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Latin American and European systems of ethics regulation of biomedical research: comparative analysis of their pertinence and application for human subjects protection

Objective

In the 20th century medical research developed systematic procedures for the evaluation of medical products. These procedures imply the testing of drugs on human subjects. After WWII, instruments were discussed to ensure appropriate protection of humans in this context. Since the revision of the Declaration of Helsinki in 1975 the advice of research ethics committees is a central requirement worldwide. Nevertheless their national legal background, membership, institutional affiliation, training of their mem bers and the awareness of their work are very heterogeneous worldwide. EULABOR is the first network ever between Europe and Latin-America in this area. It aims to evaluate the systems of ethics regulation of biomedical research involving human subjects and tissues, considering their pertinence and consequences in the context of socio-economic conditions and cultures in Argentina, Brazil, Chile, Mexico, Uruguay, France, Germany and Spain. The ultimate objective is to propose new perspectives to deal with eth ical issues of biomedical research. The dialogue and mutual understanding guarantee transparency in global research and in the ethical reviews will ensure common standards while respecting the different cultural backgrounds. EULABOR will propose training p rograms for different audiences to give them some insight in the ethical dimension of research. Moreover, it will discuss tools to improve the awareness of the public and stakeholders on ethical issues, taking into account the differences between Northern and Southern countries. The strengthening of ethics regulations systems will allow the populations to benefit from medical research by attracting clinical research fulfilling international requirements, and answering crucial public health issues. Finally, by achieving what they set out to do, EULABOR's partners and Advisory Board may improve the respect of patients' rights in health care in developing countries which would fit with EDCTP #'

Call for proposal

FP6-2004-SCIENCE-AND-SOCIETY-9
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Funding Scheme

SSA - Specific Support Action

Coordinator

INSTITUT NATIONAL DE LA SANTÉ ET DE LA RECHERCHE MÉDICALE
Address
Rue De Tolbiac, 101
Paris
France

Participants (6)

EPSON FOUNDATION - INSTITUTE OF TECHNOETHICS
Spain
Address
C. Gran De Gracia, 140, Pral. 2A
Barcelona
UNIVERSIDAD DE SANTIAGO DE CHILE
Chile
Address
Alameda3363
Santiago
SECRETARIA DE SALUD
Mexico
Address
Periferico Sur 4118 - Colonia Jardines Del Pedregal - Delegacion Alvaro Obregon
Mexico D.f.
BIO&SUR - ASOCIACIÓN CIVIL HOSPITAL DE CLÍNICAS DE LA UNIVERSIDAD DE BUENOS AIRES
Argentina
Address
Av. Cordoba N° 2351 - Piso (Bioética)
Buenos Aires
FUNDAÇÃO OSWALDO CRUZ
Brazil
Address
Av. Brazil 4365 - Manguinhos
Rio De Janeiro
INSTITUT FÜR WISSENSCHAFT UND ETHIK E.V.
Germany
Address
Bonner Talweg 57
Bonn