HHS policy to oversee gain-of-function virus research unclear, GAO says

A congressional oversight agency has determined that oversight by the Department of Health and Human Services (HHS) for research involving highly transmissible viruses such as the coronavirus lacks clarity regarding the requirements for such studies and recommends that the department develop new risk assessment standards.

The Government Accountability Office (GAO) conducted its own study of federal oversight of gain-of-function research. This investigation was prompted by a provision included in the CARES Act that directed the agency to review ongoing efforts to prepare for, respond to, and recover from the COVID-19 pandemic.

Gain-of-function research, which has come under intense congressional scrutiny throughout the pandemic, is a process in which pathogens are modified in a way that enhances 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 undergo additional review when they identify research proposals involving “enhanced potential pandemic pathogens” being considered for federal funding. .

Under this framework, a non-binding recommendation has been issued for the appropriate agency to consider when awarding federal funding for the reported study. The GAO noted that three research proposal submissions have been reviewed since the framework’s promulgation in 2017, all referred to the department by the National Institute of Health (NIH).

The GAO said in its report that the surveillance conducted as part of 2017 “does not fully address the key elements of effective surveillance.” The framework fell short in terms of transparency and performing reviews, according to the watchdog.

The GAO report identified vague language that did not clearly identify expectations.

For example, while the framework requires agencies to submit proposals for 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 certainties regarding research intent and likelihood of results,” the report read.

The departmental review panel that reviews research proposals also lacks transparency, according to the GAO. The agency’s study found that there was not enough transparency about the composition of the group and how it applied the Framework Standards when reviewing proposals.

“As little is known about the composition of the Departmental Review Group, it is unclear whether the Departmental Review Group is equipped with the full range of technical expertise needed to critically assess the 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 made three recommendations to HHS. The report recommended that a standard for the term “reasonably anticipated” be developed to ensure consistency and also recommended that non-sensitive information regarding the ministerial 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 modifying the Division of Select Agents and Toxins (DSAT), which is responsible for maintaining a list of pathogens that pose a serious threat. for public health.

According to the GAO, the division faces an issue of expanding surveillance to new pathogens such as the coronavirus at risk of impacting the public health response due to federal requirements related to pathogens that are added to the DSAT list. Due to these limitations, the SARS-CoV-2 virus has not yet been added to the division’s list.

HHS disagreed or disagreed with the first two recommendations made in the GAO report and agreed with the final recommendation regarding potential changes to the DSAT.