¿Se considera bioético el uso de placebo en ensayos clínicos pediátricos?
El Código de Núremberg, la Declaración de Helsinki, el Informe Belmont y diversas regulaciones internacionales enfatizan la importancia de la participación de los niños en la investigación clínica. Se espera poder garantizar el acceso a la información necesaria para la salud y el desarrollo de los n...
- Autores:
-
Buitrago Beltran, Cristian Camilo
- Tipo de recurso:
- https://purl.org/coar/resource_type/c_7a1f
- Fecha de publicación:
- 2025
- Institución:
- Universidad El Bosque
- Repositorio:
- Repositorio U. El Bosque
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- spa
- OAI Identifier:
- oai:repositorio.unbosque.edu.co:20.500.12495/13866
- Acceso en línea:
- https://hdl.handle.net/20.500.12495/13866
- Palabra clave:
- Pacientes pediátricos
Placebo
Bioética
Consentimiento Informado
Principialismo
Pediatric Patients
Placebo
Bioethics
Informed Consent
Principlism
WB60
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- License
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¿Se considera bioético el uso de placebo en ensayos clínicos pediátricos? |
| dc.title.translated.none.fl_str_mv |
Is the Use of Placebo in Pediatric Clinical Trials Considered Bioethical? |
| title |
¿Se considera bioético el uso de placebo en ensayos clínicos pediátricos? |
| spellingShingle |
¿Se considera bioético el uso de placebo en ensayos clínicos pediátricos? Pacientes pediátricos Placebo Bioética Consentimiento Informado Principialismo Pediatric Patients Placebo Bioethics Informed Consent Principlism WB60 |
| title_short |
¿Se considera bioético el uso de placebo en ensayos clínicos pediátricos? |
| title_full |
¿Se considera bioético el uso de placebo en ensayos clínicos pediátricos? |
| title_fullStr |
¿Se considera bioético el uso de placebo en ensayos clínicos pediátricos? |
| title_full_unstemmed |
¿Se considera bioético el uso de placebo en ensayos clínicos pediátricos? |
| title_sort |
¿Se considera bioético el uso de placebo en ensayos clínicos pediátricos? |
| dc.creator.fl_str_mv |
Buitrago Beltran, Cristian Camilo |
| dc.contributor.advisor.none.fl_str_mv |
Duran Pulido, Tania Leonor |
| dc.contributor.author.none.fl_str_mv |
Buitrago Beltran, Cristian Camilo |
| dc.subject.none.fl_str_mv |
Pacientes pediátricos Placebo Bioética Consentimiento Informado Principialismo |
| topic |
Pacientes pediátricos Placebo Bioética Consentimiento Informado Principialismo Pediatric Patients Placebo Bioethics Informed Consent Principlism WB60 |
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Pediatric Patients Placebo Bioethics Informed Consent Principlism |
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WB60 |
| description |
El Código de Núremberg, la Declaración de Helsinki, el Informe Belmont y diversas regulaciones internacionales enfatizan la importancia de la participación de los niños en la investigación clínica. Se espera poder garantizar el acceso a la información necesaria para la salud y el desarrollo de los niños, promover la cooperación internacional y apoyar el derecho a acceder al máximo nivel posible de servicios de salud y tratamiento. La cuestión bioética relevante en la investigación clínica infantil es el uso de placebos en pediatría. El gran aporte clínico del placebo se puede contribuir a su mejora sistemática de los resultados del tratamiento y al menor riesgo de efectos secundarios. Los placebos denominados open-label podrían considerarse una buena alternativa, ya que han demostrado ser seguros y eficaces, lo cual conllevaría un uso abiertamente informado al paciente, reduciendo así los eventos adversos. El consentimiento informado personalizado puede aumentar la comprensión del paciente y reducir los riesgos en muchos pacientes. Beauchamp & Childress abordan la autonomía en la asistencia sanitaria y en la ética médica. El paradigma básico de la autonomía es el consentimiento expreso e informado, que es clave para la ética de la asistencia sanitaria. El consentimiento informado se centra en la necesidad de compartir los riesgos de la intervención con los pacientes para respetar su autonomía. Los principios de la bioética en el uso de placebo incluyen autonomía, beneficencia, no-maleficencia y justicia. |
