rapidly. Such innovation gives rise to new benefits as well as risks, at an ever-increasing pace. Within this context, regulatory regimes must function in order to address policymakers’ objectives. Innovation, though, can challenge the functioning and effectiveness of regulatory regimes. Questions over fit, effectiveness, and capacity of these regimes to ensure the safe entry of such technologies, and their products, onto the market will be asked in parallel to their development. With this (...) in mind, this article examines the strengths and weaknesses of current regulatory frameworks, including those designed for biotechnology, cosmetics, novel organisms, and foods, in order to inform and help shape Australia’s regulatory landscape around innovation. By focusing on Australia, the article illustrates the need to assess future changes to regulatory frameworks using a careful balancing of key factors. These include, for example, horizon scanning and monitoring, availability of appropriate data, existing health, safety, environmental, ethical, and social risks and impacts, and regulatory capacity. The article argues that rather than using one of these factors in isolation, a careful assessment of where each factor stands can lead regulators to an approach that properly manages the potential risks of emerging technologies. (shrink)

Poor ethical decision–making costs industry billions of dollars a year and damages the images of corporations. Thus, by answering the question ‘Why do individuals behave as they do when confronted with ethical issues?’ ethical theory can provide businesses with a means to create a more ethical climate and a more successful operation. This study tested the Ethical Decision–Making Model with accountability (Beu & Buckley 2001), which uses theory that suggests that ethical behavior is influenced by the individual, the issue, social (...) relationships (accountability), and the organization in which the employee is embedded (Brass, Butterfield & Skaggs 1988; Frink & Klimoski 1998). The results showed that individuals’ thought processes (cognitive moral development), personalities (locus of control, hostility and aggression, Machiavellianism), and gender influence how they respond to ethical dilemmas, as well as the salience of the moral issue (moral intensity) and the environmental context (work/school). (shrink)

Drug Safety Communications are used by the Food and Drug Administration to inform health care providers, patients, caregivers, and the general public about safety issues related to FDA-approved drugs. To assess patient knowledge of the messaging contained in DSCs related to the sleep aids zolpidem and eszopiclone, we conducted a large, cross-sectional patient survey of 1,982 commercially insured patients selected by stratified random sampling from the Optum Research Database who had filled at least two prescriptions for either zolpidem or eszopiclone (...) between July 1, 2012 and June 30, 2013. Among the 594 respondents, two-thirds reported hearing generally about drug safety information prior to starting a new drug, with the remaining one-third “rarely” or “never” hearing such information. Providers and pharmacists were primary sources of drug safety information. Two-thirds of zolpidem users and half of eszopiclone users reported having heard about the related DSC messages, ability to accurately identify the major factual messages was limited. Respondents reacted to new drug safety information about their sleep aids by reporting that they would want to learn about alternative ways to help them sleep and seek out more information about the safety of their specific sleeping pill. Opportunities may exist for the FDA to work with providers and pharmacies to help ensure the DSC information is more widely received and is more fully understood by those taking the affected medications. (shrink)

The United States has long been a model for accessible, affordable education, as exemplified by the country's public universities. And yet less than 60 percent of the students entering American universities today are graduating. Why is this happening, and what can be done? Crossing the Finish Line provides the most detailed exploration ever of college completion at America's public universities. This groundbreaking book sheds light on such serious issues as dropout rates linked to race, gender, and socioeconomic status. Probing graduation (...) rates at twenty-one flagship public universities and four statewide systems of public higher education, the authors focus on the progress of students in the entering class of 1999--from entry to graduation, transfer, or withdrawal. They examine the effects of parental education, family income, race and gender, high school grades, test scores, financial aid, and characteristics of universities attended. The conclusions are compelling: minority students and students from poor families have markedly lower graduation rates--and take longer to earn degrees--even when other variables are taken into account. Noting the strong performance of transfer students and the effects of financial constraints on student retention, the authors call for improved transfer and financial aid policies, and suggest ways of improving the sorting processes that match students to institutions. An outstanding combination of evidence and analysis, Crossing the Finish Line should be read by everyone who cares about the nation's higher education system. (shrink)

In the human quest for meaning, work occupies a central position. Most adults spend the majority of their waking hours at work, which often serves as a primary source of purpose, belongingness, and identity. In light of these benefits to employees and their organizations, organizational scholars are increasingly interested in understanding the factors that contribute to meaningful work, such as the design of jobs, interpersonal relationships, and organizational missions and cultures. In a separate line of inquiry, scholars of business ethics (...) have examined meaningful work as a moral issue concerning the management of others and ourselves, exploring whether there are definable characteristics of meaningful work to which we have moral rights, and whether there are moral duties to ourselves and others to fulfill those rights. In this article, we examine contemporary developments in both disciplines about the nature, causes, and consequences of meaningful work; we explore linkages between these disciplines; and we offer conclusions and research opportunities regarding the interface of ethical and organizational perspectives on performing and providing meaningful work. (shrink)

At almost every election, Americans are inclined to say that this is the most consequential election in American history. 2020 is no exception. However, what is particularly remarkable about the No...

