A didactic approach to presenting verbal and visual information to children participating in research protocols: the comic book informed assent

Abstract

OBJECTIVE:When children participate in research protocols, consent (by a parent or legal guardian) and assent (by the children) must be given. Understanding research protocols can be challenging for an adult and even more difficult for a child. The aim of this study was to describe the development of a comic book created to facilitate children's understanding of informed assent with clear and simple language.METHODS:Five researchers with scores above seven according to the Fehring criteria developed the comic book, avoiding the use of technical terminology. Twenty children between 7 and 12 years old, and enrolled in a larger study, responded using a Likert scale and questions about the clarity of texts and illustrations. The final version met National Health System Resolutions (Resoluções do Conselho Nacional da Saúde - CNS n° 196/1996 and 466/2012).RESULTS:The comic book assent presents a short story containing information about a real study: the invitation to participate, objectives, methods, instruments, procedures, risks, benefits, and the researchers' contact information. Most of the participants answered that they perceived the content of the text to be “Excellent” (40%) and “Very good” (40%), and the illustrations were perceived as “Excellent” (45%) and “Very good” (55%).CONCLUSION:The construction of a simple and clear model of informed assent is possible, and this model should be used in experiments with children.

<p>Analysis of motor performance in individuals with cerebral palsy using a non-immersive virtual reality task &ndash; a pilot study</p>

“…This study was approved by the Uninorte Ethics Committee of the Barão do Rio Branco Faculty under protocol 1.996.775 and was conducted in accordance with the Declaration of Helsinki. Participants or their legal representatives (for minors) signed the informed consent form 26…”

Helping Them Decide: A Scoping Review of Interventions Used to Help Minors Understand the Concept and Process of Assent

“…Massetti et al, developed a comic book with the goal of helping minors understand the concept of assent using illustrations and simple language (29). Twenty minors between the ages of 7 and 12 years, and who were participating in a trial to evaluate performance on a computational task (AKA the real study), were enrolled.…”

“…The comic book study's participants responded by using a Likert scale to score the clarity of the text and the illustrations. According to Massetti et al, most participants found the content of the comic book either "excellent" or "very good, " thus offering a viable option for obtaining informed assent (29).…”

Effect of Combined Therapy of Virtual Reality and Transcranial Direct Current Stimulation in Children and Adolescents With Cerebral Palsy: A Study Protocol for a Triple-Blinded Randomized Controlled Crossover Trial

“…Participants will be included if they have: the agreement to participate in the research from themselves [by signing assent form ( 33 )] and their legal guardians (by signing a consent form); a clinical diagnosis of CP will be carried out by a neuropaediatric clinician; with GMFCS levels I to IV and MACS I to IV; age ranging from 4 to 14 years.…”