{ "article": { "LEGIARTI000049975880": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "R1126-13", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2024-07-14" } }, "META_COMMUN": { "ID": "LEGIARTI000049975880", "URL": "article/LEGI/ARTI/00/00/49/97/58/LEGIARTI000049975880.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000049967627", "@num": "6", "#text": "Décret n°2024-795 du 8 juillet 2024 - art. 6", "@sens": "cible", "@cidtexte": "JORFTEXT000049962633", "@nortexte": "TSSP2329890D", "@numtexte": "2024-795", "@typelien": "CREE", "@naturetexte": "DECRET", "@datesignatexte": "2024-07-08" }, { "@id": "LEGIARTI000006685825", "@num": "L1121-1", "#text": "Code de la santé publique - art. L1121-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000049975874", "@fin": "2999-01-01", "#text": "Sous-section 3 : Demande de modification substantielle", "@debut": "2024-07-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000049975852", "@fin": "2999-01-01", "#text": "Section 2 : Evaluation par les comités de protection des personnes", "@debut": "2024-07-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000049975844", "@fin": "2999-01-01", "#text": "Chapitre VI : Dispositions particulières relatives aux études des performances", "@debut": "2024-07-14" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006160948", "@fin": "2017-05-11", "#text": "Titre II : Recherches biomédicales", "@debut": "2003-05-27" }, { "@id": "LEGISCTA000034773672", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2017-05-11" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006145467", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@debut": "2003-05-27" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006132378", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-12-23" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006112927", "@fin": "2999-01-01", "#text": "Partie réglementaire", "@debut": "2000-12-23" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000049975880", "@fin": "2999-01-01", "@num": "R1126-13", "@etat": "VIGUEUR", "@debut": "2024-07-14", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Pour les demandes de modifications substantielles de la liste des sites d'investigation ou des investigateurs principaux définis à l'article L. 1121-1, le président émet l'avis au nom du comité sur proposition d'un seul rapporteur.

