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 (DURC).
This policy requires the development of a risk mitigation plan for DURC research and is based upon the risk and benefits assessment. A copy of the draft risk mitigation plan must be sent within 90 days of the DURC Subcommittee’s determination that the research is DURC to: 1) the USG funding agency for federally funded research; or 2) for non-federally funded research, to the USG agency, designated by NIH, for review and final approval. In addition, all risk mitigations plans must be revised as needed and reviewed on an annual basis.
Some basic information is required for a risk mitigation plan as follows:
The DURC Subcommittee will review the proposed biosafety and biosecurity measures under which the DURC will be conducted as part of the risk/benefit assessment. The ICDUR will work with the PI to develop a draft of the risk mitigation plan incorporating the results of the risk/benefit assessment. This will include the guidelines and requirements of BMBL, the NIH Guidelines, and the Select Agent Regulations. In addition, the risk/benefit assessment will be used to determine whether or not additional biosafety or biosecurity measures are warranted for conducting the research.
In addition to the requirements stated above, University of Wisconsin-Madison risk mitigation plans will incorporate the following information at minimum:
The draft risk mitigation will then be reviewed by the DURC Subcommittee before the ICDUR sends it to the relevant program officer at the USG agency funding the research or in the event of non-federal funded research to the NIH-appointed USG agency for review and final approval. The DURC research cannot begin until the risk mitigation plan is approved by the USG agency.
In the event the DURC Subcommittee requires assistance in developing a risk mitigation plan or in the event the only viable risk mitigation measures are to not conduct the research in question or to not communicate the results, the ICDUR will contact the USG funding agency for consultation.
The DURC Subcommittee will review active risk mitigation plans at least annually and when the plans have been revised. The ICDUR will set a schedule for the review of the plans and contact the appropriate USG agency within 30 days of any changes to the risk mitigation plan or status of the DURC research at the university. The DURC Subcommittee will use the following criteria to review a risk mitigation plan: