| Summary: | 碩士 === 國立清華大學 === 科技法律研究所 === 106 === Since the United States completed the revision and announcement of the federal regulations on the subject protection – Common Rule in 2017, and is expected to be implemented in 2019, this article will introduce and analyze the Common Rule before the revision, the obstacles encountered in practice, the public's critique of the common rules, the final revision of the Common Rule, and the two important matters related to the revision : "Change of the informed consent process and elements ", “allow to use broad consent" for relevant academic discussions.
In the end, based on the discussion, this article tried to propose possible revision to the scheme of Taiwan's current regulatory system, and advice to add new elements that should be provided to subjects in the informed consent process.
This article hope that based on these discussion, the current Taiwan standard will be feasible, and can ensure the harmonious development of the biotechnology industry while protecting the right of the human subjects.
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