Clinical trial recruitment for COVID-19 studies faces a new challenge: Rampant misinformation.
“We’ve found that misinformation crowds out everything else,” says Tim K. Mackey, MAS, PhD, associate professor at the University of California, San Diego School of Medicine, and director of healthcare research and policy at UC San Diego Extension.
Since COVID-19 was declared a national emergency and pandemic, fake news, false cures, ill-informed posts, and conspiracy theories have dominated the social media space. People were urged to spend $99 for a 14-day cure from COVID-19 or to mix their saliva with a pawpaw tree and garlic. Posts claimed they could order a do-it-yourself coronavirus test kit. Photos of hydroxychloroquine tablets were listed for sale, as were personal protective equipment (PPE).1
On Facebook, thousands of people shared a conspiracy theory that claimed Microsoft co-founder Bill Gates planned the COVID-19 pandemic. Other posts falsely claimed that Gates, Anthony Fauci, MD, George Soros, and Jeffrey Epstein were investors in vaccine research that received $1 billion dollars from the federal government.2
Also, Gates, who appears to be a COVID-19 conspiracy theorist’s favorite target, was claimed to have a plan to implant trackable microchips in Americans, via a coronavirus vaccine. A YouGov poll suggested 28% of Americans believed the outlandish claim.3
“As everyone knows, in addition to the actual pandemic going on, there’s an infodemic where a lot of misinformation related to COVID-19 has been proliferating,” said David Rand, PhD, professor of brain and cognitive sciences at the Massachusetts Institute of Technology. Rand spoke at an Aug. 19 WIRB-Copernicus Group (WCG) webinar for IRBs and the research community. “Partly on social media, part of it coming from tweets, and it’s having a serious impact on our ability to deal with the pandemic.”
One of the challenges from an IRB perspective involves informed consent and public trust in the shadows of the misinformation world. For example, rumors circulated in Chicago that white people would receive a COVID-19 vaccine, but Black people would receive placebo, says Wenora Johnson, a cancer research and patient advocate. Johnson also spoke at the Aug. 19 WCG webinar.
“It just leaves me at a loss for words,” Johnson says. “Misinformation impacts minority communities the hardest. Period.”
Because of both factual historical research atrocities, such as the Tuskegee syphilis experiment, and rumors and misinformation, minority communities are less willing to participate in research, Johnson says. (See story on disparities in COVID-19 research in this issue.)
Early in the pandemic, misinformation on Chinese social media feeds filled the gap of what people knew and did not know. There was little science-based information about how to deal with COVID-19, so China’s Weibo posts spread erroneous information, Mackey says.
“The lack of information creates the environment for misinformation to grow and spread later on,” he explains.
The same phenomenon of false information also spread in the United States, beginning in early 2020. This misinformation was mostly about unsubstantiated herbal remedies. “Not enough was known about the disease,” Mackey says. “What people were peddling were preventive treatment options that had no scientific basis.”
As the outbreak continued, testing became the focus because misinformation followed the trajectory of the pandemic.
It is important that IRBs and the research community monitor and address the spread of misinformation because of the potential effect on prospective clinical trial participants.
“An IRB professional needs to know what information is out there so they can administer informed consent,” Mackey says. “Hopefully, they are in a position to be a gatekeeper or someone who can combat some of the misinformation.”
While this is not the typical role of IRB professionals and clinical trial staff, this also is not the usual research environment.
“Unfortunately, we’re in the middle of a pandemic, and there’s way more misinformation than good information,” Mackey says. “It’s way easier to say something fake about a pandemic than to give good information about what works and is tested.”
Researchers will need to release evidence-based information about COVID-19 to improve recruitment for clinical trials for vaccines and therapeutics, he notes.
“The IRB and clinical trial professionals are at the frontline of talking about misinformation and making sure that patients don’t have misinformation impacting their participation in clinical research,” Mackey says.
IRBs could even ask COVID-19 study investigators to address misinformation in their informed consent process.
“Should you bring up misinformation in an informed consent document? With COVID-related studies, I think you have to,” Mackey says. “For other studies, it’s subjective.”
At the very least, IRBs should ask researchers how they plan to deal with misinformation and whether they are pointing potential research participants to correct resources and information. “If a person is exposed to misinformation, how does that impact their participation in the clinical trial?” he asks.
For instance, misinformation could cause participants to be lost to follow-up, or lead to reduced compliance with the study protocol or treatment regimen, Mackey says.
“If I’m an African American, and I enrolled in a COVID vaccine trial, and I heard that only white people get the treatment arm, then I may drop out,” he says. “You should say to people that this rumor is misinformation, you’re completely randomizing, and you don’t have any bias in the study, but those are hard concepts to explain to someone.”
One tactic research institutions could employ is to hold town hall meetings in communities where COVID-19 clinical trials are held, says Aisha Langford, MPH, PhD, assistant professor in the department of population health at NYU Grossman School of Medicine, and co-director of the Clinical and Translational Science Institute at NYU Langone Health.
The broader issue in COVID-19 study recruitment is the general public does not know much about how clinical trials work. Everyone could benefit from town hall meetings and educational sessions about COVID-19 vaccine research, Langford says.
“There is some confusion and concern about vaccines, in general, so having educational sessions and town halls about COVID-19 vaccines will be very helpful for people,” she adds. “They can ask questions, express concerns, and get accurate information because there’s a lot of bad information on the internet.”
Research organizations also can put accurate resources and links for COVID-19 on their websites and distribute brochures and pamphlets that explain how clinical trials and vaccine research work.
“I think it will be very important, even when a vaccine is proven to be safe and effective, that people have information about when to get vaccinated, where to get it, and why it’s safe,” Langford says. “Maybe it will be virtual town halls for a long time, but we need to have good health education and patient materials, including decision support tools and patient support tools to help people feel more comfortable with taking a vaccine because it’s good for themselves and for society.”
- Mackey TK, Li J, Purushothaman V, et al. Big data, natural language processing, and deep learning to detect and characterize illicit COVID-19 product sales: Infoveillance study on Twitter and Instagram. JMIR Pub Health Surveill 2020;6:e20794.
- Reuters. Fact check: Bill Gates is not responsible for COVID-19. Sept. 10, 2020. https://www.reuters.com/article/uk-factcheck-gates-idUSKBN2613CK?fbclid=IwAR2cJlHbxHcdlBqBiMcmxI8BBaapW3NPQS4WqPtkO9i5bwwmf-YZoAV7I-I
- Goodman J, Carmichael F. Coronavirus: Bill Gates “microchip” conspiracy theory and other vaccine claims fact-checked. BBC News, May 30, 2020. https://www.bbc.com/news/52847648?prompt