Experts Call on Congress to Quickly Implement New Gain of Function Oversight System After NIH ‘Failure’

The P4 laboratory on the campus of the Wuhan Institute of Virology in Wuhan, Hubei Province, China, on May 13, 2020. Hector Retamal/AFP via Getty Images

Experts urged Congress on Aug. 3 to implement a new oversight system over risky research conducted in or funded by the United States, saying that the present system is ill-equipped to identify problematic experiments.

Two Department of Health and Human Services agencies, the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention are currently required to analyze whether proposed projects meet the definition of research “involving enhanced potential pandemic pathogens,” or pathogens that could lead to a pandemic.

Projects that meet the definition are referred to a committee made up of members appointed by the health secretary, with the panel deciding whether the projects can move forward.

The current system, known as the PC3O framework, isn’t working, experts say.

Richard Ebright, a laboratory director at the Waksman Institute of Microbiology, said the system “in principle” provides for adequate oversight, but “in practice largely has existed only on paper.”

In the 4 1/2 years since the policy was announced, only three projects have been approved, while a number of others—including work done in Wuhan, China, that was funded by the NIH—weren’t flagged “due to a failure by the NIH to identify and flag all covered projects,” according to Ebright.

He was testifying before the Senate during the first congressional hearing on risky biological research, known formally as gain-of-function research, since the COVID-19 pandemic began.

Another witness, Massachusetts Institute of Technology biologist Kevin Esvelt, said the NIH has a long history of funding projects that are aimed at enhancing the transmissibility of viruses, including lethal pathogens, but that many of the projects weren’t flagged by the agency.

“It’s been a failure, I think at this point in time,” Dr. Steven Quay, CEO of Atossa Therapeutics, told the panel.

The Department of Health and Human Services, the NIH, and the Centers for Disease Control and Prevention didn’t respond to requests for comment.

Dr. Anthony Fauci, a top NIH director, said in June that the agency wouldn’t stop funding research in China.

Solutions

Sen. Rand Paul (R-Ky.), who was leading the hearing, said he sees the need for additional hearings and legislation dealing with the matter. He hoped for bipartisan support for a measure improving oversight.

The experts had different ideas for solutions, but all agreed that the NIH should no longer oversee grants that the agency itself hands out.

Ebright said the oversight should be tasked to a single, independent federal agency that doesn’t perform or fund research and that regulations governing the oversight should be codified. Those regulations should include mandatory oversight and enforcement provisions.

The risky research “was performed because it’s fast, easy, fundable, and publishable in the academic research ecosystem,” he said. “Because of these incentives, self-regulation from within the community is insufficient. The scientific research community will follow the incentives; it will never effectively self-regulate on these issues.”

Esvelt suggested that Congress stop funding what he called “pandemic virus identification experiments,” which refers to experiments that “could substantially increase our confidence that a virus would cause a pandemic if repeatedly introduced.”

“When it comes to identifying pandemic-capable viruses that could kill millions of people and will necessarily be shared with scientists worldwide who will be able to access them, I do not think that we should be doing it. I do not think that China should be doing it. I do not think that anyone should be doing it because it is expected to kill 100 times as many people as it might save, even if we could perfectly prevent an identified natural virus from spilling over,” he said.

Quay proposed having institutional review boards oversee the risky experiments. The board system is used for human clinical trials.

Cathy He contributed to this report.