" } }, "LEGIARTI000006685825": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2004-08-11", "DATE_DEBUT": "2000-06-22" } }, "META_COMMUN": { "ID": "LEGIARTI000006685825", "URL": "article/LEGI/ARTI/00/00/06/68/58/LEGIARTI000006685825.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1121L01XXAA" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000031932044", "@num": "54", "#text": "Loi n° 78-17 du 6 janvier 1978 - art. 54 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000886460", "@numtexte": "78-17", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1978-01-06" }, { "@id": "LEGIARTI000033219654", "@num": "58", "#text": "Loi n° 78-17 du 6 janvier 1978 - art. 58 (M)", "@sens": "cible", "@cidtexte": "JORFTEXT000000886460", "@numtexte": "78-17", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1978-01-06" }, { "@id": "LEGIARTI000037823087", "@num": "59", "#text": "Loi n° 78-17 du 6 janvier 1978 - art. 59 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000886460", "@numtexte": "78-17", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1978-01-06" }, { "@id": "LEGIARTI000038888847", "@num": "76", "#text": "Loi n° 78-17 du 6 janvier 1978 - art. 76 (VD)", "@sens": "cible", "@cidtexte": "JORFTEXT000000886460", "@numtexte": "78-17", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1978-01-06" }, { "@id": "LEGIARTI000006700002", "@num": "2", "#text": "Décret n°95-1172 du 6 novembre 1995 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000737358", "@nortexte": "SANP9502594D", "@numtexte": "95-1172", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "1995-11-06" }, { "@id": "JORFTEXT000000217229", "#text": "Ordonnance 2000-548 2000-06-15", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@id": "JORFTEXT000000227015", "#text": "Loi 2002-303 2002-03-04 art. 92 JORF 5 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000020350738", "@num": "3", "#text": "Arrêté du 16 août 2006 - art. 3 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000640165", "@nortexte": "SANP0623371A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006868631", "@num": "30", "#text": "Décret n° 2007-358 du 19 mars 2007 - art. 30 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000000821090", "@nortexte": "AGRG0700644D", "@numtexte": "2007-358", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2007-03-19" }, { "@id": "LEGIARTI000020317489", "@num": "2", "#text": "Arrêté du 9 mars 2007 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000649637", "@nortexte": "SANP0721150A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2007-03-09" }, { "@id": "LEGIARTI000020317485", "@num": "3", "#text": "Arrêté du 9 mars 2007 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000649637", "@nortexte": "SANP0721150A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2007-03-09" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000047718215", "@num": "2", "#text": "Arrêté du 23 janvier 2009 - art. 2 (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000020214008", "@nortexte": "SASP0902336A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-01-23" }, { "@id": "LEGIARTI000047718206", "@num": "3", "#text": "Arrêté du 23 janvier 2009 - art. 3 (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000020214008", "@nortexte": "SASP0902336A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-01-23" }, { "@id": "LEGITEXT000020317153", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020315174", "@nortexte": "SASP0904389A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020349078", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020348114", "@nortexte": "SASP0904450A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000042012478", "@num": "7", "#text": "Ordonnance n° 2010-49 du 13 janvier 2010 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021683301", "@nortexte": "SASX0927179R", "@numtexte": "2010-49", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGIARTI000030781727", "@num": "Annexe II", "#text": "ARRÊTÉ du 12 juin 2015 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030780467", "@nortexte": "AFSH1514265A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-06-12" }, { "@id": "LEGIARTI000031427986", "@num": "Annexe II", "#text": "DÉCRET n°2015-1410 du 5 novembre 2015 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031425096", "@nortexte": "MENX1523045D", "@numtexte": "2015-1410", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2015-11-05" }, { "@id": "LEGIARTI000033205198", "@num": "56", "#text": "LOI n°2016-1321 du 7 octobre 2016 - art. 56", "@sens": "cible", "@cidtexte": "JORFTEXT000033202746", "@nortexte": "ECFI1524250L", "@numtexte": "2016-1321", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-10-07" }, { "@id": "LEGIARTI000033546110", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000033538105", "@nortexte": "AFSP1635581A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGITEXT000033547014", "#text": "Arrêté du 2 décembre 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545436", "@nortexte": "AFSP1635568A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGITEXT000033547075", "#text": "Arrêté du 2 décembre 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545461", "@nortexte": "AFSP1635571A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGITEXT000033547573", "#text": "Arrêté du 2 décembre 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545487", "@nortexte": "AFSP1635578A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033546905", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545422", "@nortexte": "AFSP1635566A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033546927", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545400", "@nortexte": "AFSP1635538A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547022", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545436", "@nortexte": "AFSP1635568A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547081", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545461", "@nortexte": "AFSP1635571A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033546843", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545387", "@nortexte": "AFSP1635532A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547576", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545487", "@nortexte": "AFSP1635578A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033546907", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545422", "@nortexte": "AFSP1635566A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033546929", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545400", "@nortexte": "AFSP1635538A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547024", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545436", "@nortexte": "AFSP1635568A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547083", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545461", "@nortexte": "AFSP1635571A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547578", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545487", "@nortexte": "AFSP1635578A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547085", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545461", "@nortexte": "AFSP1635571A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033546911", "@num": "4", "#text": "Arrêté du 2 décembre 2016 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545422", "@nortexte": "AFSP1635566A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000034117390", "#text": "Arrêté du 2 décembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553393", "@nortexte": "AFSP1635663A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033554485", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033554521", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553371", "@nortexte": "AFSP1635658A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033556723", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553393", "@nortexte": "AFSP1635663A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033554487", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033554523", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553371", "@nortexte": "AFSP1635658A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033554525", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553371", "@nortexte": "AFSP1635658A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGITEXT000034113495", "#text": "Arrêté du 23 février 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034104356", "@nortexte": "AFSP1705902A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034637787", "@num": "2", "#text": "Arrêté du 3 mai 2017 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000034598769", "@nortexte": "AFSP1713689A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-05-03" }, { "@id": "LEGIARTI000036565500", "@num": "1", "#text": "Arrêté du 30 janvier 2018 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036564676", "@nortexte": "SSAP1802860A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-01-30" }, { "@id": "LEGIARTI000036934032", "#text": "Arrêté du 5 avril 2018 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000036783379", "@nortexte": "SSAP1809483A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-05" }, { "@id": "LEGITEXT000036868315", "#text": "Arrêté du 12 avril 2018 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036805796", "@nortexte": "SSAP1810239A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-12" }, { "@id": "LEGITEXT000043165231", "#text": "Arrêté du 12 avril 2018 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036805820", "@nortexte": "SSAP1810240A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-12" }, { "@id": "LEGIARTI000036868331", "@num": "Annexe 1", "#text": "Arrêté du 12 avril 2018 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036805796", "@nortexte": "SSAP1810239A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-12" }, { "@id": "LEGIARTI000043165236", "@num": "Annexe 1", "#text": "Arrêté du 12 avril 2018 - art. 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Les essais ou expérimentations organisés et pratiqués sur l'être humain en vue du développement des connaissances biologiques ou médicales sont autorisés dans les conditions prévues au présent livre et sont désignés ci-après par les termes : \"recherche biomédicale\".
