FACTORS INFLUENCING TURN-AROUND TIME OF ETHICS REVIEW IN TANZANIA: ASSESSMENT OF PROTOCOL REVIEW SYSTEMS

Abstract

Ethics review of health research protocols is paramount for the protection of the rights, safety, and welfare of research participants. The review of protocols is done by designated committees called Research Ethics Committees (RECs). In Tanzania, the National Research Ethics Committee (NatHREC) processes a large volume of protocols every year. Although the turnaround time of ethics review has been identified as a concern for stakeholders involved in the review process, there is a lack of comprehensive research on the specific factors that influence the duration of the review process by examining the research protocols themselves. While the long review timelines have significant implications for the timely commencement of research activities, as well as questions regarding the capacity of research ethics committees (RECs), the existing literature does not adequately address this aspect. The study aimed to assess the factors that influenced the turnaround time of ethics review at the National Health Research Ethics Committee (NatHREC) for research protocols submitted between January 2018 and August 2019. This specific time frame was chosen to capture a substantial sample of protocols and provide a comprehensive understanding of the factors affecting the review process during that period and also because during this period the REC employed two different review systems for protocol review. Several factors were identified as influencing the turnaround time of the ethics review process. Firstly, the review systems played a significant role as during the study period, the REC employed two different review systems; Precursor Protocol Review System (PPRs) and Improved Protocol Review System (IPRs) which proved to be more time-efficient. Secondly, the type of study being reviewed also had an influence on turnaround time as clinical trials had a longer review turnaround time than non-clinical trials. Additionally, the time taken for researchers to resubmit their protocols for review affected the overall turnaround time. If researchers took longer to make necessary revisions, it would naturally extend the review process. By focusing on the NatHREC, which is a prominent and nationally recognized research ethics committee, the study aimed to explore the factors that are influential within a well-established and reputable review system. Understanding the specific factors that contribute to the turnaround time at this committee would provide valuable insights for other similar committees and research ethics bodies across the country. Overall, the study highlighted the importance of addressing factors that influence the turnaround time of the review process to improve the efficiency of the process. The findings suggest that implementing the IPRS can significantly reduce the time taken for ethics review, benefiting both researchers and research participants.