article · Tanzania Medical Journal
International guidelines require obtaining permission from community leaders before conducting biomedical research in low-resource settings, whilst still mandating individual informed consent. This exploratory case study examined the involvement of community leaders in the informed consent process during malaria clinical trials across three villages in the Tanga region of Tanzania. Using in-depth, semi-structured interviews and thematic analysis, the investigation highlighted the operational dynamics between local leaders and investigators. Key findings reveal a need for a clear division of responsibilities to prevent community leaders from exerting undue influence over potential participants. Furthermore, information sharing during the process raised concerns regarding participant confidentiality. Defining roles and maintaining transparent communication throughout the trial lifecycle supports voluntary participation, safeguards confidentiality, and promotes trust.
Conducting ethical biomedical research in low-resource communities relies on balancing community leadership engagement with individual autonomy. Ensuring that community leaders do not inadvertently compromise confidentiality or pressure residents into participating is critical for protecting human subjects, upholding voluntary informed consent, and preserving trust between clinical researchers and local populations.
The abstract does not indicate an application pathway, as it focuses on clinical trial ethics and qualitative governance procedures rather than a commercial product or service.
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Background International ethical guidelines for biomedical research involving human subjects recognize the importance of obtaining permission from community leaders before conducting research in low-resource countries. The guidelines emphasize that community permission does not replace the requirement for individual informed consent. However, there is limited understanding of the role of community leaders’ play in this process. This study aimed to explore the experiences of community leaders’ involvement in the informed consent process during malaria clinical trial conducted in Tanzania. Methods This exploratory case study was conducted in three purposively selected villages in Tanga region. In-depth interviews were conducted with community leaders using a semi-structured interview guide and all interviews were audio-recorded using a digital recorder. Data were organized using NVivo software, and thematic analysis was applied. Results The study identified key themes in involving community leaders during obtaining consent. A clear demarcation of responsibilities between community leaders and researchers is necessary to minimize the potential influence of leaders’ authority over community. shared information raised concerns about maintaining participants confidentiality. Conclusion and Recommendation The findings suggest that study information and clear demarcation of responsibilities between community leaders and researchers should be communicated clearly from beginning to end. This promotes trust, supports voluntary participation, ensures confidentiality, and provides a clear understanding of the risks and benefits involved.
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DOI: 10.4314/38theq22
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