\n
Les recherches biomédicales dont on attend un bénéfice direct pour la personne qui s'y prête sont dénommées recherches biomédicales avec bénéfice individuel direct. Toutes les autres recherches, qu'elles portent sur des personnes malades ou non, sont dénommées sans bénéfice individuel direct.
\n
La personne physique ou morale qui prend l'initiative d'une recherche biomédicale sur l'être humain est dénommée le promoteur. La ou les personnes physiques qui dirigent et surveillent la réalisation de la recherche sont dénommées les investigateurs.
\n
Lorsque plusieurs personnes prennent l'initiative d'une même recherche, elles peuvent désigner une personne physique ou morale qui aura la qualité de promoteur et assume les obligations correspondantes en application du présent livre.
\n
Lorsque le promoteur d'une recherche confie sa réalisation à plusieurs investigateurs, il désigne parmi eux un investigateur coordonnateur.
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Les recherches organisées et pratiquées sur l'être humain en vue du développement des connaissances biologiques ou médicales sont autorisées dans les conditions prévues au présent livre et sont désignées ci-après par les termes \"recherche biomédicale\".
\n
Les dispositions du présent titre ne s'appliquent pas :
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1° Aux recherches dans lesquelles tous les actes sont pratiqués et les produits utilisés de manière habituelle, sans aucune procédure supplémentaire ou inhabituelle de diagnostic ou de surveillance ;
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2° Aux recherches visant à évaluer les soins courants, autres que celles portant sur des produits mentionnés à l'article L. 5311-1 et figurant sur une liste fixée par décret en Conseil d'Etat, lorsque tous les actes sont pratiqués et les produits utilisés de manière habituelle mais que des modalités particulières de surveillance sont prévues par un protocole, obligatoirement soumis à l'avis consultatif du comité mentionné à l'article L. 1123-1. Ce protocole précise également les modalités d'information des personnes concernées.
\n
La personne physique ou la personne morale qui prend l'initiative d'une recherche biomédicale sur l'être humain, qui en assure la gestion et qui vérifie que son financement est prévu, est dénommée le promoteur. Celui-ci ou son représentant légal doit être établi dans la Communauté européenne. Lorsque plusieurs personnes prennent l'initiative d'une même recherche biomédicale, elles désignent une personne physique ou morale qui aura la qualité de promoteur et assumera les obligations correspondantes en application du présent livre.
\n
La ou les personnes physiques qui dirigent et surveillent la réalisation de la recherche sur un lieu sont dénommées investigateurs.
\n
Lorsque le promoteur d'une recherche biomédicale confie sa réalisation à plusieurs investigateurs, sur un même lieu ou sur plusieurs lieux en France, le promoteur désigne parmi les investigateurs un coordonnateur.
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Les recherches organisées et pratiquées sur l'être humain en vue du développement des connaissances biologiques ou médicales sont autorisées dans les conditions prévues au présent livre et sont désignées ci-après par les termes \" recherche biomédicale \".
\n
Les dispositions du présent titre ne s'appliquent pas :
\n
1° Aux recherches dans lesquelles tous les actes sont pratiqués et les produits utilisés de manière habituelle, sans aucune procédure supplémentaire ou inhabituelle de diagnostic ou de surveillance ;
\n
2° Aux recherches visant à évaluer les soins courants, autres que celles portant sur les médicaments, lorsque tous les actes sont pratiqués et les produits utilisés de manière habituelle mais que des modalités particulières de surveillance sont prévues par un protocole, obligatoirement soumis à l'avis du comité mentionné à l'article L. 1123-1. Ce protocole précise également les modalités d'information des personnes concernées. Les recherches ne peuvent être mises en oeuvre qu'après avis favorable, rendu dans un délai fixé par voie réglementaire, de l'un des comités de protection des personnes compétent pour le lieu où sont mises en oeuvre les recherches. La demande auprès du comité est faite par la personne physique ou morale qui prend l'initiative de ces recherches, en assure la gestion et vérifie que son financement est prévu. Lorsque les recherches portent sur des produits mentionnés à l'article L. 5311-1 à l'exception des médicaments, et figurant sur une liste fixée par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé, le comité de protection des personnes s'assure auprès de l'Agence française de sécurité sanitaire des produits de santé que les conditions d'utilisation dans les recherches de ces produits sont conformes à leur destination et à leurs conditions d'utilisation courante.L'avis défavorable du comité mentionne, le cas échéant, que les recherches ne relèvent pas du présent 2°. Après le commencement des recherches, toute modification substantielle de celles-ci doit obtenir préalablement à leur mise en oeuvre un nouvel avis favorable du comité.
\n
La personne physique ou la personne morale qui prend l'initiative d'une recherche biomédicale sur l'être humain, qui en assure la gestion et qui vérifie que son financement est prévu, est dénommée le promoteur. Celui-ci ou son représentant légal doit être établi dans la Communauté européenne. Lorsque plusieurs personnes prennent l'initiative d'une même recherche biomédicale, elles désignent une personne physique ou morale qui aura la qualité de promoteur et assumera les obligations correspondantes en application du présent livre.
\n
La ou les personnes physiques qui dirigent et surveillent la réalisation de la recherche sur un lieu sont dénommées investigateurs.
\n
Lorsque le promoteur d'une recherche biomédicale confie sa réalisation à plusieurs investigateurs, sur un même lieu ou sur plusieurs lieux en France, le promoteur désigne parmi les investigateurs un coordonnateur.
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Les recherches organisées et pratiquées sur l'être humain en vue du développement des connaissances biologiques ou médicales sont autorisées dans les conditions prévues au présent livre et sont désignées ci-après par les termes \" recherche biomédicale \".
\n
Les dispositions du présent titre ne s'appliquent pas :
\n
1° Aux recherches dans lesquelles tous les actes sont pratiqués et les produits utilisés de manière habituelle, sans aucune procédure supplémentaire ou inhabituelle de diagnostic ou de surveillance ;
\n
2° Aux recherches visant à évaluer les soins courants, autres que celles portant sur les médicaments, lorsque tous les actes sont pratiqués et les produits utilisés de manière habituelle mais que des modalités particulières de surveillance sont prévues par un protocole, obligatoirement soumis à l'avis du comité mentionné à l'article L. 1123-1. Ce protocole précise également les modalités d'information des personnes concernées. Les recherches ne peuvent être mises en oeuvre qu'après avis favorable, rendu dans un délai fixé par voie réglementaire, de l'un des comités de protection des personnes compétent pour le lieu où sont mises en oeuvre les recherches. La demande auprès du comité est faite par la personne physique ou morale qui prend l'initiative de ces recherches, en assure la gestion et vérifie que son financement est prévu. Lorsque les recherches portent sur des produits mentionnés à l'article L. 5311-1 à l'exception des médicaments, et figurant sur une liste fixée par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence française de sécurité sanitaire des produits de santé, le comité de protection des personnes s'assure auprès de l'Agence française de sécurité sanitaire des produits de santé que les conditions d'utilisation dans les recherches de ces produits sont conformes à leur destination et à leurs conditions d'utilisation courante.L'avis défavorable du comité mentionne, le cas échéant, que les recherches ne relèvent pas du présent 2°. Après le commencement des recherches, toute modification substantielle de celles-ci doit obtenir préalablement à leur mise en oeuvre un nouvel avis favorable du comité.
\n
La personne physique ou la personne morale qui prend l'initiative d'une recherche biomédicale sur l'être humain, qui en assure la gestion et qui vérifie que son financement est prévu, est dénommée le promoteur. Celui-ci ou son représentant légal doit être établi dans l'Union européenne. Lorsque plusieurs personnes prennent l'initiative d'une même recherche biomédicale, elles désignent une personne physique ou morale qui aura la qualité de promoteur et assumera les obligations correspondantes en application du présent livre.
\n
La ou les personnes physiques qui dirigent et surveillent la réalisation de la recherche sur un lieu sont dénommées investigateurs.
\n
Lorsque le promoteur d'une recherche biomédicale confie sa réalisation à plusieurs investigateurs, sur un même lieu ou sur plusieurs lieux en France, le promoteur désigne parmi les investigateurs un coordonnateur.
" } }, "LEGIARTI000025104470": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2016-06-18", "DATE_DEBUT": "2012-05-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025104470", "URL": "article/LEGI/ARTI/00/00/25/10/44/LEGIARTI000025104470.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Loi n° 2011-2012 du 29 décembre 2011 article 41 III : Les présentes dispositions entrent en vigueur à une date prévue par le décret pris pour leur application et au plus tard le 1er août 2012. Dès cette entrée en vigueur, l'Agence nationale de sécurité du médicament et des produits de santé exerce l'ensemble des droits et supporte l'ensemble des obligations de l'Agence française de sécurité sanitaire des produits de santé. Jusqu'à l'entrée en vigueur mentionnée au premier alinéa du présent III, les compétences et pouvoirs que la présente loi attribue à l'Agence nationale de sécurité du médicament et des produits de santé sont exercés par l'Agence française de sécurité sanitaire des produits de santé.

