Consentimiento informado en investigación clínica: revisión de la literatura 2012-2022
Resumen
El consentimiento informado implica una obligación legal del profesional sanitario previo al acto médico especialmente con respecto a procedimientos diagnósticos, terapéuticos, preventivos o quirúrgicos. En investigación clínica, involucra un proceso donde una persona decide de manera voluntaria su participación en una investigación. El propósito de este estudio fue realizar una revisión de literatura en relación con artículos primarios sobre consentimiento informado en investigación clínica publicados entre 2012 y 2022. Se realizó la revisión de estos artículos, cuyo objeto de estudio fuera el consentimiento informado en investigación clínica. Bases de datos consultadas: Pubmed, Embase, Proquest, Google Scholar y Web of Science, además de revistas especializadas. Las búsquedas se hicieron entre diciembre de 2022 y enero de 2023. Los resultados del proceso de búsqueda fueron 705 artículos y 55 cumplieron criterios de inclusión. La mayoría eran de carácter observacional y cualitativo (29,1%, respectivamente). El principal núcleo temático fue la comprensión. 94,5% estaban escritos en inglés (n = 52), y 5,5% en español (n=3). En conclusión, la comprensión de la información y el binomio información-comunicación constituyen componentes esenciales en el contexto de la investigación clínica. Como alternativa o complemento al consentimiento informado habitual se consolidan recursos multimedia como el video.
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