Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are a novel approach for conducting clinical trials that potentially bring important benefits for research, including several collateral benefits. The position of collateral benefits in risk-benefit assessments is currently unclear. DCTs raise therefore questions about how these benefits should be assessed. This paper aims to reconsider the different types of research benefits, and their position in risk-benefit assessments. We first (...) propose a categorization of research benefits, based on the types of benefits that can be distinguished from the literature and ethical guidelines. Secondly, we will reconsider the position of collateral benefits. We argue that these benefits are not fundamentally different from other benefits of research and can therefore be included in risk-benefit assessments of DCTs. (shrink)

Makin argues that doctors1 should defer to each patient’s attitude to risk, over and above standard, utility-based and outcome-focussed medical decision-making models, in selecting treatment options for that patient.1 Although Makin articulates the problem as a dilemma of whether ‘to give the treatment or to withhold it’, it can be assumed that his question is whether the doctor should offer a certain treatment; because both the General Medical Council and law require doctors to engage patients in shared decision-making (SDM) (...) and to obtain consent before ‘giving’ any treatment. Yet, Makin is correct in asserting that doctors ‘make choices on behalf of their patients on a daily basis’ insofar that doctors do have to make certain a priori decisions. SDM requires a starting point—a range of clinically appropriate or reasonable options—on which patients and doctors can collaboratively deliberate in order to reach a treatment decision; and the doctor has to set out this starting point.2 Thus, Makin’s reductive claim is that doctors should take each patient’s risk attitude into account in setting out the starting points for SDM. In this commentary, I will explore UK case law in response to Makin’s proposal; because, ultimately, doctors have to work within the legal framework. Makin relies on the bioethical principles of respect …. (shrink)

To clarify the proper role of values in science, focusing on controversial expert responses to Covid-19, this article examines the status of (in)convenient hypotheses. Polarizing cases like health experts downplaying mask efficacy to save resources for healthcare workers, or scientists dismissing “accidental lab leak” hypotheses in view of potential xenophobia, plausibly involve modifying evidential standards for (in)convenient claims. Societies could accept that scientists handle (in)convenient claims just like nonscientists, and give experts less political power. Or societies could hold scientists to (...) a higher bar, by expecting them not to modify evidential standards to avoid costs only incidentally tied to error. (shrink)

At the heart of the book - two views (naturalist and humanist) on the dangers of and Prospects of "scientific and technological progress," that defining the face of modern civilization. Its leaders are now the information, genetic cal and biological technology.

Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to for example data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT practice. Digitalization has impacts that go beyond (...) its direct purposes, by shaping behaviors, experiences, social relations, and values. We examine four elements of the informed consent procedure that are affected by DCTs, while taking these soft impacts of technologies into account: (i) informing participants and testing understanding, (ii) freedoms in relation to responsibilities and burdens, (iii) trust in participant-researcher relations, and (iv) impacts on the concept of privacy. Our analysis reveals that a broad view is key for optimal conduct of DCTs. In addition, it provides insight into the ethical impacts of DCTs on informed consent. Technologies such as DCTs potentially have profound impacts which are not immediately addressed by the existing regulatory frameworks, but nonetheless important to recognize. These findings can guide future practices of DCTs to foster the important values of clinical research in this novel approach for conducting clinical trials. (shrink)

The co-evolutionary concept of three-modal stable evolutionary strategy of Homo sapiens is developed. The concept based on the principle of evolutionary complementarity of anthropogenesis: value of evolutionary risk and evolutionary path of human evolution are defined by descriptive (evolutionary efficiency) and creative-teleological (evolutionary correctness) parameters simultaneously, that cannot be instrumental reduced to other ones. Resulting volume of both parameters define the vectors of biological, social, cultural and techno-rationalistic human evolution by two gear mechanism — genetic and cultural co-evolution and (...) techno-humanitarian balance. Explanatory model and methodology of evaluation of creatively teleological evolutionary risk component of NBIC technological complex is proposed. Integral part of the model is evolutionary semantics (time-varying semantic code, the compliance of the biological, socio-cultural and techno-rationalist adaptive modules of human stable evolutionary strategy). (shrink)