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2025 |
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2025-01 |
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Aguilera, B., & Beca, J. P. (2018). Análisis ético de la entrega parcial de información al paciente para prevenir efectos nocebo. Revista Médica de Chile, 146(4), 518-522. https://doi.org/10.4067/s0034-98872018000400518 Assembly, U. G. (1989). Convention on the Rights of the Child. United Nations, Treaty Series, 1577(3), 1-23. Bavdekar, S. B. (2013). Pediatric clinical trials. Perspectives In Clinical Research, 4(1), 89. https://doi.org/10.4103/2229-3485.106403 Beauchamp, T. L., & Childress, J. F. (1999). Principios de etica biomedica. Masson. Burns, J. P. (2003). Research in children. Critical Care Medicine, 31(Supplement), S131-S136. https://doi.org/10.1097/01.ccm.0000054905.39382.58 Celedon, C. (2008). Criterios para el uso del placebo: Aspectos éticos. Revista de OtorrinolaringologíA y CirugíA de Cabeza y Cuello, 68(3). https://doi.org/10.4067/s0718-48162008000400007 Christensen, M. L. (2012). Best Pharmaceuticals for Children Act and Pediatric Research Equity Act: Time for Permanent Status. The Journal Of Pediatric Pharmacology And Therapeutics, 17(2), 140-141. https://doi.org/10.5863/1551-6776-17.2.140 Coleman, D. (2007). The Legal Ethics of Pediatric Research. Duke Law Journal, 57(517-624). Colloca, L., & Miller, F. G. (2011). The Nocebo Effect and Its Relevance for Clinical Practice. Psychosomatic Medicine, 73(7), 598-603. https://doi.org/10.1097/psy.0b013e3182294a50 Cortés, M. S., López, M. T. E., & Tobler, C. C. A. (2016). Los menores y adolescentes en la investigación clínica. Tensiones y aspectos éticos. Escritos, 24(53), 345-367. https://doi.org/10.18566/escr.v24n53.a06 Czerniak, E., Oberlander, T. F., Weimer, K., Kossowsky, J., & Enck, P. (2020). “Placebo by Proxy” and “Nocebo by Proxy” in Children: A Review of Parents’ Role in Treatment Outcomes. Frontiers In Psychiatry, 11. https://doi.org/10.3389/fpsyt.2020.00169 Davidson, A. J., & O’brien, M. (2009). Ethics and medical research in children. Pediatric Anesthesia, 19(10), 994-1004. https://doi.org/10.1111/j.1460-9592.2009.03117.x Derivan, A. T., Leventhal, B. L., March, J., Wolraich, M., & Zito, J. M. (2004). The Ethical Use of Placebo in Clinical Trials Involving Children. Journal Of Child And Adolescent Psychopharmacology, 14(2), 169-174. https://doi.org/10.1089/1044546041649057 Di Pietro, M. L., Cutrera, R., Teleman, A. A., & Barbaccia, M. L. (2015). Placebo-controlled trials in pediatrics and the child’s best interest. The Italian Journal Of Pediatrics/Italian Journal Of Pediatrics, 41(1). https://doi.org/10.1186/s13052-015-0118-6 Diekema, D. S. (2006). Conducting ethical research in pediatrics: A brief historical overview and review of pediatric regulations. The Journal Of Pediatrics, 149(1), S3-S11. https://doi.org/10.1016/j.jpeds.2006.04.043 Evers, A. W., Colloca, L., Blease, C., Annoni, M., Atlas, L. Y., Benedetti, F., Bingel, U., Büchel, C., Carvalho, C., Colagiuri, B., Crum, A. J., Enck, P., Gaab, J., Geers, A. L., Howick, J., Jensen, K. B., Kirsch, I., Meissner, K., Napadow, V., . . . Kelley, J. M. (2018). Implications of Placebo and Nocebo Effects for Clinical Practice: Expert Consensus. Psychotherapy And Psychosomatics, 87(4), 204-210. https://doi.org/10.1159/000490354 