March 9, 2013

New Rules for Institutional Oversight of Dual-Use Research

The White House Office of Science and Technology Policy (OSTP) has issued new proposed rules for how dual use research of concern (DURC) is to be monitored by institutions that conduct such federally funded research. The guidelines apply to research with a defined list of agents that could potentially generate altered pathogens with more virulence or defenses than the native pathogen (e.g., influenza H5N1 with increased resistance to antiviral drugs). Almost all of the agents listed are select agentsEffectively, the policy requires such institutions to conduct their own biosecurity review, and communicate the review process and outcome to the federal funding agency.The document also places responsibility on a principal investigator (PI) to identify such experiments and bring them to the attention of the relevant review body at her institution. The policy is directed to risk identification and mitigation; it is not intended to denigrate such research: 
It is important to note that research that meets the definition of DURC often increases our understanding of the biology of pathogens and makes critical contributions to the development of new diagnostic, prevention, and treatment measures, improvements in public, animal, and plant health surveillance, and the enhancement of emergency preparedness and response efforts. Thus, designating research as DURC should not be seen as a negative categorization, but simply an indication that the research may warrant additional oversight in order to reduce the risks that the knowledge, information, products, or technologies generated could be used in a manner that results in harm. As a general matter, designation of research as DURC does not mean that the research should not be conducted or communicated. 
Thus, OSTP contemplates the dissemination of knowledge that is gathered by DURC research; however, there is a likelihood that the NSABB could be recruited again to review specific DURC publications; see here. The new policy complements the earlier 2012 DURC policy for funding agencies; it was intended 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)” and required that a "risk assessment be completed prior to the funding decision." That focused on the responsibility of federal funding agencies to ensure proper review. Now, the institutions that host DURC research must overlay a specific biosecurity review in addition to existing biosafety (IBC) and institutional review board (IRB) requirements; reaction is mixed. Some of the new review procedures might be challenged as excessive or duplicative in view of the already existing Federal Select Agent Program which “oversees the possession, use and transfer of biological select agents and toxins, which have the potential to pose a severe threat to public, animal or plant health or to animal or plant products.” Public comments on the new rules can be filed until April 23, 2013.

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