Ethics approval and consent to participate
TB
MINOR, NAIROBI
The protocol has been reviewed and approved by the Cameroon National Ethics Committee for Research in Human Health (CNERSH) (number 2018/12/ 1131/CE/CNERSH/SP dated 14 Dec 2018), the Kenyatta National Hospital University of Nairobi Ethical Review Committee (KNH UON-ERC) (number KNH-ERC/A/44 dated 07 Feb 2019), the WHO ERC (number ERC 0003099 dated 5 Mar 2019) and the US IRB Advarra, (number MOD00404608 dated 16 Apr 2019). Considering different types of data collected, different consent procedures were sought. At the cluster level, we obtained a waiver of consent to abstract data from routine clinic registers, forms, and charts. Prior to their enrollment and the initiation of study specific procedures, written informed consent was obtained for all parents/caregivers of children with presumptive TB. Informed consent procedures were conducted by a trained study nurse in private areas free from general view and out of hearing reach. The Cameroon and Kenya Research Ethics committee state that mature minor (married, pregnant, a mother or a household head) are allowed to give consent from him or herself. Therefore, additional parental permission was not sought for eligible participants who had a mother who is under 18 (in Kenya) or 21 (in Cameroon) years of age. However, ability to provide informed consent was a criterion for entry, such that if a very young mother was determined not to be capable of understanding and providing true informed consent by study nurse, her child would not be eligible. All methods were carried out in accordance with relevant guidelines and regulations.