{"id":2857,"date":"2025-08-30T16:38:23","date_gmt":"2025-08-30T19:38:23","guid":{"rendered":"https:\/\/www.npcrs.com.br\/regulation\/legislation-and-standards\/"},"modified":"2025-11-03T21:17:39","modified_gmt":"2025-11-04T00:17:39","slug":"legislation-and-standards","status":"publish","type":"page","link":"https:\/\/www.npcrs.com.br\/en\/clinical-research\/regulation\/legislation-and-standards\/","title":{"rendered":"LEGISLATION AND STANDARDS"},"content":{"rendered":"<p>[et_pb_section fb_built=&#8221;1&#8243; fullwidth=&#8221;on&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; background_enable_color=&#8221;off&#8221; use_background_color_gradient=&#8221;on&#8221; background_color_gradient_stops=&#8221;rgba(20,120,196,0.85) 0%|rgba(20,120,196,0.85) 100%&#8221; background_color_gradient_overlays_image=&#8221;on&#8221; background_image=&#8221;https:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/dna-estudos.jpg&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_fullwidth_header title=&#8221;LEGISLATION AND STANDARDS&#8221; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; title_font=&#8221;|700||on|||||&#8221; background_enable_color=&#8221;off&#8221; background_enable_image=&#8221;off&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;]<\/p>\n<p>Official references that guarantee ethics, safety and quality in our clinical research<\/p>\n<p>[\/et_pb_fullwidth_header][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||30px|||&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_row column_structure=&#8221;2_3,1_3&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_column type=&#8221;2_3&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_text _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; custom_padding=&#8221;||16px|||&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<p data-start=\"327\" data-end=\"502\">Clinical research is guided by ethical and legal standards that ensure the protection of participants, the scientific validity of studies and the responsibility of the institutions involved.<\/p>\n<p data-start=\"327\" data-end=\"502\">In this section, we gather the main regulatory frameworks that guide the work of NPCRS, ensuring scientific rigor, respect for human dignity and compliance with international best practices.<\/p>\n<p>[\/et_pb_text][et_pb_divider _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][\/et_pb_divider][\/et_pb_column][et_pb_column type=&#8221;1_3&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_image src=&#8221;https:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/leis-estudos-clinicos-1.jpg&#8221; title_text=&#8221;leis-estudos-clinicos-1&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; box_shadow_style=&#8221;preset4&#8243; box_shadow_horizontal=&#8221;8px&#8221; box_shadow_vertical=&#8221;8px&#8221; box_shadow_color=&#8221;#1478C4&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221; sticky_enabled=&#8221;0&#8243;][\/et_pb_image][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_column type=&#8221;4_4&#8243; _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_text _builder_version=&#8221;4.27.4&#8243; _module_preset=&#8221;default&#8221; hover_enabled=&#8221;0&#8243; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221; sticky_enabled=&#8221;0&#8243;]<\/p>\n<h2>Click to access the documents in PDF format<\/h2>\n<p><a href=\"https:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/Codigo-de-Nuremberg-1947.pdf\" target=\"_blank\" rel=\"noopener\" title=\"Co\u0301digo de Nu\u0308remberg \u2013 1947\"><i class=\"fi fi-sr-file-pdf icone-pdf\"><\/i>  Co\u0301digo de Nu\u0308remberg \u2013 1947<\/a><\/p>\n<p><a href=\"https:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/Declaracao-de-Helsinque-2013.pdf\" target=\"_blank\" rel=\"noopener\" title=\"Declara\u00e7\u00e3o de Helsinque 2013\"><i class=\"fi fi-sr-file-pdf icone-pdf\"><\/i>  Declara\u00e7\u00e3o de Helsinque 2013<\/a><\/p>\n<p><a href=\"https:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/Documento-das-Americas-de-2005.pdf\" target=\"_blank\" rel=\"noopener\" title=\"Boas Pr\u00e1ticas Cl\u00ednicas: Documento das Am\u00e9ricas de 2005\"><i class=\"fi fi-sr-file-pdf icone-pdf\"><\/i>  Boas Pr\u00e1ticas Cl\u00ednicas: Documento das Am\u00e9ricas de 2005<\/a><\/p>\n<p><a href=\"https:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/Instrucao-Normativa-n-4-de-2009-Anvisa.pdf\" target=\"_blank\" rel=\"noopener\" title=\"Instru\u00e7\u00e3o Normativa n\u00b04 de 2009 Anvisa\"><i class=\"fi fi-sr-file-pdf icone-pdf\"><\/i>  Instru\u00e7\u00e3o Normativa n\u00b04 de 2009 Anvisa<\/a><\/p>\n<p><a href=\"https:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/Normativa-21-de-02-Outubro-2017.pdf\" target=\"_blank\" rel=\"noopener\" title=\"Normativa n\u00b021 de 02 de Outubro de 2017\"><i class=\"fi fi-sr-file-pdf icone-pdf\"><\/i>  Normativa n\u00b021 de 02 de Outubro de 2017<\/a><\/p>\n<p><a