<?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>0123-3122</journal-id>
<journal-title><![CDATA[Persona y Bioética]]></journal-title>
<abbrev-journal-title><![CDATA[pers.bioét.]]></abbrev-journal-title>
<issn>0123-3122</issn>
<publisher>
<publisher-name><![CDATA[Universidad de la Sabana]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S0123-31222016000200232</article-id>
<article-id pub-id-type="doi">10.5294/PEBI.2016.20.2.8</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[CONSENTIMIENTO INFORMADO EN INVESTIGACIÓN CLÍNICA: UN PROCESO DINÁMICO]]></article-title>
<article-title xml:lang="en"><![CDATA[INFORMED CONSENT IN CLINICAL RESEARCH: A DYNAMIC PROCESS]]></article-title>
<article-title xml:lang="pt"><![CDATA[CONSENTIMENTO INFORMADO EM PESQUISA CLÍNICA: UM PROCESSO DINÂMICO]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Carreño-Dueñas]]></surname>
<given-names><![CDATA[José Alexander]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,Instituto Nacional de Cancerología  ]]></institution>
<addr-line><![CDATA[ ]]></addr-line>
<country>Colombia</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>07</month>
<year>2016</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>07</month>
<year>2016</year>
</pub-date>
<volume>20</volume>
<numero>2</numero>
<fpage>232</fpage>
<lpage>243</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_arttext&amp;pid=S0123-31222016000200232&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_abstract&amp;pid=S0123-31222016000200232&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.co/scielo.php?script=sci_pdf&amp;pid=S0123-31222016000200232&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen En investigación clínica, el consentimiento informado es un documento legal y un mecanismo para respetar la dignidad y proteger los derechos y el bienestar de los sujetos participantes; debe incluir información sobre el propósito de la investigación, la justificación, los riesgos y beneficios, que le permitan a un sujeto decidir voluntariamente su participación. Como es deber del investigador velar por la protección de la vida, la salud, la dignidad, la integridad, el derecho a la autodeterminación, la intimidad y la confidencialidad de los sujetos que enrole en un estudio, tiene que establecer un diálogo permanente con estos para valorar los riesgos y la seguridad de la participación; esta condición se convierte en un proceso dinámico que no comienza ni termina únicamente con la firma del documento, y que no solamente debe trascender la legalidad, sino acercarse a la ética y la legitimidad.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract In clinical research, informed consent is both a legal document and mechanism for respecting the dignity of participating subjects and protecting their rights and wellbeing. It should include information on the purpose of the research, its justification, and the risks and the benefits involved, so as to enable a subject to decide to participate voluntarily. Because it is the researcher's duty to ensure protection of the life, health, dignity, integrity, right to self-determination, privacy and confidentiality of the subjects who take part in a study, the researcher must establish a permanent dialogue with them to assess the risks and safety inherent in their participation. This condition becomes a dynamic process that neither begins nor ends when informed consent is signed. It goes beyond legality and becomes a question of ethics and legitimacy.]]></p></abstract>
<abstract abstract-type="short" xml:lang="pt"><p><![CDATA[Resumo Em pesquisa clínica, o consentimento informado é um documento legal e um mecanismo para respeitar a dignidade e proteger os direitos e o bem-estar dos sujeitos participantes; deve incluir informação sobre o propósito da pesquisa, a justificativa, os riscos e benefícios, que permitam a um sujeito decidir voluntariamente sua participação. Como é dever do pesquisador velar pela proteção da vida, da saúde, da dignidade, da integridade, do direito à autodeterminação, da intimidade e da confidencialidade dos sujeitos que se envolvam num estudo, tem que estabelecer um diálogo permanente com estes para valorizar os riscos e a segurança da participação; essa condição torna-se um processo dinâmico que não começa nem termina unicamente com a assinatura do documento, e que não somente deve transcender a legalidade, mas, sim, se aproximar à ética e à legitimidade.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[consentimiento informado]]></kwd>
<kwd lng="es"><![CDATA[sujetos de investigación]]></kwd>
<kwd lng="es"><![CDATA[experimentación humana]]></kwd>
<kwd lng="es"><![CDATA[ensayos clínicos controlados]]></kwd>
<kwd lng="es"><![CDATA[investigación biomédica]]></kwd>
<kwd lng="en"><![CDATA[Informed consent]]></kwd>
<kwd lng="en"><![CDATA[research subjects]]></kwd>
<kwd lng="en"><![CDATA[human experimentation]]></kwd>
<kwd lng="en"><![CDATA[controlled clinical trials]]></kwd>
<kwd lng="en"><![CDATA[biomedical]]></kwd>
<kwd lng="pt"><![CDATA[consentimento informado]]></kwd>
<kwd lng="pt"><![CDATA[sujeitos de pesquisa]]></kwd>
<kwd lng="pt"><![CDATA[experimentação humana]]></kwd>
<kwd lng="pt"><![CDATA[ensaios clínicos controlados]]></kwd>
<kwd lng="pt"><![CDATA[pesquisa biomédica]]></kwd>
</kwd-group>
</article-meta>
</front><back>
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