Sources of evolutionary risk for stable strategy of adaptive Homo sapiens are an imbalance of: (1) the intra-genomic co-evolution (intragenomic conflicts); (2) the gene-cultural co-evolution; (3) inter-cultural co-evolution; (4) techno-humanitarian balance; (5) inter-technological conflicts (technological traps). At least phenomenologically the components of the evolutionary risk are reversible, but in the aggregate they are in potentio irreversible destructive ones for biosocial, and cultural self-identity of Homo sapiens. When the actual evolution is the subject of a rationalist control and/or manipulation, (...) the magnitude of the 4th and 5th components of the evolutionary risk reaches a level of existential significance. (shrink)

Stem cells are likely to be used as an alternate source of biological material for neural transplantation to treat Parkinson’s disease in the not too distant future. Among the several ethical criteria that must be fulfilled before proceeding with clinical research, a favourable benefit to risk ratio must be obtained. The potential benefits to the participant and to society are evaluated relative to the risks in an attempt to offer the participants a reasonable choice. Through examination of preclinical studies (...) transplanting stem cells in animals and the transplantation of fetal tissue in patients with Parkinson’s disease, a current set of potential benefits and risks for neural transplantation of stem cells in clinical research of Parkinson’s disease are derived. The potential benefits to research participants undergoing stem cell transplantation are relief of parkinsonian symptoms and decreasing doses of parkinsonian drugs. Transplantation of stem cells as a treatment for Parkinson’s disease may benefit society by providing knowledge that can be used to help determine better treatments in the future. The risks to research participants undergoing stem cell transplantation include tumour formation, inappropriate stem cell migration, immune rejection of transplanted stem cells, haemorrhage during neurosurgery and postoperative infection. Although some of these risks are general to neurosurgical transplantation and may not be reduced for participants, the potential risk of tumour formation and inappropriate stem cell migration must be minimised before obtaining a favourable potential benefit to risk calculus and to provide participants with a reasonable choice before they enrol in clinical studies. (shrink)

We investigate risk associated with the violation of a constraint, which is desirable but hardly satisfiable in all possible states of nature.

In the last several months, several major disciplines have started their initial reckoning with what ChatGPT and other Large Language Models (LLMs) mean for them – law, medicine, business among other professions. With a heavy dose of humility, given how fast the technology is moving and how uncertain its social implications are, this article attempts to give some early tentative thoughts on what ChatGPT might mean for bioethics. I will first argue that many bioethics issues raised by ChatGPT are similar (...) to those raised by current medical AI – built into devices, decision support tools, data analytics, etc. These include issues of data ownership, consent for data use, data representativeness and bias, and privacy. I describe how these familiar issues appear somewhat differently in the ChatGPT context, but much of the existing bioethical thinking on these issues provides a strong starting point. There are, however, a few “new-ish” issues I highlight – by new-ish I mean issues that while perhaps not truly new seem much more important for it than other forms of medical AI. These include issues about informed consent and the right to know we are dealing with an AI, the problem of medical deepfakes, the risk of oligopoly and inequitable access related to foundational models, environmental effects, and on the positive side opportunities for the democratization of knowledge and empowering patients. I also discuss how races towards dominance (between large companies and between the U.S. and geopolitical rivals like China) risk sidelining ethics. (shrink)

Voters satisfy maximin or maximax in their choices between sets of alternatives and secure a Pareto improvement by all voting strategically under simple majority voting for particular sincere preferences. Thus the assumption that strategic voting is a bad thing is challenged and the idea that we should reject voting because of the possibility of misrepresentation dismissed.

It is a pleasure to comment on Giulia Cavaliere’s ‘ Gestation, Equality and Freedom: Ectogenesis as a Political Perspective’ in what one might say is ‘enthusiastic disagreement’. The enthusiastic part is because the article is deserving of much praise for adding an important feminist and political theoretical perspective on ectogenesis. The disagreement may come more from disciplinary differences or disposition. As I understand her argument, Cavaliere intends to attack two common arguments in favour of research into ectogenesis—that is, gestation of (...) a human fetus outside the womb—one that sounds in the potential of the technology to promote equality, the other that it has the potential to promote liberty. On the first her critique is that the risks and burdens of gestation for women are most pronounced for the worst off, but ectogenesis is unlikely to be used by them. On the second her critique is, i nter alia, that treating ‘ectogenesis as a means to address workplace inequalities calls for solutions that change the way society reproduces itself rather than a labour market …. (shrink)

