Biobanking and Privacy Law in Brazil

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Brazilian Law n. 11.105, March 24, 2005.

Brazilian Law n. 9.434, February 4, 1997.

Brazil Ministry of Health, Ordinance 2.201 – National Guidelines for Biorepository and Biobank of Human Biological Material for Research Purpose (2011), available at <http://bvsms.saude.gov.br/bvs/saudelegis/gm/2011/prt2201_14_09_2011.html> (last visited October 16, 2015).

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Brazilian Law n. 9.279, May 14, 1996.

Brazilian Law n. 10.205, March 10, 2001.

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The CEPs (Comitês de Ética em Pesquisa) are equivalent to the American Institutional Review Boards (IRB) and the Canadian Research Ethics Boards (REB). To the purposes of this paper, the CEPs will be named as Institutional Review Boards.

Brazil National Health Council, Resolution 441/11 – Brazilian Resolution on the Storage and Use of Human Biological Material in Research Projects , 2011, available at <http://conselho.saude.gov.br/web_comissoes/conep/aquivos/resolucoes/resolucoes.htm> (last visited November 10, 2015).

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See Cambon-Thonsem , supra note 3.

Marodin G. França P. H. Salgueiro J. B. , “Alternatives of Informed Consent for Storage and Use of Human Biological Material for Research Purposes: Brazilian Regulation,” Developing World Bioethics 14, no. 3 (2014): 127–131 [hereinafter cited as Marodin 2014].

Marodin G. França P. Rocha J. C. , “Biobanking for Health Research in Brazil: Present Challenges and Future Directions,” Revista Panamericana de Salud Pública 31, no. 6 (2012): 523–528 [hereinafter cited as Marodin 2012].

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Moore v. Regents of the University of California , 793 P.2d 479 (Cal. 1990).

Washington University v. Catalona , 490 F.3d 667 (8th Cir. 2007), cert. denied, 552 U.S. 1166 (2008).

See Cambon-Thonsem , supra note 3.

Hansson M. G. Dillner J. Bartram C. R. , “Should Donors Be Allowed to Give Broad Consent to Future Biobank Research?” Lancet Oncology 7, no. 3 (2006): 266–269.

See Marodin 2012, supra note 27.

See McGuire , supra note 30.

De Faria P. L. De Campos A. P. , “A Nova Lei sobre Informação de Saúde, Informação Genética e Biobancos – Guia das Disposições mais Importantes,” Revista Portuguesa de Saúde Pública 23, no. 1 (2005): 97–112.

Public Law 110–233, 122 Stat.881 (2008).

See McGuire , supra note 30.

See Marodin 2014, supra note 26.

O'Doherty K. C. Burgess M. M. Edwards K. , “From Consent to Institutions: Designing Adaptive Governance for Genomic Biobanks,” Social Science and Medicine 73, no. 3 (2011): 367–374.

Brazil National Health Council, Resolution 446/11 – Guidelines for Composition of National Commission on Research Ethics (CONEP) (2011), available at <http://conselho.saude.gov.br/web_comissoes/conep/aquivos/resolucoes/resolucoes.htm> (last visited November 11, 2015)

Brazil National Health Council, Resolution 370/07 – Guidelines for Registration of CEPs (2007), available at <http://conselho.saude.gov.br/web_comissoes/conep/aquivos/resolucoes/resolucoes.htm> (last visited October 16, 2015).