{"id":1182,"date":"2023-04-06T10:15:14","date_gmt":"2023-04-06T08:15:14","guid":{"rendered":"https:\/\/guide-recherche-asso.info\/?page_id=1182"},"modified":"2023-04-06T10:47:58","modified_gmt":"2023-04-06T08:47:58","slug":"cadre-reglementaire","status":"publish","type":"page","link":"https:\/\/guide-recherche-asso.info\/index.php\/cadre-reglementaire\/","title":{"rendered":"Cadre r\u00e9glementaire"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"1182\" class=\"elementor elementor-1182\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-a3a1945 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"a3a1945\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-0f87fcd\" data-id=\"0f87fcd\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-d5ec519 elementor-widget elementor-widget-heading\" data-id=\"d5ec519\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Cadre r\u00e9glementaire<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-e4a9fef elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"e4a9fef\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-7ae6e5b\" data-id=\"7ae6e5b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-4b53ee5 elementor-widget elementor-widget-image\" data-id=\"4b53ee5\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/guide-recherche-asso.info\/wp-content\/uploads\/2023\/01\/B4W-GDR-Banderole-Comprendre.png\" title=\"\" alt=\"\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-705e9fa elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"705e9fa\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-a68bb2b\" data-id=\"a68bb2b\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e8477c7 elementor-widget elementor-widget-text-editor\" data-id=\"e8477c7\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Certaines pratiques de recherche sont r\u00e8glement\u00e9es. C\u2019est le cas entre autres des\u00a0:<\/p><ul><li>Recherches impliquant la personne humaine (RIPH), encadr\u00e9es par <a href=\"https:\/\/www.legifrance.gouv.fr\/loda\/id\/JORFTEXT000025441587\" target=\"_blank\" rel=\"noopener\">la loi Jard\u00e9<\/a>\u00a0<\/li><\/ul><p style=\"padding-left: 40px;\">Elles doivent toutes recevoir \u00e9galement un avis favorable d\u2019un Comit\u00e9 de Protection des Personnes (CPP). Elles peuvent \u00eatre de 3 types :<\/p><ul><li style=\"list-style-type: none;\"><ul><li>RIPH-1 : interventionnel (intervention non justifi\u00e9e par la prise en charge habituelle).<\/li><\/ul><\/li><\/ul><p style=\"padding-left: 80px;\">Ces recherches doivent \u00e9galement obtenir une autorisation de l&rsquo;ANSM (Agence Nationale de S\u00e9curit\u00e9 du M\u00e9dicament) \u2013 elles peuvent b\u00e9n\u00e9ficier de conseils en ce sens par le GIO \u2013 <a href=\"https:\/\/ansm.sante.fr\/vos-demarches\/chercheur\/guichet-innovation-et-orientation-gio\" target=\"_blank\" rel=\"noopener\">Guichet Innovation et Orientation<\/a>. Ces recherches n\u00e9cessitent, apr\u00e8s information individuelle, le recueil \u00e9crit du consentement libre et \u00e9clair\u00e9 des participants.<\/p><ul><li style=\"list-style-type: none;\"><ul><li>RIPH-2 : faiblement interventionnel (pr\u00e9l\u00e8vement, collecte).<\/li><\/ul><\/li><\/ul><p style=\"padding-left: 80px;\">L&rsquo;ANSM doit \u00eatre inform\u00e9e. Ces recherches n\u00e9cessitent, apr\u00e8s information individuelle, le recueil oral ou \u00e9crit du consentement libre et \u00e9clair\u00e9 des participants.<\/p><ul><li style=\"list-style-type: none;\"><ul><li>RIPH-3 : non interventionnel (actes r\u00e9alis\u00e9s dans le cadre du soin).<\/li><\/ul><\/li><\/ul><p style=\"padding-left: 80px;\">L&rsquo;ANSM doit \u00eatre inform\u00e9e. Ces recherches n\u00e9cessitent, apr\u00e8s information individuelle, une d\u00e9claration de non-opposition des participants.<\/p><ul><li>Recherches sur la personne humaine mais n&rsquo;impliquant pas directement la personne humaine (Non-RIPH).