Stable adaptive strategy of Homo sapiens (SASH) is a result of the integration in the three-module fractal adaptations based on three independent processes of generation, replication, and the implementation of adaptations — genetic, socio-cultural and symbolic ones. The evolutionary landscape SASH is a topos of several evolutionary multi-dimensional vectors: 1) extraversional projective-activity behavioral intention (adaptive inversion 1), 2) mimesis (socio-cultural inheritance), 3) social (Machiavellian) intelligence, 4) the extension of inter-individual communication beyond their own social groups and their own species in (...) the rest of the world, 5) the symbolic system of communication (symbolic inheritance), 6) spiritualistic trans- formation of emotionally-shaped components of mentality, 7) the dominance of the rationalist thought mentality (enhancer of adaptive inverse 1), 8) a recursive distribution of projective-activity intentions on the man himself his genome, psyche and culture (Adaptive Inversion 2), 9) introversional reorientation of the vector of cognitive activity (adaptive inversion 3). (shrink)

Aging of the organism is associated with highly reproducible DNA methylation (DNAm) changes, which facilitate estimation of donor age. Cancer is also associated with DNAm changes, which may contribute to disease development. Here, we speculate that age‐associated DNAm changes may increase the risk of tumor initiation. Notably, when using epigenetic signatures for age‐estimations tumor cells are often predicted to be much older than the chronological age of the patient. We demonstrate that aberrant hypermethylation within the gene DNA methyltransferase 3A (...) (DNMT3A) – which may contribute to initiation of acute myeloid leukemia (AML) – is particularly observed in AML samples that reveal significantly more age‐associated DNAm changes. The functional relevance of age‐associated DNAm changes remains to be elucidated, but they occur genome wide, in a highly reproducible manner, and most likely influence chromatin organization – and hence may favor acquisition of aberrant DNAm patterns contributing to cancer in the elderly. (shrink)

We explore how risk preferences affect pro-social behavior under uncertainty. We analyze a modified dictator game in which the dictator can, by reducing her own sure payoff, increase the odds that an unknown recipient wins a lottery. We first augment a standard social preferences model with reference-dependent risk attitudes and then test the model’s predictions for the dictator’s giving behavior using a laboratory experiment. Consistent with the predictions of the model, we find that the relationship between giving behavior (...) and a giver’s loss aversion is mediated by the strength of the giver’s pro-social preferences. Among more pro-social dictators, an increase in loss aversion increases the likelihood that a dictator contributes to a recipient. (shrink)

Objectives To evaluate whether the requirement of “minimal risk and burden” for paediatric research without direct benefit to the subjects compromises the ability to obtain data necessary for improving paediatric care. To provide evidence-based reflections on the EU recommendation that allows for a higher level of risk. Design and setting Systematic analysis of the approval/rejection decisions made by the Dutch Central Committee on Research involving Human Subjects (CCMO). Review methods The analysis included 165 proposals for paediatric research without (...) direct benefit that were reviewed by the CCMO between January, 2000, and July, 2007. A separate, in-depth analysis of all drug studies included 18 early phase drug studies and nine other drug studies without direct benefit. Results 11 out of 165 studies were definitively rejected because the CCMO did not regard the risk and/or burden to be minimal. In three of these 11 cases (including two early phase drug studies) the requirement of minimal risk and burden was cited as the only reason for rejection. Four other early phase drug studies also involved risks and/or burdens that were not regarded to be minimal but were nevertheless approved. Conclusions The requirement of minimal risk and burden, aiming to protect research subjects, occasionally leads to rejection of protocols. Early phase drug studies relatively often do not comply with the requirement. Committees may find ways to approve important studies that formally should be rejected, but that is not a desirable solution. The regulatory framework should be revised to make such occasional exceptions to the requirement legitimate and transparent. (shrink)

Evidence of risk aversion in laboratory settings over small stakes leads to a priori implausible levels of risk aversion over large stakes under certain assumptions. One core assumption in statements of this calibration puzzle is that small-stakes risk aversion is observed over all levels of wealth, or over a â sufficiently largeâ range of wealth. Although this assumption is viewed as self-evident from the vast experimental literature showing risk aversion over laboratory stakes, it actually requires that (...) lab wealth be varied for a given subject as one evaluates the risk attitudes of the subject. We consider evidence from a simple design that tests this assumption, and find that the assumption is strikingly rejected for a large sample of subjects from a population of college students. We conclude that the implausible predictions that flow from these assumptions do not apply to one specialized population widely used to study economic behavior in laboratory experiments. (shrink)

