The University of Denver Institutional Biosafety Committee (IBC) is responsible for ensuring that research involving recombinant DNA, Select Agents and other biological hazards at the University of Denver is in compliance with established National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules and other applicable regulations. To carry out this oversight, the IBC has three main tasks:
- Reviewing research proposals involving biological hazards
- Developing emergency plans for accidental biohazard spills
- Providing consultation to PIs on biosafety issues.
Reviewing research proposals involving biological hazards:
The IBC considers and approves, or prohibits, proposed research by assessing:
- The appropriate containment and biosafety (BL) levels
- The facilities, procedures, and practices to be used
- The training and expertise of the personnel who will be conducting the research.
There are four classes of experiments (Click here for descriptions). Each has specific approval requirements:
- Class A experiments require review by the NIH and the IBC before initiation.
- Class B experiments require IBC approval before initiation.
- Class C experiments require IBC review simultaneously with initiation.
- Class D experiments are exempt from NIH Guidelines and may commence prior to, but do require, IBC approval.
All new protocol applications and major amendments must be reviewed by the IBC at one of the convened meetings (typically in March, June, September, December). Annual/Final Reports and minor amendments may be reviewed by the IBC Chair. All protocol documents should be submitted to the IBC through DU's electronic protocol management system, IRBNet.
All laboratory personnel must complete the following PRIOR to working with biological materials:
- CITI Training for Investigators, Staff and Students Handling Biohazards, Biosafety/Biosecurity Course. Instructions can be found here
- EH&S Bloodbourne Pathogens course and Lab Safety Course
- Any additional training from PI with respect to specific materials unique to the lab
All trainings lab members receive should be documented digitally or on paper. Here is a template . These records will be checked by Research Compliance and/or the IBC.
For information as who qualifies as "personnel" , click here.
Reporting Lab Accidents and Illnesses
All spills and exposures must be reported to the following:
- Principal Investigator (immediately)
- Biological Safety Officer, Roger Clark 303-871-3473 (immediately)
- Risk Management, 303-871-2327 (within 24 hours)
- IBC (may be reported through the BSO)
- NIH/OBA—for exposures or spills involving recombinant DNA ONLY (report will be coordinated by the IBC)
The IBC must assure that both research and teaching labs are in compliance with NIH Guidelines. If the teaching lab (in its entirety) falls under one of the NIH exemption categories, submit an IBC Exemption Application. If it does not, complete an IBC Protocol Application. You may submit all the labs taught by one PI under one umbrella protocol.
For more information on what biological hazards require an IBC protocol , Click here.
Exemptions for rDNA
The University of Denver requires that all use of recombinant DNA be registered with the IBC. Many common uses of recombinant DNA, however, qualify for exemption under Section III-F of the NIH Guidelines. If your use of recombinant DNA qualifies for an exemption under these criteria, please fill out the IBC Exemption application. After review, the IBC will provide an exemption decision. If any changes are made to protocols for a study that has received an exemption from the IBC, an amendment must be submitted to the IBC.
If your use of recombinant DNA does not meet any of the exemption criteria, you must submit a protocol application and undergo a full review by the IBC.
IBC requires a protocol for the use of animals and recombinant DNA or other biological hazards. The animal containment level may be different from the containment level approved for handling your recombinant construct in the lab. All work with animals must be approved by the Institutional Animal Care and Use Committee(IACUC) and the IBC.
Investigators planning to administer recombinant DNA to animals should refer to Appendix Q and Section III-D-4 of the NIH Guidelines for information on biological and physical containment practices.
General questions regarding the IBC should be directed to firstname.lastname@example.org