New project article reflecting on informed consent for vaccine research in pediatric population published in Frontiers in Pediatrics Journal

Project partners OPBG, LUMSA and AND CG have published a new article today. The paper is called “Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach” and has been featured in Frontiers in Pediatrics Journal.

Clinical trials are frequently necessary in children at different growth and developmental stages due to children’s diverse needs which differ to adults. As the ability to understand complex information evolves with age and children are less likely to express their needs and defend their interests, they are considered less able to give consent. Hence they do not have the legal capacity to do it.

The article, which corresponds to the project deliverable 2.3, reports details on methodology, insights, ideas, and solutions generated to co-design multimedia informed consent prototypes for experimental vaccine studies targeted at the pediatric population.

This article is part of the research topic Pediatric Specificities of Medical Liability: Improvement Measures in Pediatric Settings.

Screenshot from the Frontiers in Pediatrics’ front page.

Read the abstract

Find the abstract here:

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.

Find the full article here.