{ "article": { "LEGIARTI000043507285": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000043507285", "URL": "article/LEGI/ARTI/00/00/43/50/72/LEGIARTI000043507285.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000043507902", "@num": "1", "#text": "Arrêté du 14 octobre 2020 - art. 1 (V)", "@sens": "source", "@cidtexte": "JORFTEXT000042424399", "@nortexte": "SSAP2027665A", "@typelien": "MODIFIE", "@naturetexte": "ARRETE", "@datesignatexte": "2020-10-14" }, { "@id": "LEGIARTI000006685825", "@num": "L1121-1", "#text": "Code de la santé publique - art. L1121-1", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685877", "@num": "L1123-6", "#text": "Code de la santé publique - art. L1123-6", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000043506990", "@nor": "SSAP2115003A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 12 mai 2021 modifiant l'arrêté du 14 octobre 2020 fixant les modalités de mise en œuvre du tirage au sort des comités de protection des personnes", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000043506990", "@c_titre_court": "Arrêté du 12 mai 2021" }, { "@fin": "2999-01-01", "#text": "Arrêté du 12 mai 2021 modifiant l'arrêté du 14 octobre 2020 fixant les modalités de mise en œuvre du tirage au sort des comités de protection des personnes", "@debut": "2021-05-19", "@id_txt": "LEGITEXT000043507283", "@c_titre_court": "Arrêté du 12 mai 2021" } ], "@ministere": "Ministère des solidarités et de la santé", "@date_publi": "2021-05-18", "@date_signature": "2021-05-12", "@num_parution_jo": "0114" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000043507285", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000043506992", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
A modifié les dispositions suivantes :

