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研究人员对南非生物样本库研究的知情同意和伦理审查的看法:一项横断面研究。

Researchers' Perspectives on Informed Consent and Ethical Review of Biobank Research in South Africa: A Cross-Sectional Study.

作者信息

Mwaka Erisa, Horn Lyn

机构信息

1 Makerere University College of Health Sciences, Kampala, Uganda.

2 University of Kwazulu-Natal, Durban, South Africa.

出版信息

J Empir Res Hum Res Ethics. 2019 Oct;14(4):307-317. doi: 10.1177/1556264619866991. Epub 2019 Aug 5.

DOI:10.1177/1556264619866991
PMID:31378129
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6733622/
Abstract

There is limited literature on the opinions and perspectives of researchers on the ethical issues in biobank research in South Africa. This study aimed to explore researchers' perspectives on informed consent and ethical review of biobank research in South Africa. An online survey was conducted among researchers and scientists at Stellenbosch University and the University of Kwazulu-Natal. The majority of researchers opined that broad consent is appropriate for biobank research. However, there was no consensus on the necessity for re-consent. Researchers were also in agreement that issues concerning informed consent and future use of samples require thorough discussions during the ethical review process. Overall, the attitude of researchers on informed consent and ethical review of biobank research was positive and ethically informed.

摘要

关于南非生物样本库研究中伦理问题的研究者观点和看法的文献有限。本研究旨在探讨南非研究者对生物样本库研究知情同意和伦理审查的观点。在斯泰伦博斯大学和夸祖鲁 - 纳塔尔大学的研究者和科学家中进行了一项在线调查。大多数研究者认为宽泛同意适用于生物样本库研究。然而,对于重新获得同意的必要性并未达成共识。研究者们还一致认为,在伦理审查过程中,有关知情同意和样本未来使用的问题需要进行深入讨论。总体而言,研究者对生物样本库研究知情同意和伦理审查的态度是积极且符合伦理规范的。

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本文引用的文献

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Managing the Unimaginable: Biobank Participant Views on Reconsent for Whole Genome Sequencing of Stored Biospecimens.应对难以想象之事:生物样本库参与者对存储生物样本进行全基因组测序重新知情同意的看法。
Biopreserv Biobank. 2019 Aug;17(4):296-302. doi: 10.1089/bio.2018.0077. Epub 2019 Mar 26.
2
Decentralisation of child tuberculosis services increases case finding and uptake of preventive therapy in Uganda.儿童结核病服务的去中心化增加了乌干达的病例发现和预防性治疗的接受率。
Int J Tuberc Lung Dis. 2018 Nov 1;22(11):1314-1321. doi: 10.5588/ijtld.18.0025.
3
"It's all about trust": reflections of researchers on the complexity and controversy surrounding biobanking in South Africa.“一切都关乎信任”:研究人员对南非生物样本库相关复杂性与争议的反思
BMC Med Ethics. 2016 Oct 10;17(1):57. doi: 10.1186/s12910-016-0140-2.
4
Data mining and biological sample exportation from South Africa: A new wave of bioexploitation under the guise of clinical care?从南非进行数据挖掘和生物样本输出:以临床护理为幌子的新一轮生物剥削?
S Afr Med J. 2016 Jan 7;106(2):136-8. doi: 10.7196/SAMJ.2016.v106i2.10248.
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Returning a Research Participant's Genomic Results to Relatives: Analysis and Recommendations.向研究参与者的亲属反馈基因组结果:分析与建议。
J Law Med Ethics. 2015 Fall;43(3):440-63. doi: 10.1111/jlme.12288.
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Biobanking Research and Human Subjects Protections: Perspectives of IRB Leaders.生物样本库研究与人体受试者保护:机构审查委员会负责人的观点
IRB. 2015 Mar-Apr;37(2):8-13.
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Broad Consent for Research With Biological Samples: Workshop Conclusions.生物样本研究的广泛同意:研讨会结论
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