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.
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。
相似文献
1
Researchers' Perspectives on Informed Consent and Ethical Review of Biobank Research in South Africa: A Cross-Sectional Study.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。
J Empir Res Hum Res Ethics. 2019 Oct;14(4):307-317. doi: 10.1177/1556264619866991. Epub 2019 Aug 5.
2
"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.
3
"It's my blood": ethical complexities in the use, storage and export of biological samples: perspectives from South African research participants.“这是我的血液”：生物样本使用、储存及出口中的伦理复杂性：南非研究参与者的观点
BMC Med Ethics. 2014 Jan 22;15:4. doi: 10.1186/1472-6939-15-4.
4
Research Ethics Committees' Oversight of Biomedical Research in South Africa: A Thematic Analysis of Ethical Issues Raised During Ethics Review of Non-Expedited Protocols.南非研究伦理委员会对生物医学研究的监督：对非快速审查方案伦理审查期间提出的伦理问题的主题分析。
J Empir Res Hum Res Ethics. 2019 Apr;14(2):107-116. doi: 10.1177/1556264618824921. Epub 2019 Jan 24.
5
Collaborative international research: ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics committee.国际合作研究：南非某机构研究伦理委员会中与人类生物样本相关的伦理和监管问题
Dev World Bioeth. 2014 Dec;14(3):150-7. doi: 10.1111/dewb.12018. Epub 2013 May 31.
6
Stakeholder perspectives on the ethico-legal dimensions of biobanking in South Africa.南非生物库伦理法律维度的利益相关者观点。
BMC Med Ethics. 2021 Jul 1;22(1):84. doi: 10.1186/s12910-021-00645-z.
7
Ethical consideration of the research proposal and the informed-consent process: An online survey of researchers and ethics committee members in Thailand.研究提案和知情同意过程的伦理考虑：泰国研究人员和伦理委员会成员的在线调查。
Account Res. 2019 Apr;26(3):176-197. doi: 10.1080/08989621.2019.1608190. Epub 2019 May 16.
8
Ethical issues of informed consent in malaria research proposals submitted to a research ethics committee in Thailand: a retrospective document review.提交给泰国研究伦理委员会的疟疾研究提案中知情同意的伦理问题：一项回顾性文件审查
BMC Med Ethics. 2017 Aug 14;18(1):50. doi: 10.1186/s12910-017-0210-0.
9
"It's for a good cause, isn't it?" - Exploring views of South African TB research participants on sample storage and re-use.“这是为了一个好的事业，不是吗？”——探索南非结核病研究参与者对样本存储和再利用的看法。
BMC Med Ethics. 2012 Jul 25;13:19. doi: 10.1186/1472-6939-13-19.
10
Researchers' Perspectives Regarding Ethical Issues of Biobank Research in the Arab Region.研究人员对阿拉伯地区生物库研究中伦理问题的看法。
Biopreserv Biobank. 2024 Apr;22(2):98-109. doi: 10.1089/bio.2022.0112. Epub 2023 Mar 23.
引用本文的文献
1
Broad consent for biobank research in South Africa - Towards an enabling ethico-legal framework.南非生物样本库研究的广泛同意——迈向有利的伦理法律框架。
Glob Bioeth. 2023 Dec 20;35(1):2288331. doi: 10.1080/11287462.2023.2288331. eCollection 2024.
2
Ethical considerations for biobanking and use of genomics data in Africa: a narrative review.非洲生物银行和基因组学数据使用的伦理考虑：叙事性综述。
BMC Med Ethics. 2023 Dec 5;24(1):108. doi: 10.1186/s12910-023-00985-y.
3
Health care users' acceptance of broad consent for storage of biological materials and associated data for research purposes in Uganda.乌干达医疗保健用户对为研究目的存储生物材料及相关数据的广泛同意的接受情况。
Wellcome Open Res. 2022 Oct 4;7:73. doi: 10.12688/wellcomeopenres.17633.2. eCollection 2022.
4
Researchers' Perspectives Regarding Ethical Issues of Biobank Research in the Arab Region.研究人员对阿拉伯地区生物库研究中伦理问题的看法。
Biopreserv Biobank. 2024 Apr;22(2):98-109. doi: 10.1089/bio.2022.0112. Epub 2023 Mar 23.
5
Stakeholder perspectives on the ethico-legal dimensions of biobanking in South Africa.南非生物库伦理法律维度的利益相关者观点。
BMC Med Ethics. 2021 Jul 1;22(1):84. doi: 10.1186/s12910-021-00645-z.
本文引用的文献
1
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.
5
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.
6
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.
7
Linking Broad Consent to Biobank Governance: Support From a Deliberative Public Engagement in California.将广泛同意与生物样本库治理相联系：来自加利福尼亚州一次审议性公众参与活动的支持。
Am J Bioeth. 2015;15(9):56-7. doi: 10.1080/15265161.2015.1062177.
8
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
Am J Bioeth. 2015;15(9):34-42. doi: 10.1080/15265161.2015.1062162.
9
Developing Ethical Practices for Public Health Research Data Sharing in South Africa: The Views and Experiences From a Diverse Sample of Research Stakeholders.制定南非公共卫生研究数据共享的道德规范：来自不同研究利益相关者样本的观点和经验。
J Empir Res Hum Res Ethics. 2015 Jul;10(3):290-301. doi: 10.1177/1556264615592386.
10
Return of genetic testing results in the era of whole-genome sequencing.全基因组测序时代的基因检测结果回报。
Nat Rev Genet. 2015 Sep;16(9):553-9. doi: 10.1038/nrg3960. Epub 2015 Aug 4.
Zotero 插件