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dc.creatorDi Tillio-Gonzalez, Dannieen
dc.creatorFischbach, Ruth L.en
dc.date.accessioned2016-01-08T23:10:22Zen
dc.date.available2016-01-08T23:10:22Zen
dc.date.created2008-12en
dc.date.issued2008-12en
dc.identifierdoi:10.1111/dewb.2008.8.issue-3en
dc.identifier.bibliographicCitationDeveloping World Bioethics 2008 December; 8(3): 167-177en
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=Harmonizing+regulations+for+biomedical+research:+a+critical+analysis+of+the+US+and+Venezuelan+systems.&title=Developing+World+Bioethics+&volume=8&issue=3&date=2008-12&au=Di+Tillio-Gonzalez,+Dannie;+Fischbach,+Ruth+L.en
dc.identifier.urihttp://dx.doi.org/10.1111/dewb.2008.8.issue-3en
dc.identifier.urihttp://hdl.handle.net/10822/953960en
dc.description.abstractThis article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze - as an example - the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in the US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non-uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries.en
dc.formatArticleen
dc.languageenen
dc.sourceeweb:320563en
dc.subjectBiomedical Researchen
dc.subjectDeveloping Countriesen
dc.subjectFederal Governmenten
dc.subjectFinancial Supporten
dc.subjectGovernmenten
dc.subjectGuidelinesen
dc.subjectHospitalsen
dc.subjectInstitutional Review Boardsen
dc.subjectOrganizationsen
dc.subjectPrivate Hospitalsen
dc.subjectResearchen
dc.subjectResearch Institutesen
dc.subjectReviewen
dc.subjectStandardsen
dc.subjectUniversitiesen
dc.subject.classificationHuman Experimentation Policy Guidelines / Institutional Review Boardsen
dc.subject.classificationSocial Control of Human Experimentationen
dc.subject.classificationInternational and Political Dimensions of Biology and Medicineen
dc.titleHarmonizing Regulations for Biomedical Research: A Critical Analysis of the US and Venezuelan Systemsen
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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