Special Article
Clinical Research Ethics in Respiratory Medicine
E. Fernández de Uzquianoa, R. Álvarez-Salab,
Corresponding author
ralvarezw.hulp@salud.madrid.org
Correspondence: Dr. R. Álvarez-Sala. Servicio de Neumología (planta 12). Hospital Universitario La Paz. Paseo de la Castellana, 261. 28046 Madrid. España
Correspondence: Dr. R. Álvarez-Sala. Servicio de Neumología (planta 12). Hospital Universitario La Paz. Paseo de la Castellana, 261. 28046 Madrid. España
Read
4500
Timeswas read the article
1762
Total PDF
2738
Total HTML
Share statistics
array:23 [ "pii" => "S1579212906601213" "issn" => "15792129" "doi" => "10.1016/S1579-2129(06)60121-3" "estado" => "S300" "fechaPublicacion" => "2006-02-01" "aid" => "60121" "copyright" => "Sociedad Española de Neumología y Cirugía Torácica (SEPAR)" "copyrightAnyo" => "2006" "documento" => "article" "crossmark" => 0 "subdocumento" => "fla" "cita" => "Arch Bronconeumol. 2006;42:74-80" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 2649 "formatos" => array:3 [ "EPUB" => 89 "HTML" => 1943 "PDF" => 617 ] ] "itemSiguiente" => array:18 [ "pii" => "S1579212906601225" "issn" => "15792129" "doi" => "10.1016/S1579-2129(06)60122-5" "estado" => "S300" "fechaPublicacion" => "2006-02-01" "aid" => "60122" "copyright" => "Sociedad Española de Neumología y Cirugía Torácica (SEPAR)" "documento" => "article" "crossmark" => 0 "subdocumento" => "rev" "cita" => "Arch Bronconeumol. 2006;42:81-91" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 7699 "formatos" => array:3 [ "EPUB" => 86 "HTML" => 6713 "PDF" => 900 ] ] "en" => array:8 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Review Article</span>" "titulo" => "Helminths and the Respiratory System" "tienePdf" => "en" "tieneTextoCompleto" => 0 "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "81" "paginaFinal" => "91" ] ] "contienePdf" => array:1 [ "en" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "J.L. Pérez-Arellano, M.A. Andrade, J. López-Abán, C. Carranza, A. Muro" "autores" => array:5 [ 0 => array:3 [ "preGrado" => "Prof" "nombre" => "J.L." "apellidos" => "Pérez-Arellano" ] 1 => array:2 [ "nombre" => "M.A." "apellidos" => "Andrade" ] 2 => array:2 [ "nombre" => "J." "apellidos" => "López-Abán" ] 3 => array:2 [ "nombre" => "C." "apellidos" => "Carranza" ] 4 => array:2 [ "nombre" => "A." "apellidos" => "Muro" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1579212906601225?idApp=UINPBA00003Z" "url" => "/15792129/0000004200000002/v1_201305150237/S1579212906601225/v1_201305150237/en/main.assets" ] "itemAnterior" => array:18 [ "pii" => "S1579212906601201" "issn" => "15792129" "doi" => "10.1016/S1579-2129(06)60120-1" "estado" => "S300" "fechaPublicacion" => "2006-02-01" "aid" => "60120" "copyright" => "Sociedad Española de Neumología y Cirugía Torácica (SEPAR)" "documento" => "article" "crossmark" => 0 "subdocumento" => "fla" "cita" => "Arch Bronconeumol. 2006;42:68-73" "abierto" => array:3 [ "ES" => false "ES2" => false "LATM" => false ] "gratuito" => false "lecturas" => array:2 [ "total" => 2442 "formatos" => array:3 [ "EPUB" => 100 "HTML" => 1725 "PDF" => 617 ] ] "en" => array:10 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Original Articles</span>" "titulo" => "Usefulness of the Guidelines of the Spanish Society of Pulmonology and Thoracic Surgery (SEPAR) in Identifying the Causes of Chronic Cough" "tienePdf" => "en" "tieneTextoCompleto" => 0 "tieneResumen" => array:2 [ 0 => "en" 1 => "es" ] "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "68" "paginaFinal" => "73" ] ] "contieneResumen" => array:2 [ "en" => true "es" => true ] "contienePdf" => array:1 [ "en" => true ] "autores" => array:1 [ 0 => array:2 [ "autoresLista" => "V. Plaza, E. Miguel, J. Bellido-Casado, M.P. Lozano, L. Ríos, I. Bolíbar" "autores" => array:6 [ 0 => array:3 [ "preGrado" => "Dr." "nombre" => "V." "apellidos" => "Plaza" ] 1 => array:2 [ "nombre" => "E." "apellidos" => "Miguel" ] 2 => array:2 [ "nombre" => "J." "apellidos" => "Bellido-Casado" ] 3 => array:2 [ "nombre" => "M.P." "apellidos" => "Lozano" ] 4 => array:2 [ "nombre" => "L." "apellidos" => "Ríos" ] 5 => array:2 [ "nombre" => "I." "apellidos" => "Bolíbar" ] ] ] ] ] "idiomaDefecto" => "en" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1579212906601201?idApp=UINPBA00003Z" "url" => "/15792129/0000004200000002/v1_201305150237/S1579212906601201/v1_201305150237/en/main.assets" ] "en" => array:14 [ "idiomaDefecto" => true "cabecera" => "<span class="elsevierStyleTextfn">Special Article</span>" "titulo" => "Clinical Research Ethics in Respiratory Medicine" "tieneTextoCompleto" => 0 "paginas" => array:1 [ 0 => array:2 [ "paginaInicial" => "74" "paginaFinal" => "80" ] ] "autores" => array:1 [ 0 => array:4 [ "autoresLista" => "E. Fernández de Uzquiano, R. Álvarez-Sala" "autores" => array:2 [ 0 => array:3 [ "nombre" => "E." "apellidos" => "Fernández de Uzquiano" "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff1" ] ] ] 1 => array:5 [ "preGrado" => "Dr." "nombre" => "R." "apellidos" => "Álvarez-Sala" "email" => array:1 [ 0 => "ralvarezw.hulp@salud.madrid.org" ] "referencia" => array:2 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff2" ] 1 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor1" ] ] ] ] "afiliaciones" => array:2 [ 0 => array:3 [ "entidad" => "Secretaría Técnica del CEIC, Hospital Universitario La Paz, Madrid, Spain" "etiqueta" => "<span class="elsevierStyleSup">a</span>" "identificador" => "aff1" ] 1 => array:3 [ "entidad" => "Servicio de Neumología, Vocal del CEIC, Hospital Universitario La Paz, Madrid, Spain" "etiqueta" => "<span class="elsevierStyleSup">b</span>" "identificador" => "aff2" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor1" "etiqueta" => "*" "correspondencia" => "Correspondence: Dr. R. Álvarez-Sala. Servicio de Neumología (planta 12). Hospital Universitario La Paz. Paseo de la Castellana, 261. 28046 Madrid. España" ] ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2005-02-15" "fechaAceptado" => "2005-03-01" "PalabrasClave" => array:2 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Key words" "identificador" => "xpalclavsec154245" "palabras" => array:4 [ 0 => "Clinical trial" 1 => "Ethics committees" 2 => "Informed consent" 3 => "Pneumology" ] ] ] "es" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Palabras clave" "identificador" => "xpalclavsec154244" "palabras" => array:4 [ 0 => "Ensayo clínico" 1 => "Comité ético de investigación clínica" 2 => "Hoja de información/consentimiento informado para los participantes" 3 => "Neumología" ] ] ] ] "tieneResumen" => true "resumen" => array:2 [ "en" => array:1 [ "resumen" => "<p class="elsevierStyleSimplePara elsevierViewall">Clinical research plays an increasingly strong role in the development of respiratory medicine. Familiarity with issues that affect research on human subjects is therefore essential, particularly so with regard to the conduct of clinical trials of medical interventions.</p><p class="elsevierStyleSimplePara elsevierViewall">This paper begins with a brief introduction to the ethics of clinical research. We highlight the importance of directives on ethics and the need to understand and comply with them when any type of experiment is conducted on humans. There follows a brief description of historical codes of bioethics and an account of their underlying principles, origins, and consequences. Finally, we discuss Spanish Royal Decree 23/2004 of February 6,2004 which came into force on May 1 that year; we outline its general principles and analyze 2 types of problem that have emerged those that result from the article requiring a “single opinion” and those of investigators who act independently of the pharmaceuticals industry.