Approaches to ensure quality of information provision and consent processes for vaccine clinical trial participation in Sub-Saharan Africa: A scoping review.
Background/Aims: To respect the rights and wellbeing of research participants, these should receive information at all stages of the trial, and procedures should be put in place to ensure a valid consent that promotes an informed, autonomous and voluntary decision-making. This review focuses on the...
| Publicado en: | Clinical Trials Vol. 22; no. 6; pp. 701 - 728 |
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| Autores principales: | , , |
| Formato: | pictorial research systematic review tables/charts Journal Article |
| Publicado: |
Sage Publications, Ltd.
Dec2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=189572176&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 189572176 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 17407745 AB6 jtl: Clinical Trials issn: 17407745 maglogo: N pubinfo: dt: Dec2025 vid: 22 iid: 6 pid: 33180 pub: Sage Publications, Ltd. place: <Blank> artinfo: ui: 189572176 186183389 189572176 189572176 10.1177/17407745251346134 189572176 ppf: 701 ppct: 27 formats: tig: atl: Approaches to ensure quality of information provision and consent processes for vaccine clinical trial participation in Sub-Saharan Africa: A scoping review. aug: au: Juan-Giner, Aitana Carrillo-Alvarez, Elena Enguita-Fernàndez, Cristina affil: Blanquerna School of Health Sciences, Universitat Ramon Llull, Barcelona, Spain sug: subj: Vaccines Therapeutic Use Clinical Trials Research Subjects Africa South of the Sahara Consumer Participation Consent Health Information Human Scoping Review Africa South of the Sahara PubMed CINAHL Database Funding Source Checklists ab: Background/Aims: To respect the rights and wellbeing of research participants, these should receive information at all stages of the trial, and procedures should be put in place to ensure a valid consent that promotes an informed, autonomous and voluntary decision-making. This review focuses on the extent and type of evidence available in relation to best practices in the information provision and consent processes for vaccine trials conducted in Sub-Saharan Africa. Methods: Ancillary studies or evaluations assessing the information and/or consent processes used in vaccine trials implemented in Sub-Saharan Africa were eligible. The databases PubMed, CINAHL, Scopus, Web of Science, African Index Medicus Google Scholar and ProQuest dissertations and thesis citation index and Open Access Theses and Dissertations were searched, without time limits. Following a deductive approach, relevant data were extracted using an extraction tool and categorised into themes. Results: The review included 46 sources reporting results from 37 studies implemented in 13 Sub-Saharan African countries. The studies covered: community engagement (n = 8); informants (n = 7); messages (n = 7); communication tools (n = 3); community groups (n = 4); consent process (n = 11); comprehension (n = 19) and dissemination of results (n = 4). They mostly represented the views of participants or parents of trial participants; researchers and trial site personnel; and community members and representatives, including those with formal informational roles. The studies showed gaps in information and consent processes leading to a lack of understanding and confusion or suspicion. The involvement of community members in information giving was essential. These were able to communicate in culturally–appropriate ways and also increase trust in the trial. Conclusions: The studies highlight complexities involved in the information and consent processes for vaccine trials implemented in Sub-Saharan Africa. These processes would benefit from a stronger consideration to the context where research takes place, including culture, language, non-biomedical conceptions and power imbalances. The views from ethics review boards were mostly absent. pubtype: Academic Journal doctype: pictorial research systematic review tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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