Formas de Revisión Ética de Proyectos de Investigación Biomédica

• María Bernardita Portales ^[1] ; Patricio Michaud ^[3] ; Sofía P Salas ^[2] ; Juan Pablo Beca ^[1]
  1. [1] Universidad del Desarrollo

     Universidad del Desarrollo

     Santiago, Chile

     
  2. [2] Universidad Diego Portales

     Universidad Diego Portales

     Santiago, Chile

     
  3. [3] Hospital Sótero del Río Comité de Ética en Investigación

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• Localización: Revista Médica de Chile, ISSN-e 0034-9887, Vol. 145, Nº. 3, 2017, págs. 386-392
• Idioma: español
• Títulos paralelos:
  • Differentiated review of biomedical research projects by ethics committees
• Enlaces
  • Texto completo
• Resumen

  • Ten years after the approval of the Chilean bill that regulates scientific research in humans (Law Nº 20.120), and considering the current status of accreditation and training of many Research Ethics Committee (REC), it is necessary to analyze their performance. We analyzed the Chilean experience with REC aiming to propose a differential type of review, considering the risks to research participants. To improve the quality of the review and the efficiency of these committees, we propose to differentiate the revisions depending on the type of project, its methods and its risks. Initially, the types of review should be classified as exempt from review, expedited review and full review by the committee. In this proposal the type of review is confirmed or can be modified by a designated member of the committee after an initial review of the project. Thus, the deliberation and review times of the committee could be optimized avoiding delays in their revision.