Harrison, Margo S. http://orcid.org/0000-0003-2940-2241
Yarinbab, Teklemariam
Dorsey-Holliman, Brooke
Aarons, Gregory A.
Betran, Ana Pilar
Goldenberg, Robert L.
Muldrow, Margaret
Article History
Received: 14 April 2021
Accepted: 3 December 2021
First Online: 15 December 2021
Declarations
:
: COMIRB: This study has been approved by the Colorado Multiple Institutional Review Board (19-1593).MTUTH: This study has been submitted to Mizan-Tepi University Teaching Hospital for review and study initiation will not occur until the study has been approved.We intend to seek verbal consent at the start of our interviews and focus groups. Verbal consents, with a discussion of risks, alternatives, and benefits, will be performed before any focus group, interview, or retreat. We will consent in the presence of a non-study staff witness to ensure participants have support and can voice understanding regarding the intent of the study; the risks, benefits, and alternatives were properly explained; and the participants had an opportunity to ask questions about the study. We will offer the participants a postcard consent, in their native language, to review in case they have specific questions regarding the consent process, and we will review the postcard consent with them if they are not literate. The consent will be sought by our local study staff, who are native Amharic speakers, which is the language in which both the consent will be sought, and study activities executed, although translators will be present to interpret if participants prefer to speak in the language of their tribe. As the study staff are also physicians, they will be able to make an informed determination of whether or not the adult subject being offered participation in the study has the capacity to provide informed consent. Any subject who is inebriated, has a mental disability, or cannot give informed consent will not be offered enrollment in the study. Legally, adolescents are unable to consent for their own care in Ethiopia but will be included if their parent/husband is able to consent and they are able to assent to participate.
: No individualized data is being presented that required consent for publication.
: The authors declare that they have no competing interests.