Genetic Ownership: A Critical Analysis of Key Legal, Social and Bioethical Debates Concerning Genetic Ownership and the Rights of the Individual

研究背景：由于能够在家中进行直接面向消费者（DTC）的基因检测，社会对个人基因信息的兴趣日益浓厚。随着这些服务的可负担性和可用性，DTC公司可以承担其客户基因档案数据的所有权，甚至可能将该数据出售给其他商业公司以获取利润（Roberts, 2018）。此外，存在着DTC遗传数据被其他第三方利用的风险，而最近这种利用的来源来自国家当局内部。2018年，美国执法机构成功地对包含DTC基因谱系数据的开放平台进行了在线搜索，以确定连环罪犯金州杀手（Phillips, 2018）。这些搜索受到批评，因为它们是在没有监管监督的情况下进行的，缺乏透明度和问责制（Murphy, 2018）。尽管如此，调查实践在美国已经聚集了巨大的势头，私营公司现在提供服务，代表执法机构进行法医遗传谱系分析和搜索，并取得了很大的成功（Greytak等人，2019）。因此，美国司法部发布了一项关于执法机构使用法医基因谱系的临时政策，以规范这一做法，并平衡公民的权利（美国司法部，2019年）。美国的调查成功并没有被英国的刑事司法机构忽视，一些评论员认为，在这里引入调查实践只是时间问题（Corbyn, 2018）。因此，存在这样一种可能性，即无辜的公众成员可能仅仅因为使用了DTC基因检测服务而面临英国执法机构的秘密审查。然而，这些问题的核心是法律和政策制定者面临的一个根本挑战，那就是在DTC基因检测的背景下定义基因所有权。如果消费者拥有由DTC基因检测分析产生的基因数据，那么对结果基因数据集的访问将由这些个人的法律权利决定。目的和目标：该项目的总体目标是创建一个学术资源，为未来的政策制定和法律改革提供信息，以规范第三方对DTC遗传数据集的访问，保护数据主体的权利，并在这些权利被侵犯时制定法律补救途径。该项目的目标将通过评估现有的法律和监管框架来实现，以确定谁拥有和享有DTC基因检测背景下遗传数据的合法权利，并确定是否需要进一步的法律保护来限制第三方利用遗传数据集和保护数据主体的权利。该研究项目还将考虑DTC基因检测公司和开放平台为保护DTC基因数据和数据主体而采取的任何额外措施。此外，还将评估法医遗传谱系对刑事司法程序、法院和公众的影响。研究的潜在应用和好处：研究项目的产出不仅有助于为未来的政策和法律改革提供信息，而且有利于审查DTC基因检测行业的现有法规，以及英国调查实践的潜在就业。此外，这项研究将提高公众在参与DTC基因检测公司的服务时对个人基因数据的合法权利的认识，澄清这些权利，并强调在网上分享基因数据时对个人及其家庭的任何影响。

Context of the research:Increased social interest in personal genetic information has been fueled by the ability to conduct Direct-to-Consumer (DTC) genetic testing at home. With the affordability and availability of these services comes the caveat that DTC companies can assume ownership of their customers' genetic profile data and may even sell that data on to other commercial companies for profit (Roberts, 2018). Additionally, the risk exists the DTC genetic data is exploited by other third parties, where, most recently, the source of that exploitation has originated from within state authorities.In 2018, United States law enforcement agencies successfully conducted online searches of an open platform containing DTC genetic genealogy data to identify the serial offender the Golden State Killer (Phillips, 2018). The searches were criticised as they were conducted without regulatory oversight, lacked transparency and also accountability (Murphy, 2018). Nonetheless, the investigative practice has gathered significant momentum within the United States where private companies now provide a service to conduct forensic genetic genealogical analysis and searches on behalf of law enforcement agencies with much publicised success (Greytak et al., 2019). Consequently, the United States Department of Justice published an interim policy on the employment of forensic genetic genealogy by law enforcement agencies to regulate the practice and also balance the rights of citizens (U.S. Department of Justice, 2019).The investigative successes in the United States have not gone unnoticed by criminal justice agencies within the United Kingdom, with some commentators suggesting it is only a matter of time before the investigative practice is introduced here (Corbyn, 2018). Therefore, the possibility exists that innocent members of the public could face covert scrutiny by law enforcement agencies within the United Kingdom simply because they engaged a DTC genetic testing service. Yet, at the heart of these issues lies a fundamental challenge for law and policy makers, and that is to define genetic ownership within the context of DTC genetic testing. If consumers owned the genetic data generated by DTC genetic testing analysis then access to resultant genetic datasets would be dictated by the legal rights of those individuals.Aims and objectives:The overall aim of this project is to create an academic resource to inform future policy development and legal reform to regulate third-party access to DTC genetic datasets and protect the rights of data subjects, setting out avenues for legal redress where those rights are breached. The objective of the project will be achieved through evaluating existing legal and regulatory frameworks to determine who owns and enjoys legal rights to genetic data within the context of DTC genetic testing and determine whether further legal protections are required to limit third-party exploitation of genetic datasets and protect the rights of data subjects. The research project will also consider any additional measures DTC genetic testing companies and open platforms have put in place to protect DTC genetic data and data subjects. Furthermore, the impact of forensic genetic genealogy on criminal justice processes, the courts, and the public will also be evaluated.Potential applications and benefits of the research:Output from the research project will not only help inform future policy and legal reform but will also benefit review of existing regulation of the DTC genetic testing industry and the potential employment of the investigative practice within the United Kingdom. Moreover, the research will enhance public awareness of individuals' legal rights to their personal genetic data when engaging the services of DTC genetic testing companies, providing clarification on those rights and highlighting any implications for the individual, and their families, when sharing genetic data online.