{ "article": { "LEGIARTI000025442809": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "3", "TYPE": "ENTIEREMENT_MODIF", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2999-01-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025442809", "URL": "article/LEGI/ARTI/00/00/25/44/28/LEGIARTI000025442809.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000025454365", "@num": "L1126-1", "#text": "Code de la santé publique - art. L1126-1 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025449694", "@num": "L1243-3", "#text": "Code de la santé publique - art. L1243-3 (VD)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFICATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025445615", "@num": "L1123-7", "#text": "Code de la santé publique - art. L1123-7 (V)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025445624", "@num": "L1243-4", "#text": "Code de la santé publique - art. L1243-4 (VD)", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "MODIFIE", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" } ] }, "CONTEXTE": { "TEXTE": { "@cid": "JORFTEXT000025441587", "@nor": "SASX0901817L", "@num": "2012-300", "@nature": "LOI", "TITRE_TXT": [ { "@fin": "2999-01-01", "#text": "LOI n° 2012-300 du 5 mars 2012 relative aux recherches impliquant la personne humaine (1)", "@debut": "2999-01-01", "@id_txt": "JORFTEXT000025441587", "@c_titre_court": "LOI n° 2012-300 du 5 mars 2012" }, { "@fin": "2999-01-01", "#text": "LOI n° 2012-300 du 5 mars 2012 relative aux recherches impliquant la personne humaine (1)", "@debut": "2012-03-07", "@id_txt": "LEGITEXT000025442808", "@c_titre_court": "LOI n°2012-300 du 5 mars 2012" } ], "@date_publi": "2012-03-06", "@date_signature": "2012-03-05", "@num_parution_jo": "0056" } }, "VERSIONS": { "VERSION": [ { "LIEN_ART": { "@id": "LEGIARTI000025442809", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "LEGI" } }, { "LIEN_ART": { "@id": "JORFARTI000025441678", "@fin": "2999-01-01", "@num": "3", "@debut": "2999-01-01", "@origine": "JORF" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

A modifié les dispositions suivantes :

