Revista Medica Herediana
ISSN 1018-130X versión impresa
LECCA GARCIA, Leonid, LLANOS-ZAVALAGA, Fernando y YGNACIO JORGE, Erika. Características de los Comités de Ética en Investigación del Perú autorizados para aprobar ensayos clínicos. Rev Med Hered, ene./mar. 2005, vol.16, no.1, p.3-10. ISSN 1018-130X.
Objective: To describe the composition and operation of the research ethics committees (CEI) that approves the ethical aspects of the clinical trials in Peru. Materials and methods: Cross-sectional study, that included Peruvian committees registered until March of 2004 in The Office Human for Research Protection (OHRP). A structured questionnaire was used, including questions over type of CEI (institutional or independent), year of registry in OHRP, members and administrative characteristics. The information was processed in software Stata 8.0 and calculated descriptive statistics. Results: Information was obtained from May to September of 2004. Of 19 CEI registered, 10 answered to the questionnaire. All fulfill the structure criteria (at least with 05 members, one of different sex, one external to the institution, and one nonscientist). 17 professions were identified, with a significant presence of physicians (34.0%). Only 68% participated in research ethics course’s in last two years. In addition, all the CEI have administrative dependency, although only 04/10 have exclusive personnel. 4/10 have meetings twice a month, 09/10 review any type of investigation, and 06/10 declare to have disapproved research proposals. The process of continuous revision consists of passive supervisions (written documents) and inspection, being limited due to: lack of human and financial resources, and support of the institution to which they are assigned. Conclusion: Although the Peruvian research ethics committes fulfill the structure requirements, the majority have deficiencies and problems for their operation, being necessary to establish the political that fortify the presence of these instances of protection of participants in research in Peru. (Rev Med Hered 2005;16:3-10).
Palabras llave: Research ethics committees; organization and administration; Ethical review; Clinical trials; Peru.
Universidad Peruana Cayetano Heredia
Facultad de Medicina "Alberto Hurtado"
Av. Honorio Delgado 430 Urb. Ingenieria, San Martin de Porres
Lima 100 - Peru