# Institutional Biosafety Committee Guidebook # About Us The Institutional Biosafety Committee (IBC) is dedicated to protecting the health and safety of everyone at UNMC who works with biohazardous agents. Some of our major responsibilities include: - Reviewing and approving recombinant DNA research projects to ensure compliance with NIH guidelines - Notifying principal investigators of the results of our reviews and approvals - Drafting campus biosafety policies and procedures, including the creation of emergency plans in the case of accidental spills and personnel contamination - Reporting any problems, violations, accidents or illnesses to the appropriate offices For further details about the IBC's roles and responsibilities, refer to [Section IV-B-2-b of the NIH Guidelines](https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.htm#_Toc3457056). ## Chairs & Administrators
 | **JoEllyn McMillan, PhD** Chair, Institutional Biosafety Committee Associate Professor, Pharmacology and Experimental Neuroscience 402-559-3074 | [Email](mailto:jmmcmillan@unmc.edu) [Biography](https://www.unmc.edu/pharmacology/faculty/mcmillan-j.html) |
 | **Peter C. Iwen, PhD** Biosafety Officer, Institutional Biosafety Committee Professor, College of Medicine Director, Nebraska Public Health Laboratory 402-559-7774 | [Email](mailto:piwen@unmc.edu) [Biography](http://www.unmc.edu/pathology/faculty/bios/iwen.html) |
 | **Jackie Hollinger, MPH** Administrator II 402-836-9403 [Email](mailto:jhollinger@unmc.edu) |
 | **Deron Anderson, MS** Back-Up Administrator 402-559-5845 [Email](mailto:deron.anderson@unmc.edu) |
**Form Type** | **Download Instructions** |
Adverse Event Report | [Download PDF](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibcforms/adverse-event-reporting-ibcform.pdf) |
Laboratory Inspection Checklist BL2 | [Download PDF](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibcforms/bsl2-inspection-checklist-ibcform.pdf) |
Laboratory Inspection Checklist BL3 | [Download PDF](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibcforms/bsl3-inspection-checklist-ibcform.pdf) |
Laboratory Inspection Checklist ABL2 | [Download PDF](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibcforms/absl2-inspection-checklist-ibcform.pdf) |
Laboratory Inspection Checklist ABL3 | [Download PDF](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibcforms/absl3-inspection-checklist-ibcform.pdf) |
CDC-Form 2 (Select Agent Transfer) | Visit the [CDC Form 2 webpage](https://www.selectagents.gov/forms/form2.htm) for Guidance Documents and Forms (Fillable and Print Only) |
CDC-Form 3 (Select Agent Loss, Theft, Release) | Visit the [CDC Form 3 webpage](https://www.selectagents.gov/forms/form3.htm) for Guidance Documents and Forms (Fillable and Print Only) |
CDC-Form 4A (Select Agent Clinical Diagnosis) | Visit the [CDC Form 4 webpage](https://www.selectagents.gov/forms/form4.htm) for Guidance Documents and Forms (Fillable and Print Only) |
CM Laboratory Inspection Checklist | [Download PDF](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibcforms/cm-lab-inspection-checklist-ibcform.pdf) |
Autoclave Core Facilities Biosafety Inspection Checklist | [Download PDF](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibcforms/autoclave-inspection-checklist-ibcform.pdf) |
Biological Spill Procedures | [Download PDF](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibcforms/bio-spill-procedures-ibcform.pdf) |
Decision Tree for Biological Spill Clean Up | [Download PDF](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibcforms/bio-spill-decision-tree-ibcform.pdf) |
Laboratory Re-commissioning ABSL-3 & BSL-3 Checklist | [Download PDF](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibcforms/lab-recommission-absl3-bsl3-ibcform.pdf) |
Biosafety Risk Assessment Summary | [Download PDF](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibcforms/risk-assessment-biosafety-ibcform.pdf) |
**Risk Group** | **Risk to the Individual and the Community** |
RG-1 | Agent that is not associated with disease in healthy adult humans |
RG-2 | Agent that is associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available |
RG-3 | Agent that is associated with serious or lethal human disease for which preventative or therapeutic interventions may be available (high individual risk but low community risk) |
RG-4 | Agent that is likely to cause serious or lethal human disease for which preventative or therapeutic interventions are not usually available (high individual risk and high community risk) |
**IMPORTANT NOTICE** On May 6, 2024, the US Government released a new *Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential* ([USG DURC-PEPP Policy](https://aspr.hhs.gov/S3/Documents/USG-Policy-for-Oversight-of-DURC-and-PEPP-May2024-508.pdf)). This policy which supersedes previous DURC policies, goes into effect on May 6, 2025. Guidance for implementing this policy can be found in the USG Implementation Guidance ([USG DURC-PEPP Guidance](https://aspr.hhs.gov/S3/Documents/USG-DURC-PEPP-Implementation-Guidance-May2024-508.pdf)). Updates to UNMC Policy and procedures are in progress. More information will be posted as it becomes available.
