HHS policy for monitoring gain-of-function virus research unclear, GAO says

A congressional watchdog agency has determined that the oversight carried out by the Department of Health and Human Services (HHS) for research involving highly transmissible viruses such as the coronavirus lacks clarity when it comes to the requirements for such studies and is recommending that the department develop new standards for assessing risk.

The Government Accountability Office (GAO) conducted a study of its own looking into federal monitoring of gain-of-function research. This inquiry was prompted by a provision included the CARES Act that tasked the agency with looking into ongoing efforts to prepare for, respond to and recover from the COVID-19 pandemic.

Gain-of-function research, which has come under heightened congressional scrutiny throughout the pandemic, is a process in which pathogens are altered in a way that improves their ability to cause disease. This form of research is often conducted to assess the potential dangers of infectious diseases and can be used to inform public health preparedness.

HHS developed a framework in 2017 for gain-of-function research, requiring agencies to submit to additional review when they identified research proposals involving “enhanced potential pandemic pathogens” being considered for federal funding.

Under this framework, a nonbinding recommendation was issued to the relevant agency to consider in granting federal funding for the flagged study. The GAO noted that three research proposal submissions have been reviewed since the framework was enacted in 2017, all referred to the department by the National Institute of Health (NIH).

The GAO said in its report that the oversight carried out under the 2017 framework “does not fully meet key elements of effective oversight.” The framework fell short in terms of transparency and performing reviews, according to the watchdog.

The GAO’s report identified vague language that failed to clearly identify expectations.

For instance, even though the framework requires agencies to submit proposals on studies that are “reasonably anticipated to create, transfer or use enhanced potential pandemic pathogens,” it does not explain what “reasonably anticipated” means.

“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,” read the report.

The departmental review group which considers the research proposals is also lacking transparency, according to the GAO. The agency’s study found that there was insufficient transparency when it came to how the group was composed and how it applied the framework standards when reviewing proposals.

“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 stated.

This lack of transparency is inconsistent with other review protocols established under HHS, according to the GAO.

Following these findings, the GAO said it has made three recommendations to HHS. The report advised that a standard for the term “reasonably anticipated” be developed in order to ensure consistency and also recommended that non-sensitive information regarding the departmental review process be shared with Congress and the public.

The GAO also recommended 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 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. Due to these limitations, the SARS-CoV-2 virus has yet to be added to the division’s list.

HHS did not agree or disagree with the first two recommendations issued in the GAO’s report and agreed with the final recommendation regarding potential changes to DSAT.