Researchers develop new checklist to prevent fraud in online clinical trials

Researchers develop new checklist to prevent fraud in online clinical trials

The rise in virtual research since the COVID-19 pandemic has created opportunities for researchers to expand and diversify clinical trials, but has also created opportunities for fraudulent participation in these trials. A new study led by Boston University School of Public Health (BUSPH) researchers led by Michael Stein, chair and professor of the Department of Health Law, Policy and Management (HLPM) at BUSPH, provides a comprehensive checklist of indicators that researchers can use to quickly identify suspicious behavior and prevent fraudulent actors from enrolling in online studies and compromising valuable data.

The most effective way to prevent these fraudulent activities, according to the report published in, is to implement a combination of automated and manual actions during the pre-screening, verification and registration processJournal of Medical Internet Research.

In addition to automated fraud detection methods, the study suggests that researchers should use a checklist of precautions to detect, as well as video conferencing and photo ID requests from participants during the verification process. These measures can detect fraudulent actors who largely rely on financial gains from research compensation before the actual registration process begins.

Modest financial compensation is a cornerstone of most studies. It's important for recognizing participants' time and effort, while also helping to increase engagement and retention. However, as opportunities for paid research increase in the online environment, so do the opportunities for fraudulent participation, from participants misrepresenting their eligibility or registering multiple times to automated bots attempting to complete online surveys. As online research becomes more common, it is essential for investigators to be vigilant and design their digital studies with fraud prevention in mind.”

Kara Magane, corresponding author of the study, senior director of research activities in HLPM at BUSPH

Digital recruitment is particularly valuable because it allows researchers to collect data from populations that are underrepresented or difficult to reach using traditional in-person methods.

“Online research has lowered the barriers to participating in research, especially for people with stigmatized diagnoses such as HIV,” says study leader Robert Siebers, HLPM research coordinator at BUSPH at the time of the study. "Allowing participants to remain in their own homes ensures a higher level of privacy and comfort than in-person research does not. Without adequate safeguards, fraudulent participation may occur due to the potential for one's identity to be more easily misrepresented online."

In the study, researchers and colleagues from BU College of Arts and Sciences, Tufts Medical Center and Brown University's Warren Alpert Medical School describe the team's own experiences with fraudulent participants in screening and enrolling people with HIV in two linked online studies: "Integrated Telehealth Intervention to Reduce Chronic Pain" and "Unhealthy Drinking in People with HIV." The randomized trials were conducted by the Boston ARCH Comorbidity Center in 2023 and 2024. After a research assistant noticed during a videoconference demonstration that a participant appeared to be wearing a wig and resembled another person who had been interviewed days earlier, the team discovered that ten fraudulent participants had enrolled in the studies and deregistered them early. The team created a checklist of precautions to be taken at each stage of the further selection process and was able to discover 37 additional fraudulent participants during the verification process. Six months later, they evaluated their enrollment protection methods and found no new fraudulent actors participating in their experiments.

Suspicious behaviors that researchers should look for during the prescreening process include similar patterns in email addresses (e.g., those that use multiple numbers), zip codes that do not match the participant's home state, or other details that appear unusually similar, such as: B. the same level of physical activity among several participants. The team says that during the screening portion, researchers should also examine participants who log in multiple times, give predictable answers or quick answers to questions that typically require thinking, or have similar accents or speech patterns to participants previously identified as fraudulent. In their experiments, the team modified the study protocol to allow on-camera phone screenings so they could monitor participants' appearance and other suspicious behavior, such as frequently muting their microphone after each question.

For baseline video interviews, the team recommends that researchers show, but do not require, participants to show photo ID on screen.

“Ensuring participant comfort and privacy is paramount for all researchers, but especially when conducting research involving stigmatized populations or diagnoses,” says Siebers. “Requiring, but not requiring, photo ID in our study was an important flexibility that allowed us to respect participants’ privacy concerns while ensuring we had the opportunity to verify an individual’s true identity when necessary.” They also didn't ask for electronic copies of IDs, he adds.

Automated methods such as IP address identification systems and bot detection tools can also be effective in detecting fraudulent activity in the early stages of the selection process. However, these methods often require financial or technological resources that may not be available to all researchers.

The team also recommends researchers coordinate with their institution's Institutional Review Board (IRB), committees that ensure research involving human subjects is ethical and compliant.

“IRBs and funding agencies can play an important role by recognizing fraud prevention as an integral part of research operations, particularly in online studies,” says Magane. "They can encourage researchers to incorporate fraud detection and prevention plans into their study protocols and allocate appropriate resources to these efforts within study budgets. They can also provide clear guidance and support in identifying and responding to research participation fraud."

Ultimately, there is no one-size-fits-all approach and any precautions should be tailored to each study design, the researchers say.

“As a research community, I'm not sure we have a handle on how much virtual research involves fraudulent participants and therefore how much published data may be biased,” says Stein, senior author of the study. "What we unexpectedly and unfortunately learned as researchers was that from the moment an online study is planned through the participant recruitment phase, researchers need to be alert to the possibility that bad actors can - and I mean that literally - ruin the reliability of their results. Fraud protection may need to be described in all published fully virtual studies in the future."

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