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dc.contributor.author
Wyss-van den Berg, Machteld
dc.contributor.author
Ogutu, Bernhards
dc.contributor.author
Sewankambo, Nelson K.
dc.contributor.author
Merten, Sonja
dc.contributor.author
Biller-Andorno, Nikola
dc.contributor.author
Tanner, Marcel
dc.date.accessioned
2021-03-08T11:36:14Z
dc.date.available
2021-01-26T17:26:39Z
dc.date.available
2021-03-08T11:36:14Z
dc.date.issued
2020-12
dc.identifier.other
10.1177/1556264620951384
en_US
dc.identifier.uri
http://hdl.handle.net/20.500.11850/465763
dc.description.abstract
When clinical trials enter human communities, two complex systems merge—creating challenges for the clinical trial team and the local human community. This is of particular relevance for clinical trials in low-resource settings where the resource scarcity can intensify existing inequities. Here we present a case study of a phase III malaria vaccine clinical trial. Through qualitative interviews with researchers and caregivers of pediatric participants we elucidate themes that shape the clinical trial system. These themes can be a useful complementary planning tool to existing research guidelines for clinical trial researchers. Respondents from both groups reported financial and social contextual realities to be major drivers in the system. We found a strong historical path dependency in the community that was closely tied to the relationships with researchers and indicative of the structural inequities. We elaborate on these findings and offer recommendations to improve trial design.
en_US
dc.language.iso
en
en_US
dc.publisher
SAGE Publications
en_US
dc.subject
bioethics
en_US
dc.subject
clinical trials
en_US
dc.subject
developing countries
en_US
dc.subject
in-depth interviews
en_US
dc.subject
international research
en_US
dc.subject
qualitative methods
en_US
dc.subject
risks
en_US
dc.subject
benefits
en_US
dc.subject
burdens of research/beneficence
en_US
dc.subject
non-maleficence
en_US
dc.subject
vaccine trials
en_US
dc.title
Communities and Clinical Trials: A Case Study from the RTS,S Malaria Vaccine Trials in Eastern Africa
en_US
dc.type
Journal Article
dc.date.published
2020-08-26
ethz.journal.title
Journal of Empirical Research on Human Research Ethics
ethz.journal.volume
15
en_US
ethz.journal.issue
5
en_US
ethz.pages.start
465
en_US
ethz.pages.end
477
en_US
ethz.publication.place
Thousand Oaks, CA
en_US
ethz.publication.status
published
en_US
ethz.leitzahl
ETH Zürich::00002 - ETH Zürich::00003 - Schulleitung und Dienste::00022 - Bereich VP Forschung / Domain VP Research::02803 - Collegium Helveticum / Collegium Helveticum
en_US
ethz.leitzahl.certified
ETH Zürich::00002 - ETH Zürich::00003 - Schulleitung und Dienste::00022 - Bereich VP Forschung / Domain VP Research::02803 - Collegium Helveticum / Collegium Helveticum
en_US
ethz.date.deposited
2021-01-26T17:26:54Z
ethz.source
FORM
ethz.eth
yes
en_US
ethz.availability
Metadata only
en_US
ethz.rosetta.installDate
2021-03-08T11:36:52Z
ethz.rosetta.lastUpdated
2021-03-08T11:36:53Z
ethz.rosetta.exportRequired
true
ethz.rosetta.versionExported
true
ethz.COinS
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