Regulatory Support Improves Subsequent IRB Approval Rates in Studies Initially Deemed Not Ready for Review: A CTSA Institution's Experience.
作者: Sonne SusanGentilin StephanieSampson Royce RBell LeslieMauney ToniYoung SummerBright KatherineFlume Patrick
作者单位: 11 Medical University of South Carolina, Charleston, SC, USA.
刊名: Journal of empirical research on human research ethics : JERHRE, 2018, Vol.13 (2), pp.139-144
来源数据库: PubMed Journal
DOI: 10.1177/1556264617752725
关键词: Institutional Review BoardsClinical researchTranslational research
原始语种摘要: We evaluated the impact of a regulatory support service (known as the Regulatory Knowledge and Support [RKS] program), part of the Medical University of South Carolina's Clinical and Translational Science Award, on the success of Institutional Review Board (IRB) applications that have previously been deemed by the IRB to be Not Ready for Review (NRR). At the time of this evaluation, 77 studies had been deemed NRR, 53 of which came from trainees and junior faculty. All the applications that received regulatory support either received IRB approval or were deemed to not be research, and therefore did not require IRB review. In all, 39.1% (n = 18) of the research teams who did not accept regulatory support successfully received IRB approval. Providing regulatory support, particularly to...
全文获取路径: PubMed  (合作)
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关键词翻译
关键词翻译
  • successfully 成功地
  • therefore 因此
  • research 
  • support 支柱
  • require 需要
  • applications 应用程序
  • regulatory 控制的
  • approval 赞成
  • deemed 被视为
  • received 接收