# Experiments Requiring IBC Approval Experiments that require IBC approval include those that involve: - the deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, - the deliberate transfer of recombinant DNA or DNA or RNA derived from recombinant DNA into human research participants (human gene transfer), - the deliberate formation of recombinant DNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram body weight, - using risk group 2 or risk group 3 agents as host-vector systems, - the cloning of DNA from risk group 2 or risk group 3 agents into non-pathogenic prokaryotes or lower eukaryotic host-vector systems, - the use of infectious or defective risk group 2 or risk group 3 agents, - whole animals in which the animal's genome has been altered by stable introduction of recombinant DNA or DNA derived into the germ-line (transgenic animal), - viable recombinant DNA-modified microorganism tested on whole animals, - genetically engineered plants by recombinant DNA methods, - more than 10 liters of culture, and - the formation of recombinant DNA molecules containing no more than two-thirds of the genome of an eukaryotic virus. ### Working with Select Agents A sub-category of risk group agents referred to as Select Agents as defined in "[The Antiterrorism and Effective Death Penalty Act of 1996, Public Law #104-132, Regulation 42CFR 72.6](http://www.gpo.gov/fdsys/pkg/PLAW-104publ132/content-detail.html)" are referred to as specific toxins and pathogens as regulated by the Department of Health and Human Services and/or the USDA. These agents require special procedures for transfer and possession. Contact the [UNMC Biosafety Officer](https://guides.unmc.edu/books/institutional-biosafety-committee-guidebook/page/about-us#bkmrk-chairs-admins) for further information concerning these biohazardous agents. # Federal Mandates for the Institution ### Per NIH Guidelines "As a condition for NIH funding ... institutions shall ensure that research conducted at or sponsored by the institution, irrespective of the source of funding, shall comply with the *NIH Guidelines*." (*[Section 1-D of the NIH Guidelines](https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.htm#_Toc3457023)*) "(The institution must) establish and implement policies that provide for the safe conduct of ... research and to ensure compliance with the *NIH Guidelines*." (*[Section IV-B-1 of the NIH Guidelines](https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.htm#_Toc3457055)*) ### Per Select Agent Rule (42 CFR Part 73) "An entity may not possess or use ... receive from ..., or transfer within the United States, a select agent or toxin unless such activities are conducted ... in accordance with the provision of this law." (*[Part 73.3 - HHS select agents and toxins](https://www.ecfr.gov/current/title-42/chapter-I/subchapter-F/part-73#73.3)*) "(it is the responsibility of the Institution to) provide information and training at the time of an individuals initial assignment to a work area where select agents or toxins are present ... (and) provide refresher training annually." (*[Part 73.13 - Restricted experiments](https://www.ecfr.gov/current/title-42/chapter-I/subchapter-F/part-73#73.13)*) # Policies Below are UNMC policies relating to biosafety (click policy number to view in PDF format): - [IBC-01](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc01-autoclave.pdf): Autoclave Operation and Safety - [IBC-02](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc02-bsc-certification.pdf): Biological Safety Cabinet Certification - [IBC-03](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc03-bsc-operation.pdf): Biological Safety Cabinet Operation - [IBC-04](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc04-incident-spill-cleanup.pdf): Biological Spill Clean-Up - [IBC-05](https://wiki.unmc.edu/index.php/Waste_Handling): Biohazardous Waste Disposal - [IBC-06](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc06-biosafety-training.pdf): Biosafety Training Program - [IBC-07](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc07-centrifuge.pdf): Centrifuge Safe Operation - [IBC-08](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc08-application-general.pdf): IBC Application & Review Process: New Protocols (General) - [IBC-09](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc09-application-select-agent.pdf): IBC Application & Review Process: New Protocols Utilizing Select Agents - [IBC-10](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc10-application-gene-transfer.pdf): IBC Application & Review Process: New Protocols Involving Human Gene Transfer - [IBC-11](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc11-lab-inspections.pdf): IBC Laboratory Inspection Process - [IBC-12](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc12-review-previously-approved-protocols.pdf): IBC Review Process for Previously Approved Protocols - [IBC-13](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc13-vaccinia-vaccination.pdf): Immunization Policy for Research Using Vaccinia Virus - [IBC-14](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc14-paraformaldehyde.pdf): Paraformaldehyde Room and Biological Safety Cabinet