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[Informed consent and the approval of evaluation committees in Mexican medical research]
1Unidad de Medicina Crítica, Hospital General de Zona No. 1 Dr. José Luis Avila Pardo, del IMSS en Aguascalientes, Ags., México.
Objective:
To establish the frequency of informed consent and review by institutional review boards in Mexican medical journals.
Design:
Retrospective review of prospective medical research published in seven Mexican medical journals between 1990-1993.
Measurements And Main Results:
391 prospective studies were analyzed: 259 (66%) were cross-sectional and 132 (34%) longitudinal; 197 (51%) descriptive and 194 (49%) comparative; 277 (71%) observational and 114 (29%) experimental. In general, the informed consent was reported in 123 studies (31%), and its institutional review board approval in 41 (10%). In the 114 experimental articles the informed consent was reported in 53 (46%) and the review board approval in 28 (25%).
Conclusions:
Most Mexican researchers do not report or do not obtain informed consent nor review board approval in the articles we reviewed. This suggests the presence of legal and ethical flaws which should be overcome.