The Institutional Biosafety Committee (IBC) advises on matters relating to the safe handling, transport, use, and disposal of biological materials, including recombinant or synthetic nucleic acid molecules, on the Urbana-Champaign campus. The committee reports to the Vice Chancellor of Research and Innovation and is co-chaired by Romana Nowak and Mary Kraft. Questions? email ibc@illinois.edu or call 217.333.2755.

If you have questions when using the system please email ibc@illinois.edu. For IT assistance or to report issues with the system email drs-dev@illinois.edu.

Enter Registration System

Materials Requiring Registration

All work with materials requiring registration must be approved by the IBC prior to initiation.  

The following materials require registration with the IBC:

• Recombinant or synthetic nucleic acid molecules (even work that is exempt from the NIH guidelines must be registered*);
• Transgenic animals (use or creation);
• Transgenic plants;
• Pathogens (human, animal, or plant);
• Human materials (cell lines; blood, blood products, tissues, any bodily fluid);
• Nonhuman primate (NHP) materials (cell lines, blood, blood products, tissues, any bodily fluid);
• Biotoxins
• Prions
• Environmental or field collected samples that harbor or may harbor pathogens (e.g. wastewater, soil, wild animal materials)

The university is responsible for ensuring that all recombinant or synthetic nucleic acid research, irrespective of funding source, is conducted "in full conformity with the provisions of the NIH Guidelines." To ensure compliance with the guidelines, campus policy requires that all recombinant or synthetic nucleic acid work must be registered with the IBC. Work cannot begin on projects involving recombinant or synthetic nucleic acids until the Principal Investigator (PI) receives a notice from the Division of Research Safety and/or the IBC allowing the initiation of work. NIH penalties for university/PI noncompliance may result in: (i) suspension, limitation, or termination of NIH funds for recombinant or synthetic nucleic acid research at the university, or (ii) a requirement for prior NIH approval of any or all recombinant or synthetic nucleic acid projects at the university.

Poliovirus Containment Initiative

Polio remains endemic in two countries resulting in outbreaks around the world. The U.S. National Authority for Containment of Poliovirus (NAC) at the Centers for Disease Control and Prevention (CDC) launched a surveillance program aimed to minimize the risk of poliovirus release from research and diagnostic laboratories. As part of this program,  the Institutional Biosafety Committee (IBC) added screening questions to the registration process to identify materials which contain or may contain poliovirus according to the criteria established in the WHO Global Action Plan (GAPIV). For more information, visit the DRS Poliovirus Containment Initiative webpage.

Registration, Projects and Numbering

All materials, facilities and personnel are found at the registration level and must be assigned to an individual project, even if you only have one project. Individual projects under that registration are submitted for review and receive approval dates.

Each PI will be assigned one IBC registration number that will not change. Projects are identified by a period after the registration number. For example, If a PI is given a registration number of IBC-555 then the first project submitted for review will be IBC-555.1.  As additional projects are added, they will be numbered in sequential order e.g. IBC-555.1, IBC-555.2, IBC-555.3.  If IBC-555.2 is completed, this number will not be reused and the next project will be numbered IBC-555.4.  

Tips for Completing/Managing Registrations

• Provide enough detail to allow IBC reviewers to understand the risk elements in the context of the research so they can verify that the proposed safety measures are sufficient.
• Focus the project on the material(s) that require registration, state where the materials will be used, the manipulations being performed, inactivation steps that may change containment, safety measures or equipment (e.g. biosafety cabinet) used to mitigate risks, and decontamination and disposal procedures.
• Be aware of the IBC meeting and submission schedule to ensure ample time for the review and approval of your registration.
• It's allowable to have one IBC project that covers work described in multiple protocols from the Institutional Animal Care and Use Committee (IACUC) and/or the Institutional Review Board (IRB).
• For IBCs that involve animal work, the associated IACUC and IBC must be in the same PIs name.
• All work that requires registration may be included in one IBC project if the work can be explained clearly. In some cases, it may be easier to separate into multiple projects if the focus is significantly different.
• All laboratory personnel may initiate, complete, or update a project on behalf of the PI.
• In the context of an IBC registration, someone may be considered as the PI if they have the responsibility and authority for the research or teaching activities being conducted, and for the staff and students participating in the work. This level of control and responsibility typically falls to a faculty member who reports directly to a Department or Unit Head. There are occasional exceptions when someone other than a faculty member has the required authority.
• All project personnel, including the PI, are required to complete safety training.
• Projects should be updated whenever there are changes in personnel, facilities, or experimental protocols/materials or at minimum on an annual basis.

Submission Deadlines/Meeting Schedule

The IBC meets once per month as per the following schedule. Complete project information must be submitted by 5 p.m. on the submission deadline date before the meeting at which your project will be reviewed. 

