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本文引用的文献

1
Quality of consent forms in pharmacogenetic studies: a survey of research ethics committees in Spain.药物遗传学研究中知情同意书的质量：西班牙研究伦理委员会的一项调查
Per Med. 2006 Aug;3(3):231-237. doi: 10.2217/17410541.3.3.231.
2
Pharmacogenetic testing: legal considerations for consent, privacy and disclosure.药物遗传学检测：同意、隐私和披露的法律考量
Per Med. 2008 Mar;5(2):155-161. doi: 10.2217/17410541.5.2.155.
3
Clinician Perspectives on Using Pharmacogenomics in Clinical Practice.临床医生对在临床实践中应用药物基因组学的观点。
Per Med. 2015;12(4):339-347. doi: 10.2217/pme.15.10.
4
Patient perceptions and recall of consent for regional anaesthesia compared with consent for surgery.与手术同意书相比，患者对区域麻醉同意书的认知和回忆。
J R Soc Med. 2015 Nov;108(11):451-6. doi: 10.1177/0141076815604494. Epub 2015 Oct 2.
5
Experiences with obtaining informed consent for genomic sequencing.获取基因组测序知情同意书的经验。
Am J Med Genet A. 2015 Nov;167A(11):2635-46. doi: 10.1002/ajmg.a.37256. Epub 2015 Jul 21.
6
Patient feedback and early outcome data with a novel tiered-binned model for multiplex breast cancer susceptibility testing.新型分层分组模型用于多重乳腺癌易感性检测的患者反馈和早期结果数据。
Genet Med. 2016 Jan;18(1):25-33. doi: 10.1038/gim.2015.19. Epub 2015 Apr 2.
7
An index of barriers for the implementation of personalised medicine and pharmacogenomics in Europe.欧洲个性化医疗和药物基因组学实施的障碍指数
Public Health Genomics. 2014;17(5-6):287-98. doi: 10.1159/000368034. Epub 2014 Nov 15.
8
Preemptive clinical pharmacogenetics implementation: current programs in five US medical centers.前瞻性临床药物遗传学实施：美国五个医疗中心的当前项目
Annu Rev Pharmacol Toxicol. 2015;55:89-106. doi: 10.1146/annurev-pharmtox-010814-124835. Epub 2014 Oct 2.
9
Multiplex genetic testing: reconsidering utility and informed consent in the era of next-generation sequencing.多重基因检测：重新审视下一代测序时代的效用与知情同意
Genet Med. 2015 Feb;17(2):97-8. doi: 10.1038/gim.2014.85. Epub 2014 Jul 17.
10
Public perceptions of pharmacogenetics.公众对药物遗传学的看法。
Pediatrics. 2014 May;133(5):e1258-67. doi: 10.1542/peds.2013-1416.

药物遗传学检测的知情同意实践与观点综述

A review of consent practices and perspectives for pharmacogenetic testing.

作者信息

Haga Susanne B, Mills Rachel

机构信息

Center for Applied Genomics & Precision Medicine, Duke University, School of Medicine, 304 Research Drive, Box 90141, Durham, NC 27708, USA.

出版信息

Pharmacogenomics. 2016 Sep;17(14):1595-605. doi: 10.2217/pgs-2016-0039. Epub 2016 Aug 17.

DOI:10.2217/pgs-2016-0039
PMID:27533720
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5220438/
Abstract

AIM

We aimed to understand consent practices for pharmacogenetic (PGx) testing.

METHODS

We conducted a literature review and analysis of consent forms from clinical laboratories offering PGx testing.

RESULTS

Our review of the literature shows a lack of consensus about the need for and type of informed consent for PGx testing. We identified 35 companies offering PGx testing and were able to confirm consent practices for 22 of those. We found a range of variability in the consent practices regarding the consent approach and information disclosed.

CONCLUSION

Variability in the consent practices among laboratories offering PGx testing mirrors the ambiguous practices and recommendations reported in the literature. Establishing a minimal set of information to be disclosed to patients may help address the disparities in consent practice.

摘要

目的

我们旨在了解药物遗传学（PGx）检测的知情同意实践情况。

方法

我们对提供PGx检测的临床实验室的知情同意书进行了文献综述和分析。

结果

我们的文献综述表明，对于PGx检测的知情同意的必要性和类型缺乏共识。我们确定了35家提供PGx检测的公司，其中22家的知情同意实践得以确认。我们发现，在同意方式和披露信息方面，知情同意实践存在一系列差异。

结论

提供PGx检测的实验室之间知情同意实践的差异反映了文献中报道的模糊做法和建议。确定向患者披露的最少信息集可能有助于解决知情同意实践中的差异。