1 Department of Obstetrics & Gynecology, Medical College of Georgia, Augusta University, Augusta, GA, USA.
2 Fertility and Infertility Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Rockville, MD, USA.
Clin Trials. 2019 Feb;16(1):3-10. doi: 10.1177/1740774518807888. Epub 2018 Oct 24.
BACKGROUND/AIMS: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network.
Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Results from two past clinical trials were also included.
While time required for actual institutional review board submission's review and initial approval was reduced with use of a single institutional review board for multicenter trials (from a mean of 66.7-24.0 days), total time was increased (to a mean of 111.2 or 123.3 days). In addition to single institutional review board approval, all institutions required local approval of some components (commonly consent language and use of local language), which varied considerably. The single institutional review board relied on local institutions for adding or removing personnel, conflict of interest review, and auditing of activities.
A single institutional review board reduced time for initial review and approval of protocols and informed consents, although time for the entire process was increased, as individual institutions retained oversight of components of required regulatory review. In order to best achieve the National Institute of Health's goals for improved efficiency in initiation and conduct of multisite clinical research, greater coordination with local institutional review boards is key to streamlining and accelerating initiation of multisite clinical research.
背景/目的：机构审查委员会对研究方案的及时审查可导致临床试验更快启动，这对于迅速将基础研究转化为临床应用至关重要。本观察性研究考察了单一机构审查委员会对国立儿童健康与人类发展研究所合作生殖医学网启动临床试验的时间和所需努力的影响。
为三项当前临床试验和两项既往临床试验从相同的六个主要临床中心收集数据，包括从机构审查委员会提交到批准的时间、提交的页数、知情同意书的长度、所需附件的数量、其他监管要求、中心或当地站点的审查顺序以及各参与站点的文件使用的语言。两项既往临床试验的结果也包括在内。
虽然对于多中心试验使用单一机构审查委员会可减少实际机构审查委员会提交的审查和初始批准所需的时间（从平均 66.7-24.0 天降至 24.0 天），但总时间却增加了（平均为 111.2 或 123.3 天）。除了单一机构审查委员会的批准外，所有机构都需要对某些部分（通常是知情同意书的语言和使用当地语言）进行当地批准，这些批准差异很大。单一机构审查委员会依靠当地机构来添加或删除人员、进行利益冲突审查和对活动进行审计。
单一机构审查委员会减少了方案和知情同意书初始审查和批准的时间，尽管整个过程的时间增加了，因为各机构保留了对所需监管审查部分的监督。为了最好地实现美国国立卫生研究院在提高多中心临床研究启动和进行效率方面的目标，与当地机构审查委员会进行更好的协调是简化和加速多中心临床研究启动的关键。
