Concealment and fabrication: The hidden price of payment for research participation?

Abstract

Paid participation in clinical research has been common and controversial for years. Discussion in scholarly literature, in guidance and regulatory documents, and among investigators and institutional review board members has centered around concerns about impairing judgment, blinding subjects to risk, exploitation, commodification, or unjust distribution of research burden [1]. The article by Devine et al. [2] in this issue addresses a different and largely understudied concern -the potential for paid research subjects to misrepresent themselves in order to gain entry into studies.These concerns have been recognized for some time. For example, concealment was at the core of the highly publicized death of Bernadette Gillcrist in 1980 [3,4]. Gillcrist, a nursing student, enrolled in a paid sleep-deprivation study, but did not report her history of anorexia, self-induced vomiting, and cardiac arrest. She then died, likely from cardiac arrest secondary to electrolyte disturbance in the context of self-induced vomiting. Warnings of deception and fabrication have since appeared in the literature and in guidance documents, and the emergence of 'professional research subjects' has generated further attention to these issues.This study helps to legitimate these concerns among experienced subjects. The fact that 75% of respondents reported some element of concealment is worrisome, as is the appreciable frequency of fabrication of health information (33% overall). Fabrication is obviously concerning, because false data involving important outcomes -whether subjects identify them as such or not -may directly affect the nature and impact of the findings generated.This study also reveals an interesting organizational element that undergirds at least some of the deception taking place. The problem of simultaneous enrollment is well known, and many investigators are likely aware that experienced subjects know common exclusion criteria. However, the

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

“…For example, some volunteers simultaneously participate in studies as depressed patients and HVs (28, 29) as there are no objective tests to diagnose depression or to prove mental health. Although there is no data on the prevalence of deception in psychiatric research, its negative impact on research integrity has recently gained more attention (6, 11, 28, 29). …”

Exceptional Risk: Healthy Volunteers' Perceptions of HIV/AIDS Clinical Trials

“…In addition, there is no centralized registry of research participants, which means that healthy volunteers can easily circumvent restrictions that could otherwise limit their trial participation. 13–15 Compensation for these trials varies dramatically based on the overall length of the trial, number of days confined to the research facility, and number of outpatient visits. The average US phase I trial typically pays between $2000 and $4000.…”

“Money Helps”: People who inject drugs and their perceptions of financial compensation and its ethical implications

“…Some scholars argue that moderate payments do not negatively affect research participants (Halpern, Karlawish, Casarett, Berlin, & Asch, 2004), but many others argue that financial compensation, particularly in the case of vulnerable research populations, can unduly influence them to choose to participate (Gelinas et al, 2018; Largent, Grady, Miller, & Wertheimer, 2013; Wong & Bernstein, 2011). Some caution that financial compensation effectively restricts research participants’ ability to provide free, uncoerced, and informed consent (Grady, 2001) and prompts participants to minimize or neglect risk taking (Bentley & Thacker, 2004; Macklin, 1981) or to engage in deception (Devine et al, 2015; Dickert, 2013) Table 1 provides a summary description of the mainthemes that emerged during the analysis. In the area of substance abuse research, some have suggested that financial compensation raises ethical questions because research participants might use financial compensation to acquire drugs (Brody & Waldron, 2000; Koocher, 1991).…”