The Ethical Crisis of Clinical Research in Brazil

Law 14.874/2024 and the Flexibilization of Brazilian Regulations for Participant Protection

Bibliographic Data

ID4190579
AuthorsFernando Hellmann (0000-0002-4692-0545, Universidade Federal de Santa Catarina), Jucélia Maria Guedert (0000-0002-7425-7568, Hospital Infantil Joana de Gusmão)
Year2024
Volume28
Publication date2024-01-01
Open AccessYes
TypeARTICLE
VenueInterface - Comunicação Saúde Educação (JOURNAL)
Journal identifiersISSN: 1414-3283 • E-ISSN: 1807-5762
PublisherFapUNIFESP (SciELO) (PUBLISHER)
DOI10.1590/interface.240271
OpenAlexW4400475321
LanguageEN
References cited14

Clinical research is an essential field for the advancement of medical science and the development of new treatments.However, the globalization of clinical trials has caused controversy, especially regarding the integrity of the data collected and possible violations of participants' rights [1][2][3] .Lobbying in Brazil by the international biopharmaceutical industry ("Big Pharma") is strong and has led to the relaxation of regulations protecting participants, raising serious ethical concerns.With the recent enactment of Law 14.874/2024 4 it is imperative to discuss how these regulatory changes affect research ethics and the need for policies that prioritize the protection of participants and national sovereignty

Clinical trial · Engineering ethics · Ethical standards · Globalization · Political science · Research ethics · Sovereignty · Biomedical Ethics and Regulation · Ethics in Clinical Research · Law · Medicine · Public Health in Brazil

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Open DOIOpen Access