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关于基因组医学实施的伦理考量:从eMERGE III研究中汲取的经验教训。

Ethical Considerations about Genomic Medicine Implementation: Lessons Learned from the eMERGE III Study.

作者信息

Inamura Kentaro

机构信息

Division of Pathology, The Cancer Institute, Japanese Foundation for Cancer Research, 3-8-31 Ariake, Koto-ku, Tokyo 135-8550, Japan.

出版信息

J Pers Med. 2020 Oct 26;10(4):195. doi: 10.3390/jpm10040195.

Abstract

The development of high-throughput techniques has permitted the accumulation of enormous amounts of genomic information. As increasing numbers of studies aim to utilize individual genomic information for diagnostic, preventive, or therapeutic purposes, Institutional Review Boards (IRBs) have a greater opportunity to review such types of study protocols. An article published in the titled, "Ethical Considerations Related to Return of Results from Genomic Medicine Projects: The eMERGE Network (Phase III) Experience" identified the common concerns of IRBs in the process of reviewing such studies, and some concerns included the readability of informed consent materials, potential risks to participants, information sharing with family members, options for withdrawal or receiving limited results, and provisions to clear participant questions. Since there is an increase in the number of genomic medicine implementation studies worldwide, the insights provided by this study would assist future researchers in protocol preparation as well as aid project review by IRB members.

摘要

高通量技术的发展使得大量基因组信息得以积累。随着越来越多的研究旨在将个体基因组信息用于诊断、预防或治疗目的,机构审查委员会(IRB)有更多机会审查此类研究方案。一篇发表在《基因组医学项目结果反馈的伦理考量:eMERGE网络(第三阶段)经验》上的文章,确定了IRB在审查此类研究过程中的常见担忧,其中一些担忧包括知情同意材料的可读性、对参与者的潜在风险、与家庭成员的信息共享、退出或接收有限结果的选择,以及解答参与者问题的规定。由于全球范围内基因组医学实施研究的数量在增加,本研究提供的见解将有助于未来研究人员制定方案,并协助IRB成员进行项目审查。

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