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Researchers' responsibilities in resource-constrained settings: experiences of implementing an ancillary care policy in a vaccine trial in the Democratic Republic of the Congo.

Authors :
Lemey, Gwen
Zola, Trésor
Larivière, Ynke
Milolo, Solange
Danoff, Engbu
Bakonga, Lazarre
Esanga, Emmanuel
Vermeiren, Peter
Maketa, Vivi
Matangila, Junior
Mitashi, Patrick
Van Damme, Pierre
Van geertruyden, Jean-Pierre
Ravinetto, Raffaella
Muhindo-Mavoko, Hypolite
Source :
Research Ethics. Jan2024, Vol. 20 Issue 1, p79-95. 17p.
Publication Year :
2024

Abstract

In this paper, we discuss challenges associated with implementing a policy for Ancillary Care (AC) for related and unrelated (serious) adverse events during an Ebola vaccine trial conducted in a remote area of the Democratic Republic of the Congo. Conducting clinical trials in resourceconstrained settings can raise context-related challenges that have implications for study participants' health and wellbeing. During the Ebola vaccine study, three participants were injured in road traffic accidents, but there were unexpected difficulties when trying to apply the AC policy. First, because of the nature of the adverse events, the insurer refused to cover the costs. Second, the AC policy did not address treatments by traditional medicine, even though traditional medicines are frequently used and highly trusted in the study community. This highlighted a contrast between the researchers' well-intentioned AC approach and the participants' legitimate preferences. The way in which researchers should address their responsibility to provide AC is not straightforward; it requires contextualization. Our experience highlights the importance of involving community representatives and the local ethics committee to ensure development of an AC policy that is culturally and ethically appropriate. Additionally, the insurance contract should clearly stipulate which adverse events are linked to the trial participation, and thus eligible for coverage, to avoid controversies when claims are made. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
17470161
Volume :
20
Issue :
1
Database :
Academic Search Index
Journal :
Research Ethics
Publication Type :
Academic Journal
Accession number :
174685688
Full Text :
https://doi.org/10.1177/17470161231194139