Le décret n° 2012-597 du 27 avril 2012 est entré en vigueur le 1er mai 2012.

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Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000018360158", "@nortexte": "SJSP0805973A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2008-03-05" }, { "@id": "LEGIARTI000047718215", "@num": "2", "#text": "Arrêté du 23 janvier 2009 - art. 2 (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000020214008", "@nortexte": "SASP0902336A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-01-23" }, { "@id": "LEGIARTI000047718206", "@num": "3", "#text": "Arrêté du 23 janvier 2009 - art. 3 (VT)", "@sens": "cible", "@cidtexte": "JORFTEXT000020214008", "@nortexte": "SASP0902336A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-01-23" }, { "@id": "LEGITEXT000020317153", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020315174", "@nortexte": "SASP0904389A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGITEXT000020349078", "#text": "Arrêté du 19 février 2009 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020348114", "@nortexte": "SASP0904450A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-02-19" }, { "@id": "LEGIARTI000042012478", "@num": "7", "#text": "Ordonnance n° 2010-49 du 13 janvier 2010 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000021683301", "@nortexte": "SASX0927179R", "@numtexte": "2010-49", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGIARTI000021782780", "@num": "Annexe au règlement intérieur", "#text": "Arrêté du 13 janvier 2010 - art. Annexe au règlement intérieur (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGIARTI000025071134", "@num": "5", "#text": "LOI n°2011-2012\n du 29 décembre 2011 - art. 5", "@sens": "cible", "@cidtexte": "JORFTEXT000025053440", "@nortexte": "ETSX1119227L", "@numtexte": "2011-2012", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2011-12-29" }, { "@id": "LEGIARTI000030781727", "@num": "Annexe II", "#text": "ARRÊTÉ du 12 juin 2015 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000030780467", "@nortexte": "AFSH1514265A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2015-06-12" }, { "@id": "LEGIARTI000031427986", "@num": "Annexe II", "#text": "DÉCRET n°2015-1410 du 5 novembre 2015 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031425096", "@nortexte": "MENX1523045D", "@numtexte": "2015-1410", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2015-11-05" }, { "@id": "LEGIARTI000033205198", "@num": "56", "#text": "LOI n°2016-1321 du 7 octobre 2016 - art. 56", "@sens": "cible", "@cidtexte": "JORFTEXT000033202746", "@nortexte": "ECFI1524250L", "@numtexte": "2016-1321", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-10-07" }, { "@id": "LEGIARTI000033546110", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000033538105", "@nortexte": "AFSP1635581A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGITEXT000033547014", "#text": "Arrêté du 2 décembre 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545436", "@nortexte": "AFSP1635568A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGITEXT000033547075", "#text": "Arrêté du 2 décembre 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545461", "@nortexte": "AFSP1635571A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGITEXT000033547573", "#text": "Arrêté du 2 décembre 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545487", "@nortexte": "AFSP1635578A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033546905", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - 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art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545387", "@nortexte": "AFSP1635532A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547576", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545487", "@nortexte": "AFSP1635578A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033546907", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545422", "@nortexte": "AFSP1635566A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033546929", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545400", "@nortexte": "AFSP1635538A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547024", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545436", "@nortexte": "AFSP1635568A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547083", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545461", "@nortexte": "AFSP1635571A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547578", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545487", "@nortexte": "AFSP1635578A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547085", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545461", "@nortexte": "AFSP1635571A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033546911", "@num": "4", "#text": "Arrêté du 2 décembre 2016 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545422", "@nortexte": "AFSP1635566A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000034117390", "#text": "Arrêté du 2 décembre 2016 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553393", "@nortexte": "AFSP1635663A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033554485", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033554521", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553371", "@nortexte": "AFSP1635658A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033556723", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553393", "@nortexte": "AFSP1635663A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033554487", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553349", "@nortexte": "AFSP1635656A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033554523", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553371", "@nortexte": "AFSP1635658A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033554525", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033553371", "@nortexte": "AFSP1635658A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGITEXT000034113495", "#text": "Arrêté du 23 février 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000034104356", "@nortexte": "AFSP1705902A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-02-23" }, { "@id": "LEGIARTI000034637787", "@num": "2", "#text": "Arrêté du 3 mai 2017 - art. 2 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000034598769", "@nortexte": "AFSP1713689A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2017-05-03" }, { "@id": "LEGIARTI000036565500", "@num": "1", "#text": "Arrêté du 30 janvier 2018 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036564676", "@nortexte": "SSAP1802860A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-01-30" }, { "@id": "LEGIARTI000036934032", "#text": "Arrêté du 5 avril 2018 - art. (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000036783379", "@nortexte": "SSAP1809483A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-05" }, { "@id": "LEGITEXT000036868315", "#text": "Arrêté du 12 avril 2018 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036805796", "@nortexte": "SSAP1810239A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-12" }, { "@id": "LEGITEXT000043165231", "#text": "Arrêté du 12 avril 2018 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036805820", "@nortexte": "SSAP1810240A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-12" }, { "@id": "LEGIARTI000036868331", "@num": "Annexe 1", "#text": "Arrêté du 12 avril 2018 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036805796", "@nortexte": "SSAP1810239A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-12" }, { "@id": "LEGIARTI000043165236", "@num": "Annexe 1", "#text": "Arrêté du 12 avril 2018 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036805820", "@nortexte": "SSAP1810240A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-12" }, { "@id": "LEGIARTI000043165243", "@num": "1", "#text": "Arrêté du 12 avril 2018 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036805820", "@nortexte": "SSAP1810240A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-12" }, { "@id": "LEGIARTI000036868321", "@num": "2", "#text": "Arrêté du 12 avril 2018 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036805796", "@nortexte": "SSAP1810239A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-12" }, { "@id": "LEGIARTI000036868327", "@num": "4", "#text": "Arrêté du 12 avril 2018 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036805796", "@nortexte": "SSAP1810239A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-12" }, { "@id": "LEGIARTI000036868323", "@num": "5", "#text": "Arrêté du 12 avril 2018 - art. 5 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036805796", "@nortexte": "SSAP1810239A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-12" }, { "@id": "LEGITEXT000038123294", "#text": "Arrêté du 21 décembre 2018 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037852311", "@nortexte": "SSAP1835310A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-12-21" }, { "@id": "LEGIARTI000038123304", "#text": "Arrêté du 21 décembre 2018 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037852311", "@nortexte": "SSAP1835310A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-12-21" }, { "@id": "LEGIARTI000038123301", "@num": "1", "#text": "Arrêté du 21 décembre 2018 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037852311", "@nortexte": "SSAP1835310A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-12-21" }, { "@id": "LEGIARTI000043345697", "@num": "54-1", "#text": "Décret n°2020-1262 du 16 octobre 2020 - art. 54-1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042430554", "@nortexte": "SSAZ2028015D", "@numtexte": "2020-1262", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-16" }, { "@id": "LEGIARTI000043345824", "@num": "52-1", "#text": "Décret