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涉及纳米医学的临床试验中的伦理问题。

Ethical issues in clinical trials involving nanomedicine.

作者信息

Resnik David B, Tinkle Sally S

机构信息

National Institute of Environmental Health Sciences, National Institutes of Health, Box 12233, Mail Drop NH06, Research Triangle Park, NC 27709, United States.

出版信息

Contemp Clin Trials. 2007 Jul;28(4):433-41. doi: 10.1016/j.cct.2006.11.001. Epub 2006 Nov 17.

Abstract

Nanomedicine shows tremendous promise for improving medical diagnosis, treatment, and prevention, but it also raises a variety of ethical concerns. Because of the paucity of data on the physicochemical properties of nanoscale materials in biological systems, clinical trials of nanomedicine products present some unique challenges related to risk minimization, management and communication involving human subjects. Although these clinical trials do not raise any truly novel ethical issues, the rapid development of nanotechnology and its potentially profound social and environmental impacts, add a sense of urgency to the problems that arise.

摘要

纳米医学在改善医学诊断、治疗和预防方面显示出巨大的前景,但也引发了各种伦理问题。由于生物系统中纳米级材料的物理化学性质的数据匮乏,纳米医学产品的临床试验在涉及人类受试者的风险最小化、管理和沟通方面存在一些独特的挑战。尽管这些临床试验没有引发任何真正新颖的伦理问题,但纳米技术的快速发展及其潜在的深远社会和环境影响,给所出现的问题增添了紧迫感。

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本文引用的文献

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Strategies to minimize risks and exploitation in phase one trials on healthy subjects.
Am J Bioeth. 2006 May-Jun;6(3):W1-13. doi: 10.1080/15265160600686281.
3
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Altern Lab Anim. 2006 May;34(2):225-39. doi: 10.1177/026119290603400204.
4
Injury to research volunteers--the clinical-research nightmare.
N Engl J Med. 2006 May 4;354(18):1869-71. doi: 10.1056/NEJMp068082.
5
How the US drug safety system should be changed.
JAMA. 2006 May 3;295(17):2072-5. doi: 10.1001/jama.295.17.2072.
7
Materials and biology. Nanotechnology takes aim at cancer.
Science. 2005 Nov 18;310(5751):1132-4. doi: 10.1126/science.310.5751.1132.
8
Ultrafine particles cross cellular membranes by nonphagocytic mechanisms in lungs and in cultured cells.
Environ Health Perspect. 2005 Nov;113(11):1555-60. doi: 10.1289/ehp.8006.
10

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