- Code de la santé publique
\nArt. L1123-7, Art. L1243-4\n
\n

" } }, "LEGIARTI000025445615": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1123-7", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2016-12-31", "DATE_DEBUT": "2012-08-01" } }, "META_COMMUN": { "ID": "LEGIARTI000025445615", "URL": "article/LEGI/ARTI/00/00/25/44/56/LEGIARTI000025445615.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "LIENS": { "LIEN": [ { "@id": "JORFTEXT000000886460", "#text": "LOI n° 78-17 du 6 janvier 1978", "@sens": "source", "@cidtexte": "JORFTEXT000000886460", "@numtexte": "78-17", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "1978-01-06" }, { "@id": "JORFTEXT000000217229", "#text": "Rapport relatif à l'ordonnance n° 2000-548 du 15 juin 2000", "@sens": "source", "@cidtexte": "JORFTEXT000000217229", "@nortexte": "MESX0000036P", "@typelien": "CODIFICATION", "@naturetexte": "RAPPORT", "@datesignatexte": "2999-01-01" }, { "@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": "LEGIARTI000006254275", "@num": "7", "#text": "Arrêté du 16 août 2006 - art. 7 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000459552", "@nortexte": "SANP0623374A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-16" }, { "@id": "LEGIARTI000006254796", "@num": "2", "#text": "Arrêté du 24 août 2006 - art. 2 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000458821", "@nortexte": "SANP0623515A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-24" }, { "@id": "LEGIARTI000006254821", "@num": "3", "#text": "Arrêté du 24 août 2006 - art. 3 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000267770", "@nortexte": "SANP0623519A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-08-24" }, { "@id": "LEGIARTI000006259059", "@num": "4", "#text": "Arrêté du 15 décembre 2006 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000819875", "@nortexte": "SANP0625093A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-12-15" }, { "@id": "LEGIARTI000006259253", "@num": "4", "#text": "Arrêté du 15 décembre 2006 - art. 4 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000241830", "@nortexte": "SANP0625180A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2006-12-15" }, { "@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": "LEGIARTI000025442809", "@num": "3", "#text": "LOI n°2012-300\n du 5 mars 2012 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000025441587", "@nortexte": "SASX0901817L", "@numtexte": "2012-300", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2012-03-05" }, { "@id": "LEGIARTI000028888417", "@num": "8", "#text": "Arrêté du 14 avril 2014 - art. 8 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000028887435", "@nortexte": "AFSP1409679A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2014-04-14" }, { "@id": "LEGIARTI000035971526", "#text": "DÉCRET n°2014-1286 du 23 octobre 2014 - art. (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000029675991", "@nortexte": "AFSX1419046D", "@numtexte": "2014-1286", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2014-10-23" }, { "@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": "LEGITEXT000043124086", "#text": "Arrêté du 26 janvier 2021 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000043121591", "@nortexte": "SSAP2102968A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2021-01-26" }, { "@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": "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": "LEGIARTI000006685852", "@num": "L1121-13", "#text": "Code de la santé publique - art. L1121-13", "@sens": "source", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000026499758", "@num": "L1123-14", "#text": "Code de la santé publique - art. L1123-14 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000025443200", "@num": "L1123-7-1", "#text": "Code de la santé publique - art. L1123-7-1 (VT)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000034477966", "@num": "L1123-7-2", "#text": "Code de la santé publique - art. L1123-7-2 (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": "LEGIARTI000006686057", "@num": "L1211-2", "#text": "Code de la santé publique - art. L1211-2", "@sens": "source", "@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": "LEGIARTI000006908370", "@num": "R1123-16", "#text": "Code de la santé publique - art. R1123-16 (M)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045303379", "@num": "R1123-26", "#text": "Code de la santé publique - art. R1123-26 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGIARTI000045303453", "@num": "R1123-4", "#text": "Code de la santé publique - art. R1123-4 (V)", "@sens": "cible", "@cidtexte": "LEGITEXT000006072665", "@typelien": "CITATION", "@naturetexte": "CODE", "@datesignatexte": "2999-01-01" }, { "@id": "LEGITEXT000006072665", "#text": "Code de la santé publique L209-12 alinéa 3", "@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" }, { "@id": "LEGIARTI000039742400", "@num": "R165-72", "#text": "Code de la sécurité sociale. - art. R165-72 (V)", "@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": "LEGIARTI000006685880", "@fin": "2004-08-07", "@num": "L1123-7", "@etat": "MODIFIE", "@debut": "2000-06-22", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685881", "@fin": "2004-08-11", "@num": "L1123-7", "@etat": "MODIFIE", "@debut": "2004-08-07", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000006685882", "@fin": "2012-08-01", "@num": "L1123-7", "@etat": "MODIFIE", "@debut": "2004-08-11", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000025445615", "@fin": "2016-12-31", "@num": "L1123-7", "@etat": "MODIFIE", "@debut": "2012-08-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000032722968", "@fin": "2018-05-25", "@num": "L1123-7", "@etat": "MODIFIE", "@debut": "2016-12-31", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037090338", "@fin": "2019-06-01", "@num": "L1123-7", "@etat": "MODIFIE", "@debut": "2018-05-25", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000037825779", "@fin": "2020-12-09", "@num": "L1123-7", "@etat": "MODIFIE", "@debut": "2019-06-01", "@origine": "LEGI" } }, { "@etat": "MODIFIE", "LIEN_ART": { "@id": "LEGIARTI000042654861", "@fin": "2021-08-04", "@num": "L1123-7", "@etat": "MODIFIE", "@debut": "2020-12-09", "@origine": "LEGI" } }, { "@etat": "VIGUEUR", "LIEN_ART": { "@id": "LEGIARTI000043896077", "@fin": "2999-01-01", "@num": "L1123-7", "@etat": "VIGUEUR", "@debut": "2021-08-04", "@origine": "LEGI" } } ] }, "BLOC_TEXTUEL": { "CONTENU": "

Le comité rend son avis sur les conditions de validité de la recherche, notamment au regard de :

- la protection des personnes, notamment la protection des participants ;

- l'adéquation, l'exhaustivité et l'intelligibilité des informations écrites à fournir ainsi que la procédure à suivre pour obtenir le consentement éclairé, et la justification de la recherche sur des personnes incapables de donner leur consentement éclairé ou, le cas échéant, pour vérifier l'absence d'opposition ;

- la nécessité éventuelle d'un délai de réflexion ;

- la nécessité éventuelle de prévoir, dans le protocole, une interdiction de participer simultanément à une autre recherche ou une période d'exclusion ;

- la pertinence de la recherche, le caractère satisfaisant de l'évaluation des bénéfices et des risques attendus et le bien-fondé des conclusions ;

