1480 lines
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1480 lines
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<li class="breadcrumb-item active is-active" aria-current="page"><em class="aou-text px-1">All of Us</em> cumple con los estándares de la FDA para entregar resultados de investigación científica de ADN a los participantes</li>
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<a aria-label="All of Us Meets FDA Standards to Deliver DNA Research Results to Participants" href="/news-events/research-highlights/allofus-meets-fda-standards-dna-results-delivery">Read in English</a>
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<time class="article-date es-date">6 September 2022</time>
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<h1 class="page-title">All of Us cumple con los estándares de la FDA para entregar resultados de investigación científica de ADN a los participantes</h1>
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<span><strong>Last Reviewed: </strong>September 6, 2022</span>
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<img src="/sites/default/files/FDA%20IDE%20New%20%28Spanish%29.png" width="1980" height="855" alt="La FDA revisa y prueba el proceso de All of Us para entregar resultados de ADN relacionados con la salud a los participantes”. Proceso: 'Cómo All of Us recibe y procesa las muestras de ADN', 'Cómo se identifican las variantes genéticas', 'Cómo se interpretan los datos genómicos' y 'Cómo reciben los participantes los informes relacionados con la salud'. Referencia: Venner E. et al. Genome Med. 2022;14(1):34." loading="lazy" typeof="foaf:Image" class="img-fluid" />
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<h2><strong>Puntos clave</strong></h2>
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<li><em>All of Us</em> recibió una exención de dispositivo de investigación de la FDA para entregar resultados de investigación científica de ADN relacionados con la salud a los participantes.</li>
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<li>Este proceso incluye cuatro pasos clave: secuenciar genomas completos, identificar variantes genéticas, interpretar información y crear informes para los participantes.</li>
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<p>El Programa Científico <em>All of Us </em>busca recolectar datos de salud, incluida información de ADN, de un millón de personas en los Estados Unidos.</p>
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<p>A cambio, el programa entregará <a href="https://www.joinallofus.org/es/learn-more/genomics-and-your-dna-results">resultados de ADN relacionados con la salud</a> en informes fáciles de leer para cada participante que los desee. Dado que el programa brindará esta información directamente a los participantes, <em>All of Us</em> trabajó con de la Administración de Alimentos y Medicamentos de los Estados Unidos (FDA, por sus siglas en inglés).</p>
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<p>En una edición reciente de <a href="https://pubmed.ncbi.nlm.nih.gov/35346344/"><em>Genome Medicine</em></a> (en inglés), los investigadores científicos de los centros genómicos de <em>All of Us </em>describen cómo recolectaron información para una exención de dispositivo de investigación científica. Una exención de dispositivo en investigación significa que <strong>hemos cumplido con los estándares de la FDA para devolver los resultados de investigación relacionados</strong> <strong>con la salud </strong>a nuestros participantes.</p>
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<h2>Por qué los informes de ADN necesitan una revisión de la FDA </h2>
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<p>Los informes de ADN relacionados con la salud de <em>All of Us</em> se basan en la secuenciación del genoma completo del ADN de los participantes. La secuenciación del genoma completo utiliza tecnología para observar casi todas las partes del ADN de una persona. Para crear estos informes, <em>All of Us</em> buscará un conjunto específico de variantes genéticas que se sabe que aumentan el riesgo de ciertas <a href="https://www.joinallofus.org/es/what-participants-receive/hereditary-disease-risk">enfermedades hereditarias</a> y otras variantes que pueden afectar <a href="https://www.joinallofus.org/es/what-participants-receive/medicine-and-your-dna">la forma en que nuestros cuerpos procesan ciertos medicamentos</a>.</p>
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<p><strong>Los informes de ADN relacionados con la salud de <em>All of Us</em> se consideran resultados de investigación científica</strong>, no una fuente de consejo o atención médica. Debido a que se entregarán directamente a los participantes, aún se requiere que estos informes cumplan con los estándares de la FDA. Cualquier hallazgo de estos informes de investigación científica debe ser confirmado con pruebas clínicas antes de que los participantes realicen cambios en su atención médica.</p>
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<h2>Verificación y validación del proceso de <em>All of Us</em></h2>
