研究人员和机构审查委员会成员对知情同意书中必要要素的理解。
Understanding of Essential Elements Required in Informed Consent Form among Researchers and Institutional Review Board Members.
作者信息
Koonrungsesomboon Nut, Laothavorn Junjira, Karbwang Juntra
机构信息
Department of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, Nagasaki, Japan ; Graduate School of Biomedical Science, Nagasaki University, Nagasaki, Japan.
Albany Law School, NY, USA.
出版信息
Trop Med Health. 2015 Jun;43(2):117-22. doi: 10.2149/tmh.2014-36. Epub 2015 Jan 31.
The process of informed consent remains a constant challenge in clinical research. The aim of the present study was to evaluate the understanding of researchers and members of Institutional Review Boards (IRBs) regarding the essential elements of an Informed Consent Form (ICF) as required by internationally recognized regulations. Using eight case studies to illustrate basic ethical elements, the study involved 107 participants, mainly from the Asia Pacific and African regions. The results showed that most of the participants had general knowledge regarding the essential elements required in an ICF. However, the issues of confidentiality of data and payment for study participation proved to be problematic for some participants, accounting for 35% and 28% of all incorrect answers respectively. This suggests that participants' understanding of the underlying concepts of the required ICF elements is limited. Ethical training of researchers and IRB members, particularly in the Asia Pacific and African regions, concerning valid informed consent is still needed.
在临床研究中，知情同意过程始终是一项挑战。本研究的目的是评估研究人员和机构审查委员会（IRB）成员对国际认可法规要求的知情同意书（ICF）基本要素的理解。该研究使用八个案例研究来说明基本伦理要素，涉及107名参与者，主要来自亚太地区和非洲地区。结果表明，大多数参与者对ICF所需的基本要素有一般了解。然而，数据保密性和研究参与报酬问题对一些参与者来说存在问题，分别占所有错误答案的35%和28%。这表明参与者对所需ICF要素的基本概念理解有限。仍需要对研究人员和IRB成员进行伦理培训，特别是在亚太地区和非洲地区，以确保有效的知情同意。
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