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 discussed informed consent. Only half of those reported that written informed consent had been obtained; few reported oral consent, and few used other methods such as online consent or completion and return of data collection 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 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. 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. (shrink)

Background In the last years, there has been an increase in publication of systematic reviews of normative literature or of normative information in bioethics. The aim of a systematic review is to search, select, analyse and synthesise literature in a transparent and systematic way in order to provide a comprehensive and unbiased overview of the information sought, predominantly as a basis for informed decision-making in health care. Traditionally, one part of the procedure when conducting a systematic review is an appraisal (...) of the quality of the literature that could be included. Main text However, while there are established methods and standards for appraising e.g. clinical studies or other empirical research, quality appraisal of normative literature in the context of a systematic review is still rather a conundrum – not only is it unclear how it could or should be done, but also the question whether it necessarily must be done is not settled yet. Based on a pragmatic definition of “normative literature” as well as on a typology of different types of systematic reviews of normative literature/information, this paper identifies and critically discusses three possible strategies of conducting quality appraisal. Conclusions The paper will argue that none of the three strategies is able to provide a general and satisfying solution to the problems associated with quality appraisal of normative literature/information. Still, the discussion of the three strategies allows outlining minimal conditions that elaborated strategies have to meet in future, and facilitates sketching a theoretically and practically promising strategy. (shrink)