title: Variability in IRBs regarding parental acceptance of passive consent.
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.
authors.affiliation: Dell Children's Medical Center of Central Texas, Austin, Texas; rhiggerson@seton.org.
authors.forename: Renee A
authors.initials: RA
authors.lastname: Higgerson
authors.affiliation: Abt Associates Inc, Cambridge, Massachusetts;
authors.forename: Lauren E W
authors.initials: LE
authors.lastname: Olsho
authors.affiliation: Dell Children's Medical Center of Central Texas, Austin, Texas;
authors.forename: LeeAnn M
authors.initials: LM
authors.lastname: Christie
authors.affiliation: Duke Children's Hospital and Health Center, Durham, North Carolina;
authors.forename: Kyle
authors.initials: K
authors.lastname: Rehder
authors.affiliation: Abt Associates Inc, Cambridge, Massachusetts;
authors.forename: Teresa
authors.initials: T
authors.lastname: Doksum
authors.affiliation: Children's Hospital of Wisconsin, Milwaukee, Wisconsin;
authors.forename: Rainer
authors.initials: R
authors.lastname: Gedeit
authors.affiliation: Yale-New Haven Children's Hospital New Haven, Connecticut;
authors.forename: John S
authors.initials: JS
authors.lastname: Giuliano
authors.affiliation: Abt Associates Inc, Bethesda, Maryland;
authors.forename: Beth
authors.initials: B
authors.lastname: Brennan
authors.affiliation: Abt Associates Inc, Atlanta, Georgia; and.
authors.forename: Rachael
authors.initials: R
authors.lastname: Wendlandt
authors.affiliation: Boston Children's Hospital, Harvard University, Boston, Massachusetts.
authors.forename: Adrienne G
authors.initials: AG
authors.lastname: Randolph
mesh_terms: D002648:Child; D015340:Epidemiologic Research Design; D028744:Ethics Committees, Research / Q000592:standards; D032984:Ethics, Research; D006776:Hospitals, Pediatric; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence* / Q000592:standards / Q000706:statistics & numerical data; D015337:Multicenter Studies as Topic; D010290:Parents; D018579:Patient Selection / Q000941:ethics; D015983:Selection Bias; D014481:United States
keywords: epidemiologic research design; ethics committees; federal regulations; opt-out; research/ethics/standards