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)

The idea for an Internet of Things has matured since its inception as a concept in 1999. People today speak openly of a Web of Things and People, and even more broadly of an Internet of Everything. As our relationships become more and more complex and enmeshed, through the use of advanced technologies, we have pondered on ways to simplify flows of communications, to collect meaningful data, and use them to make timely decisions with respect to optimisation and efficiency. At (...) their core, these flows of communications are pathways to registers of interaction, and tell the intricate story of outputs at various units of analysis- things, vehicles, animals, people, organisations, industries, even governments. In this trend toward evidence-based enquiry, data is the enabling force driving the growth of IoT infrastructure. This paper uses the case of location-based services, which are integral to IoT approaches, to demonstrate that new technologies are complex in their effects on society. Fundamental to IoT is the spatial element, and through this capability, the tracking and monitoring of everything, from the smallest nut and bolt, to the largest shipping liner to the mapping of planet earth, and from the whereabouts of the minor to that of the prime minister. How this information is stored, who has access, and what they will do with it, is arguable depending on the stated answers. In this case study of location-based services we concentrate on control and trust, two overarching themes that have been very much neglected, and use the outcomes of this research to inform the development of a socio-ethical conceptual framework that can be applied to minimise the unintended negative consequences of advanced technologies. We posit it is not enough to claim objectivity through information ethics approaches alone, and present instead a socio-ethical impact framework. Sociality therefore binds together that higher ideal of praxis where the living thing is the central and most valued actor of a system. (shrink)

At the forefront of international concerns about global legislation and regulation, a host of noted environmentalists and business ethicists examine ethical issues in consumption from the points of view of environmental sustainability, economic development, and free enterprise.

The ability to extrapolate essential gist through the analysis and synthesis of information, prediction of potential outcomes, abstraction of ideas, and integration of relationships with world knowledge is critical for higher-order learning. The present study investigated the efficacy of cognitive training to elicit improvements in gist-reasoning and fact recall ability in 556 public middle-school students (grades seven and eight), versus a sample of 357 middle school students who served as a comparison group, to determine if changes in gist-reasoning and fact (...) recall were demonstrated without cognitive training. The results showed that, in general, cognitive training increased gist-reasoning and fact recall abilities in students from families in poverty as well as students from families living above poverty. However, the magnitude of gains in gist-reasoning varied as a function of gender and grade-level. Our primary findings were that seventh and eighth grade girls and eighth grade boys showed significant increases in gist-reasoning after training regardless of socioeconomic status. There were no significant increases in gist-reasoning or fact recall ability for the 357 middle school students who served in the comparison group. We postulate that cognitive training in middle school is efficacious for improving gist-reasoning ability and fact recall in students from all socioeconomic levels. (shrink)

A child’s death is a profound loss for mothers and affects hundreds of thousands of women. Mothers report inconsolable and progressive grief that is distinct from depression and impacts daily emotions and functions. The brain mechanisms responsible for this relatively common and profound mental health problem are unclear, hampering its clinical recognition and care. In an initial exploration of this condition, we used resting state functional MRI (fMRI) scans to examine functional connectivity in key circuits, and task-based fMRI to examine (...) brain network activity in grieving mothers in response to pictures of their deceased child and as well as recognizable deceased celebrities and unfamiliar individuals. We compared nine mothers who had lost an adult child and aged-matched control mothers with a living child of a similar age. Additionally, we collected diffusion imaging scans to probe structural connectivity and complemented the imaging studies with neuropsychological assessments. Increased functional activation in Ventral Attention/Salience Networks accompanied by a reduced activation in the medial prefrontal cortex in response to the deceased child’s picture robustly distinguished the grieving mothers from controls. Heightened resting-state functional connectivity between the paraventricular thalamic nucleus (PVT) and the amygdala distinguished the grieving mothers from the controls and correlated with subjective grief severity. Structurally, maternal grief and its severity were associated with alterations in corticolimbic white matter tracts. Finally, grieving mothers performed worse than controls on neuropsychological tests of learning, memory, and executive function, linked with grief severity. Reduced activation in cortical regions inhibiting emotions and changes in the PVT circuitry—a region involved in long-term emotional memories and decision making under conflict—distinguish grieving mothers from controls. Notably, the magnitude of neurobiological changes correlates with the subjective severity of grief. Together, these new discoveries delineate a prevalent and under-recognized mental health syndrome and chart a path for its appreciation and care. (shrink)

Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons. We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.

Introduction No consent for health and medical research is appropriate when the criteria for a waiver of consent are met, yet some ethics committees and data custodians still require informed consent. Methods A single-blind parallel-group randomised controlled trial: 1129 families of children born at a South Australian hospital were sent information explaining data linkage of childhood immunisation and hospital records for vaccine safety surveillance with 4 weeks to opt in or opt out by reply form, telephone or email. A subsequent (...) telephone interview gauged the intent of 1026 parents (91%) in relation to their actions and the sociodemographic differences between participants and non-participants in each arm. Results The participation rate was 21% (n=120/564) in the opt-in arm and 96% (n=540/565) in the opt-out arm (χ2 (1 df) = 567.7, p<0.001). Participants in the opt-in arm were more likely than non-participants to be older, married/de facto, university educated and of higher socioeconomic status. Participants in the opt-out arm were similar to non-participants, except men were more likely to opt out. Substantial proportions did not receive, understand or properly consider study invitations, and opting in or opting out behaviour was often at odds with parents' stated underlying intentions. Conclusions The opt-in approach resulted in low participation and a biased sample that would render any subsequent data linkage unfeasible, while the opt-out approach achieved high participation and a representative sample. The waiver of consent afforded under current privacy regulations for data linkage studies meeting all appropriate criteria should be granted by ethics committees, and supported by data custodians. Trial registration number Australian New Zealand Clinical Trials Registry ACTRN12610000332022. (shrink)