Concealment and fabrication by experienced research subjects
Concealment and fabrication by experienced research subjects
复制标题
DOI：
10.1177/1740774513492917
复制
发表时间：
2013-12-01
期刊：
影响因子：
2.7
通讯作者：
Ciraulo, Domenic A.
中科院分区：
文献类型：
--
作者：
Devine, Eric G.;Waters, Megan E.;Ciraulo, Domenic A.
背景研究发现，参加多项研究的受试者有时会使用欺骗来克服限制性筛选标准。欺骗会破坏受试者安全和研究完整性。对于有经验的研究对象在多大程度上使用欺骗手段，以及什么类型的信息被隐藏、隐瞒，目的本研究探讨了欺骗的流行率和类型的欺骗所使用的主体登记在多个研究。在至少参加过两项研究的100名受试者中，测量了一份用于进入临床试验的欺骗行为报告结果四分之三的受试者报告在他们的一生中向研究人员隐瞒了一些健康信息，以避免被排除在研究对象之外。32%的样本隐瞒了健康问题，28%的样本隐瞒了处方药的使用，20%的样本隐瞒了娱乐性药物的使用。四分之一的受试者报告夸大症状，以符合研究条件和14%的报告假装有健康状况，以quality.Limitations虽然这项研究发现高利率的终身欺骗行为，这种行为的频率和背景是未知的。了解的背景和频率的欺骗将告知在何种程度上，它危及研究的完整性和safety.Conclusion欺骗的使用威胁参与者的安全和研究结果的完整性。欺骗可能部分由不适当的诱惑、过度限制的进入标准和对健康控制的需求增加所推动。旨在发现研究对象中欺骗行为的筛查措施将有助于保护受试者和确保研究结果的质量。
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.