Informed consent under debate: Impacts of Law No. 14.874/2024
Vigil Sanit Debate, Rio de Janeiro, 2026, v.14: e02479| Published on: 2026-02-10
DOI:
https://doi.org/10.22239/2317-269X.02479Keywords:
Clinical Trial, Drug Legislation, Health Surveillance, Research Ethics, Informed Consent Form, DrugsAbstract
Introduction: The enactment of Law No. 14,874/2024 marks a historic milestone in the regulation of clinical research in Brazil, granting the force of law to ethical principles previously established only through resolutions. This transformation aims to provide greater legal certainty and expedite regulatory processes while posing new challenges to the protection and autonomy of research participants. Objective: This manuscript aimed to critically examine the regulatory framework established by Law No. 14,874/2024, with a focus on its impact on the process of obtaining the Informed Consent Form (ICF) in clinical research conducted in Brazil. Method: It offered a normative and critical analysis of the new legal structure in light of previous national guidelines and international ethical standards, with the purpose of identifying institutional advancements, operational risks, and implementation gaps that directly affect the protection of research participants. Results: The new legislation consolidates and replaces historic regulations, such as CNS Resolutions No. 196/1996 and No. 466/2012, by granting greater legal force to ethical guidelines and introducing mechanisms for the centralization of ethical review, reduction of bureaucratic barriers, and acceleration of regulatory procedures. Conclusion: Despite these advances, which may increase the country’s attractiveness for clinical trials, significant challenges remain, particularly regarding the effectiveness of the ICF in light of Brazil’s regional, educational, and sociocultural inequalities. The original contribution of this study lies in its critical reflection on the potential disconnect between the normative assumptions of Law No. 14,874/2024 and the actual conditions for ICF comprehension by research participants. By doing so, the manuscript seeks to address a gap still scarcely explored in the literature: the ethical effectiveness of the new law in terms of communication, autonomy, and justice in participant recruitment and informed consent across diverse and vulnerable contexts.
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Author Biographies
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Sergio Carlos Assis de Jesus Junior, Departamento de Pós-Graduação em Ciências Médicas, Instituto D’Or de Pesquisa e Ensino (IDOR), Rio de Janeiro, RJ, Brasil | Laboratório de Pesquisa em Imunização e Vigilância em Saúde (LIVS), Instituto Nacional de Infectologia (INI), Fundação Oswaldo Cruz (Fiocruz), Rio de Janeiro, RJ, Brasil
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Daniele Fernandes de Aguiar, Departamento de Pós-Graduação em Ciências Médicas, Instituto D’Or de Pesquisa e Ensino (IDOR), Rio de Janeiro, RJ, Brasil
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José Cerbino Neto, Departamento de Pós-Graduação em Ciências Médicas, Instituto D’Or de Pesquisa e Ensino (IDOR), Rio de Janeiro, RJ, Brasil
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Data Availability Statement
Os dados utilizados para a elaboração deste manuscrito são de acesso restrito ou já se encontram devidamente indicados nas referências bibliográficas citadas ao longo do texto. Não há banco de dados adicional disponível para compartilhamento público.
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