was read the article
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"documento" => "article" "subdocumento" => "sco" "cita" => "Med Clin. 2015;144:465-9" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 110 "formatos" => array:2 [ "HTML" => 94 "PDF" => 16 ] ] "es" => array:11 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Artículo especial</span>" "titulo" => "Almacenamiento de muestras humanas aptas para investigación: autonomía y datos genéticos" "tienePdf" => "es" "tieneTextoCompleto" => "es" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "465" "paginaFinal" => "469" ] ] "titulosAlternativos" => array:1 [ "en" => array:1 [ "titulo" => "Storage of human samples for research: Autonomy and genomic data" ] ] "contieneTextoCompleto" => array:1 [ "es" => true ] "contienePdf" => array:1 [ "es" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0005" "etiqueta" => "Figura 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2153 "Ancho" => 2936 "Tamanyo" => 355248 ] ] "descripcion" => array:1 [ "es" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Régimen de utilización de muestras previsto en el Real Decreto 1716/2011.</p> <p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">CEExt biobanco: Comité Ético Externo de los Biobancos; CEI: Comité Ético de Investigación.</p> <p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Fuente: García del Pozo et al.<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">9</span></a></p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "M. Concepción Martín-Arribas, Emma Fernández-de Uzquiano, Leyre de Sola Perea, Javier Arias-Díaz" "autores" => array:4 [ 0 => array:2 [ "nombre" => "M. Concepción" "apellidos" => "Martín-Arribas" ] 1 => array:2 [ "nombre" => "Emma" "apellidos" => "Fernández-de Uzquiano" ] 2 => array:2 [ "nombre" => "Leyre" "apellidos" => "de Sola Perea" ] 3 => array:2 [ "nombre" => "Javier" "apellidos" => "Arias-Díaz" ] ] ] ] ] "idiomaDefecto" => "es" "Traduccion" => array:1 [ "en" => array:9 [ "pii" => "S2387020615003034" "doi" => "10.1016/j.medcle.2015.12.038" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2387020615003034?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0025775314007465?idApp=UINPBA00004N" "url" => "/00257753/0000014400000010/v2_201505051026/S0025775314007465/v2_201505051026/es/main.assets" ] ] "itemSiguiente" => array:19 [ "pii" => "S2387020615002831" "issn" => "23870206" "doi" => "10.1016/j.medcle.2015.12.018" "estado" => "S300" "fechaPublicacion" => "2015-05-21" "aid" => "3170" "copyright" => "Elsevier España, S.L.U." "documento" => "simple-article" "crossmark" => 1 "subdocumento" => "crp" "cita" => "Med Clin. 2015;144:470-4" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 63 "formatos" => array:2 [ "HTML" => 59 "PDF" => 4 ] ] "en" => array:11 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Diagnosis and treatment</span>" "titulo" => "Large gastric folds: Differential diagnosis" "tienePdf" => "en" "tieneTextoCompleto" => "en" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "470" "paginaFinal" => "474" ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Pliegues gástricos engrosados: diagnóstico diferencial" ] ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 773 "Ancho" => 995 "Tamanyo" => 106297 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Gastric subepithelial lesion covered by normal-looking mucosa. The ecoendoscopy-guided biopsy helped diagnose a gastrointestinal stromal tumour.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Ana García García de Paredes, Javier Martínez González, Laura Crespo Pérez" "autores" => array:3 [ 0 => array:2 [ "nombre" => "Ana" "apellidos" => "García García de Paredes" ] 1 => array:2 [ "nombre" => "Javier" "apellidos" => "Martínez González" ] 2 => array:2 [ "nombre" => "Laura" "apellidos" => "Crespo Pérez" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S0025775314008215" "doi" => "10.1016/j.medcli.2014.11.007" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0025775314008215?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2387020615002831?idApp=UINPBA00004N" "url" => "/23870206/0000014400000010/v1_201601310051/S2387020615002831/v1_201601310051/en/main.assets" ] "itemAnterior" => array:19 [ "pii" => "S2387020615002673" "issn" => "23870206" "doi" => "10.1016/j.medcle.2015.12.014" "estado" => "S300" "fechaPublicacion" => "2015-05-21" "aid" => "2958" "copyright" => "Elsevier España, S.L.U." "documento" => "article" "crossmark" => 1 "subdocumento" => "rev" "cita" => "Med Clin. 2015;144:457-64" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 68 "formatos" => array:2 [ "HTML" => 55 "PDF" => 13 ] ] "en" => array:13 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Review</span>" "titulo" => "Neuroepigenetics: Desoxyribonucleic acid methylation in Alzheimer's disease and other dementias" "tienePdf" => "en" "tieneTextoCompleto" => "en" "tieneResumen" => array:2 [ 0 => "en" 1 => "es" ] "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "457" "paginaFinal" => "464" ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Neuroepigenética: metilación del ADN en la enfermedad de Alzheimer y otras demencias" ] ] "contieneResumen" => array:2 [ "en" => true "es" => true ] "contieneTextoCompleto" => array:1 [ "en" => true ] "contienePdf" => array:1 [ "en" => true ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:7 [ "identificador" => "fig0010" "etiqueta" => "Fig. 2" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr2.jpeg" "Alto" => 1258 "Ancho" => 2085 "Tamanyo" => 143267 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">DNA methylation potential. The figure presents a simplified diagram of the metabolic pathway for DNA methylation and methylation potential (SAM/SAH ratio). Both SAM and 5-MTHF are central donors of methyl groups in this process.