Luzingu, Joy Kinko
Stroupe, Nancy
Alaofe, Halimatou
Jacobs, Elizabeth
Ernst, Kacey
Article History
Received: 20 June 2022
Accepted: 8 December 2022
First Online: 23 December 2022
Declarations
:
: The original protocol of this study was submitted to the Institutional Review Board (IRB) of the University of Arizona and the Human Subject Review was not required (Protocol #2103586251), as we used de-identified data from the ASSP project. As presented to the IRB of the University of Arizona, the protocol of this study was considered not to meet the definition of research as defined by 45 CFR (Code for Federal Regulations) 46.102(l). The definition of research cited in the regulations issued by U.S. Department of Health and Human Services states that "Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes." Therefore, the study did not require oversight by the University of Arizona IRB, and the ethical approval was waived. The data analyzed in this study was obtained from the ASSP project in which all the methods were carried out in accordance with relevant guidelines and regulations, and both the Tulane University IRB and Kinshasa School of Public Health IRB approved the project.
: Not applicable.
: The authors declare that they have no competing interests.