人类标本在研究中的使用：不断演变的美国监管、政策及科学态势。
Use of human specimens in research: the evolving United States regulatory, policy, and scientific landscape.
作者信息
Bledsoe Marianna J, Grizzle William E
机构信息
Silver Spring, MD, USA.
Division of Anatomic Pathology, Department of Pathology, The University of Alabama at Birmingham, Birmingham, AL, USA.
出版信息
Diagn Histopathol (Oxf). 2013 Sep;19(9):322-330. doi: 10.1016/j.mpdhp.2013.06.015.
The use of human specimens in research has contributed to significant scientific and medical advancements. However, the development of sophisticated whole genome and informatics technologies and the increase in specimen and data sharing have raised new questions about the identifiability of specimens and the protection of participants in human specimen research. In the US, new regulations and policies are being considered to address these changes. This review discusses the current and proposed regulations as they apply to specimen research, as well as relevant policy discussions. It summarizes the ways that researchers and other stakeholders can provide their input to these discussions and policy development efforts. Input from all the stakeholders in specimen research will be essential for the development of policies that facilitate such research while at the same time protecting the rights and welfare of research participants.
在研究中使用人体标本推动了重大的科学和医学进步。然而，先进的全基因组和信息学技术的发展以及标本和数据共享的增加，引发了关于标本可识别性以及人体标本研究参与者保护方面的新问题。在美国，正在考虑制定新的法规和政策来应对这些变化。本综述讨论了适用于标本研究的现行法规和拟议法规，以及相关的政策讨论。它总结了研究人员和其他利益相关者为这些讨论和政策制定工作提供意见的方式。标本研究中所有利益相关者的意见对于制定既能促进此类研究又能同时保护研究参与者权利和福利的政策至关重要。
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