Using the IRB Harmonization and Reliance Document Can Reduce Review and Regulatory Delays for the Benefit of All.
作者信息
Sodeke Stephen
机构信息
a Tuskegee University National Center for Bioethics in Research and Health Care & College of Veterinary Medicine, Nursing, and Allied Heath.
出版信息
Am J Bioeth. 2016 Aug;16(8):46-8. doi: 10.1080/15265161.2016.1187217.
Abstract
摘要
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Using the IRB Harmonization and Reliance Document Can Reduce Review and Regulatory Delays for the Benefit of All.使用《机构审查委员会协调与依赖文件》可减少审查和监管延迟，使各方受益。
Am J Bioeth. 2016 Aug;16(8):46-8. doi: 10.1080/15265161.2016.1187217.
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本文引用的文献
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IRB and Research Regulatory Delays Within the Military Health System: Do They Really Matter? And If So, Why and for Whom?军内医疗体系中的机构审查委员会和研究监管延迟：它们真的重要吗？如果重要，原因是什么，又对谁重要？
Am J Bioeth. 2016 Aug;16(8):30-7. doi: 10.1080/15265161.2016.1187212.
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The need for reform of human subjects protections in military health research.军事健康研究中人类受试者保护改革的必要性。
Mil Med. 2012 Feb;177(2):204-8. doi: 10.7205/milmed-d-11-00281.
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Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform.机构审查委员会给研究带来的负担：证据现状及其对监管改革的影响。
Milbank Q. 2011 Dec;89(4):599-627. doi: 10.1111/j.1468-0009.2011.00644.x.
4
Protecting research participants while reducing regulatory burdens.在减轻监管负担的同时保护研究参与者。
JAMA. 2011 Nov 23;306(20):2260-1. doi: 10.1001/jama.2011.1727.
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Partnering to harmonize IRBs for community-engaged research to reduce health disparities.携手合作，协调机构审查委员会以开展社区参与研究，减少健康差距。
J Health Care Poor Underserved. 2011;22(4 Suppl):8-15. doi: 10.1353/hpu.2011.0157.
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7
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8
The challenges of IRB review and human subjects protections in practice-based research.基于实践的研究中机构审查委员会（IRB）审查及人类受试者保护面临的挑战。
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