Stokes, Jamie R. http://orcid.org/0000-0002-5279-2332
Png, May Ee
Jain, Abhilash
Greig, Aina V. H.
Shirkey, Beverly A.
Dritsaki, Melina
Cook, Jonathan A.
Funding for this research was provided by:
Research for Patient Benefit Programme (PB-PG-1215-20041)
Article History
Received: 18 February 2020
Accepted: 3 September 2020
First Online: 7 October 2020
Ethics approval and consent to participate
: The National Research Ethics Committee approved the NINJA trial on 4 June 2019 (18/SC/0024).Delegated members of the research team who are appropriately trained have obtained informed consent from the patient’s parent/legal guardian.Written and verbal versions of the Participant Information and Informed Consent have been given to the participant’s parent/legal guardian. The patient has also been provided with an information sheet informing them about the trial, with separate and distinct information sheets available for the following age groups: under 7, 7–10, and 11 years of age or over. It has been clearly stated to the patient and their parent/legal guardian that the child is free to withdraw from the trial at any time for any reason without prejudice to further care, and with no obligation to provide the reason for withdrawal. The patient’s parent/legal guardian has been asked to complete a standardised consent form if both they and the patient are willing to participate in the study.
: Not applicable.
: The authors declare that they have no competing interests.