Policy on Amendments
The Institutional Biosafety Committees (IBC) of Tufts University Cummings School of Veterinary Medicine (TCSVM) and Tufts University/Tufts Medical Center have the responsibility to review and approve all changes to previously approved registrations. Depending upon the type of amendment, the approval may require review by the full IBC or it may be approved administratively by a Biosafety Officer (BSO). Examples of the kinds of changes that fall into each review designation are listed below. This list is not comprehensive and it is also important to understand that the Biosafety Officer may call for full Committee review of an amendment. NOTE: If the amendment includes significant changes to the original registration, you may be required to complete a new registration instead of an amendment.
The IBC Amendment Form must be submitted to the IBC to amend an existing approved registration prior to initiation of the changes proposed. The amendment should be submitted directly to the IBC (firstname.lastname@example.org). It will then be forwarded to the relevant Biosafety Officer for preliminary review and determination of the kind of review necessary, see below.
AMENDMENTS THAT REQUIRE FULL COMMITTEE APPROVAL (such as, but not limited to):
- Change in Biosafety Level
- Addition/Change in use of recombinant or synthetic nucleic acid molecules not exempt
- Significant change in Exposure Response Plan
- A change in Principal Investigator must be done at a convened IBC meeting if the research has received OBA/RAC approval under Appendix M-II-B-5
If Full Committee Review is required, the Biosafety Officer will work with the Principal Investigator to determine the best course of action for approval of the change requested (i.e. submission of the amendment or submission of a new registration instead). The Biosafety Officer will also perform a pre-review and work with the investigator to revise the amendment, if necessary. Submission to the full Committee proceeds as for all Committee-reviewed research.
AMENDMENTS THAT CAN BE ADMINISTRATIVELY APPROVED (such as, but not limited to):
- Addition of new laboratory area
- Addition of recombinant or synthetic nucleic acid molecules that are exempt
If Administrative Approval is appropriate – and a Biosafety Officer is required to approve – the change will proceed as described in the “Policy on IBC Administrative Approval Process.” The IBC will be notified of all administrative approvals at the following meeting.