{"id":4401,"date":"2025-10-03T06:39:09","date_gmt":"2025-10-03T06:39:09","guid":{"rendered":"https:\/\/francisa43.sg-host.com\/?page_id=4401"},"modified":"2025-10-03T06:39:51","modified_gmt":"2025-10-03T06:39:51","slug":"normes-dagrement","status":"publish","type":"page","link":"https:\/\/www.hracanada.org\/francais\/normes-dagrement\/","title":{"rendered":"Normes d’agr\u00e9ment"},"content":{"rendered":"\t\t
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Normes d'agr\u00e9ment<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Normes d\u2019agr\u00e9ment<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Le programme d\u2019agr\u00e9ment de HRA Canada est fond\u00e9 sur les normes \u00e9labor\u00e9es par l\u2019Organisme de normalisation de la recherche humaine (ONRH).<\/a><\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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L\u2019ONRH est un organisme canadien d’\u00e9laboration de normes sans but lucratif qui \u00e9labore des normes pertinentes pour les Canadiens qui m\u00e8nent, supervisent et participent \u00e0 la recherche sur l’\u00eatre humain. HRSO adh\u00e8re au Code de pratique pour l’\u00e9laboration, l’adoption et l’application des normes de l’Accord de de l’Organisation mondiale du commerce sur les obstacles techniques au commerce<\/a>.\u00a0<\/p>

HRA Canada a obtenu une licence exclusive d’utilisation des normes de l’ONRH pour l’\u00e9valuation de la conformit\u00e9 (agr\u00e9ment).<\/p>

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Documents normatifs<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Loi sur les aliments et drogues <\/a><\/p>

Loi sur la protection des renseignements personnels et les documents \u00e9lectroniques (LPRPDE)<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tR\u00e8glements canadiens<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

R\u00e8glement sur les aliments et drogues, titre 5, partie C<\/a><\/p>

R\u00e8glement sur les produits de sant\u00e9 naturels, partie 4<\/a><\/p>

R\u00e8glement sur les instruments m\u00e9dicaux, partie 3<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tPolitiques, directives et normes<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

Cadre de r\u00e9f\u00e9rence des trois organismes sur la conduite responsable de la recherche (2016)<\/a><\/p>

CAN\/HRSO-100.01-2020 D\u00e9veloppement d\u2019un programme de protection des participants \u00e0 la recherche (PPPR)<\/a><\/p>

CAN\/HRSO-200.01-2021\u00c9valuation \u00e9thique et surveillance de la recherche avec des \u00eatres humains<\/a><\/p>

CAN\/HRSO-300.01-2022 La conduite de la recherche avec des \u00eatres humains<\/a><\/p>

Council for International Organizations of Medical Sciences (CIOMS): International Ethical Guidelines for Biomedical Research Involving Human Subjects<\/a><\/p>

D\u00e9couvertes fortuites significatives \u2013 L\u2019\u00e9nonc\u00e9 de politique des trois conseils: \u00c9thique de la recherche avec les \u00eatres humains \u2013 EPTC 2 (2018)<\/a><\/p>

\u00c9nonc\u00e9 de politique des trois conseils: \u00c9thique de la recherche avec des \u00eatres humains \u2013 EPTC 2 (2022)<\/a><\/p>

HRSO-100.02-2023 D\u00e9veloppement d\u2019un programme de formation pour la protection des participants \u00e0 la recherche<\/a><\/p>

Good Clinical Data Management Practices (GCDMP)<\/a><\/p>

International Council for Harmonization (ICH) Good Clinical Practice (GCP) Guideline<\/a><\/p>

Interpr\u00e9tations \u2013 L\u2019\u00e9nonc\u00e9 politique des trois conseils: \u00c9thique de la recherche avec des \u00eatres humains<\/a><\/p>

ISO 14155:2020 Clinical Investigation of Medical Devices for Human Subjects \u2013 Good Clinical Practice<\/a><\/p>

Politique des trois organismes sur la gestion des donn\u00e9es de recherche (2021)<\/a><\/p>

Rapport Belmont: Principes \u00e9thiques et directives concernant la protection des sujets humains dans le cadre de la recherche<\/a><\/p>

The First Nations Principles of Ownership, Control, Access, and Possession OCAP\u00ae (OCAP\u00ae is a registered trademark of the First Nations Information Governance Centre (FNIGC))<\/a><\/p>

World Health Organization \u2013 Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants<\/a><\/p>

