Reporting of ethical approval and informed consent in clinical research published in leading nursing journals: a retrospective observational study

• Published in: BMC medical ethics 2019-12, Vol.20 (1), p.94-94, Article 94
• Main Authors: Wu, Yanni, Howarth, Michelle, Zhou, Chunlan, Hu, Mingyu, Cong, Weilian
• Format: Article
• Language: English
• Subjects: Bioethics; Biomedical Research; Clinical research; Clinical trials; Committees; Confidentiality - ethics; Data collection; Disclosure of information; Editorial Policies; Education; Ethical approval; Ethical aspects; Ethics; Human subjects; Impact factors; Informed Consent; Medical care quality; Medical ethics; Medical journals; Medical research; Nurses; Nursing; Nursing Care; Nursing journal; Observational studies; Periodicals as Topic; Publishing; Publishing - ethics; Research ethics; Researchers; Retrospective Studies
• ISSN: 1472-6939; 1472-6939
• DOI: 10.1186/s12910-019-0431-5

Ethical considerations play a prominent role in the protection of 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. This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review. 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 and text relating to ethical review has been extracted. From these, most of prospective clinical studies (87.5%) discussed informed consent. Only half of those (52.9%) reported that written informed consent had been obtained; few (3.6%) reported oral consent, and few (6.8%) used other methods 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 most of clinical studies (93.7%) 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 financial support was received (all P