title: Concealment and fabrication by experienced research subjects.
abstract: BACKGROUND
  Subjects who enroll in multiple studies have been found to use deception at times to overcome restrictive screening criteria. Deception undermines subject safety as well as study integrity. Little is known about the extent to which experienced research subjects use deception and what type of information is concealed, withheld, or distorted.
  
  
  OBJECTIVE
  This study examined the prevalence of deception and types of deception used by subjects enrolling in multiple studies.
  
  
  METHODS
  Self-report of deceptive behavior used to gain entry into clinical trials was measured among a sample of 100 subjects who had participated in at least two studies in the past year.
  
  
  RESULTS
  Three quarters of subjects reported concealing some health information from researchers in their lifetime to avoid exclusion from enrollment in a study. Health problems were concealed by 32% of the sample, use of prescribed medications by 28%, and recreational drug use by 20% of the sample. One quarter of subjects reported exaggerating symptoms in order to qualify for a study and 14% reported pretending to have a health condition in order to qualify.
  
  
  CONCLUSIONS
  Although this study finds high rates of lifetime deceptive behavior, the frequency and context of this behavior is unknown. Understanding the context and frequency of deception will inform the extent to which it jeopardizes study integrity and safety.
  
  
  CONCLUSIONS
  The use of deception threatens both participant safety and the integrity of research findings. Deception may be fueled in part by undue inducements, overly restrictive criteria for entry, and increased demand for healthy controls. Screening measures designed to detect deception among study subjects would aid in both protecting subjects and ensuring the quality of research findings.
authors.affiliation: aDepartment of Psychiatry, Boston University School of Medicine, Boston, MA, USA.
authors.forename: Eric G
authors.initials: EG
authors.lastname: Devine
authors.forename: Megan E
authors.initials: ME
authors.lastname: Waters
authors.forename: Megan
authors.initials: M
authors.lastname: Putnam
authors.forename: Caitlin
authors.initials: C
authors.lastname: Surprise
authors.forename: Katie
authors.initials: K
authors.lastname: O'Malley
authors.forename: Courtney
authors.initials: C
authors.lastname: Richambault
authors.forename: Rachel L
authors.initials: RL
authors.lastname: Fishman
authors.forename: Clifford M
authors.initials: CM
authors.lastname: Knapp
authors.forename: Elissa H
authors.initials: EH
authors.lastname: Patterson
authors.forename: Ofra
authors.initials: O
authors.lastname: Sarid-Segal
authors.forename: Chris
authors.initials: C
authors.lastname: Streeter
authors.forename: Laurie
authors.initials: L
authors.lastname: Colanari
authors.forename: Domenic A
authors.initials: DA
authors.lastname: Ciraulo
mesh_terms: D002986:Clinical Trials as Topic; D008192:Deception; D005260:Female; D006801:Humans; D007182:Income; D008297:Male; D008875:Middle Aged; D009042:Motivation; D018579:Patient Selection; D035842:Research Subjects; D057566:Self Report; D012737:Sex Factors; D014478:Unemployment