Research Ethics, Volume 18, Issue 1, Page 64-83, January 2022. Automated, wearable cameras can benefit health-related research by capturing accurate and objective information about individuals’ daily experiences. However, wearable cameras present unique privacy- and confidentiality-related risks due to the possibility of the images capturing identifying or sensitive information from participants and third parties. Although best practice guidelines for ethical research with wearable cameras have been published, limited information exists on the risks of studies using wearable cameras. The aim of this (...) literature review was to survey risks related to using wearable cameras, and precautions taken to reduce those risks, as reported in empirical research. Forty-five publications, comprising 36 independent studies, were reviewed, and findings revealed that participants’ primary concerns with using wearable cameras included physical inconvenience and discomfort in certain situations. None of the studies reviewed reported any serious adverse events. Although it is possible that reported findings do not include all risks experienced by participants in research with wearable cameras, our findings suggest a low level of risk to participants. However, it is important that investigators adopt recommended precautions, which can promote autonomy and reduce risks, including participant discomfort. (shrink)

To understand how small business entrepreneurs respond to government policy one has to know their risk and time preferences. Are they risk averse, or have high discount rates, such that they are hard to motivate? We have conducted a set of field experiments in Denmark that will allow a direct characterization of small business entrepreneurs in terms of these traits. We build on experimental tasks that are well established in the literature. The results do not suggest that small (...) business entrepreneurs are more or less risk averse than the general population under the assumption of Expected Utility Theory. However, we generally find an S-shaped probability weighting function for both small business entrepreneurs and non-entrepreneurs, with entrepreneurs being more optimistic about the chance of occurrence for the best outcome in lotteries with real monetary outcomes. The results also point to a significant difference in individual discount rates between entrepreneurs and non-entrepreneurs: entrepreneurs are willing to wait longer for certain rewards than the general population. (shrink)

On April 13, 2010, Nebraska enacted a new state ban on abortion in the Pain-Capable Unborn Child Protection Act that ha caught the attention of many on both sides of the abortion debate, and has inspired other states to attempt similar measures. The statute requires the referring or abortion-providing physician to make a “determination of the probable postfertilization age of the unborn child” and makes it illegal to induce or attempt to perform or induce an abortion upon a woman when (...) the “probable postfertilization age” of the fetus is “twenty or more weeks” unless the doctor determines in “reasonable medical judgment she has a condition which so complicates her medical condition as to necessitate the abortion of her pregnancy to avert her death or to avert serious risk of substantial and irreversible physical impairment of a major bodily function or it is necessary to preserve the life of an unborn child.”. (shrink)

The aim of this study is to examine the factors influencing ethical business decision-making on environmental issues, among employees of SMEs. To do so, a survey study was performed with 394 top managers of SMEs in the UAE using a questionnaire, and the data was statistically evaluated using SmartPLS 3.0. The results suggest that prior technology use has significant positive relationships with ethical decision-making and the level of risk acceptance. Furthermore, perceived competitive pressure has significant positive relationships with ethical (...) decision-making and confidence level. In comparison, the level of risk acceptance and confidence level have significant positive relationships with ethical decision-making. Results also demonstrate that the level of risk acceptance mediates the relationship between prior technology use and ethical decision-making. There is also a significant and positive association between perceived competitive pressure and ethical decision-making with a mediating impact of the confidence level. (shrink)

We argue that in implanted neurotechnology research, participants and researchers experience what Henry Richardson has called “moral entanglement.” Participants partially entrust researchers with access to their brains and thus to information that would otherwise be private, leading to created intimacies and special obligations of beneficence for researchers and research funding agencies. One of these obligations, we argue, is about continued access to beneficial technology once a trial ends. We make the case for moral entanglement in this context through exploration of (...) participants’ vulnerability, uncompensated risks and burdens, depth of relationship with the research team, and dependence on researchers in implanted neurotechnology trials. (shrink)