Faraone, S. V., Newcorn, J. H., Cipriani, A., Brandeis, D., Kaiser, A., Hohmann, S., Haege, A., & Cortese, S. (2021). Placebo and nocebo responses in randomised, controlled trials of medications for ADHD: a systematic review and meta-analysis. Molecular Psychiatry, 27(1), 212-219. https://doi.org/10.1038/s41380-021-01134-w Faria, V., Talbert, C., Goturi, N., Borsook, D., Lebel, A., Kaptchuk, T. J., Kirsch, I., Kelley, J. M., & Moulton, E. A. (2023). Placebos in pediatrics: A cross-sectional survey investigating physicians’ perspectives. Journal Of Psychosomatic Research, 172, 111421. https://doi.org/10.1016/j.jpsychores.2023.111421 Finniss, D. G., Kaptchuk, T. J., Miller, F., & Benedetti, F. (2010). Biological, clinical, and ethical advances of placebo effects. The Lancet, 375(9715), 686-695. https://doi.org/10.1016/s0140-6736(09)61706-2 Flynn, J. T. (2003). Ethics of Placebo Use in Pediatric Clinical Trials. Hypertension, 42(5), 865-869. https://doi.org/10.1161/01.hyp.0000095616.91352.2e Fregnani, J. H. T. G., Carvalho, A. L., Paranhos, F. R. L., De Souza Viana, L., Serrano, S. V., Cárcano, F., Ferreira, J. F. M., Zier, S. S., Gontijo, P. A. M., Stefanoff, C. G., França, P. H. C., De Almeida Bendati, M. M., Marodin, G., & De Almeida Venâncio, J. A. (2015). Ética del uso del placebo en la investigación clínica: propuesta de algoritmos para la toma de decisiones. Revista Bioética, 23(3), 456-467. https://doi.org/10.1590/1983-80422015233082 Gómez-Díaz, R. A., Rodarte, N. W., Robles, S. C., & Aguilar-Salinas, C. A. (2011). The Ethical Use of Placebo in Pediatric Research. Journal Of Clinical Research & Bioethics, 02(07). https://doi.org/10.4172/2155-9627.1000120 He. (2008). Ethical considerations for clinical trials on medicinal products conducted with the paediatric population. Eur. J. Health Law, 15, 223-250. Henschel, A., Rothenberger, L., & Boos, J. (2010). Randomized Clinical Trials in Children - Ethical and Methodological Issues. Current Pharmaceutical Design, 16(22), 2407-2415. https://doi.org/10.2174/138161210791959854 Hottois, G. (2007). La ciencia entre valores modernos y posmodernidad. Kimpres Ltda. Howick, J. (2020). Unethical informed consent caused by overlooking poorly measured nocebo effects. Journal Of Medical Ethics, 47(9), 590-594. https://doi.org/10.1136/medethics-2019-105903 Iniesta Sáez, J. I., & Di Pietro, M. L. (2016). La investigación clínica sin beneficio directo en niños y el estándar del mejor interés. Cuadernos de Bioética, 27(90), 125-137. https://dialnet.unirioja.es/servlet/articulo?codigo=5684445 Joseph, P. D., Caldwell, P. H., Barnes, E. H., Hynes, K., Choong, C. S., Turner, S., Vosk, C., White, J., Richichi, K., & Craig, J. C. (2018). Completeness of protocols for clinical trials in children submitted to ethics committees. Journal Of Paediatrics And Child Health, 55(3), 291-298. https://doi.org/10.1111/jpc.14189 Joseph, P. D., Craig, J. C., & Caldwell, P. H. (2013). Clinical trials in children. British Journal Of Clinical Pharmacology, 79(3), 357-369. https://doi.org/10.1111/bcp.12305 Keränen, T., Halkoaho, A., Itkonen, E., & Pietilä, A. (2015). Placebo-controlled clinical trials: how trial documents justify the use of randomisation and placebo. BMC Medical Ethics, 16(1). https://doi.org/10.1186/1472-6939-16-2 Kipnis, K. (2003). Seven vulnerabilities in the pediatric research subject. Theoretical Medicine And Bioethics, 24(2), 107-120. https://doi.org/10.1023/a:1024646912928 Kottow, M. (2016). Bioética en investigación clínica con seres humanos. Nuevos Folios de Bioética, 19, 5-22. MacLeod, S. M., Knoppert, D. C., Stanton-Jean, M., & Avard, D. (2014). Pediatric Clinical Drug Trials in Low-Income Countries: Key Ethical Issues. Pediatric Drugs, 17(1), 83-90. https://doi.org/10.1007/s40272-014-0103-3 Millum, J., & Grady, C. (2013). The ethics of