</p><p class="elsevierStyleSimplePara elsevierViewall">The situation of clinical research in respiratory medicine at our hospital is then described. Finally, the 7 requirements of ethical research listed by Emanuel and colleagues are proposed as a tool pneumologists can use to analyze and assess whether or not a specific trial meets minimum ethical requirements.</p>" ] "es" => array:1 [ "resumen" => "<p class="elsevierStyleSimplePara elsevierViewall">La investigación clínica en neumología desempeña un papel cada vez más relevante en el desarrollo de la especialidad. Por ello se hace necesario el conocimiento de los aspectos éticos en investigación con seres humanos y, en concreto, en ensayos clínicos con medicamentos.</p><p class="elsevierStyleSimplePara elsevierViewall">Se comienza la revisión con una breve introducción a los aspectos éticos en investigación clínica resaltando su importancia y obligado conocimiento y cumplimiento a la hora de Ilevar a cabo cualquier tipo de experimentación en seres humanos. Posteriormente, se realiza una breve descripción de los códigos éticos históricos y de los principios de la bioética mencionando su origen, así como las consecuencias que de ellos se derivan. Nos detenemos en el reciente Real Decreto 223/2004, de 6 de febrero, que entró en vigor en España el pasado 1 de mayo de 2004, para destacar sus principios generales y analizar los principales problemas que de él se derivan, fundamentalmente 2 los que son consecuencia de la exigencia del “dictamen único”, y los relativos a los investigadores cuando actúan como promotores independientes de la industria farmacéutica. Se describe el papel de la neumología dentro de la investigación clínica con medicamentos en nuestro hospital, para posteriormente proponer los 7 requisitos del grupo de Emanuel como guía práctica para ayudar a los investigadores en neumología a analizar y valorar si un determinado ensayo cumple las mínimas exigencias de la ética clínica.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "REFERENCES" "seccion" => array:1 [ 0 => array:1 [ "bibliografiaReferencia" => array:27 [ 0 => array:3 [ "identificador" => "bib1" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "El investigador clínico ante las auditorías" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "A Gil Aguado" 1 => "P Lavilla" 2 => "J García Puig" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "Farmacoterapia" "fecha" => "1996" "volumen" => "13" "paginaInicial" => "231" "paginaFinal" => "236" ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib2" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "La regulación legal de la investigación clínica" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "OM Bakke" 1 => "X Carné" 2 => "F García Alonso" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "LibroEditado" => array:4 [ "titulo" => "Ensayos clínicos con medicamentos. Fundamentos básicos, metodología y práctica" "paginaInicial" => "13" "paginaFinal" => "22" "serieFecha" => "1994" ] ] ] ] ] ] 2 => array:3 [ "identificador" => "bib3" "etiqueta" => "3" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Generalidades del ensayoclínico en asma" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "JL Álvarez-Sala Walter" 1 => "M Calle Rubio" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "LibroEditado" => array:4 [ "titulo" => "El ensayo clínico en el asma" "paginaInicial" => "1" "paginaFinal" => "9" "serieFecha" => "1999" ] ] ] ] ] ] 3 => array:3 [ "identificador" => "bib4" "etiqueta" => "4" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "És ético realizar ensayos clínicos controlados con placebo en el desarrollo de un nuevo fármaco para el trastorno depresivo mayor? (I). Consideraciones sobre el valor intrínseco y validez científica del estudio" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "D Gracia" 1 => "J Lahuerta" 2 => "X Carné" 3 => "R Dal-Ré" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "Med Clin (Barc)" "fecha" => "2004" "volumen" => "123" "paginaInicial" => "546" "paginaFinal" => "550" ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib5" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Institutional review board approval and publication of human research results" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:2 [ 0 => "RJ Amdur" 1 => "C Biddle" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:6 [ "tituloSerie" => "JAMA" "fecha" => "1997" "volumen" => "277" "paginaInicial" => "909" "paginaFinal" => "914" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/9062330" "web" => "Medline" ] ] ] ] ] ] ] ] 5 => array:3 [ "identificador" => "bib6" "etiqueta" => "6" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "The Nüremberg Code and the Nüremberg trial. A reappraisal" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "J Katz" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:6 [ "tituloSerie" => "JAMA" "fecha" => "1996" "volumen" => "276" "paginaInicial" => "1662" "paginaFinal" => "1666" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/8922453" "web" => "Medline" ] ] ] ] ] ] ] ] 6 => array:3 [ "identificador" => "bib7" "etiqueta" => "7" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Declaration of Helsinki. adopted by the 18th World Medical Association, Helsinki, Finland, 1964, and attended in Tokyo in 1975, in Venice in 1993, in Hong-Kong in 1989, in South Africa in 1996, and in Edinburgh, Scotland, in October 2000" "autores" => array:1 [ 0 => array:2 [ "colaboracion" => "Word Medical Association" "etal" => false ] ] ] ] "host" => array:1 [ 0 => array:1 [ "WWW" => array:1 [ "link" => "Available from: www.wits.ac.za/bioethics/helsinki.htm" ] ] ] ] ] ] 7 => array:3 [ "identificador" => "bib8" "etiqueta" => "8" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:1 [ "autores" => array:1 [ 0 => array:2 [ "colaboracion" => "National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research" "etal" => false ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Libro" => array:4 [ "titulo" => "The Belmont Report" "fecha" => "1979" "editorial" => "US Government Printing Office" "editorialLocalizacion" => "Washington, DC" ] ] ] ] ] ] 8 => array:3 [ "identificador" => "bib9" "etiqueta" => "9" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:1 [ "autores" => array:1 [ 0 => array:2 [ "colaboracion" => "Council for International Organizations of Medical Sciences" "etal" => false ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Libro" => array:4 [ "titulo" => "International ethical guidelines for biomedical research involving human subjects" "fecha" => "2002" "editorial" => "CIOMS" "editorialLocalizacion" => "Geneva" ] ] ] ] ] ] 9 => array:3 [ "identificador" => "bib10" "etiqueta" => "10" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:1 [ "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "D Gracia" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Libro" => array:4 [ "titulo" => "Fundamentos debioética" "fecha" => "1989" "editorial" => "EUDEMA" "editorialLocalizacion" => "Madrid" ] ] ] ] ] ] 10 => array:3 [ "identificador" => "bib11" "etiqueta" => "11" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "¿Es ético realizar ensayos clínicos controlados con placebo en el desarrollo de un fármaco