Global regulatory developments for clinical stem cell research: diversification and challenges to collaborations

In this article, we explore regulatory developments in stem cell medicine in seven jurisdictions: Japan, China, India, Argentina, Brazil, the USA and the EU. We will show that the research methods, ethical standards and approval procedures for the market use of clinical stem cell interventions are undergoing an important process of global diversification. We will discuss the implications of this process for international harmonization and the conduct of multicountry clinical research collaborations. It will become clear that the increasing heterogeneity of research standards and regulations in the stem cell field presents a significant challenge to international clinical trial partnerships, especially with countries that diverge from the regulatory models that have been developed in the USA and the EU

Bilateral proximal tibia fracture

A bilateral fracture of the proximal tibia is rare in children. We describe a girl with a bilateral fracture just distal of the epiphyseal plate after minimal trauma

The Economics and Politics of Contracting out with the Private Sector: Evidence from the US Transit Industry

The paper studies contracting practices in the US transit industry. It employs the methods of transaction cost economics and public choice theory to develop an empirical model of bus contracting in the US transit industry. The empirical results shed light on why transit services in the US remain largely public, despite many attempts to introduce competition by contracting out services to the private sector. The results show that the decision by transit agencies to contract out with the private sector is constrained by the transaction costs of contracting and the institutional and subsidy arrangements that govern the transit industry in the US. Services that require idiosyncratic investments to provide large densities of passengers are less likely to be contracted out than those services that are provided using standard, small vehicles. Similarly, increases in federal subsidies and dedicated subsidies are found to discourage contracting out with the private sector. On the other hand, increases in state and local subsidies, other things being equal, encourage contracting. Agencies that have high labor costs –– indicating strong labor unions –– are less likely to contract out. In light of these findings, the paper concludes that piecemeal contracting out of services is not likely to increase the role of the private sector in the provision of public transit services. Structures of subsidies and federal arrangements creates intertwined incentives that discourage contracting by transit agencies, thus foiling the attempts to increase efficiencies by establishing competition for transit markets.Institute of Transport and Logistics Studies. Faculty of Economics and Business. The University of Sydne

Attitudes on the donation of human embryos for stem cell research among Chinese IVF patients and students

Bioethical debates on the use of human embryos and oocytes for stem cell research have often been criticized for the lack of empirical insights into the perceptions and experiences of the women and couples who are asked to donate these tissues in the IVF clinic. Empirical studies that have investigated the attitudes of IVF patients and citizens on the (potential) donation of their embryos and oocytes have been scarce and have focused predominantly on the situation in Europe and Australia. This article examines the viewpoints on the donation of embryos for stem cell research among IVF patients and students in China. Research into the perceptions of patients is based on in-depth interviews with IVF patients and IVF clinicians. Research into the attitudes of students is based on a quantitative survey study (n=427). The empirical findings in this paper indicate that perceptions of the donation of human embryos for stem cell research in China are far more diverse and complex than has commonly been suggested. Claims that ethical concerns regarding the donation and use of embryos and oocytes for stem cell research are typical for Western societies but absent in China cannot be upheld. The article shows that research into the situated perceptions and cultural specificities of human tissue donation can play a crucial role in the deconstruction of politicized bioethical argumentation and the (often ill-informed) assumptions about “others” that underlie socio-ethical debates on the moral dilemmas of technology developments in the life sciences

Motivations for seeking experimental treatment in Japan

In this article on innovative medical treatment for serious conditions in Japan we aim to revise two widespread notions: first, that people living with severe conditions are all waiting for a cure or are impatient to try out experimental treatment, in particular regenerative medicine. Showing that motivations for cure seeking are complex and linked to somatic identity, we argue that gaining a cure also means a new social normality, which for some people narrows the only normality that is meaningful to them; and, second, that people living with a serious (latent) condition necessarily define their lives as not normal in the light of normalization. People with a condition conceptualise normal life variously and multiply in the light of both individual and collective experiences. The two revisions are crucial to attempts at understanding what makes people seek experimental medicine. Comparing the narratives of people with four different conditions – spinal cord injury, Duchenne muscular dystrophy, Diabetes Mellitus type 1 and cardiovascular disease – it becomes clear that the difference between seeking treatment or not largely depends on somatic identities; rather than through notions of (ab)normality, it is more adequately understood in terms of the experience of somatic lacking and wholeness

Ultrasound markers for prediction of complex gastroschisis and adverse outcome: longitudinal prospective nationwide cohort study

Objectives: To identify antenatal ultrasound markers that can differentiate between simple and complex gastroschisis and assess their predictive value. Methods: This was a prospective nationwide study of pregnancies with isolated fetal gastroschisis that underwent serial longitudinal ultrasound examination at regular specified intervals between 20 and 37 weeks' gestation. The primary outcome was simple or complex (i.e. involving bowel atresia, volvulus, perforation or necrosis) gastroschisis at birth. Fetal biometry (abdominal circumference and estimated fetal weight), the occurrence of polyhydramnios, intra- and extra-abdominal bowel diameters and the pulsatility index (PI) of the superior mesenteric artery (SMA) were assessed. Linear mixed modeling was used to compare the individual trajectories of cases with simple and those with complex gastroschisis, and logistic regression analysis was used to estimate the strength of association between the ultrasound parameters and outcome. Results: Of 104 pregnancies with isolated fetal gastroschisis included, four ended in intrauterine death. Eighty-one (81%) liveborn infants with simple and 19 (19%) with complex gastroschisis were included in the analysis. We found no relationship between fetal biometric variables and complex gastroschisis. The SMA-PI was significantly lower in fetuses with gastroschisis than in healthy controls, but did not differentiate between simple and complex gastroschisis. Both intra- and extra-abdominal bowel diameters were larger in cases with complex, compared to those with simple, gastroschisis (P < 0.001 and P < 0.005, respectively). The presence of intra-abdominal bowel diameter ≥ 97.7th percentile on at least three occasions, not necessarily on successive examinations, was associated with an increased risk of the fetus having complex gastroschisis (relative risk, 1.56 (95% CI, 1.02–2.10); P = 0.006; positive predictive value, 50.0%; negative predictive value, 81.4%). Conclusions: This large prospective longitudinal study found that intra-abdominal bowel dilatation when present repeatedly during fetal development can differentiate between simple and complex gastroschisis; however, the positive predictive value is low, and therefore the clinical usefulness of this marker is limited