placebo-controlled trials: Methodological justifications. Contemporary Clinical Trials, 36(2), 510-514. https://doi.org/10.1016/j.cct.2013.09.003 Momper, J. D., Green, D. J., Park, K., Burckart, G. J., & Snyder, D. L. (2020). Ethical Considerations for Pediatric Placebo-Controlled Trials: FDA Outcomes and Perspectives. Therapeutic Innovation & Regulatory Science, 55(2), 282-303. https://doi.org/10.1007/s43441-020-00214-3 Morales-Olivas, F., & Morales-Carpi, C. (2006). Clinical Trials in Children. Reviews On Recent Clinical Trials, 1(3), 251-258. https://doi.org/10.2174/157488706778250087 Neuenschwander, R., Weik, E., Tipper, C. M., Jensen, K., & Oberlander, T. F. (2020). Conditioned Placebo- and Nocebo-Like Effects in Adolescents: The Role of Conscious Awareness, Sensory Discrimination, and Executive Function. Frontiers In Psychiatry, 11. https://doi.org/10.3389/fpsyt.2020.586455 Paumgartten, F. J. R. (2021). Equipoise, placebo in clinical trials and Brazilian Code of Medical Ethics. Revista Da Associação Médica Brasileira, 67(4), 490-495. https://doi.org/10.1590/1806-9282.20200929 Podany, A. (2015). PedSAP 2017 Book 1 - Research and Study Design in Pediatrics [Bookstore]. Buck ML, Manasco KB, editors. Ramirez, I., & Cabrera, C. (1998). La bioética y el uso de placebo en ensayos clínicos controlados. Rev Med IMSS, 41(1), 65-73. Rivera, D. R., & Hartzema, A. G. (2013). Pediatric exclusivity. Annals Of Pharmacotherapy, 48(3), 369-379. https://doi.org/10.1177/1060028013514031 Ruggieri, L., Ceci, A., Bartoloni, F., Elie, V., Felisi, M., Jacqz-Aigrain, E., Lupo, M., Malik, S., Manfredi, C., Reggiardo, G., Demotes, J., & Bonifazi, D. (2021). Paediatric clinical research in Europe: an insight on experts’ needs and perspectives. Contemporary Clinical Trials Communications, 21, 100735. https://doi.org/10.1016/j.conctc.2021.100735 Sanderson, C., Hardy, J., Spruyt, O., & Currow, D. C. (2013). Placebo and Nocebo Effects in Randomized Controlled Trials: The Implications for Research and Practice. Journal Of Pain And Symptom Management, 46(5), 722-730. https://doi.org/10.1016/j.jpainsymman.2012.12.005 Shakhnovich, V., Hornik, C. P., Kearns, G. L., Weigel, J., & Abdel‐Rahman, S. M. (2019). How to Conduct Clinical Trials in Children: A Tutorial. Clinical And Translational Science, 12(3), 218-230. https://doi.org/10.1111/cts.12615 Stang, A., Hense, H., Jöckel, K., Turner, E. H., & Tramèr, M. R. (2005). Is It Always Unethical to Use a Placebo in a Clinical Trial? PLoS Medicine, 2(3), e72. https://doi.org/10.1371/journal.pmed.0020072 Subramanian, D., Cruz, C. V., & Garcia-Bournissen, F. (2022). Systematic Review of Early Phase Pediatric Clinical Pharmacology Trials. The Journal Of Pediatric Pharmacology And Therapeutics, 27(7), 609-617. https://doi.org/10.5863/1551-6776-27.7.609 Trogen, B., Caplan, A., & Klass, P. (2017). The Ethics of Open-Label Placebos in Pediatrics. PEDIATRICS, 140(2), e20164328. https://doi.org/10.1542/peds.2016-4328 United Nations Committee On The Rights Of The Child. (2013). General comment No. 14 (2013) on the right of the child to have his or her best interests taken as a primary consideration (art. 3, para. 1). (CRC/C/GC/14 Para 44). Webster, R. K., Weinman, J., & Rubin, G. J. (2018). Ethical issues surrounding the study of nocebo effects: Recommendations for deceptive research. British Journal Of Health Psychology, 23(4), 775-781. https://doi.org/10.1111/bjhp.12331 World Medical Association Declaration of Helsinki. (2024). JAMA. https://doi.org/10.1001/jama.2024.21972 |
