A comparative analysis of biomedical research ethics regulation systems in Europe and Latin America with regard to the protection of human subjects

• Published in: Journal of medical ethics Vol. 36; no. 12; pp. 750 - 753
• Main Authors: Lamas, Eugenia, Ferrer, Marcela, Molina, Alberto, Salinas, Rodrigo, Hevia, Adriana, Bota, Alexandre, Feinholz, Dafna, Fuchs, Michael, Schramm, Roland, Tealdi, Juan-Carlos, Zorrilla, Sergio
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group Ltd and Institute of Medical Ethics 01.12.2010; BMJ Publishing Group; BMJ Publishing Group LTD
• Subjects: 20th century; applied and professional ethics; Bioethics; Biomedical research; Biomedical Research - ethics; Biomedical Research - legislation & jurisprudence; Clinical medicine; Comparative analysis; Compliance; Countries; developing countries; Drug regulation; Economic regulation; Ethics; Ethics Committees, Research; ethics committees/consultation; Ethics, Research; Europe; Government Regulation; Human Experimentation - ethics; Human subjects; Humans; International agreements; International organizations; Latin America; Legislation; Medical research; Pharmaceutical industry; policy guidelines/institutional review boards/review committees; Public health; Qualitative comparative analysis; Regulation; Regulatory legislation; Research centers; Research ethics; research ethics committees; Research Subjects - legislation & jurisprudence; Europe; Latin America; Argentina; Brazil; Mexico; France; Chile; Germany; Spain
• ISSN: 0306-6800; 1473-4257; 1473-4257
• DOI: 10.1136/jme.2009.035097

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.