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

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 existence of ‘research kingpins’ and networks for sharing screening tips is eye-opening. This report does not identify how common these practices are, but the presence of organized efforts to skirt exclusion criteria raises the level of concern. In fact, this study adds to other recent data in spurring a shift in thinking about the potential impact of money on enrollment decisions. In contrast to traditional concerns about blinding subjects to risk, for example, several recent studies have suggested that payment may not impair understanding and may actually sensitize potential participants to concerns about risk. Cryder et al. [5] demonstrated that higher payments correlated with increased time reading online study information and relatively higher rating of the riskiness of trial participation. Other studies have also suggested that increased amounts of money do not have outsized effects on enrollment willingness or diminish appreciation of risks [6,7]. These studies, which have been used to support arguments that payment likely does not impair decisions [8], interestingly cohere with the finding of Devine et al. of a positive correlation between deceptive practices and concern about risk. Taken together, it appears that deception may be a calculated practice undertaken by individuals with self-interested motives who are aware of and sensitive to risk as opposed to being blinded to or irrationally unconcerned with risk. These data are thus consistent with a shift away from worries about compromised consent or justice issues and have interesting and important potential implications. The principal shift is toward greater emphasis on protection of scientific integrity as opposed to protection of subjects. Regardless of one’s view of who bears ethical responsibility for harm to subjects that result from deception, these practices are indisputably problematic if they occur with significant frequency due to their scientific implications and their potential to jeopardize the