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是否需要对常见规则进行更改以解决不断发展的研究领域？以人类微生物组计划为例的案例研究。

Are changes to the common rule necessary to address evolving areas of research? A case study focusing on the human microbiome project.

机构信息

University of Maryland School of Law.

出版信息

J Law Med Ethics. 2013 Summer;41(2):454-69. doi: 10.1111/jlme.12055.

DOI:10.1111/jlme.12055
PMID:23802897
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5761648/
Abstract

This article examines ways in which research conducted under the Human Microbiome Project, an effort to establish a "reference catalogue" of the micro-organisms present in the human body and determine how changes in those micro-organisms affect health and disease, raise challenging issues for regulation of human subject research. The article focuses on issues related to subject selection and recruitment, group stigma, and informational risks, and explores whether: (1) the Common Rule or proposed changes to the Rule adequately address these issues and (2) the Common Rule is the most appropriate vehicle to provide regulatory oversight and guidance on these topics.

摘要

本文探讨了人类微生物组计划（一项旨在建立人体中存在的微生物“参考目录”并确定这些微生物的变化如何影响健康和疾病的研究）所进行的研究引发的监管问题。文章主要关注与研究对象的选择和招募、群体污名化以及信息风险相关的问题，并探讨了以下问题：（1）《普通规则》或对规则的拟议修改是否充分解决了这些问题；以及（2）《普通规则》是否是提供这些主题监管监督和指导的最合适工具。