- Arrêté du 14 octobre 2020
\n Art. 1\n
\n

\n
" } }, "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 :
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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 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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R165-71 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171001", "@fin": "2004-08-11", "#text": "Chapitre III : Comités consultatifs de protection des personnes.", "@debut": "2000-06-22" } ] }, "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": "LEGIARTI000006685877", "@fin": "2004-08-11", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685878", "@fin": "2006-04-19", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685879", "@fin": "2014-07-01", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2006-04-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025457411", "@fin": "2016-12-31", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2014-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032722977", "@fin": "2018-01-19", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2016-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000036515039", "@fin": "2018-10-19", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2018-01-19", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000037504414", "@fin": "2999-01-01", "@num": "L1123-6", "@etat": "VIGUEUR", "@debut": "2018-10-19", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Avant de réaliser une recherche biomédicale sur l'être humain, tout investigateur est tenu d'en soumettre le projet à l'avis de l'un des comités consultatifs de protection des personnes dans la recherche biomédicale compétents pour la région où l'investigateur exerce son activité. Il ne peut solliciter qu'un seul avis par projet de recherche.
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Dans le cas d'une recherche confiée à plusieurs investigateurs, cet avis est demandé par l'investigateur coordonnateur, qui soumet le projet dans les conditions définies au premier alinéa du présent article.
" } }, "LEGIARTI000006685878": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1123-6", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2006-04-19", "DATE_DEBUT": "2004-08-11" } }, "META_COMMUN": { "ID": "LEGIARTI000006685878", "URL": "article/LEGI/ARTI/00/00/06/68/58/LEGIARTI000006685878.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1123L06XXAB" } }, "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": "LEGIARTI000037823065", "@num": "64", "#text": "Loi n° 78-17 du 6 janvier 1978 - art. 64 (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": "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": "JORFTEXT000000787078", "#text": "Loi 2004-806 2004-08-09 art. 90 I, V JORF 11 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787078", "@nortexte": "SANX0300055L", "@numtexte": "2004-806", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-09" }, { "@id": "LEGIARTI000006697711", "@num": "90", "#text": "Loi n°2004-806 du 9 août 2004 - art. 90 () JORF 11 août 2004", "@sens": "source", "@cidtexte": "JORFTEXT000000787078", "@nortexte": "SANX0300055L", "@numtexte": "2004-806", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-09" }, { "@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": "LEGIARTI000020978232", "@num": "1", "#text": "Arrêté du 27 juillet 2009 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020976763", "@nortexte": "SASP0918147A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-07-27" }, { "@id": "LEGIARTI000021782680", "@num": "Annexe", "#text": "Arrêté du 13 janvier 2010 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000038123294", "#text": "Arrêté du 21 décembre 2018 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037852311", "@nortexte": "SSAP1835310A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-12-21" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000043507902", "@num": "1", "#text": "Arrêté du 14 octobre 2020 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042424399", "@nortexte": "SSAP2027665A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-10-14" }, { "@id": "LEGITEXT000042617376", "#text": "Décret n°2020-1517 du 3 décembre 2020 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042613082", "@nortexte": "SSAP2030877D", "@numtexte": "2020-1517", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-12-03" }, { "@id": "LEGITEXT000043124086", "#text": "Arrêté du 26 janvier 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043121591", "@nortexte": "SSAP2102968A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-01-26" }, { "@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": "LEGIARTI000043709597", "@num": "2", "#text": "Arrêté du 17 février 2021 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043156138", "@nortexte": "SSAP2105517A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-17" }, { "@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": "LEGIARTI000044296010", "@num": "ANNEXE 1", "#text": "Arrêté du 25 octobre 2021 - art. ANNEXE 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000044294342", "@nortexte": "SSAP2132225A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-10-25" }, { "@id": "LEGIARTI000033417486", "@num": "D1123-34", "#text": "Code de la santé publique - art. D1123-34 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000037090350", "@num": "L1122-1", "#text": "Code de la santé publique - art. L1122-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025444881", "@num": "L1123-1-1", "#text": "Code de la santé publique - art. L1123-1-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000020039276", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685887", "@num": "L1123-9", "#text": "Code de la santé publique - art. L1123-9 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685930", "@num": "L1126-5", "#text": "Code de la santé publique - art. L1126-5 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692628", "@num": "L209-12", "#text": "Code de la santé publique - art. 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Avant de réaliser une recherche biomédicale sur l'être humain, le promoteur est tenu d'en soumettre le projet à l'avis de l'un des comités de protection des personnes compétents pour le lieu où l'investigateur ou, le cas échéant, l'investigateur coordonnateur, exerce son activité. Il ne peut solliciter qu'un seul avis par projet de recherche.
\n
Toutefois, en cas d'avis défavorable du comité, le promoteur peut demander au ministre chargé de la santé de soumettre le projet de recherche, pour un second examen, à un autre comité désigné par le ministre, dans des conditions définies par voie réglementaire.
" } }, "LEGIARTI000006685879": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1123-6", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2014-07-01", "DATE_DEBUT": "2006-04-19" } }, "META_COMMUN": { "ID": "LEGIARTI000006685879", "URL": "article/LEGI/ARTI/00/00/06/68/58/LEGIARTI000006685879.xml", "NATURE": "Article", "ORIGINE": "LEGI", "ANCIEN_ID": "SPANXXXXXXX1X1123L06XXAC" } }, "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": "LEGIARTI000037823065", "@num": "64", "#text": "Loi n° 78-17 du 6 janvier 1978 - art. 64 (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": "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": "LEGIARTI000006435853", "@num": "31", "#text": "loi n°2006-450 du 18 avril 2006 - art. 31 () JORF 19 avril 2006", "@sens": "source", "@cidtexte": "JORFTEXT000000426953", "@nortexte": "MENX0500251L", "@numtexte": "2006-450", "@typelien": "MODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2006-04-18" }, { "@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": "LEGIARTI000020978232", "@num": "1", "#text": "Arrêté du 27 juillet 2009 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000020976763", "@nortexte": "SASP0918147A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2009-07-27" }, { "@id": "LEGIARTI000021782680", "@num": "Annexe", "#text": "Arrêté du 13 janvier 2010 - art. Annexe (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000021782073", "@nortexte": "SASP1001133A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2010-01-13" }, { "@id": "LEGITEXT000038123294", "#text": "Arrêté du 21 décembre 2018 