The Experiences of Institutional Review Committees in Conducting Post-approval and Site-monitoring of Research Projects in Ethiopia: A mixed-method Research
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Date
2024-06
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Addis Ababa University
Abstract
Background: Research showed a high magnitude of research misconduct in Africa.
Despite the need, ethics committees in Africa seldom monitor studies after approval.
Moreover, research showed inconsistencies in post-approval monitoring by ethics
committees and a lack of data supporting the practice. Thus, the study aimed to explore the
experiences, opportunities, and challenges of post-approval and site monitoring of studies
by ethics committees in Ethiopia.
Methods: A concurrent mixed-method study involving an institution-based cross-
sectional, descriptive qualitative study, and a document review of on-site monitoring was
done on the fourteen institutions. The quantitative survey was done on 84 members using
a self-administered structured questionnaire and 14 in-depth interviews were conducted
with purposively selected members from each institution. Moreover, a review of site
monitoring reports was done using a checklist. The survey data and document review were
analyzed descriptively and the in-depth interviews were analyzed thematically and
integrated using MAXQDA software.
Results: Less than half of the members, 39 (46.4%), indicated they had prior on-site
monitoring experience and over 84% of the members had previous experience of ongoing
review of protocols. The most frequent challenges were a lack of system, resources, and
contextual difficulties. The data revealed procedure infractions and deviations during site
monitoring, along with the corresponding measures. In addition, the capacity, availability
of universities and research institutes, and the existence of trigger factors all presented
opportunities for continued follow-ups.
Conclusions and Recommendations: The common passive way of monitoring of studies
by ethics committees is inadequate to protect the study participants. Given the presence of
such research flaws, it is imperative to strengthen the capacity of the ethics committees and
more emphasis should be given to active monitoring of studies by ethics committees and
all research stakeholders should support the monitoring activities.
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Keywords
Post-approval monitoring, on-site monitoring, ongoing follow-up, research ethics committee