Informed consent is a central ethical principle in research involving human subjects, evolving from the Nuremberg Code, established after the atrocities of World War II, to the contemporary challenges posed by artificial intelligence. Documents such as the Declaration of Helsinki and the Universal Declaration on Bioethics and Human Rights emphasize the importance of respecting participants’ autonomy and rights. In Brazil, research ethics is regulated by the National Research Ethics System, with adapted norms, including the use of electronic consent, particularly after the COVID-19 pandemic. Artificial intelligence introduces ethical challenges such as transparency, explainability, and algorithmic biases, which can compromise participants’ understanding of processes. The evolution of consent must keep pace with technological advancements, ensuring that individuals understand the risks and maintain control over their data, thus preserving their autonomy and dignity in a digital transformation era.
Keywords:
Informed consent; Personal autonomy; Bioethics; Artificial intelligence