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INFORMED CONSENT

Fig. Prof. Kirsty Donald, South African NeuroDev PI, discussing the project with a patient in the S6 Developmental clinic at Red Cross War Memorial Children's Hospital, South Africa, Cape Town.

Informed Consent Process

​The NeuroDEV consent was developed jointly by the project investigators in consultation with bioethicists, psychologists and healthcare and project staff. Together, they sought a consent process that provides important scientific information whilst also being understandable. Staff members were trained in how to seek informed consent for the NeuroDEV studies, for instance through role-play where study team members took on the role of research participants.

Before enrolling a child in the study, a staff member describes the goals and requirements of participation in conversation with the parent in their native language. If the parent agrees, he or she (or both) signs an informed consent document (see below). The consent form explains how data will be collected, what the information will be used for, who will use it, and how we is kept safe and anonymous. 

 

Consent for Participation

Before enrolling a child in the study, a  staff member describes the goals and requirements of participation in conversation with the parent. If the parent agrees, he or she (or both) signs an informed consent document (see below). The consent form explains how data will be collected, what the information will be used for, who will use it, and how it is kept safe and anonymous. 

To make sure that parents understand the consent form, NeuroDev uses a dialogue-based questionnaire called the University of California Brief Assessment of Capacity to Consent (UBACC). In addition, to help engage children and adolescents, the research team uses social stories to visualize the key messages from the consent. A social story describes procedures through diagrams and simple language, tailored to age-specific levels (See Visual Aids below).

Fig. Social stories are printed and made into laminated cards to be able to easily show participants.