<?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>2594-2166</journal-id>
<journal-title><![CDATA[Medicina y ética]]></journal-title>
<abbrev-journal-title><![CDATA[Med. ética]]></abbrev-journal-title>
<issn>2594-2166</issn>
<publisher>
<publisher-name><![CDATA[Universidad Anáhuac México, Facultad de Bioética]]></publisher-name>
</publisher>
</journal-meta>
<article-meta>
<article-id>S2594-21662019000200605</article-id>
<title-group>
<article-title xml:lang="es"><![CDATA[Aspectos éticos del consentimiento informado en la investigación translacional/clínica y sobre el sesgo o prejuicio en los ensayos clínicos]]></article-title>
<article-title xml:lang="en"><![CDATA[Ethical issues concerning informed consent in translational/clinical research and vaccination bias and informed consent]]></article-title>
</title-group>
<contrib-group>
<contrib contrib-type="author">
<name>
<surname><![CDATA[García Gómez]]></surname>
<given-names><![CDATA[Alberto]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Garasic]]></surname>
<given-names><![CDATA[Mirko Daniel]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
<contrib contrib-type="author">
<name>
<surname><![CDATA[Cubillo Díaz-Valdés]]></surname>
<given-names><![CDATA[María]]></given-names>
</name>
<xref ref-type="aff" rid="Aff"/>
</contrib>
</contrib-group>
<aff id="Af1">
<institution><![CDATA[,UNESCO Chair in Bioethics and Human Rights  ]]></institution>
<addr-line><![CDATA[Rome ]]></addr-line>
<country>Italy</country>
</aff>
<aff id="Af2">
<institution><![CDATA[,GSK  ]]></institution>
<addr-line><![CDATA[Madrid ]]></addr-line>
<country>Spain</country>
</aff>
<pub-date pub-type="pub">
<day>00</day>
<month>06</month>
<year>2019</year>
</pub-date>
<pub-date pub-type="epub">
<day>00</day>
<month>06</month>
<year>2019</year>
</pub-date>
<volume>30</volume>
<numero>2</numero>
<fpage>605</fpage>
<lpage>635</lpage>
<copyright-statement/>
<copyright-year/>
<self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_arttext&amp;pid=S2594-21662019000200605&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_abstract&amp;pid=S2594-21662019000200605&amp;lng=en&amp;nrm=iso"></self-uri><self-uri xlink:href="http://www.scielo.org.mx/scielo.php?script=sci_pdf&amp;pid=S2594-21662019000200605&amp;lng=en&amp;nrm=iso"></self-uri><abstract abstract-type="short" xml:lang="es"><p><![CDATA[Resumen Mejorar la educación en salud de los pacientes en relación con las prácticas médicas y la investigación es esencial para defender el principio del respeto a la autonomía, es decir, respetar la capacidad del paciente para tomar decisiones autónomas con respecto a las intervenciones médicas o a la participación en la investigación que refleje las creencias y valores del paciente. Este artículo considera los desafíos del consentimiento informado (es decir, brechas éticas, barreras y necesidades prioritarias) que son exclusivos de ciertos grupos vulnerables, como preadolescentes, adolescentes y mujeres embarazadas, con un énfasis específico en cómo deben tomarse en cuenta las variables neurobioéticas, multiculturales e interreligiosas para valorar la idoneidad de los documentos actuales que se basan en la noción de consentimiento informado. Al explorar cómo hemos de mejorar el proceso de obtención del consentimiento informado, este artículo presta especial atención a la relevancia del sesgo y la privacidad en el debate, sugiriendo nuevas formas de intervención para reducir los efectos del sesgo o prejuicio implícito.]]></p></abstract>
