1. Dual Use Research of Concern Boston University and Boston Medical Center

2. Scope of Presentation The goal of this presentation is to provide a general awareness on the dual use dilemma as it relates to academic research. The specific aims are to provide: A brief h istorical and regulatory perspective leading up to the formulation of Dual Use Research of Concern (DURC). The National Science Advisory Board for Biosecurity (NSABB) proposed framework. Familiarity to the DURC criteria. Understanding the initial steps that BU/BMC have taken to address the issue of Dual Use. The Principal Investigator’s role.

3. Changing Regulatory Climate The United States Government recognized that information gained from life sciences research could potentially be misused in a way that could threaten public health and safety, agricultural crops and other plants, animals, the environment, or materiel. It therefore charged the National Science Advisory Board for Biosecurity (NSABB) to develop a framework for the oversight of “Dual Use Research of Concern” (DURC).

4. National Science Advisory Board for Biosecurity (NSABB) 2004 NSABB The National Science Advisory Board for Biosecurity (NSABB) has been charged to develop guidelines for the oversight of “Dual Use Research of Concern” (DURC)

5. Dual Use Research of Concern (DURC) Definition of DURC* “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”. * Source: National Science Advisory Board for Biosecurity (NSABB)

6. Dual Use Biosecurity Dilemma Example: Re-construction of 1918 flu virus published papers (Tumpey 2005 and Taubenberger 2005). Risk: Information may be misused by others to construct similar deadly pathogens for bio- weapon. Other Example: Aerosolized drug delivery Engineered large porous micro carriers (“whiffle balls”) deliver more drugs into the lung. Risk: Information may allow others to use the technology/approach for delivery aerosolized bio-weapons.

7. Regulatory Outcome The Federal Government is expected to establish guidelines, based on NSABB recommendations, that will require research institutions to govern the execution and public communication of DURC. * Strongly promote the free and open exchange of information.

8. BU/BMC Advisory Committee on DURC In July 2009, BU-BMC Advisory Committee on DURC issued its report with the following key recommendations to be implemented in two phases: Phase I Conduct awareness education and training for BU/BMC. Set up an interim review and decision process for DURC related research. Phase II Develop and implement an institutional policy. Implementation of policy and maintenance.

9. BU/BMC Advisory Committee on DURC Possible Outcome of Reviews Allow research to continue unfettered Modify research so it is no longer a DURC Allow the study to continue with constraints Do not allow the research to move forward

10. Experiments Identified by NSABB NSABB identified seven categories that meets DURC: Enhances the harmful consequences of a biological agent or toxin. Disrupts the immunity or the effectiveness of an immunization without clinical and/or agricultural justification. Confers to a biological agent or toxin, resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitate their ability to evade detection methodologies. Increases the stability, transmissibility, or the ability to disseminate a biological agent or toxin. Alters the host range or tropism of a biological agent or toxin. Enhances the susceptibility of a host population. Generates a novel pathogenic agent or toxin or reconstitute an eradicated or extinct biological agent. * Already part of screening process of research by the IBC.

11. Assessment and Evaluation Initial assessment of research by Principal Investigator for Dual Use Scientific Review by Federal Advisory Panel or Private Sector Consultant Institutional Action by OGC, Administration, Others Technical Safety Committee Review by IBC / LSC EHS

12. Next Steps The federal government has not adopted recommendations by NSABB. Additional guidelines will be developed for institutions to follow. Although the regulation is not in place, the institution will begin to address the dilemma in the event that such research takes place. The institution will determine the entity that will be in charge to help govern and address the dilemma. The Institution will need to work with you to seek advise and recommendations in order to implement the recommendations by the Ad-hoc committee on DURC.