Review Process

Once a project is submitted for review, you will receive an email confirming receipt. In most cases,* the project will be assigned to a panel of faculty reviewers who will review the project to verify your risk assessment for the proposed work. Once submitted for review, the project will be locked.   The next step is the question and answer period where the reviewers will ask questions directly in the project. When the review period is complete, the PI and the personnel on the project will be notified via email that their responses to questions are due by a specific date for before the upcoming IBC meeting. Simultaneously, the DRS research safety professional overseeing the project review will determine if any BL-2 or ABL-2 audits are required. All rooms where work will be performed at Biosafety Level 2 or Animal Biosafety Level 2 must be audited before work can begin in that space and will be audited annually thereafter through the laboratory audit program. 

Approvals will not be issued until all questions and audit findings have been addressed and all required training completed. 

*Some lower risk projects (e.g,. Recombinant DNA projects requiring Biosafety Level 1 containment) may qualify for review by a DRS research safety professional. In these situations, the review process may be expedited. However, the best approach is to plan for the timeline outlined above and in the Submission Deadline/Meeting Schedule section.

IBC Approval

An IBC project is valid for 5 years.  DRS will send reminders to review and update if no changes have been made for 12 months. Major updates/amendments may require to be re-reviewed by the IBC however the approval date will not change. 

Required Training

Required Training for work with recombinant or synthetic nucleic acids 

NIH requires training when performing experiments with recombinant or synthetic nucleic acids including transgenic plants and animals (including knockouts). This training requirement will be met by completion of the NIH Guidelines Overview module. 

Required Training for work at Biosafety Level 1

Basic training requirements for all laboratories are outlined on the Safety Training Checklist webpage as part of a required Laboratory Safety Plan. This includes the on-line training module, Laboratory Safety.

Required Training for work at Biosafety Level 2

Additional training and information specific to work at Biosafety level 2 should include:

• Review of laboratory biosafety level criteria as outlined in the Biosafety in Microbiological and Biomedical Laboratories (BMBL) 6th Edition
• Completion of the DRS course Understanding Biosafety  
• The Biosafety Level 2 Guide supplements the Laboratory Safety Guide/Chemical Hygiene Plan for your Lab Safety Plan.
• Review of  Storage of Risk Group 2 Biological Materials  guidance document
• Review of Biological Material Transport webpage and completion of additional transportation training as required
• Personnel working with human materials must also attend the Safe Handling of Human Cell Lines/Materials in a Research Laboratory course once and then repeat the on-line refresher training annually and review the University of Illinois at Urbana-Champaign Bloodborne Pathogen Exposure Control Plan

Review of the following DRS Guidance documents for all equipment being used in the laboratory:

• Biological Safety Cabinets
• Protecting Vacuum Lines From Biohazards
• Autoclave Safety and Operation
• Biological Samples Stored in Liquid Nitrogen

Review of the following DRS Guidance documents for all applicable waste generated in the laboratory:

• User Treatment of Biological Waste
• Laboratory Sharps
• Autoclave - Waste and Validation
• Biological Materials Requiring Incineration
• Biotoxin Treatment & Disposal

Laboratory-Specific Training

• Review of IBC project registration information that outlines laboratory and experiment-specific safety procedures and requirements.
• Review of laboratory-specific policies developed by the laboratory group that outlines how certain Biosafety Level 2 requirements will be implemented within the laboratory group and associated facilities. 
• Review of all applicable Standard Operating Procedures (see Standard Operating Procedures webpage for information on SOP development).

Dual Use Research of Concern (DURC)

Some scientific and technological advances that provide great benefits to society can also be used maliciously. Research yielding new technologies or information with the potential for both benevolent and malevolent applications is referred to as "dual use research". This small subset of life sciences research with the highest potential for yielding knowledge, products, or technology that could be directly misapplied to threaten public health or national security is referred to as "Dual Use Research of Concern (DURC)."

The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern outlines the criteria for what qualifies as DURC. A list of the 15 agents and toxins and descriptions of the 7 experimental effects for potential DURC research are found here.

To better understand the DURC requirements and when research meets the DURC criteria, the NIH-Office of Sciences Policy provides an overview and case study approach for research that requires oversight of life sciences DURC.

A one time online training entitled DURC Policy Overview is required to be taken by the following campus personnel; 

• All PIs, staff, and students whose research uses any of the agents or toxins subject to the policy.
• IBC members.
• Administrative staff supporting the IBC.

Review of Potential DURC Projects

To comply with the US government DURC policy, a campus Institutional Review Entity (IRE) has been established to review research for DURC which is coordinated through the IBC.

It is the responsibility of the Principal Investigator to identify research involving one or more of the agents and toxins on the DURC list and notify the IRE-IBC for review of its DURC potential. The formal review starts with the PI submission of the DURC Review Application which is submitted to ibc@illinois.edu in conjunction with the IBC registration to determine whether or not the project meets the DURC definition. For research that is determined to be DURC, a subcommittee will work with the PI to draft a risk mitigation plan to be submitted to the applicable US government funding agency. 

DURC Review Application Form

References

NIH Guidelines

Biosafety in Microbiological and Biomedical Laboratories (BMBL 6th Edition)