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Ethical, Legal, Social and Governance Issues in Non-Traditional Genetics and Genomics

非传统遗传学和基因组学中的伦理、法律、社会和治理问题

基本信息

批准号：
9921450
负责人：
MAXWELL J MEHLMAN
金额：
$ 8.03万
依托单位：
CASE WESTERN RESERVE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-05-01 至 2021-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9921450
关键词：
Agriculture Animals Archaea Attention Bacteria Benefits and Risks Bioethics Biological Biology Bioterrorism CRISPR/Cas technology Communities Computer software Crime Data Development Equipment Ethics Feedback Funding Future Gene Targeting Genes Genetic Genomics Human Individual Industry Informal Social Control Institutional Review Boards International Laws Legal Mammals Methodology Modification Odds Ratio Peer Review Plants Policies Policy Analysis Protocols documentation Public Health Publications Regulation Reporting Research Research Personnel Review Literature Risk Safety Sales Science Self Administration Source System Talents Techniques Technology Time United States United States National Institutes of Health ethical legal social implication experimental study fungus gene therapy innovation institutional biosafety committee interest meetings mindfulness open source science education skills social media symposium

项目摘要

A large and highly heterogeneous group of individuals conducts genetic and genomic research outside of traditional corporate and academic settings. They can be an important source of innovation, but their activities largely take place beyond the purview of existing regulatory systems for promoting safe and ethical practices. Historically the gene-targeting technology available for non-traditional biology (NTB) experiments has been limited, and therefore they have attracted little regulatory attention. New techniques such as CRISPR-cas9, however, may create a need for alternate governance approaches. The investigators will explore whether alternate governance approaches might be needed and, if so, what governance approaches would be most likely to enable non-traditional experiments to be conducted safely and ethically. To accomplish this overall objective, the project will identify current types of NTB activities and those likely in the near future; consider the risks and benefits of current and near-term NTB; conduct a policy analysis of the current governance approach and potential alternate approaches; disseminate a preliminary report of their findings to stakeholders, and incorporate their feedback into a final report that they will disseminate through peer-reviewed publications, formal presentations to scientific, legal, bioethics, and policy conferences, policy briefs, and presentations to NTB community labs, meetings, and conferences.

一个庞大且高度异质的个体群体进行遗传和基因组研究在传统的公司和学术环境之外。它们可以成为创新，但他们的活动在很大程度上超出了现有的监管范围促进安全和道德实践的系统。从历史上看，可用于非传统生物学（NTB）实验的材料有限，因此，几乎没有引起监管部门的注意。然而，CRISPR-cas9等新技术可能这就产生了对替代治理方法的需求。调查人员将探讨是否可能需要替代的治理方法，如果需要，什么治理方法最有可能使非传统实验能够安全和道德地进行。为实现这一总体目标，该项目将查明目前的非关税壁垒活动类型，考虑当前和近期非关税壁垒的风险和利益; 对当前的治理方法和潜在的替代方法进行政策分析向利益攸关方分发关于其调查结果的初步报告，将他们的反馈意见纳入最后报告，并通过同行评审的出版物传播，在科学、法律的、生物伦理学和政策会议、政策简报上作正式介绍，在NTB社区实验室、会议和研讨会上的演讲。