Scientists engaged in global health research are increasingly faced with barriers to access and use of human tissues from the developing world communities where much of their research is targeted. In part, the problem can be traced to distrust of researchers from affluent countries, given the history of 'scientific-imperialism' and 'biocolonialism' reflected in past well publicized cases of exploitation of research participants from low to middle income countries. To a considerable extent, the failure to adequately engage host communities, the opacity (...) of informed consent, and the lack of fair benefit-sharing have played a significant role in eroding trust. These ethical considerations are central to biomedical research in low to middle income countries and failure to attend to them can inadvertently contribute to exploitation and erode trust. A 'tissue trust' may be a plausible means for enabling access to human tissues for research in a manner that is responsive to the ethical challenges considered. Preventing exploitation and restoring trust while simultaneously promoting global health research calls for innovative approaches to human tissues research. A tissue trust can reduce the risk of exploitation and promote host capacity as a key benefit. (shrink)

Banks play a unique role in society. They not only maximize profits but also consider the interests of stakeholders. We investigate whether banks consider firms’ pollution records in their lending decisions. The evidence shows that banks offer significantly higher loan spreads, higher total borrowing costs, shorter loan maturities, and greater collateral to firms with higher levels of chemical pollution. The costly effects are stronger for borrowers with greater risk and weaker corporate governance. Further, the results show that banks with (...) higher social responsibility account for their borrowers’ environmental performance and charge higher loan spreads to those with poor performance. These results support the idea that banks with higher social responsibility can promote the practice of business ethics in firms. (shrink)

Ample research links mothers’ postpartum depression (PPD) to adverse interactions with their infants. However, most studies relied on general population samples, whereas a substantial number of women are at elevated depression risk. The purpose of this study was to describe mothers’ interactions with their 6- and 12-month-old infants among women at elevated risk, although with a range of symptom severity. We also identified higher-order factors that best characterized the interactions and tested longitudinal consistency of these factors from 6 (...) to 12 months of infant age. We leveraged data from eight projects across the United States (n = 647), using standardized depression measures and an adaptation of the NICHD Mother-Infant Interaction Scales. Overall, these depression-vulnerable mothers showed high levels of sensitivity and positive regard and low levels of intrusiveness, detachment, and negative regard with their infants. Factor analyses of maternal behaviors identified two overarching factors—“positive engagement” and “negative intrusiveness” that were comparable at 6 and 12 months of infant age. Mothers’ ability to regulate depressed mood was a key behavior that defined “positive engagement” in factor loadings. An exceptionally strong loading of intrusiveness on the second factor suggested its central importance for women at elevated depression risk. Mothers with severe depressive symptoms had significantly more “negative intrusiveness” and less “positive engagement” with their 6-month-old infants than women with moderate or fewer depressive symptoms, suggesting a potential tipping point at which symptoms may interfere with the quality of care. Results provide the foundation for further research into predictors and moderators of women’s interactions with their infant among women at elevated risk for PPD. They also indicate a need for evidence-based interventions that can support more severely depressed women in providing optimal care. (shrink)

Major depression (MD) is a highly heterogeneous diagnostic category. Diverse symptoms such as sad mood, anhedonia, and fatigue are routinely added to an unweighted sum-score, and cutoffs are used to distinguish between depressed participants and healthy controls. Researchers then investigate outcome variables like MD risk factors, biomarkers, and treatment response in such samples. These practices presuppose that (1) depression is a discrete condition, and that (2) symptoms are interchangeable indicators of this latent disorder. Here I review these two assumptions, (...) elucidate their historical roots, show how deeply engrained they are in psychological and psychiatric research, and document that they contrast with evidence. Depression is not a consistent syndrome with clearly demarcated boundaries, and depression symptoms are not interchangeable indicators of an underlying disorder. Current research practices lump individuals with very different problems into one category, which has contributed to the remarkably slow progress in key research domains such as the development of efficacious antidepressants or the identification of biomarkers for depression. The recently proposed network framework offers an alternative to the problematic assumptions. MD is not understood as a distinct condition, but as heterogeneous symptom cluster that substantially overlaps with other syndromes such as anxiety disorders. MD is not framed as an underlying disease with a number of equivalent indicators, but as a network of symptoms that have direct causal influence on each other: insomnia can cause fatigue which then triggers concentration and psychomotor problems. This approach offers new opportunities for constructing an empirically based classification system and has broad implications for future research. (shrink)

