Abstract

Objective: Clinical trials are an important tool for determining the efficacy and safety of medical treatments. They are scientific studies involving human volunteers and are conducted under the supervision of ethics committees. In recent years, many regulations and guidelines have been published to regulate clinical trials and set ethical standards for research.

Methods: In this study, the applications made to the Ethics Committee for Non-drug Clinical Research of University of Health Sciences Turkey, İzmir Tepecik Education and Research Hospital were retrospectively analyzed. The general characteristics of the applications made to the Ethics Committee, approval and rejection rates, problems and criticisms frequently encountered during the review of the applications were evaluated and the data were analyzed using SPSS.

Results: It was found that most of the files reviewed were approved, but were subject to significant criticism. During the 4 years studied, it was found that the number of files submitted to the ethics committee and the rate of approved files increased each year. It was noted that most of the applications were singlecenter studies, but the budget requests were low and the scientific basis of the investigators was inadequate.

Conclusion: The findings suggest that investigators should pay more attention to methodology and improve the informed consent process. By addressing these deficiencies, clinical trials can be conducted according to ethical and scientific standards.