IBC Registration Process

PIs must complete and submit an IBC registration/biological summary to register research or teaching activities that involves the use of biological materials. Biological materials may include, but is not limited to the following:

  • Recombinant / 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, as well as animal remains and insects that may harbor zoonotic pathogens

The UConn IBC for Storrs and Regional Campuses, use an electronic database called HuskySMS (Powered by SciShield), to review and approve registrations and amendments. The lab must be bio-enabled by the IBC Coordinator. Please contact the IBC office via email, ibc@uconn.edu, to begin the registration process.

To access HuskySMS, use the following link, uconn.scishield.com. Personnel can log in using their UConn NetID and password.

If you have any questions about HuskySMS and need help, please feel free to contact ibc@uconn.edu with  “HuskySMS Support” in the subject line.

The IBC registration process solicits information to describe how biological materials are being used in the lab, the source and nature of the rsNA 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 activities involving RG2 organisms as host-vector systems, cloning RG2 DNA into non-pathogenic bacteria, use of infectious or replication-defective viral vectors, as well as rsNA constructs in animals or plants must not begin until the committee has reviewed and approved the submission.

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:

    • IBC Registrations/biological summaries 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 five 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 Administrative Edits – The IBC Registration will be administratively approved by the Chair once the PI certifies and submits administrative edits made by the IBC Office.

The IBC Coordinator will send an email to the PI within HuskySMS, requesting their review and certification of administrative changes made by the IBC Office.  The PI will have 14 days from the date of the ‘Administrative Edits’ email, to submit the revised bio-summary. If PIs cannot meet this deadline, they must contact the IBC Coordinator or the IBC Chairperson, to request an extension.

  • Approved with Minor Revisions Requested – The IBC Registration will be administratively approved by the Chair pending satisfactory receipt of additional information.

The IBC Coordinator will send an email to the PI within HuskySMS, requesting additional information.  The PI will have 14 days from the date of the ‘needs additional information’ email, to submit their revisions. If PIs cannot meet this deadline, they must contact the IBC Coordinator or the IBC Chairperson, to request an extension.

  • 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.