The Trump administration has issued an abrupt "stop work order" for a critical clinical trial system, leaving medical researchers across the United States shocked and concerned about the future of ongoing and planned clinical studies.
The system, known as SMART IRB (Streamlined, Multisite, Accelerated Resources for Trials Institutional Review Board), was developed at Harvard University 15 years ago and has been instrumental in accelerating the launch of multisite clinical trials while maintaining rigorous patient protections.
"We were told to cease all work...immediately," stated an April 22 announcement on the program's website. "The order did not include a reason or explanation."
Impact on Clinical Research
SMART IRB has been a cornerstone of modern clinical research infrastructure, receiving $2 million annually from the National Institutes of Health (NIH). The system was designed to address two critical challenges: ensuring proper protections for human participants in large clinical trials while preventing oversight procedures from delaying research progress.
Dr. Barbara Bierer, director of SMART IRB, expressed her dismay to Fortune: "People were really shocked. We were, I have to say, not anticipating this at all."
The timing of the shutdown coincided with other contract terminations affecting Harvard research programs investigating conditions ranging from ALS to acute radiation syndrome. These actions followed Harvard's rejection of government demands regarding changes to governance, hiring practices, and "audits" of viewpoints.
Critical Role During the Pandemic
The SMART IRB system proved particularly valuable during the COVID-19 pandemic, enabling more than 300 coronavirus studies to rapidly commence when quick scientific responses were crucial.
"The numbers are remarkable considering that when the COVID-19 pandemic began, science and medicine needed to pivot at lightning speed to meet the challenge, and that's not something biomedical science is known for," explained a 2023 Harvard Medical School article.
Without SMART IRB, multisite clinical trials typically face delays of nine months or longer as each institutional review board conducts its due diligence to ensure human research participant protections. The streamlined system reduced this process to as little as 20 minutes in some cases.
Research Community Response
In a not-yet-published op-ed shared with Fortune, Dr. Bierer wrote, "We had taken 15 years to build what was destroyed with a single email, halting vital research across the country."
She further warned in the Harvard Gazette that "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."
Temporary Solutions and Uncertain Future
Despite the federal funding cutoff, Harvard University has temporarily stepped in to support SMART IRB operations, allowing staff to continue answering help desk questions and assisting researchers through the process to keep trials running. However, it remains unclear how long this stopgap measure can be maintained.
When asked for comment, the NIH directed inquiries to a website listing terminated grants, citing the Presidential Memo "Radical Transparency About Wasteful Spending."
Contradiction with Stated Policy Goals
Dr. Bierer noted the irony in the situation: "What the Trump administration says it wants to do is to make the government more efficient, and get rid of challenges that don't necessarily improve the lives of Americans. But this really does exactly that. It does make the government more efficient and does improve the lives of all Americans. It takes away these months of delays."
The research community now faces significant uncertainty about how to proceed with multisite clinical trials that were depending on the SMART IRB infrastructure, potentially delaying the development and approval of new treatments for various conditions.
Broader Implications for Medical Research
The shutdown of SMART IRB represents what Dr. Bierer calls "a giant step backward" for American medical research. Without this coordinated system, the clinical trial landscape may revert to slower, more fragmented processes that delay bringing new treatments to patients.
The collaborative relationship between Harvard researchers and the NIH had been exemplary, with Dr. Bierer describing NIH staff as "the best collaborators you can imagine." The NIH had even taken over the IT aspects of the system to integrate it with other government research platforms, making the sudden termination all the more perplexing to those involved.
As the situation develops, researchers and healthcare professionals are advocating for the reinstatement of this vital research infrastructure that has demonstrably accelerated medical advances while maintaining rigorous ethical standards.
