Researchers Introduce Checklist to Combat Fraud in Online Trials

The surge in virtual research following the COVID-19 pandemic has brought significant advancements in clinical trials but has also introduced new risks, including fraudulent participation. A recent study led by researchers from the Boston University School of Public Health (BUSPH), under the guidance of Michael Stein, Chair and Professor of the Department of Health Law, Policy & Management, has developed a comprehensive checklist aimed at identifying and mitigating suspicious behavior in online studies.

Published in the Journal of Medical Internet Research, the study emphasizes that to effectively counter fraudulent activities, researchers must employ a combination of automated and manual strategies during the prescreening, screening, and enrollment stages. The report highlights that the most effective measures include utilizing a checklist of precautions, conducting videoconferencing, and requesting photo identification from participants as part of the screening process.

The growing trend of compensated research presents both opportunities and vulnerabilities. While modest remuneration is essential for acknowledging participants’ time and effort, it can also attract individuals seeking financial gain through fraudulent means, such as misrepresenting eligibility or enrolling multiple times. The study notes that as online research continues to expand, researchers must remain vigilant to ensure the integrity of their data.

Kara Magane, the study’s corresponding author and Senior Director of Research Operations at BUSPH, underscores the importance of safeguarding against fraud. The ability to conduct digital recruitment is invaluable, particularly for reaching underrepresented populations. Robert Siebers, the study’s lead author and a research coordinator at BUSPH, points out that online research allows individuals with stigmatized diagnoses, such as HIV, to participate in a more comfortable and private environment. However, the anonymity of the internet can facilitate identity misrepresentation.

The research team shared their firsthand experience with fraudulent participants while screening individuals for two linked online trials: the “Integrated Telehealth Intervention to Reduce Chronic Pain” and “Unhealthy Drinking Among People Living With HIV.” Conducted through the Boston ARCH Comorbidity Center in 2023 and 2024, the trials revealed a concerning issue when a research assistant noticed a participant who appeared suspiciously similar to another individual interviewed just days prior. This led to the discovery of 10 fraudulent participants, who were promptly disenrolled.

In response to these challenges, the team established a checklist of precautions to follow during each stage of the selection process. This proactive measure enabled them to identify an additional 37 fraudulent participants during screening. Six months later, they confirmed that no new fraudulent actors had managed to infiltrate their trials, showcasing the effectiveness of their updated protocols.

Researchers are advised to remain alert for certain indicators that may signal fraudulent behavior. During the prescreening process, attention should be given to unusual patterns in email addresses, mismatched zip codes, and similar levels of physical activity reported by participants. When screening, caution is warranted for individuals who enroll multiple times or provide inconsistent responses.

To enhance the integrity of the screening process, the team modified their study protocol to allow phone screenings to occur via video, enabling them to monitor participants’ appearances and behaviors. They suggested that participants be asked, but not required, to show photo identification during baseline interviews. This approach balances the need for security with the importance of respecting participant privacy, particularly for those in sensitive situations.

While automated methods, such as IP address identification and bot detection tools, can effectively flag fraudulent activities, these technologies often require resources that may not be accessible to all researchers. Therefore, collaboration with Institutional Review Boards (IRBs) is crucial. Magane emphasizes that IRBs and funding agencies should recognize fraud prevention as an essential component of research workflows, particularly for online studies.

Ultimately, the researchers acknowledge that there is no universal solution to this issue. Each study should tailor its fraud prevention measures to its specific design. Stein warns that without adequate precautions, the reliability of research findings may be compromised. “As a community of researchers, we must acknowledge the potential for fraudulent participation in virtual research and its impact on published data,” he states.

The findings from this study highlight the necessity of implementing robust fraud prevention strategies in online clinical trials to ensure the integrity and reliability of research outcomes.