Mostrar el registro sencillo del ítem

AutorMarodin, Gabriela
AutorFrança, Paulo Henrique Condeixa de
AutorSalgueiro, Jennifer Braathen
AutorMotta, Marcia Luz da
AutorTannous, Gysélle Saddi
AutorLopes, Anibal Gil
Fecha de acceso2019-10-07T13:14:20Z
Fecha de disponibilización2019-10-07T13:14:20Z
Fecha de publicación2014
ReferenciaMARODIN, Gabriela. Alternatives of informed consent for storage and use of human biological material for research purposes: Brazilian regulation. Developing World Bioethics, v. 14, n. 3, p. 127-131, 2014.pt_BR
ISSN1471-8731pt_BR
URIhttps://www.arca.fiocruz.br/handle/icict/36218
Idiomaengpt_BR
EditorWileypt_BR
Derechos de autorrestricted accesspt_BR
TítuloAlternatives of informed consent for storage and use of human biological material for research purposes: Brazilian regulationpt_BR
Tipo del documentoArticle
DOI10.1111/dewb.12012
Resumen en InglésInformed 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.pt_BR
AfiliaciónBrazilian National Committee for Ethics in Research. Brasília, DF, Brazil / Brazilian Ministry of Health. Brasília, DF, Brazil.pt_BR
AfiliaciónRegional University of Joinville. Joinville, SC, Brazil / Brazilian National Committee for Ethics in Research. Brasília, DF, Brazil.pt_BR
AfiliaciónFundação 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.pt_BR
AfiliaciónBrazilian National Committee for Ethics in Research. Brasília, DF, Brazil / Brazilian Ministry of Health. Department of Science and Technology. Brasília, DF, Brazil.pt_BR
AfiliaciónBrazilian National Committee for Ethics in Research. Brasília, DF, Brazil / National Health Council. Brasília, DF, Brazil.pt_BR
AfiliaciónFederal 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.pt_BR
Palavras clave en InglêsInformed consentpt_BR
Palavras clave en InglêsConfidentiality & privacypt_BR
Palavras clave en InglêsRegulatory issuespt_BR
Palavras clave en InglêsEthics committeespt_BR
Palavras clave en InglêsBiomedical researchpt_BR
e-ISSN1471-8847
Fecha de embargo2021-10-07


Ficheros en el ítem

application/pdf
Nombre:
ve_Marodin_Gabriela_etal_INI_2 ...
Tamaño:
90.11Kb
Formato:
application/
Ver/Abrir

Este ítem aparece en la(s) siguiente(s) colección(ones)

Mostrar el registro sencillo del ítem