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Improving how researchers share results with participants

Denise Kent

Over the course of four years, around 1,200 patients enrolled in a UIC-led study of long COVID-19 will visit one of two clinics, four to five times a year, spending hours with scientists and subjecting themselves to lab work, questionnaires, procedures and genetic testing.

Researchers will gather “a tremendous amount of information” about the participants in the study, called RECOVER, to understand long-term effects of COVID-19, says UIC Nursing clinical assistant professor Denise Kent, PhD, APRN.

But what will the participants gain in return?

“There are two sides,” Kent says. “We can’t do research without participants. They need to be recognized as a valuable part of the team, of the project. If we want to ask people to keep coming, to let us keep poking them so we can get more information, then we have to ask, what are we doing for them?”

That’s where Kent comes in. She received a grant to conduct a pilot study on how to improve the return of results to study participants who are enrolled in RECOVER, the $22 million, NIH-funded study of long COVID. RECOVER is led by UIC and includes a consortium of Illinois public health departments, healthcare providers and community organizations from Chicago and Peoria, called ILLInet. Kent’s pilot funding comes from the ILLInet Executive Committee.

Kent, who visits UI Health’s Mile Square Health Center weekly to work with study participants, said the goal of her pilot study – MIRROR – is to create a tool that will allow participants to indicate preferences for receiving results, which she hopes can then be used in other large-scale research studies.

More transparency needed Heading link

Kent says that while the participants will receive compensation for their involvement in the study – with cash or gift cards for each visit – she also wants to be sure that participants are receiving valid, usable health information in a personalized format.

“In the literature today, it’s really becoming apparent that there needs to be more transparency between the research participants and the researcher,” says Kent. “[We don’t want them coming] to the clinic for two hours to have tests done, then walking away, and thinking, ‘I don’t know what you learned, in general, and I don’t know what you learned about me, specifically.’”

Kent credits Jerry Krishnan, MD, UIC professor of medicine and public health and lead principal investigator of RECOVER, with recognizing the need to bring in an expert in patient communications. The National Academy of Science, Engineering and Medicine published a report in 2018 citing the lack of a standardized process to inform individuals about their research results.

She adds that, while Institutional Review Boards regulate the use of participants in research studies, they don’t ask researchers how – or if – they plan to return individual research results, or the results of the entire study, to participants.

“It’s an unregulated part of doing research,” Kent says. “There currently is no standard.”

Researchers need to balance the value of transparency against the possibility of sharing results with unknown validity, she says.

“It’s not a one-size-fits-all,” she says, adding that some people may be comfortable reading and translating their own health information on a web portal, while others may want to sit down with a provider to review their results. In studies that collect genetic information, some participants may want that information while others may not.

“We don’t want to cause them stress,” she says. “We don’t want to give them information we don’t understand ourselves. If we know what it means, we need to make sure we share with them. If we don’t know what it means, we need to be transparent about that, too.”

She adds that RECOVER is an evolving study, and scientists don’t know what they’ll learn in the next four years about long COVID.

“Maybe it will be something that will be pertinent to [the participants] and [their] families, that [they’ll] want to know,” she says. “We need to have a mindset of transparency, recognizing that the research participants are a valuable part of the team.”

Kent’s pilot study includes collaborators from the UIC College of Medicine, UI Health community partners and UIC Nursing, including: Dean Eileen Collins, PhD, RN, FAAN, ATSF; associate professor Cynthia Fritschi, PhD, APRN, CDE; professor Crystal Patil, PhD; and assistant professor Chang Park, PhD.