</p> <p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">DNMT: DNA methyltransferase; SAM: S-adenosylmethionine; SAH: S-adenosylhomocysteine; THF: tetrahydrofolate; 5-MTHF: 5-methylenetetrahydrofolate.</p>" ] ] ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "Maite Mendioroz Iriarte, Laura Pulido Fontes, Iván Méndez-López" "autores" => array:3 [ 0 => array:2 [ "nombre" => "Maite" "apellidos" => "Mendioroz Iriarte" ] 1 => array:2 [ "nombre" => "Laura" "apellidos" => "Pulido Fontes" ] 2 => array:2 [ "nombre" => "Iván" "apellidos" => "Méndez-López" ] ] ] ] ] "idiomaDefecto" => "en" "Traduccion" => array:1 [ "es" => array:9 [ "pii" => "S0025775314002693" "doi" => "10.1016/j.medcli.2014.03.023" "estado" => "S300" "subdocumento" => "" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:1 [ "total" => 0 ] "idiomaDefecto" => "es" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S0025775314002693?idApp=UINPBA00004N" ] ] "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2387020615002673?idApp=UINPBA00004N" "url" => "/23870206/0000014400000010/v1_201601310051/S2387020615002673/v1_201601310051/en/main.assets" ] "en" => array:17 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Special article</span>" "titulo" => "Storage of human samples for research: Autonomy and genomic data" "tieneTextoCompleto" => true "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "465" "paginaFinal" => "469" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "M. Concepción Martín-Arribas, Emma Fernández-de Uzquiano, Leyre de Sola Perea, Javier Arias-Díaz" "autores" => array:4 [ 0 => array:4 [ "nombre" => "M. Concepción" "apellidos" => "Martín-Arribas" "email" => array:1 [ 0 => "comartin@isciii.es" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Emma" "apellidos" => "Fernández-de Uzquiano" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] ] ] 2 => array:3 [ "nombre" => "Leyre" "apellidos" => "de Sola Perea" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] ] ] 3 => array:3 [ "nombre" => "Javier" "apellidos" => "Arias-Díaz" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">d</span>" "identificador" => "aff0020" ] ] ] ] "afiliaciones" => array:4 [ 0 => array:3 [ "entidad" => "Comité de Ética de la Investigación y Bienestar Animal, Instituto de Salud Carlos III, Madrid, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Comité Ético de Investigación Clínica, Hospital Universitario La Paz, Madrid, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Instituto de Salud Carlos III, Madrid, Spain" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Departamento de Cirugía, Universidad Complutense de Madrid, Madrid, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Almacenamiento de muestras humanas aptas para investigación: autonomía y datos genéticos" ] ] "resumenGrafico" => array:2 [ "original" => 0 "multimedia" => array:8 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "fuente" => "<span class="elsevierStyleItalic">Source</span>: García del Pozo et al.<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">9</span></a>" "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2010 "Ancho" => 2936 "Tamanyo" => 333362 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Sample usage system established by Royal Decree 1716/2011. Biobank CEExt: Biobank External Ethics Committee; REC: Research Ethics Committee.</p>" ] ] ] "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">The collection of human biological material and associated data, storage practices and use of samples are considered key processes in biomedical research due to the opportunities that they offer as a source of information, particularly in genetic research. However, the extraction and use of biological samples also entails potential conflicts or ethical issues that concern the people from whom they originate, the healthcare professionals who handle them, the researchers, and society in general.</p><p id="par0010" class="elsevierStylePara elsevierViewall">The main moral concerns posed by the use of biological samples for research relate to obtaining consent, protecting confidentiality and the way in which results or incidental findings that are of interest to the participant or their family members are handled.<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">1</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The values to promote in human research could be summed up as showing respect for the participant's dignity and autonomy (principle of autonomy) and seeking health benefits for society, together with the moral obligation to maximise the potential benefits and minimise potential damage (beneficence and non-maleficence), as well as distributing fairly the risks and costs, on the one hand, and benefits on the other hand (justice). Likewise, we must not forget the legal principle in a regulated activity such as clinical research.</p><p id="par0020" class="elsevierStylePara elsevierViewall">All this has led to the development of a number of important guidelines and regulations related to obtaining, storing and using human biological samples. In Spain, following the law on Biomedical Research (14/2007 dated 3 July; <span class="elsevierStyleItalic">Ley 14/2007 de 3 de julio, de Investigación Biomédica</span> [LIB]),<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">2</span></a> and the Royal Decree (RD) on biobanks<a class="elsevierStyleCrossRef" href="#bib0105"><span class="elsevierStyleSup">3</span></a> (1716/2011 dated 18 November), a regulatory framework on this matter was developed in compliance with guidelines from the Council of Europe.<a class="elsevierStyleCrossRef" href="#bib0110"><span class="elsevierStyleSup">4</span></a> In the present study, we seek to address through the analysis of a single case some of the situations that both researchers and Research Ethics Committees (RECs) more frequently face from the ethical and legal points of view.