Os impactos da lei geral de proteção de dados na pesquisa clínica: aspectos contratuais

Abstract

This article aims to address how the Brazilian General Data Protection Law (LGPD) impacted the practice of clinical research in Brazil after its enactment, including its impacts on contractual terms, drawing a parallel between the informed consent form (ICF), mandatory document signed by the study subject, as data subject and main subject of this structure, demonstrating that the lawful basis of both themes is equal: the prior consent by the data subject. It is also aims to demonstrate at the end of this work that even after the entry into force of the LGPD, some issues regarding data protection are already protected in clinical research, either through infra-legal regulations currently in force in Brazil, or through foreign legal regulations. The methodology used was bibliographic research, deepened by the author's previous knowledge about the subject, obtained through her practical work, as well as the observation between different models of clinical research agreements, signed both with the public administration and with private institutions, with in order to analyze how the provisions regarding data protection are listed in such documents. Finally, this article does not aim to address aspects of the clinical research agreement within the scope of international law, characterizing it as an international agreement