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本文引用的文献

1
Biospecimen Reporting for Improved Study Quality.生物样本报告以提高研究质量。
Biopreserv Biobank. 2011 Apr;9(1):57-70. doi: 10.1089/bio.2010.0036.
2
Qualitative thematic analysis of consent forms used in cancer genome sequencing.癌症基因组测序中使用的知情同意书的定性主题分析。
BMC Med Ethics. 2011 Jul 19;12:14. doi: 10.1186/1472-6939-12-14.
3
Quality Assurance in Tissue Resources Supporting Biomedical Research.支持生物医学研究的组织资源中的质量保证。
Cell Preserv Technol. 2008 Jul 30;6(2):113-118. doi: 10.1089/cpt.2008.9993..
4
Public perspectives on returning genetics and genomics research results.公众对返还遗传学和基因组学研究结果的看法。
Public Health Genomics. 2011;14(6):346-55. doi: 10.1159/000324933. Epub 2011 May 7.
5
Disclosing individual CDKN2A research results to melanoma survivors: interest, impact, and demands on researchers.向黑色素瘤幸存者披露个体 CDKN2A 研究结果:利益、影响和对研究人员的要求。
Cancer Epidemiol Biomarkers Prev. 2011 Mar;20(3):522-9. doi: 10.1158/1055-9965.EPI-10-1045. Epub 2011 Feb 9.
6
Missing part delays space mission.部件缺失延误太空任务。
Nature. 2011 Jan 20;469(7330):280. doi: 10.1038/469280a.
7
Ethical and practical guidelines for reporting genetic research results to study participants: updated guidelines from a National Heart, Lung, and Blood Institute working group.向研究参与者报告基因研究结果的伦理与实践指南:美国国立心肺血液研究所工作组的更新指南
Circ Cardiovasc Genet. 2010 Dec;3(6):574-80. doi: 10.1161/CIRCGENETICS.110.958827.
8
Communication of biobanks' research results: what do (potential) participants want?生物银行研究结果的交流:(潜在)参与者想要什么?
Am J Med Genet A. 2010 Oct;152A(10):2482-92. doi: 10.1002/ajmg.a.33617.
9
Offering individual genetic research results: context matters.提供个体基因研究结果:背景很重要。
Sci Transl Med. 2010 Jun 30;2(38):38cm20. doi: 10.1126/scitranslmed.3000952.
10
Biobank research: reporting results to individual participants.生物样本库研究:向个体参与者报告结果。
Eur J Health Law. 2009 Sep;16(3):229-47. doi: 10.1163/157180909x453062.

生物银行在个体研究结果回报方面的实际实施问题和挑战。

Practical implementation issues and challenges for biobanks in the return of individual research results.

机构信息

Department of Veterans Affairs, Washington, DC, USA.

出版信息

Genet Med. 2012 Apr;14(4):478-83. doi: 10.1038/gim.2011.67. Epub 2012 Feb 9.

DOI:10.1038/gim.2011.67
PMID:22323073
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3388905/
Abstract

Whether or not to give research results back to individuals whose specimens are used for biomedical research is a subject of considerable controversy. Much of the debate has been focused around the ethical and legal concerns with some consideration of broader social issues such as whether or not people will be affected by such information for employment or health care. Much less attention has been paid to biobanks that collect the specimens used to generate the research findings and the issues and operational requirements for implementing return of individual research results. In this article, we give the biobanks' perspective and highlight that given the diversity among the types of biobanks, it may be difficult to design and implement a blanket policy in this complex area. We discuss the variability in the types of biobanks and some important issues that should be considered in determining whether or not research results should be provided to individuals whose specimens are used in biomedical research. We also discuss challenges that should be considered in implementing any approaches to the return of research results.

摘要

是否将研究成果归还给生物医学研究中使用其样本的个人是一个颇具争议的话题。大部分争论集中在伦理和法律问题上,也有一些人考虑了更广泛的社会问题,例如人们是否会因这些信息而在就业或医疗保健方面受到影响。然而,对于收集用于生成研究结果的样本的生物库以及实施个体研究结果返还的问题和操作要求,关注较少。在本文中,我们从生物库的角度出发,并强调鉴于生物库类型的多样性,在这个复杂的领域中设计和实施全面的政策可能具有一定难度。我们讨论了生物库类型的可变性,以及在确定是否应向在生物医学研究中使用其样本的个人提供研究结果时应考虑的一些重要问题。我们还讨论了在实施任何研究结果返还方法时应考虑的挑战。