PIs complete the IBC Registration form to register teaching or research activities using recombinant or synthetic nucleic acid molecules (rsNA). The IBC Registration is submitted to the IBC Coordinator via e-mail.
The IBC Registration solicits information to describe the source and nature of the DNA constructs, host/vector systems, and potential risks to human health and the environment with emphasis on practices, biological controls and engineering controls used to contain potentially hazardous materials.
After submitting the completed IBC Registration, the following steps one (1) through five (5) occur:
Step 1: Notification of Receipt of Registration A unique registration number is assigned to all new or renewed submissions. The IBC Coordinator will send an e-mail notifying the PI that the registration has been received. The e-mail will include the newly assigned registration number and the date of the upcoming IBC meeting.
Step 2: Preliminary Review All new registrations will be pre-reviewed by the IBC Coordinator, IBSO and IBC Chair. The PI will be notified by e-mail of any comments or suggested revisions with a date to respond. The PI will then make any necessary changes to the registration thereby making it suitable for committee review.
Step 3: Classification of Experiments Investigators make an initial classification of their rsNA experiments based on the NIH Guidelines. The IBC Coordinator and IBSO, in consultation with the Chair or an IBC member, screen the registration to verify the PI’s initial classification. The Chair, or his/her designee, makes the final determination of the type of review required.
Step 4: IBC Review Once the registration has been classified, it is placed into one (1) of the three (3) review categories below:
Projects in the following categories generally require full committee review:
- Projects involving microorganisms that are pathogenic to humans and/or animals (Risk Group 2 or higher).
- Projects involving organisms that could have a significant impact on the environment if accidentally released from the lab (i.e. exotic plants, non-indigenous plant pathogens or regulated insects).
- Projects involving activities that are subject to the NIH Guidelines, section III-A through III-D, and require containment under BSL-2, BSL-3, or involve large scale production under BSL1-LS or BSL2-LS.
- Human gene therapy trials subject to NIH Guidelines, section III-C.
- Registrations involving a contentious issue that the IBSO is not able to resolve.
- Projects classified as III-E under the NIH Guidelines will be summarized and presented to the full committee at the next regularly scheduled meeting.
- During the meeting, the IBC will vote for approval all listed III-E protocols. Any IBC member can request full committee review of any of the listed III-E registrations. Full committee review will occur at the next scheduled meeting.
The IBC has delegated authority to the IBSO to approve minor administrative matters with notification to the IBC Chair. Minor administrative matters include but are not limited to:
- IBC Registrations that are classified under III-F of the NIH Guidelines.
- Minor amendments that do not affect the originally assigned biosafety level(s), risk group, or NIH classification(s).
- Addition of grant titles utilizing the same host/vector systems.
- Non rsNA registrations
Step 5: IBC Decision
All committee decisions are communicated to the PI in writing.
For registrations requiring full committee review, one (1) of four (4) determinations below will be made:
- Approved – The IBC Registration was approved as written.
A letter approving the registration will be signed by the Chair and sent to the PI. Copies of the approval letter will also be provided to SPS, the Department Head, and other applicable research compliance committees (IRB, IACUC, and SCRO).
- Approved with Stipulations – The IBC Registration will be administratively approved by the Chair pending satisfactory receipt of additional information.
A letter requesting additional information will be signed by the Chair and sent to the PI. The PI will have 30 days from the date of the ‘needs additional information’ letter to submit their revision. If PIs cannot meet this deadline, they must contact the IBSO and/or IBC Chairperson.
- Deferred – This decision is used when the full committee has reviewed a registration at a convened meeting and has significant concerns with the registration or other relevant material. The registration may require significant clarifications in order to adequately assess risk.
A letter stating the reason(s) for deferral and date to resubmit for full committee review will be signed by the Chair and sent to the PI.
- Rejected – The IBC Registration was not approved.
A letter stating the reasons for not approving the registration will be signed by the Chair and sent to the PI.