Issues in the management of simple and complex meconium ileus

Various surgical methods are used to treat meconium ileus (MI), including resection with enterostomy (RES), primary anastomosis (RPA), and purse-string enterotomy with intra-operative lavage (PSI). The aim of this study is to discuss the surgical treatment of MI, based on our experience. Of the 41 MI patients treated at our institution between 1984 and 2007, 18 had simple MI and 23 had complex MI. These groups were analyzed according to treatment modality, concentrating on length of hospital stay, complications [peritonitis, septicemia, adhesive small bowel obstruction (ASBO), and malabsorption/diarrhea], need for additional surgical procedures, mortality. Of the 18 patients with simple MI, 7 (39%) were successfully treated with diluted Gastrografin® enema. The remaining 11 patients were treated surgically: two underwent RPA, of whom one died; five had RES, of whom one developed ASBO; four underwent PSI, of whom two developed peritonitis. In the complex MI group, 14 patients underwent RPA, with peritonitis occurring in three (one died); nine underwent RES, of whom two developed ASBO. In patients with simple MI, conservative treatment with diluted Gastrografin® enema is an effective initial treatment in our hands. In case of failure, RES is advisable. Patients with complex MI are candidates for RES. RPA and PSI seem to have higher complication rate

Oppilaitten eettinen toimijuus videotutkimuksessa

The rapid development of various recording technologies in recent years has created appealing opportunities for researchers to document and study science, technology, engineering, and mathematics (STEM) learning in ways which previously were either impossible, high-priced, or impractical. The potential access that low-cost and ever-smaller recorders provide us has been wisely tempered with cautions that researchers critically reflect on whether the benefits of the research outweigh the invasion of participants’ privacy, especially in research with children. These cautions rightfully place the burden of ethical deliberation on the researcher. However, by so doing they also direct attention away from the ethical work done by study participants and overshadow their agency in relation to the research. In effect, the cautions join and reinforce dominant narratives of participant, especially children’s, vulnerability in research and the researcher as the main ethical actor during the research process. This study seeks to balance such narratives by drawing attention to how children demonstrate their awareness of the audience of nearby recorders to each other and, through such actions, also create spaces for private, out-of-view interaction they do not wish to be recorded. With demonstrative vignettes from a yearlong ethnographic study of children’s learning in an alternative STEM learning infrastructure, the study argues that such moments highlight children’s ethical agency in research.The rapid development of various recording technologies in recent years has created appealing opportunities for researchers to document and study science, technology, engineering, and mathematics (STEM) learning in ways which previously were either impossible, high-priced, or impractical. The potential access that low-cost and ever-smaller recorders provide us has been wisely tempered with cautions that researchers critically reflect on whether the benefits of the research outweigh the invasion of participants’ privacy, especially in research with children. These cautions rightfully place the burden of ethical deliberation on the researcher. However, by so doing they also direct attention away from the ethical work done by study participants and overshadow their agency in relation to the research. In effect, the cautions join and reinforce dominant narratives of participants’, especially children’s, vulnerability in research and the researcher as the main ethical actor during the research process. This study seeks to balance such narratives by drawing attention to how children demonstrate their awareness of the audience of nearby recorders to each other and, through such actions, also create spaces for private, out-of-view interaction they do not wish to be recorded. With demonstrative vignettes from a yearlong ethnographic study of children’s learning in an alternative STEM learning infrastructure, the study argues that such moments highlight children’s ethical agency in research.Peer reviewe

Local biologicals and the politics of standardization: Making ethical pluripotent stem cells in the United Kingdom and Japan

In 2003, the United Kingdom and Japan had adopted relatively similar approaches to human embryonic stem cells science. The decade since has witnessed significant divergence in their national policies as differing responses to ethical questions about research use of human embryos emerged. The United Kingdom pursued a vision of ‘institutionally accredited stem cells’ by reconfiguring the role of the Human Fertilisation and Embryology Authority and establishing the UK Stem Cell Bank. In contrast, Japan followed a vision of ‘technically advanced stem cells’ by developing induced pluripotent stem cells and supporting its research programs enthusiastically. Our research – drawing upon extensive fieldwork in both countries – demonstrates the socio-technical arrangements developed to instantiate these visions and articulates their divergence while at the same time revealing their connectedness. This relationship becomes progressively evident as the two visions face each other in the politics of standardization in global stem cell science. Drawing on Franklin’s concept of local/global biological, we discuss the connectedness of the two local arrangements. In so doing, we explicate the future challenges for both countries as they need to demonstrate the significance of their visions in this global enterprise, while the success of one would likely undermine the significance of the other