Johnson Ann R, Kasimatis Singleton Megan, Ozier Julie, Serdoz Emily, Beadles Jennifer G, Maddox-Regis Janelle, Mumford Sarah, Burr Jeri, Dean J Michael, Ford Daniel E, Bernard Gordon R
University of Utah Health Sciences Center, Salt Lake City, UT, USA.
Johns Hopkins University School of Medicine, Baltimore, MD, USA.
J Clin Transl Sci. 2022 Apr 19;6(1):e53. doi: 10.1017/cts.2022.391. eCollection 2022.
The Trial Innovation Network has established an infrastructure for single IRB review in response to federal policies. The Network's single IRB (sIRBs) have successfully supported over 70 multisite studies via more than 800 reliance arrangements. This has generated several lessons learned that can benefit the national clinical research enterprise, as we work to improve the conduct of clinical trials. These lessons include distinguishing the roles of the single IRB from institutional Human Research Protections programs, establishing a consistent sIRB review model, standardizing collection of local context and supplemental, study-specific information, and educating and empowering lead study teams to support their sites.
试验创新网络已根据联邦政策建立了单一机构审查委员会审查的基础设施。该网络的单一机构审查委员会（sIRB）已通过800多项依赖安排成功支持了70多项多中心研究。在我们努力改进临床试验开展工作的过程中，这产生了一些经验教训，可使国家临床研究企业受益。这些经验教训包括区分单一机构审查委员会与机构人类研究保护计划的作用、建立一致的单一机构审查委员会审查模式、规范当地背景和补充的特定研究信息的收集，以及对牵头研究团队进行培训并赋予其权力以支持其各研究点。
