Trials Use Flexible Approaches to Reconsenting Patients During Outbreak
Although FDA regulations require sponsors to disclose significant trial changes to participants and obtain their permission to continue in the trial, “reconsent” is not an official regulatory term and there are no specific rules on how to convey those changes.
“It’s a word we’ve kind of created in the research space because it makes sense in terms of describing how we provide new information to people,” says David Borasky, WCG Clinical vice president of IRB compliance. “Because of that, there are few limitations on how we can present information to research subjects, or new information or changed information.”
How sponsors best handle reconsenting patients during the COVID-19 pandemic depends on their own individual studies. Some sponsors have created addendums to consent documents describing briefly what changed, while others sent memos or opted to speak to participants about the modifications.
“We’ve … had research sites that, given the nature of their research and how they’re already interacting with subjects, wanted to orally brief participants by phone or in person to talk about what’s changing there,” Borasky said during a WCG webinar last week.
In Borasky’s experience, the least common method during the pandemic has been revising consent documents. While some sponsors have gone that route, study changes made in response to the pandemic are often “fairly discreet and limited in very specific ways” and may not necessarily warrant revising the consent document itself.
Borasky said the HHS Secretary’s Advisory Committee on Human Research Protections (SACHRP) takes the same view for handling reconsent, advising IRBs to “encourage use of the least burdensome approach for the participant” when new information must be presented.
He reminded researchers, though, that changes to previously approved research do require IRB approval. Generally, IRBs want to review changes in study procedures that can affect participant safety or research integrity — such as eliminating or reducing the number of study visits, moving off-site to telemedicine or home healthcare, and the collection of off-site lab specimens.
“We would obviously be concerned if we were eliminating visits that had to do with monitoring subject safety or collecting information about the well-being of participants that we thought was integral to ensuring that they’re doing well in the study and not having any issues,” he said.
Borasky noted that the most common topics on sponsors’ minds haven’t changed in the past few weeks. They center around reducing the number of study visits required by protocols, the use of home visits, telemedicine and commercial/consumer laboratories, shipping investigational products directly to participants, and how information should be conveyed to subjects.
But as the research community somewhat settles in to making those adjustments, other topics have arisen, he said, such as patient compensation based on in-person visits. Borasky explained that in the eyes of WCG’s IRBs, studies are allowed to keep paying subjects if they move to remote visits. Conversely, they can also reduce or cease payments to participants in response to decreased burdens of participation. The IRB’s job is to protect patients against undue inducement in the consent process, he said, and WCG’s IRBs don’t believe patient payments fit that category.
Electronic consent and electronic signatures have also come up as a topic of interest to sponsors. He advised that not all e-signature tools comply with Part 11, the FDA’s regulation for electronic records and signatures for agency-regulated research. While not all commercially available e-consent solutions meet regulations as is, Adobe, DocuSign and other e-signature products have Part 11-compliant versions available. However, sponsors should be aware that the FDA has not yet indicated if they will show flexibility for e-signatures during the pandemic, he said.
To listen to a recording of the webinar, click here: https://bit.ly/2XZpi77.