Understanding constraints and enablers of turnaround time for ethics review

Abstract

Background Independent ethics review is one of the fundamental principles of research ethics. The body of literature has documented increasing bureaucratic delays associated with ethics review, which has impacted the start of research activities. This study aimed to determine the extent of variability in turnaround times for protocol review among different institutional review boards (IRBs) within Tanzania. It also assessed the challenges and experiences of submitting and reviewing protocols after introducing the tablet PC, from the perspectives of Ifakara Health Institute IRB (IHI-IRB) members and investigators. Methods This cross-sectional study employed a mixed-methods approach which consisted of qualitative and quantitative approaches. The quantitative data were obtained retrospectively from databases of seven selected IRBs in Tanzania. Purposive sampling was used to select seven IRBs for inclusion in the study. Seven IRB secretaries and their assistants from five institutions were interviewed to respond to the research questions. In addition, 19 in-depth interviews were conducted with IRB members and investigators to explore their experiences of using tablet PCs in reviewing protocols and in submitting electronic proposals, respectively. This study was conducted in mainland Tanzania and Zanzibar. Quantitative secondary data were analysed using Stata software (quantitative data analysis software, version 10). Qualitative data were categorised in an Excel spreadsheet and analysed using thematic analysis. Results The median time for ethics review across the visited sites was 32 days and ranged from 1 to 396 days. Qualitative results found that eleven thematic issues emerged from in-depth interviews with IRB members and the secretariat in the visited study areas. Generally, looking into the procedures for submission of protocols to the secretariat of the IRB, these were more or less the same across IRB institutions in Tanzania. However, investigators sometimes failed to adhere to the submission checklist and guidelines which resulted in delays in the timeous review of protocols. Most of the IRB members and investigators preferred electronic submission for its ease of use and reduced burdens associated with paper-based submissions, such as printing, distribution and misplacing of protocols. Conclusion Data from this study suggest that there is an urgent need to address the issues raised in order to improve the turnaround time of protocol review in Tanzania. Investigators should adhere to the submission checklist and guidelines to avoid delays in the ethics approval process. Ethics review boards need to invest in technology and system strengthening to facilitate timeous processing of ethics applications.