title: Understanding parental refusal of permission for child participation in surgical prospective trials.
abstract: OBJECTIVE
  The success of prospective randomized trials relies on voluntary participation, which has been perceived as a barrier for successful trials in children who rely on parental permission. We sought to identify the reasons parents decline child participation to understand potential limitations in the consent process.
  
  
  METHODS
  A prospective observational study was conducted in 92 patients asked to participate in prospective randomized trials between 2012 and 2015. Parental reasons for refusal were documented.
  
  
  RESULTS
  The 92 refusals were distributed between studies investigating the management of circumcision, gastroschisis, pectus excavatum, appendicitis, pyloric stenosis, undescended testicles, abdominal abscess and gastroesophageal reflux. Reasons for refusal included preference of treatment path (37 %), inability to follow up (21 %), unspecified resistance to participate in research (18 %), preference to maintain independent surgeon decision (16 %), and desire for historically standard treatment (8 %). Of the families who opted to pursue a specific treatment arm rather than randomization, 35 % had prior experience with that treatment, 32 % had researched the procedure, 18 % wished to pursue the minimal intervention and 15 % did not specify.
  
  
  CONCLUSIONS
  Parental preference of therapy is the most common reason for refusal of study participation. This variable could be influenced with more effective explanation of study rationale and existing equipoise.
authors.affiliation: Department of Pediatric Surgery, Children's Mercy Hospital, 2401 Gillham Rd, Kansas City, MO, 64108, USA.
authors.forename: Katherine W
authors.initials: KW
authors.lastname: Gonzalez
authors.affiliation: Department of Pediatric Surgery, Duke Children's Hospital and Health Center, DUMC 3815, Durham, NC, 27710, USA.
authors.forename: Obinna O
authors.initials: OO
authors.lastname: Adibe
authors.affiliation: Department of Pediatric Surgery, Children's Mercy Hospital, 2401 Gillham Rd, Kansas City, MO, 64108, USA.
authors.forename: Brian G
authors.initials: BG
authors.lastname: Dalton
authors.affiliation: Department of Pediatric Surgery, Children's Mercy Hospital, 2401 Gillham Rd, Kansas City, MO, 64108, USA.
authors.forename: Amita A
authors.initials: AA
authors.lastname: Desai
authors.affiliation: Department of Pediatric Surgery, Children's Mercy Hospital, 2401 Gillham Rd, Kansas City, MO, 64108, USA.
authors.forename: Susan W
authors.initials: SW
authors.lastname: Sharp
authors.affiliation: Department of Pediatric Surgery, Children's Mercy Hospital, 2401 Gillham Rd, Kansas City, MO, 64108, USA. sspeter@cmh.edu.
authors.forename: Shawn D
authors.initials: SD
authors.lastname: St Peter
mesh_terms: D035843:Biomedical Research; D032882:Comprehension; D013502:General Surgery; D006801:Humans; D010290:Parents / Q000523:psychology; D011446:Prospective Studies; D016032:Randomized Controlled Trials as Topic / Q000523:psychology*; D045808:Refusal to Participate / Q000523:psychology*
keywords: Consent; Participation; Pediatric research; Refusal