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患者对退出式基因组生物样本库的知晓与认可。

Patient awareness and approval for an opt-out genomic biorepository.

作者信息

Brothers Kyle B, Westbrook Mathew J, Wright M Frances, Myers John A, Morrison Daniel R, Madison Jennifer L, Pulley Jill M, Clayton Ellen Wright

机构信息

Center for Biomedical Ethics & Society, Vanderbilt University, Nashville, TN, USA ; Department of Pediatrics, Vanderbilt University & the Monroe Carell Jr.Children's Hospital at Vanderbilt, Nashville, TN, USA ; Kosair Charites Pediatric Clinical, Research Unit, Department of Pediatrics, University of Louisville, School of Medicine, Louisville, KY, USA.

Center for Biomedical Ethics & Society, Vanderbilt University, Nashville, TN, USA.

出版信息

Per Med. 2013 Jun;10(4). doi: 10.2217/pme.13.34.

DOI:10.2217/pme.13.34
PMID:24416062
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3882901/
Abstract

AIM

In this study, we sought to assess patient awareness and perceptions of an opt-out biorepository.

MATERIALS & METHODS: We conducted exit interviews with adult patients and parents of pediatric patients having their blood drawn as part of their clinical care at Vanderbilt University Medical Center (TN, USA).

RESULTS

32.9% of all patients and parents of pediatric patients report having heard of the opt-out biorepository, while 92.4% approve of this research effort based on a brief description. Awareness that leftover blood could be used for research increased among adult patients during the study period, from 34.3 to 50.0%.

CONCLUSION

These findings will inform ongoing assessments of the suitability of opt-out and opt-in methods as alternatives to written informed consent for inclusion in a biorepository.

摘要

目的

在本研究中,我们试图评估患者对退出式生物样本库的认知和看法。

材料与方法

我们对在美国田纳西州范德比尔特大学医学中心接受临床护理时进行抽血的成年患者及儿科患者的家长进行了出院访谈。

结果

所有患者及儿科患者的家长中,32.9%报告听说过退出式生物样本库,而基于简短描述,92.4%的人赞成这项研究工作。在研究期间,成年患者中知晓剩余血液可用于研究的比例从34.3%增至50.0%。

结论

这些发现将为正在进行的关于退出式和加入式方法作为书面知情同意之外纳入生物样本库替代方案的适用性评估提供参考。

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Patient awareness and approval for an opt-out genomic biorepository.患者对退出式基因组生物样本库的知晓与认可。
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Improving the informed consent process in international collaborative rare disease research: effective consent for effective research.改善国际合作罕见病研究中的知情同意程序:有效的研究需要有效的同意。
Eur J Hum Genet. 2016 Aug;24(9):1248-54. doi: 10.1038/ejhg.2016.2. Epub 2016 Feb 10.
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A systematic literature review of individuals' perspectives on broad consent and data sharing in the United States.关于美国个人对广泛同意和数据共享观点的系统文献综述。
Genet Med. 2016 Jul;18(7):663-71. doi: 10.1038/gim.2015.138. Epub 2015 Nov 19.
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The MICHR Genomic DNA BioLibrary: An Empirical Study of the Ethics of Biorepository Development.密歇根临床与健康研究中心基因组DNA生物文库:生物样本库开发伦理的实证研究
J Empir Res Hum Res Ethics. 2015 Feb;10(1):37-48. doi: 10.1177/1556264614564975. Epub 2015 Jan 6.
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Ethical and practical challenges to studying patients who opt out of large-scale biorepository research.研究选择退出大规模生物库研究的患者所面临的伦理和实践挑战。
J Am Med Inform Assoc. 2013 Dec;20(e2):e221-5. doi: 10.1136/amiajnl-2013-001937. Epub 2013 Jul 25.

本文引用的文献

1
The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.《贝尔蒙报告》。保护人类研究受试者的伦理原则与准则。
J Am Coll Dent. 2014 Summer;81(3):4-13.
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Identifying personal genomes by surname inference.姓氏推断识别个人基因组。
Science. 2013 Jan 18;339(6117):321-4. doi: 10.1126/science.1229566.
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Challenges in creating an opt-in biobank with a registrar-based consent process and a commercial EHR.创建一个基于注册器的同意流程和商业电子健康记录的选择加入生物银行的挑战。
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Two large-scale surveys on community attitudes toward an opt-out biobank.两项关于社区对默认生物库态度的大规模调查。
Am J Med Genet A. 2011 Dec;155A(12):2982-90. doi: 10.1002/ajmg.a.34304. Epub 2011 Nov 7.
5
Biobanking in pediatrics: the human nonsubjects approach.儿科生物样本库:人类非受试者方法。
Per Med. 2011 Jan;8(1):79. doi: 10.2217/pme.10.70.
6
Research ethics. Research practice and participant preferences: the growing gulf.研究伦理。研究实践与参与者偏好:日益扩大的差距。
Science. 2011 Jan 21;331(6015):287-8. doi: 10.1126/science.1199000.
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"Human non-subjects research": privacy and compliance.“人类非受试者研究”:隐私与合规
Am J Bioeth. 2010 Sep;10(9):15-7. doi: 10.1080/15265161.2010.492891.
8
Principles of human subjects protections applied in an opt-out, de-identified biobank.适用于默认选择、去识别生物库的人体受试者保护原则。
Clin Transl Sci. 2010 Feb;3(1):42-8. doi: 10.1111/j.1752-8062.2010.00175.x.
9
Effectiveness of the informed consent process for a pediatric resuscitation trial.知情同意过程对儿科复苏试验的有效性。
Pediatrics. 2010 Apr;125(4):e866-75. doi: 10.1542/peds.2009-2427. Epub 2010 Mar 15.
10
Research understanding, attitude and awareness towards biobanking: a survey among Italian twin participants to a genetic epidemiological study.对生物样本库的研究理解、态度和认知:对一项遗传流行病学研究的意大利双胞胎参与者的调查
BMC Med Ethics. 2009 Jun 16;10:4. doi: 10.1186/1472-6939-10-4.