How to Maximize Children's Involvement in Non-therapeutic Research-Lessons Learnt From EFFECTOR.

Karolien Van De Maele,Roland Devlieger,Inge Gies

doi:10.3389/fped.2020.00047

Abstract

Background: Children are vulnerable study subjects, especially in non-therapeutic research. Nowadays more attention is paid to the children's voice in both decision-making on participation and their experience of clinical research procedures.Methods: We share our experiences from a long-term, cross-sectional, non-therapeutic follow-up study in the offspring of mothers who participated in scientific research during their pregnancy.Results: During the data collection process, different strategies were developed to achieve a satisfactory participation rate with a focus on the involvement of the children. All study documents and measurements were assembled into a superhero framework. This theme is flexible and attracts children of a wide age-span. In order to inform the children before the study visit, a visually attractive assent was created as well as a superhero video. During the study visit, a sticker diploma was used with similar visuals from the assent. The toddlers received a superhero-cape. The children were involved in the decision-making process during the whole process.Discussion and conclusion: From our experience during the EFFECTOR data collection process, parents and their children can be motivated to participate in a long-term, non-therapeutic, follow-up study when child friendly and adequate communication is used. Framing in a superhero theme is simple and suitable for children of a wide age-span.

Highlights

Children are considered to be vulnerable research study subjects and in recent years, more attention has been paid to their own voice in the process of consent and participation in scientific research [1, 2]
Our aim is to provide an example of different strategies that we used during the EFFECTOR-study to optimize participation and minimalize physical and mental discomfort experienced by the children [14]
The photographs were re-used on the sticker diploma, which resulted in a sense of recognition for the children

Summary

Introduction

Children are considered to be vulnerable research study subjects and in recent years, more attention has been paid to their own voice in the process of consent and participation in scientific research [1, 2]. A specific entity in scientific research are the non-therapeutic studies, where no direct therapeutic consequence for the participating children follows the study participation. This particular type of research might provide important information for the future [8,9,10]. Possible complaints from children are physical (such as pain and unpleasantness) and/or mental discomforts (such as anxiety, worries, and boredom) and should be taken into consideration [12] Some noninvasive procedures, such as assessment of sexual development, could be perceived as burdensome as invasive procedures (e.g., venipuncture) [13]. Nowadays more attention is paid to the children’s voice in both decision-making on participation and their experience of clinical research procedures

Objectives

Results

Conclusion