RESUMO
PURPOSE: Many studies have found evidence that research subjects engage in deceptive practices while participating in health-related studies. Little is known, however, about how often subjects use deception and the percentage of studies a typical subject will contaminate with false data. This study examined the frequency of use of different types of deception among a sample of subjects who admit to using deception. METHODS: A sample of 59 subjects who had participated in at least two health-related studies in the past 12 months and admitted to using deception in at least one were interviewed. Subjects were asked a series of questions about concealing information and fabricating information to gain entry into studies. Subjects were also asked about falsifying data after being enrolled in a health-related study. All study data reported pertains to only subjects who reported using deception in health-related studies and is based on subjects' study participation only within the last 12 months from the date of the interview. RESULTS: Subjects who conceal information in order to enroll in trials reported using concealment in about two thirds (67%) of the trials they participated in over the past 12 months. On average, these subjects' use of concealment was highest for mental health information (58% of studies) and physical health information (57% of studies). The average frequency of fabricating information in order to enroll in trials was 53% with exaggerating health symptoms (45% of studies) and pretending to have a health condition (39% of studies) as the two most widely used strategies. Subjects who falsify study data after enrollment reported doing so 40% of the time. These subjects falsely reported improvement in the health condition being studied in 38% of the trials they took part in. Subjects who admitted to throwing away study medication to create the appearance of compliance reported doing so 32% of the time. LIMITATIONS: Although this study provides evidence that subjects who admit to using deception contaminate a high percentage of studies, larger and more geographically diverse samples are needed to understand the full extent of the problem of deceptive subjects in research. Regional economic, cultural, or organizational factors may be related to the rate of subjects using deception. It is also possible that this sample underrepresents the use of deception as there are likely subjects who use deception that would be unwilling to admit the extent of this behavior. CONCLUSION: Deceptive subject's behavior poses a threat to the integrity of research findings. Given that deceptive subjects contaminate a high percentage of studies they take part in by concealing information, fabricating information, and falsifying study data after enrollment, efforts to identify and exclude these subjects is important to the integrity of research findings. Strategies to exclude deceptive subjects from health research should be used to inform study designs. Widespread adoption of research subject identity registries could greatly reduce the scope of studies that a single deceptive subject could contaminate. Technological solutions that provide an objective measure of medication compliance may be valuable tools for limiting fraudulent reports of compliance.
RESUMO
Clinical trials within the US face an increasing challenge with the recruitment of quality candidates. One readily available group of subjects that have high rates of participation in clinical research are subjects who enroll in multiple trials for the purpose of generating income through study payments. Aside from issues of safety and generalizability, evidence suggests that these subjects employ methods of deception to qualify for the strict entrance criteria of some studies, including concealing information and fabricating information. Including these subjects in research poses a significant risk to the integrity of data quality and study designs. Strategies to limit enrollment of subjects whose motivation is generating income have not been systematically addressed in the literature. The present paper is intended to provide investigators with a range of strategies for developing and implementing a study protocol with protections to minimize the enrollment of subjects whose primary motivation for enrolling is to generate income. This multifaceted approach includes recommendations for advertising strategies, payment strategies, telephone screening strategies, and baseline screening strategies. The approach also includes recommendations for attending to inconsistent study data and subject motivation. Implementing these strategies may be more or less important depending upon the vulnerability of the study design to subject deception. Although these strategies may help researchers exclude subjects with a higher rate of deceptive practices, widespread adoption of subject registries would go a long way to decrease the chances of subjects enrolling in multiple studies or more than once in the same study.
