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

Abstract

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.

Reporting Ethics Approval in Articles on Criminality. An Audit of Adherence to Swedish Legislation

“…Previous studies have observed that failure to report ethics approval varies by study design (Asplund & Hulter Åsberg, 2021; Block et al, 2006; Pitak-Arnnop et al, 2009; Schroter et al, 2006; Temel, 2022). Our present observations show that in studies with personal data on crime, failure to report ethics approval is nearly twice as common in studies with a qualitative design compared with studies with other observational designs.…”

“…Failure to report ethics approval has been described as occurring frequently in articles related to health sciences (e.g., Asplund & Hulter Åsberg, 2021; Schroter et al, 2006; Temel, 2022) and social sciences (Asplund & Hulter Åsberg, 2021). In health sciences, where adherence to research ethics regulations has been studied most extensively, the proportion of articles involving personal data according to the GDPR that lack information on ethics approval ranges markedly between research disciplines (Asplund & Hulter Åsberg, 2021; Uecker et al, 2020; Wu et al, 2019) and between scientific journals (Block et al, 2006; Pitak-Arnnop et al, 2009; Schroter et al, 2006).…”