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Regulatory Requirements

The NIH Guidelines Section IV-B-2-b-(5) states that the Institutional Biosafety Committee (IBC) is responsible for periodically reviewing recombinant or synthetic nucleic acid molecule research conducted at the institution to ensure compliance with the NIH Guidelines. The IBC has extended this mandate to include review of work involving additional biological materials as detailed in the IBC Scope.

Approval Timeframe

At Tufts University/Tufts Medical Center, IBC Biological Materials Registrations are approved for three years, after which they will expire, and no work can continue. Allowance of a grace period beyond the expiration date would be out of compliance with both regulatory and institutional requirements. The Principal Investigator (PI) should also be aware that continuing to work on an expired registration is a violation of NIH grants policy and of other federal and local regulations governing the specified work. This is considered performance of unapproved work and would constitute an issue of non-compliance.

Annual Renewal

A brief Annual Renewal must be submitted to keep the registration active after the first and second year of the registration. PIs are required to complete an annual renewal form, which is provided by the IBC Office. If it is not submitted by the deadline provided, the IBC may terminate the registration.

De Novo Review

If the work is still active at the end of the three-year approval period, a complete de novo (new) IBC registration form must be submitted and approved by the IBC before the current approval timeframe expires. This review is referred to as a “de novo” review because the registration receives the same scrutiny by the IBC as if it were a brand-new submission. A notification is sent to the PI by the IBC Office well in advance of the expiration date that includes resubmission instructions. Notifications will continue to be sent until either a new registration is submitted, or the PI confirms that the registration can be terminated (see Terminations/Expirations of Registrations below).

If the PI will renew the work, the registration should be submitted early enough to avoid delays that could lead to a lapse in approval. It is recommended to submit to the meeting that occurs in the month prior to the original registration expiration (e.g., registrations expiring in June should be submitted for review at the May IBC meeting) to ensure proper time for review and approval (see submission deadlines here). If a delay is imminent and de novo approval will not be in place by the expiration of the registration, the PI must confirm that work will cease by the expiration date and that no work will continue until approval is granted.

Terminations/Expirations of Registrations

If the PI will allow the registration to expire or would like to terminate the project before its expiration date, the IBC Office must obtain written confirmation from the PI prior to the expiration date that no work will continue. The disposal, transfer, or storage of the biological materials needs to be recorded and the Biosafety Office may follow up with the PI to ensure proper management of the materials.