Renee A Higgerson1, Lauren E W Olsho2, LeeAnn M Christie3, Kyle Rehder4, Teresa Doksum2, Rainer Gedeit5, John S Giuliano6, Beth Brennan7, Rachael Wendlandt8, Adrienne G Randolph9. 1. Dell Children's Medical Center of Central Texas, Austin, Texas; rhiggerson@seton.org. 2. Abt Associates Inc, Cambridge, Massachusetts; 3. Dell Children's Medical Center of Central Texas, Austin, Texas; 4. Duke Children's Hospital and Health Center, Durham, North Carolina; 5. Children's Hospital of Wisconsin, Milwaukee, Wisconsin; 6. Yale-New Haven Children's Hospital New Haven, Connecticut; 7. Abt Associates Inc, Bethesda, Maryland; 8. Abt Associates Inc, Atlanta, Georgia; and. 9. Boston Children's Hospital, Harvard University, Boston, Massachusetts.
Abstract
OBJECTIVE: 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. METHODS: 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. RESULTS: 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%. CONCLUSIONS: 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.
OBJECTIVE: 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. METHODS: 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. RESULTS: 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%. CONCLUSIONS: 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.
Authors: Laura M Dember; Patrick Archdeacon; Mahesh Krishnan; Eduardo Lacson; Shari M Ling; Prabir Roy-Chaudhury; Kimberly A Smith; Michael F Flessner Journal: J Am Soc Nephrol Date: 2016-07-11 Impact factor: 10.121
Authors: Ross E McKinney; Laura M Beskow; Daniel E Ford; John D Lantos; Jonathan McCall; Bray Patrick-Lake; Mark J Pletcher; Brian Rath; Hollie Schmidt; Kevin Weinfurt Journal: Clin Trials Date: 2015-09-15 Impact factor: 2.486