Obtaining meaningful informed consent: preliminary results of a study to develop visual informed consent forms with children

Abstract

This pilot study explores children's understanding of informed consent (IC) and the potential of participatory visual methods for improving the IC process. Strategies used to improve the IC process have generated mixed evidence as to their ability to increase understanding and willingness to participate among potential research participants. Two workshops with 13 children aged 8–12 years were held to discuss the content of IC forms, particularly confidentiality and voluntary participation, and the children took photographs to represent these concepts. Simplified written IC forms generated boredom, disengagement, and/or anxiety for some children. Preliminary results of this pilot study indicate the potential to enhance the IC process by using participatory visual methods with children to make visual IC forms.

Keywords:

• informed consent
• research ethics
• visual methods
• participatory photography
• children
• young people

Acknowledgements

We are grateful to all the children and adults who participated or otherwise helped with this study. We would like to thank Cécile Rousseau for her assistance with this manuscript, and Jo-Ann Jette, Claudia Mitchell, and members of the Research Ethics Board at the CSSS-DLM for support that facilitated timely data collection. The editor and two anonymous reviewers provided useful feedback on an earlier draft.

Funding

This work was supported by the Fonds de Recherche en Santé du Québec, through a New Investigator Award to Dr Ruiz-Casares.

Notes

1. In this paper, ‘informed consent' refers both to the agreement provided by parents or guardians as well as by children themselves.