Pancras, Godwin
Ezekiel, Mangi
Nderitu, David
Mbugi, Erasto
Merz, Jon F.
Article History
Received: 22 June 2022
Accepted: 9 December 2022
First Online: 15 December 2022
Declarations
:
: Ethical approval was sought and approved by the Muhimbili University of Health and Allied Sciences Research Ethics Committee (MUHAS-REC-07-2019-04.E1) and the National Health Research Ethics Committee (NIMR/HQ/R.8a/Vol. IX/3543). The study was conducted per ethics guidelines for health research in Tanzania and the Declaration of Helsinki. All study participants provided voluntary written informed consent.
: Not applicable.
: All authors have no competing interests to declare except JFM. Since 1997, JFM has been a paid expert witness in 3 civil cases involving the adequacy of informed consent and IRB review in research, twice for the defence and once for the plaintiff, as well as the 4th case for plaintiffs involving the definition of human subjects research, all in the United States. In the last 3 years, JFM has received financial compensation for service on several Data and Safety Monitoring Boards for the US NIH and the American College of Radiology Imaging Network, and service on a pharmacogenomics ethics advisory board for Merck. JFM received partial salary support as a moderator of the IRB Forum (ExternalRef removed) through a grant from Public Responsibility in Medicine & Research (PRIMR) from 2012 to 2020.