Decontamination - [IBC-17](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc17-lab-decommissioning.pdf): Laboratory Decommissioning - [IBC-19](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc19-lab-commissioning-bsl2.pdf): Laboratory Commissioning, BL-2 - [IBC-20](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc20-lab-commissioning-bsl3.pdf): Laboratory Commissioning, BL-3 - [IBC-24](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc24-adverse-events.pdf): Reporting Adverse Event - [IBC-29](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc29-bsl3-access.pdf): Personnel Access for BL-3 Containment - [IBC-30](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc30-shipreceive-category-a.pdf): Category A High Consequence Pathogens - [IBC-32](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc32-fed-permits-to-ship.pdf): Federal Permits for Shipment of Human Pathogens - [IBC-33](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc33-unl-campus-protocols.pdf): Off-site Laboratories - [IBC-34](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc34-risk-assess-containment.pdf): Biosafety Risk Factor Assessment Process to Determine Appropriate Containment - [IBC-35](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc35-recombinant-dna-exempt.pdf): Registration Process for the Use of Exempt Recombinant DNA - [IBC-36](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc36-visiting-scientists-students.pdf): Visiting Scientist and Student for Access - [IBC-37](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc37-serum-banking.pdf): Serum Banking - [IBC-38](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc38-ppe-biohazards.pdf): Personal Protective Equipment - [IBC-39](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc39-pest-management.pdf): Pest Management - [IBC-40](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc40-bsl3-material-removal.pdf): Removal of Materials from the ABSL-3 or BSL-3 Laboratory - [IBC-41](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc41-sharps.pdf): Safe Handling and Disposal of Sharps - [IBC-42](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc42-durc-oversight.pdf): Dual Use Research of Concern (DURC) Oversight - [IBC-43](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc43-human-primate-materials.pdf): Use of Human and Nonhuman Primate Tissues, Cells, and Cell Lines - [IBC-44](https://www.unmc.edu/vcr/_documents/compliance-ibc/ibc44-noncompliance.pdf): Allegations of Noncompliance # Resources ## Guidelines - [CDC/NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL)](https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf) (6th edition; June 2020) - Selection, Installation and Use of Biological Safety Cabinets, Appendix A ([see page 395 of BMBL](https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf#page=395)) - [Health Canada Laboratory Biosafety Guidelines](https://www.canada.ca/en/public-health/services/canadian-biosafety-standards-guidelines.html) - [NIH Guidelines for Research Involving Recombinant DNA Molecules](https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.htm) (April 2024) - [WHO Laboratory Biosafety Manual](https://www.who.int/publications/i/item/9789240011311)(4th edition; December 2020) ## Websites - [American Biological Safety Association](https://absa.org/) - [CDC Import Permits Program](https://www.cdc.gov/import-permit-program/php/index.html) - [CDC Select Agent Program](https://www.selectagents.gov/) - [Health Canada Pathogen Safety Data Sheets (PSDSs)](http://www.phac-aspc.gc.ca/lab-bio/res/psds-ftss/index-eng.php) (previously MSDS for infectious substances) - [OSHA Bloodborne Pathogen Standard](https://www.osha.gov/bloodborne-pathogens) (per [29CFR 1910.1030](https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1030)) - [Risk Group Classification for Infectious Substances](https://my.absa.org/Riskgroups) - [UNMC Laboratory Safety Manual](https://www.unmc.edu/ehs/safety/lab-safety/lab-safety-manual.html) - [UNMC Shipment of Hazardous Materials or Dangerous Goods Policy](https://wiki.unmc.edu/index.php?title=Shipping_Hazardous_Materials) - [UNMC Radiation Safety Manual](https://www.unmc.edu/ehs/Manuals/rsm_2024.pdf) # Submission Deadlines The IBC meets on the second Thursday of each month. In order for a protocol to be reviewed at a meeting, it must be submitted 10 days prior to the meeting date by 12 PM CT.**IBC Full Board Submission Deadline\*** | **Date of IBC Meeting** |
December 30, 2024 | January 9, 2025 |
February 3, 2025 | February 13, 2025 |
March 3, 2025 | March 13, 2025 |
March 31, 2025 | April 10, 2025 |
April 28, 2025 | May 8, 2025 |
June 2, 2025 | June 12, 2025 |
June 30, 2025 | July 10, 2025 |
August 4, 2025 | August 14, 2025 |
September 1, 2025 | September 11, 2025 |
September 29, 2025 | October 9, 2025 |
November 3, 2025 | November 13, 2025 |
December 1, 2025 | December 11, 2025 |
*\*Protocols must be submitted before 12 PM CT on the submission deadline to be reviewed at the next IBC meeting.* |
Your training will appear on [Canvas](https://unmc.instructure.com/) within 48 hours of assignment. If you do not see it after this time, please contact the IBC administrative office at