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000037852311", "@nortexte": "SSAP1835310A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2018-12-21" }, { "@id": "LEGIARTI000042645749", "@num": "17", "#text": "Ordonnance n°2020-460 du 22 avril 2020 - art. 17 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000041814597", "@nortexte": "ECOX2009794R", "@numtexte": "2020-460", "@typelien": "CITATION", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2020-04-22" }, { "@id": "LEGIARTI000043507902", "@num": "1", "#text": "Arrêté du 14 octobre 2020 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042424399", "@nortexte": "SSAP2027665A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2020-10-14" }, { "@id": "LEGITEXT000042617376", "#text": "Décret n°2020-1517 du 3 décembre 2020 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000042613082", "@nortexte": "SSAP2030877D", "@numtexte": "2020-1517", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2020-12-03" }, { "@id": "LEGITEXT000043124086", "#text": "Arrêté du 26 janvier 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043121591", "@nortexte": "SSAP2102968A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-01-26" }, { "@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": "LEGIARTI000043709597", "@num": "2", "#text": "Arrêté du 17 février 2021 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043156138", "@nortexte": "SSAP2105517A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-02-17" }, { "@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": "LEGIARTI000044296010", "@num": "ANNEXE 1", "#text": "Arrêté du 25 octobre 2021 - art. 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L1122-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025444881", "@num": "L1123-1-1", "#text": "Code de la santé publique - art. L1123-1-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000020039276", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685887", "@num": "L1123-9", "#text": "Code de la santé publique - art. L1123-9 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685930", "@num": "L1126-5", "#text": "Code de la santé publique - art. L1126-5 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692628", "@num": "L209-12", "#text": "Code de la santé publique - art. L209-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908318", "@num": "R1121-3", "#text": "Code de la santé publique - art. R1121-3 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033417784", "@num": "R1121-6", "#text": "Code de la santé publique - art. R1121-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986826", "@num": "R1123-20-1", "#text": "Code de la santé publique - art. R1123-20-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908397", "@num": "R1123-28", "#text": "Code de la santé publique - art. R1123-28 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986731", "@num": "R1123-71", "#text": "Code de la santé publique - art. R1123-71 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908472", "@num": "R1125-2", "#text": "Code de la santé publique - art. R1125-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798962", "@num": "R2037-2", "#text": "Code de la santé publique - art. R2037-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788178", "@num": "R5121-13", "#text": "Code de la santé publique - art. R5121-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776257", "@num": "R5121-15", "#text": "Code de la santé publique - art. R5121-15 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L209-12 alinéas 1 et 2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030253361", "@num": "R165-71", "#text": "Code de la sécurité sociale. - art. R165-71 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171003", "@fin": "2999-01-01", "#text": "Chapitre III : Comités de protection des personnes et autorité compétente", "@debut": "2004-08-11" } ] }, "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": "LEGIARTI000006685877", "@fin": "2004-08-11", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685878", "@fin": "2006-04-19", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685879", "@fin": "2014-07-01", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2006-04-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025457411", "@fin": "2016-12-31", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2014-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032722977", "@fin": "2018-01-19", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2016-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000036515039", "@fin": "2018-10-19", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2018-01-19", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000037504414", "@fin": "2999-01-01", "@num": "L1123-6", "@etat": "VIGUEUR", "@debut": "2018-10-19", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
Avant de réaliser une recherche biomédicale sur l'être humain, le promoteur est tenu d'en soumettre le projet à l'avis de l'un des comités de protection des personnes compétents pour le lieu où l'investigateur ou, le cas échéant, l'investigateur coordonnateur, exerce son activité. Il ne peut solliciter qu'un seul avis par projet de recherche.
\n
Toutefois, en cas d'avis défavorable du comité, le promoteur peut demander au ministre chargé de la santé de soumettre le projet de recherche, pour un second examen, à un autre comité désigné par le ministre, dans des conditions définies par voie réglementaire.
\n
Le ministre chargé de la santé peut être saisi de la même demande en cas d'avis défavorable du comité de protection des personnes sur une recherche définie au 2° de l'article L. 1121-1.
" } }, "LEGIARTI000021942025": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1121-1", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2012-05-01", "DATE_DEBUT": "2010-02-26" } }, "META_COMMUN": { "ID": "LEGIARTI000021942025", "URL": "article/LEGI/ARTI/00/00/21/94/20/LEGIARTI000021942025.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "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": "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": "LEGIARTI000021869972", "@num": "26", "#text": "Ordonnance n°2010-177\n du 23 février 2010 - art. 26", "@sens": "cible", "@cidtexte": "JORFTEXT000021868310", "@nortexte": "SASX0930688R", "@numtexte": "2010-177", "@typelien": "MODIFIE", "@naturetexte": "ORDONNANCE", "@datesignatexte": "2010-02-23" }, { "@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. (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 - art. 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043507013", "@nortexte": "SSAP2115206A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-05-17" }, { "@id": "LEGIARTI000043507364", "@num": "2", "#text": "Arrêté du 17 mai 2021 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043507013", "@nortexte": "SSAP2115206A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-05-17" }, { "@id": "LEGIARTI000043577332", "@num": "41", "#text": "Arrêté du 1 juin 2021 - art. 41 (Ab)", "@sens": "cible", "@cidtexte": "JORFTEXT000043575801", "@nortexte": "SSAZ2116944A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-01" }, { "@id": "LEGIARTI000043726876", "@num": "1", "#text": "Arrêté du 28 juin 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043715910", "@nortexte": "SSAP2120022A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-06-28" }, { "@id": "LEGIARTI000044296010", "@num": "ANNEXE 1", "#text": "Arrêté du 25 octobre 2021 - art. 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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 \".
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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 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.
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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.
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La ou les personnes physiques qui dirigent et surveillent la réalisation de la recherche sur un lieu sont dénommées investigateurs.
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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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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 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.

