Variability in IRBs regarding parental acceptance of passive consent.

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Higgerson, RA; Olsho, LEW; Christie, LM; Rehder, K; Doksum, T; Gedeit, R; Giuliano, JS; Brennan, B; Wendlandt, R; Randolph, AG; PALISI PICFlu Study Investigators,

Published Date

  • August 2014

Published In

Volume / Issue

  • 134 / 2

Start / End Page

  • e496 - e503

PubMed ID

  • 25002659

Electronic International Standard Serial Number (EISSN)

  • 1098-4275

Digital Object Identifier (DOI)

  • 10.1542/peds.2013-4190


  • eng

Conference Location

  • United States