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Duran Pulido, Tania LeonorBuitrago Beltran, Cristian Camilo2025-02-06T20:16:53Z2025-02-06T20:16:53Z2025-01https://hdl.handle.net/20.500.12495/13866instname:Universidad El Bosquereponame:Repositorio Institucional Universidad El Bosquerepourl:https://repositorio.unbosque.edu.coEl Código de Núremberg, la Declaración de Helsinki, el Informe Belmont y diversas regulaciones internacionales enfatizan la importancia de la participación de los niños en la investigación clínica. Se espera poder garantizar el acceso a la información necesaria para la salud y el desarrollo de los niños, promover la cooperación internacional y apoyar el derecho a acceder al máximo nivel posible de servicios de salud y tratamiento. La cuestión bioética relevante en la investigación clínica infantil es el uso de placebos en pediatría. El gran aporte clínico del placebo se puede contribuir a su mejora sistemática de los resultados del tratamiento y al menor riesgo de efectos secundarios. Los placebos denominados open-label podrían considerarse una buena alternativa, ya que han demostrado ser seguros y eficaces, lo cual conllevaría un uso abiertamente informado al paciente, reduciendo así los eventos adversos. El consentimiento informado personalizado puede aumentar la comprensión del paciente y reducir los riesgos en muchos pacientes. Beauchamp & Childress abordan la autonomía en la asistencia sanitaria y en la ética médica. El paradigma básico de la autonomía es el consentimiento expreso e informado, que es clave para la ética de la asistencia sanitaria. El consentimiento informado se centra en la necesidad de compartir los riesgos de la intervención con los pacientes para respetar su autonomía. Los principios de la bioética en el uso de placebo incluyen autonomía, beneficencia, no-maleficencia y justicia.Especialista en BioéticaEspecializaciónThe Nuremberg Code, the Declaration of Helsinki, the Belmont Report and various international regulations emphasize the importance of children's participation in clinical research. It is hoped that this will ensure access to information necessary for children's health and development, promote international cooperation and support the right to access the highest possible level of health services and treatment. The relevant bioethical issue in pediatric clinical research is the use of placebos in pediatrics. The great clinical contribution of placebos can be contributed to their systematic improvement of treatment outcomes and lower risk of side effects. So-called open-label placebos could be considered a good alternative, since they have been shown to be safe and effective, which would lead to openly informed use by the patient, thus reducing adverse events. Personalized informed consent can increase patient understanding and reduce risks in many patients. Beauchamp & Childress address autonomy in healthcare and medical ethics. The basic paradigm of autonomy is express and informed consent, which is key to healthcare ethics. Informed consent focuses on the need to share the risks of the intervention with patients in order to respect their autonomy. Bioethical principles in the use of placebo include autonomy, beneficence, non-maleficence and justice.application/pdfAttribution-NonCommercial-ShareAlike 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-sa/4.0/Acceso abiertohttps://purl.org/coar/access_right/c_abf2http://purl.org/coar/access_right/c_abf2Pacientes pediátricosPlaceboBioéticaConsentimiento InformadoPrincipialismoPediatric PatientsPlaceboBioethicsInformed ConsentPrinciplismWB60¿Se considera bioético el uso de placebo en ensayos clínicos pediátricos?Is the Use of Placebo in Pediatric Clinical Trials Considered Bioethical?Especialización en BioéticaUniversidad El BosqueDepartamento de BioéticaTesis/Trabajo de grado - Monografía - Especializaciónhttps://purl.org/coar/resource_type/c_7a1fhttp://purl.org/coar/resource_type/c_7a1finfo:eu-repo/semantics/bachelorThesishttps://purl.org/coar/version/c_ab4af688f83e57aaAguilera, B., & Beca, J. P. (2018). 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