Franca R. Jones, Ph.D.
Assistant Director, Chemical and Biological Countermeasures
Office of Science and Technology Policy
Eisenhower Executive Office Building
1650 Pennsylvania Avenue
Washington, DC 20504
Dear Dr. Jones:
The American Society for Microbiology (ASM) is responding to the February 22, 2013 Federal Register (Vol. 78, No. 36) Notice requesting comments on the proposed United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern which establishes institutional review and oversight requirements for certain categories of life sciences research at institutions that accept federal funding for such research. The ASM recognizes the importance of reducing the threat of misuse of knowledge generated by the life sciences community. It also recognizes that the generation of such knowledge is global and essential for the future health and well-being of humankind. As such, there is a need to balance carefully any requirements for the oversight of dual use research of concern (DURC) so that it does not discourage critical research or place an undue burden on life sciences research conducted in the United States. To be effective oversight requirements imposed in the United States regarding DURC can only provide the intended protection if they serve as a model for wider internationally harmonized activities and if researchers and institutions in the United States that are not funded by the federal government voluntarily comply with the guidance for oversight of DURC.
With this in mind, the ASM offers the following general comments on the proposed DURC policy:
- The overall approach of oversight which focuses on the 15 microorganisms and toxins of most concern as possible high consequence agents is an appropriate approach for limiting the number of researchers and institutions that will have increased oversight responsibilities. For the most part researchers working with these agents already must comply with the extensive requirements of the select agent regulations and the additional oversight that would be imposed for considering DURC would not likely discourage them from those important research activities. Restricting DURC consideration to the second tier of 7 categories of research activities of most concern further limits the impact on the research community and appropriately focuses the oversight.
- We recognize that the proposed oversight would include any research on botulinum toxin that involves one of the 7 DURC categories. We believe that the guidance should be clarified to indicate that this does not apply to possession and uses of botulinum toxin below the levels specified by the select agent regulations unless it involves research on botulinum toxin that would fall into one of the 7 categories of potential dual use concern.
- Extending the proposed institutional DURC oversight policy to other non-select agents, including avirulent strains and genes, could have serious negative consequences since much work with such agents involves development of vaccines and other means of controlling the spread of infectious agents.
- The ASM supports having local oversight of research. PIs in particular are in the best position to judge possible DURC aspects of proposed research. Institutions have the right to decide which research should be performed at their facilities and the proposed local review process will aid in the exercise of institutional responsibility. Funding agencies, such as the NIH, also will review research proposals for DURC and require plans for reducing any risk of misuse of information generated in that research.
- Within the academic setting the review committees that are assembled consist of diverse representatives. Many of the representatives on the normal review committees, such as the IBC, will be from disciplines outside the sphere of expertise required to clearly assess whether the PI, and the Risk Mitigation Plan have fully addressed the risks and security concerns of such research.
- Institutions will require a great deal of guidance and training to ensure that they have the technical understanding needed to carry out this important review function. Even the NSABB with its high level of scientific and security expertise has struggled with evaluating DURC and designing appropriate mitigation strategies. We believe that as was the case in the early days of the implementation of the Recombinant DNA Guidelines where the RAC played a central and critical role in reviewing cases that the NSABB will have to serve this role until there is sufficient precedent to provide adequate guidance to institutions. It will be very important to provide avenues for inquiry that are clearly outlined with contact information, training materials and published guidelines (akin to the BMBL) that specifically address DURC to facilitate a fair and uniform approach to research in these much needed areas.
- We agree with allowing institutions to designate appropriate review committees but are especially concerned that those committees will not currently have the expertise necessary to evaluate DURC. IBCs may be the appropriate body to review the research for possible DURC as long as the norm of openness of IBC deliberations can be balanced with the need to protect the security aspects of DURC consideration. Having a single body like the IBC review the biosafety aspects of the research as well as the DURC considerations would reduce duplication of effort and increase the efficiency of the review. As already indicated, however, this will require specific guidance from the Federal Government.
- It is unclear what mitigation strategies institutions could require other than emphasizing why the benefits outweigh the concerns once the research had begun. There are not mechanisms for restricting free dissemination of research knowledge in the life sciences other than classification. Non-classified research funded by the US Government is intended for public use. The NIH has indicated that if it funds research it does not intend to restrict the publication of the research results. If institutions were to restrict publication or dissemination of the knowledge generated by that research they would be invoking the deemed export regulations which would potentially have serious implications for collaboration and the advancement of critical life sciences research. Furthermore, section 7.1.F states that “When researchers are planning to communicate DURC, it is their duty to ensure that it is done in a responsible manner….” It is unclear what is meant by that statement, and whether the policy is suggesting certain information should be withheld, redacted, or otherwise restricted.
- The guidance provides specific time frames for the institution to determine that research fulfills the criteria for DURC, submit that information to the funding agency for review, and submit a risk mitigation plan to the funding agency for review. However, there are no specified time frames for the funding agency to provide feedback to the institution. This is very important as prolonged review processes could lead to substantial delays in initiating the work. In addition, there should be some process specified for how disagreements or differences of opinion would be adjudicated and resolved.
- A statement at the end of section 7.2 acknowledges the potential that DURC research may involve multiple institutions, and that each involved institution should review the research and develop a risk mitigation plan. However, there is no guidance regarding how any differences in determination should be addressed or how different approaches to risk mitigation should be resolved. Would this need to be done by the funding agency, or between the involved institutions?
As indicated earlier, much guidance will be needed for the implementation of this DURC policy. We appreciate the opportunity to comment and look forward to further discussion of DURC policy, particularly on the development of institutional guidance and training.
Jeffery F. Miller, Ph.D., President, ASM
Roberto Kolter, Ph.D., Chair, Public and Scientific Affairs Board
Ronald M. Atlas, Ph.D., Cochair, Committee on Biodefense
Kenneth I. Berns, M.D., Ph.D., Cochair, Committee on Biodefense
Stephen M. Ostroff, M.D., Chair, Committee on Public Health