Basu, Biswanath
Preussler, Stella
Sander, Anja
Mahapatra, T. K. S.
Schaefer, Franz http://orcid.org/0000-0001-7564-9937
Article History
Received: 12 February 2020
Accepted: 5 November 2020
First Online: 30 November 2020
Ethics approval and consent to participate
: The original study protocol was approved on 13th February 2019 (NMC/586) by the Ethics Committee (Institutional Review Board) of Nil Ratan Sircar Medical College, Kolkata, India following approval of institute scientific committee.Informed written and audiovisual consent from the parents (and assent of the child if > 7 yr old) will be obtained before enrolment by investigators and resident doctors at NRS Medical College & Hospital, Kolkata, India, after provision of detailed oral and written information concerning the context of the study, potential benefit to the child and comprehensive safety aspects. The informed consent process will be in accordance with International Council for Harmonization and Good Clinical Practice, the Declaration of Helsinki and local regulatory requirements. Parent information sheet containing background information, safety of the study and possible benefit will be provided prior to obtaining consent for the study. The investigator will ensure that the subjects’ anonymity is maintained. Any protocol amendment will be notified to all relevant parties following fresh ethics clearance. On the case report forms or other documents, participants will not be identified by their names, but by their assigned identification number. If participant names are included on copies of documents submitted to the principal investigator, the names will be obliterated and the assigned subject numbers added to the documents.
: Not applicable.
: The authors declare that they have no competing interests for the overall trial and the study site.