BACKGROUND Over the past two decades, Uganda has experienced a significant increase in clinical research driven by both industry and the need to combat the emergence and re-emergence of infectious disease epidemics. This has broadened the spectrum of research proposals that need evaluation by Research Ethics Committees (RECs) with associated requirement for new expertise. We assessed the competencies of REC members in review of research protocols with complex and new research study designs to guide development of a training curriculum to improve the quality of review.
METHODS This was a cross-sectional study design, with quantitative and qualitative data collection methods. We used a structured pre-coded questionnaire to collect data on competencies of REC members in review of research protocols with complex and new research study designs. Research Ethics Committee members were also asked to outline a list of additional topics for which they needed training. Data from coded questions was entered into Epidata Version 3.1 and then exported to STATA Version14.1 for analysis. Descriptive analysis was performed for quantitative data and findings were presented using percentages and frequencies.
RESULTS We enrolled 55/97 REC members from 6 RECs, 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 (6, 10.9%) and reverse pharmacology design (6, 10.9%,), and highest for cluster randomized study design (29, 52.7%) and implementation science research (29, 52.7%).
CONCLUSION There is lack of competence in review of research protocols with complex and new study design and our analysis suggests that additional training in this area is an urgent priority.