A Systematic Review Finds Underreporting Of Ethics Approval, Informed Consent, And Incentives In Clinical Trials

Ly Quoc Trung,Mostafa Ebraheem Morra, Nguyen Duc Truong,Tarek Turk, Ahmed Elshafie, Amr Foly, Dao Ngoc Hien Tam,Ahmed Iraqi, Trinh Thi Hong Van,Ahmed Elgebaly, Tran Nhu Ngoc,Tran Le Huy Vu, Ngan Thy Chu,Kenji Hirayama,Juntra Karbwang,Nguyen Tien Huy

JOURNAL OF CLINICAL EPIDEMIOLOGY(2017)

引用 0|浏览0
暂无评分
摘要
Objectives: In this study, we aim to review researchers' reporting practices of the ethics statement, financial incentives, and local ethical committees' profile in their clinical trials.Study Design and Setting: A systematic search was done through top-ranked 50 medical journals (Scimago Ranking) to retrieve 2,000 latest publications. Only primary clinical trials were included with no restriction to language or participants.Results: Among the 927 included trials, 14 trials (1.5%) did not report an ethical statement and two-third (63%) did not completely report the investigated components (Institutional Review eBoard approval, Helsinki Declaration, and informed consent). Moreover, 21 trials (2.26%) reported motivational incentives with the method and amount of payment for participants. Of them, 15 trials offered monetary incentives to participants in different forms. In the remaining six trials, the incentives were mainly medical benefits. Only one trial reported the profile or quality of local Institutional Review Board.Conclusion: A potential gap in the reporting practices of ethics statement and financial incentives was addressed in this review. Authors are urged to fully report all ethical components related to their study, including incentives and compensations plan. Medical journals are also recommended to implement further publication requirements concerning ethics reporting. (C) 2017 Elsevier Inc. All rights reserved.
更多
查看译文
关键词
Ethics,Incentives,Randomized controlled trial,Informed consent,Ethical approval,Reporting quality
AI 理解论文
溯源树
样例
生成溯源树,研究论文发展脉络
Chat Paper
正在生成论文摘要