title: Biobanking and Privacy Law in Brazil.
abstract: This article analyzes the current regulatory framework for biobanking, genomic research, and protection of privacy in Brazil. It is divided in four parts. The first describes the biobanking context in Brazil and its evolution in recent years. In the second, the entire regulatory framework on biobanking and genomic research is analyzed. The third part focuses on the critical evaluation of this regulatory framework, specifically on some major ethical dilemmas in biobanking. The fourth part describes the characteristics of the Brazilian biobanking and human research governance system, known as the CEP/CONEP system. Finally, the conclusion summarizes the information in the article and its contribution to the study of the biobanking ethical challenges, especially the protection of privacy. It is highlighted that biobanking regulatory harmonization among countries is necessary, since it increases scientific possibilities that can come from broader cooperation among biobanks and several research centers on the national and international levels.
authors.affiliation: Professor of Health Law at Universidade de São Paulo since 1997. She was a Visiting Professor at Columbia University (School of International and Public Affairs - 1995), at the Université de Nantes (Faculté de Droit - 2003, 2004 and 2006), at the Université de Paris X (Faculté de Droit - 2007 to 2012), and at the Université Paris V (Faculté de Droit - 2014 and 2015). She is the Founding Director of the Center for Studies and Research on Health Law (1988) and acts as scientific coordinator of the Research Center for Health Law at Universidade de São Paulo.
authors.forename: Sueli Gandolfi
authors.initials: SG
authors.lastname: Dallari
authors.affiliation: Assistant researcher at the Center for Studies and Research on Health Law.
authors.forename: Felipe Angel Bocchi
authors.initials: FA
authors.lastname: Castellaro
authors.affiliation: Researcher at the Institute of Tropical Medicine at the University of Sao Paulo.
authors.forename: Iara Coelho Zito
authors.initials: IC
authors.lastname: Guerriero
mesh_terms: D022126:Access to Information / Q000331:legislation & jurisprudence; D018070:Biological Specimen Banks / Q000331:legislation & jurisprudence*; D001938:Brazil; D003219:Confidentiality / Q000331:legislation & jurisprudence*; D036281:Genetic Research / Q000331:legislation & jurisprudence; D006801:Humans