PIs must complete and submit an IBC registration/biological summary 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 University of Connecticut’s IBC is now using HuskySMS Powered by BioRAFT, a new electronic database for registrations and amendments submitted to the IBC. The former registration system is no longer available. All new registrations and renewals must be submitted via HuskySMS, by completing a biological summary. The following link, uconn.bioraft.com, can be used to access the new database. Personnel can log in using their UConn NetID and password.
Amendments to existing registrations can still be submitted using the current amendment form which is then emailed to firstname.lastname@example.org.
Previously approved registrations will eventually be accessible as attached PDF’s in a PI’s lab dashboard in HuskySMS. Please contact email@example.com if you need a copy of your registration or amendments, and one is not available in your “documents” tab in HuskySMS.
If you have any questions about HuskySMS and need help, please feel free to contact firstname.lastname@example.org 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 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 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 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:
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/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 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 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.