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利用单一机构审查委员会咨询服务满足研究团队的教育需求。

Using single IRB consultations to meet the educational needs of investigative teams.

作者信息

Johnson Ann R, Pautler Mary, Burr Jeri S, Abdelsamad Nael, VanBuren John M, Rigtrup Lisa M, Dean J Michael, Rothwell Erin

机构信息

University of Utah, Institutional Review Board, 75 S 2000 E, Salt Lake City, UT, 84112, USA.

University of Utah School of Medicine, Department of Pediatrics, 295 Chipeta Way, Salt Lake City, UT, 84108, USA.

出版信息

Contemp Clin Trials Commun. 2022 Aug 11;29:100971. doi: 10.1016/j.conctc.2022.100971. eCollection 2022 Oct.

DOI:10.1016/j.conctc.2022.100971
PMID:36033361
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9403494/
Abstract

Single IRB (SIRB) consultation resources were established by the Utah Trial Innovation Center to assist and educate investigative teams prior to the submission of funding applications for multisite, cooperative research. Qualitative analysis of the written consultation materials and meeting minutes revealed the most common areas of education needed by investigative teams, including (a) the differences and relationships between the IRB and a Human Research Protection Program (HRPP); (b) the main phases of the SIRB process; and (c) the use of technology platforms for documentation of SIRB review processes. For investigative teams who are inexperienced with using a SIRB, such consultation in the pre-award period is likely to fill in knowledge gaps and improve the study start-up process.

摘要

犹他州试验创新中心设立了单一机构审查委员会(SIRB)咨询资源,以便在提交多中心合作研究的资金申请之前,协助并培训研究团队。对书面咨询材料和会议记录的定性分析揭示了研究团队最需要培训的领域,包括:(a)机构审查委员会(IRB)与人类研究保护计划(HRPP)之间的差异和关系;(b)SIRB流程的主要阶段;(c)用于记录SIRB审查流程的技术平台的使用。对于没有使用SIRB经验的研究团队而言,在授标前阶段进行此类咨询可能会填补知识空白并改善研究启动流程。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0c5/9403494/b245c51f84ce/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0c5/9403494/043713fc4517/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0c5/9403494/6a0b540b5d04/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0c5/9403494/b245c51f84ce/gr3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0c5/9403494/043713fc4517/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0c5/9403494/6a0b540b5d04/gr2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f0c5/9403494/b245c51f84ce/gr3.jpg

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Stakeholder Experiences with the Single IRB Review Process and Recommendations for Food and Drug Administration Guidance.
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Resources to assist in the transition to a single IRB model for multisite clinical trials.协助向多中心临床试验单一独立伦理委员会模式过渡的资源。
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"You Really Do Have to Know the Local Context": IRB Administrators and Researchers on the Implications of the NIH Single IRB Mandate for Multisite Genomic Studies.“你确实必须了解当地情况”:机构审查委员会管理人员和研究人员谈美国国立卫生研究院单一机构审查委员会授权对多中心基因组研究的影响
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