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After parental/guardian consent was given, private discussion and thorough explanation of the study to the minor followed, and the minor was asked to provide written informed assent to study participation.
Subjects provided written informed consent and children gave assent to study participation.
All children age 13 or less provide assent to study participation in addition to parent or guardian consent.
Only children whose legal guardian consented to their participation and those who gave assent to study participation were eligible to participate in the study.
Pupils whose legal guardian consented to their participation, and those who gave assent to study participation, were eligible to participate in the study.
Of approximately 1,534 eligible children invited across all participating schools, 375 (24%) children provided written parental consent and child assent to study participation.
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Written consent was obtained from guardians, and written assent was obtained from each child, with an oral review of both consent and assent prior to study enrollment.
Patients provided written informed consent, or the legal guardian's written informed consent with age appropriate patient verbal or written assent, prior to study participation.
To participate in the cognitive interviews at The Children's Hospital at Scott and White (S&W) and the University of North Carolina (UNC), participants needed to meet the following criteria: between the ages of 8 and 17 years inclusive; speak and read English; provide informed assent prior to study entry; and provide parent or guardian informed consent.
Hopes of an improvement in behavioural symptoms and of better social functioning motivated both the legal minors and their parents to assent or consent to study participation.
The study was approved by the Southampton and South West Hampshire Research Ethics Committee B. Participants <16 years of age provided assent to the study procedures, and informed consent was signed by the parent or caregiver.
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