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


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


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.


CONCLUSIONS
Findings from this study demonstrate that Ayurvedic clinical research articles lack in reporting ethics committee approval and written informed consent.
Professional Medical Writer, Airoli, Navi Mumbai, Maharashtra, India.
Pravin M
PM
Bolshete
Ethics committee approval; publication ethics; written informed consent