文章基本信息

标题：The quality of consent form structure in biomedical research: a study from Jordan and Sudan
本地全文：下载
作者：Mariam Abbas Ibrahim ; Osama Y Alshogran ; Omar F Khabour 等
期刊名称：Journal of Multidisciplinary Healthcare
印刷版ISSN：1178-2390
电子版ISSN：1178-2390
出版年度：2019
卷号：12
页码：727-731
DOI：10.2147/JMDH.S219316
出版社：Dove Medical Press Ltd
摘要：Background: Informed consent is one of the primary standards of ethical clinical research. This study assessed the quality of the informed consent forms (ICF) utilized in medical research conducted in Sudan and Jordan. Subjects and methods: A total of 435 studies that were performed at health sciences schools in Jordan and Sudan were initially screened for the presence of ICF. Of these, 189 studies were reviewed for the major components of ICF using a standard checklist. Results: The majority of the reviewed ICFs did not achieve the full standards of the universal guidelines for the informed consent structure. The following elements were described in >50% of consent forms reviewed from both countries: study title, objectives, research investigators, description of study procedure, and confidentiality. Other essential elements such as duration of the subject’s participation, risks/benefits, compensation, voluntary participation, and contact information were poorly described. Conclusion: The major elements of ICFs were not adequately described in medical research studies from Jordan and Sudan. Improved understanding of major elements of ICF among researchers in the examined countries is necessary. Clear and informative consent template can be very valuable in this perspective.
关键词：informed consent form; human research; medical sciences; Sudan; Jordan