Reporting ethics committee approval and informed consent: Review of an Ayurvedic journal.

INTRODUCTION: Reporting of ethical approval and informed consent in clinical research articles involving human subjects is necessary as per the International Committee of Medical Journal Editors (ICMJE).

AIM: To assess the reporting of ethics committee approval and informed consent in clinical research articles published in AYU journal.

MATERIALS AND METHODS: This was a retrospective analysis of published articles in AYU from 2012 to 2014. All original articles (clinical research) were included. Data was collected to note - Ethics Committee approval and written informed consent (assent from children when applicable). Descriptive statistics was used to report the findings.

RESULTS: A total of 104 articles were included in this analysis. Of these, 38 articles included children. Ethics committee approval was reported in 53 (51.0%) articles and consent was also reported in 51 (49.0%) articles. Thirty-eight (36.5%) articles reported both ethics committee approval and consent, whereas 38 (36.5%) articles did not report both. Only five articles reported consent from guardian or parent whereas none of the articles were reported assent.

CONCLUSION: Findings from this study demonstrate that Ayurvedic clinical research articles lack in reporting ethics committee approval and written informed consent.