论人类遗传资源立法中的知情同意:现实困惑与变革路径

Informed Consent in the Legislation of Human Genetic Resources:The Realistic Perplex and Response Approach

后基因组时代,人类遗传资源成为生命科技领域创新性研究的资源基础。人类遗传资源的伦理与法律规范的特殊性可能在于"人"作为主体的自主决定权,以及"人与人类"的"社会/自然"属性的复杂性。这种特殊性在知情同意范畴内体现得尤为深刻。当"人"的自主决定权面对人类遗传资源的长效性和遗传性特征以及"人与人类"的"社会/自然"属性的复杂性时,便产生了个人同意、家庭同意与群体同意、概括同意与具体同意、本人同意与代理同意等实践难题。面对这些难题,在人类遗传资源立法的渐进变革中应保持法律规范与生命伦理规范间的张力,对知情同意在立法中适度规定。

In the post-genome era, the human genetic resources are the base of innovative research in the field of life science and technology. The particularity of human genetic resources in ethical and legal norm may lie in the discretionary power of ＂human＂ as the subject and the complexity of social and natural attribute of ＂human and mankind＂. This particularity is profoundly reflected in the scope of informed consent. When the discretionary power of ＂human＂ as the subject is confronted with the long residual action and hereditary of human genetic resources and the complexity of social and natural attribute of ＂human and mankind＂, challenge in practice between personal consent and proxy consent, family consent and group or community consent, broad consent and specific consent as well as informed consent and re-consent is thus emerging. The reasonable provision in human genetic resources-related legislation on informed consent should take into account both the human dignity and discretionary power and the particularity of human genetic resources and human social and natural attribute.