Janakiram Chandrashekar, Porteri Corinna
a Department of Public Health Dentistry , Amrita School of Dentistry , Edapally , Ernakulam , India.
b Bioethics Unit , IRCCS San Giovanni Di Dio Fatebenefratelli , Brescia , Italy.
Account Res. 2016;23(3):163-177. doi: 10.1080/08989621.2015.1100540.
To study the proportion of articles reporting ethical review board (ERB) approval and informed consent process (ICP) in articles published in dental journals in India.
A descriptive study was designed, and ten Indian dental journals published by different dental specialty professional associations were selected. Among 702 retrieved articles, from 40 issues of the 10 selected journals published in 2008 and 2011, 428 meet the inclusion criteria, and they were analyzed. The entire text of the articles was manually searched for statements for ICP and ERB approval. The data was retrieved independently by two observers using an ad hoc developed template.
10.3% (44) of authors stated ICP, while 9.8 % (42) reported ERB approval in their articles; 6.1% (26) articles reported both the ICP and ERB. There are 21 times more chances that authors who report the ERB will also report ICP in their articles when compared to authors who report either ICP or ERB only (OR 21.3, 95% CI 8.5-52.8). Seven journals stated the ethical process reporting in the instructions for authors. Overall, 15.7% articles declared the conflicts of interests.
The low compliance of reporting ethical protection measures in dental research among Indian dental journals is of high concern.
研究印度牙科杂志发表的文章中报告伦理审查委员会(ERB)批准和知情同意过程(ICP)的文章比例。
设计了一项描述性研究,选取了由不同牙科专业协会出版的10种印度牙科杂志。在从2008年和2011年出版的10种选定杂志的40期检索到的702篇文章中,428篇符合纳入标准,并对其进行了分析。人工在文章全文中搜索关于ICP和ERB批准的声明。两名观察者使用专门开发的模板独立检索数据。
10.3%(44)的作者在文章中声明了ICP,而9.8%(42)报告了ERB批准;6.1%(26)的文章同时报告了ICP和ERB。与仅报告ICP或ERB的作者相比,报告ERB的作者在文章中也报告ICP的可能性高出21倍(比值比21.3,95%可信区间8.5 - 52.8)。7种杂志在作者须知中说明了伦理过程报告。总体而言,15.7%的文章声明了利益冲突。
印度牙科杂志在牙科研究中报告伦理保护措施的低依从性令人高度关注。