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Objectives</span><p id="par0025" class="elsevierStylePara elsevierViewall">The objectives for the analysis of this clinical case are to set forth the issues that researchers and RECs more frequently face when addressing studies that involve genetic analyses and to propose some solutions to facilitate the decision-making process.</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0015">Case presentation</span><p id="par0030" class="elsevierStylePara elsevierViewall">In this article we will tackle the ethical assessment of a research proposal in which biological samples from minors will be used. The analysis will focus on the description of facts and values in conflict, the investigation of possible courses of action, and the identification of the optimal way forward<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">5</span></a> in relation to 3 specific aspects: the collection and use of samples, research on minors, and the handling of genetic data.</p><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0020">Relevant facts</span><p id="par0035" class="elsevierStylePara elsevierViewall">The researcher wishes to use samples collected from previous projects in a new research study. These are stored in a registered collection, along with samples donated by other colleagues. It is unknown whether the samples were obtained with consent for their storage and use in research, or if they are coded (reversibly dissociated), or anonymous. Additionally, the researcher contemplates collecting new samples and, to this effect, she is going to request the parents’ consent to use the remainder of the biological samples obtained for diagnosis for research purposes. The researcher informed the parents that genetic analysis would be performed, the results of which could be of interest to other family members. The disease under investigation emerges in very young children whose survival can range from months to a few years.</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Values in conflict</span><p id="par0040" class="elsevierStylePara elsevierViewall">In the use of biological samples obtained for diagnostic purposes or from previous research projects, when there is no consent for future use, the conflict lies between the need to respect the autonomy and intimacy of the participants and the need to obtain scientifically valid results.</p><p id="par0045" class="elsevierStylePara elsevierViewall">If, additionally, samples are taken from minors, then the people involved in the research project must especially take into account the need to justify the importance of the knowledge and the way the samples have been obtained.</p><p id="par0050" class="elsevierStylePara elsevierViewall">Genetic analyses particularly affect the right to information, in as much as people have the right to know or not to know, as well as the right to autonomy and confidentiality. The parents’ right not to know (autonomy) could be maleficent to third parties if the information obtained from the analysis were to be the source of useful genetic advice for family planning.</p></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Legal aspects</span><p id="par0055" class="elsevierStylePara elsevierViewall">The REC must verify not only the ethical aspects but also the legal aspects and, in its deliberations, it must make sure that its resolutions comply with the regulations in force, which in this sense could be considered as “minimal ethics.”</p><p id="par0060" class="elsevierStylePara elsevierViewall">Spain's LIB establishes that to take biological samples and perform genetic analyses, the participant must be informed and their express written consent must be obtained. If the participant is a minor, then it is mandatory to inform them about the terms of use of the samples so that they can exercise their rights in due course.</p><p id="par0065" class="elsevierStylePara elsevierViewall">Likewise, research using biological samples and data is subject to protection under Spain's Organic Law 15/1999 on the Protection of Personal Data (<span class="elsevierStyleItalic">Ley Orgánica 15/1999, de Protección de Datos de Carácter Personal</span>),<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">6</span></a> and RD 1720/2007, which regulates its implementation.<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">7</span></a></p><p id="par0070" class="elsevierStylePara elsevierViewall">However, to ensure that the circulation of samples is limited to a context that preserves the protection of due guarantees, RD 1716/2011 states that the donation of samples should be conducted under a certified contract or agreement between the parties.</p><p id="par0075" class="elsevierStylePara elsevierViewall">Likewise, it is envisaged that the conditions under which biological samples are collected from minors for biomedical research purposes should be subject to additional guarantees, such as the vital importance of obtaining relevant knowledge about the disease in order to understand it, mitigate it or cure it. And, that the aforementioned knowledge cannot be obtained by other means (within the adult population), and that the minor's guardians give their consent. The natural guardians of a minor are the minor's parents. This constitutes part of their parental authority, which is the set of rights and duties that the law grants them with respect to their children.<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">8</span></a> It should be remembered that when the research does not involve invasive procedures (additional to those required for diagnosis), it is not necessary to notify the Public Prosecutor.