IBC Application and Process

• Please reference the IBC Protocol Flow Chart. Your protocol may go through an expedited review, or it may require a full committee review per the NIH Guidelines. Research Integrity and Compliance will be in communication with you regarding the review process and outcome of your pending protocol.

In the application you will be asked to:

• List all current lab personnel involved with this work.
• List your laboratory space used for this work.
  • If you are utilizing another researcher lab space, please indicate it on the application.
• Provide certificates and/or training proof for:
  • Basic Biosafety CITI training (applicable for BSL-1) OR the General Biosafety course done through EHSRM via Canvas.
  • BSL-2 training (done through EHSRM via Canvas).
  • Bloodborne Pathogen training (Only required for specific labs. If you are unsure as to whether or not this applies to your lab, you will be notified by the IBC. Training will be completed through EHSRM via Canvas.)
• Provide a record of a current satisfactory inspection by Environmental Health, Safety, and Risk Management (EHSRM) within the past 12 months (including the resolution of any corrective action items). See the EHSRM webpage for the inspection process. Note that this is a different inspection than the quarterly inspections. It is an annual requirement for all active IBC protocols.
• Explain your research goals and identify the types of potentially hazardous biological materials you plan to use: rDNA, including transgenic animals and plants; infectious agents; biological toxins; and materials derived from human and certain vertebrate animal sources.
• Describe any administration of these potentially hazardous biological materials to animals or to plants.

Per compliance with the NIH Guidelines for Research Involving Recombinant DNA and Synthetic Nucleic Acid Molecules and university policy, experiments involving the following must submit a protocol for review and approval by the IBC:

Experiments qualifying as exempt under Section III-F of the NIH Guidelines

Experiments involving low risk biological agents (risk group 1)

Blood draws that are being performed on patients not known to be actively infected with any bloodborne pathogens

Teaching activities that involve any of the materials listed above

All other research must go through full IBC review and approval. All other research that requires IBC review and approval includes:

• Non-exempt experiments under Sections III-A, III-B, III-C, III-D, and III-E of the NIH Guidelines
• Experiments involving the use of known human pathogens or risky environmental biological agents, including bacteria, archaea, viruses, fungi, protozoa, helminths, arthropods, prions, and biological toxins
• Research involving human cells/ tissues/ organs (unpreserved) and bodily fluids. This includes use of established or primary cell lines, stem cells, urine samples, known infected blood samples, fecal samples, and other bodily fluids
• Experiments involving handling of non-human primate cells/ tissues/ organs/ bodily fluids
• Experiments involving handling of any other animal cells/ tissues if animal was infected with a biological agent (Example: animal brought in for necropsy after being found dead in wild)
• Use of animals as models for studying biological agents and toxins
• Nanotechnology involving biological agents
• Teaching activities that involve any of the materials listed above

At present time, we do not have an electronic submission system in place but are working towards initiating an electronic protocol submission within Kuali. Current state and federal guidelines mandate that all the information on the form be asked of researchers to ensure we are being compliant with all policies and guidelines. Note that about half of the form may or may not need to be completed. The information requested helps reviewers evaluate the research protocol quicker to speed up the approval process.

An active IBC Protocol will need to be renewed and reviewed every three years. Research requiring an active IBC Protocol will be outlined in the NIH Guidelines. The IBC can also determine that a proposed project is higher risk and will request that an IBC Protocol Application be submitted. Refer to the resources in Guidelines and Biosafety Resources to determine containment recommendations for your proposed research activities.  

Registering your work with the IBC involves filling out the IBC Determination only. The determination will serve as documentation for the biological/potentially biohazardous materials, along with procedures being performed on these materials. Members of the IBC will review these materials and procedures, and if approved, a registration letter will be issued to you. Registration does not require a three-year renewal. However, if new materials and procedures are being added into your lab space, complete an additional IBC Determination Request.[MCA1] [MCA2] 

Per university policy, all designated lab spaces designated as a BSL-1 or BSL-2 must have an up-to-date biosafety inspection on file. These are different then the quarterly inspections and are performed by the BSO, Ms. Elsie Romano. Biosafety training needs to be completed for the researcher/teacher of record, any IA’s teaching the labs, and authorized personnel working on a research project. Students enrolled in instructional labs do not need to complete the training. Reference the training and lab inspection requirements for which training applies to you.