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Regulations and Institutional Policy

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:

  • Recombinant or synthetic nucleic acid research considered exempt under the NIH Guidelines.
  • Infectious Agents classified as Risk Group 1 or Risk Group 2; require Biosafety Level 1 or Biosafety Level 2 practices and procedures.
  • Toxins of biological origin that are not classified as a Select Agent Toxin.
  • Human Source Material including, but not limited to blood, tissue, and cell lines.

Administrative Approval Process

In accordance with the regulations and institutional policy, the following method should be used for Administrative Approvals.

  1. Principal Investigators (PI) should submit the completed Biological Materials Registration Biological Materials Registration Form to the IBC office via ibc-office@tufts.edu. A Biosafety Officer will begin the pre-review process.
  1. The Biosafety Officer will communicate directly with the PI throughout the review process. Based on the review by the BSO and Committee members, if necessary, the PI may need to provide additional information so that a complete Risk Assessment can be completed by the BSO.
  1. Upon completion of the Risk Assessment and confirmation that the laboratory meets the required Biosafety Level, the BSO will generate an approval letter which will be sent to the PI. The approval letter will outline the required Biosafety Level and/or Animal Biosafety Level for the work described in the registration.
  1. Administrative Approvals will be granted for a 3 year period. A de novo registration form must be submitted and approved prior to the expiration date if the work is to continue uninterrupted. If approval is not granted by the expiration date, all work with the biological agents must stop immediately.
  1. Upon initial review of the registration, the Biosafety Officer may determine that the registration should go to the IBC for a full discussion prior to approval. The Biosafety Officer will notify the PI of this decision prior to submitting the registration to the IBC.