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Review and Approval Process

Registration of Research

  • The NIH Guidelines require all rDNA research at NIH sponsored institutions to be reviewed and approved by the IBC. (Note: NIH has classified certain rDNA work as Exempt from the requirements of the Guidelines. However, local regulations do not accept this exemption and do require all rDNA, including that considered Exempt by the NIH, to be registered with and approved by the IBC.) rDNA work (not considered exempt) cannot be administratively approved.

Determination of Administrative Approval or Full Committee Approval

There are two types of IBC approvals that can be obtained. See “Administrative Approval Policy.” Much of the determination is based on the type of biohazardous agent used. Some registrations and amendments do not need to be reviewed by the full Committee. For this research, the Biosafety Officer has the authority to approve. The BSO may contact you directly for required revisions prior to providing the Approval. For other research, full Committee review is required. ALL NON-EXEMPT rDNA MUST BE REVIEWED BY FULL COMMITTEE. For this research, the following submission and review processed is explained further in the following section.

Submission and Pre-Review Process

    1. Principal Investigators must first complete the Biological Materials Registration Form. The completed draft is to be sent to ibc-office@tufts.edu in electronic format.

    2. It will be sent to the EHS office and the relevant Biosafety Officer (BSO) who will be responsible for pre-reviewing the draft prior to approval or full Committee submission. The Biosafety Officer 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.

    3. If full Committee review is required, the BSO will forward the final version to the IBC Manager for inclusion in the Agenda for the next IBC meeting. Please note that adhering to pre-review and submission deadlines is critical to being included on the next meeting agenda. These dates, along with the meeting dates, can be found here.

    4. The registration will be reviewed at the IBC meeting. The Committee’s decision will be communicated in writing to the PI shortly after the meeting.

Requirements to be Met after Approval

    1. If your Approval letter contains stipulations, it is the Principal Investigator’s responsibility to ensure that these requirements are completed PRIOR to initiating work.

    2. Laboratories must be inspected annually to ensure compliance with all regulatory and institutional policies and procedures. This inspection will be completed by a Biosafety Officer.

    3. All staff listed on an active registration must participate in specified trainings. See “Policy for Mandatory Biosafety Training.” Additional trainings may be mandated by the IBC dependant upon the biohazardous agent used. The IBC office will track all personnel training. Email reminders will be sent to each individual regarding required training renewals.

    4. Agent-specific Exposure Response Plans must be developed and all staff must be attached with the Biological Materials Registration Form. The laboratory staff must understand and comply with the requirements of each plan.

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Amendments

Amendments to an approved registration should be submitted via email to the ibc-office@tufts.edu and will be sent on to the Biosafety Officer for review. Amendments include minor changes to a currently approved registration. The Biosafety Officer will determine if the change can be approved as an amendment or if a new Biological Materials Registration form is necessary instead. The Biosafety Officer will communicate this decision back to the investigator during the preliminary pre-review stage.

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