<\/li><\/ul><p style=\"padding-left: 40px;\">Il y a obligation \u00e0 informer les personnes, mais pas \u00e0 obtenir un consentement sign\u00e9. Ces recherches peuvent \u00eatre examin\u00e9es par des \u00ab\u00a0comit\u00e9s d&rsquo;\u00e9thique pour la recherche\u00a0\u00bb (universitaires par ex.).<\/p><p style=\"padding-left: 40px;\">Si les recherches recourent \u00e0 des donn\u00e9es personnelles, le projet est examin\u00e9 par la CNIL (Commission Nationale de l&rsquo;Informatique et des Libert\u00e9s) et par le d\u00e9l\u00e9gu\u00e9 \u00e0 la protection des donn\u00e9es. Si les recherches recourent \u00e0 des donn\u00e9es personnelles de sant\u00e9, le projet est examin\u00e9 par le CESREES (Comit\u00e9 \u00e9thique et scientifique pour les recherches, les \u00e9tudes et les \u00e9valuations dans le domaine de la sant\u00e9) avant la CNIL.<\/p><ul><li>Recherches sur <a href=\"https:\/\/guide-recherche-asso.info\/index.php\/technologies-et-materiaux\/\" target=\"_blank\" rel=\"noopener\">les mod\u00e8les animaux<\/a>.<\/li><\/ul><p style=\"padding-left: 40px;\">Elles n\u00e9cessitent une \u00e9valuation par un Comit\u00e9 d\u2019\u00c9thique en Exp\u00e9rimentation Animale (CEEA).<\/p><p><em>\u00a0<\/em><\/p><p><span style=\"color: #999999;\"><em>Pour aller plus loin :\u00a0<\/em><\/span><\/p><p><span style=\"color: #999999;\"><em>Les pratiques de recherche r\u00e8glement\u00e9es<\/em><\/span><\/p><p><span style=\"color: #999999;\"><a style=\"color: #999999;\" href=\"https:\/\/www.enseignementsup-recherche.gouv.fr\/fr\/pratiques-de-recherche-reglementees-49865\"><em>https:\/\/www.enseignementsup-recherche.gouv.fr\/fr\/pratiques-de-recherche-reglementees-49865<\/em><\/a><\/span><\/p><p><span style=\"color: #999999;\"><em>Logigramme d\u2019aide \u00e0 la qualification juridique d\u2019un projet de recherche avec des donn\u00e9es personnelles<\/em><\/span><\/p><p><span style=\"color: #999999;\"><a style=\"color: #999999;\" href=\"https:\/\/data.ird.fr\/wp-content\/uploads\/2021\/01\/logigramme-sante-IRD-V1-2020.pdf\"><em>https:\/\/data.ird.fr\/wp-content\/uploads\/2021\/01\/logigramme-sante-IRD-V1-2020.pdf<\/em><\/a><\/span><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-f114759 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"f114759\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-ea17fc6\" data-id=\"ea17fc6\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-ffede38 elementor-widget elementor-widget-image\" data-id=\"ffede38\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/guide-recherche-asso.info\/wp-content\/uploads\/2023\/01\/B4W-GDR-Banderole-Simpliquer.png\" title=\"\" alt=\"\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-50a4f93 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"50a4f93\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-d37fa54\" data-id=\"d37fa54\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-34119d6 elementor-widget elementor-widget-heading\" data-id=\"34119d6\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">repr\u00e9senter les usagers<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-cab7785 elementor-widget elementor-widget-text-editor\" data-id=\"cab7785\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>Des mandats de repr\u00e9sentants des usagers sont r\u00e9serv\u00e9s dans certaines instances r\u00e8glementaires de recherche :<\/p><ul><li>Comit\u00e9 de Protection des Personnes (CPP) : pour veiller \u00e0 l&rsquo;\u00e9thique et \u00e0 la clart\u00e9 de l&rsquo;information d\u00e9livr\u00e9e au patient.<\/li><\/ul><p style=\"padding-left: 40px;\"><span style=\"color: #999999;\"><em>Pour aller plus loin :\u00a0<\/em><\/span><em><a href=\"https:\/\/urlz.fr\/iaGt\" target=\"_blank\" rel=\"noopener\">Devenez repr\u00e9sentant des usagers au sein d\u2019un Comit\u00e9 de Protection des Personnes<\/a><\/em><\/p><ul><li>Centres Hospitalo-Universitaires (CHU) : certains CHU r\u00e9servent des si\u00e8ges pour les repr\u00e9sentants des usagers dans leur comit\u00e9 d&rsquo;\u00e9thique.