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约旦基因研究中的知情同意书挑战

Informed Consent Form Challenges for Genetic Research in Jordan.

作者信息

Alkaraki Almuthanna K, Khabour Omar F, Alzoubi Karem H, Al-Ebbini Lina M K, Altaany Zaid

机构信息

Department of Biological Sciences, Faculty of Science, Yarmouk University, Irbid 21163, Jordan.

Department of Medical Laboratory Sciences, Faculty of Applied Medical Sciences, Jordan University of Science and Technology, Irbid 22110, Jordan.

出版信息

J Multidiscip Healthc. 2020 Mar 5;13:235-239. doi: 10.2147/JMDH.S243669. eCollection 2020.

Abstract

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.

摘要

背景

知情同意是涉及人类受试者研究的一项强制性要求。应为人类受试者提供知情同意书(ICF),以确认他们自愿参与研究的意愿。伦理和法律义务要求在ICF中纳入知情同意的基本要素。

目的

评估从约旦完成的不同基因研究中获得的ICF内容,以及它们对国际协调会议-良好临床实践(ICHGCP)提出的伦理准则的遵守情况。

方法和措施

根据ICHGCP提出的良好临床实践标准,对从约旦两所主要大学的硕士论文和资助申请中获得的44份ICF进行了分析。对ICF中是否存在ICF主要项目/类别进行评分。

结果

结果显示,所检查的ICF中存在信息不足的情况。最高信息得分为20分中的17分,最低得分为20分中的1分。所有研究的ICF的平均得分为6.18±3.65。大多数研究的ICF中缺少的基本项目/类别包括关于自愿参与的声明、数据保密、对研究参与者的补偿、研究的风险/益处以及研究人员的联系信息。

结论

ICF缺少一些必需的项目。这可能反映出约旦研究人员对最低知情同意要求的了解不足,突出了该国进行研究伦理培训的必要性。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b76/7062388/a5747b4c03d3/JMDH-13-235-g0001.jpg

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