" } }, "LEGIARTI000025457411": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1123-6", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2016-12-31", "DATE_DEBUT": "2014-07-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025457411", "URL": "article/LEGI/ARTI/00/00/25/45/74/LEGIARTI000025457411.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "

Conformément aux dispositions du b du 9° de l'article 1er de la loi n° 2012-300 du 5 mars 2012, ces dispositions entrent en vigueur à l'échéance d'un délai de deux ans suivant la publication des décrets d'application de ladite loi et, au plus tard, le 1er juillet 2014.

Avant de réaliser une recherche impliquant la personne humaine, le promoteur en soumet le projet à l'avis d'un comité de protection des personnes désigné de manière aléatoire par la commission nationale mentionnée à l'article L. 1123-1-1. Il ne peut solliciter qu'un avis par projet de recherche.

Avant que le comité rende son avis, le promoteur peut demander à la commission nationale de désigner un autre comité de protection des personnes pour l'examen du projet. La commission nationale désigne ce second comité de manière aléatoire dans un délai ne pouvant excéder un mois à compter de la demande.

En cas d'avis défavorable du comité, le promoteur peut demander à la commission nationale de soumettre le projet, pour un second examen, à un autre comité de protection des personnes. La commission nationale désigne cet autre comité de manière aléatoire dans un délai ne pouvant excéder un mois à compter de la demande.

\n
" } }, "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.

" } }, "LEGIARTI000032722977": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1123-6", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2018-01-19", "DATE_DEBUT": "2016-12-31" } }, "META_COMMUN": { "ID": "LEGIARTI000032722977", "URL": "article/LEGI/ARTI/00/00/32/72/29/LEGIARTI000032722977.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "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": "LEGIARTI000037823065", "@num": "64", "#text": "Loi n° 78-17 du 6 janvier 1978 - art. 64 (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": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. 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R1123-20-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908397", "@num": "R1123-28", "#text": "Code de la santé publique - art. R1123-28 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986731", "@num": "R1123-71", "#text": "Code de la santé publique - art. R1123-71 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908472", "@num": "R1125-2", "#text": "Code de la santé publique - art. R1125-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798962", "@num": "R2037-2", "#text": "Code de la santé publique - art. 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R165-71 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171003", "@fin": "2999-01-01", "#text": "Chapitre III : Comités de protection des personnes et autorité compétente", "@debut": "2004-08-11" } ] }, "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": "LEGIARTI000006685877", "@fin": "2004-08-11", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685878", "@fin": "2006-04-19", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685879", "@fin": "2014-07-01", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2006-04-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025457411", "@fin": "2016-12-31", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2014-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032722977", "@fin": "2018-01-19", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2016-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000036515039", "@fin": "2018-10-19", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2018-01-19", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000037504414", "@fin": "2999-01-01", "@num": "L1123-6", "@etat": "VIGUEUR", "@debut": "2018-10-19", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Avant de réaliser une recherche impliquant la personne humaine, le promoteur en soumet le projet à l'avis d'un comité de protection des personnes désigné de manière aléatoire dans des conditions prévues à l'article L. 1123-14. Il ne peut solliciter qu'un avis par projet de recherche.

En cas d'avis défavorable du comité, le promoteur peut demander au ministre chargé de la santé de soumettre le projet, pour un second examen, à un autre comité de protection des personnes selon des modalités prévues à l'article L. 1123-14.

" } }, "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.

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I. - Avant de réaliser une recherche impliquant la personne humaine, le promoteur en soumet le projet à l'avis d'un comité de protection des personnes désigné de manière aléatoire dans des conditions prévues à l'article L. 1123-14. Il ne peut solliciter qu'un avis par projet de recherche.

