Faculty Collaboration Database

Variability in IRBs regarding parental acceptance of passive consent. Pediatrics 2014 Aug;134(2):e496-503

Date

07/09/2014

Pubmed ID

25002659

DOI

10.1542/peds.2013-4190

Scopus ID

2-s2.0-84905276157 (requires institutional sign-in at Scopus site)   11 Citations

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.

Author List

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

Author

Rainer G. Gedeit MD Associate Chief Medical Officer in the Children's Administration department at Children's Wisconsin

MESH terms used to index this publication - Major topics in bold

Child
Epidemiologic Research Design
Ethics Committees, Research
Ethics, Research
Hospitals, Pediatric
Humans
Informed Consent
Multicenter Studies as Topic
Parents
Patient Selection
Selection Bias
United States