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The IRB granted approval for an information statement in lieu of formal informed consent.
Each participant gave informed consent for their participation to the study and indicated so by signing a formal informed consent statement.
At the mobile examination unit, a formal informed consent procedure was conducted which provided participants with information of all study procedures.
All caregivers and children will be given oral and written information about the study before a request for formal informed consent/assent is signed.
As the aim cannot be to obtain informed consent in a legal meaning from legal minors or young children, the primary target of clinical investigators in clinical studies with an ethical position should be to improve information for minors and not to obtain a "formal" informed consent.
The study was deemed minimal risk and formal informed consent was not required, however all participants were provided with an information sheet about our research protocol.
Similar(19)
Formal written informed consents were not requested.
Formal written informed consent was obtained for each child.
Formal written informed consent was obtained from each patient.
Formal written informed consent was not required because the investigation did not affect normal medical care or modify the doctor-patient relationship.
Formal written informed consent was obtained from 30 donors with OA, who were undergoing total knee arthroplasty (mean age 72 years, mean body mass index (BMI) 31.5 kg/m), prior to obtaining articular cartilage samples from their knee joints.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com