CHHS Weighs In on Obama’s New Plan for High-Risk Biological Research

March 30th, 2012

A few months ago biomedical researchers at the University of Wisconsin and in The Netherlands attempted to publish what amounted to a new recipe on how to manipulate the avian flu virus in a way that could easily infect humans. Their data raised significant concerns over how to weigh the potential health and medical benefits of such research versus the potential risks posed by an accidental or malicious release of the virus onto an unsuspecting population. This research was funded by the federal government and was meant to enhance the development of vaccines and other countermeasures against this mutated strain, if or when the virus naturally mutated into an airborne strain. Yet the concern here is that the risks of this NIH-funded research went unnoticed by the federal government until the scientific journal requested guidance on the publication of the research and the scientific methodology used to alter the virus. Without proper oversight, biomedical research on highly pathogenic agents represents a clear and present danger to homeland security, public health, and the global community.

On March 29, 2012, the Obama administration issued its first formal response in the form of a new policy governing the oversight of life science dual use research of concern. This new policy calls for a systematic review of all federally-funded academic research programs based on a series of criteria. First, granting agencies must identify all projects which utilize a particularly nefarious subset of the previously identified Select Agent Registry, a listing of the various biological agents that the United States regulates due to their potential risks. Next, after determining research projects that utilize the subset of select agents, the agencies must categorize the type of research experiments being conducted. If the experiments attempt to enhance the pathogen’s harmful consequences, change the host range, alter its susceptibility to vaccines, confer an ability to evade detection, or improve infectivity, the experiments are flagged as DURCs. For research that meets the above criteria, an individual assessment is conducted to ascertain the risks and potential benefits of such projects. Identified risks are incorporated into a risk mitigation plan that suggests mechanisms to improve the security and scientific safety of the experiments, monitors or modifies communication of the research findings and overall improves cooperation between the researchers and the federal agency funding the agency. Failure to comply with the risk mitigation plan puts the researcher at risk to lose their federal funding.

Overall, this policy is a firm step in the right direction. While the value of basic and applied biomedical research is unquestioned, its conduct must occur in a safe and responsible manner respectful of national security concerns and the general public welfare. As the primary funder of many of these projects, the federal government has a vested interest and responsibility to ensure that the research remains benevolent in nature and does not pose an undue risk to communities. By implementing a review of all current and future research, agencies should have greater ability to assess the security risks, inform homeland security and public safety counterparts about potential threats, and define appropriate priority biodefense funding in the future.

One area still lacking from the new policy on oversight of biomedical research is cooperation and information sharing with the municipal, local and state authorities that are responsible for the safety of their populations. Should an accident occur in one of these DURC laboratories, it would be incumbent upon the local and state responders to respond to protect their communities. Unfortunately, with little or no communication about the potential biological research risks in their communities, the first responders and medical communities are at a significant disadvantage and enhanced risk due to this information deficit. While the open sharing of the precise location, agents and nature of the experiments present a potential further security risk, an intermediate model of information sharing across levels of government could provide local and state responders with the appropriate level of information to ensure a safe and effective level of community preparedness. Simply by limited local and state awareness to the types of select agents being used in their jurisdictions, the responders could ensure appropriate utilization of personal protective equipment (PPE), the ability to identify unusual symptoms associated with these rare select agents, and the stockpiling of local medical countermeasures necessary to combat the specific pathogens.

Earl Stoddard, PhD, MPH is the Public Health Program Manager at CHHS.

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