Watchdog Says HHS Management of COVID Gain-of-Function Research ‘Does Not Fully Meet Key Elements of Effective Oversight’

The ‘Government Accountability Office’ (GAO) has concluded a study looking into federal monitoring of “gain-of-function” research conducted by the U.S. Department of Health and Human Services (HHS).

The GAO’s inquiry was prompted by a provision included in the bipartisan ‘CARES Act’ of March 2020.

The congressional watchdog group found that oversight carried out by HHS for gain-of-function research—a process that improves the ability of a pathogen to cause disease—“does not fully meet key elements of effective oversight” and “lacks clarity when it comes to the requirements for such studies,” The Hill reports.

Back in 2017, HHS required agencies who want to conduct gain-of-function research to submit to additional review when they identified research proposals involving “enhanced potential pandemic pathogens.”

According to the GAO, all three research proposal submissions that HHS, led by Secretary Xavier Becerra, reviewed since the framework was enacted in 2017 had been referred to the department by the National Institute of Health (NIH).

Apparently, this corroborates Kentucky Senator Rand Paul’s (R) assertion that the NIH had played a major role in the U.S. conducting gain of function research in Wuhan, China, even though the NIH “pretended it didn’t meet their ‘gain of function’ definition to avoid their own oversight mechanism,” Washington Post columnist Josh Rogin tweeted at the time. “SorryNotSorry if that doesn’t fit your favorite narrative,” he said.

Moreover, the GAO’s new report shows that HHS oversight of gain-of-function research “fell short in terms of transparency and performing reviews.”

For example, HHS agencies are required to submit special proposals on studies that are “reasonably anticipated to create, transfer or use enhanced potential pandemic pathogens.” But HHS did not specify what “reasonably anticipated” means, and the GAO’s report argued that “the phrase ‘reasonably anticipated’ allows for subjective interpretation and covers a range of certainty regarding the intent of the research and the likelihood of the results.”

The HHS body in charge of reviewing research proposals “is also lacking transparency,” the watchdog report shows, not only in “how the group was composed” but also “how it applied the framework standards when reviewing proposals.”

The GAO report said HHS is not even able to “evaluate risks” associated with gain-of-function research: “Because little is known about the composition of the departmental review group, it is not clear whether the departmental review group is equipped with the full range of technical expertise needed to critically evaluate risks associated with proposed research involving enhanced potential pandemic pathogens,” the report reads.

It’s worth noting that The Hill mentions HHS’s lack of transparency is inconsistent with “other review protocols established” by the department, but doesn’t identify which protocols those are.

In response to the findings, the GAO has made three recommendations for HHS to develop:

First, the watchdog advises that HHS clarify what the term “reasonably anticipated” means.

It also recommends that non-sensitive information regarding the departmental review process be shared with Congress and the public.

Finally, the GAO recommends that HHS and the Centers for Disease Control and Prevention (CDC) “consider changes to the Division of Select Agents and Toxins (DSAT), which is tasked with maintaining a list of pathogens that pose a severe threat to public health,” according to The Hill. Apparently, the coronavirus—which CNN says was the “leading cause of death” in 2022—hasn’t even been added to the DSAT’s list yet, a realist that threatens a “risk of impacting the public health response.”

And even though HHS did not agree or disagree with the first two recommendations, it did agree with the final recommendation regarding potential changes to DSAT.

According to the GAO, the division faces an issue with expanding oversight to new pathogens such as the coronavirus at the risk of impacting the public health response due to the federal requirements involved with pathogens that are added to DSAT’s list.

The biggest health agencies in the United States, including the CDC, NIH (National Institutes of Health), and FDA (Food and Drug Administration), are subordinate to HSS.

HHS’s motto is “Improving the health, safety, and well-being of America.”

As of Friday morning, these revelations have yet to be widely reported by mainstream media outlets.