| Brazil, Ministry of Health |
Nuremberg Code. 1947. Available at: https://bvsms.saude.gov.br/bvs/publicacoes/codigo_nuremberg.pdf(10) |
| Federative Republic of Brazil |
Federal Constitution of Brazil of 1988 [In Portuguese, Constituição Federativa do Brasil de 1988 (Artigo 5º, inciso X)]. Available at: https://www.planalto.gov.br/ccivil_03/constituicao/constituicao.htm(11)
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| European Medicines Agency |
ICH E 3: Structure and content of clinical study reports - Step 5, 1996. Available at: https://www.ema.europa.eu/en/ich-e3-structure-content-clinical-study-reports-scientific-guideline(3) |
| Federative Republic of Brazil |
Brazilian Civil Code, Law 10,406 of January 10, 2002 [In Portuguese, Código Civil Brasileiro, Lei nº 10.406, de 10 de janeiro de 2002]. Available at: http://www.planalto.gov.br/ccivil_03/leis/2002/L10406.htm(12) |
| Food And Drug Administration (FDA) |
Health Insurance Portability and Accountability Act. HIPAA Privacy Rule. Last version: 2003. Available at:
https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html(13) |
| United Nations Educational, Scientific and Cultural Organization (UNESCO) |
International Declaration on Human Genetic Data. UNESCO, 2004. Available at:
https://bvsms.saude.gov.br/bvs/publicacoes/declaracao_inter_dados_genericos.pdf(14) |
| United Nations Educational, Scientific and Cultural Organization (UNESCO) |
Universal Declaration on Bioethics and Human Rights, 2006. Available at:
https://unesdoc.unesco.org/ark:/48223/pf0000146180_por(15) |
| Brazil, Ministry of Health |
Decree 2,201 of September 14, 2011. Establishes the Brazilian National Guidelines for Biorepositories and Biobanks of Human Biological Material for Research Purposes [In Portuguese, Portaria nº 2.201, de 14 de setembro de 2011. Estabelece as Diretrizes Nacionais para Biorrepositório e Biobanco de Material Biológico Humano com Finalidade de Pesquisa]. Available at: https://bvsms.saude.gov.br/bvs/saudelegis/gm/2011/prt2201_14_09_2011.html(16) |
| Brazilian National Research Ethics Committee (In Portuguese, Comissão Nacional de Pesquisa com Seres Humanos - CONEP) |
Resolution 441 of May 12, 2011. Guidelines and regulatory standards for research involving human beings [In Portuguese, Resolução nº 441, de 12 de maio de 2011. Diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos]. Available at: https://bvsms.saude.gov.br/bvs/saudelegis/cns/2011/res0441_12_05_2011.html(17) |
| Brazilian National Research Ethics Committee (In Portuguese, Comissão Nacional de Pesquisa com Seres Humanos - CONEP) |
Circular Letter 039, dated July 19, 2011 [In Portuguese, Carta Circular nº 039, de 19 de julho de 2011]. Available at: https://www.gov.br/conselho-nacional-de-saude/pt-br/camaras-tecnicas-e-comissoes/conep/legislacao/cartas-circulares/carta-circular-no-039-de-19-de-julho-de-2011.pdf/view(18) |
| Brazilian National Research Ethics Committee (In Portuguese, Comissão Nacional de Pesquisa com Seres Humanos - CONEP) |
Resolution 466 of December 12, 2012. Guidelines and regulatory standards for research involving human beings. Brazilian National Health Council ((In Portuguese, Conselho Nacional de Saúde - CNS), Ministry of Health [In Portuguese, Resolução nº 466, de 12 de dezembro de 2012. Diretrizes e normas regulamentadoras de pesquisas envolvendo seres humanos. Conselho Nacional de Saúde (CNS), Ministério da Saúde]. Available at: https://www.gov.br/conselho-nacional-de-saude/pt-br/atos-normativos/resolucoes/2012/resolucao-no-466.pdf/view(19) |
| Brazilian National Research Ethics Committee (In Portuguese, Comissão Nacional de Pesquisa com Seres Humanos - CONEP) |
Resolution 510 of April 7, 2016. Resolution establishing the rules applicable to research in the Humanities and Social Sciences [In Portuguese, Resolução nº 510, de 7 de abril de 2016. Resolução que dispõe sobre as normas aplicáveis a pesquisas em Ciências Humanas e Sociais]. Available at:
https://bvsms.saude.gov.br/bvs/saudelegis/cns/2016/res0510_07_04_2016.html(20) |
| The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) |
E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). Available at: https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf(21) |
| European Union |
General Data Protection Regulation (GDPR) - EU 2016/679. Available at: https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng(22) |
| Federative Republic of Brazil |
Law 13,709 of August 14, 2018. Provides for the protection of personal data and amends Law 12,965 of April 23, 2014 (Brazilian Internet Bill of Rights) [In Portuguese, Lei nº 13.709, de 14 de agosto de 2018. Dispõe sobre a proteção de dados pessoais e altera a Lei nº 12.965, de 23 de abril de 2014 (Marco Civil da Internet)]. Available at: http://www.planalto.gov.br/ccivil_03/_ato2015-2018/2018/lei/L13709.htm(4) |
| Brazilian Federal Council of Medicine (In Portuguese, Conselho Federal de Medicina - CFM) |
CFM Resolution 2,217 of September 27, 2018. Code of Medical Ethics [In Portuguese, Resolução CFM nº 2.217, de 27 de setembro de 2018. Código de Ética Médica]. Available at: https://portal.cfm.org.br/images/PDF/cem2019.pdf(23) |
| Brazilian National Data Protection Authority (In Portuguese, Autoridade Nacional de Proteção de Dados - ANPD) |
Technical Study on the legal bases for personal data processing. Brasília, DF [In Portuguese, Estudo Técnico sobre bases legais para o tratamento de dados pessoais. Brasília, DF]. Available at: https://www.gov.br/anpd/pt-br/centrais-de-conteudo/documentos-tecnicos-orientativos/estudo-tecnico-a-lgpd-e-o-tratamento-de-dados-pessoais-para-fins-academicos-e-para-a-realizacao-de-estudos-por-orgao-de-pesquisa.pdf(24) |
| Brazilian National Data Protection Authority (In Portuguese, Autoridade Nacional de Proteção de Dados - ANPD) |
Guide ‘Processing of personal data for academic purposes and for conducting studies and research’, by Vargas et al., 2023. Brasília, DF [In Portuguese, Guia orientativo ‘Tratamento de dados pessoais para fins acadêmicos e para a realização de estudos e pesquisas’, de Vargas et al., 2023]. Brasília, DF. Available at: https://www.gov.br/anpd/pt-br/centrais-de-conteudo/materiais-educativos-e-publicacoes/web-guia-anpd-tratamento-de-dados-para-fins-academicos.pdf(25) |
| Brazilian National Research Ethics Committee (In Portuguese, Comissão Nacional de Pesquisa com Seres Humanos - CONEP) |
Resolution 738 of February 2024. Provides for the use of databases for scientific research involving human participants [In Portuguese, Resolução nº 738, de Fevereiro de 2024. Dispõe sobre uso de bancos de dados com finalidade de pesquisa científica envolvendo seres humanos]. Available at: https://www.gov.br/conselho-nacional-de-saude/pt-br/atos-normativos/resolucoes/2024/resolucao-no-738.pdf/view(8) |
| World Medical Association (WMA) |
WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Participants amended by the 75th WMA General Assembly, Helsinki, Finland, October 2024. Available at: https://www.wma.net/policies-post/wma-declaration-of-helsinki/(26) |
Research involving participants and Brazilian General Data Protection Law