</p><p id="par0080" class="elsevierStylePara elsevierViewall">Regarding the collection and use of samples in this case, certain facts need to be taken into consideration since they pose several ethical issues.</p><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Is it right to undertake research using samples—initially obtained for diagnostic purposes—without the participant's consent to use them for research?</span><p id="par0085" class="elsevierStylePara elsevierViewall">Respecting people's autonomy and privacy compels us to obtain and use samples for research purposes that are to be stored anonymously or coded in collections or biobanks after having obtained previous written consent from the participant, once they have received the relevant information. As in other countries, Spanish regulations establish the minimum information that the participant should receive in the process of obtaining consent (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>).</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0090" class="elsevierStylePara elsevierViewall">This issue, affecting the autonomy (lack of consent for research purposes) and maleficence principles (risk of the misuse of information and breach of confidentiality) is resolved in the LIB and RD on biobanks which define it as an exceptional situation when pursuing a potential common benefit (benefits arising from the research).</p><p id="par0095" class="elsevierStylePara elsevierViewall">In the case we are dealing with, samples from groups A and B (<a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a>) could come from diagnostic remains or from previous projects, which researchers had kept. In group A (samples collected prior to LIB), the REC must verify whether overall consent to conduct research was obtained, which would be common with samples from previous projects and rare with samples left over following diagnostic tests. In the absence of consent for research, the REC could demand proof that a reasonable effort had been made to obtain it, although it could consider classifying the situation as of an exceptional nature, permitted under the LIB as a second transitory provision. In group B, the REC should ask for the signed consent and verify whether storage and subsequent use for research in the study was authorised. In the absence of signed consent, it must be applied for. If this is not possible, or if it represents a clearly unreasonable effort, and as an exception, then the REC could propose the samples be anonymised or assess whether they can be used without consent but in an identifiable manner, provided that the requirements of RD 1716/2011, article 24, are met.</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia></span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Can samples in collections be transferred to other researchers without express consent?</span><p id="par0100" class="elsevierStylePara elsevierViewall">We must not forget that in many hospital services, and particularly in Anatomical Pathology, there are significant numbers of samples which have been gathered for diagnostic purposes and that, once their objective has been fulfilled, are potentially useful for research.</p><p id="par0105" class="elsevierStylePara elsevierViewall">The use of these remains, or of samples obtained during previous research projects, in new research without any kind of consent would be an extreme course of action. The other extreme would be to decide to wholly respect autonomy and require informed consent for each donation or use of a sample other than for the study for which consent was initially required. RD 1716/2011 clearly distinguishes only three options for the use of human samples for biomedical research purposes: specific projects, collections and biobanks<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">9</span></a> (<a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a>).</p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0110" class="elsevierStylePara elsevierViewall">In the case in question, the researcher has chosen the collection option to manage the samples that she stores. The RD describes a collection of human biological samples is an “organised set, intended to be permanent […] preserved outside of the organisational sphere of a biobank.” A collection is established through an authorised research project, the main researcher of which is responsible for its safe-keeping and use. The use of these samples is limited to the line or type of specific research anticipated in the initial consent document. In this context, the researcher's collections cannot be transferred to third parties, nor can she have access to samples from other collections, unless she again obtains consent to this effect. This does not mean that the researcher responsible for the collection cannot cooperate with other researchers, who could have access to the samples within the context of the specific study. We should distinguish between this situation and that of a donation since the researcher responsible for the collection continues to be the person who protects the samples throughout the research.</p><p id="par0115" class="elsevierStylePara elsevierViewall">Therefore, to answer the question, the REC should assess the timeframe within which they were collected (before or after the LIB was passed) and the features of the informed consent document that the donor signed (storage approval, the type of research for which they can be used, or potential limitations for their use). Furthermore, the REC should verify whether the collection is registered with the National Registry of Biobanks, but they must take into account that this does not imply that the requirements for obtaining the samples were adequately met since the researcher is the person who registers the collection, without any supervision, rather than samples being stored at an approved biobank.