The University of Wisconsin–Madison will meet the requirements stated in the United States Government (USG) Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern for the review and risk assessment of potential Dual Use Research of Concern (DURC). The DURC Subcommittee, which is a subcommittee of the Institutional Biosafety Committee (IBC), will serve as the primary reviewer of potential research for DURC. The process the DURC Subcommittee will use to review research is described below.
The USG Policy requires that principal investigators conduct an assessment of their work before it begins and provide it to the DURC Subcommittee for review. This will be done using the Notification of Potential DURC Form located on the Office of Biological Safety’s website on the DURC page. This form will be emailed to the Institutional Contact for Dual Use Research (ICDUR) for review and follow up. The ICDUR will contact the principal investigator (PI) to obtain the materials for the DURC Subcommittee to review in addition to the initial PI assessment.
The ICDUR will notify DURC Subcommittee members of the need for the upcoming review and provide materials for review before the agreed upon scheduled meeting time to allow each member to independently determine whether or not they feel the research is potentially DURC. Whenever possible the members of the DURC Subcommittee will meet in person to discuss the research and their findings. The review will be based upon whether or not the research could result in one or more of the following seven experimental effects described in the USG Policy:
If the DURC Subcommittee determines the research will not result in one of the seven experimental effects described above, the research does not require further review. However, if there is a change in the research that could reasonably produce one of the seven experimental effects, the PI must notify the ICDUR and supply a revised assessment.
If the DURC Subcommittee determines the research under review could potentially result in one or more of the experimental effects described above, then the work is at a minimum dual use research (DUR). The subcommittee will then perform a risk/benefit assessment to determine if the research is DURC (research that could reasonably be misapplied to pose a significant threat) using the criteria below:
After conducting the analysis and weighing the risk and benefits, the DURC Subcommittee will determine whether or not the research is DUR or DURC and, if it is DURC, whether or not it should proceed. If it should proceed, there will be a discussion of what risk mitigation measures are warranted. This discussion will be relayed to the PI by the ICDUR. The ICDUR will work with the PI to develop a risk mitigation plan that will be reviewed by the DURC Subcommittee and subsequently sent to the USG Funding Agency for approval. The ICDUR will consult with the USG Funding Agency and ask for guidance if: 1) the DURC Subcommittee cannot determine whether or not the research is DUR or DURC; 2) the scope of the research falls outside of the USG Policy, but presents a significant risk; or, 3) clarification is required about the USG Policy.
The ICDUR will incorporate the answers to the questions listed into a report that the DURC Subcommittee will review. This report will then be reviewed by the IBC and BTF if the research is determined to be DURC.
If the research does not meet the criteria listed in the USG policy, and would not result in one or more of the seven experimental effects, the risk benefit analysis will not be conducted and the report will not be reviewed by the IBC or BTF.
If the research does meet the criteria listed in the USG policy, but does not meet the definition of DURC based upon the risk benefit analysis, the report will not be reviewed by the IBC or BTF.
It is important to note that the DURC Subcommittee will also review products of research determined to potentially contain DURC, including manuscripts. The PI is responsible for sending all manuscripts for research potentially containing DURC to the DURC Subcommittee for review before submission to his/her journal of choice. The ICDUR will review individual experiments and presentations for DURC and seek advice of the DURC Subcommittee when needed.
The ICDUR will keep all documentation for the DURC Subcommittee reviews and assessments.
08-28-2015
