Biosafety Office

 

Application Review

The IBC will review each protocol application to determine if the proposed project is in compliance with University policies and pertinent regulations and/or guidelines. Review will consist of, but not be limited to:

 

 

Besides reviewing the proposal, a physical inspection will be conducted for biosafety containment level 1, 2 and 3 laboratories, facilities, and farms if the inspection report is not current. Biosafety containment level 1 laboratories, facilities, and farms will be inspected by the BSO/ABSO as a team and approved for a term of 5 years. Biosafety containment level 2 and 3 laboratories, facilities, and farms which are not used for select agent work will be inspected by the BSO/ABSO as a team or in conjunction with IBC members and approved for a term not to exceed 3 years. Biosafety containment level 2 and 3 laboratories and facilities which are used for select agent work will be inspected annually by the BSO/ABSO with at least two members of the IBC. It is imperative that the investigator or instructor and/or the lab manager be present to answer questions regarding the laboratory. For inspection of BSL-2 laboratories, only the investigator or lab manager need be present. The BSO or designee will certify in writing the findings of lab inspections to the IBC.

The IBC meets every other month to discuss, review, and vote on proposed activities involving biohazardous materials. Proposals may need to be modified in order to secure IBC approval. The results of IBC review will be conveyed to the investigator or instructor. The project may not start until the investigator or instructor receives approval from the IBC via the Office of University Research Compliance.

 

Types of Review

The type of review (i.e., review at a convened meeting or a subset of IBC review) depends upon aspects of the specific project. For example, experiments that are exempt from the NIH Guidelines may be reviewed by a subcommittee of the IBC and granted full approval. Other protocols involving Risk Group I or Risk Group 2 organisms may be similarly reviewed by a subset of the IBC. Protocols involving recombinant or synthetic nucleic acid molecules with Risk Group 2 organisms or involving the use of any Risk Group 3 or higher organisms will be reviewed by the full IBC at a convened meeting. Approval periods for exempt recombinant or synthetic nucleic acid molecules and BSL-1 protocols will not exceed five years. All other protocols will be approved for three years, except those projects involving select agents or toxins. Projects involving select agents or toxins will be approved for one year. Nonetheless, investigators and instructors must complete an annual protocol review questionnaire for each protocol so that the Office of University Research Compliance has a record of all ongoing projects.