Background: Pediatric consent documents should enable children to make an informed, voluntary choice to consent or dissent to research participation. However, these documents are often complicated and hard to read, and children fail to comprehend essential research information. A reason for this problem is that writers of consent material generally have a different educational level and perception than their intended target group. Therefore, in this study, children participated in the development of new consent material in a participatory process.

Methods: The new consent format consists of a comic strip with general research information and a form with specific trial details, the latter being currently under construction. A draft for the comic strip was initially developed in a top-down manner by a science communicator and an artist, to ensure that all important information was present. Subsequently, the draft was presented in two school classes of the target group: children aged 10-14. Children provided input for further development in qualitative interviews and in a survey on understanding and user-satisfaction. The comic strip was improved, and re-evaluated among four school classes of varying ages and educational levels. Results: The first round of feedback revealed that children liked the story-format of the comic strip and were interested in the information presented. However, the children were often confused by the structure of the story. In addition, they all indicated that the story was too long. In response to this input, the comic strip was divided into chapters and color-coding was applied to distinguish different parts. Story length was reduced and the booklet size was altered. Additional adaptations were made based on detailed feedback from the interviews. In the second feedbackround, reading time was shorter and more children understood the content of the story. New feedback was collected in order to further improve the comic strip. Discussion: Information provided to children in the informed consent process should optimally reach the target group. To this aim, a participatory development of pediatric consent material was set up. Participating children were enthusiastic about their input in the development and offered useful feedback and new perspectives. Participatory research is a promising means to reach target groups that are not often heard, connect to their information needs and empower them to make informed decisions.

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Public Communication of Science and Technology

 

Development of new pediatric consent material with children in a participatory process

Ronella Grootens-Wiegers   Leiden University - Science Communication & Society, Netherlands

Jos van den Broek   Leiden University - Science Communication & Society, Netherlands

Martine Vries   Leidsch Universitair Medisch Centrum, Netherlands

Background: Pediatric consent documents should enable children to make an informed, voluntary choice to consent or dissent to research participation. However, these documents are often complicated and hard to read, and children fail to comprehend essential research information. A reason for this problem is that writers of consent material generally have a different educational level and perception than their intended target group. Therefore, in this study, children participated in the development of new consent material in a participatory process.

Methods: The new consent format consists of a comic strip with general research information and a form with specific trial details, the latter being currently under construction. A draft for the comic strip was initially developed in a top-down manner by a science communicator and an artist, to ensure that all important information was present. Subsequently, the draft was presented in two school classes of the target group: children aged 10-14. Children provided input for further development in qualitative interviews and in a survey on understanding and user-satisfaction. The comic strip was improved, and re-evaluated among four school classes of varying ages and educational levels. Results: The first round of feedback revealed that children liked the story-format of the comic strip and were interested in the information presented. However, the children were often confused by the structure of the story. In addition, they all indicated that the story was too long. In response to this input, the comic strip was divided into chapters and color-coding was applied to distinguish different parts. Story length was reduced and the booklet size was altered. Additional adaptations were made based on detailed feedback from the interviews. In the second feedbackround, reading time was shorter and more children understood the content of the story. New feedback was collected in order to further improve the comic strip. Discussion: Information provided to children in the informed consent process should optimally reach the target group. To this aim, a participatory development of pediatric consent material was set up. Participating children were enthusiastic about their input in the development and offered useful feedback and new perspectives. Participatory research is a promising means to reach target groups that are not often heard, connect to their information needs and empower them to make informed decisions.

A copy of the full paper has not yet been submitted.

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