para el trastorno depresivo mayor? (y II). Relación beneficio/riesgo y consentimiento informado. Conclusiones" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "J Lahuerta" 1 => "D Gracia" 2 => "M Casas" 3 => "E Baca" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "Med Clin (Barc)" "fecha" => "2004" "volumen" => "123" "paginaInicial" => "585" "paginaFinal" => "590" ] ] ] ] ] ] 11 => array:3 [ "identificador" => "bib12" "etiqueta" => "12" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:1 [ "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "D Gracia" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Libro" => array:4 [ "titulo" => "Procedimientos de decisión en ética clínica" "fecha" => "1991" "editorial" => "EUDEMA" "editorialLocalizacion" => "Madrid" ] ] ] ] ] ] 12 => array:3 [ "identificador" => "bib13" "etiqueta" => "13" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Clinical investigations: proposed establishment of regulations on obligations of sponsors and monitors" "autores" => array:1 [ 0 => array:2 [ "colaboracion" => "Food and Drug Administration" "etal" => false ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "Fed Reg" "fecha" => "1977" "volumen" => "42" "paginaInicial" => "49612" "paginaFinal" => "49630" ] ] ] ] ] ] 13 => array:3 [ "identificador" => "bib14" "etiqueta" => "14" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "EEC Note for guidance: good clinical practice for trials on medicinal products in the European Community" "autores" => array:1 [ 0 => array:2 [ "colaboracion" => "CPMP Working Party of Efficacy of Medicinal Products" "etal" => false ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:6 [ "tituloSerie" => "Pharmacol Toxicol" "fecha" => "1990" "volumen" => "67" "paginaInicial" => "361" "paginaFinal" => "372" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/2077532" "web" => "Medline" ] ] ] ] ] ] ] ] 14 => array:3 [ "identificador" => "bib15" "etiqueta" => "15" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "El consentimiento informado en la investigación clínica" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "A Gil" 1 => "P Lavilla" 2 => "E Fernández de Uzquiano" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "An Pediatr Contin" "fecha" => "2003" "volumen" => "1" "paginaInicial" => "109" "paginaFinal" => "118" ] ] ] ] ] ] 15 => array:3 [ "identificador" => "bib16" "etiqueta" => "16" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Ley 25/1990, de 20 de diciembre, del Medicamento. BOE no. 306, de 22 de diciembre de 1990, 2643." ] ] ] 16 => array:3 [ "identificador" => "bib17" "etiqueta" => "17" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Real Decreto 561/1993, de 16 de abril, por el que se establecen los requisitos para la realización de ensayos clínicos con medicamentos. Madrid: Ministerio de Sanidad y Consumo. BOE no. 114, de 13 de mayo de 1993, 1476." ] ] ] 17 => array:3 [ "identificador" => "bib18" "etiqueta" => "18" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Real Decreto 223/2004, de 6 de febrero, por el que se regulan los ensayos clínicos con medicamentos. BOE n.<span class="elsevierStyleSup">o</span> 33, de 7 de febrero de 2004. p. 5429–43." ] ] ] 18 => array:3 [ "identificador" => "bib19" "etiqueta" => "19" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Directiva 2001/20/CE del Parlamento Europeo y del Consejo de 4 de abril de 2001, relativa a la aproximación de las disposiciones legales, reglamentarias y administrativas de los Estados Miembro sobre la aplicación de buenas prácticas clínicas en la realización de ensayos clínicos de medicamentos de uso humano. DOCE no. L121, de 1 de mayo de 2001. p. 33–4." ] ] ] 19 => array:3 [ "identificador" => "bib20" "etiqueta" => "20" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Consejo de Europa. Convenio para la protección de los derechos humanos y la dignidad del ser humano con respecto a las aplicaciones de la biología y la medicina (convenio relativo a los derechos humanos y la biomedicina), Oviedo 4 de abril de 1997. BOE no. 251, de 20 de octubre de 1999, 36825–30." ] ] ] 20 => array:3 [ "identificador" => "bib21" "etiqueta" => "21" "referencia" => array:1 [ 0 => array:1 [ "referenciaCompleta" => "Ley Orgánica 15/1999, de 13 de diciembre, de Protección de Datos de Carácter Personal. BOE, de 14 de diciembre de 1999, 43088–99." ] ] ] 21 => array:3 [ "identificador" => "bib22" "etiqueta" => "22" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:1 [ "titulo" => "EMEA Workhop on "Ethical considerations in clinical trials." 2001" ] ] "host" => array:1 [ 0 => array:1 [ "WWW" => array:1 [ "link" => "Available from: www.emea.eu.int" ] ] ] ] ] ] 22 => array:3 [ "identificador" => "bib23" "etiqueta" => "23" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "El Real Decreto 223/2004 de ensayos clínicos y su aplicación" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "T Millán Rusillo" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "Inv Clin Farm" "fecha" => "2004" "volumen" => "1" "paginaInicial" => "19" "paginaFinal" => "20" ] ] ] ] ] ] 23 => array:3 [ "identificador" => "bib24" "etiqueta" => "24" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Investigación en ensayos clínicos en la Comunidad Europea: luces y sobras del nuevo RD 223/2004" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:4 [ 0 => "P Lavilla" 1 => "E Fernández de Uzquiano" 2 => "A Gil Aguado" 3 => "J Frías" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "Inv Clin Farm" "fecha" => "2004" "volumen" => "1" "paginaInicial" => "21" "paginaFinal" => "24" ] ] ] ] ] ] 24 => array:3 [ "identificador" => "bib25" "etiqueta" => "25" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "What makes clinical research ethical?" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:3 [ 0 => "EJ Emanuel" 1 => "D Wendler" 2 => "C Grady" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:6 [ "tituloSerie" => "JAMA" "fecha" => "2000" "volumen" => "283" "paginaInicial" => "2701" "paginaFinal" => "2711" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/10819955" "web" => "Medline" ] ] ] ] ] ] ] ] 25 => array:3 [ "identificador" => "bib26" "etiqueta" => "26" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:1 [ "titulo" => "Note of clarification on paragraph 29 of the WHA Declaration of Helsinki" ] ] "host" => array:1 [ 0 => array:1 [ "WWW" => array:2 [ "link" => "Available from: wwma.net/e/policy/b3.htm" "fecha" => "2002" ] ] ] ] ] ] 26 => array:3 [ "identificador" => "bib27" "etiqueta" => "27" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Protecting research subjects-The crisis at Johns Hopkins" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:1 [ 0 => "R Steinbrook" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1056/NEJM200202283460924" "Revista" => array:6 [ "tituloSerie" => "N Engl J Med" "fecha" => "2002" "volumen" => "346" "paginaInicial" => "716" "paginaFinal" => "720" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/11870258" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/15792129/0000004200000002/v1_201305150237/S1579212906601213/v1_201305150237/en/main.assets" "Apartado" => null "PDF" => "https://static.elsevier.es/multimedia/15792129/0000004200000002/v1_201305150237/S1579212906601213/v1_201305150237/en/main.pdf?idApp=UINPBA00003Z&text.app=https://archbronconeumol.org/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S1579212906601213?idApp=UINPBA00003Z" ]
| Year/Month | Html | Total | |
|---|---|---|---|
