An examination of timelines in the expedited ethics review process at the University of KwaZulu-Natal, biomedical research ethics committee.

Abstract

Purpose This study examined the timelines of the expedited ethics review process at the University of KwaZulu-Natal Biomedical Research Ethics Committee. The purpose of the study was to evaluate timeframes of BREC review processes for expedited ethics applications and identify specific phases in the review process associated with delays in the time taken to obtain ethical clearance. Method A sample of 200 cases of research proposals submitted to BREC for expedited review in two consecutive years, 2013 and 2014, were reviewed. The researcher drew 100 cases from 2013 and 100 cases from 2014. The research took every third referenced expedited review application in the year 2013 and 2014 until the sample of 200 cases was reached. Results There were noticeable delays in the BREC review process, mainly from the applicants. The descriptive statistics show that it took a mean of 24.22 days and a median of 18.00 days for reviewers to respond to applicants. It took a mean and mode of 65.66 and 14.00 days, respectively, for applicants to respond to reviewers. These were the longest phases of the UKZN/BREC expedited ethics review process. The modal time it took for the protocols to receive final approval was 140 days. Conclusion The study showed that the BREC expedited review process had a slow turnaround time of 140 days. The phase that contributed most to delays was the time it took applicants to respond to queries. This phase is not under the control of BREC. Recommendations This data highlights the slowest elements of the ethics review process. Researchers and the UKZN/BREC should identify why these are the slowest phases and make efforts to improve these data in a future follow-up audit of these timelines. A forthcoming electronic document management system might also assist, and hopefully future data will show improvements in the slowest phases illuminated by the current study.