GAO Report Reveals Inadequate HHS Oversight of Research Involving Enhanced Potential Pandemic Pathogens

The Department of Health and Human Services (HHS) has established an oversight framework for research involving potential pandemic pathogens, such as SARS-CoV-2, the virus responsible for COVID-19. However, a new report from the Government Accountability Office (GAO) has revealed that this framework fails to meet key elements of effective oversight, leaving the department without assurance that it is reviewing all necessary research proposals.

The GAO report was prompted by a provision in the CARES Act, which tasked the agency with looking into ongoing efforts to prepare for, respond to, and recover from the COVID-19 pandemic.^[0] The report focused on grants awarded through the EcoHealth Alliance to several recipients, including the Wuhan Institute of Virology.^[1]

The report found that HHS’s oversight framework does not provide a clear standard for interpreting the term “reasonably anticipated”, which is used to determine which research proposals should be referred for additional review.^[2] Additionally, the framework does not provide sufficient transparency and fails to perform appropriate reviews.

The report also found that EcoHealth Alliance had improperly used nearly $90,000 in grant funds since 2014, including for salaries and bonuses, travel, and tuition.^[3] In response, EcoHealth President Peter Daszak said they have already reimbursed NIH for these unallowed costs.^[4]

The GAO report is a precursor to a debate that will heat up at the National Institutes of Health (NIH) over the next few weeks.^[5] 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.^[6]

Investigating pandemic pathogens is essential to guarantee the country's readiness to anticipate, react to, and recover from public health crises.^[7] However, in light of this report, it is clear that HHS must take additional steps to improve its oversight of research involving enhanced potential pandemic pathogens. This includes developing and documenting a standard for “reasonably anticipated” and assessing the risk of statutory limitations.^[8] Only then will research involving pandemic potential pathogens be conducted safely and ethically.^[9]

0. “Health Care — Oversight of pathogen research unclear” The Hill, 20 Jan. 2023, https://thehill.com/policy/3820439-health-care-oversight-of-pathogen-research-unclear/

1. “‘Extremely disconcerting': NIH didn't track U.S. funds going to Chinese virus research, watchdog finds” Yahoo News, 27 Jan. 2023, https://news.yahoo.com/extremely-disconcerting-nih-didnt-track-us-funds-going-to-chinese-virus-research-watchdog-finds-004808475.html

2. “GAO: HHS Could Improve Oversight of Research Involving Enhanced Potential Pandemic Pathogens – HS Today” HSToday, 21 Jan. 2023, https://www.hstoday.us/federal-pages/government-reports-and-summaries/gao-hhs-could-improve-oversight-of-research-involving-enhanced-potential-pandemic-pathogens

3. “NIH Urged to Consider Banning Wuhan Institute of Virology From Future Grants” The Intercept, 26 Jan. 2023, https://theintercept.com/2023/01/26/coronavirus-nih-ecohealth-wuhan/

4. “Watchdog knocks NIH oversight of alliance that oversaw funds to Wuhan lab” WDAF FOX4 Kansas City, 26 Jan. 2023, https://fox4kc.com/politics/hill-politics/watchdog-knocks-nih-oversight-of-alliance-that-oversaw-funds-to-wuhan-lab/

5. “Watchdog: HHS needs more pathogen research guardrails – STAT” STAT, 18 Jan. 2023, https://www.statnews.com/2023/01/18/hhs-needs-better-oversight-of-research-that-alters-pathogens-government-watchdog-says/

6. “Expert panel proposes stringent biosecurity oversight to avert future pandemics” News-Medical.Net, 25 Jan. 2023, https://www.news-medical.net/news/20230125/Expert-panel-proposes-stringent-biosecurity-oversight-to-avert-future-pandemics.aspx

7. “McMorris Rodgers: Federal draft report reiterates concerns over P3CO framework” Ripon Advance, 24 Jan. 2023, https://riponadvance.com/stories/mcmorris-rodgers-federal-draft-report-reiterates-concerns-over-p3co-framework/

8. “Public Health Preparedness: HHS Could Improve Oversight of Research Involving Enhanced Potential Pandemic …” Government Accountability Office, 18 Jan. 2023, https://www.gao.gov/products/gao-23-105455

9. “Watchdog faults HHS oversight of research on possible pandemic pathogens” Axios, 19 Jan. 2023, https://www.axios.com/2023/01/19/watchdog-hhs-high-risk-research