A Retrospective Aspect at the Evaluations of a University Clinical Research Ethics Committee: The Unseen Reasons Behind the Disapproved Studies

Objective: The process of conducting medical research on human subjects is secured by a number of regulations from its planning phase through its publication as an original article.Ethics Committees (ECs) play an important role in the follow-up and evaluation of the study.In this study, we present an evaluation of the experiences of the "Clinical Research Ethics Committee" of a university. Methods:The characteristics of EC applications, reasons for rejection (technical, scientific, ethical), and files that did not reapply to the committee after the revision request were analyzed.Results: One thousand and fifty-seven (73.96%) of the 1429 files were accepted with minor corrections at the first examination and 15 files were rejected (1.04%).Of the applications, 357 (24.98%) were returned to the EC agenda with major correction requests.Scientific reasons were reported in 19 (90.5%) of the rejected files, ethical reasons were reported in 12 (57%) and technical reasons were reported in 8 (38.1).The rejection rate increased to 8.24% when the same files were reevaluated and did not reapply to the EC after the revision request (6.8%). Conclusion:ECs seek revisions for a significant portion of submissions and offer researchers scientific and ethical advice.