<?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>0034-7450</journal-id>
<journal-title><![CDATA[Revista Colombiana de Psiquiatría]]></journal-title>
<abbrev-journal-title><![CDATA[rev.colomb.psiquiatr.]]></abbrev-journal-title>
<issn>0034-7450</issn>
<publisher>
<publisher-name><![CDATA[Asociacion Colombiana de Psiquiatria.]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0034-74502021000100057</article-id>
<article-id pub-id-type="doi">10.1016/j.rcp.2018.10.005</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[¿Qué lineamientos bioéticos y biojurídicos se deben seguir al realizar pruebas farmacogenéticas y farmacogenómicas en ensayos clínicos de psiquiatría en Colombia para proteger los datos genéticos y los derechos de los sujetos de investigación?]]></article-title>
<article-title xml:lang="en"><![CDATA[Which bioethical and bio-legal guidelines should be followed when performing pharmacogenetic and pharmacogenomic tests in psychiatry clinical trials in Colombia, to protect genetic data and the rights of research subjects?]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Pacheco Padrón]]></surname>
<given-names><![CDATA[Ana Patricia]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Ramos Gil]]></surname>
<given-names><![CDATA[Felicia Daelé]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,E.S.E. Hospital Mental de Antioquia  ]]></institution>
<addr-line><![CDATA[Bello ]]></addr-line>
<country>Colombia</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>03</month>
<year>2021</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>03</month>
<year>2021</year>
</pub-date>
<volume>50</volume>
<numero>1</numero>
<fpage>57</fpage>
<lpage>63</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_arttext&amp;pid=S0034-74502021000100057&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_abstract&amp;pid=S0034-74502021000100057&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_pdf&amp;pid=S0034-74502021000100057&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[RESUMEN El presente artículo es el resultado de una investigación, desde las perspectivas bioética y biojurídica, acerca de los lineamientos existentes en Colombia para el manejo de las pruebas farmacogenómicas y farmacogenéticas en los ensayos clínicos. La revisión de la legislación existente en nuestro medio se comparó con estándares internacionales y los propuestos por organismos supranacionales. Se encontró que en Colombia falta una regulación específica en esta área, lo que expone a una serie de riesgos bioéticos y jurídicos a los participantes e investigadores. No se deben subestimar estos riesgos, pues comprometen la viabilidad ética de la investigación clínica y básica en nuestro medio. Al final, desde la perspectiva de la ética de los principios, se proponen una serie de acciones para la creación y la promoción a escala nacional de lineamientos que sirvan para conformar una legislación aplicable a la protección de los datos genéticos y, por ende, los derechos de los sujetos que participan en esta clase de estudios de investigación en Colombia.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[ABSTRACT This paper is the result of research, from the bioethics and bio-legal perspectives, on the existing guidelines in Colombia for the handling of pharmacogenomic and pharmacogenetic tests in clinical trials. Colombian legislation on this kind of research was reviewed and then compared with international and supranational standards. It was found that Colombia lacks specific legislation in this area, a situation that puts both participants and researchers at risk, from bioethical and legal perspectives. These risks should not be underestimated, as they compromise the ethical viability of clinical and basic research in our setting. In the end, a proposal, based on principles of ethics is made, proposing a series of actions for the creation and promotion nationwide of guidelines which can be used to shape legislation to be applied to protect the genetic data and the rights of subjects participating in these types of research studies in Colombia.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Farmacogenómica]]></kwd>
<kwd lng="es"><![CDATA[Ensayos clínicos]]></kwd>
<kwd lng="es"><![CDATA[Psiquiatría]]></kwd>
<kwd lng="es"><![CDATA[Datos genéticos]]></kwd>
<kwd lng="en"><![CDATA[Pharmacogenomics]]></kwd>
<kwd lng="en"><![CDATA[Clinical trials]]></kwd>
<kwd lng="en"><![CDATA[Psychiatry]]></kwd>
<kwd lng="en"><![CDATA[Genetic data]]></kwd>
</kwd-group>
</article-meta>
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