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 molecules, on the Urbana-Champaign campus. The committee reports to the Vice Chancellor of Research and is co-chaired by Carol Maddox and Mary Kraft. 

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.
  

*Due to the COVID-19 pandemic, the IBC has instituted Interim Biosafety Guidelines when handling primary human and non-human 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.

Tips for Completing/Managing Registrations

• Provide enough detail to allow the IBC reviewer to understand the risk elements in the context of the research and to verify that proposed safety measures are adequate.
• Focus the project on the material(s) that require registration, how and where the materials will be used, and the safety measures proposed to mitigate risks.
• Be aware of the IBC meeting and submission schedule to ensure ample time for the review and approval of your registration.
• One IBC registration can cover multiple grants and protocols from the Institutional Animal Care and Use Committee (IACUC) and/or the Institutional Review Board (IRB).
• All work that requires registration can and should be included in one IBC project if the work can be explained clearly in the materials and methods section. In some cases, multiple registrations may be required. 
• IBC approvals are valid for five years.
• All laboratory personnel may initiate, complete, or update a registration on behalf of the PI.
• A PI is the only person who may submit a project to the IBC for review. 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.

For a preview of the project registration questions click the Registration Forms Preview PDF. The PDF is intended for preview purposes only and will not be accepted as a project registration.

Submission Deadlines/Meeting Schedule

The IBC meets once per month as per the following schedule. Complete registration 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 submitted, you will receive an email confirming receipt of the registration. In most cases,* the project will be assigned to a panel of faculty reviewers who will verify your risk assessment for the proposed work. On-line forms will be in PDF format so that changes cannot be made during the initial review. Review questions will be attached directly to the registration. When the review is complete, the PI and those with editing capabilities will be notified via email that their response is required. Simultaneously, the biosafety 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 on a regular basis. 

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.

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) 5th Edition
• Completion of the DRS course Understanding Biosafety  
• 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

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 5th Edition)