BACKGROUND 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. METHODS 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. 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 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 < 0.05). 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.

中文翻译：

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在领先的护理杂志上发表的临床研究中的伦理批准和知情同意的报告：回顾性观察研究。

背景技术伦理学考虑因素在临床研究中在保护人类受试者中起着重要作用。迄今为止，尚未探索在国际护理杂志上发表的临床研究中的伦理保护公开内容。我们的研究目标是调查在领先国际护理杂志上发表的临床研究中有关伦理批准和知情同意的报告。方法这是一项回顾性观察研究。检索了2015年至2017年间在SCI期刊引文报告中五种领先的国际护理期刊上发表的所有临床研究，以进行伦理审查的证据。结果从2015年至2017年间发表的所有五种领先护理期刊的内容中，总共确定了2041篇被引用的文献。纳入了1284项临床研究，并提取了有关道德审查的文本。从这些，大多数前瞻性临床研究（87.5％）讨论了知情同意。只有一半（52.9％）的人表示已获得书面知情同意；很少（3.6％）的人表示接受口头同意，很少（6.8％）的人使用其他方法，例如在线同意或完成和返回数据收集（如调查）表示同意。值得注意的是，其中36.2％的受访者没有描述获得知情同意的方法，而只是描述“同意是从参与者或同意参加研究的参与者中获得的”。此外，尽管大多数临床研究（93.7％）都提到了伦理学认可；其中92.5％的人表示了道德委员会的名称，有趣的是，只有37个。1％的人提到了道德认可参考。不同研究类型，国家/地区以及是否获得财务支持的报告伦理批准率不同（所有P <0.05）。结论领先的国际护理期刊的伦理报告显示了进步，但是需要提高护理临床研究的伦理报告的透明度和标准。