U.S. National Institutes of Health (NIH) regulations on research that increases one or more aspects of a pathogen need improvement, according to a group of advisers tasked with reviewing the rules.
If experiments meet certain definitions, they are supposed to be reviewed before being funded by the U.S. government under an oversight system implemented in 2012. The system is meant to ensure that the benefits of risky experiments called gain-of-function research outweigh the risks.
That’s due in part to the definitions that trigger reviews being “too narrow,” including the definition for “potential pandemic pathogens” (PPPs), the expert advisers said.
The framework requires the review of research that “involves, or is reasonably anticipated to involve, creation, transfer, or use of enhanced PPPs.”
PPPs are defined as being likely highly transmissible and likely highly virulent; enhanced PPPs are defined as a PPP “resulting from the enhancement of the transmissibility and/or virulence of a pathogen.”
Misinterpretations can happen due to the current definitions, such as excluding research on pathogens that aren’t PPPs but that is expected to result in the creation of a pathogen that meets one or both definitions, the board said.
“The thresholds conveyed by the terms ‘highly transmissible’ and ‘highly virulent’ could result in some research not being appropriately evaluated, such as those that could result in a pathogen with moderate transmissibility, or moderate virulence, which could still have severe impacts on public health, health care system capacity, or national security,” Syra Madad, an epidemiologist who helped lead the board’s work, said during a Jan. 27 meeting reviewing the report.
Among the group’s recommendations is expanding the definition of an enhanced PPP and imposing U.S. regulations on all foreign laboratories funded by the United States that are conducting risky experiments.
The report represents one of the final steps in work that began in January 2020 but was paused due to the COVID-19 pandemic. Dr. Lawrence Tabak, the acting NIH director, asked the board to resume the work in 2022.
The board can only make recommendations. It is up to U.S. government officials whether to approve them.
The NIH and its partners, including the White House Office of Science and Technology Policy, will “consider” the report as part of reviewing the oversight framework, Tabak said in a statement.
During the meeting, the board voted in favor of finalizing the draft findings, with the incorporation of comments from members of the public who shared their views.
Some experts urged caution, arguing that stricter oversight could impede necessary experiments.
“Although the committee and the reason we’re doing this is well-intentioned, we have to be really careful of unintended consequences,” Jeremy Kamil, an associate professor of microbiology and immunology at Louisiana State University, said. Too many regulations would lead to the delay in developing crucial drugs, he said.
Others said the recommendations would help improve the system but would not go far enough.
That includes the framework explicitly applying to all U.S. government agencies, not just the Department of Health and Human Services, the NIH’s parent agency, Dr. Tom Inglesby said.
Inglesby, director of the Johns Hopkins Center for Health Security, also said the board should “be more explicit about how research is referred to department level review,” adding, “It’s not clear how that happens now, who does that and there really isn’t a record of it.”
Rep. Cathy McMorris Rodgers (R-Wash.), chairwoman of the House Energy and Commerce Committee, said the report underscored the need for changes to the framework.
“I am encouraged that now even the Biden administration recognizes this fact. However, these recommendations are just the start, and our committee’s oversight will push for greater transparency into how the United States makes funding decisions regarding potentially risky pathogenic research,” Rodgers said in a statement.
The office said officials should work with the NIH and other funding agencies to clearly define “reasonably anticipated” and to be more transparent with information, much of which is currently withheld from the public.
Around the same time, the Department of Health and Human Services’ inspector general said that NIH officials failed to adequately monitor money granted to EcoHealth Alliance, the New York-based group that funneled some of the funds to the Wuhan Institute of Virology. That lab is situated near where the first COVID-19 cases were detected.
The deficient monitoring limited the ability of the NIH to “understand the nature of the research conducted, identify potential problem areas, and take corrective action,” the watchdog said.
