A network approach to studying research programmes : mobilizing and coordinating public responses to HIV/AIDS

Based on the analysis of the Medical and Public Health Research programme (Commission of the European Communities), the paper shows how new scientific communities are created in response to the HIV/AIDS problem. We analyze how actors are mobilized (three mobilization modes : public impetus, scientists'initiative, scientists' initiative with public networking) and how their work is coordinated. We defend the hypothesis that these new scientific communities are flexible cooperation networks. In the case of AIDS research, there are only a limited number of network types (the data collection structure, the forum, the thematic partition with harmonization of research practices, the starred around a central facility). The coordination of these scientific cooperative networks passes through fixed and circulating intermediaries. The management of these intermediaries is a major activity for involved actors. thus, our aim is not to study the wider social context, but to analyze networking in response to policy initiatives. (Résumé d'auteur

PRE-MARKET CLINICAL EVALUATIONS OF INNOVATIVE HIGH-RISK MEDICAL DEVICES IN EUROPE

Objectives:High-quality clinical evidence is most often lacking when novel high-risk devices enter the European market. At the same time, a randomized controlled trial (RCT) is often initiated as a requirement for obtaining market access in the US. Should coverage in Europe be postponed until RCT data are available? We studied the premarket clinical evaluation of innovative high-risk medical devices in Europe compared with the US, and with medicines, where appropriate.Methods:The literature and regulatory documents were checked. Representatives from industry, Competent Authorities, Notified Bodies, Ethics Committees, and HTA agencies were consulted. We also discuss patient safety and the transparency of information.Results:In contrast to the US, there is no requirement in Europe to demonstrate the clinical efficacy of high-risk devices in the premarket phase. Patients in Europe can thus have earlier access to a potentially lifesaving device, but at the risk of insufficiently documented efficacy and safety. Variations in the stringency of clinical reviews, both at the level of Notified Bodies and Competent Authorities, do not guarantee patient safety. We tried to document the design of premarket trials in Europe and number of patients exposed, but failed as this information is not made public. Furthermore, the Helsinki Declaration is not followed with respect to the registration and publication of premarket trials.Conclusions:For innovative high-risk devices, new EU legislation should require the premarket demonstration of clinical efficacy and safety, using an RCT if possible, and a transparent clinical review, preferably centralized.</jats:p

Comparison of educational facilitation approaches for Grade R English Additional Language learning in rural Mpumalanga

The Early Childhood Development Manager in Mpumalanga is faced with the problem of providing evidence-based guidance of the best facilitation approach in the Grade R context. An investigation on the effect of   facilitation, i.e. play-based or formal instruction, on Grade R performance scores in English Additional Language (EAL) learning was conducted.  Literature findings attest to formal learning contributing to better   performance scores than play-based learning, yet most rural schools in Mpumalanga use the play-based approach. The English Language Proficiency (ELP) standards assessment tool is reported to have no cultural bias and was used to collect the data. The tool assessed learners’ listening and speaking skills in EAL. A quantitative methodology was followed, using a static two-group comparison design. Participants in the two groups were matched according to age and all had a similar exposure period to EAL learning, a rural upbringing, poverty level, and all were mainstream  learners. Inter-rater reliability was obtained since two raters assessed learners’ proficiency in EAL skills. A one-way Analysis of Variance (ANOVA) was used to analyse the data. It was found that the formal based approach contributed to better EAL scores when compared to the play-based  approach. Implications for practice are discussed.Keywords: EAL learning; ELP standards assessment tool; formal  instruction;Grade R facilitation; learners’ first language; play-based approach

Tales of Emergence - Synthetic Biology as a Scientific Community in the Making

International audienceThis article locates the beginnings of a synthetic biology network and thereby probes the formation of a potential disciplinary community. We consider the ways that ideas of community are mobilized, both by scientists and policy-makers in building an agenda for new forms of knowledge work, and by social scientists as an analytical device to understand new formations for knowledge production. As participants in, and analysts of, a network in synthetic biology, we describe our current understanding of synthetic biology by telling four tales of community making. The first tale tells of the mobilization of synthetic biology within a European context. The second tale describes the approach to synthetic biology community formation in the UK. The third narrates the creation of an institutionally based, funded 'network in synthetic biology'. The final tale de-localizes community-making efforts by focussing on 'devices' that make communities. In tying together these tales, our analysis suggests that the potential community can be understood in terms of 'movements'--the (re)orientation and enrolment of people, stories, disciplines and policies; and of 'stickiness'--the objects and glues that begin to bind together the various constitutive elements of community