Kredo, Tamara http://orcid.org/0000-0001-7115-9535
Effa, Emmanuel
Mbeye, Nyanyiwe
Mabetha, Denny
Schmidt, Bey-MarriƩ
Rohwer, Anke
McCaul, Michael
Kallon, Idriss Ibrahim
Munabi-Babigumira, Susan
Glenton, Claire
Young, Taryn
Lewin, Simon
Vandvik, Per Olav
Cooper, Sara
Funding for this research was provided by:
European and Developing Countries Clinical Trials Partnership (RIA2020S-3303-GELA)
Article History
Received: 2 June 2023
Accepted: 20 July 2024
First Online: 19 August 2024
Declarations
:
: Ethics approval has been obtained in each partner country (South Africa, Malawi and Nigeria) from the respective Health Research Ethics Committees or Institutional Review Boards. Information about the project will be provided to, and consent obtained from, all participants completing the online surveys and interviews and all participants taking part in the meetings. The consent forms will make explicit the voluntary nature of participation, that there will be no negative consequences if they decide not to participate and in the case of the interviews and meetings observations will ask explicitly for permission for the interview or meeting to be recorded. The online surveys will ask participants to provide the last six numbers of their ID as a unique identifier to track their capacity development needs and progress throughout the project. To help protect their confidentiality, the information they provide will be private, deidentified and no names will be used. In addition, all cookies and IP address collectors will be disabled to ensure confidentiality. All interview and meeting recordings on the digital recorders will be destroyed following safe storage and transcription, and any identifying information will be redacted from all transcripts. All study data, including recordings, will be stored electronically using password-controlled software only accessible to key project members and project analysts. Reports of study findings will not identify individual participants. We do not anticipate any specific harms or serious risks to participants. However, there is a risk of breaches of confidentiality for participants who take part in guideline panel and steering group committee project meetings. At the start of all meetings, participants will be introduced to each other. The member names of these groups will not be anonymous as they will play an ongoing role in the GELA project. At the start of each meeting, we will discuss the importance of maintaining confidentiality by everyone. As part of guideline development processes, all guideline members will need to declare conflicts of interests and sign a confidentiality agreement. We will explain, however, that while the researchers undertake to maintain confidentiality, we cannot guarantee that other meeting participants will, and there is, thus, a risk of breaches of confidentiality. We will ensure participants are aware of this risk. Participants may also feel anxiety or distress expressing negative views about project activities. Where there is this potential and where participants identify concerns, we will reassure participants of the steps that will be taken to ensure confidentiality.
: Not applicable.
: All authors declared no competing interests.