篇名

基因重組研究的未來監督:國家醫學院委員會提出之建議   免費試閱

並列篇名

Future Oversight of Recombinant DNA Research: Recommendations of an Institute of Medicine Committee

中文摘要

美國國家衛生研究院在1974年建立了重組DNA諮詢委員會,以因應公眾對於藉由重組DNA(rDNA)來作基因物質操作上的安全性疑慮。過去40年來在基因轉殖研究上的經驗,已讓人們對其風險有更多的了解。隨著基因轉殖技術的成熟,整體的管制環境仍十分複雜。在管制機構重疊、科學上的了解與社會上接受度提高等背景下,美國國家衛生研究院委託國家醫學院針對基因轉殖研究是否有必要額外的加以監督進行評估。本文認為,未來臨床試驗的監督需要強化現有的機構能力與專業,讓那些需要額外監督的研究案件成為少數。這樣才能實現為研究受試者提供嚴格保護、跨科學領域的應用更加一致、急迫推進重要科學發現等偉大的目標。

英文摘要

The National Institutes of Health (NIH) established the Recombinant DNA Advisory Committee (RAC) in 1974 in response to public concerns about the safety of manipulating genetic material through recombinant DNA. The accumulation of 40 years of experience with gene transfer research has led to a better understanding of the risks. Yet, as gene transfer research has matured, the complexity of the overall regulatory environment has remained. It is within the context of overlapping regulatory authority and improved scientific understanding and social acceptance that the NIH commissioned the Institute of Medicine (IOM) to assess whether gene transfer research continues to warrant additional oversight. This paper argues that the future of clinical trial oversight needs to reinforce and augment existing institutional capacities and expertise so that the need for additional review becomes a rare occurrence. That would fulfill the admirable goals of rigorous safeguards for research participants, consistency of application across scientific realms, and the imperative of advancing important scientific discoveries.

起訖頁

043-050

出版單位
DOI

10.3966/241553062020020040004  複製DOI  DOI查詢

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