<?xml version="1.0" encoding="ISO-8859-1"?><article xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
<front>
<journal-meta>
<journal-id>0016-3813</journal-id>
<journal-title><![CDATA[Gaceta médica de México]]></journal-title>
<abbrev-journal-title><![CDATA[Gac. Méd. Méx]]></abbrev-journal-title>
<issn>0016-3813</issn>
<publisher>
<publisher-name><![CDATA[Academia Nacional de Medicina de México A.C.]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0016-38132023000500439</article-id>
<article-id pub-id-type="doi">10.24875/gmm.23000256</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Hacia la objetividad en la valoración ética: legibilidad como parte de la comprensión de los formatos de consentimiento informado]]></article-title>
<article-title xml:lang="en"><![CDATA[Towards objectivity in ethical assessment: legibility as part of informed consent form comprehension]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Verástegui]]></surname>
<given-names><![CDATA[Emma]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Páez]]></surname>
<given-names><![CDATA[Ricardo]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Arrieta]]></surname>
<given-names><![CDATA[Oscar]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Instituto Nacional de Cancerología Departamento de Cuidados Paliativos ]]></institution>
<addr-line><![CDATA[ Ciudad de México]]></addr-line>
<country>México</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,Universidad Nacional Autónoma de México Programa de Maestría y Doctorado en Bioética ]]></institution>
<addr-line><![CDATA[ Ciudad de México]]></addr-line>
<country>México</country>
</aff>
<aff id="Af3">
<institution><![CDATA[,Instituto Nacional de Cancerología Dirección General ]]></institution>
<addr-line><![CDATA[ Ciudad de México]]></addr-line>
<country>México</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>10</month>
<year>2023</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>10</month>
<year>2023</year>
</pub-date>
<volume>159</volume>
<numero>5</numero>
<fpage>439</fpage>
<lpage>444</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_arttext&amp;pid=S0016-38132023000500439&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_abstract&amp;pid=S0016-38132023000500439&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_pdf&amp;pid=S0016-38132023000500439&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen  Antecedentes: Se describe la experiencia sobre la legibilidad de los formatos de consentimiento informado (FCI) del Comité de Ética en Investigación del Instituto Nacional de Cancerología de México.  Objetivo: Evaluar la legibilidad de una muestra seleccionada aleatoriamente de FCI sometidos para revisión entre el 1 de marzo de 2022 y el 31 de marzo de 2023. Se determinó el número de páginas, el tiempo que el lector invierte para leer el texto y el grado de escolaridad necesario para comprenderlo.  Resultados: Más de la mitad de FCI de investigaciones internas mostraron ser algo o muy difíciles de leer, la escolaridad necesaria para comprenderlos fue hasta de 9.9 años y el tiempo de lectura fue corto. Los textos de los FCI de investigaciones internacionales multicéntricas estuvieron dirigidos a un nivel escolar promedio de 5.5 años y tuvieron una legibilidad normal. La mayor parte de los ensayos externos requiere un tiempo de lectura superior a los 60 minutos por FCI.  Conclusión: Es necesario disponer de herramientas que den objetividad a la evaluación de los FCI en investigación por parte de los comités de ética y sean indicadores de su comprensión, tales como la legibilidad de los documentos.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract  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.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Bioética]]></kwd>
<kwd lng="es"><![CDATA[Comprensión]]></kwd>
<kwd lng="es"><![CDATA[Consentimiento informado]]></kwd>
<kwd lng="es"><![CDATA[Investigación. Lectura]]></kwd>
<kwd lng="en"><![CDATA[Bioethics]]></kwd>
<kwd lng="en"><![CDATA[Comprehension]]></kwd>
<kwd lng="en"><![CDATA[Informed consent]]></kwd>
<kwd lng="en"><![CDATA[Research. Reading]]></kwd>
</kwd-group>
</article-meta>
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