href=\"https:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/Normativa-190-de-03-Outubro-2017.pdf\" target=\"_blank\" rel=\"noopener\" title=\"Normativa n\u00b0190 de 03 de Outubro de 2017\"><i class=\"fi fi-sr-file-pdf icone-pdf\"><\/i>  Normativa n\u00b0190 de 03 de Outubro de 2017<\/a><\/p>\n<p><a href=\"https:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/Normativa-20-de-2017-Medicamentos-Anvisa.pdf\" target=\"_blank\" rel=\"noopener\" title=\"Normativa n\u00b020 de 2017 de Medicamentos Anvisa.pdf\"><i class=\"fi fi-sr-file-pdf icone-pdf\"><\/i>  Normativa n\u00b020 de 2017 de Medicamentos Anvisa.pdf<\/a><\/p>\n<p><a href=\"https:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/RDC-10-2015-Anvisa.pdf\" target=\"_blank\" rel=\"noopener\" title=\"Resolu\u00e7\u00e3o da Diretoria Colegiada \u2013 RDC n\u00b010 de 20 de fevereiro de 2015\"><i class=\"fi fi-sr-file-pdf icone-pdf\"><\/i>  Resolu\u00e7\u00e3o da Diretoria Colegiada \u2013 RDC n\u00b010 de 20 de fevereiro de 2015<\/a><\/p>\n<p><a href=\"https:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/Resolucao-N-466-de-12-dezembro-2012.pdf\" target=\"_blank\" rel=\"noopener\" title=\"Resolu\u00e7\u00e3o n\u00b0466 de 12 de dezembro de 2012\"><i class=\"fi fi-sr-file-pdf icone-pdf\"><\/i>  Resolu\u00e7\u00e3o n\u00b0466 de 12 de dezembro de 2012<\/a><\/p>\n<p><a href=\"https:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/E6_R2_Addendum_GCP_2016.pdf\" target=\"_blank\" rel=\"noopener\" title=\"Good Practice clinical \u2013 R2_Adendo_Ingl\u00eas_2016\"><i class=\"fi fi-sr-file-pdf icone-pdf\"><\/i>  Good Practice clinical \u2013 R2_Adendo_Ingl\u00eas_2016<\/a><\/p>\n<p><a href=\"https:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/Resolucao-510-de-2016-CONEP.pdf\" target=\"_blank\" rel=\"noopener\" title=\"RESOLU\u00c7\u00c3O N\u00ba 510, DE 07 DE ABRIL DE 2016\"><i class=\"fi fi-sr-file-pdf icone-pdf\"><\/i>  RESOLU\u00c7\u00c3O N\u00ba 510, DE 07 DE ABRIL DE 2016<\/a><\/p>\n<p><a href=\"https:\/\/www.npcrs.com.br\/wp-content\/uploads\/2025\/09\/RDC-214-de-2018.pdf\" target=\"_blank\" rel=\"noopener\" title=\"RDC N\u00ba 214, DE 7 DE FEVEREIRO DE 2018\"><i class=\"fi fi-sr-file-pdf icone-pdf\"><\/i>  RDC N\u00ba 214, DE 7 DE FEVEREIRO DE 2018<\/a>[\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=&#8221;1&#8243; 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button_text_color=&#8221;#F3F4F6&#8243; button_bg_color=&#8221;#1478C4&#8243; button_border_color=&#8221;RGBA(255,255,255,0)&#8221; button_border_radius=&#8221;8px&#8221; button_font=&#8221;Montserrat|||on|||||&#8221; button_icon=&#8221;&#xe101;||divi||400&#8243; button_icon_placement=&#8221;left&#8221; button_on_hover=&#8221;off&#8221; box_shadow_style_button=&#8221;preset3&#8243; box_shadow_vertical_button=&#8221;10px&#8221; box_shadow_blur_button=&#8221;14px&#8221; box_shadow_color_button=&#8221;rgba(17,24,39,0.59)&#8221; global_colors_info=&#8221;{}&#8221; theme_builder_area=&#8221;post_content&#8221;][et_pb_slide heading=&#8221;Be a Volunteer&#8221; button_text=&#8221;Participate&#8221; button_link=&#8221;@ET-DC@eyJkeW5hbWljIjp0cnVlLCJjb250ZW50IjoicG9zdF9saW5rX3VybF9wYWdlIiwic2V0dGluZ3MiOnsicG9zdF9pZCI6IjExMiJ9fQ==@&#8221; _builder_version=&#8221;4.27.4&#8243; _dynamic_attributes=&#8221;button_link&#8221; _module_preset=&#8221;default&#8221; header_text_align=&#8221;center&#8221; 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Your participation makes a difference.[\/et_pb_slide][\/et_pb_fullwidth_slider][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Official references that guarantee ethics, safety and quality in our clinical researchClinical research is guided by ethical and legal standards that ensure the protection of participants, the scientific validity of studies and the responsibility of the institutions involved. In this section, we gather the main regulatory frameworks that guide the work of NPCRS, ensuring scientific [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":2851,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","_joinchat":[],"footnotes":""},"class_list":["post-2857","page","type-page","status-publish","hentry"],"acf":[],"_links":{"self":[{"href":"https:\/\/www.npcrs.com.br\/en\/wp-json\/wp\/v2\/pages\/2857","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.npcrs.com.br\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.npcrs.com.br\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.npcrs.com.br\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/www.npcrs.com.br\/en\/wp-json\/wp\/v2\/comments?post=2857"}],"version-history":[{"count":2,"href":"https:\/\/www.npcrs.com.br\/en\/wp-json\/wp\/v2\/pages\/2857\/revisions"}],"predecessor-version":[{"id":2859,"href":"https:\/\/www.npcrs.com.br\/en\/wp-json\/wp\/v2\/pages\/2857\/revisions\/2859"}],"up":[{"embeddable":true,"href":"https:\/\/www.npcrs.com.br\/en\/wp-json\/wp\/v2\/pages\/2851"}],"wp:attachment":[{"href":"https:\/\/www.npcrs.com.br\/en\/wp-json\/wp\/v2\/media?parent=2857"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}