</p><p id="par0120" class="elsevierStylePara elsevierViewall">Lastly, samples added to a biobank could be used in any biomedical research, provided that the participant or, if appropriate, their guardians have given their consent to these terms. <a class="elsevierStyleCrossRef" href="#fig0005">Fig. 1</a> shows the characteristics for each of the purposes in the collection of samples.</p><p id="par0125" class="elsevierStylePara elsevierViewall">The REC could assess whether the samples that constitute collections fulfil the minimum requirements to be stored in a biobank system and, in that case, suggest that the researcher store them under this system to facilitate the assessment of future projects for which their use is proposed. Likewise, if the researcher is requested to obtain a new consent document, the corresponding form could include this option.</p><p id="par0130" class="elsevierStylePara elsevierViewall">Since the samples belong to minors, the case could pose other ethical issues:</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">What is the best way to inform and obtain informed consent when sample donors are minors? Is the risk reasonable? Is the purpose of the research to improve the well-being of the paediatric population?</span><p id="par0135" class="elsevierStylePara elsevierViewall">The protection of vulnerable population groups, such as the paediatric population, has been a matter of special concern to people involved in research.<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">10</span></a> The interest in minimising risks and the prospective damage that they could cause has been a source of concern in the field of biomedicine for decades and it still inspires numerous debates and procedural guidelines.<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">11</span></a></p><p id="par0140" class="elsevierStylePara elsevierViewall">In the case in question, the source individuals are minors and their guardians must give their consent to the use of the samples for research purposes. Although minors are required to be involved in decision-making, it would not apply in this case, since these are very young children.</p><p id="par0145" class="elsevierStylePara elsevierViewall">The higher the level of vulnerability of the population subject to study, the lower the level of admissible research risks.<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">12</span></a> The LIB states that when research is not expected to generate direct benefits for the individual's health, as may happen in this case, it must involve minimal risks and inconveniences to the participant. In the study analysed, the collection of samples does not pose any additional risks for the participants, since the biological samples that will be used for biomedical research purposes were already obtained for health care reasons.</p><p id="par0150" class="elsevierStylePara elsevierViewall">In addition, the purpose of the research is to improve the well-being of the paediatric population. Moreover, the disease under study only affects the paediatric population and, therefore, knowledge could not be obtained by other means.</p><p id="par0155" class="elsevierStylePara elsevierViewall">Although it does not apply in the case in question, an issue that arises in relation to incorporating biological samples from minors in biobanks has to do with the guarantees that they have to be able to exert their rights (voluntary participation, right to information) when they reach the age of consent. RD 1716/2011 envisages that the minor should be informed about the terms of use of samples as a requisite assumption so they can exercise their rights in due course. In this regard, the task of the researcher or of the person in charge of the biobank is to convey this information to the guardians and to the minor as well, considering their level of maturity, where appropriate.<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">13</span></a></p><p id="par0160" class="elsevierStylePara elsevierViewall">With respect to the biobank's obligation to re-contact minors when they have reached the age of consent and their samples are to be transferred for study purposes, discrepancies exist among RECs, although in general they agree that an effort must be made to obtain the minor's consent when they are old enough to give it. There are currently different opinions and more than one law against these cautionary measures. There is a lack of clarity on this matter. However, some positions are becoming clear; for instance, section 3.2 of the Centre of Genomics and Policy's <span class="elsevierStyleItalic">Best Practices for Health Research Involving Children and Adolescents</span><a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">14</span></a> states that researchers should seek the consent of the minor according to their level of development and capacity. When the child is legally capable of providing fully informed consent or if they attain the legal age of consent during the research, researchers should seek informed consent.</p><p id="par0165" class="elsevierStylePara elsevierViewall">On the other hand, article 14.4 of the Council of Europe's consultation paper <span class="elsevierStyleItalic">Working document on research on biological materials of human origin</span><a class="elsevierStyleCrossRef" href="#bib0165"><span class="elsevierStyleSup">15</span></a> states: When a person not able to give consent, from whom biological samples have been collected for purposes other than for storage for future research, attains the age of consent, the consent of that person for continued storage and research use of their biological materials should be sought.</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">How should genetic information obtained as a result of research be handled? What has the researcher anticipated in connection with the genetic data?