- l'adéquation entre les objectifs poursuivis et les moyens mis en oeuvre ;

- la qualification du ou des investigateurs ;

- les montants et les modalités d'indemnisation des participants ;

- les modalités de recrutement des participants ;

- la pertinence scientifique et éthique des projets de constitution de collections d'échantillons biologiques au cours de recherches impliquant la personne humaine ;

- la méthodologie de la recherche au regard des dispositions de la loi n° 78-17 du 6 janvier 1978 relative à l'informatique, aux fichiers et aux libertés, la nécessité du recours à la collecte et au traitement de données à caractère personnel et la pertinence de celles-ci par rapport à l'objectif de la recherche, préalablement à la saisine de la Commission nationale de l'informatique et des libertés.

Le protocole soumis par le promoteur d'une recherche mentionnée aux 1° ou 2° de l'article L. 1121-1 au comité de protection des personnes et, le cas échéant, à l'autorité compétente indique, de manière motivée, si la constitution d'un comité de surveillance indépendant est ou non prévue.

Le comité s'assure, avant de rendre son avis, que les conditions de l'article L. 1121-13 sont satisfaites. L'autorité compétente est informée des modifications apportées au protocole de recherche introduites à la demande du comité de protection des personnes.

Outre les missions qui leur sont confiées en matière de recherches impliquant la personne humaine, les comités sont également consultés en cas d'utilisation d'éléments et de produits du corps humain à des fins scientifiques relevant d'un changement substantiel de finalité par rapport au consentement initialement donné, dans les conditions prévues à l'article L. 1211-2. \n

Le comité se prononce par avis motivé dans un délai fixé par voie réglementaire.

En cas de faute du comité dans l'exercice de sa mission, la responsabilité de l'Etat est engagée.

Sur demande auprès du comité de protection des personnes concerné, l'Agence nationale de sécurité du médicament et des produits de santé a accès à toutes informations utiles relatives aux recherches mentionnées aux 2° et 3° de l'article L. 1121-1.

" } }, "LEGIARTI000025445624": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1243-4", "ETAT": "VIGUEUR", "TYPE": "AUTONOME", "DATE_FIN": "2999-01-01", "DATE_DEBUT": "2012-03-07" } }, "META_COMMUN": { "ID": "LEGIARTI000025445624", "URL": "article/LEGI/ARTI/00/00/25/44/56/LEGIARTI000025445624.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
" }, "LIENS": { "LIEN": [ { "@id": "LEGIARTI000006697607", "@num": "36", "#text": "Loi n°2004-800 du 6 août 2004 - art. 36 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000441469", "@nortexte": "SANX0100053L", "@numtexte": "2004-800", "@typelien": "CITATION", "@naturetexte": "LOI", "@datesignatexte": "2004-08-06" }, { "@id": "LEGIARTI000038468903", "@num": "Annexe 1", "#text": "Arrêté du 16 août 2007 - art. Annexe 1 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000000274626", "@nortexte": "ESRR0757114A", "@typelien": "CITATION", "@naturetexte": "ARRETE", "@datesignatexte": "2007-08-16" }, { "@id": "LEGIARTI000025442809", "@num": "3", "#text": "LOI n°2012-300\n du 5 mars 2012 - art. 3", "@sens": "cible", "@cidtexte": "JORFTEXT000025441587", "@nortexte": "SASX0901817L", "@numtexte": "2012-300", "@typelien": "MODIFIE", "@naturetexte": "LOI", "@datesignatexte": "2012-03-05" }, { "@id": "LEGITEXT000035994792", "#text": "Décret n°2017-1549 du 8 novembre 2017 (V)", "@sens": "cible", "@cidtexte": "JORFTEXT000035994293", "@nortexte": "ESRR1700188D", "@numtexte": "2017-1549", "@typelien": "CITATION", "@naturetexte": "DECRET", "@datesignatexte": "2017-11-08" }, { "@id": "LEGIARTI000038467130", "#text": "Arrêté du 17 avril 2019 - art. 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\n

Tout organisme qui assure la conservation et la préparation de tissus et cellules, d'organes, de sang, de ses composants et de ses produits dérivés, issus du corps humain en vue de leur cession pour un usage scientifique doit être titulaire d'une autorisation délivrée par le ministre chargé de la recherche. Lorsque l'organisme est un établissement de santé, l'autorisation est délivrée de manière conjointe par le ministre chargé de la recherche et le directeur général de l'agence régionale de santé territorialement compétent.

