Improving Informed Consent for Novel Vaccine Research in a Pediatric Hospital Setting Using a Blended Research-Design Approach

Abstract

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.

Informed consent and assent guide for paediatric clinical trials in Europe

“…To date, there are only a limited number of public ethical and practical guidance documents regarding consent and assent design specifically for paediatric clinical trials. Some learnt societies have provided articles, books, videos, and recommendations, practical guidance and training programmes for all stakeholders 20–25. However, none of these existing materials provide similarly detailed instructions for the design of the paediatric consent, assent or agreement document structure, and guide for the whole consent process, including the voice of children.…”

“…4 The aim of the new guide for paediatric ICs and assents Some EU-funded projects and learnt societies have developed new practical tools, guidance, design methods and training programmes for supporting paediatric clinical trials. [20][21][22][23][24][25] The aim of this new guide was to provide more practical easy-to-use tool for designing the content of IC and assent documents to enhance the high-quality ethical standards of paediatric clinical trials. This guide can be adapted to all types of paediatric clinical trials on a case-by-case basis, and it can also be used to promote the involvement of children in the consent process.…”

“…Some learnt societies have provided articles, books, videos, and recommendations, practical guidance and training programmes for all stakeholders. [20][21][22][23][24][25] However, none of these existing materials provide similarly detailed instructions for the design of the paediatric consent, assent or agreement document structure, and guide for the whole consent process, including the voice of children.…”

“…Some EU-funded projects and learnt societies have developed new practical tools, guidance, design methods and training programmes for supporting paediatric clinical trials 20–25. The aim of this new guide was to provide more practical easy-to-use tool for designing the content of IC and assent documents to enhance the high-quality ethical standards of paediatric clinical trials.…”

Informed Consent and Protection of Personal Data in Genetic Research on COVID-19

“…Currently, there are many informed consent models [ 29 , 30 ], varying from quite restricted models of specific informed consent [ 31 ] to forms that allow very broad authorization ( open consent [ 32 ]); in between, there is partially narrow consent , multi-layered consent, non-restricted broad consent [ 33 ], and blanket consent, which allows any research to use the biological samples and related data.…”