Stoffel Brandy, Sorkness Christine, Pech Carol
IRB Facilitator, Inner-City Asthma Consortium, University of Wisconsin-Madison, 800 University Bay Dr., Suite 105, Madison, WI 53705, , fax: 608-265-5811,
Distinguished Professor of Pharmacy and Medicine, Senior Associate Executive Director, Institute for Clinical and Translational, Research, and Co-Investigator for Inner-City Asthma Consortium, University of Wisconsin-Madison,
Contemp Clin Trials Commun. 2017 Dec;8:114-121. doi: 10.1016/j.conctc.2017.09.001. Epub 2017 Sep 6.
In 2014, the Request for Applications from the National Institutes of Health (NIH) for continued funding of a multi-site clinical and mechanistic research network, Inner City Asthma Consortium (ICAC), called for "efficient IRB review and approval for multi-center studies" and "IRB approval within 30 days from submission". These requirements were precursors to the NIH policy of single IRB review for multi-site studies. Here we share our challenges, implementation processes, results, and recommendations, using a single, independent IRB.
2014年，美国国立卫生研究院（NIH）发布了一份申请通知，要求为一个多中心临床与机制研究网络——内城哮喘联盟（ICAC）提供持续资金，其中呼吁“对多中心研究进行高效的机构审查委员会（IRB）审查与批准”，以及“在提交申请后30天内获得IRB批准”。这些要求是NIH关于多中心研究采用单一IRB审查政策的前身。在此，我们将分享我们使用单一独立IRB时所面临的挑战、实施过程、结果及建议。
