A situation analysis of competences of research ethics committee members regarding review of research protocols with complex and emerging study designs in Uganda
Loading...
Date
2021
Journal Title
Journal ISSN
Volume Title
Publisher
BMC medical ethics
Abstract
Over the past two decades, Uganda has experienced a significant increase in clinical research driven by
both academia and industry. This has been combined with a broader spectrum of research proposals, with respect to
methodologies and types of intervention that need evaluation by Research Ethics Committees (RECs) with associated
increased requirement for expertise. We assessed the competencies of REC members regarding review of research
protocols with complex and emerging research study designs. The aim was to guide development of a training curriculum
to improve the quality of scientific and ethical review.
Methods: This was a cross-sectional study design, with quantitative data collection methods. Research Ethics
Committee members completed a structured pre-coded questionnaire on current competence with complex and
emerging study design. REC members were asked to outline a list of additional topics for which they needed training.
Data from coded questions were entered into Epidata Version 3.1 and then exported to STATA Version14.1 for analysis.
Descriptive analysis was performed and findings are presented using percentages and frequencies.
Results: We enrolled 55 REC members from 6 RECs who have a total of 97 members. The majority of whom were
males (56.4%, n = 31/55). The level of competence for review of selected study design was lowest for Controlled
Human Infection Model (10.9%, n = 6) and reverse pharmacology design (10.9%, n = 6), and highest for cluster randomized
study design (52.7%, n = 29) and implementation science research (52.7%, n = 29).
Conclusion: Competence for review of research protocols with complex and emerging study design was low among
participating REC members. We recommend prioritising training of REC members on complex and emerging study
designs to enhance quality of research protocol review.
Description
Keywords
Complex and emerging study designs, Research Ethics Committees, Competence
Citation
Ainembabazi, P., Castelnuovo, B., Okoboi, S., Arinaitwe, W. J., Parkes-Ratanshi, R., & Byakika-Kibwika, P. (2021). A situation analysis of competences of research ethics committee members regarding review of research protocols with complex and emerging study designs in Uganda. BMC medical ethics, 22(1), 1-7. https://doi.org/10.1186/s12910-021-00692-6