Navabi Nader, Shahravan Arash, Modaberi Ali
Oral and Dental Diseases Research Center, Kerman University of Medical Sciences, Kerman, Iran.
Iran J Public Health. 2013 Jun 1;42(6):594-601. eCollection 2013.
Ethical consideration is a basic requirement for design of randomized clinical trials. The purpose of this study was to assess whether reports of Iranian dental clinical trials complied with the requirements of the ethical principles of human research.
In this retrospective observational study electronic search was performed to identify all dental clinical trials published between 2001 and 2011. Each trial report was assessed for inclusion of a statement that 17 items about research ethics.
Totally 242 papers were identified, of which 15.3%, stated that ethical approval had been obtained and 50.4% of the trial reports indicated that informed consent had been obtained. The mean ethical score for the mentioned studies was 7/68 out of 17.
Most Iranian dental clinical trial reports failed to consider important ethical principles. The reporting of the ethical issues associated with these trials could be improved further not only by the instructions to authors, but also by Journal editors refusing to publish trials that do not comply.
伦理考量是随机临床试验设计的基本要求。本研究旨在评估伊朗牙科临床试验报告是否符合人体研究伦理原则的要求。
在这项回顾性观察研究中，通过电子检索来识别2001年至2011年间发表的所有牙科临床试验。对每份试验报告进行评估，看是否包含一份关于17项研究伦理内容的声明。
共识别出242篇论文，其中15.3%表明已获得伦理批准，50.4%的试验报告表明已获得知情同意。上述研究的平均伦理得分在17分中为7.68分。
大多数伊朗牙科临床试验报告未考虑重要的伦理原则。不仅通过对作者的指导，而且通过期刊编辑拒绝发表不符合要求的试验，与这些试验相关的伦理问题报告可以得到进一步改善。
