文章基本信息

标题：Informed Consent Form Challenges for Genetic Research in Jordan
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作者：Almuthanna K Alkaraki ; Omar F Khabour ; Karem H Alzoubi 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：2020
卷号：13
页码：235-239
DOI：10.2147/JMDH.S243669
出版社：Dove Medical Press Ltd
摘要：Background: Informed consent is an obligatory requirement for research engaging human subjects. Informed consent form (ICF) should be provided for human subjects to confirm their willingness for voluntary participation in a study. Ethical and legal obligations necessitate the presence of informed consent essential items to be built into the ICF. Objective: To evaluate the content of ICFs obtained from different genetic studies accomplished in Jordan and their adherence to ethical guidelines proposed by the International Conference on Harmonization—Good Clinical Practice (ICHGCP). Methods and Measures: A total of 44 ICFs obtained from master theses and grant proposals at two major universities in Jordan were analyzed according to the good clinical practice criteria proposed by ICHGCP. ICFs were scored for the presence or absence of ICF main items/categories. Results: Results show inadequate information present in the examined ICFs. The highest information score was 17 out of 20, while the lowest score was one out of 20. The average score for all studied ICFs was 6.18± 3.65. Among essential items/categories that were absent from the majority of studied ICFs were a statement about voluntary participation, confidentiality of data, compensation to study participants, risk/benefits of the study, and researchers’ contact information. Conclusion: The ICFs were missing a number of required items. This could reflect inadequate knowledge about minimal informed consent requirements among Jordanian investigators highlighting the need for research ethical training in the country..
关键词：informed consent form; challenges; genetic research; Jordan