title: Noninvitation of eligible individuals to participate in pediatric studies: a qualitative study.
abstract: OBJECTIVE
  To identify subjective factors that lead investigators not to invite eligible individuals to participate in pediatric studies.
  
  
  METHODS
  Qualitative study with semistructured interviews.
  
  
  METHODS
  Four pediatric teaching hospitals in Paris.
  
  
  METHODS
  Pediatric investigators (n=24).
  
  
  METHODS
  Report by investigator that eligible patients were not invited by him or her to participate in a clinical research study.
  
  
  RESULTS
  Sixty-three percent of investigators (15 of 24) reported not inviting eligible patients. The noninvitation patterns were global (ie, investigators did not invite anyone) (37.5% [9/24]) or targeted specific patient subgroups (37.5% [9/24]). Noninvitation was often described as driven by ethical concerns related to the study design or patients or by anticipated patient refusal (58.3% [14/24]). None of the investigators kept records of noninvitation rates or refusal rates. Investigators estimated refusal rates of 1% to 10%, and none remembered a study that had failed because of potential subjects' refusals (including healthy participants).
  
  
  CONCLUSIONS
  Noninvitation to participate in studies is not an absence of action but rather is an organized practice that reflects investigators' perceptions. Consequences are practical (eg, recruitment bias and study failure) and ethical (eg, unequal access to trials and failure to respect the autonomy of eligible patients). Our data suggest an urgent need for quantitative studies aimed at documenting and understanding noninvitation of eligible patients to participate in research studies in pediatrics and in other medical specialties.
authors.affiliation: Institut Gustave-Roussy, Villejuif, Unité de Recherche en Sciences Humaines et Sociales, Assistance Publique-Hôpitaux de Paris, Hôpital Robert-Debré, Paris, France. amiel@igr.fr
authors.forename: Philippe
authors.initials: P
authors.lastname: Amiel
authors.forename: Delphine
authors.initials: D
authors.lastname: Moreau
authors.forename: Claire
authors.initials: C
authors.lastname: Vincent-Genod
authors.forename: Corinne
authors.initials: C
authors.lastname: Alberti
authors.forename: Régis
authors.initials: R
authors.lastname: Hankard
authors.forename: Philippe
authors.initials: P
authors.lastname: Ravaud
authors.forename: Serge
authors.initials: S
authors.lastname: Gottot
authors.forename: Claude
authors.initials: C
authors.lastname: Gaultier
mesh_terms: D001291:Attitude of Health Personnel; D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics; D003657:Decision Making; D004341:Drug Evaluation / Q000941:ethics; D005260:Female; D006776:Hospitals, Pediatric; D006784:Hospitals, Teaching; D006801:Humans; D007407:Interviews as Topic; D008297:Male; D010297:Paris; D018579:Patient Selection / Q000941:ethics; D010372:Pediatrics / Q000941:ethics; D010465:Perception; D036301:Qualitative Research; D045808:Refusal to Participate; D015983:Selection Bias