Manu, Alexander https://orcid.org/0000-0001-5230-6413
Arifeen, Shams
Williams, John
Mwasanya, Edward
Zaka, Nabila
Plowman, Beth Anne
Jackson, Debra
Wobil, Priscilla
Dickson, Kim
Funding for this research was provided by:
Bill and Melinda Gates Foundation
Article History
Received: 2 August 2017
Accepted: 27 June 2018
First Online: 9 July 2018
Ethics approval and consent to participate
: Prior to the onset of the assessment, country-specific adaptations of the study protocol have been approved by the Ethics Committee and Institutional Review Boards of the International Centre for Diarrhoeal Diseases Research (Bangladesh); Navrongo Health Research Centre of the Ghana Health Service (Ghana) and the National Institute of Medical Research (Tanzania). The approval also included references to allow for pooling of data across all three countries for analysis.This is an observational study in which pregnant women presenting in labour within the health facilities, health facility staff and managers are being observed or interviewed. There are no conceivable direct safety concerns. Mothers having a still birth or newborn death will be excluded from interviews to avoid distress to already traumatized individuals. Observation of care might involve invading the privacy of the patient and might be distressing to the care provider but participants will be reassured before the observations begin. Each respondent was individually consented for participation in the study. Facility staff were also assured that the study is not a fault-finding mission and assured that any information they provide or that will be collected on their practices will be confidential and will not affect their position within the facility or in the health services. Data collectors read out a standard study information sheet and the consent form to all respondents in a language of their preference and checked for understanding before a request was made for consent. Participation will be voluntary with assurance of participants’ rights to withdraw from the assessment at any stage, even after initial consent. Agreement to participate in the study was indicated by a signature or a thumbprint. Confidentiality of all data collected is being maintained, always, and accessible only to senior project staff and to the study coordinators. The database is being stored on a security protected server, with password access only by senior project staff. The data forms are being stored in secure storage to be kept for a set minimum period agreed between UNICEF and the respective countries after the end of the study. Analyses will present aggregate results without identifier information. All interviews are being conducted in the respondents’ preferred language. For the qualitative interviews, consent is being taken for recording the interview.
: Not applicable.
: One co-author, Debra Jackson, was an editor of this journal till April 2018 but the decision and process of submission was completely transparent and all the authors declare no conflict of or competing interests.
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