Nutrition researcher at the Academy of Nutrition and Dietetics.
Clinical research manager at the University of New Mexico Health Science Center.
Ethics Hum Res. 2023 Jul-Aug;45(4):16-29. doi: 10.1002/eahr.500173.
From 2018 to 2020, U.S. federal mandates began requiring the use of a single institutional review board (sIRB) of record for federally funded, multisite studies. With an interest in the efficiency of site activation, we compared the frequency with which local review and approval and three different reliance options (ways to establish a reliance agreement between the sIRB and the relying institution) were used during this period in a multisite, non-federally funded study (ClinicalTrials.gov identifier: NCT03928548). Using general linear models, we analyzed the relationships between local reliance or approval and sIRB of record approval times and (a) the regulatory option selected and (b) relying-site and process characteristics. Eighty-five sites received sIRB approval through 72 submissions (40% using local review, 46% using the SMART IRB agreement, 10% using an IRB authorization agreement, and 4% using a letter of support). Median time to establish a local reliance or study approval and sIRB approval were longest for sites using a SMART IRB agreement. Study-site region and the time of submission were significantly associated with local reliance or approval time, which averaged 129 and 107 days faster for Midwestern (p = 0.03) or Western (p = 0.02) sites, respectively, and 70 days slower for Northeastern sites (p = 0.42) compared with sites in the South, and 91 days slower when regulatory communication was initiated during or after February 2019 compared with before (p = 0.02). Similar relationships between sIRB approval time and region and time frame were observed; in addition, approval time was 103 days slower for sites affiliated with a research 1 (R1) university versus not (p = 0.02). Region of the country, time frame, and R1 university affiliation were associated with variations in study-site activation in a non-federally funded, multisite study.
从 2018 年到 2020 年，美国联邦授权开始要求使用单一机构审查委员会（sIRB）作为记录，以进行联邦资助的多地点研究。我们对现场激活的效率感兴趣，因此在这个期间，我们比较了在一个多地点、非联邦资助的研究（ClinicalTrials.gov 标识符：NCT03928548）中，当地审查和批准以及三种不同的依赖选项（在 sIRB 和依赖机构之间建立依赖协议的方式）的使用频率。使用广义线性模型，我们分析了当地依赖或批准与 sIRB 记录批准时间之间的关系，并考虑了（a）选择的监管选项和（b）依赖地点和过程特征。85 个地点通过 72 次提交获得了 sIRB 批准（40%使用当地审查，46%使用 SMART IRB 协议，10%使用 IRB 授权协议，4%使用支持信）。使用 SMART IRB 协议的地点建立当地依赖或研究批准和 sIRB 批准的中位时间最长。研究地点所在地区和提交时间与当地依赖或批准时间显著相关，中西部（p = 0.03）或西部（p = 0.02）地点的平均时间分别快 129 天和 107 天，而东北部地点的时间慢 70 天（p = 0.42），与南部地区相比；与 2019 年 2 月之前相比，监管沟通在 2 月或之后开始时，时间慢 91 天（p = 0.02）。在 sIRB 批准时间与地区和时间框架之间也观察到类似的关系；此外，与不隶属于 R1 大学的地点相比，隶属于 R1 大学的地点的批准时间慢 103 天（p = 0.02）。国家地区、时间框架和 R1 大学隶属关系与非联邦资助的多地点研究中研究地点激活的变化有关。