| 2024 November | 2 | 3 | 5 |
| 2024 October | 32 | 22 | 54 |
| 2024 September | 25 | 14 | 39 |
| 2024 August | 42 | 31 | 73 |
| 2024 July | 28 | 21 | 49 |
| 2024 June | 37 | 18 | 55 |
| 2024 May | 37 | 31 | 68 |
| 2024 April | 13 | 22 | 35 |
| 2024 March | 23 | 14 | 37 |
| 2024 February | 26 | 17 | 43 |
| 2023 March | 4 | 3 | 7 |
| 2023 February | 14 | 10 | 24 |
| 2023 January | 19 | 31 | 50 |
| 2022 December | 18 | 33 | 51 |
| 2022 November | 25 | 23 | 48 |
| 2022 October | 22 | 28 | 50 |
| 2022 September | 16 | 24 | 40 |
| 2022 August | 19 | 35 | 54 |
| 2022 July | 17 | 41 | 58 |
| 2022 June | 17 | 34 | 51 |
| 2022 May | 14 | 41 | 55 |
| 2022 April | 15 | 29 | 44 |
| 2022 March | 13 | 34 | 47 |
| 2022 February | 16 | 24 | 40 |
| 2022 January | 18 | 36 | 54 |
| 2021 December | 18 | 56 | 74 |
| 2021 November | 14 | 44 | 58 |
| 2021 October | 19 | 56 | 75 |
| 2021 September | 23 | 45 | 68 |
| 2021 August | 11 | 29 | 40 |
| 2021 July | 9 | 25 | 34 |
| 2021 June | 22 | 33 | 55 |
| 2021 May | 19 | 30 | 49 |
| 2021 April | 26 | 46 | 72 |
| 2021 March | 13 | 28 | 41 |
| 2021 February | 5 | 13 | 18 |
| 2021 January | 13 | 14 | 27 |
| 2020 December | 12 | 16 | 28 |
| 2020 November | 6 | 7 | 13 |
| 2020 October | 4 | 3 | 7 |
| 2020 September | 5 | 4 | 9 |
| 2020 August | 13 | 9 | 22 |
| 2020 July | 6 | 18 | 24 |
| 2020 June | 9 | 7 | 16 |
| 2020 May | 11 | 17 | 28 |
| 2020 April | 13 | 16 | 29 |
| 2020 March | 8 | 8 | 16 |
| 2020 February | 11 | 11 | 22 |
| 2020 January | 19 | 14 | 33 |
| 2019 December | 11 | 14 | 25 |
| 2019 November | 10 | 10 | 20 |
| 2019 October | 3 | 5 | 8 |
| 2019 September | 5 | 11 | 16 |
| 2019 August | 12 | 5 | 17 |
| 2019 July | 13 | 15 | 28 |
| 2019 June | 5 | 7 | 12 |
| 2019 May | 10 | 7 | 17 |
| 2019 April | 14 | 11 | 25 |
| 2019 March | 12 | 16 | 28 |
| 2019 February | 12 | 10 | 22 |
| 2019 January | 12 | 11 | 23 |
| 2018 December | 14 | 15 | 29 |
| 2018 November | 21 | 9 | 30 |
| 2018 October | 13 | 18 | 31 |
| 2018 September | 8 | 12 | 20 |
| 2018 May | 4 | 0 | 4 |
| 2018 April | 6 | 4 | 10 |
| 2018 March | 1 | 2 | 3 |
| 2018 February | 5 | 5 | 10 |
| 2018 January | 2 | 6 | 8 |
| 2017 December | 4 | 4 | 8 |
| 2017 November | 4 | 5 | 9 |
| 2017 October | 6 | 11 | 17 |
| 2017 September | 6 | 11 | 17 |
| 2017 August | 14 | 14 | 28 |
| 2017 July | 5 | 4 | 9 |
| 2017 June | 10 | 11 | 21 |
| 2017 May | 14 | 10 | 24 |
| 2017 April | 9 | 2 | 11 |
| 2017 March | 8 | 8 | 16 |
| 2017 February | 4 | 3 | 7 |
| 2017 January | 2 | 1 | 3 |
| 2016 December | 10 | 8 | 18 |
| 2016 November | 12 | 6 | 18 |
| 2016 October | 19 | 5 | 24 |
| 2016 September | 14 | 7 | 21 |
| 2016 August | 14 | 4 | 18 |
| 2016 July | 13 | 4 | 17 |
| 2016 March | 1 | 0 | 1 |
| 2016 February | 1 | 0 | 1 |
| 2015 December | 3 | 0 | 3 |
| 2015 October | 54 | 11 | 65 |
| 2015 September | 69 | 7 | 76 |
| 2015 August | 47 | 11 | 58 |
| 2015 July | 63 | 6 | 69 |
| 2015 June | 62 | 7 | 69 |
| 2015 May | 43 | 10 | 53 |
| 2015 April | 49 | 6 | 55 |
| 2015 March | 35 | 15 | 50 |
| 2015 February | 37 | 9 | 46 |
| 2015 January | 41 | 11 | 52 |
| 2014 December | 46 | 7 | 53 |
| 2014 November | 45 | 7 | 52 |
| 2014 October | 70 | 11 | 81 |
| 2014 September | 46 | 8 | 54 |
| 2014 August | 46 | 6 | 52 |
| 2014 July | 41 | 4 | 45 |
| 2014 June | 59 | 9 | 68 |
| 2014 May | 68 | 12 | 80 |
| 2014 April | 54 | 9 | 63 |
| 2014 March | 61 | 8 | 69 |
| 2014 February | 50 | 14 | 64 |
| 2014 January | 64 | 10 | 74 |
| 2013 December | 42 | 14 | 56 |
| 2013 November | 45 | 9 | 54 |
| 2013 October | 51 | 10 | 61 |
| 2013 September | 50 | 8 | 58 |
| 2013 August | 51 | 10 | 61 |
| 2013 July | 52 | 14 | 66 |
| 2013 June | 35 | 8 | 43 |
| 2013 May | 41 | 6 | 47 |
| 2013 April | 22 | 4 | 26 |
| 2013 March | 12 | 2 | 14 |
Show all
