Tamariz Leonardo, Gajardo Mitscher, Still Carolyn H, Gren Lisa H, Clark Elizabeth, Walsh Sandy, Whittle Jeff, Nord John, Ramsey Thomas, Contreras Gabriel
Miami VA Healthcare System and the Division of Population Health and Computational Medicine, University of Miami, FL, USA.
Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.
Contemp Clin Trials Commun. 2019 Jul 6;15:100407. doi: 10.1016/j.conctc.2019.100407. eCollection 2019 Sep.
Federal agencies have encouraged the use of central institutional review boards (CIRBs) for multi-site clinical trials. There is limited evidence supporting the use of CIRBs. Our aim is to evaluate how SPRINT sites regulated by CIRBs performed regarding informed consent readability and participant trial adherence compared to those regulated by local IRBs.
We conducted a cohort study using the SPRINT clinical trial. We collected the IRB of record from the stamped and approved 2012 informed consents from each of the sites. We defined CIRB as an IRB for more than one SPRINT site. Our outcomes were informed consent readability measured using the Flesch-Kincaid readability scale and trial adherence defined as a loss to follow-up, consent withdrawal, and missed last 3-month visit.
Sixty-one percent of all SPRINT sites used a CIRB as their IRB of record. The adjusted mean grade reading level for CIRB consents was 13.4 (95% CI 12.6-13.8) compared to 12.3 (95% CI 12.1-13.1) for non CIRB consents (p = 0.07). CIRB sites had similar rates of withdrawal of consent and loss to follow-up as non-CIRB sites; subjects missing the last appointment of the study were more likely to come from sites regulated by a CIRB. The Veterans Affairs CIRB had the lowest rate of withdrawal of consent (1.9%) and the lowest rate of missed appointments (1.9%) among CIRBs.
Niether CIRB-regulated sites nor IRB regulated sites enforce the recommended readability level of the informed consent documents. Sites regulated by both IRBs had similar participant trial adherence.
联邦机构鼓励在多中心临床试验中使用中央机构审查委员会（CIRB）。支持使用CIRB的证据有限。我们的目的是评估由CIRB监管的SPRINT研究点在知情同意书可读性和参与者试验依从性方面与由当地机构审查委员会（IRB）监管的研究点相比表现如何。
我们使用SPRINT临床试验进行了一项队列研究。我们从每个研究点加盖印章并批准的2012年知情同意书中收集记录在案的IRB。我们将CIRB定义为负责一个以上SPRINT研究点的IRB。我们的结果是使用弗莱什-金凯德可读性量表测量的知情同意书可读性，以及定义为失访、同意撤回和错过最后一次3个月访视的试验依从性。
所有SPRINT研究点中有61%使用CIRB作为其记录在案的IRB。CIRB同意书的调整后平均阅读年级水平为13.4（95%可信区间12.6-13.8），而非CIRB同意书为12.3（95%可信区间12.1-13.1）（p = 0.07）。CIRB研究点的同意撤回率和失访率与非CIRB研究点相似；错过研究最后一次预约的受试者更有可能来自由CIRB监管的研究点。退伍军人事务部CIRB在CIRB中同意撤回率最低（1.9%），错过预约率最低（1.9%）。
CIRB监管的研究点和IRB监管的研究点均未执行知情同意书文件建议的可读性水平。由两个IRB监管的研究点在参与者试验依从性方面相似。
