Biobanking, consent, and commercialization in international genetics research: the Type 1 Diabetes Genetics Consortium.
Biobanking, consent, and commercialization in international genetics research: the Type 1 Diabetes Genetics Consortium.
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DOI：
10.1177/1740774510373492
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发表时间：
2010
期刊：
影响因子：
--
通讯作者：
T1DGC
中科院分区：
文献类型：
--
作者：
Hall MA;King NM;Perdue LH;Hilner JE;Akolkar B;Greenbaum CJ;McKeon C;T1DGC
背景和目的本文描述了在1型糖尿病遗传学联合会（T1DGC）中遇到的一些典型的国际遗传生物银行的伦理、法律和社会问题。方法通过研究其他国际生物银行研究的范例和经验教训，并投入大量时间和资源来识别、解决和持续监测伦理和监管问题，T1DGC能够最大限度地减少一些早期研究报告的问题。根据本研究的经验，可以得出以下几个重要结论：(1)研究伦理审查和知情同意的基本国际标准在发达国家基本一致；(2)当同意书在当地进行改编并翻译成不同的语言时，差异是不可避免的，因此需要在开始研究之前迅速进行中央审查和解决。(3)为研究的不同要素提供单独的“复选框”同意会造成混淆，可能不是必需的。(4)无论是在美国还是在国际上，创造不朽的细胞系来帮助未来的研究是被广泛接受的。(5)对储存样本的使用施加一些限制有助于在世界范围内获得伦理批准。允许捐赠样本的潜在商业用途在一些亚洲国家是有争议的。(7)获得政府批准既费时又费力，还需要法律和外交技巧。
Background and Purpose This article describes several ethical, legal, and social issues typical of international genetics biobanking, as encountered in the Type 1 Diabetes Genetics Consortium (T1DGC). Methods By studying the examples set and lessons learned from other international biobanking studies and by devoting considerable time and resources to identifying, addressing, and continually monitoring ethical and regulatory concerns, T1DGC was able to minimize the problems reported by some earlier studies. Conclusions Several important conclusions can be drawn based on the experience in this study: (1) Basic international standards for research ethics review and informed consent are broadly consistent across developed countries. (2) When consent forms are adapted locally and translated into different languages, discrepancies are inevitable and therefore require prompt central review and resolution before research is initiated. (3) Providing separate ‘check-box’ consent for different elements of a study creates confusion and may not be essential. (4) Creating immortalized cell lines to aid future research is broadly acceptable, both in the US and internationally. (5) Imposing some limits on the use of stored samples aids in obtaining ethics approvals worldwide. (6) Allowing potential commercial uses of donated samples is controversial in some Asian countries. (7) Obtaining government approvals can be labor-intensive and time-consuming, and can require legal and diplomatic skills.
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影响因子：
2.2
作者：
Renegar, G;Webster, CJ;Brazell, C
通讯作者：
Brazell, C
影响因子：
3.4
作者：
Blustein, Jan;Regenstein, Marsha;Billings, John
通讯作者：
Billings, John
影响因子：
1.4
作者：
Brody, B
通讯作者：
Brody, B
影响因子：
1.4
作者：
Brody, Barucb
通讯作者：
Brody, Barucb
DOI：
10.1017/cbo9780511545566.027
发表时间：
2008-01-01
期刊：
CAMBRIDGE TEXTBOOK OF BIOETHICS
影响因子：
--
作者：
Knoppers, Bartha Maria;Saginur, Madelaine
通讯作者：
Saginur, Madelaine