当前位置: X-MOL 学术Am. J. Hum. Genet. › 论文详情
Our official English website, www.x-mol.net, welcomes your feedback! (Note: you will need to create a separate account there.)
“Choice of law” in precision medicine research
American Journal of Human Genetics ( IF 9.8 ) Pub Date : 2022-08-05 , DOI: 10.1016/j.ajhg.2022.06.009
Laura M Beskow 1 , Leslie E Wolf 2
Affiliation  

Large-scale precision medicine research requires massive amounts of data representing people from all walks of life; thus, in the US, it is often multistate research. Significant legal and ethical quandaries arise as a result of the patchwork of laws states have enacted that may apply to research, are not preempted by federal law, and may impose requirements or provide participant rights and protections that differ from other states. Determining which state’s laws apply, and under what circumstances, is not solved by the transition to a single-IRB model and researchers cannot simply choose one state’s laws to apply uniformly. At a minimum, the current process of meeting each state’s requirements could be made more reliable and efficient. To fundamentally change this status quo, however, requires action at multiple levels. Federally, well-known gaps in the Genetic Information Nondiscrimination Act should be closed, and a coherent system of compensation for research injury—including non-physical injuries—should be developed. States should clarify which of their laws are intended to apply to research and work collaboratively to harmonize them. At the level of individual research projects, numerous policies and procedures could be standardized through authoritative guidelines. Examples include clarifying the scope of broad consent, understanding and upholding Certificates of Confidentiality, offering individual research results responsibly, and consistently disseminating aggregate results to participants and the public. Overall, development of a choice of law framework specific to the research context could significantly promote clarity and consistency.



中文翻译:

精准医学研究中的“法则选择”

大规模的精准医学研究需要海量的代表各行各业人群的数据;因此,在美国,它通常是多州研究。由于各州颁布的可能适用于研究的法律错综复杂,未被联邦法律取代,并且可能强加要求或提供与其他州不同的参与者权利和保护,因此出现了重大的法律和道德困境。确定哪个州的法律适用以及在什么情况下适用,并不能通过过渡到单一 IRB 模型来解决,研究人员不能简单地选择一个州的法律来统一应用。至少,当前满足每个州要求的过程可以变得更加可靠和高效。然而,要从根本上改变这种现状,需要在多个层面采取行动。联邦政府,遗传信息非歧视法案中众所周知的漏洞应该被弥补,并且应该制定一个连贯的研究伤害赔偿制度 - 包括非身体伤害。各国应阐明其哪些法律旨在适用于研究并协同工作以协调这些法律。在单个研究项目层面,许多政策和程序可以通过权威指南进行标准化。示例包括澄清广泛同意的范围、理解和维护保密证书、负责任地提供个人研究结果,以及始终如一地向参与者和公众传播汇总结果。总体而言,针对特定研究背景制定法律框架选择可以显着提高清晰度和一致性。

更新日期:2022-08-05
down
wechat
bug