n°2020-1310 du 29 octobre 2020 - art. 52-1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042475143", "@nortexte": "SSAZ2029612D", "@numtexte": "2020-1310", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-10-29" }, { "@id": "LEGIARTI000043097503", "@num": "1", "#text": "Arrêté du 26 janvier 2021 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043096707", "@nortexte": "SSAP2102976A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-01-26" }, { "@id": "LEGIARTI000043097554", "@num": "1", "#text": "Arrêté du 26 janvier 2021 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043096720", "@nortexte": "SSAP2102981A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-01-26" }, { "@id": "LEGIARTI000043097600", "@num": "1", "#text": "Arrêté du 26 janvier 2021 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043096732", "@nortexte": "SSAP2102992A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-01-26" }, { "@id": "LEGIARTI000043098100", "@num": "1", "#text": "Arrêté du 26 janvier 2021 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043096744", "@nortexte": "SSAP2102998A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-01-26" }, { "@id": "LEGIARTI000043124094", "@num": "1", "#text": "Arrêté du 26 janvier 2021 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043121591", "@nortexte": "SSAP2102968A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-01-26" }, { "@id": "LEGITEXT000043157298", "#text": "Arrêté du 17 février 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043156146", "@nortexte": "SSAP2105595A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-17" }, { "@id": "LEGIARTI000043157279", "@num": "1", "#text": "Arrêté du 17 février 2021 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043156138", "@nortexte": "SSAP2105517A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-17" }, { "@id": "LEGITEXT000043165043", "#text": "Arrêté du 17 février 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043162656", "@nortexte": "SSAP2105597A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-17" }, { "@id": "LEGIARTI000043345664", "@num": "1", "#text": "Décret n°2021-425 du 10 avril 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043345061", "@nortexte": "SSAZ2111133D", "@numtexte": "2021-425", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-04-10" }, { "@id": "LEGIARTI000043345666", "@num": "2", "#text": "Décret n°2021-425 du 10 avril 2021 - art. 2", "@sens": "cible", "@cidtexte": "JORFTEXT000043345061", "@nortexte": "SSAZ2111133D", "@numtexte": "2021-425", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2021-04-10" }, { "@id": "LEGIARTI000043507285", "@num": "1", "#text": "Arrêté du 12 mai 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043506990", "@nortexte": "SSAP2115003A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-05-12" }, { "@id": "LEGITEXT000043507349", "#text": "Arrêté du 17 mai 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043507013", "@nortexte": "SSAP2115206A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-05-17" }, { "@id": "LEGIARTI000043507358", "@num": "1", "#text": "Arrêté du 17 mai 2021 - 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Les recherches organisées et pratiquées sur l'être humain en vue du développement des connaissances biologiques ou médicales sont autorisées dans les conditions prévues au présent livre et sont désignées ci-après par les termes \" recherche biomédicale \".
\n
Les dispositions du présent titre ne s'appliquent pas :
\n
1° Aux recherches dans lesquelles tous les actes sont pratiqués et les produits utilisés de manière habituelle, sans aucune procédure supplémentaire ou inhabituelle de diagnostic ou de surveillance ;
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2° Aux recherches visant à évaluer les soins courants, autres que celles portant sur les médicaments, lorsque tous les actes sont pratiqués et les produits utilisés de manière habituelle mais que des modalités particulières de surveillance sont prévues par un protocole, obligatoirement soumis à l'avis du comité mentionné à l'article L. 1123-1. Ce protocole précise également les modalités d'information des personnes concernées. Les recherches ne peuvent être mises en oeuvre qu'après avis favorable, rendu dans un délai fixé par voie réglementaire, de l'un des comités de protection des personnes compétent pour le lieu où sont mises en oeuvre les recherches. La demande auprès du comité est faite par la personne physique ou morale qui prend l'initiative de ces recherches, en assure la gestion et vérifie que son financement est prévu. Lorsque les recherches portent sur des produits mentionnés à l'article L. 5311-1 à l'exception des médicaments, et figurant sur une liste fixée par arrêté du ministre chargé de la santé, pris sur proposition du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé , le comité de protection des personnes s'assure auprès de l'Agence nationale de sécurité du médicament et des produits de santé que les conditions d'utilisation dans les recherches de ces produits sont conformes à leur destination et à leurs conditions d'utilisation courante. L'avis défavorable du comité mentionne, le cas échéant, que les recherches ne relèvent pas du présent 2°. Après le commencement des recherches, toute modification substantielle de celles-ci doit obtenir préalablement à leur mise en oeuvre un nouvel avis favorable du comité.
\n
La personne physique ou la personne morale qui prend l'initiative d'une recherche biomédicale sur l'être humain, qui en assure la gestion et qui vérifie que son financement est prévu, est dénommée le promoteur. Celui-ci ou son représentant légal doit être établi dans l'Union européenne. Lorsque plusieurs personnes prennent l'initiative d'une même recherche biomédicale, elles désignent une personne physique ou morale qui aura la qualité de promoteur et assumera les obligations correspondantes en application du présent livre.
\n
La ou les personnes physiques qui dirigent et surveillent la réalisation de la recherche sur un lieu sont dénommées investigateurs.
\n
Lorsque le promoteur d'une recherche biomédicale confie sa réalisation à plusieurs investigateurs, sur un même lieu ou sur plusieurs lieux en France, le promoteur désigne parmi les investigateurs un coordonnateur.
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R6133-18 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000032723038", "@num": "223-8", "#text": "Code pénal - art. 223-8 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006070719", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006170998", "@fin": "2016-12-31", "#text": "Chapitre Ier : Principes généraux", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000032722874", "@fin": "2999-01-01", "#text": "Chapitre Ier : Principes généraux relatifs aux recherches impliquant la personne humaine", "@debut": "2016-12-31" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006154978", "@fin": "2012-03-07", "#text": "Titre II : Recherches biomédicales", "@debut": "2000-06-22" }, { "@id": "LEGISCTA000025457387", "@fin": "2999-01-01", "#text": "Titre II : Recherches impliquant la personne humaine", "@debut": "2012-03-07" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006140603", "@fin": "2999-01-01", "#text": "Livre Ier : Protection des personnes en matière de santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006125345", "@fin": "2999-01-01", "#text": "Première partie : Protection générale de la santé", "@debut": "2000-06-22" } ] }, "TITRE_TM": [ { "@id": "LEGISCTA000006103419", "@fin": "2999-01-01", "#text": "Partie législative", "@debut": "2000-06-22" } ] }, "@cid": "LEGITEXT000006072665", "@nature": "CODE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Code de la santé publique", "@debut": "1953-10-07", "@id_txt": "LEGITEXT000006072665", "@c_titre_court": "Code de la santé publique" } ], "@date_publi": "2999-01-01", "@date_signature": "2999-01-01" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685825", "@fin": "2004-08-11", "@num": "L1121-1", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685826", "@fin": "2006-04-19", "@num": "L1121-1", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685827", "@fin": "2010-02-26", "@num": "L1121-1", "@etat": "MODIFIE", "@debut": "2006-04-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000021942025", "@fin": "2012-05-01", "@num": "L1121-1", "@etat": "MODIFIE", "@debut": "2010-02-26", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025104470", "@fin": "2016-06-18", "@num": "L1121-1", "@etat": "MODIFIE", "@debut": "2012-05-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE_MORT_NE", "LIEN_ART": { "@id": "LEGIARTI000025449446", "@fin": "2016-06-18", "@num": "L1121-1", "@etat": "MODIFIE_MORT_NE", "@debut": "2222-02-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032744876", "@fin": "2016-12-31", "@num": "L1121-1", "@etat": "MODIFIE", "@debut": "2016-06-18", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032722870", "@fin": "2022-04-22", "@num": "L1121-1", "@etat": "MODIFIE", "@debut": "2016-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000045629992", "@fin": "2022-07-31", "@num": "L1121-1", "@etat": "MODIFIE", "@debut": "2022-04-22", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000046125746", "@fin": "2999-01-01", "@num": "L1121-1", "@etat": "VIGUEUR", "@debut": "2022-07-31", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Les recherches organisées et pratiquées sur l'être humain en vue du développement des connaissances biologiques ou médicales sont autorisées dans les conditions prévues au présent livre et sont désignées ci-après par les termes \" recherche impliquant la personne humaine \".

