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Tipo
ArtículoDerechos de autor
Acceso restringido
Fecha del embargo
2021-10-07
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- INI - Artigos de Periódicos [3397]
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ALTERNATIVES OF INFORMED CONSENT FOR STORAGE AND USE OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSES: BRAZILIAN REGULATION
Confidentiality & privacy
Regulatory issues
Ethics committees
Biomedical research
Autor
Afiliación
Brazilian National Committee for Ethics in Research. Brasília, DF, Brazil / Brazilian Ministry of Health. Brasília, DF, Brazil.
Regional University of Joinville. Joinville, SC, Brazil / Brazilian National Committee for Ethics in Research. Brasília, DF, Brazil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil / Brazilian Ministry of Health. Department of Science and Technology. Brasília, DF, Brazil.
Brazilian National Committee for Ethics in Research. Brasília, DF, Brazil / Brazilian Ministry of Health. Department of Science and Technology. Brasília, DF, Brazil.
Brazilian National Committee for Ethics in Research. Brasília, DF, Brazil / National Health Council. Brasília, DF, Brazil.
Federal University of Rio de Janeiro. Rio de Janeiro, RJ, Brazil / Brazilian National Committee for Ethics in Research. Brasília, DF, Brazil / National Health Council. Brasília, DF, Brazil / Brazilian National Academy of Medicine. Rio de Janeiro, RJ, Brazil.
Regional University of Joinville. Joinville, SC, Brazil / Brazilian National Committee for Ethics in Research. Brasília, DF, Brazil.
Fundação Oswaldo Cruz. Instituto Nacional de Infectologia Evandro Chagas. Rio de Janeiro, RJ, Brasil / Brazilian Ministry of Health. Department of Science and Technology. Brasília, DF, Brazil.
Brazilian National Committee for Ethics in Research. Brasília, DF, Brazil / Brazilian Ministry of Health. Department of Science and Technology. Brasília, DF, Brazil.
Brazilian National Committee for Ethics in Research. Brasília, DF, Brazil / National Health Council. Brasília, DF, Brazil.
Federal University of Rio de Janeiro. Rio de Janeiro, RJ, Brazil / Brazilian National Committee for Ethics in Research. Brasília, DF, Brazil / National Health Council. Brasília, DF, Brazil / Brazilian National Academy of Medicine. Rio de Janeiro, RJ, Brazil.
Resumen en ingles
Informed consent is recognized as a primary ethical requirement to conduct research involving humans. In the investigations with the use of human biological material, informed consent (IC) assumes a differentiated condition on account of the many future possibilities. This work presents suitable alternatives for IC regarding the storage and use of human biological material in research, according to new Brazilian regulations. Both norms – Resolution 441/11 of the National Health Council, approved on 12 May 2011, and Ordinance 2.201 (NATIONAL GUIDELINES FOR BIOREPOSITORIES AND BIOBANKS OF HUMAN BIOLOGICAL MATERIAL FOR RESEARCH PURPOSE) of the Brazil Ministry of Health, approved on 14 September 2011 – state that the consent of subjects for the collection, storage and use of samples stored in Biobanks is necessarily established by means of a Free and Informed Consent Form (ICF). In order to obtain individual and formal statements, this form should contain the following two mutually exclusive options: an explanation about the use of the stored material in each research study, and the need for new consent or the waiver thereof when the material is used for a new study. On the other hand, ICF suitable for Biorepositories must be exclusive and related to specific research. Although Brazilian and international regulations identify the main aspects to be included in the IC, efforts are still necessary to improve the consent process, so that the document will become a bond of trust between subject and researcher.
Palabras clave en ingles
Informed consentConfidentiality & privacy
Regulatory issues
Ethics committees
Biomedical research
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