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

Unseen Reasons Behind the Disapproved Clinical Research

Authors

  • Canan Uluoğlu Department of Medical Pharmacology, Gazi University Faculty of Medicine, Ankara, Türkiye
  • Ali Kağan Coşkun Department of Medical Pharmacology, Gazi University Faculty of Medicine, Ankara, Türkiye
  • Utku Aykan Department of Medical Pharmacology, Gazi University Faculty of Medicine, Ankara, Türkiye

Keywords:

Ethics Committee, Attitude, Research, Legislation

Abstract

Objective: The process of conducting a medical research done on human subjects are secured by a number of regulations from its planning phase through its publishing as an original article. Ethics committees play an important role in the follow-up and evaluation of this process. In this study, we present an evaluation of the experiences of the “Clinical Research Ethics Committee“ of a university.

Methods: The characteristics of the ethics committee applications, the reasons for rejection (technical, scientific, ethical) and the files that did not reapply to the committee after the revision request were analyzed.

Results: 1057 (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 taken back to the ethics committee agenda with major correction requests. While 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 evaluated together with the files that did not reapply to the ethics committee after the revision request (6.8%).

Conclusion: Ethics committees seek revisions for a significant portion of the submissions and offer researchers scientific and ethical advice. The majority of the applications are approved with the aid of this consultation. In our study, most of the files that did not receive approval from the ethics committee were actually those that did not return after the revision request. The difficulties of the legislation seem to be an important reason for researchers to withdraw their application files.

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Published

09.01.2025

Issue

Section

Original Research

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