Recombinant and synthetic nucleic acid research must be done in accordance with the current edition of the NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules. These guidelines require all non-exempt recombinant and synthetic nucleic acid molecules to be reviewed and approved by the Institutional Biosafety Committee. Additionally, the Institutions abide by the “permissible toxin amount” definition as classified by the Department of Health and Human Services. For each toxin listed in the National Select Agent Registry, if the amount per Principal Investigator does not exceed the stated limit at any time, it is not regulated. Select Agent and Toxin regulation (42 CFR 73, 9 CFR 121, and 7 CFR 331). Agents used in amounts above these limits will be reviewed and approved by the convened Institutional Biosafety Committee (IBC).
Research involving biological material outside of the definitions given above does not require review and approval from the convened IBC. Instead, research with this material can be reviewed and Administratively Approved by a Biosafety Officer (BSO). All Administrative Approvals will be reported to the IBC at the meeting following Approval.
Administrative Approvals are allowed for the following biological material:
In accordance with the regulations and institutional policy, the following method should be used for Administrative Approvals.