BIOSAFETY COMMITTEE PROTOCOL REVIEW PROCEDURES

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

The BSO will inform the Principal Investigator that the current MUA is about to expire and that an extension or modification is required.
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.
All actions taken under this section will be reported to the IBC at the next scheduled regular meeting.

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.
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.