title: A comparative analysis of biomedical research ethics regulation systems in Europe and Latin America with regard to the protection of human subjects.
abstract: 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 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.
authors.affiliation: INSERM, 101 rue de Tolbiac, 75654 Paris Cedex 13, France. eugenia.lamas@inserm.fr
authors.forename: Eugenia
authors.initials: E
authors.lastname: Lamas
authors.forename: Marcela
authors.initials: M
authors.lastname: Ferrer
authors.forename: Alberto
authors.initials: A
authors.lastname: Molina
authors.forename: Rodrigo
authors.initials: R
authors.lastname: Salinas
authors.forename: Adriana
authors.initials: A
authors.lastname: Hevia
authors.forename: Alexandre
authors.initials: A
authors.lastname: Bota
authors.forename: Dafna
authors.initials: D
authors.lastname: Feinholz
authors.forename: Michael
authors.initials: M
authors.lastname: Fuchs
authors.forename: Roland
authors.initials: R
authors.lastname: Schramm
authors.forename: Juan-Carlos
authors.initials: JC
authors.lastname: Tealdi
authors.forename: Sergio
authors.initials: S
authors.lastname: Zorrilla
mesh_terms: D001675:Bioethics; D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research; D032984:Ethics, Research; D005060:Europe; D033161:Government Regulation; D006805:Human Experimentation / Q000941:ethics*; D006801:Humans; D007843:Latin America; D035842:Research Subjects / Q000331:legislation & jurisprudence