<abstract abstract-type="short" xml:lang="en"><p><![CDATA[Abstract Improving the health literacy of patients in relation to medical practices and research is essential for upholding the principle of respect for autonomy-that is, respecting the patient&#8217;s ability to make self-governed choices regarding medical interventions or research participation that reflects the patient&#8217;s beliefs and values. This paper considers the challenges of informed consent (i.e. ethical gaps, barriers, and priority needs) that are unique to certain vulnerable groups, namely preadolescents, adolescents, and pregnant women, with a specific emphasis on how neurobioethical, multicultural and interreligious variables should be taken into account when assessing the appropriateness of the current documents relying on the notion of informed consent. In exploring how we are to improve the process of obtaining informed consent, this contribution pays particular attention to the relevance of bias and privacy in the debate, suggesting new ways of intervening so to reduce the effects of implicit bias.]]></p></abstract>
<kwd-group>
<kwd lng="es"><![CDATA[Autonomía]]></kwd>
<kwd lng="es"><![CDATA[Sesgo]]></kwd>
<kwd lng="es"><![CDATA[Prejuicio]]></kwd>
<kwd lng="es"><![CDATA[Bioética]]></kwd>
<kwd lng="es"><![CDATA[Competencia]]></kwd>
<kwd lng="es"><![CDATA[Consentimiento informado]]></kwd>
<kwd lng="es"><![CDATA[Vacunación]]></kwd>
<kwd lng="en"><![CDATA[Autonomy]]></kwd>
<kwd lng="en"><![CDATA[Bias]]></kwd>
<kwd lng="en"><![CDATA[Bioethics]]></kwd>
<kwd lng="en"><![CDATA[Competence]]></kwd>
<kwd lng="en"><![CDATA[Informed consent]]></kwd>
<kwd lng="en"><![CDATA[Vaccination]]></kwd>
</kwd-group>
</article-meta>
</front><back>
<ref-list>
<ref id="B1">
<label>1.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Bester]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
<name>
<surname><![CDATA[Cole]]></surname>
<given-names><![CDATA[CM]]></given-names>
</name>
<name>
<surname><![CDATA[Kodish]]></surname>
<given-names><![CDATA[E.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[The Limits of Informed Consent for an Overwhelmed Patient: Clinicians&#8217; Role in Protecting Patients and Preventing Overwhelm]]></article-title>
<source><![CDATA[AMA journal of ethics]]></source>
<year>2016</year>
<volume>18</volume>
<numero>9</numero>
<issue>9</issue>
<page-range>869</page-range></nlm-citation>
</ref>
<ref id="B2">
<label>2.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Blair]]></surname>
<given-names><![CDATA[IV]]></given-names>
</name>
<name>
<surname><![CDATA[Steiner]]></surname>
<given-names><![CDATA[JF]]></given-names>
</name>
<name>
<surname><![CDATA[Havranek]]></surname>
<given-names><![CDATA[EP.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Unconscious (implicit) bias and health disparities: where do we go from here?]]></article-title>
<source><![CDATA[The Permanente Journal]]></source>
<year>2011</year>
<volume>15</volume>
<numero>2</numero>
<issue>2</issue>
<page-range>71</page-range></nlm-citation>
</ref>
<ref id="B3">
<label>3.</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Cooper]]></surname>
<given-names><![CDATA[L.]]></given-names>
</name>
</person-group>
<source><![CDATA[Overcoming Healthcare Disparities: The role of patient-centeredcare-College of Public Health and Health Professions celebrating 50 years]]></source>
<year>2008</year>
<publisher-loc><![CDATA[Gainesville ]]></publisher-loc>
<publisher-name><![CDATA[University of Florida]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B4">
<label>4.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Durant]]></surname>
<given-names><![CDATA[RW]]></given-names>
</name>
<name>
<surname><![CDATA[Wenzel]]></surname>
<given-names><![CDATA[JA]]></given-names>
</name>
<name>
<surname><![CDATA[Scarinci]]></surname>
<given-names><![CDATA[IC]]></given-names>
</name>
<name>
<surname><![CDATA[Paterniti]]></surname>
<given-names><![CDATA[DA]]></given-names>
</name>
<name>
<surname><![CDATA[Fouad]]></surname>
<given-names><![CDATA[MN]]></given-names>
</name>
<name>
<surname><![CDATA[Hurd]]></surname>
<given-names><![CDATA[TC]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Perspectives on barriers and facilitators to minority recruitment for clinical trials among cancer center leaders, investigators, research staff, and referring clinicians: enhancing minority participation in clinical trials (EMPaCT)]]></article-title>
