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Pediatrics. 2014 Aug;134(2):e496-503. doi: 10.1542/peds.2013-4190. Epub 2014 Jul 7.

Variability in IRBs regarding parental acceptance of passive consent.

Author information

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.

KEYWORDS:

epidemiologic research design; ethics committees; federal regulations; opt-out; research/ethics/standards

PMID:
25002659
DOI:
10.1542/peds.2013-4190
[Indexed for MEDLINE]

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