World Medical Association – Declaration of Helsinki \u2013 Ethical Principles for Medical Research Involving Human Subjects<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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US Code of Federal Regulations Title 21<\/a><\/p>

US Code of Federal Regulations Title 45<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t

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\n\t\t\t\t\t\t\t\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t<\/i><\/span>\n\t\t\t\t\t\t\t\t\t\t\t\t\t\t<\/span>\n\t\t\t\t\t\t\t\t\t\t\t\tAutres documents connexes (Informatif)<\/a>\n\t\t\t\t\t<\/div>\n\t\t\t\t\t

An ethical framework for biomedical research, authored by Emanuel EJ, Wendler D, and Grady C (2008) in Emanuel EJ, Grady C, Crouch RA, Lie R, Miller FG, and Wendler D (Editors), The Oxford Textbook of Clinical Research Ethics <\/i>(pages 123\u2013 135). Oxford, UK: Oxford University Press.<\/a><\/p>

A Systems Approach to Human Research Protection: Innovation in Healthcare, authored by Alexander G. Karabanow, BSc, BAA; Janice E. Parente, BSc, PhD; Jacquelyn Legere, RN, BN,CIPP\/C; Ann Munro Heesters, BEd, BA(Hons.), MA, PhD<\/a><\/p>

Canada’s Clinical Trial Infrastructure: A Prescription for Improved Access to New Medicines (2012) – Standing Senate Committee on Social Affairs, Science and Technology<\/a><\/p>

Canadian governance of human research involving human subjects: is anyone minding the store? – authored by Michael McDonald, BA, MA, PhD<\/a><\/p>

CARE Principles for Indigenous Data Governance<\/a><\/p>

Gouvernance de la recherche dans le domaine de la sante\u0301 avec des sujets humains, r\u00e9dig\u00e9 par Michael McDonald, BA, MA, PhD<\/a><\/p>

Institute of Medicine \u2013 Preserving Public Trust: Accreditation and Human Research Participant Protection Programs<\/a><\/p>

National Council on Ethics in Human Research (NCEHR): Options for the Development of an Accreditation System for Human Research Protection Programs, 2005<\/a><\/p>

Rapport sur l\u2019e\u0301valuation des me\u0301canismes de contro\u0302le en matie\u0300re de recherche clinique au Que\u0301bec, r\u00e9dig\u00e9 par Pierre Deschamps, BCL, CM<\/a><\/p>

Research Ethics Broadly Writ: Beyond REB Review. Anderson, JA, Sawatzky-Girling, B., McDonald, M, Pullman, D., Saginur, R, Sampson, HA, and Willison, DJ (2011), Health Law Review 19(3), 12-24.<\/a><\/p>

SPIRIT 2013 Statement: Defining standard protocol items for clinical trials.\u00a0<\/span><\/a><\/p>

SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials.<\/a><\/p>

The Experts Committee for Human Research Participant Protection in Canada (2008) Moving Ahead: Final Report, Ottawa.<\/a><\/p>

What Makes Clinical Research Ethical? Emanuel EJ, Wendler D, and Grady C. (2000) JAMA 283(20):2701\u20132711<\/a><\/p><\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"

Normes d’agr\u00e9ment Normes d\u2019agr\u00e9ment Le programme d\u2019agr\u00e9ment de HRA Canada est fond\u00e9 sur les normes \u00e9labor\u00e9es par l\u2019Organisme de normalisation de la recherche humaine (ONRH). L\u2019ONRH est un organisme canadien d’\u00e9laboration de normes sans but lucratif qui \u00e9labore des normes pertinentes pour les Canadiens qui m\u00e8nent, supervisent et participent \u00e0 la recherche sur l’\u00eatre humain. […]<\/p>\n","protected":false},"author":5,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"site-sidebar-layout":"no-sidebar","site-content-layout":"page-builder","ast-site-content-layout":"full-width-container","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"disabled","ast-breadcrumbs-content":"","ast-featured-img":"disabled","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"enabled","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"set","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"class_list":["post-4401","page","type-page","status-publish","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.hracanada.org\/francais\/wp-json\/wp\/v2\/pages\/4401","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.hracanada.org\/francais\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.hracanada.org\/francais\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.hracanada.org\/francais\/wp-json\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.hracanada.org\/francais\/wp-json\/wp\/v2\/comments?post=4401"}],"version-history":[{"count":0,"href":"https:\/\/www.hracanada.org\/francais\/wp-json\/wp\/v2\/pages\/4401\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.hracanada.org\/francais\/wp-json\/wp\/v2\/media?parent=4401"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}