University Responsibilities

  1. The University is responsible for ensuring that rsNAM activities comply with the NIH Guidelines. Compliance authority on campus is placed with the IBC, appointed by and advisory to the Vice President for Research. According to its charge, this committee:
  • Acts on behalf of the University for research involving rsNAM to:
    •  Review for compliance with the NIH Guidelines all non-exempt rsNAM research to be conducted at or sponsored by the University and approve those research projects that are in conformity with the NIH Guidelines. This review shall include:
      • An independent assessment of the containment levels required by the NIH Guidelines for the proposed research.
      • An assessment of the facilities, procedures, practices, and training and expertise of personnel involved in rsNAM research.
      • Ensuring that all aspects of Appendix M have been appropriately addressed by a PI involved in human gene transfer experiments.
      • Ensuring that no research participant is enrolled in a human gene transfer experiment until the Recombinant DNA Advisory Committee (RAC) review process has been completed.
      • Consideration of the issues raised and recommendations made as a result of RAC review of human gene transfer protocols, along with the PI’s response to those recommendations.
      • Ensuring final IBC approval is granted only after the RAC review process has been completed.
      • Ensuring compliance with all surveillance, data reporting, and adverse event reporting as required by the NIH Guidelines.
    • Notify investigators of the results of committee reviews.
    • Set containment levels for certain specified experiments.
    • Review periodically rsNAM research being conducted at the University to ensure compliance with the NIH Guidelines.
    • Adopt emergency plans covering accidental spills and personnel contamination resulting from such research.
    • Report within 30 days to the Institutional Official in the Office of the Vice President for Research and to the NIH any significant problems with or violations of the NIH Guidelines and any significant research-related accidents or illnesses. Spills or accidents in BSL2 labs resulting in an overt exposure must be immediately reported to NIH OBA; spills or accidents occurring in BSL3 labs resulting in an overt or potential exposure must be immediately reported to NIH OBA.
    • Prohibit initiation of experiments not explicitly covered by the NIH Guidelines until NIH establishes the required containment.
    • Perform such other functions as may be delegated to the committee by the NIH Guidelines.

2. Provides consultation to Environmental Health & Safety (EHS) and PIs handling biohazards.

3. Require that each member complete the training course “rDNA research, NIH Guidelines,” available online through the EHS website. In addition, information will periodically be discussed during IBC meetings that will provide updates to members’ training.