Ethical approval and informed consent reporting in ASEAN journals: a systematic review. (2nd December 2019)

• Record Type: Journal Article
• Authors: Laothavorn, Junjira; Wongwai, Pantipa; Prakash Dumre, Shyam; Kongjam, Panida; Na-Bangchang, Kesara; Karbwang, Juntra
• Is Part Of: Current medical research and opinion. Volume 35:Number 12(2019)
• Page Start: 2179
• Page End: 2186
• Publication Date: 2019-12-02
• Subjects: Publication -- ethics -- ethical approval -- informed consent; Clinical medicine -- Periodicals; Therapeutics -- Periodicals; 615.5
• DOI: 10.1080/03007995.2019.1647505
• Languages: English
• ISSNs: 0300-7995

Abstract

Abstract: Background and objective: 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. Methods: 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 p -value < .05 being considered statistically significant. Results: 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: p = .002; IC: p = .019). Conclusions: 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.