Thursday, March 29, 2012

U.S. Issues New DURC Oversight Rules

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BSL-4 Lab Worker - Photo Credit –USAMRIID

 


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While the current H5N1 research row has centered around the publication of two specific research projects (see NSABB To Re-examine H5N1 Research Risks), the bigger issues at play involve how we oversee (and fund) future life sciences research in order to avoid future controversies.

 

To that end, today the Office of Science Policy at the NIH released a 4 page set of guidelines for DURC (Duel Use Research of Concern) projects, and ordered a review of all current life sciences projects.

 

For those unfamiliar with the lexicon of biomedical research, DURC in this new policy is defined as:

 

. . . life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security

 

The scope of this new policy is to cover research on the most dangerous of biological organisms, listing;

 

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

Specifically any research that seeks to:

 

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 (III.1) above.

 

 

While this new policy does not automatically halt or defund research found to meet the DURC definition, it does require greater agency oversight and an assessment of the risks and benefits of any research, along with the development of appropriate risk and safety measures.

 

As far as `teeth’ in this new policy, if perceived risks cannot be satisfactorily mitigated Federal Agencies may request voluntary redaction of scientific papers, may move to `classify’ the research, or may withhold or terminate financial support.

 

Agencies that conduct or fund life sciences research are instructed to perform a review to identify any projects that meet the DURC definition, and if found, to:

 

 

c)  Assess the risks and benefits of such projects, including how research methodologies may
generate risks and/or whether open access to the knowledge, information, products, or technologies  generates risk.


d)  Based on the risk assessment, in collaboration with the institution or researcher, develop a risk
mitigation plan
to apply any necessary and appropriate risk mitigation measures.  In addition:

  • i)  For DURC that is proposed and not yet funded, departments and agencies will assess
    whether to incorporate risk mitigation measures in the grant, contract, or agreement.

  • ii)  For currently funded DURC, funding departments and agencies will consider modifying the grant, contract, or agreement to incorporate risk mitigation measures. If such modifications are not possible or desirable, departments and agencies will seek voluntary implementation of mitigation measures by the institution. 

 

 

You can access the full policy on the Office of Biotechnology Activity’s News Page:

 

Now Available:

US Government Issues Policy on Oversight of Life Science Dual Use Resarch of Concern:

The purpose of this Policy is to establish regular review of United States Government funded or conducted research with certain high-consequence pathogens and toxins for its potential to be dual use research of concern (DURC) in order to: (a) mitigate risks where appropriate; and (b) collect information needed to inform the development of an updated policy, as needed, for the oversight of DURC. The fundamental aim of this oversight is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.

(March 29, 2012)

 

 

And just as I was finishing this post up, I saw that Lisa Schnirring at CIDRAP NEWS has an excellent overview of this new policy.   Read it at:

 

US debuts life sciences dual-use research policy

Lisa Schnirring * Staff Writer

 

It will be interesting to see how this new policy is received by scientists working in the life sciences field.

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