Par dérogation, les activités prévues au premier alinéa exercées dans le cadre d'une recherche impliquant la personne humaine sont régies par le titre II du livre Ier de la première partie du présent code.

\n
" } }, "LEGIARTI000025449694": { "META": { "META_SPEC": { "META_ARTICLE": { "NUM": "L1243-3", "ETAT": "MODIFIE", "TYPE": "AUTONOME", "DATE_FIN": "2021-08-04", "DATE_DEBUT": "2012-03-07" } }, "META_COMMUN": { "ID": "LEGIARTI000025449694", "URL": "article/LEGI/ARTI/00/00/25/44/96/LEGIARTI000025449694.xml", "NATURE": "Article", "ORIGINE": "LEGI" } }, "NOTA": { "CONTENU": "
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Tout organisme qui en a fait la déclaration préalable auprès du ministre chargé de la recherche peut, pour les besoins de ses propres programmes de recherche, assurer la conservation et la préparation à des fins scientifiques de tissus et de cellules issus du corps humain ainsi que la préparation et la conservation des organes, du sang, de ses composants et de ses produits dérivés. Ces activités incluent la constitution et l'utilisation de collections d'échantillons biologiques humains. Lorsque l'organisme est un établissement de santé, la déclaration est faite conjointement au ministre chargé de la recherche et au directeur général de l'agence régionale de santé territorialement compétent.

Les termes \" collections d'échantillons biologiques humains \" désignent la réunion, à des fins scientifiques, de prélèvements biologiques effectués sur un groupe de personnes identifiées et sélectionnées en fonction des caractéristiques cliniques ou biologiques d'un ou plusieurs membres du groupe, ainsi que des dérivés de ces prélèvements.

Le ministre chargé de la recherche et, le cas échéant, le directeur général de l'agence régionale de santé territorialement compétent peuvent s'opposer, dans un délai fixé par voie réglementaire, à l'exercice des activités ainsi déclarées si la finalité scientifique de l'activité n'est pas établie, si les conditions d'approvisionnement, de conservation et d'utilisation des tissus et cellules issus du corps humain ne présentent pas les garanties suffisantes pour assurer le respect soit des dispositions du titre Ier du présent livre, soit des règles en vigueur en matière de sécurité des personnes exerçant une activité professionnelle sur le site, soit des dispositions applicables en matière de protection de l'environnement.

Le ministre chargé de la recherche et, le cas échéant, le directeur général de l'agence régionale de santé territorialement compétent peuvent à tout moment suspendre ou interdire les activités qui ne répondent plus à ces exigences.

Les activités prévues au premier alinéa exercées dans le cadre d'une recherche impliquant la personne humaine sont régies par les dispositions spécifiques à ces recherches.

L'Agence nationale de sécurité du médicament et des produits de santé est informée des activités de conservation ou de préparation à des fins scientifiques de tissus et cellules du corps humain réalisées sur le même site que des activités de même nature exercées à des fins thérapeutiques. Dans ce cas, la suspension ou l'interdiction de l'exercice des activités déclarées est de droit quand elle est demandée par l'Agence nationale de sécurité du médicament et des produits de santé pour des raisons de sécurité sanitaire.

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Comme il est dit à l'article 223-8 du code pénal ci-après reproduit :

\" Le fait de pratiquer ou de faire pratiquer sur une personne une recherche mentionnée aux 1° ou 2° de l'article L. 1121-1 du code de la santé publique sans avoir recueilli le consentement libre, éclairé et, le cas échéant, écrit de l'intéressé, des titulaires de l'autorité parentale ou du tuteur ou d'autres personnes, autorités ou organes désignés pour consentir à la recherche ou pour l'autoriser, dans les cas prévus par le code de la santé publique, est puni de trois ans d'emprisonnement et de 45 000 € d'amende.

Les mêmes peines sont applicables lorsque la recherche interventionnelle est pratiquée alors que le consentement a été retiré.

Les mêmes peines sont applicables lorsqu'une recherche non interventionnelle est pratiquée alors que la personne s'y est opposée.

Les dispositions du présent article ne sont pas applicables à l'examen des caractéristiques génétiques d'une personne ou à son identification par ses empreintes génétiques effectués à des fins de recherche scientifique. \"

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Article 3 ENTIEREMENT_MODIF (LOI n° 2012-300 du 5 mars 2012 relative aux recherches impliquant la personne humaine (1))