Annals of Health Law
measured during the 1918 Spanish influenza pandemic that reportedly
killed one-third of the world’s population at that time.7 To date, no
effective treatments or vaccines have been developed that would reduce
mortality and morbidity rates during a H5N1 pandemic.8 Consequently,
any research on H5N1 that describes its adaptability to infect humans
through forms other than direct contact (e.g., aerosol) raises significant
concerns that the findings from such research could be adapted for
malevolent applications intended to harm populations and societies (viz., a
bioterrorism attack).9 Furthermore, such research brings an inherent risk of
an accidental release of the biological agent being studied into the
surrounding population and community.10
Such Dual-Use Research of Concern (“DURC”) has come to the
forefront of all debates regarding the importance of conducting cutting-edge
research on highly pathogenic and deadly disease agents ( i.e., “dangerous
research”) in recent years.11 The central question in this debate is whether
society is better off not studying certain diseases because the risk that such
research will be used for sinister purposes outweighs the benefits it may
have on responses to future pandemics.12
7. Terrence M. Tumpey et al., Characterization of the Reconstructed 1918 Spanish
Influenza Pandemic Virus, 310 SCI. 77 (2005).
8. For definition of “pandemic,” see supra note 4.
9. Special Issue: H5N1, 336(6088) SCI. 1473 (2012), available at
10. Joel O. Wertheim, The Re-Emergence of H1N1 Influenza Virus in 1977: A
Cautionary Tale for Estimating Divergence Times Using Biologically Unrealistic Sampling
Dates, 5(6) PLOS ONE e11184 (2010), available at www.plosone.org/article/info%3Adoi%
2F10.1371%2Fjournal.pone.0011184. See also infra III( B).
11. See infra Part III.
12. The U.S. government considers biological-based threats to public welfare a public
policy priority. A variety of activities support public health emergency management efforts
at the federal, state, and local levels. These include statutorily-authorized initiatives to
support research efforts aimed at developing medical countermeasures to dangerous
pathogens and biological agents, as well as efforts to develop various preparedness,
response, recovery, and mitigation capabilities for bioterrorist incidents or natural events
involving such pathogens or biological agents. See, e.g., Project BioShield Act of 2004,
Pub. L. No. 108-276, 118 Stat. 835 (2004); Office of Public Health, Emergency
Preparedness Statement of Organization, Functions, and Delegations of Authority, 71 Fed.
Reg. 38,403, (July 6, 2006); 2012 HHS PHEMCE Strategy and Implementation Plan, U.S.
DEP’T HEALTH & HUMAN SERVS., www.phe.gov/Preparedness/mcm/phemce/Pages/
strategy.aspx (last updated Dec. 10, 2012); Public Health Emergency Medical
Countermeasures Enterprise, U.S. DEP’T HEALTH & HUMAN SERVS., http://www.phe.gov/
Preparedness/mcm/phemce/Pages/ default.aspx (last updated Dec. 10, 2012); Public Health
Preparedness Capabilities: National Standards for State and Local Planning, U.S. CTRS.
FOR DISEASE CONTROL & PREVENTION (2011), http://www.cdc.gov/phpr/capabilities/