[Independent ethics committees for clinical research in Argentina. An evaluation and a system to guarantee their independence].
The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT) requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the assumed autonomy of the former can be reduced to merely a relationship of "service provider-customer". The Institutional Review Board of the Mar del Plata s Community Hospital has evaluated, between 2005 and 2006, thirty three research protocols (with their corresponding information sheets for patients and informed consent forms) previously approved by a non-institutional Independent Ethics Committee. The median number of objections made by the Institutional Review Board, which prompted the previously mentioned protocols to be modified in order to be approved, was of three per protocol. In other words, the accreditation of an Independent Ethics Committee requires a system that guarantees actual independence from the sponsors and/or researchers, as well as management control mechanisms that may lead them into an eventual loss of accreditation. Several measures are proposed in order to correct the deficiencies of the present system.
Gonorazky
Sergio E
SE
Departamento de Investigación, Consejo Institucional de Revisión de Estudios de Investigación, Hospital Privado de Comunidad, Mar del Plata, Argentina. segonora@ciudad.com.ar
D001118:Argentina; D002986:Clinical Trials as Topic / Q000941:ethics* / Q000331:legislation & jurisprudence; D016265:Conflict of Interest / Q000331:legislation & jurisprudence; D004345:Drug Industry / Q000941:ethics; D026724:Ethical Review; D028744:Ethics Committees, Research / Q000941:ethics / Q000331:legislation & jurisprudence / Q000592:standards*; D006805:Human Experimentation / Q000941:ethics* / Q000331:legislation & jurisprudence; D006801:Humans; D007258:Informed Consent / Q000941:ethics; D010344:Patient Advocacy / Q000941:ethics