OA-506 Working towards better guidance for studies that involve African healthy volunteers in the context of the VolREthics initiative

BackgroundThere are well-recognised ethical guidelines for biomedical research, though a lack of specific guidance for studies targeting healthy volunteers. Noting this, the Ethics Committee of the French National Institute for Health and Medical Research (Inserm) convened an initiative to propose e...

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Bibliographic Details
Published in:BMJ global health 2023-12, Vol.8 (Suppl 10), p.A17-A18
Main Authors: Allen, Elizabeth, Mwanga-Amumpaire, Juliet, Chi, Primus Che, Toohey, Jacintha, Bompart, François, Hirsch, François, Sevene, Esperança
Format: Article
Language:English
Subjects:
Abstracts of Oral Presentations
Bioethics
Medical research
Participation
Volunteers
Workshops
Online Access:Request full text
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Summary:BackgroundThere are well-recognised ethical guidelines for biomedical research, though a lack of specific guidance for studies targeting healthy volunteers. Noting this, the Ethics Committee of the French National Institute for Health and Medical Research (Inserm) convened an initiative to propose elaboration of good practices to protect health volunteers in research, VolREthics. Online discussions and workshops were held at international and regional levels since February 2022 to debate experiences and best practices. This abstract presents the summary of findings from the African regional perspective.MethodsAn online Sub-Saharan Africa workshop was convened in May 2022. A pre-workshop questionnaire to capture the regional context better was distributed, and notes during the event taken. Feedback from all regional meetings and plans for developing international guidance were discussed at a workshop in Brussels, April 2023, with representatives from regulatory agencies, manufacturers, research institutions and funders, ethicists and healthy volunteers.Results78 people from 21 (14 African) countries and 3 healthy volunteers attended the African workshop, 39 completing questionnaires. Concerns raised included inadequate community engagement, informed consent, feedback of results and guidance on/compensation for secondary use of data, plus economic and/or educational vulnerability of participants. The risk of exploitation or harm, and potential for compromised scientific validity of studies was also mentioned. Proposed solutions were better oversight through legislation and competent ethics committees, national guidelines for compensation, appropriate conditions for confinement, improved dialogue between stakeholders, and innovative learning and engagement to build trust in collaboration with relevant partners such as The Global Health Network’s African communities of practices. ConclusionThis important initiative has established momentum for closing gaps in how studies enrolling healthy volunteers are conducted ethically and equitably. Further discussions with colleagues from other regions involved in VolREthics should enrich the approach toward sound good practices.Sponsorship: European Commission, EDCTP, Inserm, Anrs-Inserm, EEIdF
ISSN:2059-7908
DOI:10.1136/bmjgh-2023-EDC.40