<source><![CDATA[Cancer]]></source>
<year>2014</year>
<volume>120</volume>
<numero>^s7</numero>
<issue>^s7</issue>
<supplement>7</supplement>
<page-range>1097-105</page-range></nlm-citation>
</ref>
<ref id="B5">
<label>5.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[FitzGerald]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[Hurst]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Implicit bias in healthcare professionals: a systematicreview]]></article-title>
<source><![CDATA[BMC medical ethics]]></source>
<year>2017</year>
<volume>18</volume>
<numero>1</numero>
<issue>1</issue>
<page-range>19</page-range></nlm-citation>
</ref>
<ref id="B6">
<label>6.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Garasic]]></surname>
<given-names><![CDATA[MD.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[The Singleton case: enforcing medical treatment to put a personto death]]></article-title>
<source><![CDATA[Med Health Care and Philos.]]></source>
<year>2013</year>
<volume>16</volume>
<numero>4</numero>
<issue>4</issue>
<page-range>795</page-range></nlm-citation>
</ref>
<ref id="B7">
<label>7.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Gorini]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Mazzocco]]></surname>
<given-names><![CDATA[K]]></given-names>
</name>
<name>
<surname><![CDATA[Pravettoni]]></surname>
<given-names><![CDATA[G.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Decision-Making Process Related to Participation in Phase I Clinical Trials: A Nonsystematic Review of the Existing Evidence]]></article-title>
<source><![CDATA[Public health genomics]]></source>
<year>2015</year>
<volume>18</volume>
<numero>6</numero>
<issue>6</issue>
<page-range>359-65</page-range></nlm-citation>
</ref>
<ref id="B8">
<label>8.</label><nlm-citation citation-type="">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Hamilton]]></surname>
<given-names><![CDATA[DL]]></given-names>
</name>
<name>
<surname><![CDATA[Trolier]]></surname>
<given-names><![CDATA[TK.]]></given-names>
</name>
</person-group>
<source><![CDATA[Stereotypes and stereotyping: An overview of the cognitive approach]]></source>
<year>1986</year>
</nlm-citation>
</ref>
<ref id="B9">
<label>9.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Hardicre]]></surname>
<given-names><![CDATA[J.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Valid informed consent in research: An introduction]]></article-title>
<source><![CDATA[British Journal of Nursing]]></source>
<year>2014</year>
<volume>23</volume>
<numero>11</numero>
<issue>11</issue>
<page-range>564-7</page-range></nlm-citation>
</ref>
<ref id="B10">
<label>10.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[John-Henderson]]></surname>
<given-names><![CDATA[NA.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Implicit Cognition]]></article-title>
<source><![CDATA[Child and Adolescent Psychiatric Clinics]]></source>
<year>2015</year>
<volume>24</volume>
<numero>4</numero>
<issue>4</issue>
<page-range>751-63</page-range></nlm-citation>
</ref>
<ref id="B11">
<label>11.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[McCabe]]></surname>
<given-names><![CDATA[MS]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[The ethical foundation of informed consent in clinical research]]></article-title>
<source><![CDATA[Seminars in oncology nursing]]></source>
<year>1999</year>
<publisher-name><![CDATA[Elsevier]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B12">
<label>12.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Newington]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Metcalfe]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Factors influencing recruitment to research: qualitative study of the experiences and perceptions of research teams]]></article-title>
