Bakonga, Lazarre

Danoff, Engbu

Esanga, Emmanuel

Larivi\ue8re, Ynke

Lemey, Gwen

Maketa, Vivi

Matangila, Junior

Milolo, Solange

Mitashi, Patrick

Muhindo-Mavoko, Hypolite

Ravinetto, Raffaella

van Damme, Pierre

Van geertruyden, Jean-Pierre

Vermeiren, Peter

Zola Matuvanga, Tr\ue9sor

Zola, Tr\ue9sor

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\u2019 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\u2019 well-intentioned AC approach and the participants\u2019 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

Institutional Repository Universiteit Antwerpen

Researchers\u2019 responsibilities in resource-constrained settings : experiences of implementing an ancillary care policy in a vaccine trial in the Democratic Republic of the Congo

Researchers\u2019 responsibilities in resource-constrained settings : experiences of implementing an ancillary care policy in a vaccine trial in the Democratic Republic of the Congo

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Institutional Repository Universiteit Antwerpen