人类基因信息利用的价值选择及规则构造

Value Selection and Rule Construction of the Utilization of Human Gene Information

精准医疗的实现以生物医学大数据的存在为前提,患者、受试者的基因信息被用于科学目的,研究者不再将研究对象视为患者,突破了传统医疗上知情同意的“信赖义务”。现代相互关联的大数据环境可能会表现出隐私的相互依存性,个人的隐私受到他人决定的影响。然而,纯个人主义的自治模式过于狭窄,其重在描述传统医患关系框架与权力格局中患者天生的弱势地位,而忽视了其他外在力量的重要性,这在新的技术、政策环境中易出现问题。自治并非唯一价值,其应当与其他价值相平衡。现今的知情同意原则是基于公正伦理学上的预设,而无弱势族群利益保护的考量。精准医疗背景下对基因信息的利用应当严格限定在新的道德框架之内,以群体维度构建基因信息的保护规则,采取“动态+广泛同意”的模式,即以合作研究模式进行,明确当事人的撤销权及其限度。

The realization of precision medicine is based on the existence of biomedical big data,and the genetic informa-tion of patients and participants is used for scientific purposes.Researchers no longer regard investigated subjects as pa-tients,which breaks the“obligation of confidence”of informed consent in traditional medicine.The modern interconnect-ed big data environments may exhibit the interdependence of privacy,where an individuals’privacy is affected by the decisions of others.However,the autonomy model of pure individualism is too narrow,and it focuses on describing the inherent disadvantaged position of patients in the traditional doctor-patient relationship framework and power pattern,while neglecting the importance of other external forces,which is prone to problems in an environment of new technology and policy.Autonomy is not the only value,it should be balanced with other values.The present informed consent is based on the presupposition of justice ethics,without considering the protection of the interests of disadvantaged groups.The utilization of genetic information in the context of precision medicine should be strictly limited within the new moral framework,constructing protection rules for genetic information from a group dimension,adopting a“dynamic and broad consent”model,that is,carried out in a cooperative research model,clarifying the rights of revocation and its limits for the parties involved.