Registration of Work

Any work that falls under the IBC Scope of Review and Responsibility MUST be registered with and approved by the Tufts University/Tufts Medical Center IBC.

Submission and Pre-Review Process

The Principal Investigator (PI) must first complete the Biological Materials Registration Form and submit the draft to the IBC Office. The draft MUST be submitted as a Microsoft Word document to allow for track changes during the pre-review process.

A Biosafety Officer (BSO) will be responsible for pre-reviewing the draft and will determine the method of approval (see more information in section below). The BSO will work directly with the PI if changes or additional information is needed. It is in the PI’s best interest to work closely with the BSO to obtain a well-drafted version of the form.

During the pre-review process, the PI must also complete any outstanding training prior to approval of the work. New PIs must take PI Training on NIH Guidelines as well as Basic Biosafety Training, which can be found here. More information about this requirement can be found in the Policy on Mandatory Biosafety Training.

Before approval can be granted, the BSO will need to evaluate the locations on campus where the work with be performed. To do so, this typically requires a walkthrough of the proposed laboratory space(s). The BSO will reach out to you to schedule this, if necessary. See more information in the Policy on Biosafety Inspections.

Determination of Administrative Approval or Full Committee Approval

All materials overseen by the IBC can be approved by one of the following methods, depending on the proposed work and the type of biological material to be used:

Administrative Review Process

If the BSO determines that the submission can be administratively approved, it must satisfactorily go through the pre-review process. Once any concerns/edits have been addressed by the PI, the BSO can approve the submission and work can begin..

Full Committee Review Process

If it is determined that the submission must go to the Full Committee for review and approval, the BSO will forward the final pre-reviewed version to the IBC Office for inclusion in the Agenda for the next IBC meeting. Please note that adhering to submission deadlines, and any pre-review deadlines that the BSO provides, is critical to being included on the next meeting agenda. Submission deadlines and IBC meeting dates can be found here.

The registration will then be reviewed at the IBC meeting and the Committee’s decision will be communicated to the PI by the IBC Office shortly after the meeting.

Requirements to be Met after Approval

• If your approval contains stipulations, it is the responsibility of the PI to ensure that these requirements are addressed as stated in document. A status update of any stipulations will be requested on the annual renewal of a registration.
• Laboratories must be inspected regularly, typically annually, to ensure compliance with all regulatory requirements and institutional policies and procedures. The inspection is completed by a Biosafety Officer. See more information in the Policy on Biosafety Inspections.
• All personnel that will be conducting work must participate in specified training and be listed as project personnel on the registration before beginning work. Review Personnel Requirements and within the training section of the registration document for more information. Additionally, personnel must be trained on the project-specific procedures and demonstrate competency to the PI or designee, prior to beginning independent work. The PI Checklist may be useful when onboarding new personnel.

Amendments

Most changes to an IBC registration must also be approved through the IBC by submitting an amendment form to the IBC Office. It will then go through the same process as stated previously. The BSO will determine if the change can be approved as an amendment or if the scope of the work requires a new Biological Materials Registration instead. The BSO will communicate this decision back to the investigator during the preliminary pre-review stage.

Personnel Amendments are handled by a separate process. See more information on the Personnel Requirements page.

For more detailed information on how submissions are reviewed, please see the Policy on IBC Review Requirements and Approval Process.