Abstract

Ethics review is a mandatory process in research involving humans and animals. Incorrect applications results in resubmissions leading to delays in obtaining ethics approval. This study was conducted to ascertain reasons for resubmission of protocols to an ethics review committee. A randomly selected sample of proposals submitted during a 3 year period for an institutional ethics review committee were analyzed to find the reasons for resubmission. The qualitative variables were analyzed through the calculation of absolute and relative frequencies Two hundred and sixty nine protocols were submitted during the study period of 3 years. Protocols for observational studies accounted for 89% while clinical trials and animal studies accounted for 7.8% and 3.3% respectively. The majority of principal investigators were those with a medical degree. Average stop clock time was 23.4 days. Majority were reviewed over 2 meetings to reach a final decision. Of the 95 reasons for returning the protocols to researchers, protocol related issues and informed consent form issues were the major reasons. The main protocol related issues were those in methodology, statistical issues and inadequate risk benefit analysis. Clinical trial related protocols needed more reviews before approval was granted. Delays in reviewing due to ERC were minimal. Most of the protocols that required resubmission had issues pertaining to methodology and informed consent forms or processes. These are easily corrected and can be avoided with careful attention to ethical issues by researchers when preparing the protocols.