Researchers Develop New Checklist To Prevent Fraud In Online Clinical Trials

The emergence successful virtual investigation since nan COVID-19 pandemic has created opportunities for researchers to grow and diversify objective trials, but it has besides opened up avenues for fraudulent information successful these studies. A caller study led by Boston University School of Public Health (BUSPH) researchers directed by Michael Stein, chair and professor of nan Department of Health Law, Policy & Management (HLPM) astatine BUSPH, provides a broad checklist of indicators that researchers tin utilize to quickly place suspicious behaviour and forestall fraudulent actors from enrolling successful online studies and compromising valuable data.

The astir effective measurement to forestall this fraudulent activity is to instrumentality a operation of automated and manual actions during nan prescreening, screening, and enrollment process, according to nan study published successful nan Journal of Medical Internet Research. 

In summation to automated fraud discovery methods, nan study suggests that researchers should utilize a checklist of precautions to spot, on pinch videoconferencing and photograph recognition requests from participants during nan screening process. These actions tin uncover fraudulent actors-who are mostly driven by financial summation from investigation compensation-before nan existent enrollment process begins.

Modest financial remuneration is simply a cornerstone of astir studies, important for recognizing participants' clip and effort, while besides helping to boost engagement and retention. However, arsenic compensated investigation opportunities grow successful nan online setting, truthful excessively do opportunities for fraudulent participation, from participants misrepresenting their eligibility aliases enrolling aggregate times, to automated bots attempting to complete online surveys. As online investigation becomes much prevalent, it is basal for investigators to beryllium vigilant and creation their integer studies pinch fraud prevention successful mind."

Kara Magane, study corresponding author, elder head of investigation operations successful HLPM astatine BUSPH

Digital recruitment is particularly valuable because it allows researchers to cod information among populations that are underrepresented aliases difficult to scope done accepted in-person methods.

"Online investigation has lowered barriers to participating successful research, peculiarly for group pinch stigmatized diagnoses, specified arsenic HIV," says study lead writer Robert Siebers, an HLPM investigation coordinator astatine BUSPH astatine nan clip of nan study. "Allowing participants to stay successful their ain location ensures higher levels of privateness and comfortableness that in-person investigation cannot. Without due guardrails, fraudulent information tin originate owed to nan expertise to much easy misrepresent one's personality online."

In nan study, nan researchers and colleagues from BU's College of Arts and Sciences, Tufts Medical Center, and nan Warren Alpert Medical School of Brown University picture nan team's ain acquisition pinch fraudulent participants erstwhile screening and enrolling group pinch HIV into 2 linked online trials: "Integrated Telehealth Intervention to Reduce Chronic Pain" and "Unhealthy Drinking Among People Living With HIV." The randomized tests were conducted done nan Boston ARCH Comorbidity Center successful 2023 and 2024. After a investigation adjunct noticed during a videoconference screening that a subordinate appeared to beryllium wearing a wig and resembled different personification who had been interviewed days prior, nan squad discovered that 10 fraudulent participants had enrolled successful nan trials, and they quickly disenrolled them astatine an early stage. The squad created a checklist of precautions to mention to during each shape of nan action process moving forward, and was capable to observe 37 further fraudulent participants during nan screening process. They evaluated their enrollment protection methods six months later and recovered nary caller fraudulent actors participating successful their trials.

Some of nan suspicious behaviour that researchers should look for during nan prescreening process see akin patterns successful email addresses (such arsenic those that usage aggregate numbers), zip codes that do not correspond to nan participant's location state, aliases different specifications that look unusually similar, specified arsenic nan aforesaid level of beingness activity among aggregate participants. During nan screening portion, nan squad says researchers should besides analyse participants who enroll aggregate times, supply predictable responses aliases swift answers to questions that typically require thought, aliases person akin accents aliases patterns of reside to participants antecedently identified arsenic fraudulent. In their trials, nan squad modified nan study protocol to let telephone screenings to return spot connected camera truthful that they could show participants' quality and different suspicious behavior, specified arsenic muting their microphone often aft each question. 

During baseline interviews connected video, nan squad recommends that researchers ask-but not mandate-that participants show photograph recognition connected nan screen.

"Ensuring subordinate comfortableness and privateness is of utmost value for each researchers, but peculiarly successful investigation that involves stigmatized populations aliases diagnoses," Siebers says. "Requesting, but not requiring, a photograph ID successful our study was a cardinal elasticity that allowed america to beryllium respectful of subordinate privateness concerns while ensuring we had nan opportunity to verify someone's existent personality erstwhile needed." They besides did not petition physics copies of IDs, he adds. 

Automated methods, specified arsenic IP reside recognition systems and bot discovery tools, tin besides beryllium effective astatine identifying fraudulent activity successful nan earliest stages of nan action process, but these methods often require financial aliases technological resources that whitethorn not beryllium disposable to each researchers.

The squad besides recommends that researchers coordinate pinch their institution's Institutional Review Board (IRB), committees that guarantee that quality investigation is ethical and compliant pinch regulations.

"IRBs and backing agencies tin play an important domiciled by recognizing fraud prevention arsenic an integral portion of investigation workflows, peculiarly for online studies," Magane says. "They tin promote researchers to see fraud discovery and prevention plans successful their study protocols, and allocate due resources for these efforts wrong study budgets. They tin besides supply clear guidance and support astir recognizing and responding to investigation information fraud."

Ultimately, location is nary one-size-fits-all approach, and each precautions should beryllium tailored to each study design, nan researchers say.

"As a organization of researchers, I'm not judge we person a grip connected really overmuch virtual investigation involves fraudulent participants and truthful really overmuch published information mightiness beryllium tainted," says Stein, elder writer author of nan study. "What we unexpectedly and unluckily learned arsenic researchers was that from nan infinitesimal of readying an online study done nan subordinate recruitment phase, researchers request to beryllium alert to nan anticipation that bad actors-and I mean that literally-can ruin nan reliability of their findings. Fraud protection whitethorn request to beryllium described successful each published afloat virtual studies going forward."