</span><p id="par0170" class="elsevierStylePara elsevierViewall">The researcher has some moral duties and obligations to fulfil (<a class="elsevierStyleCrossRef" href="#tbl0015">Table 3</a>) and the REC must verify that the required measures to protect the rights of the participants are being taken within the research, in particular<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">2</span></a>:<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">a.</span><p id="par0175" class="elsevierStylePara elsevierViewall">The right to receive information prior to tests being conducted.</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">b.</span><p id="par0180" class="elsevierStylePara elsevierViewall">The right to give express, specific consent for genetic analysis to be carried out.</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">c.</span><p id="par0185" class="elsevierStylePara elsevierViewall">The right to information and the right not to know, as well as the right to know the boundaries of confidentiality in connection with family interests.</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">d.</span><p id="par0190" class="elsevierStylePara elsevierViewall">The right to be ensured confidentiality and the protection of genetic data.</p></li><li class="elsevierStyleListItem" id="lsti0025"><span class="elsevierStyleLabel">e.</span><p id="par0195" class="elsevierStylePara elsevierViewall">The right to receive genetic advice.</p></li></ul></p><elsevierMultimedia ident="tbl0015"></elsevierMultimedia><p id="par0200" class="elsevierStylePara elsevierViewall">Regarding the right to receive information prior to tests being conducted, parents should be informed about:<ul class="elsevierStyleList" id="lis0010"><li class="elsevierStyleListItem" id="lsti0030"><span class="elsevierStyleLabel">a.</span><p id="par0205" class="elsevierStylePara elsevierViewall">The purpose of the genetic analysis for which they are giving their consent.</p></li><li class="elsevierStyleListItem" id="lsti0035"><span class="elsevierStyleLabel">b.</span><p id="par0210" class="elsevierStylePara elsevierViewall">The location where the analysis will take place and the subsequent destination of the biological sample following analysis.</p></li><li class="elsevierStyleListItem" id="lsti0040"><span class="elsevierStyleLabel">c.</span><p id="par0215" class="elsevierStylePara elsevierViewall">The people who will have access to the results of the analysis when these will not be subject to dissociation or anonymisation procedures.</p></li><li class="elsevierStyleListItem" id="lsti0045"><span class="elsevierStyleLabel">d.</span><p id="par0220" class="elsevierStylePara elsevierViewall">The possibility of unexpected findings and their potential significance to them, as well as their right to determine if they wish to receive this information or not.</p></li><li class="elsevierStyleListItem" id="lsti0050"><span class="elsevierStyleLabel">e.</span><p id="par0225" class="elsevierStylePara elsevierViewall">The consequences that the information obtained may have on family members and the advantages of their sharing this information with family members.</p></li><li class="elsevierStyleListItem" id="lsti0055"><span class="elsevierStyleLabel">f.</span><p id="par0230" class="elsevierStylePara elsevierViewall">The commitment to offer genetic advice once the results of the analysis have been obtained and assessed.</p></li></ul></p><p id="par0235" class="elsevierStylePara elsevierViewall">With respect to the right to information and the right not to know, parents will be informed about the genetic data of a private nature obtained through the genetic analysis according to their wishes.</p><p id="par0240" class="elsevierStylePara elsevierViewall">They could exert their right not to be informed about the results of a genetic analysis. In this case, the regulations take into account the possibility of providing the necessary information for follow-up treatment. The researcher must ensure that the parents understand that if this information is crucial to avoiding serious harm to the health of biological family members, then the benefits of revealing essential data to avoid harm would be explained to them.</p><p id="par0245" class="elsevierStylePara elsevierViewall">Another issue involves what should be done with the information that parents do not want to know about. Some authors think that this information should be destroyed, stored in their medical history or delivered to the patient in a sealed envelope. These last two options contemplate the possibility of discussing the information in the future.<a class="elsevierStyleCrossRef" href="#bib0170"><span class="elsevierStyleSup">16</span></a></p><p id="par0250" class="elsevierStylePara elsevierViewall">As for the right to be sure of confidentiality, the staff who have access to genetic data while carrying out their work will be obliged to maintain permanent secrecy. Only with the express written consent of the person from whom the data was collected can genetic information of a private nature be revealed to third parties.</p><p id="par0255" class="elsevierStylePara elsevierViewall">If it is not possible to publish the results of any research without identifying the participants, then these results will only be published having obtained specific consent.</p><p id="par0260" class="elsevierStylePara elsevierViewall">If the genomic data obtained were of such interest that it might be shared via national or international genomic research networks, then the researcher will make sure that these structures are regulated by a code of conduct that follows accepted ethical standards,<a class="elsevierStyleCrossRef" href="#bib0175"><span class="elsevierStyleSup">17</span></a> providing that the requirements of local laws are met.