"On Dual Use Research of Concern" by Tejong Lim
Needless to say, research in the life sciences has led to innumerable advances, but we would be irresponsible to laud such progress without considering the inherent risks. The government provides funding to scientists who are expected to publish their research for public knowledge so that others may learn from their findings. Unfortunately, the same knowledge made available to benefit society can also harm it. Bioweapons have been used since even 600 BC, ranging from contaminating water wells to hurling plague-ridden cadavers over enemy walls, and modern scientific knowledge has significantly increased the potential harm that can be inflicted.
Public awareness of the potential misuse of scientific research increased dramatically in 2001 when the Wimmer lab at the State University of New York synthetically assembled poliovirus de novo with commercial oligonucleotides based on their previous paper from 1991. The oligonucleotides were assembled to form the poliovirus complementary DNA (cDNA), which was then transcribed by RNA polymerase to synthesize the RNA genome. After translation of the genome, the capsid proteins self-assembled to form the poliovirus. Virulence tests and receptor-specific antibodies in mice demonstrated the virulence of the synthetic poliovirus to match that of the wild type strain and the possibility of in vitro synthesis of infectious agents de novo. Although the Wimmer lab’s objective was to support the World Health Organization’s “closing strategies of the poliovirus eradication campaign”, the ability to synthesize the infectious agent for poliomyelitis has the obvious potential for bioterrorism. Wimmer was criticized for enabling potential bioterrorists to create a deadly pathogen; if poliovirus could be artificially synthesized, the same process could theoretically generate other viruses. The debate demonstrated the need for more practical regulation of research publication to minimize the risk of bioterrorism without impeding scientific progress.
Research relating to knowledge with both beneficial and pernicious potential is called dual use research of concern, or DURC. In 2004, the Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology responded to growing worries by forming the National Science Advisory Board for Biosecurity (NSABB), a United States advisory panel to the National Institutes of Health (NIH) made up of 25 voting members appointed by the Secretary of the Department of Health and Human Services (HHS) and with expertise in fields ranging from microbiology to national defense.[1,4] The NSABB now defines DURC as “research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment, or materiel.” Despite these actions, the exact classification for research posing a true threat and in need of censorship remains unclear.
How much of a threat is bioterrorism that research publication should be censored? Bioweapon usage has been uncommon in the recent decades, with the most recent scare being Amerithrax in 2001. Silicon traces with the anthrax spores caused fear that the spores had been weaponized to increase virulence, but later investigations concluded that the silicon was naturally occurring. Scientists have been unable to reproduce the same powered spores, indicating that the anthrax was not a direct consequence of public research. No bioterrorist attack directly enabled by research publication has occurred as of yet, perhaps due to the extra time, funds, and skills needed to prepare and use pathogens as opposed to firearms or explosives. Further, pathogens can take days to kill their host while more conventional weapons are often much quicker.
The most recent debate over DURC arose in December 2011, when the NSABB reviewed two NIH-funded research papers on factors enhancing H5N1 influenza transmissibility. The NSABB recommended that the HHS require the two labs to omit the methodologies to prevent replication of their experiments, while general conclusions could remain. When HHS called for Yoshihiro Kawaoka of the University of Wisconsin and Ron Fouchier of the Erasmus Medical Center to redact their experimental methods, a heated argument ensued. Kawaoka, who identified four gene mutations that enhanced H5N1 transmissibility, argued that his research’s benefits significantly outweighed the risks. “The redaction of our manuscript, intended to contain risk, will make it harder for legitimate scientists to get this information while failing to provide a barrier to those who would do harm,” Kawaoka claimed. His colleague Fouchier agreed, “By following the NSABB advice, the world will not get any safer, it may actually get less safe.” After months of debate, another review convinced the NSABB to allow the full publication of both papers in May 2012. The NSABB admitted to overreacting and attributed its reconsideration to a new DURC policy and to Fouchier’s revision to the paper emphasizing the low lethality of his experimental virus.
As the H5N1 debate demonstrates, the current research atmosphere favors the publication of DURC. From 2004 to 2008, only 28 papers were examined for DURC out of the 74000 papers received by Nature and its journals, and currently, no paper has been rejected by any journal for risk of bioterrorism. The World Health Organization stated in February 2012 at the Technical Consultation on H5N1 Research Issues, “Final responsibility for the identification and implementation of appropriate risk assessment, mitigation, and containment measures for work with laboratory-modified H5N1 strains lies with individual countries and facilities.” Further, the US government in 2012 implemented the Government Policy for Oversight of Life Sciences Dual Use Research of Concern, establishing research guidelines for a narrow scope of only 15 agents. Scientists therefore largely have the current responsibility of deciding whether to publicize their findings, but the effectiveness of this model remains dubious due to its tolerant subjectivity and lack of standardized censorship. A safer strategy might enforce stricter governmental censorship of experimental methods and require researchers to obtain permission from the NSABB before accessing censored information. More centralized DURC regulation on a global scale may also prevent risky knowledge from being published in a country with lenient standards. Hopefully, a catastrophic bioterrorist incident will not be needed for policymakers to establish more practical, well-defined DURC regulations.
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