Letter to the Editor
Clinical investigation and informed consent form in times of COVID-19 pandemic. A vision from the comitee ethics of research
Investigación clínica y consentimiento informado en época de pandemia COVID-19. Una visión desde la ética de la investigación
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A vision from the comitee ethics of research" "tieneTextoCompleto" => true "saludo" => "Dear Editor:" "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "e307" "paginaFinal" => "e308" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "Antonio Cervera Barajas, Mónica Saldaña Valderas" "autores" => array:2 [ 0 => array:4 [ "nombre" => "Antonio" "apellidos" => "Cervera Barajas" "email" => array:1 [ 0 => "acervera@us.es" ] "referencia" => array:4 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff0005" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff0010" ] 2 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] 3 => array:2 [ "etiqueta" => "*" "identificador" => "cor0005" ] ] ] 1 => array:3 [ "nombre" => "Mónica" "apellidos" => "Saldaña Valderas" "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">c</span>" "identificador" => "aff0015" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">d</span>" "identificador" => "aff0020" ] ] ] ] "afiliaciones" => array:4 [ 0 => array:3 [ "entidad" => "Unidad Ensayos Clínicos Fase I-II, Hospital Universitario Virgen del Rocío, Sevilla, Spain" "etiqueta" => "a" "identificador" => "aff0005" ] 1 => array:3 [ "entidad" => "Máster Ensayos Clínicos, Universidad de Sevilla, Sevilla, Spain" "etiqueta" => "b" "identificador" => "aff0010" ] 2 => array:3 [ "entidad" => "Comité Coordinador Ética e Investigación Bioética de Andalucía" "etiqueta" => "c" "identificador" => "aff0015" ] 3 => array:3 [ "entidad" => "Farmacología Clínica, Hospital Universitario Puerta del Mar, Cádiz, Spain" "etiqueta" => "d" "identificador" => "aff0020" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "Investigación clínica y consentimiento informado en época de pandemia COVID-19. Una visión desde la ética de la investigación" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">The exceptional situation created by the SARS-CoV-2 pandemic has raised a number of very serious health, social and economic problems.</p><p id="par0010" class="elsevierStylePara elsevierViewall">Because of the lack of knowledge of SARS-CoV-2 and the absence of treatments for Covid-19, clinical research is paramount and will need to establish the efficacy, reliability and safety of new diagnostic, prophylactic and therapeutic approaches to this pressing health problem<a class="elsevierStyleCrossRef" href="#bib0005"><span class="elsevierStyleSup">1</span></a> in an agile, flexible and pragmatic manner.</p><p id="par0015" class="elsevierStylePara elsevierViewall">Research during the outbreak is an ethical obligation and it is important that studies address local priorities, conform in design to local capacities and are acceptable to the affected population,<a class="elsevierStyleCrossRef" href="#bib0010"><span class="elsevierStyleSup">2</span></a> while joining forces in the international arena to share information and results. This exceptional clinical situation has generated a surge of interest among both established and emerging researchers and many clinicians with little or no research experience, resulting in a flood of research projects submitted to Research Ethics Committees (RECs).</p><p id="par0020" class="elsevierStylePara elsevierViewall">RECs face an unfamiliar situation where, according to the Pan American Health Organization and the World Health Organization, alternatives to the ordinary ethics review processes need to be found to reduce the obstacles that arise during the conduct of research and to provide an efficient response to time and needs. Covid-19-related clinical research involves finding a balance between speeding up the ethical review processes of projects and ensuring their methodological rigor.</p><p id="par0025" class="elsevierStylePara elsevierViewall">There is a need to develop flexible and alternative procedures for ethical review that allow for efficient communication, harmonisation of criteria, cooperation between committees and interrelation between committees and health authorities, and even foster international collaboration.</p><p id="par0030" class="elsevierStylePara elsevierViewall">This health emergency situation has also generated a new healthcare framework in which it may be difficult to gain access to potential candidates to participate in a clinical trial or to their relatives, both because of their extremely serious clinical condition and because of the strict isolation measures and the lockdown of the population, circumstances that considerably hinder one of the basic pillars of research ethics, namely the appropriate procedure for requesting informed consent.