Responding to Congressional inquiry related to oversight of research

Steve Ackerman is Vice Chancellor for Research and Graduate Education at UW–Madison.

UW–Madison has been engaged in ongoing discussion with Sen. Ron Johnson’s office and with Rep. Mike Gallagher’s office since a USA Today opinion piece published on April 11, 2023. UW–Madison stands by its record of safety and compliance with all federal and institutional oversight in both of the biosafety incidents described at Wisconsin and is providing additional information to its members of Congress. The university also supports and will continue to engage in additional discussion regarding federal oversight of research. 

To clarify a couple matters addressed in an April 25 letter from Wisconsin’s Republican Congressional delegation to the U.S. Secretary of Health and Human Services and the directors of the CDC and NIH: 

With regard to the November 2013 incident —  

As the university describes in a recent post, UW–Madison did have quarantine space for the researcher who incurred a needle stick while working with H5N1. That researcher was appropriately quarantined in the proper location at their private residence following what was correctly deemed a low-risk exposure. It was not a high-risk exposure because the researcher was not exposed to virus through respiratory or mucosal means (eyes, mouth, nose). Influenza virus is not known to be transmitted through needles into the skin, muscles or blood. 

While reviewing that incident, however, NIH noted a discrepancy in the quarantine location described by the lab in the event that a high-risk exposure was to occur in the future. The needle stick was not a high-risk exposure. The university worked with the lab to update the planned quarantine location should a high-risk exposure occur. 

With respect to the December 2019 incident –

Consultation between the UW–Madison Responsible Official, Biological Safety Officer, and infectious disease medical providers immediately following the incident led to the determination that the momentary hose disconnection in the lab was not an exposure or potential exposure. The trainee was not exposed or potentially exposed to H5N1 virus.  

This determination was made because the hose disconnection was so brief that the air in the trainees’ respirator would have still been HEPA-filtered air; virus was locked away; the ferrets that potentially were infected with H5N1 virus were in biocontainment cages with HEPA-filters; and the surfaces within the room, including the researchers’ sleeves and gloves, had been decontaminated. The work was also taking place in a facility where air is constantly pulled away from and out of the room — the air within the room is fully exchanged at frequent intervals. 

As the letter states, the university immediately reported the hose disconnection to the Centers for Disease Control and Prevention, as required by the Federal Select Agent Program, which has different reporting requirements than the National Institutes of Health. The university did not immediately report the hose disconnection to the National Institutes of Health because the disconnection was not an exposure or potential exposure and therefore did not meet the requirements for immediate reporting to the NIH. 

Despite this, following the Dec. 9 incident, within days the lab contacted the National Institute of Allergy and Infectious Diseases (within the NIH) to verbally discuss the incident. The lab subsequently followed up with a written summary of the incident, on Dec. 19. Following a series of meetings in January 2020, the university provided an incident report to the NIH as the agency requested. The NIH did not convey to the university that it believed the incident was an exposure or potential exposure, and in March 2020, NIH told the university that “the actions taken in response to this incident appear appropriate”  

UW–Madison takes seriously the safe and responsible conduct of research and follows its reporting requirements.