title: Informed consent and research subject understanding of clinical trials.
abstract: BACKGROUND
  Current evidence suggests many clinical trial participants have incomplete understanding of research objectives and methods.
  
  
  OBJECTIVE
  Determine consent standards compliance, satisfaction with facility and study staff, and research subject understanding of clinical trials.
  
  
  METHODS
  Retrospective review of responses gathered when subjects were interviewed at the inception of clinical trial participation.
  
  
  METHODS
  Clinical research unit at the University of Wisconsin, Madison.
  
  
  METHODS
  Clinical trials participants on the research unit.
  
  
  METHODS
  Understanding of the particular trial in which each subject was participating; research team compliance with informed consent standards; and satisfaction with the research facility, staff, and clinical trials teams.
  
  
  RESULTS
  423 of 570 research participants were oncology patients; 298 were males. Age range was 10 to 90 years old (mean of 56.6 (+/- 16.6) years old). Most subjects (99%) had signed the consent form; 97% reported satisfaction with the research facility and 96% with the study staff. Four-fifths of participants had accurate knowledge of study aims, methods, and risks, but 20% of subjects understood considerably less. Oncology subjects were older (mean age 60.1 [+/- 12.5] years vs 46.4 [+/- 21.9] years, P < 0.001). Non-oncology subjects and patients under age 61 demonstrated superior study knowledge (P < 0.001).
  
  
  CONCLUSIONS
  Compliance with informed consent standards and satisfaction with services and staff was excellent. Future efforts should focus on better informing older subjects and those on oncology trials.
authors.affiliation: University of Wisconsin School of Medicine and Public Health Clinical and Translational Research Core, Department of Pediatrics, USA. mhooverregan@pediatrics.wisc.edu
authors.forename: Margo
authors.initials: M
authors.lastname: Hoover-Regan
authors.forename: Tara
authors.initials: T
authors.lastname: Becker
authors.forename: Mary Jane
authors.initials: MJ
authors.lastname: Williams
authors.forename: Yoram
authors.initials: Y
authors.lastname: Shenker
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000704:Analysis of Variance; D002648:Child; D002986:Clinical Trials as Topic / Q000941:ethics*; D005260:Female; D006801:Humans; D007258:Informed Consent; D007407:Interviews as Topic; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D035842:Research Subjects; D012189:Retrospective Studies; D014922:Wisconsin