Safety, Science, or Both? Deceptive Healthy Volunteers: Psychiatric Conditions Uncovered by Objective Methods of Screening

Abstract

Previous reports document a high prevalence of psychopathology and highlight the importance of mental health screening of healthy volunteers in psychiatric research. Psychiatric research has typically used self-report scales and structured clinical interviews to rule out psychopathology. These subjective methods are often unreliable as some volunteers conceal their psychiatric conditions and substance use. Here we describe illustrative cases of psychiatric conditions in healthy volunteers that were uncovered by objective methods of screening including physical exam, laboratory testing, toxicology screen, and chart review.

Participation of Healthy Volunteers in Clinical Trials – Motives, Barriers and Ethical Issues

“…39 Masking of psychiatric disorders is easier than medical illnesses due to the absence of signs and lack of biomarkers. 40 Deception by research participants is a dynamic ethical dilemma that may lead to flawed results and may harm the patient when applied in clinical practice. Concealment, fabrication, and collusion are in practice to varied degrees ranging from 03% to 25% among healthy volunteers in numerous studies.…”

Frequency of concealment, fabrication and falsification of study data by deceptive subjects

“…For example, in an HIV prevention trial testing medication for HIV pre-exposure prophylaxis that was conducted in sub-Saharan Africa, it was discovered that 34% of the sample was simultaneously enrolled in another HIV prevention trial [ 6 ], presumably to minimize their risk of HIV infection. Irrespective of subjects' motivations for using deception or the labels we choose to describe them, these subjects pose a substantial risk to the integrity of our studies because they conceal exclusionary information, enroll in the same study more than once, enroll in multiple studies concurrently, pretend to have the health condition being studied and enroll in studies for which they have no intention of benefitting from [ 1 , 2 , 4 , 5 , [7] , [8] , [9] ]. The potential impact of subjects who pretend to have a health condition and then report improvement once enrolled – making these subjects’ treatment “destined to succeed” -- has been modeled by McCann and colleagues and it is estimated that sample size requirements more than double if just 10% of the sample is comprised of subjects who are destined to succeed [ 10 ].…”

Why knowing healthy controls matters

“…As these examples demonstrate, volunteer-provided history is often not sufficient to determine the eligibility of HVs (3)(4)(5). Volunteer-provided history can be inaccurate for various reasons such as financial incentive or discomfort disclosing psychiatric disorder (5,6). Additionally, some medical conditions that affect brain such as hypertension are often asymptomatic.…”

“…While self-reports may be appropriate for some research, studies involving quantitative objective measures should also use objective screening methods such as physical examination and a toxicology screen. Objective methods of screening have been shown to uncover not only medical but also psychiatric conditions (e.g., eating disorders, signs of self-injurious behavior, substance use) not revealed in the psychiatric history and a structured clinical interview (5,6). Toxicology screening may have the added advantage of perhaps deterring HVs who use drugs from participating in mental health studies.…”

“…Although objective methods of screening increase the upfront cost, they are justified if they provide information that is important for research integrity and participants' safety (6). Yet the fact remains that researchers, particularly non-clinicians, may not have the awareness, time, or resources for adequate screening of HVs.…”