Thriemer, Kamala http://orcid.org/0000-0001-7536-7497
Degaga, Tamiru Shibru
Christian, Michael
Alam, Mohammad Shafiul
Ley, Benedikt
Hossain, Mohammad Sharif
Kibria, Mohammad Golam
Tego, Tedla Teferi
Abate, Dagimawie Tadesse
Weston, Sophie
Karahalios, Amalia
Rajasekhar, Megha
Simpson, Julie A.
Rumaseb, Angela
Mnjala, Hellen
Lee, Grant
Anose, Rodas Temesgen
Kidane, Fitsum Getahun
Woyessa, Adugna
Baird, Kevin
Sutanto, Inge
Hailu, Asrat
Price, Ric N.
Funding for this research was provided by:
Australian Academy of Science (Regional Collaborations Program)
Bill and Melinda Gates Foundation (INV-010504)
National Health and Medical Research Council (APP1132975)
Article History
Received: 7 April 2022
Accepted: 26 April 2022
First Online: 18 May 2022
Declarations
:
: This study was formally reviewed and approval to the relevant national ethics boards. No participant will be enrolled or samples processed before written approval from these bodies is obtained.The study protocol received ethics approval from the Human Research Ethics Committee of the Northern Territory Department of Health and Menzies School of Health Research (HREC)- Australia (#19-3288), Research Review Committee and Ethical review Committee of icddr,b- Bangladesh (# PR-19001), Institutional Research Ethics Review Board of Arba Minch University- Ethiopia (# CMHS/12033883/111), National Research Ethics Review Council (NRERC)-Ethiopia (# MoSHE//RD/14.113028/19), Food Medicine and Health Care Administration and Control Authority of Ethiopia (EFDA)- Ethiopia (# 02/25/22/143), Badan Pom (BPOM)- Indonesia (# R-RG.01.06.32.321.09.20.630/556, Universitas Indonesia- Indonesia (# KET-357/UN2.F1/ETIK/PPM.00.02/2020), Pemerintah Kabupaten Sumba Timur- Indonesia (# S-B 633/UN2.F1.D/PPM.00.00/2020), Oxford Tropical Research Ethics Committee (Ox-Trec)- UK (# 65-19).The study will be carried out according to the principles stated in the Declaration of Helsinki (Ethical Principles for Medical Research Involving Human Subjects) as amended in 2008, all applicable regulations and according to established international scientific standards.Any substantial amendments to the protocol or the Informed Consent Form will also be submitted for approval to the same ECs and competent authorities and will be implemented only after approval has been obtained.The information and consent forms will be translated to local language and back translated to English to ensure adequate translation. Written informed consent will be obtained from all participants or their legal guardians. Information provided during the consenting process will include description of the sample collection procedure, aim of the study, details on the data collected, potential benefits and risks, and assurance of confidentiality for all information and results generated by the study. Legal representatives of enrolled children will be asked for written informed consent. Information and consent form will be read out to all participants not fully literate; illiterate participants willing to participate will provide consent by a fingerprint in the presence of a witness. All participants will be thoroughly informed about their right to withdraw consent at any time without having to provide a reason for withdrawal or having to fear negative consequences.
: This manuscript does not contain individual personal data from patients they will be presented in reports of the trial results. Informed consent materials are available, on request, from the corresponding author.
: The authors declare that they have no competing interests.