Document is current

Article History

Received: 28 August 2019

Accepted: 22 November 2019

First Online: 19 December 2019

Ethical approval and consent to participate

: The investigators of the study have training in good clinical practice and research ethics in humans, and the collection of human tissue. The study received ethical approval prior to the enrolment of participants. Ethical approval for the study were obtained from Great Lakes University of Kisumu (Ref: GREC/010/248/2016) and London School of Hygiene and Tropical Medicine (Ref: 14695), and University of Iowa (Ref: 00000099). The primary study participants are infants aged < 6 months and the secondary participants are their caregivers. We deem that the infants are unable to either consent or assent to participate so consent is sought from the primary caregiver for the infant by specialized field workers. A participant information sheet (PIS) and consent statement is read in the preferred local language (Dholuo or Swahili) and a written copy of both documents provided. Consent forms are signed and dated by the caregiver. In the case of illiterate participants, an independent witness will sign and date the consent form and a fingerprint will be collected from the participant. If study participants withdraw from the study subsequent to enrolment, any data already collected and analysed will be used, unless the participant requests otherwise, but no further analysis will be done nor samples kept.

: A paragraph in the PIS informs the participant that study findings will be published in scientific journals. The statement says, “At the end of study, all data from questionnaires and samples will be analysed by researchers working with the London School of Hygiene and Tropical Medicine, Great Lakes University of Kisumu and the University of Iowa. Results of the questionnaires will be summarized anonymously and presented at community meetings convened by Great Lakes University of Kisumu which participant’s will be invited to and will be able to ask questions of the research team if there is anything which the participant does not understand. The overall results of the research will be presented to Kisumu County Ministry of Health and Published in Scientific journals.”

: All authors declare that they have no competing interests, whether financial or non-financial.