Of the stop work order, Dr. Barbara Bieber, director of the system known as the SMART IRB (streamlined, multisite, accelerated resources for trials institutional review board), tells Fortune, “People were really shocked. We were, I have to say, not anticipating this at all.”
The system, funded by a $2 million annual federal contract from the National Institutes of Health (NIH), was created by researchers at Harvard University 15 years ago to tackle two issues: to ensure proper protections for the human patients participating in large clinical trials, and to make sure those oversights did not slow down the study from getting underway. Typically, without the SMART IRB, it could take many months to get a large clinical study up and running; with the system in place, it can happen as quickly as within 20 minutes.
“We want to bring new treatments to people that need them as quickly as possible,” says Bieber. In a not-yet-published op-ed shared with Fortune, she wrote of the stop work order, “We had taken 15 years to build what was destroyed with a single email, halting vital research across the country.”
Plus, Bieber told the Gazette, “Studies halted midstream risk significant harms to participants and communities and can reinforce public skepticism and mistrust for the research enterprise and inhibit the commitment of researchers and institutions to fully, honestly, and collaboratively work with the communities they serve.”
At the height of the pandemic, the SMART IRB enabled more than 300 COVID studies to quickly get off the ground.
One big obstacle when it comes to multi-site clinical trials getting underway quickly is that institutional review boards (IRBs) must take due diligence to make sure human research participants are protected—a process that could take nine months or longer. “But at the height of the pandemic,” the news release notes, “the science needed to advance knowledge of SARS-CoV-2 couldn’t wait that long.” Luckily, the SMART IRB meant it didn’t have to.
But now, due to the inexplicable stop work order, says Bieber, “Instead of a coordinated system that advances research, we are taking a giant step backward and compromising the research to improve the health of all Americans.”
It’s further baffling, she says, as “The people that we work with at NIH have been the best collaborators you can imagine. They’re responsive, they’re helpful. They took over the IT side of this, because they could do it more effectively and integrate it with other systems that they have going …They were very enthusiastic about this and, you’d have to speak to them, but I think equally surprised.”
In the meantime, as the system itself remains available, Bieber says employees of Harvard—which doesn’t own the collaborative system, but administers it— have been volunteering to keep it going, answering help desk questions and just assisting researchers move through the SMART IRB process to keep trials up and running. Though it’s uncertain how long they’ll be able to keep it up.
“What the Trump administration says it wants to do is to make the government more efficient, and get rid of challenges that don’t that don’t necessarily improve the lives of Americans,” Bieber says. “And this really does that. It takes away these months of delays.”
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