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.
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.
Authors: Henry W Mahncke; Sarah-Jane Kim; Annika Rose; Catherine Stasio; Peter Buckley; Stanley Caroff; Erica Duncan; Sarah Yasmin; L Fredrik Jarskog; J Steven Lamberti; Keith Nuechterlein; Martin Strassnig; Dawn Velligan; Joseph Ventura; Trina Walker; T Scott Stroup; Richard S E Keefe Journal: Schizophr Res Date: 2019-03-28 Impact factor: 4.939
Authors: Jennifer S Gewandter; Robert H Dworkin; Dennis C Turk; Eric G Devine; David Hewitt; Mark P Jensen; Nathaniel P Katz; Amy A Kirkwood; Richard Malamut; John D Markman; Bernard Vrijens; Laurie Burke; James N Campbell; Daniel B Carr; Philip G Conaghan; Penney Cowan; Mittie K Doyle; Robert R Edwards; Scott R Evans; John T Farrar; Roy Freeman; Ian Gilron; Dean Juge; Robert D Kerns; Ernest A Kopecky; Michael P McDermott; Gwendolyn Niebler; Kushang V Patel; Richard Rauck; Andrew S C Rice; Michael Rowbotham; Nelson E Sessler; Lee S Simon; Neil Singla; Vladimir Skljarevski; Tina Tockarshewsky; Geertrui F Vanhove; Ajay D Wasan; James Witter Journal: J Pain Date: 2019-12-13 Impact factor: 5.820
Authors: Eric G Devine; Clifford M Knapp; Ofra Sarid-Segal; Sean M O'Keefe; Cale Wardell; Morgan Baskett; Ashley Pecchia; Katie Ferrell; Domenic A Ciraulo Journal: Contemp Clin Trials Date: 2014-12-18 Impact factor: 2.226