Quelle régulation pour l’arrêt d’un protocole de recherche clinique de thérapie génique somatique ? État des lieux auprès des cliniciens-chercheurs européens

Depuis 2002, le débat sur les risques associés à la thérapie génique est initié suite à l’annonce que deux enfants inclus dans un essai thérapeutique impliquant une thérapie génique ont développé des effets indésirables important. En Janvier 2005, le débat sur les risques reprit suite à l’interruption du protocole sur les enfants bulle du Pr Fischer à l’hôpital Necker de Paris. Nous avons donc étudié le processus impliqué ainsi que la réflexion éthique associée aux décisions d’arrêt de protocole de recherche. Notre travail a été mené par une équipe pluridisciplinaire combinant chercheurs en santé, généticiens et éthiciens. Nous avons étudié la participation des chercheurs, des patients, des institutions officielles, des comités d’éthique ainsi que des associations de patients dans le processus de décision d’interruption d’un protocole de recherche.Nous avons également analysé les critères jugés les plus pertinents dans l’arrêt d’un protocole de recherche. Enfin nous avons analysé le point de vue des personnes directement impliquées dans la thérapie génique au moyen d’un questionnaire. Toutes les personnes contactées ont présenté un poster de recherche au congrès de la Société Européenne de Thérapie Génique. 62 personnes d’autant d’équipes de recherche différentes, de 17 pays, sur les 350 contactés ont répondu. Selon eux, la décision d’arrêt d’un protocole de recherche doit être prise suite à une consultation des chercheurs, des patients, du ministère de tutelle, d’une agence nationale de régulation ou d’un comité d’éthique ; la légitimité étant accordée à des décisions prises en commun par les chercheurs, les patients et les comités d’éthique. Les incidents sérieux et de façon plus surprenante, les incidents moins graves sont jugés comme étant des critères suffisants pour interrompre un essai. Nous avons fini par analyser les conséquences éthiques, telles que balance bénéfice/risque, processus de régulation ou responsabilité, de ces critères sur l’arrêt d’un protocole de recherche.In 2002, the debate on the risks of gene therapy was initiated following the annoucement that two children included in a clinical trial developed serious adverse effects. In January 2005, the debate was reignited following the interruption of the “bubble kids protocol” at the Hôpital Necker in Paris. We have thus investigated the ethical stakes involved in decisions to stop protocols. This work was carried out by a multidisciplinary team combining ethics researchers and geneticists. We studied the specific participation of researchers, patients, official institution, ethics committees and patient associations in the processes that can lead to an interruption of trial.We also analysed the criterion judged most relevant for halting a trial. Finally, we analyzed the perspective of the actors implicated directly in the provision of gene therapy, by means of a questionnaire. All the individuals contacted had presented a scientific poster at the European Society of Gene Therapy. 62 out of 350 persons, from 17 countries, responded to our questionnaire. According to these respondants, decisions to stop a trial should be taken after consultation with researchers, patients, the ministry, national agencies or ethics committees. Legitimacy was accorded to joint decision-making by researchers, patients and committees. Serious incidents, and surprisingly less serious incidents, clearly emerge as criterion for stopping a trial. We conclude by analyzing the ethical consequences, such as risk/benefit ratios, regulatory processes and responsibility, associated with these criterions and decisions to stop a trial

Procedure for secondary bleaching brined cherries with sodium chlorite

Published October 1970. Facts and recommendations in this publication may no longer be valid. Please look for up-to-date information in the OSU Extension Catalog: http://extension.oregonstate.edu/catalo

Assessment of the Performance of Osmotically Driven Polymeric Membrane Processes

The universal water scarceness and the extensive ordeals with energy cost in conjunction with the undesirable ecological effects have advanced the improvement of novel osmotically driven membrane processes. Membrane processes which are osmotically driven are developing type of membrane separation procedures that apply concentrated brines to separate liquid streams. They are adaptable in various applications; hence, allow them to be an attractive substitute for drug release, wastewater treatment and the production and recovery of energy. Although, internal concentration polarization (ICP) occurs in membrane practises which are osmotically driven as a consequence of hindered diffusion of solute in a porous stratum, their interest has even increased. Here we review two natural membrane processes that are osmotically driven; Forward osmosis (FO) and Pressure retarded osmosis (PRO). Thus, the major points are as follows: 1) it was highlighted in this review, that the major developments in FO process, important for the process efficiency is to choose a suitable membrane and draw solution. 2) The recent evaluation, understanding and optimizing the activities of fouling throughout the osmotic dilution of seawater employing FO was discussed. 3) Recent advancements of FO in the application of food processing was reviewed. 4) It was highlighted that the main concept of PRO for power generation is the energy of mixing that offers great assessment of the nonexpansion work which could be generated from mixing; nonetheless, the development of effective membranes with appropriate arrangement and performance is needed for the advancement of PRO process for power generation. 5) One major challenge of osmotically driven membrane processes, most recent developments and model development to predict their performances were discussed

Qualification de nouveaux produits d'apport en alliage base nickel a haute teneur en chrome

SIGLEAvailable at INIST (FR), Document Supply Service, under shelf-number : 26165 A, issue : a.1996 n.146 / INIST-CNRS - Institut de l'Information Scientifique et TechniqueFRFranc