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Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach
It is necessary to conduct Clinical Trials in children, including for novel vaccines. Children cannot legally provide valid consent, but can assent to research participation. Informed consent and assent communications are frequently criticized for their lack of comprehensibility and often, researche...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7835206/ https://www.ncbi.nlm.nih.gov/pubmed/33511090 http://dx.doi.org/10.3389/fped.2020.520803 |
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author | Jackson, Sally M. Daverio, Margherita Perez, Silvia Lorenzo Gesualdo, Francesco Tozzi, Alberto E. |
author_facet | Jackson, Sally M. Daverio, Margherita Perez, Silvia Lorenzo Gesualdo, Francesco Tozzi, Alberto E. |
author_sort | Jackson, Sally M. |
collection | PubMed |
description | It is necessary to conduct Clinical Trials in children, including for novel vaccines. Children cannot legally provide valid consent, but can assent to research participation. Informed consent and assent communications are frequently criticized for their lack of comprehensibility and often, researchers do not involve patients in informed consent design. We tested a blended research-design approach to co-design multimedia informed consent prototypes for experimental vaccine studies targeted at the pediatric population. We report details on the methodology utilized, and the insights, ideas, and prototype solutions we generated using social media data analysis, a survey, and workshops. A survey of clinical trial researchers indicated that while the most did not use technology for informed consent, they considered its utilization favorable. Social media analysis enabled researchers to quickly understand where community perspectives were concordant and discordant and build their understanding of the types of topics that they may want to focus on during the design workshops. Participatory design workshops for children and their families reaped insights, ideas, and prototypes for a range of tools including apps and websites. Participants felt that the prototypes were better able to communicate necessary content than the original text document format. We propose using a participatory, mixed-methods approach to design informed consent so that it is better adapted to patients' needs. Such an approach would be helpful in better addressing the needs of different segments of the populations involved in clinical trials. Further evidence should be gained about the impact of this strategy in improving recruitment, decreasing withdrawals and litigations, and improving patient satisfaction during clinical trials. |
format | Online Article Text |
id | pubmed-7835206 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-78352062021-01-27 Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach Jackson, Sally M. Daverio, Margherita Perez, Silvia Lorenzo Gesualdo, Francesco Tozzi, Alberto E. Front Pediatr Pediatrics It is necessary to conduct Clinical Trials in children, including for novel vaccines. Children cannot legally provide valid consent, but can assent to research participation. Informed consent and assent communications are frequently criticized for their lack of comprehensibility and often, researchers do not involve patients in informed consent design. We tested a blended research-design approach to co-design multimedia informed consent prototypes for experimental vaccine studies targeted at the pediatric population. We report details on the methodology utilized, and the insights, ideas, and prototype solutions we generated using social media data analysis, a survey, and workshops. A survey of clinical trial researchers indicated that while the most did not use technology for informed consent, they considered its utilization favorable. Social media analysis enabled researchers to quickly understand where community perspectives were concordant and discordant and build their understanding of the types of topics that they may want to focus on during the design workshops. Participatory design workshops for children and their families reaped insights, ideas, and prototypes for a range of tools including apps and websites. Participants felt that the prototypes were better able to communicate necessary content than the original text document format. We propose using a participatory, mixed-methods approach to design informed consent so that it is better adapted to patients' needs. Such an approach would be helpful in better addressing the needs of different segments of the populations involved in clinical trials. Further evidence should be gained about the impact of this strategy in improving recruitment, decreasing withdrawals and litigations, and improving patient satisfaction during clinical trials. Frontiers Media S.A. 2021-01-12 /pmc/articles/PMC7835206/ /pubmed/33511090 http://dx.doi.org/10.3389/fped.2020.520803 Text en Copyright © 2021 Jackson, Daverio, Perez, Gesualdo and Tozzi. http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Pediatrics Jackson, Sally M. Daverio, Margherita Perez, Silvia Lorenzo Gesualdo, Francesco Tozzi, Alberto E. Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach |
title | Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach |
title_full | Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach |
title_fullStr | Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach |
title_full_unstemmed | Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach |
title_short | Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach |
title_sort | improving informed consent for novel vaccine research in a pediatric hospital setting using a blended research-design approach |
topic | Pediatrics |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7835206/ https://www.ncbi.nlm.nih.gov/pubmed/33511090 http://dx.doi.org/10.3389/fped.2020.520803 |
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