Abstract
BackgroundOver 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.MethodsThis 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.ResultsWe 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).ConclusionCompetence 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.
Highlights
Over the past two decades, Uganda has experienced a significant increase in clinical research driven by both academia and industry
Ainembabazi et al BMC Med Ethics (2021) 22:132 and industry. Much of this focuses on the need to combat the emergence and re-emergence of infectious disease epidemics; including HIV, hemorrhagic fevers, tuberculosis, malaria, neglected tropical diseases, non-communicable diseases and the recent Severe Acute Respiratory Syndrome Corona Virus-2 that causes Corona virus disease-19 (COVID-19) [2,3,4,5]
This study aimed to assess the competencies of Research Ethics Committees (REC) members regarding review of research protocols with complex and emerging research study designs, in order to guide development of a relevant training curriculum for REC members
Summary
Over the past two decades, Uganda has experienced a significant increase in clinical research driven by both academia and industry. Ainembabazi et al BMC Med Ethics (2021) 22:132 and industry Much of this focuses on the need to combat the emergence and re-emergence of infectious disease epidemics; including HIV, hemorrhagic fevers, tuberculosis, malaria, neglected tropical diseases, non-communicable diseases and the recent Severe Acute Respiratory Syndrome Corona Virus-2 that causes Corona virus disease-19 (COVID-19) [2,3,4,5]. This has broadened the spectrum of research activities in the quest for solutions to improve health and wellbeing. Zika virus in 1947 and 1948, Burkitt’s lymphoma in the 1960s, Buruli ulcer in the early 1960s, Busoga hernia in 1964 and HIV/AIDs in the late 1980s [6,7,8,9,10]
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