Institutional Biosafety Committee Review Procedures

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Last Updated: Oct 08, 2024, 02:54 PM

Determining Who Needs Biosafety Committee Approval

Southern Illinois University, Carbondale (SIUC) Principal Investigators (PIs) planning to carry out research or teaching which may involve biological hazards shall submit a written Memorandum of Understanding (MUA) application form to the Institutional Biosafety Committee (IBC) for review and approval. Studies which are designated Biosafety Level 1 are "exempt" from Committee review and can usually be reviewed and approved solely by the Biological Safety Officer (BSO). Researchers using any of the following shall complete and submit an MUA application form for review and approval:

  • Recombinant DNA
  • Agents that are potentially infectious for humans, animals or plants
  • Toxins
  • Human blood, body fluids, or unfixed tissue
  • Tissues, organ or cell cultures of human origin
  • Human gene therapy
  • Old World primates or sheep; certain Old World primates can transmit herpes B virus and sheep can transmit Coxiella burnetii, the  causative agent of Q-fever

For researchers working with potentially infectious agents and human subjects or experimental animals, IBC review is necessary in addition to review by the  SIUC Human Subjects Committee and/or the SIUC Animal Care Committee.

**The Human Subjects and Animal Care Committees do not consider biosafety issues during their respective reviews. They rely on the Institutional Biosafety Committee to perform this aspect of the review.**

PIs whose research comes under the governance of any of the following campus rules or governmental regulations are required to complete a MUA, and where applicable, maintain a medical surveillance program for laboratory employees:

  • NIH Guidelines for Research Involving Recombinant DNA Molecules
  • International, Federal and State Transport Regulations

Procedures for Reviewing MUAs

  1. If the proposed project involving either DNA recombinant research or the use of biological materials has been assessed to require a level of containment of Biosafety Level 1 (BL1) or its equivalent (Group I, Class 1, or Low Risk), the MUA may be approved by the IBC Chair if the BSO and one other member of the IBC (selected by the BSO with concurrence by the Chair) recommend approval.

    1. The BSO or any member of the IBC who reviews the MUA may insist that the MUA be reviewed by the full committee.

    2. Copies of MUAs approved under these provisions will be submitted to all IBC members for comment.

  2. Proposed research that requires containment of Biosafety Level 2 (BL2) or its equivalent may be approved by the IBC Chair if the BSO and at least two other members of the IBC (selected by the BSO with concurrence by the Chair) recommend approval. Provisions (a) and (b) above also shall apply.

  3. Proposed research that requires containment of Biosafety Level 3 (BL3) or its equivalent requires approval of the IBC at a scheduled meeting.

  4. All MUAs reviewed and approved under provisions of paragraphs 1 and 2 (above) shall be on the agenda for discussion at the next scheduled regular meeting. 

Procedures for Continuing Work Under on Old MUA

  1. The BSO will inform the Principal Investigator that the current MUA is about to expire and that an extension or modification is required.

  2. Inform BSO in writing that you wish to continue work under the old MUA.

    1. If there are no changes to your protocol send a memo to that effect.

    2. If there are minor changes to the protocol submit an Amendment to Original Protocol form.

    3. If there are major changes to the protocol submit a new MUA.

  3. All actions taken under this section will be reported to the IBC at the next scheduled regular meeting. 

Procedures for Amending an MUA

  1. Modifications of the experimental protocol such as disinfectant changes, use of same agent in a different form, or changes in vector or host organisms that do not alter classification of the experiment or safety of the protocol require that an Amendment to Original Protocol form be submitted to the BSO for review.

    1. The MUA amendment may be approved by the IBC Chair and one other member of the IBC.

    2. Approved amendments will be reported to the IBC at the next regular scheduled meeting.

  2. Major protocol adjustments such as changes/additions to chemical or biological agents, changes in animal model, or use of vector or host organisms that change classification of the experiment require completion of a new MUA following normal procedures. 

Forms