<\/li><\/ul><p style=\"padding-left: 40px;\"><span style=\"color: #999999;\"><em>Pour aller plus loin :\u00a0<\/em><\/span><em><a href=\"https:\/\/urlz.fr\/iaGz\" target=\"_blank\" rel=\"noopener\">Devenez repr\u00e9sentant des usagers dans les CHU<\/a><\/em><\/p><ul><li>Universit\u00e9 : les comit\u00e9s \u00e9thiques pour la recherche universitaire incluent parfois des membres externes, tels que des repr\u00e9sentants associatifs.<\/li><\/ul><p style=\"padding-left: 40px;\"><span style=\"color: #999999;\"><em>Pour aller plus loin :\u00a0<\/em><\/span><em><a href=\"https:\/\/urlz.fr\/iaGK\" target=\"_blank\" rel=\"noopener\">Le r\u00f4le du repr\u00e9sentant du public dans les comit\u00e9s d\u2019\u00e9thique de la recherche<\/a><\/em><\/p><ul><li>Comit\u00e9 \u00e9thique et scientifique pour les recherches, les \u00e9tudes et les \u00e9valuations dans le domaine de la sant\u00e9 (CESREES)\u00a0: il doit comprendre deux repr\u00e9sentants de l\u2019Union nationale des associations agr\u00e9\u00e9es d\u2019usagers du syst\u00e8me de sant\u00e9.<\/li><\/ul>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-edd95a8 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"edd95a8\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-8a7e2c5\" data-id=\"8a7e2c5\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-e750b66 elementor-widget elementor-widget-image\" data-id=\"e750b66\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"image.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<img decoding=\"async\" src=\"https:\/\/guide-recherche-asso.info\/wp-content\/uploads\/2023\/01\/B4W-GDR-Banderole-Temoigner.png\" title=\"\" alt=\"\" loading=\"lazy\" \/>\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-ef4b7bd elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"ef4b7bd\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-c7a92cc\" data-id=\"c7a92cc\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-f998bda elementor-widget elementor-widget-text-editor\" data-id=\"f998bda\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><em>T\u00e9moignages \u00e0 venir.<\/em><\/p><p><em>Si vous souhaitez t\u00e9moigner, n&rsquo;h\u00e9sitez pas \u00e0 nous contacter.<\/em><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d414c30 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d414c30\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-de6bf7c\" data-id=\"de6bf7c\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6a216f0 elementor-widget elementor-widget-spacer\" data-id=\"6a216f0\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"spacer.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t<div class=\"elementor-spacer\">\n\t\t\t<div class=\"elementor-spacer-inner\"><\/div>\n\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>Cadre r\u00e9glementaire Certaines pratiques de recherche sont r\u00e8glement\u00e9es. C\u2019est le cas entre autres des\u00a0: Recherches impliquant la personne humaine (RIPH), encadr\u00e9es par la loi Jard\u00e9\u00a0 Elles doivent toutes recevoir \u00e9galement un avis favorable d\u2019un Comit\u00e9 de Protection des Personnes (CPP). Elles peuvent \u00eatre de 3 types : RIPH-1 : interventionnel (intervention non justifi\u00e9e par la [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-1182","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/guide-recherche-asso.info\/index.php\/wp-json\/wp\/v2\/pages\/1182","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/guide-recherche-asso.info\/index.php\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/guide-recherche-asso.info\/index.php\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/guide-recherche-asso.info\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/guide-recherche-asso.info\/index.php\/wp-json\/wp\/v2\/comments?post=1182"}],"version-history":[{"count":22,"href":"https:\/\/guide-recherche-asso.info\/index.php\/wp-json\/wp\/v2\/pages\/1182\/revisions"}],"predecessor-version":[{"id":1209,"href":"https:\/\/guide-recherche-asso.info\/index.php\/wp-json\/wp\/v2\/pages\/1182\/revisions\/1209"}],"wp:attachment":[{"href":"https:\/\/guide-recherche-asso.info\/index.php\/wp-json\/wp\/v2\/media?parent=1182"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}