<source><![CDATA[BMC medical research methodology]]></source>
<year>2014</year>
<volume>14</volume>
<numero>1</numero>
<issue>1</issue>
<page-range>10</page-range></nlm-citation>
</ref>
<ref id="B13">
<label>13.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[O&#8217;Brien]]></surname>
<given-names><![CDATA[RL]]></given-names>
</name>
<name>
<surname><![CDATA[Kosoko-Lasaki]]></surname>
<given-names><![CDATA[O]]></given-names>
</name>
<name>
<surname><![CDATA[Cook]]></surname>
<given-names><![CDATA[CT]]></given-names>
</name>
<name>
<surname><![CDATA[Kissell]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
<name>
<surname><![CDATA[Peak]]></surname>
<given-names><![CDATA[F]]></given-names>
</name>
<name>
<surname><![CDATA[Williams]]></surname>
<given-names><![CDATA[EH.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Self-assessment of cultural attitudes and competence of clinical investigators to enhance recruitment and participation of minority populations in research]]></article-title>
<source><![CDATA[Journal of the National Medical Association]]></source>
<year>2006</year>
<volume>98</volume>
<numero>5</numero>
<issue>5</issue>
<page-range>674</page-range></nlm-citation>
</ref>
<ref id="B14">
<label>14.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Ross]]></surname>
<given-names><![CDATA[S]]></given-names>
</name>
<name>
<surname><![CDATA[Grant]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Counsell]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[Gillespie]]></surname>
<given-names><![CDATA[W]]></given-names>
</name>
<name>
<surname><![CDATA[Russell]]></surname>
<given-names><![CDATA[I]]></given-names>
</name>
<name>
<surname><![CDATA[Prescott]]></surname>
<given-names><![CDATA[R.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Barriers to participation in randomised controlled trials: a systematic review]]></article-title>
<source><![CDATA[Journal of clinical epidemiology]]></source>
<year>1999</year>
<volume>52</volume>
<numero>12</numero>
<issue>12</issue>
<page-range>1143-56</page-range></nlm-citation>
</ref>
<ref id="B15">
<label>15.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Sabin]]></surname>
<given-names><![CDATA[DJA]]></given-names>
</name>
<name>
<surname><![CDATA[Nosek]]></surname>
<given-names><![CDATA[DBA]]></given-names>
</name>
<name>
<surname><![CDATA[Greenwald]]></surname>
<given-names><![CDATA[DAG]]></given-names>
</name>
<name>
<surname><![CDATA[Rivara]]></surname>
<given-names><![CDATA[DFP]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Physicians&#8217; implicit and explicit attitudes about race by MD race, ethnicity, and gender]]></article-title>
<source><![CDATA[Journal of Health Care for the Poor and Underserved]]></source>
<year>2009</year>
<volume>20</volume>
<numero>3</numero>
<issue>3</issue>
<page-range>896</page-range></nlm-citation>
</ref>
<ref id="B16">
<label>16.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Sheikh]]></surname>
<given-names><![CDATA[A]]></given-names>
</name>
<name>
<surname><![CDATA[Halani]]></surname>
<given-names><![CDATA[L]]></given-names>
</name>
<name>
<surname><![CDATA[Bhopal]]></surname>
<given-names><![CDATA[R]]></given-names>
</name>
<name>
<surname><![CDATA[Netuveli]]></surname>
<given-names><![CDATA[G]]></given-names>
</name>
<name>
<surname><![CDATA[Partridge]]></surname>
<given-names><![CDATA[MR]]></given-names>
</name>
<name>
<surname><![CDATA[Car]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Facilitating the recruitment of minority ethnic people into research: qualitative case study of South Asians and asthma]]></article-title>
<source><![CDATA[PLoS Med.]]></source>
<year>2009</year>
<volume>6</volume>
<numero>10</numero>
<issue>10</issue>
</nlm-citation>
</ref>
<ref id="B17">
<label>17.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Steinberg]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Disclosure of information and informed consent: ethical and practical considerations]]></article-title>