II. - Les dispositions du I ne sont pas applicables au comité de protection des personnes prévu à l'article L. 1123-16 lorsque son avis doit être recueilli pour un projet de recherche relevant du secret de la défense nationale mentionnée au chapitre III bis.

" } }, "LEGIARTI000037504414": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1123-6", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2018-10-19" } }, "META_COMMUN": { "ID": "LEGIARTI000037504414", "URL": "article/LEGI/ARTI/00/00/37/50/44/LEGIARTI000037504414.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "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": "LEGIARTI000037823065", "@num": "64", "#text": "Loi n° 78-17 du 6 janvier 1978 - art. 64 (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": "JORFTEXT000000227015", "#text": "Loi n°2002-303 du 4 mars 2002", "@sens": "source", "@cidtexte": "JORFTEXT000000227015", "@nortexte": "MESX0100092L", "@numtexte": "2002-303", "@typelien": "CODIFICATION", "@naturetexte": "LOI", "@datesignatexte": "2002-03-04" }, { "@id": "LEGIARTI000018361459", "@num": "Annexe", "#text": "Arrêté du 5 mars 2008 - art. 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L1123-1-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685895", "@num": "L1123-14", "#text": "Code de la santé publique - art. L1123-14", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000036505929", "@num": "L1123-16", "#text": "Code de la santé publique - art. L1123-16", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000020039276", "@num": "L1123-8", "#text": "Code de la santé publique - art. L1123-8 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685887", "@num": "L1123-9", "#text": "Code de la santé publique - art. L1123-9 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006685930", "@num": "L1126-5", "#text": "Code de la santé publique - art. L1126-5 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006692628", "@num": "L209-12", "#text": "Code de la santé publique - art. L209-12 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908318", "@num": "R1121-3", "#text": "Code de la santé publique - art. R1121-3 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000033417784", "@num": "R1121-6", "#text": "Code de la santé publique - art. R1121-6 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986826", "@num": "R1123-20-1", "#text": "Code de la santé publique - art. R1123-20-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908397", "@num": "R1123-28", "#text": "Code de la santé publique - art. R1123-28 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000049986731", "@num": "R1123-71", "#text": "Code de la santé publique - art. R1123-71 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006908472", "@num": "R1125-2", "#text": "Code de la santé publique - art. R1125-2 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000006798962", "@num": "R2037-2", "#text": "Code de la santé publique - art. R2037-2 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025788178", "@num": "R5121-13", "#text": "Code de la santé publique - art. R5121-13 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000018776257", "@num": "R5121-15", "#text": "Code de la santé publique - art. R5121-15 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L209-12 alinéas 1 et 2", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CONCORDANCE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000030253361", "@num": "R165-71", "#text": "Code de la sécurité sociale. - art. R165-71 (Ab)", "@sens": "cible", "@cidtexte": "LEGITEXT000006073189", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "TM": { "TM": { "TM": { "TM": { "TM": { "TITRE_TM": [ { "@id": "LEGISCTA000006171003", "@fin": "2999-01-01", "#text": "Chapitre III : Comités de protection des personnes et autorité compétente", "@debut": "2004-08-11" } ] }, "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": "LEGIARTI000006685877", "@fin": "2004-08-11", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685878", "@fin": "2006-04-19", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685879", "@fin": "2014-07-01", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2006-04-19", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025457411", "@fin": "2016-12-31", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2014-07-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032722977", "@fin": "2018-01-19", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2016-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000036515039", "@fin": "2018-10-19", "@num": "L1123-6", "@etat": "MODIFIE", "@debut": "2018-01-19", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000037504414", "@fin": "2999-01-01", "@num": "L1123-6", "@etat": "VIGUEUR", "@debut": "2018-10-19", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

I.-Avant de réaliser une recherche impliquant la personne humaine, le promoteur en soumet le projet à l'avis d'un comité de protection des personnes désigné de manière aléatoire parmi les comités disponibles et disposant de la compétence nécessaire à l'examen du projet, dans des conditions prévues à l'article L. 1123-14. Il ne peut solliciter qu'un avis par projet de recherche.

II.-Les dispositions du I ne sont pas applicables au comité de protection des personnes prévu à l'article L. 1123-16 lorsque son avis doit être recueilli pour un projet de recherche relevant du secret de la défense nationale mentionnée au chapitre III bis.