Over the last decades, educational programs involving age simulation suits emerged with the ambition to further the understanding of age-related loss experiences, enhance empathy and reduce negative attitudes toward older adults in healthcare settings and in younger age groups at large. However, the impact of such “instant aging” interventions on individuals’ personal views on aging have not been studied yet. The aim of the current study is to address possible effects of ASS interventions on multiple outcomes related to views on (...) aging, i.e., aging-related cognitions, awareness of age-related change and age stereotypes. Moreover, we explore effects on broader constructs with relevance to aging, i.e., perceived obsolescence, risk perceptions, as well as desired support through technology. In a within-subjects design, N = 40 participants went through a series of established geriatric assessments with and without an ASS. Views on aging constructs were assessed in standardized questionnaires before and after the ASS intervention. Changes in aging-related cognitions were observed, with more negative expectations regarding social integration and continuous development after wearing the ASS. AARC and age stereotypes did not change from pre- to post-assessment, but participants reported an increased susceptibility to age-associated impairments and stronger feelings of obsolescence. Those participants who exhibited higher difficulties in geriatric assessments while wearing the suit reported higher openness to be supported by intelligent assistive devices or robots afterwards. We conclude that ASS interventions should only be combined with education on losses and gains during the aging process to prevent negative effects on individual views on aging. On the other hand, potentials regarding technology acceptance and formation of intentions to engage in prevention and health behaviors among middle-aged to young-old adults are discussed. (shrink)

The target articles in this issue advance our understanding of bioethical considerations in pragmatic trials (Garland, Morain, and Sugarman 2023; Morain and Largent 2023). Both articles appreciate...

It is not unknown for participants in discussions of ethics to prefix their claims with a profession of their religious faith—to say, for instance, “Well, I’m a Christian/Muslim/whatever, so I think that …”. Other participants in the debate may well worry about how to respond without the risk of giving offence or appearing ad hominem. Within a teaching environment, the worry may be even more acute. Nevertheless, it is suggested in this paper that such worries should not be allowed (...) to impede debate; moreover, a teacher who let such prefixes pass without critique would be considered a poor teacher. In fact, a kind of duty for a teacher of ethics is to be contrary and to play the apostate. (shrink)

Battin et al examined data on deaths from physician-assisted suicide in Oregon and on PAS and voluntary euthanasia in The Netherlands. This paper reviews the methodology used in their examination and questions the conclusions drawn from it—namely, that there is for the most part ‘no evidence of heightened risk’ to vulnerable people from the legalisation of PAS or VE. This critique focuses on the evidence about PAS in Oregon. It suggests that vulnerability to PAS cannot be categorised simply by (...) reference to race, gender or other socioeconomic status and that the impetus to seek PAS derives from factors, including emotional state, reactions to loss, personality type and situation and possibly to PAS contagion, all factors that apply across the social spectrum. It also argues, on the basis of official reports from the Oregon Health Department on the working of the Oregon Death with Dignity Act since 2008, that, contrary to the conclusions drawn by Battin et al, the highest resort to PAS in Oregon is among the elderly and, on the basis of research published since Battin et al reported, that there is reason to believe that some terminally ill patients in Oregon are taking their own lives with lethal drugs supplied by doctors despite having had depression at the time when they were assessed and cleared for PAS. (shrink)

Initial responses to questionnaires used to assess participants' understanding of informed consent for malaria vaccine trials conducted in the United States and Mali were tallied. Total scores were analyzed by age, sex, literacy (if known), and location. Ninety-two percent (92%) of answers by United States participants and 85% of answers by Malian participants were correct. Questions more likely to be answered incorrectly in Mali related to risk, and to the type of vaccine. For adult participants, independent predictors of higher (...) scores were younger age and female sex in the United States, and male sex in Mali. Scores in the United States were higher than in Mali (P = 0.005). Despite this difference participants at both sites were well informed overall. Although interpretation must be qualified because questionnaires were not intended as research tools and were not standardized among sites, these results do not support concerns about systematic low understanding among research participants in developing versus developed countries. (shrink)

