Protecting Human Subjects in Genetic Enhancement Research

保护基因增强研究中的人类受试者

• 批准号: 7212100
• 负责人: MAXWELL J MEHLMAN
• 金额: $ 37.5万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-23 至 2009-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7212100
• 关键词: Address; Attention; Autoexperimentation; Bioethics Consultants; Clinical; Clinical Research; Clinical Trials; Conceptions; Condition; Consensus; Development; Disease; Enhancement Technology; Future; Gene Mutation; Gene Transfer; Genetic Enhancement; Genetic Research; Genetic screening method; Germ Lines; Goals; Guidelines; Hand; Human; Human Genetics; Human Subject Research; Innovative Therapy; Intervention; Investigation; Knowledge; Label; Light; Modality; Normalcy; Participant; Pharmaceutical Preparations; Policies; Policy Maker; Policy Research; Purpose; Recombinant DNA; Regulation; Research; Research Ethics; Research Personnel; Research Subjects; Resistance; Risk; Safety; Science Policy; Societies; Somatotropin; Standards of Weights and Measures; System; Taboo; Therapeutic; Therapeutic Human Experimentation; Therapeutic Intervention; Vulnerable Populations; base; design; disability; falls; gene therapy; genetic technology; human subject; improved; research study; spelling; trait

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.

研究人员和生物伦理学家已经制定了在涉及基因技术的临床实验中保护人类受试者的指导方针。

项目成果

Ethical and legal issues in enhancement research on human subjects.

人类受试者增强研究中的伦理和法律问题。

• DOI: 10.1017/s0963180110000605
• 发表时间: 2011
• 期刊: Cambridge quarterly of healthcare ethics : CQ : the international journal of healthcare ethics committees
• 作者: Mehlman,MaxwellJ;Berg,JessicaW;Juengst,EricT;Kodish,Eric
• 通讯作者: Kodish,Eric