Don’t Overwhelm IRBs with Data During Remote Trials

Challace Pahlevan-Ibrekic

Challace Pahlevan-Ibrekic, Director of Clinical Research, Northwell Health/Feinstein Institutes for Medical Research

There’s an understandable tendency for sites conducting a trial remotely to err on the side of volume over focus when sending information to the institutional review board (IRB)—unfortunately, doing so can be counterproductive and make everyone’s job more difficult, says Challace Pahlevan-Ibrekic, director of clinical research at Northwell Health/Feinstein Institutes for Medical Research.

She’s had recent experience on “both sides of the aisle,” first on an IRB and now on the research side, and her perspective has changed a bit when analyzing both roles. “I underestimated how hard it was to conduct research with humans,” she says, noting that issues like informed consent require “a flexibility” to adjust on-the-fly if a patient isn’t clearly understanding the information being presented.

It takes work up front—and a willingness to “tweak” along the way—to find the right balance of information the IRB needs to do its jobs most effectively, agrees Alexandra Perrin, a clinical research assistant with the Center for Personalized Health at Northwell Health.

However, both Perrin and Pahlevan-Ibrekic caution against using a firehose when delivering information to the IRB, especially in trials where much or all of the activities are conducted remotely.

“With remote trials, everything is in writing,” notes Pahlevan-Ibrekic. “But IRBs don’t need to see everything, such as patient scripts, because those interactions are sometimes organic” and don’t always follow a formal script, she notes. “There’s definitely a tendency from some to send too much information to the IRB,” she adds.

If flexibility is key, so too is understanding that success is about being willing to adjust, Perrin stresses. “There’s triage and constant revising with ongoing modifications” to maintain the proper balance of information flow, she says.

“There’s no one size fits all, either,” Pahlevan-Ibrekic says. “It’s different for each installation” and can vary among different types of trials, she adds.

Two-way trust is also an important foundation. By determining what information the IRB does and doesn’t need, the site is taking on a level of risk, she notes. “And the IRB is taking risk” that the site will make the right decisions and supply pertinent information on a timely basis, she notes.

Author: Michael Causey