Il existe trois catégories de recherches impliquant la personne humaine :

1° Les recherches interventionnelles qui comportent une intervention sur la personne non justifiée par sa prise en charge habituelle ;

2° Les recherches interventionnelles qui ne portent pas sur des médicaments et ne comportent que des risques et des contraintes minimes, dont la liste est fixée par arrêté du ministre chargé de la santé, après avis du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé ;

3° Les recherches non interventionnelles dans lesquelles tous les actes sont pratiqués et les produits utilisés de manière habituelle, sans procédure supplémentaire ou inhabituelle de diagnostic, de traitement ou de surveillance.

La personne physique ou la personne morale qui est responsable d'une recherche impliquant la personne humaine, en assure la gestion et vérifie que son financement est prévu, est dénommée le promoteur. Celui-ci ou son représentant légal doit être établi dans l'Union européenne. Lorsque plusieurs personnes prennent l'initiative d'une même recherche impliquant la personne humaine, elles désignent une personne physique ou morale qui aura la qualité de promoteur et assumera les obligations correspondantes en application du présent livre.

La ou les personnes physiques qui dirigent et surveillent la réalisation de la recherche sur un lieu sont dénommées investigateurs.

Lorsque le promoteur d'une recherche impliquant la personne humaine confie sa réalisation à plusieurs investigateurs sur plusieurs lieux en France, le promoteur désigne parmi les investigateurs un coordonnateur.

Si, sur un lieu, la recherche est réalisée par une équipe, l'investigateur est le responsable de l'équipe et est dénommé investigateur principal.

" } }, "LEGIARTI000032722870": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-04-22", "DATE_DEBUT": "2016-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000032722870", "URL": "article/LEGI/ARTI/00/00/32/72/28/LEGIARTI000032722870.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément au I de l'article 8 de l'ordonnance n° 2016-800 du 16 juin 2016, ces dispositions, à l'exception de celles issues des a et c du 2° de l'article 1er de ladite ordonnance, entrent en vigueur à compter de la publication des décrets prévus par le code de la santé publique pour son application et au plus tard le 31 décembre 2016.

Il existe trois catégories de recherches impliquant la personne humaine :

1° Les recherches interventionnelles qui comportent une intervention sur la personne non justifiée par sa prise en charge habituelle ;

2° Les recherches interventionnelles qui ne comportent que des risques et des contraintes minimes, dont la liste est fixée par arrêté du ministre chargé de la santé, après avis du directeur général de l'Agence nationale de sécurité du médicament et des produits de santé ;

3° Les recherches non interventionnelles qui ne comportent aucun risque ni contrainte dans lesquelles tous les actes sont pratiqués et les produits utilisés de manière habituelle.

La ou les personnes physiques qui dirigent et surveillent la réalisation de la recherche sur un lieu sont dénommées investigateurs.

Si, sur un lieu, la recherche est réalisée par une équipe, l'investigateur est le responsable de l'équipe et est dénommé investigateur principal.

Les dispositions du présent titre, à l'exception de celles mentionnées au chapitre IV, ne sont pas applicables aux essais cliniques de médicaments régis par les dispositions du règlement (UE) n° 536/2014 du Parlement européen et du Conseil du 16 avril 2014.

" } }, "LEGIARTI000032744876": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2016-12-31", "DATE_DEBUT": "2016-06-18" } }, "META_COMMUN": { "ID": "LEGIARTI000032744876", "URL": "article/LEGI/ARTI/00/00/32/74/48/LEGIARTI000032744876.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément au II de l'article 8 de l'ordonnance n° 2016-800 du 16 juin 2016, ces dispositions, issues des a et c du 2° de l'article 1er de ladite ordonnance, entrent en vigueur à la date d'entrée en vigueur du règlement européen (UE) n° 536/2014 du 16 avril 2014.

Il existe trois catégories de recherches impliquant la personne humaine :

1° Les recherches interventionnelles qui comportent une intervention sur la personne non justifiée par sa prise en charge habituelle ;

La ou les personnes physiques qui dirigent et surveillent la réalisation de la recherche sur un lieu sont dénommées investigateurs.

Si, sur un lieu, la recherche est réalisée par une équipe, l'investigateur est le responsable de l'équipe et est dénommé investigateur principal.

" } }, "LEGIARTI000045629992": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2022-07-31", "DATE_DEBUT": "2022-04-22" } }, "META_COMMUN": { "ID": "LEGIARTI000045629992", "URL": "article/LEGI/ARTI/00/00/45/62/99/LEGIARTI000045629992.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Se reporter aux modalités d'application prévues aux I, II, III et VI de l'article 17 de l'ordonnance n° 2022-582 du 20 avril 2022.

Il existe trois catégories de recherches impliquant la personne humaine :

1° Les recherches interventionnelles qui comportent une intervention sur la personne non justifiée par sa prise en charge habituelle ;

3° Les recherches non interventionnelles qui ne comportent aucun risque ni contrainte dans lesquelles tous les actes sont pratiqués et les produits utilisés de manière habituelle.

La ou les personnes physiques qui dirigent et surveillent la réalisation de la recherche sur un lieu sont dénommées investigateurs.

Si, sur un lieu, la recherche est réalisée par une équipe, l'investigateur est le responsable de l'équipe et est dénommé investigateur principal.

Les dispositions du présent titre, à l'exception de celles mentionnées aux chapitres IV et V, ne sont pas applicables aux :
\n
\n a) Essais cliniques de médicaments régis par les dispositions du règlement (UE) n° 536/2014 du Parlement européen et du Conseil du 16 avril 2014 ;
\n
\n b) Investigations cliniques de dispositifs mentionnés à l'article premier du règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 régis par les dispositions de ce règlement.

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(V)", "@sens": "cible", "@cidtexte": "JORFTEXT000031425096", "@nortexte": "MENX1523045D", "@numtexte": "2015-1410", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2015-11-05" }, { "@id": "LEGIARTI000033205198", "@num": "56", "#text": "LOI n°2016-1321 du 7 octobre 2016 - art. 56", "@sens": "cible", "@cidtexte": "JORFTEXT000033202746", "@nortexte": "ECFI1524250L", "@numtexte": "2016-1321", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2016-10-07" }, { "@id": "LEGIARTI000033546110", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000033538105", "@nortexte": "AFSP1635581A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGITEXT000033547014", "#text": "Arrêté du 2 décembre 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545436", "@nortexte": "AFSP1635568A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGITEXT000033547075", "#text": "Arrêté du 2 décembre 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545461", "@nortexte": "AFSP1635571A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGITEXT000033547573", "#text": "Arrêté du 2 décembre 2016 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545487", "@nortexte": "AFSP1635578A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033546905", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545422", "@nortexte": "AFSP1635566A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033546927", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545400", "@nortexte": "AFSP1635538A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547022", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545436", "@nortexte": "AFSP1635568A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547081", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545461", "@nortexte": "AFSP1635571A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033546843", "@num": "1", "#text": "Arrêté du 2 décembre 2016 - 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art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545436", "@nortexte": "AFSP1635568A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547083", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545461", "@nortexte": "AFSP1635571A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547578", "@num": "2", "#text": "Arrêté du 2 décembre 2016 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545487", "@nortexte": "AFSP1635578A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033547085", "@num": "3", "#text": "Arrêté du 2 décembre 2016 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545461", "@nortexte": "AFSP1635571A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000033546911", "@num": "4", "#text": "Arrêté du 2 décembre 2016 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000033545422", "@nortexte": "AFSP1635566A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2016-12-02" }, { "@id": "LEGIARTI000034117390", "#text": "Arrêté du 2 décembre 2016 - art. 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(Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000036783379", "@nortexte": "SSAP1809483A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-05" }, { "@id": "LEGITEXT000036868315", "#text": "Arrêté du 12 avril 2018 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036805796", "@nortexte": "SSAP1810239A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-12" }, { "@id": "LEGITEXT000043165231", "#text": "Arrêté du 12 avril 2018 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000036805820", "@nortexte": "SSAP1810240A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-04-12" }, { "@id": "LEGIARTI000036868331", "@num": "Annexe 1", "#text": "Arrêté du 12 avril 2018 - art. 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Il existe trois catégories de recherches impliquant la personne humaine :

