Children's views on their participation in vaccine clinical trials
DOI:
https://doi.org/10.52611/confluencia.2026.1471Keywords:
Cross-sectional studies, Vaccination, Minors, Bioethics, Health knowledge, Attitudes and PracticeAbstract
Introduction: Since the start of the COVID-19 pandemic, efforts have been made to develop vaccines tailored to the needs of children and adolescents, a group from whom it is important to gather information regarding their participation in clinical trials. Objective: To determine the opinion of children and adolescents aged 7 to 11 and 12 to 17 years regarding their participation in clinical trials for vaccine development, considering the recent inclusion of this demographic in trials in Chile. Methodology: A quantitative descriptive, cross-sectional study using a questionnaire administered to 427 children and adolescents from two schools in the Metropolitan Region. The instrument assessed opinions, concerns, motivations, and willingness to participate in clinical trials. Result: 53,6% of the 7-11 age group and 55,4% of the 12-17 age group agreed with the participation of minors in clinical trials. Additionally, 45% and 42,4%, respectively, indicated their willingness to participate. The primary motivation was the desire to aid in vaccine development, although moderate concerns were evident, particularly regarding potential long-term effects. Discussion: The results reflect a predominantly positive attitude towards pediatric clinical research, with age-group differences in comprehension and argumentation. A clear awareness of justice, altruism, and appreciation for informed consent was observed. Conclusion: Including the voices of children and adolescents in the design of clinical research is essential to ensure respect, understanding, and truly meaningful participation.
Downloads
References
Consejo de Organizaciones Internacionales de las Ciencias Médicas. Pautas éticas internacionales para la investigación relacionada con la salud con seres humanos. 4ª ed. [Internet]. Ginebra: Organización Panamericana de la Salud; 2017 [citado el 18 de julio 2025]. Disponible en: https://cioms.ch/wp-content/uploads/2017/12/CIOMS-EthicalGuideline_SP_INTERIOR-FINAL.pdf
Montgomery J, Banner M, Burls A, Caney S, Clancy T, Farsides B, et al. Children and clinical research: ethical issues [Internet]. UK: Nuffield Council on Bioethics; 2015 [citado el 18 de julio 2025]. Disponible en: https://cdn.nuffieldbioethics.org/wp-content/uploads/Children-and-clinical-research.pdf
Mangochi H, Gooding K, Bennett A, Parker M, Desmond N, Bull S. How should assent to research be sought in low income settings? Perspectives from parents and children in Southern Malawi. BMC Med Ethics [Internet]. 2019 [citado el 18 de julio 2025];20(1):32. Disponible en: https://doi.org/10.1186/s12910-019-0369-7
Madden L, Shilling V, Woolfall K, Sowden E, Smyth R, Williamson P, et al. Questioning assent: how are children’s views included as families make decisions about clinical trials? Child Care Health Dev [Internet]. 2016 [citado el 18 de julio 2025];42(6):900-8. Disponible en: https://doi.org/10.1111/cch.12347
Kricorian K, Civen R, Equils O. COVID-19 vaccine hesitancy: misinformation and perceptions of vaccine safety. Hum Vaccin Immunother [Internet]. 2022 [citado el 18 de julio 2025];18(1):1950504. Disponible en: https://doi.org/10.1080/21645515.2021.1950504
Al-Sheyab NA, Alomari MA, Khabour OF, Shattnawi KK, Alzoubi KH. Assent and consent in pediatric and adolescent research: school children's perspectives. Adolesc Health Med Ther [Internet]. 2019 [citado el 18 de julio 2025];10:7-14. Disponible en: https://doi.org/10.2147/AHMT.S185553
