Graduate Program in Bioclinical Sciences, Thammsart University, Pathumthani, Thailand.
Department of Ophthalmology, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.
Curr Med Res Opin. 2019 Dec;35(12):2179-2186. doi: 10.1080/03007995.2019.1647505. Epub 2019 Sep 13.
Scientific publication is a way to disseminate knowledge to the scientific community. However, an article usually has very little information on how and why ethical approval (EA) and informed consent (IC) was obtained, which can make it very difficult for a reader to evaluate the ethical validity of the study. While many internationally recognized journals and publishers have already adopted a high EA/IC reporting standard, many journals still fail to do so. The aim of this study was to explore the EA/IC reporting standards, as well as their implementation, of the Association of Southeastern Asian Nation (ASEAN) member journals. A literature search was performed in PubMed for articles that were published in journals from ASEAN member states in 2016. The articles were then reviewed, categorized into study types, and given two scores-one for their EA statement and one for their IC statement-ranging from 0-4. A list of journals was compiled from the articles retrieved and their instructions to authors regarding EA/IC statements were scored on a scale of 0-2. The data was statistically analyzed using Chi-square test (2-sided) with SPSS (version 21) with -value < .05 being considered statistically significant. While a high proportion of articles adequately reported EA, many failed to report IC. Journals with better EA and IC instruction scores had a higher percentage of articles that adequately reported EA/IC. There were significant relationships between EA/IC statement scores and journals' instructions scores (EA: = .002; IC: = .019). There may be a need for journals to play key roles in advocating the importance of reporting EA and IC by strictly enforcing high EA/IC reporting standards and refusing the publication of articles that fail to comply.
科学出版物是向科学界传播知识的一种方式。然而，一篇文章通常很少提供有关如何以及为何获得伦理批准 (EA) 和知情同意 (IC) 的信息，这使得读者很难评估研究的伦理有效性。虽然许多国际认可的期刊和出版商已经采用了高 EA/IC 报告标准，但许多期刊仍然没有这样做。本研究旨在探讨东盟成员国期刊的 EA/IC 报告标准及其实施情况。在 PubMed 中进行了文献检索，以查找 2016 年在东盟成员国期刊上发表的文章。然后对这些文章进行了审查，根据研究类型进行了分类，并对 EA 声明和 IC 声明分别进行了评分，评分范围为 0-4。从检索到的文章中编制了一份期刊清单，并对其关于 EA/IC 声明的作者说明进行了评分，评分范围为 0-2。使用 SPSS（版本 21）的 Chi-square 检验（双侧）对数据进行了统计分析，-值 <.05 被认为具有统计学意义。虽然相当一部分文章充分报告了 EA，但许多文章未能报告 IC。EA 和 IC 指导得分较高的期刊，充分报告 EA/IC 的文章比例较高。EA/IC 声明得分与期刊说明得分之间存在显著关系（EA：=.002；IC：=.019）。期刊可能需要发挥关键作用，通过严格执行高 EA/IC 报告标准并拒绝发表不符合要求的文章，倡导报告 EA 和 IC 的重要性。
