| 曹诗雨,武志昂.我国临床试验中人类遗传资源政府规制研究[J].中国药事,2019,33(2):131-136 |
| 我国临床试验中人类遗传资源政府规制研究 |
| Research on Government Regulation of Human Genetic Resources of Clinical Trials in China |
| 投稿时间：2018-04-10 |
| DOI：10.16153/j.1002-7777.2019.02.003 |
| 中文关键词: 临床试验 人类遗传资源 政府规制 |
| 英文关键词: clinical trial human genetic resources government regulation |
| 基金项目: |
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| 中文摘要: |
| 目的：介绍我国临床试验中人类遗传资源的规制现状，提出一些完善建议，以期实现更好的规制效果。方法：采用政府规制理论，从市场失灵角度分析规制的必要性，并从规制目的、规制主体、规制客体、规制手段、规制环境五个要素全面梳理规制现状。结论：我国临床试验中人类遗传资源的规制取得了显著成绩，但规制细节仍有待完善。 |
| 英文摘要: |
| Objective: To introduce the regulation of human genetic resources of clinical trials in China, and to put forward some suggestions for its improvement so as to achieve better regulatory effects. Methods: The necessity of regulation was analyzed from the perspective of market failure with the government regulation theory. The current status of regulation was comprehensively analyzed from the five factors:the regulatory purpose, the regulatory subject, the regulatory object, the regulatory means and the regulatory environment. Results and Conclusion: The regulation of human genetic resources of clinical trials in China has achieved remarkable achievements, but some details of regulation still need to be improved. |
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