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Which way for genetic-test regulation? Assign regulation appropriate to the level of risk.

作者信息

Javitt Gail

机构信息

Berman Institute of Bioethics, Johns Hopkins University, USA.

出版信息

Nature. 2010 Aug 12;466(7308):817-8. doi: 10.1038/466817a.

DOI:10.1038/466817a
PMID:20703288
Abstract
摘要

相似文献

1
Which way for genetic-test regulation? Assign regulation appropriate to the level of risk.基因检测监管何去何从?根据风险水平进行适当监管。
Nature. 2010 Aug 12;466(7308):817-8. doi: 10.1038/466817a.
2
Which way for genetic-test regulation? Leave test interpretation to specialists.基因检测监管何去何从?将检测解读工作交给专家。
Nature. 2010 Aug 12;466(7308):816-7. doi: 10.1038/466816a.
3
Regulation: The FDA is overcautious on consumer genomics.监管:美国食品药品监督管理局(FDA)对消费者基因组学过于谨慎。
Nature. 2014 Jan 16;505(7483):286-7. doi: 10.1038/505286a.
4
Standard issue.标准配置。
Nature. 2010 Aug 12;466(7308):797. doi: 10.1038/466797a.
5
Putting DNA to the test.对DNA进行检测。
Nature. 2009 Oct 8;461(7265):697-8. doi: 10.1038/461697b.
6
Innovation, risk, and patient empowerment: the FDA-mandated withdrawal of 23andMe's Personal Genome Service.创新、风险与患者赋权:美国食品药品监督管理局强制要求23andMe公司撤回其个人基因组服务
JAMA. 2014 Feb 26;311(8):793-4. doi: 10.1001/jama.2014.148.
7
Genetic horoscopes: is it all in the genes? Points for regulatory control of direct-to-consumer genetic testing.基因星象:一切都由基因决定吗?关于直接面向消费者的基因检测监管控制的要点。
Eur J Hum Genet. 2009 Jul;17(7):857-9. doi: 10.1038/ejhg.2008.246. Epub 2009 Mar 4.
8
The FDA and 23andMe: violating the First Amendment or protecting the rights of consumers?美国食品药品监督管理局与23andMe公司:是违反了第一修正案还是在保护消费者权益?
Clin Chem. 2014 Jun;60(6):835-7. doi: 10.1373/clinchem.2014.223321. Epub 2014 May 1.
9
Science and regulation. Regulating direct-to-consumer personal genome testing.科学与监管。规范面向消费者的个人基因组检测。
Science. 2010 Oct 8;330(6001):181-2. doi: 10.1126/science.1194006.
10
Direct to consumer genetic tests.直接面向消费者的基因检测。
Eur J Hum Genet. 2009 Sep;17(9):1111. doi: 10.1038/ejhg.2009.66. Epub 2009 Apr 29.

引用本文的文献

1
Awareness and attitude of the public toward personalized medicine in Korea.韩国公众对个性化医学的认知和态度。
PLoS One. 2018 Feb 16;13(2):e0192856. doi: 10.1371/journal.pone.0192856. eCollection 2018.
2
FDA's Proposed Guidance for Laboratory Developed Tests: How Should Regulators Balance the Risks and Promise of Innovation in Clinical Genetics?美国食品药品监督管理局关于实验室自建检测的拟议指南:监管机构应如何平衡临床遗传学创新的风险与前景?
FDLIs Food Drug Policy Forum. 2015 Mar;5(2). Epub 2015 Feb 25.
3
Field of genes: an investigation of sports-related genetic testing.

本文引用的文献

1
Informational content, literacy demands, and usability of websites offering health-related genetic tests directly to consumers.向消费者直接提供与健康相关的基因检测服务的网站的信息内容、文化程度要求和可用性。
Genet Med. 2010 May;12(5):304-12. doi: 10.1097/GIM.0b013e3181dbd8b2.
2
Evaluation of risk prediction updates from commercial genome-wide scans.商业全基因组扫描风险预测更新的评估。
Genet Med. 2009 Aug;11(8):588-94. doi: 10.1097/GIM.0b013e3181b13a4f.
3
Genomic profiles for disease risk: predictive or premature?疾病风险的基因组图谱:是预测性的还是为时过早?
基因领域:运动相关基因检测研究。
J Pers Med. 2012 Sep 12;2(3):119-37. doi: 10.3390/jpm2030119.
4
Ethical and Professional Challenges Encountered by Laboratory Genetic Counselors.实验室遗传咨询师面临的伦理和职业挑战。
J Genet Couns. 2015 Aug;24(4):580-96. doi: 10.1007/s10897-014-9787-3. Epub 2014 Nov 16.
5
Genetic data and electronic health records: a discussion of ethical, logistical and technological considerations.遗传数据和电子健康记录:伦理、后勤和技术考虑因素的讨论。
J Am Med Inform Assoc. 2014 Jan-Feb;21(1):171-80. doi: 10.1136/amiajnl-2013-001694. Epub 2013 Jun 14.
6
Neither as harmful as feared by critics nor as empowering as promised by providers: risk information offered direct to consumer by personal genomics companies.既不像批评者所担心的那样有害,也不像供应商所承诺的那样具有赋权作用:个人基因组公司直接向消费者提供的风险信息。
J Community Genet. 2014 Jan;5(1):59-68. doi: 10.1007/s12687-012-0094-0. Epub 2012 Apr 5.
7
Direct-to-consumer personalized genomic testing.直接面向消费者的个性化基因组检测。
Hum Mol Genet. 2011 Oct 15;20(R2):R132-41. doi: 10.1093/hmg/ddr349. Epub 2011 Aug 9.
8
Direct-to-consumer testing: if consumers are not anxious, why are policymakers?直接面向消费者的检测:如果消费者不焦虑,政策制定者为何焦虑?
Hum Genet. 2011 Jul;130(1):23-5. doi: 10.1007/s00439-011-0987-8. Epub 2011 Apr 11.
9
Genetic testing for aldehyde dehydrogenase 2 deficiency in young adults.
Pharmacogenomics J. 2011 Aug;11(4):247-50. doi: 10.1038/tpj.2011.3. Epub 2011 Feb 15.
10
Bring on the biomarkers.引入生物标志物。
Nature. 2011 Jan 13;469(7329):156-7. doi: 10.1038/469156a.
JAMA. 2008 Mar 19;299(11):1353-5. doi: 10.1001/jama.299.11.1353.
4
A critical appraisal of the scientific basis of commercial genomic profiles used to assess health risks and personalize health interventions.对用于评估健康风险和个性化健康干预措施的商业基因组图谱的科学依据进行批判性评估。
Am J Hum Genet. 2008 Mar;82(3):593-9. doi: 10.1016/j.ajhg.2007.12.020.
5
Direct-to-consumer genetic tests, government oversight, and the First Amendment: what the government can (and can't) do to protect the public's health.直接面向消费者的基因检测、政府监管与第一修正案:政府为保护公众健康所能做(及不能做)之事。
Oklahoma Law Rev. 2004 Summer;57(2):251-302.