Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a bibliometric analysis

Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a bibliometric analysis
Wu, Y, Howarth, ML, Zhou, C and Cong, W
BMC Medical Ethics, 10 May 2019
Abstract
Background
Ethical considerations play a prominent role in the protection of protect human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals.
Methods
We used a research based on bibliometric analysis. All clinical research published in the five leading international nursing journals from the SCI Journal Citation Reports (2017 version) between 2015 and 2017 were retrieved to evaluate for evidence of ethical review.
Results
A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included in the text to extract the data of ethical review. From these, a total of 87.5% of prospective clinical studies mentioned informed consent. Only 52.9% of those reported that written informed consent had been obtained;3.6% reported oral consent, and 6.8% used other ways such as online consent or completion and return of data collection (such as surveys) to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “consent was obtained from participants or participants agreed to join in the research”. Furthermore, whilst 93.7% of clinical studies mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether mentioning financial support (all P<0.05). In addition, positive statistically significant correlations were found between reporting informed consent, reporting written informed consent, reporting ethical approval, naming of ethical committee, and reporting ethical approval reference number in the five leading international nursing journals (all P<0.01).
Conclusion
The reporting of ethics in leading international nursing journals demonstrates progress but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required.