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Regulating Genomics: Time for a Broader Vision

机译:监管基因组学:视野开阔

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摘要

IN 2010, THE U.S. GOVERNMENT ACCOUNTABILITY OFFICE PAINTED A GRIM PICTURE of direct-to-consumer (DTC) genetic services that fueled debates and signaled regulatory action (www.gao.gov/products/GAO-10-847T). Now, online genetics services that offer tests to users without the involvement of a clinician have become a bone of contention in Europe as well. At the same time, European bioethics commissions and professional bodies are grappling with ethical and legal concerns. In 2012, the European Academies of Science Advisory Council (EASAC) and the Federation of European Academies of Medicine (FEAM) jointly published a report that addresses scientific, regulatory, and ethical issues related to DTC genetic testing for health purposes. This report-the farthest-reaching one thus far in terms of organizations and countries represented-set out to pursue a balanced approach that avoids both overregulation and "relinquishing strategy-setting to the private sector" (www.easac.eu).
机译:2010年,美国政府问责局将直接面向消费者(DTC)的遗传服务描绘成一张恐怖图片,引发了辩论并发出了监管行动(www.gao.gov/products/GAO-10-847T)。现在,在没有临床医生参与的情况下向用户提供测试的在线遗传学服务也已成为欧洲争论的焦点。同时,欧洲生物伦理委员会和专业机构正在努力解决伦理和法律问题。 2012年,欧洲科学研究院顾问委员会(EASAC)和欧洲医学研究院联合会(FEAM)共同发布了一份报告,该报告探讨了出于健康目的与DTC基因测试相关的科学,法规和道德问题。该报告是迄今为止在组织和国家方面影响最广的报告,着眼于寻求一种平衡的方法,既避免过度监管,又避免“放弃制定战略给私营部门”(www.easac.eu)。

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