Sunday, April 1, 2012

New dual use federal policy announced

The federal government revised its policy last week regarding potential dual use research. Dual use research is essentially any research that could be used for both good and evil purposes. The research to initiate the new policy was done on highly pathogenic H5N1. Scientists discovered mutations that would allow these deadly viruses to transmit in mammals. This gives researchers, surveillance workers and public health officials a better understanding of what to look for and how these viruses work. However, fears arose that this information could be used by terrorist to make a bio-weapon; thus the dual use designation.

The policy identifies 15 high risk pathogens and toxins and has called for all funding agencies to identify all federally funded research involving these agents within 60 days. Within 90 days the agencies are required to report all instances of research involving the 15 agents that could be considered dual use. Furthermore, the funding agency, institution and lead scientists of studies found to have dual use risks are to create a "risk mitigation plan". This could include modification of methodology, moving research to more secure labs, and alteration of how the research is communicated to the public and scientific community.

The funding agencies "will determine whether it is appropriate to:
request voluntary redaction of the research publications or communications, classify the research, not provide or terminate research funding."

Previously, research done at the NIH and the CDC was reviewed for possible dual use. This was done only for in house studies. The new policy would apply this same standard to all research carried out with NIH or CDC funding. Here is the kicker: these reviews are to be performed for <i>all current<i/> studies as well as future studies. It also appears this will affect research funded by other government agencies such as the USDA and the DOD.

I get why this policy was made. I agree with the vast majority of it. I am not sure how I feel about grandfathering in current research. It doesn't seem fair to drastically change the game half way through.

"Oh you used the CDC grant to conduct your thesis research on HPAI H7N1 and you are about present your 5 years of work to your PhD committee. Sorry, we just classified that so you can't tell anyone about it. Good luck getting a post-doc though."

The 15 agents are:
a) Avian influenza virus (highly pathogenic)
b) Bacillus anthracis
c) Botulinum neurotoxin
d) Burkholderia mallei
e) Burkholderia pseudomallei
f) Ebola virus
g) Foot-and-mouth disease virus
h) Francisella tularensis
i) Marburg virus
j) Reconstructed 1918 Influenza virus
k) Rinderpest virus
l) Toxin-producing strains of Clostridium botulinum
m) Variola major virus
n) Variola minor virus
o) Yersinia pestis

The 7 types of dual use research:
a) Enhances the harmful consequences of the agent or toxin;
b) Disrupts immunity or the effectiveness of an immunization against the agent or toxin without
clinical or agricultural justification;
c) Confers to the agent or toxin resistance to clinically or agriculturally useful prophylactic or
therapeutic interventions against that agent or toxin or facilitates their ability to evade
detection methodologies;
d) Increases the stability, transmissibility, or the ability to disseminate the agent or toxin;
e) Alters the host range or tropism of the agent or toxin;
f) Enhances the susceptibility of a host population to the agent or toxin; or
g) Generates or reconstitutes an eradicated or extinct agent or toxin listed in Section

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