基因组学和遗传研究中的知情同意。
Informed consent in genomics and genetic research.
机构信息
Center for Medical Ethics and Health Policy, Baylor College of Medicine, Houston, TX 77030, USA.
出版信息
Annu Rev Genomics Hum Genet. 2010;11:361-81. doi: 10.1146/annurev-genom-082509-141711.
Abstract
There are several features of genetic and genomic research that challenge established norms of informed consent. In this paper, we discuss these challenges, explore specific elements of informed consent for genetic and genomic research conducted in the United States, and consider alternative consent models that have been proposed. All of these models attempt to balance the obligation to respect and protect research participants with the larger social interest in advancing beneficial research as quickly as possible.
摘要
遗传和基因组研究有几个特点，对既定的知情同意规范提出了挑战。本文讨论了这些挑战，探讨了在美国进行的遗传和基因组研究中知情同意的具体要素，并考虑了已经提出的替代同意模式。所有这些模式都试图在尊重和保护研究参与者的义务与尽快推进有益研究的更大社会利益之间取得平衡。
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本文引用的文献
1
The Belmont Report. Ethical principles and guidelines for the protection of human subjects of research.
J Am Coll Dent. 2014 Summer;81(3):4-13.
2
The eMERGE Network: a consortium of biorepositories linked to electronic medical records data for conducting genomic studies.
BMC Med Genomics. 2011 Jan 26;4:13. doi: 10.1186/1755-8794-4-13.
3
Declaration of Helsinki. Ethical principles for medical research involving human subjects.
J Indian Med Assoc. 2009 Jun;107(6):403-5.
4
A new statistic and its power to infer membership in a genome-wide association study using genotype frequencies.
Nat Genet. 2009 Nov;41(11):1253-7. doi: 10.1038/ng.455. Epub 2009 Oct 4.
5
Prospective biorepository participants' perspectives on access to research results.
J Empir Res Hum Res Ethics. 2009 Sep;4(3):99-111. doi: 10.1525/jer.2009.4.3.99.
6
The ethical use of existing samples for genome research.
Genet Med. 2009 Oct;11(10):712-5. doi: 10.1097/GIM.0b013e3181b2e168.
7
Genomic privacy and limits of individual detection in a pool.
Nat Genet. 2009 Sep;41(9):965-7. doi: 10.1038/ng.436. Epub 2009 Aug 23.
8
Obtaining 'fresh' consent for genetic research with biological samples archived 10 years ago.
Eur J Cancer. 2009 May;45(7):1168-1174. doi: 10.1016/j.ejca.2008.11.022. Epub 2009 Feb 14.
9
The Genetic Information Nondiscrimination Act: fear factor or fantasy island?
Hastings Cent Rep. 2008 Nov-Dec;38(6):11-2. doi: 10.1353/hcr.0.0077.
10
Assessing the understanding of biobank participants.
Am J Med Genet A. 2009 Feb;149A(2):188-98. doi: 10.1002/ajmg.a.32635.
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