</p><p id="par0035" class="elsevierStylePara elsevierViewall">The European Medicines Agency has made a series of recommendations on how informed consent can be obtained for participation in clinical trials with medicinal products in this situation<a class="elsevierStyleCrossRef" href="#bib0020"><span class="elsevierStyleSup">4</span></a> which attempts to facilitate and make this procedure more flexible, allowing oral consent to be confirmed in writing as soon as the situation allows it, mentioning this situation in the patient’s medical record.</p><p id="par0040" class="elsevierStylePara elsevierViewall">With regard to informed consent for studies with clinical data or biological samples, the Spanish Bioethics Committee<a class="elsevierStyleCrossRef" href="#bib0025"><span class="elsevierStyleSup">5</span></a> published a report on 28 April that clarifies that the Spanish legal system allows the secondary use of health data and biological samples without the requirement to obtain express consent from the source subjects and that these projects must be previously approved by the REC.</p><p id="par0045" class="elsevierStylePara elsevierViewall">RECs now play a key role, as they are the entities responsible for assessing the methodological, ethical and legal quality of research projects and must ensure that informed consent is properly granted as a guarantee of respect for the fundamental rights of the subjects – also and especially – in a health emergency situation.</p><p id="par0050" class="elsevierStylePara elsevierViewall">RECs should develop mechanisms to speed up ethics review processes, such as the creation of standing committees with full decision-making capacity on behalf of the REC, virtual e-mail meetings of pre-defined duration that allow all REC members to participate without the need for their simultaneous physical presence, and strategies to integrate the work of different RECs to avoid duplication of evaluations<a class="elsevierStyleCrossRef" href="#bib0015"><span class="elsevierStyleSup">3</span></a> through a national electronic application and to ensure that the research that took place in this time of emergency, uncertainty and haste was of high quality and guaranteed the fundamental freedoms of the individuals who participated in it. Mutual recognition between ethics committees is now more necessary than ever.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Cervera Barajas A, Saldaña Valderas M. Investigación clínica y consentimiento informado en época de pandemia COVID-19. Una visión desde la ética de la investigación. Med Clin (Barc). 2021;157:e307–e308.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0005" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "La AEMPS está trabajando en diferentes vías de investigación clínica para el tratamiento del COVID-19. Nota Inf. 17 de Mar de 2020. Available from: <a target="_blank" href="https://www.mscbs.gob.es/gabinete/notasPrensa.do?metodo=detalle&id=4818">https://www.mscbs.gob.es/gabinete/notasPrensa.do?metodo=detalle&id=4818</a>." ] ] ] 1 => array:3 [ "identificador" => "bib0010" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "La Ética de la Investigación en épocas de Pandemia Research ethics in the pandemic era" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "J. Bartoli" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.22529/me.2020.5(2)01" "Revista" => array:5 [ "tituloSerie" => "Rev. Methodo" "fecha" => "2020" "volumen" => "5" "paginaInicial" => "38" "paginaFinal" => "40" ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib0015" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Organización Panamericana de la Salud/Organización Mundial de la Salud. Orientación ética sobre cuestiones planteadas por la pandemia del nuevo coronavirus (COVID-19). 2016. Available from: <a target="_blank" href="https://www.paho.org/en/documents/ethics-guidance-issues-raised-novel-coronavirus-disease-covid-19-pandemic">https://www.paho.org/en/documents/ethics-guidance-issues-raised-novel-coronavirus-disease-covid-19-pandemic</a>." ] ] ] 3 => array:3 [ "identificador" => "bib0020" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "EMA. Guidance on the management of clinical trials during the COVID-19 (Coronavirus) pandemic. Versión 3. 28/04/2020. Available from: <a target="_blank" href="https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf">https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf</a>." ] ] ] 4 => array:3 [ "identificador" => "bib0025" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Asociación Espa˜nola de Bioética. Consideraciones bioéticas ante el Covid-19 de AEBI. 2020. Available from: <a target="_blank" href="http://aebioetica.org/archivos/Consideraciones_2.pdf">http://aebioetica.org/archivos/Consideraciones_2.pdf</a>." ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/23870206/0000015700000009/v1_202111060623/S2387020621005398/v1_202111060623/en/main.assets" "Apartado" => array:4 [ "identificador" => "43309" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Letters to the Editor" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/23870206/0000015700000009/v1_202111060623/S2387020621005398/v1_202111060623/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2387020621005398?idApp=UINPBA00004N" ]
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