1° Les recherches interventionnelles qui comportent une intervention sur la personne non justifiée par sa prise en charge habituelle ;

3° Les recherches non interventionnelles qui ne comportent aucun risque ni contrainte dans lesquelles tous les actes sont pratiqués et les produits utilisés de manière habituelle.

La ou les personnes physiques qui dirigent et surveillent la réalisation de la recherche sur un lieu sont dénommées investigateurs.

Si, sur un lieu, la recherche est réalisée par une équipe, l'investigateur est le responsable de l'équipe et est dénommé investigateur principal.

Les dispositions du présent titre, à l'exception de celles mentionnées aux chapitres IV, V et VI, ne sont pas applicables aux :
\n
\na) Essais cliniques de médicaments régis par les dispositions du règlement (UE) n° 536/2014 du Parlement européen et du Conseil du 16 avril 2014 ;
\n
\nb) Investigations cliniques de dispositifs mentionnés à l'article premier du règlement (UE) 2017/745 du Parlement européen et du Conseil du 5 avril 2017 régis par les dispositions de ce règlement.

c) Etudes des performances de dispositifs médicaux de diagnostic in vitro mentionnés à l'article premier du règlement (UE) 2017/746 du Parlement européen et du Conseil du 5 avril 2017 régies par les dispositions de ce règlement.
\n
\n Par dérogation à l'alinéa précédent, relèvent des chapitres I à III bis, à l'exception des dispositions de l'article L. 1123-10, et du chapitre VIII du présent titre les recherches impliquant la personne humaine portant sur des dispositifs mentionnés à l'article premier du règlement (UE) précité, qui ne sont pas régies par ce règlement et répondent à au moins une des conditions suivantes :

-étude conduite sur un dispositif portant le marquage CE, utilisé ou non dans sa destination, ou ne portant pas le marquage CE, dont les résultats ne peuvent pas influencer les décisions relatives à la prise en charge du participant ou ne sont pas utilisés pour orienter les soins, et ne comportant ni prélèvement chirurgical invasif réalisé aux seules fins de l'étude, ni aucune procédure invasive supplémentaire ou d'autres risques pour le participant à l'étude ;
\n
\n-étude conduite sur un dispositif portant le marquage CE et utilisé dans sa destination, dont les résultats peuvent influencer les décisions relatives à la prise en charge du participant ou être utilisés pour orienter les soins, et ne comportant pas de procédure additionnelle invasive ou lourde ;
\n
\n-étude évaluant des dispositifs mentionnés au paragraphe 5 de l'article 5 du règlement (UE) précité fabriqués et utilisés exclusivement dans les établissements de santé, au sens du même règlement, et qui satisfont à l'ensemble des conditions mentionnées aux points a à i de ce paragraphe 5.

\n
\n Dans le cadre de ces recherches, la notification des événements indésirables graves et des défectuosités de dispositifs mentionnés à l'article premier du règlement (UE) précité survenus s'effectue conformément à l'article 76 du même règlement.