Safar HA, Mustafa AS, McHugh TD. COVID-19 vaccine development: What lessons can we learn from TB? Ann Clin Microbiol Antimicrob [Internet]. 2020 [citado el 18 de julio 2025];19(1):56. Disponible en: https://doi.org/10.1186/s12941-020-00402-x
Lee ACK, Morling JR. COVID-19 vaccine dilemmas. Public Health [Internet]. 2022 [citado el 18 de julio 2025];202:10-1. Disponible en: https://doi.org/10.1016/j.puhe.2021.01.009
Pontificia Universidad Católica de Chile. Facultad de Ciencias Biológicas. Estudio de la UC confirma que vacuna CoronaVac es eficaz y segura en niños, niñas y adolescentes [Internet]. Chile: PUC; 2022 [citado el 18 de julio 2025]. Disponible en: https://biologia.uc.cl/estudio-de-la-uc-confirma-que-vacuna-coronavac-es-eficaz-y-segura-en-ninos-ninas-y-adolescentes/
Shakhnovich V, Hornik CP, Kearns GL, Weigel J, Abdel-Rahman SM. How to Conduct Clinical Trials in Children: A Tutorial. Clin Transl Sci [Internet]. 2019 [citado el 18 de julio 2025];12(3):218-30. Disponible en: https://doi.org/10.1111/cts.12615
Hirschfeld S, Lagler FB, Kindblom JM. Prerequisites to support high-quality clinical trials in children and young people. Arch Dis Child [Internet]. 2021 [citado el 18 de julio 2025];106(5):423-8. Disponible en: https://doi.org/10.1136/archdischild-2019-318677
Norris ML, Spettigue W, Obeid N. Pragmatic clinical trials to advance research in children and adolescents with eating disorders. Int J Eat Disord [Internet]. 2024 [citado el 18 de julio 2025];57(6):1350-6. Disponible en: https://doi.org/10.1002/eat.24209
Blume S. Anti-vaccination movements and their interpretations. Soc Sci Med [Internet]. 2006 [citado el 18 de julio 2025];62(3):628-42. Disponible en: https://doi.org/10.1016/j.socscimed.2005.06.020
Joseph PD, Craig JC, Caldwell PH. Clinical trials in children. Br J Clin Pharmacol [Internet]. 2015 [citado el 18 de julio 2025];79(3):357-69. Disponible en: https://doi.org/10.1111/bcp.12305
Storey D. COVID-19 Vaccine Hesitancy. Glob Health Sci Pract [Internet]. 2022 [citado el 18 de julio 2025];10(1):e2200043. Disponible en: https://doi.org/10.9745/GHSP-D-22-00043
Tromp K, Zwaan CM, van de Vathorst S. Motivations of children and their parents to participate in drug research: a systematic review. Eur J Pediatr [Internet]. 2016 [citado el 18 de julio 2025];175(5):599-612. Disponible en: https://doi.org/10.1007/s00431-016-2715-9
Hirani S, Ojukwu E, Bandara NA. Understanding the Role of Prosocial Behavior in Youth Mental Health: Findings from a Scoping Review. Adolescents [Internet]. 2022 [citado el 18 de julio 2025];2(3):358-80. Disponible en: https://doi.org/10.3390/adolescents2030028
Rossi WC, Reynolds W, Nelson RM. Child assent and parental permission in pediatric research. Theor Med Bioeth [Internet]. 2003 [citado el 18 de julio 2025];24(2):131-48. Disponible en: https://doi.org/10.1023/a:1024690712019
Reddy V, Padman S. Global Perspectives On Pediatric Healthcare: Challenges And Solutions In Diverse Settings. Afr J Biomed Res [Internet]. 2024 [citado el 18 de julio 2025];27(1S):229-36. Disponible en: https://doi.org/10.53555/AJBR.v27i1S.1300
Bierer BE, Koppelman E, Croker AK, Hosseinzadeh S, Hovinga C, Joffe S, et al. Engaging children and adolescents in the design and conduct of paediatric research. Front Pediatr [Internet]. 2024 [citado el 18 de julio 2025];12:1481754. Disponible en: https://doi.org/10.3389/fped.2024.1481754
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2026 Revista Confluencia

This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.



