A Critical Assessment of the Quality of Reporting of Ethical Protections in Medical Papers Published in Turkey.

The Declaration of Helsinki (DoH), the International Committee of Medical Journal Editors (ICMJE) recommendations, and the Committee on Publication Ethics (COPE) guidelines outline the basic principles for ethical conduct and publication of human-subject research, most notably informed consent (IC) and research ethics committee (REC) approval. This retrospective observational study was a first study to investigate the quality of reporting of these protections in a selected sample of medical papers published in Turkey. A total of 573 research articles published in the official journals of six leading Turkish medical schools between January 2018 and December 2020 were searched for information on obtaining (i) REC approval, (ii) written IC from research subjects or their legal guardians/representatives, and (iii) an REC-granted IC waiver when it was found, as stated in the DoH, "impossible or impracticable to obtain consent" from research subjects. Similarly, a total of 166 case reports were searched for a statement about publication-specific IC, as was recommended by COPE. Despite a statistically significant improvement over the years, the overall rates were found to be unsatisfactory. The protections were particularly misused or underused in retrospective research, where the rates of reporting written IC (15.41% vs. 48.61%) and REC approval with date and reference number information (45.38% vs. 61.11%) were significantly lower than in prospective research (p < .05). Both the practices of seeking and granting an IC waiver when no IC was obtained were extremely rare (n = 3). It was also found that the requirement of structured ethical information in research papers was associated with higher levels of ethics compliance, and that medical publishing in Turkey needed specific improvements, including better implementation of the protections already adopted in principle, clearer instructions for authors, more rigorous editorial scrutiny, and greater commitment to rejecting substandard submissions.