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The protocol was approved by the institutional review boards of the sites in the HEALTHY Study Group, and parents and students provided appropriate signed informed consent and assent for data collection.
All teacher participants provided informed assent prior to data collection.
Parents could opt not to include their students in the study, and all student participants provided informed assent prior to data collection.
In NIH's proposal, researchers requesting materials are expected not to sign anything that unduly limits academic freedom or publication, nor are they allowed to assent to withholding data or grant reach-through rights.
The study protocols, informed consent and assent forms, and data collection instruments were approved by the human research ethics committee of Asociación Benéfica PRISMA (FWA 00001219).
The Ministry of Health also approved the study and the study was explained to hospital management teams who provided their assent prior to data collection.
Following an opt-out deadline of at least two weeks, schools were visited to obtain child assent and collect baseline data.
Written informed consent was obtained from all participant parents for themselves and on behalf of their child, and children's verbal assent at time of data collection was obtained.
Patients assented to have their data used anonymously for research in all cases as per New York State Department of Health requirements for informed consent.
Parental consent and child assent were obtained prior to data collection.
He obtained written informed consent from the primary care giver and verbal assent from the child before data collection.
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