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IBC Review & Approval

IBC Registrations – Biological Summary in HuskySMS

To register biological materials planned for use in a lab, Principal Investigators (PIs) must submit an IBC registration for review and approval. Complete a biological summary within the HuskySMS database.

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IBC Registrations must be bio-enabled by Environmental Health & Safety (EHS). Please email ibc@uconn.edu to request access to the Bio Tab in HuskySMS.

*Note – Biological materials include, but are not limited to the following:

  • Recombinant or synthetic nucleic acid (rsNA) molecules
  • Bacteria and their phages and plasmids
  • Viruses, viral vectors, and their particles (including prions)
  • Biological toxins
  • Fungi
  • 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

Submit IBC Registration Prior to Initiation:

Depending on the type of experiments planned, some projects can begin while a submission is pending approval, while others require full committee review and approval before work can begin. To determine the level of review required, Biosafety must conduct a thorough review of the submission, referred to as the preliminary review.

Once the preliminary review is complete, PIs will receive a status update which will include next steps required in order for projects to begin.

Projects involving pathogens, risk group 2 (RG2) host-vector systems, introduction of rsNA from pathogens into non-pathogenic bacteria, use of viral vectors, as well as rsNA constructs in animals or plants must not begin until the committee has reviewed and approved the submission.

Project Form – Experimental and Procedural Details

Providing detailed descriptions of work with biological materials is an important part of the registration process. It is the responsibility of the IBC to conduct comprehensive risk assessments. Submissions that lack sufficient detail to determine the risk associated with research, will not be able to move forward in the review process. Especially in cases where the IBC is unable to confidently assign containment levels.

Comprehensive Risk Assessments should consider the following: agent specific hazards, manipulations planned, source of rsNA constructs, gene targets and function, host-vector systems, etc. Potential risks to human health and the environment should be described. Emphasis on practices and procedures implemented to minimize risk (e.g. use of BSC) is helpful when conducting risk assessments.

IBC Review & Approval Process

After submitting the completed biological summary, the following steps occur:

Step 1: Notification of Receipt of Registration Once a biological summary is submitted and is ready for review, an email notification will be sent to the PI indicating that the registration status has changed to under EHS Review.

Step 2:  Preliminary Review All new biological summaries will undergo a preliminary review 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 email with any requests to modify the biological summary. The PI will then make any necessary changes to the registration and contact the Coordinator within HuskySMS to ensure changes have been submitted, thereby making it suitable for committee review.

Step 3:  Classification of Experiments PIs 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 primary reviewer (as needed), screen the registration to verify the PI’s initial classification. The IBSO and the IBC Coordinator make the final determination for the level of review required.

Step 4: IBC Review Once the registration has been classified, it is placed into one of the two review categories below:

Full Committee Review & Approval

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.

Administrative Approval by IBSO

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:

    • Research 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 five determinations below will be made:

  • Approved as Written – Submission was approved with no edits or follow up required.

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 Conditions – Minor edits are required, but do not affect the risk assessment or NIH classifications determined by the committee. Updated submission will be administratively approved by the Chair .

Minor edits are required, but do not affect the risk assessment or NIH classifications determined by the committee. IBC office will email the PI with the requested revisions, who then must revise as requested, and submit the updates within 30 days.

  • Defer or Request Major Revisions – 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.