</p><p id="par0265" class="elsevierStylePara elsevierViewall">Parents must be guaranteed access to adequate genetic advice should they wish to seek it. During the genetic advice process, it is essential to explain the implications of genetic tests, the limitations of their reliability, taking into consideration that the results have been obtained within a research setting, and the limitations regarding their potential predictive capacity. Likewise, they should be informed about the potential consequences for the biological family and their reproductive options.<a class="elsevierStyleCrossRef" href="#bib0180"><span class="elsevierStyleSup">18</span></a></p></span></span></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Conflict of interest</span><p id="par0270" class="elsevierStylePara elsevierViewall">The authors declare that there are no conflicts of interest.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:5 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Introduction" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Objectives" ] 2 => array:3 [ "identificador" => "sec0015" "titulo" => "Case presentation" "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0020" "titulo" => "Relevant facts" ] 1 => array:2 [ "identificador" => "sec0025" "titulo" => "Values in conflict" ] 2 => array:3 [ "identificador" => "sec0030" "titulo" => "Legal aspects" "secciones" => array:4 [ 0 => array:2 [ "identificador" => "sec0035" "titulo" => "Is it right to undertake research using samples—initially obtained for diagnostic purposes—without the participant's consent to use them for research?" ] 1 => array:2 [ "identificador" => "sec0040" "titulo" => "Can samples in collections be transferred to other researchers without express consent?" ] 2 => array:2 [ "identificador" => "sec0045" "titulo" => "What is the best way to inform and obtain informed consent when sample donors are minors? Is the risk reasonable? Is the purpose of the research to improve the well-being of the paediatric population?" ] 3 => array:2 [ "identificador" => "sec0050" "titulo" => "How should genetic information obtained as a result of research be handled? What has the researcher anticipated in connection with the genetic data?" ] ] ] ] ] 3 => array:2 [ "identificador" => "sec0055" "titulo" => "Conflict of interest" ] 4 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2014-08-18" "fechaAceptado" => "2014-09-25" "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Martín-Arribas MC, Fernández-de Uzquiano E, de Sola Perea L, Arias-Díaz J. Almacenamiento de muestras humanas aptas para investigación: autonomía y datos genéticos. Med Clin (Barc). 2015;144:465–469.</p>" ] ] "multimedia" => array:4 [ 0 => array:8 [ "identificador" => "fig0005" "etiqueta" => "Fig. 1" "tipo" => "MULTIMEDIAFIGURA" "mostrarFloat" => true "mostrarDisplay" => false "fuente" => "<span class="elsevierStyleItalic">Source</span>: García del Pozo et al.<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">9</span></a>" "figura" => array:1 [ 0 => array:4 [ "imagen" => "gr1.jpeg" "Alto" => 2010 "Ancho" => 2936 "Tamanyo" => 333362 ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Sample usage system established by Royal Decree 1716/2011. Biobank CEExt: Biobank External Ethics Committee; REC: Research Ethics Committee.</p>" ] ] 1 => array:7 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:1 [ "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Description of the research project or lines of research for which consent is given \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Identity of the person in charge of the research \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Instruction that the donated sample is to be used only within the scope of a: project, collection, biobank \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Instruction that the participant will have at their disposal all the information relating to the research projects in which the sample will be used \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Expected benefits arising from the research project or the biobank \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Potential issues associated with the donation and the collection of the sample \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Location where the analysis will take place and ultimate destination of the sample \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Guarantees for the protection of confidentiality \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">ARCO rights: right to data access, consent rectification, cancellation and objection, full or partial \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Possibility of including some restriction on the use of samples \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Waiver of any right of an economic nature. Nevertheless, there could be financial compensation for the trouble and other inconveniences that may derive from participation in the study \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">That, in the case of a prospective biobank closure, the information about the destination of the samples will be at their disposal in the National Registry of Biobanks \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab983059.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Minimum information to obtain informed consent in this case.</p>" ] ] 2 => array:7 [ "identificador" => "tbl0010" "etiqueta" => "Table 2" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:2 [ "leyenda" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">LIB: Law on biomedical research; LOPD: Organic Law on the Protection of Personal Data.