Concealment and fabrication by experienced research subjects

• Published in: Clinical trials (London, England) Vol. 10; no. 6; pp. 935 - 948
• Main Authors: Devine, Eric G, Waters, Megan E, Putnam, Megan, Surprise, Caitlin, O’Malley, Katie, Richambault, Courtney, Fishman, Rachel L, Knapp, Clifford M, Patterson, Elissa H, Sarid-Segal, Ofra, Streeter, Chris, Colanari, Laurie, Ciraulo, Domenic A
• Format: Journal Article
• Language: English
• Published: London, England SAGE Publications 01.12.2013; Sage Publications Ltd
• Subjects: Bioethics; Clinical trials; Clinical Trials as Topic; Deception; Female; Human subjects; Humans; Income; Male; Middle Aged; Motivation; Patient Selection; Research Subjects; Self Report; Sex Factors; Unemployment
• ISSN: 1740-7745; 1740-7753; 1740-7753
• DOI: 10.1177/1740774513492917

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. Purpose 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. Limitations 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. Conclusion 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.