HHS needs better oversight of research that alters pathogens, government watchdog says

WASHINGTON — The health department’s oversight of research that could enhance dangerous pathogens has vague parameters, a lack of transparency, and “does not fully meet the key elements of effective oversight,” a nonpartisan federal watchdog found in a report released Wednesday.

The Government Accountability Office’s report is a precursor to a debate that will heat up at the National Institutes of Health over the next few weeks. NIH has an advisory board for biosecurity that’s expected to discuss a draft review of the agency’s oversight of this kind of research at a Jan. 27 meeting, and the materials are expected to be released ahead of time.

This kind of study, also called gain-of-function research, in which scientists develop sometimes more dangerous versions of diseases to study them, has long been controversial — in the fall of 2014, the Department of Health and Human Services paused funding for the research entirely to re-evaluate policy governing which research is worth the risk.


HHS developed an oversight framework for the research in 2017, but GAO investigators listed quite a few concerns.

Since 2017, NIH has only reviewed three research projects under that framework, and reviewers made one of the projects pivot to an alternative method that didn’t include gain-of-function research. GAO analysts said the language around what projects should undergo extra review is too vague, and recommended that HHS develop and document a standard to ensure consistency.


The GAO also wasn’t able to get much transparency into who was even doing the reviews. The chair of the review group said reviewers’ identities were hidden for their personal protection, but the GAO said that more general, non-identifying information about the makeup of the group could be provided to the public to ensure that people with appropriate expertise were included.

Another concern reviewers raised was that the NIH only reviews research that receives federal funding.

“A lack of knowledge about the scope and location of privately funded research being conducted means that there is a risk that an adverse public health event could result from unknown actors in unknown locations conducting high-risk research,” the GAO wrote.

Finally, the GAO raised concerns about a Centers for Disease Control and Prevention program that regulates the possession, use, and transfer of certain pathogens, and whether exceptions for emergency situations are appropriate.

Beyond the GAO’s report and the NIH’s coming draft, there are broader examinations of this kind of research in the works.

Preparedness legislation Congress passed in December directed the White House Office of Science and Technology Policy to establish a consistent policy for oversight of research that could create, transfer or use pathogens with pandemic potential, and update it every four years. The guidelines would have to make clear which proposals should be reviewed, enhance transparency, and ensure policy is in sync across different departments.

A House Republican leader who will likely be conducting congressional oversight of the NIH said the GAO report affirms her concerns about gain-of-function research.

“The American public deserve to know to what extent their tax dollars are being used to fund pathogenic research that has the potential to cause a pandemic,” said House Energy & Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.).

Source: STAT