Reporting of ethical considerations in clinical trials in Chinese nursing journals

Background: It is acknowledged that publishers now require all primary research papers to demonstratethat they have obtained ethical approval for their research.Objectives: To assess the rate of reporting of ethical approval in clinical trials in core nursing journals inmainland China.Research design:A retrospective observational study.Participants:All clinical trials published in all of the 12 core nursing periodicals from 2016 edition ChinaScience and Technology Journal Citation Report (core version) between 2013 and 2016 were retrieved by handto explicate rate of reporting ethical approval and informed consent.Ethical considerations:The study did not require approval from the research ethics committee as it didnot involve human subjects or records.Results:In total, 40,278 papers were published in 12 nursing periodicals between 2013 and 2016. Out ofthese, 9488 (23.6%) focused on clinical trials. Informed consent obtained from patients or the legallyauthorized representative was reported in 51.8% of clinical trials. Notably, only 27.4% of clinical trialsreported that they had obtained written consent. Furthermore, 25.9% of clinical trials described ethicalapproval; however, the rate of reporting informed consent and ethical approval in these 12 nursing journalsin China during 4 years from 2013 to 2016 improved markedly, with 38.1%, 44.0%, 59.0% and 66.6%,respectively (p<0.001), and 17.6%, 21.9%, 28.6% and 35.8%, respectively (p<0.001). In addition, bothreporting informed consent and reporting written informed consent had a positive significant correlationwith the reporting ethical approval (p<0.05 or p