A congressional oversight agency has determined that the Department of Health and Human Services (HHS) oversight of research involving highly contagious viruses such as MERS-CoV lacks clarity when it comes to requirements for such studies and is recommending that the department be developed. New standards for risk assessment.
The Government Accountability Office (GAO) conducted its own study looking at federal oversight of job acquisition research. This inquiry was made through a provision that included the CARES Act that mandated the agency to consider ongoing efforts to prepare for, respond to, and recover from the COVID-19 pandemic.
Gain-of-function research, which has been under close scrutiny from Congress throughout the pandemic, is a process in which pathogens are altered in a way that improves their ability to cause disease. This type of research is often done to assess potential risks for infectious diseases and can be used to inform public health preparedness.
HHS instituted a framework in 2017 for gain-of-function research, requiring agencies to submit to additional review when they identify research proposals including “potential pandemic pathogens” that are being considered for federal funding.
Under this framework, a non-binding recommendation was made for the relevant agency to consider awarding federal funding to the science-laden study. GAO noted that it has reviewed three research proposals since the framework was enacted in 2017, all of which have been referred to the department by the National Institute of Health (NIH).
The Government Accountability Office said in its report that oversight under the 2017 framework “does not fully meet the key elements of effective oversight.” According to the censors, the framework fell short in terms of transparency and performance reviews.
The GAO report identified vague language that failed to clearly articulate expectations.
For example, although the framework requires agencies to submit proposals for studies that are “reasonably expected to generate, transfer, or use improved epidemiological pathogens,” it does not clarify what “reasonably expected” means.
“The statement ‘reasonably expected’ 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 administrative review group that considers research proposals also lacks transparency, according to the Government Accountability Office. The agency’s study found that there was insufficient transparency when it came to how the group was formed and how it applied framework standards when reviewing proposals.
“Because so little is known about the composition of the Administrative Review Group, it is not clear whether the Administrative Review Group is equipped with the full range of technical expertise needed to critically assess the risks associated with proposed research involving improved potential pandemic pathogens,” the report stated.
This lack of transparency is inconsistent with other audit protocols established under HHS, according to the Government Accountability Office.
After those findings, the Government Accountability Office said it made three recommendations to HHS. The report advised setting a standard for the term “reasonably expected” in order to ensure consistency and also recommended that non-sensitive information related to the administrative review process be shared with Congress and the public.
The GAO has also recommended that HHS and the Centers for Disease Control and Prevention (CDC) consider changes to the Division of Selection Agents and Toxins (DSAT), which is tasked with maintaining a list of pathogens that pose a serious threat to public health.
According to the GAO, the department is having trouble expanding oversight to include new pathogens like the coronavirus at risk of affecting the public health response due to federal requirements regarding pathogens being added to the DSAT list. Because of these limitations, SARS-CoV-2 was not added to the department’s list.
HHS did not agree or disagree with the first two recommendations made in the GAO report and agreed with the final recommendation regarding potential changes to the DSAT.