Higgerson Renee A, Olsho Lauren E W, Christie LeeAnn M, Rehder Kyle, Doksum Teresa, Gedeit Rainer, Giuliano John S, Brennan Beth, Wendlandt Rachael, Randolph Adrienne G
Dell Children's Medical Center of Central Texas, Austin, Texas;
Abt Associates Inc, Cambridge, Massachusetts;
Pediatrics. 2014 Aug;134(2):e496-503. doi: 10.1542/peds.2013-4190. Epub 2014 Jul 7.
Passive, opt-out recruitment strategies have the potential to improve efficiency and enlarge the participant pool for clinical studies. We report on the feasibility of using a passive consent strategy for a multicenter pediatric study.
We assessed the response to passive and active control recruitment strategies used in a multicenter pediatric cohort study and describe the variability in acceptance among institutional review boards (IRBs) and parents of pediatric patients.
Twenty-six pediatric centers submitted IRB applications; 24 centers participated. Sixteen IRBs approved the proposed passive recruitment strategy, and 6 IRBs required active consent strategies; 2 centers used a modified participation mode using control subjects from neighboring centers. In all, 4529 potential participants were identified across 22 centers. In the pre-enrollment phase, opt-out rates were significantly lower in the passive consent group compared with the active recruitment centers (1.6% vs. 11.8%; P < .001). During the enrollment phase, however, refusal rates in the passive consent group were significantly higher (38.1% vs. 12.2%; P = .004). The overall refusal rate across both groups was 33.3%.
IRB variability in interpretation and application of regulations affects consistency of study procedure across sites and may reduce validity of study findings. Opt-out consent allowed us to create a large representative pool of control subjects. Parents were more likely to refuse to be approached for a study in the pre-enrollment phase when active consent was used, but were more likely to decline actual study enrollment when passive consent was used in the pre-enrollment period.
被动式、选择退出招募策略有潜力提高效率并扩大临床研究的参与者群体。我们报告了在一项多中心儿科研究中使用被动同意策略的可行性。
我们评估了在一项多中心儿科队列研究中使用的被动和主动对照招募策略的反应，并描述了机构审查委员会（IRB）和儿科患者家长接受程度的差异。
26个儿科中心提交了IRB申请；24个中心参与。16个IRB批准了提议的被动招募策略，6个IRB要求采用主动同意策略；2个中心采用了一种改良的参与模式，使用来自相邻中心的对照受试者。总共在22个中心识别出4529名潜在参与者。在预招募阶段，被动同意组的退出率显著低于主动招募中心（1.6%对11.8%；P < .001）。然而，在招募阶段，被动同意组的拒绝率显著更高（38.1%对12.2%；P = .004）。两组的总体拒绝率为33.3%。
IRB在法规解释和应用方面的差异影响了各研究地点研究程序的一致性，并可能降低研究结果的有效性。选择退出同意使我们能够创建一个具有代表性的大型对照受试者群体。当采用主动同意时，家长在预招募阶段更有可能拒绝参与研究，但在预招募阶段采用被动同意时，家长更有可能拒绝实际参与研究。