" } }, "LEGIARTI000043507902": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2021-05-19" } }, "META_COMMUN": { "ID": "LEGIARTI000043507902", "URL": "article/LEGI/ARTI/00/00/43/50/79/LEGIARTI000043507902.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000043507285", "@num": "1", "#text": "Arrêté du 12 mai 2021 - art. 1", "@sens": "cible", "@cidtexte": "JORFTEXT000043506990", "@nortexte": "SSAP2115003A", "@typelien": "MODIFIE", "@naturetexte": "ARRETE", "@datesignatexte": "2021-05-12" }, { "@id": "LEGIARTI000006685877", "@num": "L1123-6", "#text": "Code de la santé publique - art. L1123-6", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "#text": "règlement (CE) n° 1223/2009", "@sens": "source", "@typelien": "CITATION" }, { "#text": "règlement (CE) n° 178/2002", "@sens": "source", "@typelien": "CITATION" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000042424399", "@nor": "SSAP2027665A", "@nature": "ARRETE", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "Arrêté du 14 octobre 2020 fixant les modalités de mise en œuvre du tirage au sort des comités de protection des personnes", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000042424399", "@c_titre_court": "Arrêté du 14 octobre 2020" }, { "@fin": "2999-01-01", "#text": "Arrêté du 14 octobre 2020 fixant les modalités de mise en œuvre du tirage au sort des comités de protection des personnes", "@debut": "2020-10-16", "@id_txt": "LEGITEXT000042425728", "@c_titre_court": "Arrêté du 14 octobre 2020" } ], "@ministere": "Ministère des solidarités et de la santé", "@date_publi": "2020-10-15", "@date_signature": "2020-10-14", "@num_parution_jo": "0251" } }, "VERSIONS": { "VERSION": [ { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042425733", "@fin": "2021-05-19", "@num": "1", "@etat": "MODIFIE", "@debut": "2020-10-16", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043507902", "@fin": "2999-01-01", "@num": "1", "@etat": "VIGUEUR", "@debut": "2021-05-19", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000042424401", "@fin": "2999-01-01", "@num": "1", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "
\n

I. - Pour la désignation du comité de protection des personnes prévue à l'article L. 1123-6 du code de la santé publique, chaque comité transmet à la direction générale de la santé, au plus tard le 7 septembre de chaque année, la programmation des séances du comité pour l'année suivante sans que le nombre de séances plénières ne puisse être inférieur à onze par an, et à douze par an pour les comités compétents pour l'évaluation des recherches mentionnées au 1° de l'article L. 1121-1 du code de la santé publique portant sur des médicaments.
\n
\nII. - Chaque comité précise dans le système d'information des recherches impliquant la personne humaine s'il dispose en son sein ou s'il peut recourir à une personne compétente en matière d'essais de phase précoce, de pédiatrie, de rayonnement en imagerie, de radiothérapie, de thérapie cellulaire et génique, d'oncologie, d'assistance médicale à la procréation et de génétique.
\n
\nIII. - Chaque comité précise dans le système d'information s'il dispose de la compétence pour traiter des dossiers relevant des procédures :

- applicables aux recherches mentionnées au 1° de l'article L. 1121-1 du code de la santé publique et portant sur des médicaments ;

- du règlement européen n° 536/2014 du Parlement européen et du Conseil du 16 avril 2014 relatif aux essais cliniques de médicaments à usage humain et abrogeant la directive 2001/20/CE ;

- prévues pour les dispositifs médicaux invasifs par le règlement européen 2017/745 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux, modifiant la directive 2001/83/CE, le règlement (CE) n° 178/2002 et le règlement (CE) n° 1223/2009 et abrogeant les directives du Conseil 90/385/CEE et 93/42/CE ;
\n
\n- prévues pour les dispositifs médicaux non invasifs telles par le règlement européen 2017/745 du Parlement européen et du Conseil du 5 avril 2017 relatif aux dispositifs médicaux, modifiant la directive 2001/83/CE, le règlement (CE) n° 178/2002 et le règlement (CE) n° 1223/2009 et abrogeant les directives du Conseil 90/385/CEE et 93/42/CE.

\n
" } }, "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.

" } }, "LEGIARTI000046125746": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1121-1", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2022-07-31" } }, "META_COMMUN": { "ID": "LEGIARTI000046125746", "URL": "article/LEGI/ARTI/00/00/46/12/57/LEGIARTI000046125746.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "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": "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. 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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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Article 1 ENTIEREMENT_MODIF (Arrêté du 12 mai 2021 modifiant l'arrêté du 14 octobre 2020 fixant les modalités de mise en œuvre du tirage au sort des comités de protection des personnes)