PIs complete the IBC Registration form(s) to register teaching or research activities using biological materials including but not limited to: rsNA, bacteria and their phages and plasmids, viruses, biological toxins, fungi, mycoplasmas, prions, and parasites; human and non-human primate tissues, body fluids, blood, blood byproducts, and cell lines; transgenic and wild type animals and plants, animal remains and insects that may harbor zoonotic pathogens.
The IBC Registration forms are submitted to the IBC Coordinator via e-mail.
The IBC Registration solicits information to describe how biological materials are being used in the lab, the source and nature of the DNA constructs, host/vector systems, potential risks to human health and the environment with emphasis on practices, as well as engineering controls used to contain potentially biohazardous materials.
Please note that research activities involving RG2 organisms as a host-vector systems, cloning RG2 DNA into non-pathogenic bacteria, infectious DNA or RNA viruses and recombinant experiments with animals or plants must not begin until the committee has reviewed and approved this registration.
After submitting the completed IBC Registration forms, the following steps occur:
Step 1: Notification of Receipt of Registration A unique registration number is assigned to all new or renewed submissions. The IBC Coordinator or designee 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 and the IBSO. The IBC Chair will conduct preliminary reviews as deemed necessary by the IBSO and IBC Coordinator. 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 (as needed), screen the registration to verify the PI’s initial classification. The IBSO and the IBC Coordinator make the final determination of the type of review required.
Step 4: IBC Review Once the registration has been classified, it is placed into one of the two review categories below:
Projects in the following categories generally require full committee review prior to the initiation of research:
- 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 reviewed by the full committee at the next regularly scheduled meeting. The IBSO will conduct primary reviews for registrations that fall into Section III-E. During the IBC meeting, the committee will vote for approval of all listed III-E protocols. Note: PIs will be notified if their registration falls into this category, as research activities may be initiated upon submission to the IBC.
The IBC has delegated authority to the IBSO to approve minor administrative matters with notification to the full committee during the next regularly scheduled meeting. 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 of four 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 Sponsored Programs Services (SPS), the Department Head, and other applicable RCS committees (IRB, IACUC, and SCRO).
- Approved with Minor Revisions Requested – 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 IBC Coordinator and sent to the PI. The PI will have 14 days from the date of the ‘needs additional information’ letter to submit their revision. If PIs cannot meet this deadline, they must contact the IBC Coordinator and/or IBC Chairperson.
- Deferred/Major Revisions Requested – This decision is used when the full committee has reviewed a registration at a convened meeting, where there are significant concerns with the registration or other relevant material. The registration may require significant clarifications in order to conduct an adequate risk assessment.
A letter stating the reasons 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.