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<p>El equipo de investigación científica trabajó con la <a href="/about/who-we-are/institutional-review-board-irb-of-all-of-us-research-program ">Junta de Revisión Institucional de <em>All of Us</em></a> (en inglés) y la FDA durante más de un año y medio para crear y probar los procedimientos que se utilizarán para proporcionar resultados de ADN relacionados con la salud personalizados a los participantes. Los esfuerzos del equipo incluyeron conversaciones con la FDA sobre cada elemento importante del proceso del programa, incluidos:</p>
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<ul>
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<li>Consentimiento del participante</li>
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<li>Procesamiento de muestras</li>
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<li>Análisis e interpretación del ADN</li>
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<li>Entrega de resultados a los participantes</li>
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</ul>
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<p><strong><em>All of Us</em> usó más de 1,200 muestras de sangre </strong>para probar su proceso de devolución de resultados de ADN relacionados con la salud. Este proceso incluye cuatro pasos clave:</p>
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<ul>
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<li>Secuenciación de genomas completos</li>
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<li>Identificación de variantes genéticas</li>
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<li>Interpretación de datos</li>
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<li>Diseño y generación de informes de los participantes</li>
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</ul>
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<p>Los resultados mostraron que los centros genómicos de <em>All of Us</em> reprodujeron coherentemente sus propios resultados. Los centros también se desempeñaron de manera acorde en todos los sitios. Estos hallazgos mostraron a la FDA que <strong>el programa puede entregar resultados consistentes a los participantes</strong>, independientemente del centro de genómico de <em>All of Us</em> que secuenció su muestra.</p>
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<p>La evaluación también mostró que los <strong>métodos de <em>All of Us</em> superaron el 99 % cuando se midió precisión y exactitud</strong>. <em>Precisión</em> significa que los métodos mostraron la misma variante de ADN en el mismo lugar cada vez que fue secuenciada<em>. Exactitud</em> significa que los métodos leyeron el ADN sin errores. La precisión y la exactitud son esenciales para garantizar que los resultados de ADN de cada participante sean informados correctamente.</p>
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<p>Pocos programas de investigación científica han detallado el proceso de pasar por una revisión de la FDA como esta. El equipo de <em>All of Us</em> publicó este artículo para compartir su experiencia con otros investigadores científicos que deseen entregar resultados a los participantes en el futuro.</p>
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<p>Además de compartir los resultados con los participantes, <em>All of Us</em> pone información de ADN a disposición de los investigadores científicos para sus estudios. Obtenga más información sobre la plataforma de datos del programa, el <a href="https://www.researchallofus.org/data-tools/workbench/">Taller Digital de Investigación Científica</a> (en inglés).</p>
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Realice investigaciones científicas con All of Us
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<li>Aprenda sobre las <strong><a href="/get-involved/opportunities-researchers">oportunidades para los investigadores</a></strong> (en inglés). </li>
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<li>Encuentre <strong><a href="/funding-and-program-partners/funding-opportunities/nih-funding-opportunities-researchers">fondos</a></strong> (en inglés) para financiar investigaciones científicas que usen datos e información de <em>All of Us</em>. </li>
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<li>Vea más <strong><a href="https://www.researchallofus.org/research-projects-directory/">proyectos de investigación científica que son posibles gracias a la información y las herramientas de <em><em><em>All of Us</em></em></em></a></strong><em> </em>(en inglés).</li>
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<img src="/sites/default/files/AoU_Photo_Miami12_WEB8_900X900_2.jpg" width="900" height="900" alt="Un participante de investigación científica proporciona una muestra de sangre" loading="lazy" typeof="foaf:Image" class="img-fluid" />
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<a href="/news-events/announcements/el-programa-cientifico-all-us-de-los-nih-entrega-los-participantes-los-resultados-geneticos-relacionados-con-la-salud" class="title_link">
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<p class="p card-title gtm-card">
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El Programa Científico <em class="aou-text">All of Us</em> de los NIH entrega a los participantes los resultados genéticos relacionados con la salud
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</p>
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</a>
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