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R1125-26 (V)", "@sens": "source", "@typelien": "CREE" }, { "@id": "LEGIARTI000049979550", "@num": "R1125-27", "#text": "Code de la santé publique - art. R1125-27 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049979552", "@num": "R1125-28", "#text": "Code de la santé publique - art. R1125-28 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049979582", "@num": "R1125-29", "#text": "Code de la santé publique - art. R1125-29 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049987026", "@num": "R1125-3", "#text": "Code de la santé publique - art. R1125-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049979574", "@num": "R1125-30", "#text": "Code de la santé publique - art. R1125-30 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049979585", "@num": "R1125-31", "#text": "Code de la santé publique - art. R1125-31 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049979596", "@num": "R1125-32", "#text": "Code de la santé publique - art. R1125-32 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049987021", "@num": "R1125-4", "#text": "Code de la santé publique - art. R1125-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049987017", "@num": "R1125-5", "#text": "Code de la santé publique - art. R1125-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049987010", "@num": "R1125-6", "#text": "Code de la santé publique - art. R1125-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986979", "@num": "R1125-7", "#text": "Code de la santé publique - art. R1125-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986970", "@num": "R1125-8", "#text": "Code de la santé publique - art. R1125-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986964", "@num": "R1125-9", "#text": "Code de la santé publique - art. R1125-9 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975848", "@num": "R1126-1", "#text": "Code de la santé publique - art. R1126-1 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975872", "@num": "R1126-10", "#text": "Code de la santé publique - art. R1126-10 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975876", "@num": "R1126-11", "#text": "Code de la santé publique - art. R1126-11 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975878", "@num": "R1126-12", "#text": "Code de la santé publique - art. R1126-12 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975880", "@num": "R1126-13", "#text": "Code de la santé publique - art. R1126-13 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975884", "@num": "R1126-14", "#text": "Code de la santé publique - art. R1126-14 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975886", "@num": "R1126-15", "#text": "Code de la santé publique - art. R1126-15 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975890", "@num": "R1126-16", "#text": "Code de la santé publique - art. R1126-16 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975894", "@num": "R1126-17", "#text": "Code de la santé publique - art. R1126-17 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975896", "@num": "R1126-18", "#text": "Code de la santé publique - art. R1126-18 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975898", "@num": "R1126-19", "#text": "Code de la santé publique - art. R1126-19 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975850", "@num": "R1126-2", "#text": "Code de la santé publique - art. R1126-2 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975900", "@num": "R1126-20", "#text": "Code de la santé publique - art. R1126-20 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975902", "@num": "R1126-21", "#text": "Code de la santé publique - art. R1126-21 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975904", "@num": "R1126-22", "#text": "Code de la santé publique - art. R1126-22 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975906", "@num": "R1126-23", "#text": "Code de la santé publique - art. R1126-23 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975910", "@num": "R1126-24", "#text": "Code de la santé publique - art. R1126-24 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975912", "@num": "R1126-25", "#text": "Code de la santé publique - art. R1126-25 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975914", "@num": "R1126-26", "#text": "Code de la santé publique - art. R1126-26 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975916", "@num": "R1126-27", "#text": "Code de la santé publique - art. R1126-27 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975918", "@num": "R1126-28", "#text": "Code de la santé publique - art. R1126-28 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975922", "@num": "R1126-29", "#text": "Code de la santé publique - art. R1126-29 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975856", "@num": "R1126-3", "#text": "Code de la santé publique - art. R1126-3 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975924", "@num": "R1126-30", "#text": "Code de la santé publique - art. R1126-30 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975928", "@num": "R1126-31", "#text": "Code de la santé publique - art. R1126-31 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975932", "@num": "R1126-32", "#text": "Code de la santé publique - art. R1126-32 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975858", "@num": "R1126-4", "#text": "Code de la santé publique - art. R1126-4 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975860", "@num": "R1126-5", "#text": "Code de la santé publique - art. R1126-5 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975864", "@num": "R1126-6", "#text": "Code de la santé publique - art. R1126-6 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975866", "@num": "R1126-7", "#text": "Code de la santé publique - art. R1126-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975868", "@num": "R1126-8", "#text": "Code de la santé publique - art. R1126-8 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049975870", "@num": "R1126-9", "#text": "Code de la santé publique - art. R1126-9 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CREE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006740893", "@num": "L165-1", "#text": "Code de la sécurité sociale. - art. L165-1", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031796188", "@num": "R160-5", "#text": "Code de la sécurité sociale. - art. R160-5", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000031796584", "@num": "R160-8", "#text": "Code de la sécurité sociale. - art. R160-8", "@sens": "source", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006792066", "@num": "L113-9", "#text": "Code des assurances - art. L113-9", "@sens": "source", "@cidtexte": "LEGITEXT000006073984", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000049962633", "@nor": "TSSP2329890D", "@num": "2024-795", "@nature": "DECRET", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Décret n° 2024-795 du 8 juillet 2024 relatif aux investigations cliniques et aux études des performances", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000049962633", "@c_titre_court": "Décret n°2024-795 du 8 juillet 2024" }, { "@fin": "2999-01-01", "#text": "Décret n° 2024-795 du 8 juillet 2024 relatif aux investigations cliniques et aux études des performances", "@debut": "2024-07-14", "@id_txt": "LEGITEXT000049967604", "@c_titre_court": "Décret n°2024-795 du 8 juillet 2024" } ], "@ministere": "Ministère du travail, de la santé et des solidarités", "@date_publi": "2024-07-13", "@date_signature": "2024-07-08", "@num_parution_jo": "0166" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000049967627", "@fin": "2999-01-01", "@num": "6", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000049962659", "@fin": "2999-01-01", "@num": "6", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A créé les dispositions suivantes :

- Code de la santé publique
\n Art. R1125-32\n
\n

\n
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A modifié les dispositions suivantes :

- Code de la santé publique
Art. R1125-1, Art. R1125-2, Art. R1125-3, Art. R1125-4, Art. R1125-5, Art. R1125-6, Art. R1125-7, Art. R1125-8, Art. R1125-9, Art. R1125-10, Art. R1125-11, Art. R1125-12, Art. R1125-13, Art. R1125-14, Art. R1125-15, Art. R1125-16, Art. R1125-17, Art. R1125-18, Art. R1125-19, Art. R1125-20, Art. R1125-21, Art. R1125-22, Art. R1125-23, Art. R1125-24, Art. R1125-25, Art. R1125-26\n
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A créé les dispositions suivantes :

- Code de la santé publique
\n Art. R1125-31\n
\n

\n
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A créé les dispositions suivantes :

- Code de la santé publique
\n Sct. Chapitre V : Dispositions particulières relatives aux investigations cliniques, Sct. Section 1 : Dispositions diverses, Sct. Section 2 : Evaluation par les comités de protection des personnes, Sct. Sous-section 1 : Désignation du comité, Sct. Sous-section 2 : Procédure relative aux demandes initiales d'investigations cliniques, Sct. Sous-section 3 : Demande de modification substantielle, Sct. Sous-section 4 : Procédure de réexamen, Sct. Sous-section 5 : Procédure accélérée, Sct. Section 2 : Assurance des promoteurs d'une investigation clinique, Sct. Section 3 : Conditions d'autorisation de certains lieux d'investigation clinique, Sct. Section 4 : Dispositions financières, Sct. Section 5 : Suspension, interdiction et fin de l'investigation clinique, Sct. Section 6 : Fichier national des personnes qui se prêtent à des investigations cliniques, Sct. Chapitre VI : Dispositions particulières relatives aux études des performances, Sct. Section 1 : Dispositions diverses, Art. R1126-1, Art. R1126-2, Sct. Section 2 : Evaluation par les comités de protection des personnes, Sct. Sous-section 1 : Désignation du comité, Art. R1126-3, Art. R1126-4, Art. R1126-5, Sct. Sous-section 2 : Procédure relative aux demandes initiales d'études des performances, Art. R1126-6, Art. R1126-7, Art. R1126-8, Art. R1126-9, Art. R1126-10, Sct. Sous-section 3 : Demande de modification substantielle, Art. R1126-11, Art. R1126-12, Art. R1126-13, Sct. Sous-section 4 : Procédure de réexamen, Art. R1126-14, Art. R1126-15, Sct. Sous-section 5 : Procédure accélérée, Art. R1126-16, Sct. Section 2 : Assurance des promoteurs d'une étude des performances, Art. R1126-17, Art. R1126-18, Art. R1126-19, Art. R1126-20, Art. R1126-21, Art. R1126-22, Art. R1126-23, Sct. Section 3 : Conditions d'autorisation de certains lieux d'étude des performances, Art. R1126-24, Art. R1126-25, Art. R1126-26, Art. R1126-27, Art. R1126-28, Sct. Section 4 : Dispositions financières, Art. R1126-29, Art. R1126-30, Sct. Section 5 : Suspension, interdiction et fin de l'étude des performances, Art. R1126-31, Sct. Section 6 : Fichier national des personnes qui se prêtent à une étude des performances, Art. R1126-32\n
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A créé les dispositions suivantes :

- Code de la santé publique
Art. R1125-24, Art. R1125-25, Art. R1125-26, Art. R1125-27, Art. R1125-28\n
\n

\n
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A créé les dispositions suivantes :

- Code de la santé publique
\n Art. R1125-29, Art. R1125-30\n
\n

\n
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Article R1126-13 AUTONOME VIGUEUR, en vigueur depuis le 14/07/2024 (Code de la santé publique)