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. The majority of the applications were approved by this consultation. In our study, most of the files that did not receive approval from the EC were actually those that did not return after the revision request. The difficulties associated with the legislation appear to be an important reason for researchers to withdraw their application files.