title: Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials.
abstract: OBJECTIVE
  To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols.
  
  
  METHODS
  Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs.
  
  
  RESULTS
  Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180-1425; study 2, $0-500; and study 3, $0-100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified > or =1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants.
  
  
  CONCLUSIONS
  In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.
authors.affiliation: Pediatric Generalist Research Group, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA. mbk@alumni.princeton.edu
authors.forename: Michael B
authors.initials: MB
authors.lastname: Kimberly
authors.forename: K Sarah
authors.initials: KS
authors.lastname: Hoehn
authors.forename: Chris
authors.initials: C
authors.lastname: Feudtner
authors.forename: Robert M
authors.initials: RM
authors.lastname: Nelson
authors.forename: Mark
authors.initials: M
authors.lastname: Schreiner
mesh_terms: D000293:Adolescent; D002648:Child; D017326:Clinical Trials, Phase III as Topic / Q000592:standards*; D035881:Compensation and Redress; D028744:Ethics Committees, Research; D032984:Ethics, Research; D006801:Humans; D006973:Hypertension / Q000188:drug therapy; D007258:Informed Consent / Q000592:standards*; D015337:Multicenter Studies as Topic; D009369:Neoplasms / Q000150:complications; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D033282:Parental Consent; D010372:Pediatrics; D012131:Respiratory Insufficiency / Q000628:therapy