<source><![CDATA[Journal of child neurology]]></source>
<year>2009</year>
<volume>24</volume>
<numero>12</numero>
<issue>12</issue>
<page-range>1568-71</page-range></nlm-citation>
</ref>
<ref id="B18">
<label>18.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Stone]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
<name>
<surname><![CDATA[Moskowitz]]></surname>
<given-names><![CDATA[GB.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Nonconscious bias in medical decision making: what can be done to reduce it?]]></article-title>
<source><![CDATA[Medical education]]></source>
<year>2011</year>
<volume>45</volume>
<numero>8</numero>
<issue>8</issue>
<page-range>768-76</page-range></nlm-citation>
</ref>
<ref id="B19">
<label>19.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Tam]]></surname>
<given-names><![CDATA[NT]]></given-names>
</name>
<name>
<surname><![CDATA[Huy]]></surname>
<given-names><![CDATA[NT]]></given-names>
</name>
<name>
<surname><![CDATA[Thoa]]></surname>
<given-names><![CDATA[LTB]]></given-names>
</name>
<name>
<surname><![CDATA[Long]]></surname>
<given-names><![CDATA[NP]]></given-names>
</name>
<name>
<surname><![CDATA[Trang]]></surname>
<given-names><![CDATA[NTH]]></given-names>
</name>
<name>
<surname><![CDATA[Hirayama]]></surname>
<given-names><![CDATA[K]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Participants&#8217; understanding of informed consent in clinical trials over three decades: systematic review and meta-analysis]]></article-title>
<source><![CDATA[Bulletin of the World Health Organization]]></source>
<year>2015</year>
<volume>93</volume>
<numero>3</numero>
<issue>3</issue>
<page-range>186-98H</page-range></nlm-citation>
</ref>
<ref id="B20">
<label>20.</label><nlm-citation citation-type="book">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Tham]]></surname>
<given-names><![CDATA[J]]></given-names>
</name>
<name>
<surname><![CDATA[Durante]]></surname>
<given-names><![CDATA[C]]></given-names>
</name>
<name>
<surname><![CDATA[García]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
</person-group>
<source><![CDATA[Religious Perspectives on Social Responsibility in Health]]></source>
<year>2018</year>
<publisher-name><![CDATA[Springer]]></publisher-name>
</nlm-citation>
</ref>
<ref id="B21">
<label>21.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Van Ryn]]></surname>
<given-names><![CDATA[M]]></given-names>
</name>
<name>
<surname><![CDATA[Saha]]></surname>
<given-names><![CDATA[S.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Exploring unconscious bias in disparities research and medical education]]></article-title>
<source><![CDATA[Jama]]></source>
<year>2011</year>
<volume>306</volume>
<numero>9</numero>
<issue>9</issue>
<page-range>995-6</page-range></nlm-citation>
</ref>
<ref id="B22">
<label>22.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Walsh]]></surname>
<given-names><![CDATA[E]]></given-names>
</name>
<name>
<surname><![CDATA[Sheridan]]></surname>
<given-names><![CDATA[A.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Factors affecting patient participation in clinical trials in Ireland: A narrative review]]></article-title>
<source><![CDATA[Contemporary Clinical Trials Communications]]></source>
<year>2016</year>
<volume>3</volume>
<page-range>23-31</page-range></nlm-citation>
</ref>
<ref id="B23">
<label>23.</label><nlm-citation citation-type="journal">
<person-group person-group-type="author">
<name>
<surname><![CDATA[Williamson]]></surname>
<given-names><![CDATA[T.]]></given-names>
</name>
</person-group>
<article-title xml:lang=""><![CDATA[Research, informed consent, and the limits of disclosure]]></article-title>
<source><![CDATA[Bioethics]]></source>
<year>2001</year>
<volume>15</volume>
<numero>4</numero>
<issue>4</issue>
<page-range>341-63</page-range></nlm-citation>
</ref>
</ref-list>
</back>
</article>
