A comparative analysis of biomedical research ethics regulation systems in Europe and Latin America with regard to the protection of human subjects
Author
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Lamas, Eugenia
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Ferrer, Marcela
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Molina, Alberto
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Salinas, Rodrigo
Author
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Hevia, Adriana
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Bota, Alexandre
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Feinholz, Dafna
Author
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Fuchs, Michael
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Schramm, Roland
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Tealdi, Juan Carlos
Author
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Zorrilla, Sergio
Admission date
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2019-03-11T13:00:44Z
Available date
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2019-03-11T13:00:44Z
Publication date
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2010
Cita de ítem
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Journal of Medical Ethics, Volumen 36, Issue 12, 2018, Pages 750-753
Identifier
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03066800
Identifier
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14734257
Identifier
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10.1136/jme.2009.035097
Identifier
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https://repositorio.uchile.cl/handle/2250/165127
Abstract
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The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining 'ethics regulation system for biomedical research' as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studi