backThe National Health Council (CNS) has approved Resolution 738/2024, which regulates the use of databases in scientific research in the health field involving human subjects. The regulation introduces significant innovations to the ethical framework of research in Brazil, addressing general principles, the responsibilities of data controllers and processors, participants’ rights, guidelines for establishing and using databases, and rules regarding free and informed consent. The resolution aims to ensure the protection of information while safeguarding participants’ dignity, privacy, freedom, honor, and image, focusing on informational self-determination and the security of personal data, prioritizing anonymization whenever possible.
The regulation establishes that database controllers, such as researchers, sponsors, and biobank managers, must adopt stringent measures to ensure information security, traceability, and integrity. Transfers of identifiable data to third parties may only occur with justification provided in the research protocol or contract and following approval by the CEP/Conep System. Furthermore, participants are guaranteed access to their stored information.
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