Progressive supranuclear palsy is a movement disorder with prominent tau neuropathology. Brain diseases with abnormal tau deposits are called tauopathies, the most common of which is Alzheimer's disease. Environmental causes of tauopathies include repetitive head trauma associated with some sports. To identify common genetic variation contributing to risk for tauopathies, we carried out a genome-wide association study of 1,114 individuals with PSP and 3,247 controls followed by a second stage in which we genotyped 1,051 cases and 3,560 controls for (...) the stage 1 SNPs that yielded P ≤ 10-3. We found significant previously unidentified signals associated with PSP risk at STX6, EIF2AK3 and MOBP. We confirmed two independent variants in MAPT affecting risk for PSP, one of which influences MAPT brain expression. The genes implicated encode proteins for vesicle-membrane fusion at the Golgi-endosomal interface, for the endoplasmic reticulum unfolded protein response and for a myelin structural component. © 2011 Nature America, Inc. All rights reserved. (shrink)

The purpose of this paper is to assess Profet’s (1992) and others’ hypothesis that nausea and vomiting in pregnancy (NVP) is adaptive. A number of studies have found an association between NVP and a decreased risk for early fetal loss (<20 weeks). It is assumed that the adaptive benefits of improved survivorship associated with NVP outweigh the minimal nutritional consequences. However, in populations that experience marginal levels of nutrition, NVP may have important nutritional consequences. To test these potential consequences, (...) a study on NVP, nutritional status, and pregnancy outcome was conducted among Turkana pastoralists, who experience seasonal and chronic nutritional stress. Interviews and anthropometric assessments were conducted on 68 pregnant Turkana women of Kenya during a 1993–1994 field season. The results from the case study suggest that women who experience NVP do encounter nutritional consequences in the later stages of pregnancy and are more likely to experience poor pregnancy outcomes. These results suggest that NVP may not be adaptive in all environmental settings, particularly among marginally nourished populations. (shrink)

The concept of quality of life is the basis for a new paradigm of clinical medicine. Its assessment is considered to be an important instrument in determining disease severity and effectiveness of different treatment modalities. Our studies are devoted to the problem of diabetes complications especially anemia in patients with diabetic kidney disease. Anemia in subjects with diabetic nephropathy may result from various pathogenic factors including erythropoietin deficiency, iron deficiency, vitamin B12 and/or folate deficiencies, the effects of proinflammatory cytokines etc. (...) Diabetic patients with anemia are at increased risk of cardiovascular accidents and death. The aim of this study was to assess the influence of anemia on the quality of life of patients with early stages of diabetic nephropathy. We investigated 127 patients with type 2 diabetes mellitus and early diabetic nephropathy. Anemia was defined according to the World Health Organization criteria. Anemic patients were divided into three groups according to the stage of chronic kidney disease. Patients’ quality of life was assessed with SF-36 health survey. Anemic patients had lower scores of physical role functioning and emotional role functioning as compared to the patients with normal hemoglobin level, irrespective of the stage of chronic kidney disease. Patients with anemia and chronic kidney disease stage 3 had lower scores of general health perceptions, physical functioning, bodily pain, vitality and mental health than patients in the non-anemic group. Social role functioning was similar in anemic and non-anemic patients. The possible mechanisms and implications of the above mentioned findings are discussed with a medical and humanitarian perspective. The directions of further studies are proposed. (shrink)

Pancreatitis is a complex, progressively destructive inflammatory disorder. Alcohol was long thought to be the primary causative agent, but genetic contributions have been of interest since the discovery that rare PRSS1, CFTR and SPINK1 variants were associated with pancreatitis risk. We now report two associations at genome-wide significance identified and replicated at PRSS1-PRSS2 and X-linked CLDN2 through a two-stage genome-wide study. The PRSS1 variant likely affects disease susceptibility by altering expression of the primary trypsinogen gene. The CLDN2 risk (...) allele is associated with atypical localization of claudin-2 in pancreatic acinar cells. The homozygous CLDN2 genotype confers the greatest risk, and its alleles interact with alcohol consumption to amplify risk. These results could partially explain the high frequency of alcohol-related pancreatitis in men. © 2012 Nature America, Inc. All rights reserved. (shrink)

This paper examines the importance of aspirations as reference points in a multi-period decision-making context. After stating their personal aspiration level, 172 individuals made six sequential decisions among risky prospects as part of a choice experiment. The results show that individuals make different risky-choices in a multi-period compared to a single-period setting. In particular, individuals’ aspiration level is their main reference point during the early stages of decision-making, while their starting status (wealth level at the start of the experiment) becomes (...) the central reference point during the later stages of their multi-period decision-making. (shrink)