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dc.creatorLamas, Eugeniaen
dc.creatorFerrer, Marcelaen
dc.creatorMolina, Albertoen
dc.creatorSalinas, Rodrigoen
dc.creatorHevia, Adrianaen
dc.creatorBota, Alexandreen
dc.creatorFeinholz, Dafnaen
dc.creatorFuchs, Michaelen
dc.creatorSchramm, Rolanden
dc.creatorTealdi, Juan-Carlosen
dc.creatorZorrilla, Sergioen
dc.date.accessioned2016-01-09T00:39:51Zen
dc.date.available2016-01-09T00:39:51Zen
dc.date.created2010-12en
dc.date.issued2010-12en
dc.identifierdoi:10.1136/jme.2009.035097en
dc.identifier.bibliographicCitationJournal of medical ethics 2010 Dec; 36(12): 750-3en
dc.identifier.urihttp://worldcatlibraries.org/registry/gateway?version=1.0&url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&atitle=A+comparative+analysis+of+biomedical+research+ethics+regulation+systems+in+Europe+and+Latin+America+with+regard+to+the+protection+of+human+subjects.&title=Journal+of+medical+ethics+&volume=36&issue=12&date=2010-12&au=Lamas,+Eugenia;+Ferrer,+Marcela;+Molina,+Alberto;+Salinas,+Rodrigo;+Hevia,+Adriana;+Bota,+Alexandre;+Feinholz,+Dafna;+Fuchs,+Michael;+Schramm,+Roland;+Tealdi,+Juan-Carlos;+Zorrilla,+Sergioen
dc.identifier.urihttp://dx.doi.org/10.1136/jme.2009.035097en
dc.identifier.urihttp://hdl.handle.net/10822/1020293en
dc.description.abstractThe 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 studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities.en
dc.formatArticleen
dc.languageenen
dc.sourceeweb:335769en
dc.subjectBiomedical Researchen
dc.subjectClinical Researchen
dc.subjectEthicsen
dc.subjectEthics Committeesen
dc.subjectGovernmenten
dc.subjectInterviewsen
dc.subjectLawsen
dc.subjectRegulationen
dc.subjectResearchen
dc.subjectResearch Ethicsen
dc.subjectResearch Ethics Committeesen
dc.subject.classificationHuman Experimentation Policy Guidelines / Institutional Review Boardsen
dc.subject.classificationInternational and Political Dimensions of Biology and Medicineen
dc.titleA Comparative Analysis of Biomedical Research Ethics Regulation Systems in Europe and Latin America With Regard to the Protection of Human Subjectsen
dc.provenanceCitation prepared by the Library and Information Services group of the Kennedy Institute of Ethics, Georgetown University for the ETHXWeb database.en
dc.provenanceCitation migrated from OpenText LiveLink Discovery Server database named EWEB hosted by the Bioethics Research Library to the DSpace collection EthxWeb hosted by DigitalGeorgetown.en


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