Towards objectivity in ethical assessment: legibility as part of informed consent form comprehension

Emma Verástegui, Departamento de Cuidados Paliativos, Instituto Nacional de Cancerología, Ciudad de México, México
Ricardo Páez, Programa de Maestría y Doctorado en Bioética, Universidad Nacional Autónoma de México, Ciudad de México, México
Oscar Arrieta, Dirección General, Instituto Nacional de Cancerología. Ciudad de México, México

Background: The experience on informed consent form (ICF) readability at the Research Ethics Committee of the National Institute of Cancerology of Mexico (INCan) is described. Objective: To evaluate the readability of a randomly-selected sample of ICFs submitted for review between March 1, 2022 and March 31, 2023. The number of pages, the time the reader takes to read the text and the level of education necessary to understand it were determined. Results: More than half the ICFs from internal investigations were shown to be somewhat or very difficult to read; the level of education required to understand them was up to 9.9 years, and the reading time was short. The ICF texts from international multicenter investigations were aimed at an average education level of 5.5 years and had normal readability. Most ICFs from external trials require a reading time of more than 60 minutes per ICF. Conclusion: It is necessary to have tools that provide objectivity to the evaluation of ICFs under investigation by ethics committees, which should be indicators of their comprehension, such as readability of the documents

Keywords: Bioethics. Comprehension. Informed consent. Research. Reading.