DESCRIPTION DE LA STRUCTURE (missions, organisation) :
Le département des pratiques de recherche réglementées est responsable de la mise en œuvre des réglementations relatives à l’utilisation, à des fins de recherche, d’animaux vivants, d’organismes génétiquement modifiés, de ressources génétiques, d’échantillons biologiques humains. Il autorise des projets de recherche en s’appuyant sur l’avis de comités d’experts et de comités d’éthiques en veillant au respect des réglementations française et européenne. Il est également force de proposition en ce qui concerne les évolutions réglementaires dans son champ d’activité et participe aux groupes de travail européens dédiés à ces réglementations. Enfin, il prend en charge les questions de bioéthiques liées à la recherche.
Cette dernière thématique est au cœur de l’activité de la cellule de bioéthique du département. La cellule traite les questions éthiques et juridiques liées à la recherche en biologie et santé humaine. Elle participe notamment à l’élaboration des textes législatifs et réglementaires ou de recommandations dans ce domaine et s’attache à étudier toute nouvelle problématique bioéthique concernant la recherche, en lien avec les parties intéressées en interne ou externe.
La cellule met également en œuvre les réglementations applicables à l’utilisation d’échantillons biologiques humains destinés à la recherche : déclaration/autorisation d’activités telles que la conservation des échantillons, leur importation ou leur exportation. Cette dernière activité place la cellule en relation directe avec les organismes de recherche publics ou privés et ses partenaires institutionnels.
L’activité de la cellule s’inscrit dans l’objectif de rapidité et d’efficacité de traitement des différentes demandes, dans le respect de la règle et de l’éthique, répondant ainsi aux attentes de la société civile. Cela requiert des procédures administratives performantes, fiables et sécurisées et une politique de communication dynamique et adaptée, tant auprès des chercheurs que du grand public.
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