Protecting Human Subjects in Genetic Enhancement Research

描述（由申请人提供）：研究人员和生物伦理学家已经制定了指导方针，以保护涉及遗传技术的临床实验中的人类受试者。 然而，这些规则是为研究治疗性干预措施而制定的，并不涉及为增强目的而可能使用遗传技术所涉及的风险。 社会已经达成了明确的共识，反对尝试对人类进行生殖系遗传干预，但遗传知识仍然可以用于其他方式的增强目的，例如使用生物合成生长激素来增加身高，或研究识别与非疾病性状相关的基因突变。在缺乏明确解决增强研究的特殊问题的指导方针的情况下，受试者可能会面临在治疗性研究中可以接受但在增强研究中不可接受的风险。 此外，由于缺乏明确的强化研究政策，这类研究很可能会进入“地下”非法或标签外使用和自我试验的领域，这可能会对研究对象和社会造成严重损害。 为了解决这一政策差距，该项目将确定治疗性和增强性遗传研究之间的伦理相关差异，并根据管理人类受试者研究的伦理原则分析这些差异，以确定当前的规则和法规是否充分限制增强性研究，如果不是，建议修改现有的规则和法规，以便社会能够有效地应对未来可能使用人类受试者进行遗传增强研究的尝试。

DESCRIPTION (provided by applicant):Researchers and bioethicists have developed guidelines to protect human subjects in clinical experiments involving genetic technologies. However, these rules were developed for investigations of therapeutic interventions and do not address the risks involved in the potential use of genetic technologies for enhancement purposes. Society has reached a clear consensus against attempting germ-line genetic interventions in humans, but genetic knowledge could still be used for enhancement purposes in other ways, such as the somatic use of biosynthetic growth hormone to increase stature, or studies to identify genetic mutations associated with non-disease traits. In the absence of guidelines that explicitly address the special issues of enhancement research, subjects could be exposed to risks that would be acceptable in the case of therapeutic research but unacceptable in the case of enhancement research. Moreover, the absence of explicit enhancement research policy is likely to drive this type of research into the realm of "underground" illicit or off-label use and self-experimentation, which could cause serious harm to research subjects and to society. To address this policy gap, this project will identify ethically relevant differences between therapeutic and enhancement genetic research and analyze these differences in terms of the ethical principles that govern human subjects research, in order to determine whether current rules and regulations adequately restrict enhancement research, and, if not, propose changes to existing rules and regulations so that society can respond effectively to possible future attempts to conduct genetic enhancement research using human subjects.