</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">Carmen P. J., MD, is a neuropaediatrician who wants to conduct a research project on a mitochondrial disease that affects very young children and which emerges with acute symptoms initially and has a variable survival rate that fluctuates between months and a few years. The purpose of the project is to detect the genes that cause the disease to be able to have a better understanding of it \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">To this effect, it is proposed to take three types of samples from patients who were diagnosed with the disease under study: \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>a. Samples collected <span class="elsevierStyleItalic">before</span> the passing of the LIB in 2007, from patients who already have a diagnosis, and which the researcher has registered in the Collection Section of the National registry of biobanks (Collection No. 000) \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>b. Samples from patients collected for diagnostic purposes <span class="elsevierStyleItalic">after</span> the LIB came into force \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>c. Samples from collections in the care of other researchers \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>d. New samples that she will prospectively collect for this study. In the case of recently-added samples, which were taken for diagnostic purposes, informed consent will be requested to use the remains for research purposes \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">The researcher has prepared an information sheet for the parents. In the document, she informs them about the objectives of the study and the research team that will perform it; that no direct benefits to their child's health are expected, although in the future, the results from the genetic analyses could be of interest to offer genetic advice to families and to understand the mechanisms associated with the disease, as well as to develop treatments for these patients \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">She also notified them that the samples would be coded on extraction and that she guarantees data confidentiality according to the provisions of the Spanish Organic Law on the Protection of Personal Data (<span class="elsevierStyleItalic">Ley Orgánica de Protección de Datos</span>, LOPD 15/1999). She also asked for their consent to add the remains of the samples to the hospital's biobank, where they could be used, until they have been exhausted, by other researchers in other studies associated with the disease \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">They are instructed that they have the right to know the individual genetic results, as well as the general information derived from the study, if so stated. \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top">They are informed about their right to decide to participate or revoke their decision at any time, with no need for any explanation and with no detriment to the medical attention received by their child. \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab983057.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Project summary.</p>" ] ] 3 => array:7 [ "identificador" => "tbl0015" "etiqueta" => "Table 3" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "tabla" => array:2 [ "leyenda" => "<p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">REC, Research Ethics Committee.</p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 0 => """ <table border="0" frame="\n \t\t\t\t\tvoid\n \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleBold">The researcher has the duty to request consent</span> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleBold">The researcher has the duty to provide information before performing the study, during the study, and once the study is finished about the results obtained.</span> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">Before</span> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleHsp" style=""></span>She must obtain authorisation from the competent authority \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleHsp" style=""></span>She must proceed according to the standards of good scientific practice \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleHsp" style=""></span>She must clearly inform the participant about the difference between clinical practice and research \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleHsp" style=""></span>She must establish the means to ask for free participation, without placing any conditions on the participants \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">During</span> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleHsp" style=""></span>She must prepare annual follow-up reports and send them to the REC, as well as any other reports that may be required \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleItalic">After</span> \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleHsp" style=""></span>To the parents (if applicable): she has the obligation to disclose individual results that could be relevant \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span><span class="elsevierStyleHsp" style=""></span>To society at large: by preparing reports and publications \t\t\t\t\t\t\n \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry " align="left" valign="top"><span class="elsevierStyleBold">After obtaining samples, their use in research must not in any way jeopardise their diagnostic use</span> \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab983058.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">Moral duties and obligations of the researcher.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:18 [ 0 => array:3 [ "identificador" => "bib0095" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Ethics and biobanks" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "M.G. 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