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.
Highlights
Legal attempts to improve transparency [1, 2] have increased the amount of information disclosed to research participants through informed consent documents, which have become increasingly lengthy and complex [3, 4]
Posts were extracted from two major news sites, La Repubblica in Italy and the BBC in the UK, and from the Facebook page of the Italian Society of Pediatrics (SIP)
The last post was extracted from the page of the Italian Society of Pediatrics (SIP) and it was about the importance of getting vaccinated against pertussis during pregnancy
Summary
Legal attempts to improve transparency [1, 2] have increased the amount of information disclosed to research participants through informed consent documents, which have become increasingly lengthy and complex [3, 4]. According to EU Regulation, informed consent needs to be concise to be understandable [2] yet comprehensiveness and conciseness are conflicting needs that can lead to poor communication at a time when potential research participants are making an important decision about their health [5, 6]. As the ability to understand complex information evolves with age and children are less likely than adults to be able to express their needs and defend their interests, they are considered less able to give consent [12], and do not have the legal capacity to do it [2]. Researchers are obliged to obtain consent from parents or legal representatives, and children can provide assent appropriate to their age and maturity [14]. Emotion and trust play a strong role in decision making, with children [18]
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