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ERIC Number: EJ1406385
Record Type: Journal
Publication Date: 2024
Pages: 17
Abstractor: As Provided
ISBN: N/A
ISSN: ISSN-1747-0161
EISSN: EISSN-2047-6094
Researchers' Responsibilities in Resource-Constrained Settings: Experiences of Implementing an Ancillary Care Policy in a Vaccine Trial in the Democratic Republic of the Congo
Gwen Lemey; Trésor Zola; Ynke Larivière; Solange Milolo; Engbu Danoff; Lazarre Bakonga; Emmanuel Esanga; Peter Vermeiren; Vivi Maketa; Junior Matangila; Patrick Mitashi; Pierre Van Damme; Jean-Pierre Van geertruyden; Raffaella Ravinetto; Hypolite Muhindo-Mavoko
Research Ethics, v20 n1 p79-95 2024
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 resource-constrained 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.
SAGE Publications. 2455 Teller Road, Thousand Oaks, CA 91320. Tel: 800-818-7243; Tel: 805-499-9774; Fax: 800-583-2665; e-mail: journals@sagepub.com; Web site: https://bibliotheek.ehb.be:2993
Publication Type: Journal Articles; Reports - Descriptive
Education Level: N/A
Audience: N/A
Language: English
Sponsor: N/A
Authoring Institution: N/A
Identifiers - Location: Congo
Grant or Contract Numbers: N/A