Reporting of ethical considerations in clinical trials in Chinese nursing journals

Wu, Y; Howarth, ML; Chunlan, Z; Xue, J; Jiexia, O; Xiaojin, L

Abstract

Background: It is acknowledged that publishers now require all primary research papers to demonstrate
that 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 in
mainland China.
Research design:
A retrospective observational study.
Participants:
All clinical trials published in all of the 12 core nursing periodicals from 2016 edition China
Science and Technology Journal Citation Report (core version) between 2013 and 2016 were retrieved by hand
to explicate rate of reporting ethical approval and informed consent.
Ethical considerations:
The study did not require approval from the research ethics committee as it did
not involve human subjects or records.
Results:
In total, 40,278 papers were published in 12 nursing periodicals between 2013 and 2016. Out of
these, 9488 (23.6%) focused on clinical trials. Informed consent obtained from patients or the legally
authorized representative was reported in 51.8% of clinical trials. Notably, only 27.4% of clinical trials
reported that they had obtained written consent. Furthermore, 25.9% of clinical trials described ethical
approval; however, the rate of reporting informed consent and ethical approval in these 12 nursing journals
in 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, both
reporting informed consent and reporting written informed consent had a positive significant correlation
with the reporting ethical approval (p<0.05 or p<0.01).

Conclusion:
Chinese scientific nursing journals have improved the rate of reporting informed consent and
ethical approval in clinical trials during the last 4 years. However, it should be noted that nearly half of clinical trials still did not report either ethical approval or whether informed consent was obtained. Efforts from
editors, researchers, sponsors and authors are needed to ensure the transparency of ethical scrutiny and
adherence to ethical guidelines in publishing clinical trials in Chinese nursing journals.

Citation

Wu, Y., Howarth, M., Chunlan, Z., Xue, J., Jiexia, O., & Xiaojin, L. (2019). Reporting of ethical considerations in clinical trials in Chinese nursing journals. Nursing Ethics, 26(4), 973-983. https://doi.org/10.1177/0969733017722191

• Journal Article Type: Article
• Acceptance Date: Aug 1, 2017
• Online Publication Date: Nov 9, 2017
• Publication Date: Jun 1, 2019
• Deposit Date: Aug 31, 2017
• Publicly Available Date: Nov 15, 2017
• Journal: Nursing Ethics
• Print ISSN: 0969-7330
• Electronic ISSN: 1477-0989
• Publisher: SAGE Publications
• Volume: 26
• Issue: 4
• Pages: 973-983
• DOI: https://doi.org/10.1177/0969733017722191
• Publisher URL: http://dx.doi.org/10.1177/0969733017722191
• Related Public URLs: http://journals.sagepub.com/home/NEJ