1. Institutional Biosafety Committee (IBC)
UTHSC IBC Chair: Mark A. Miller, Ph.D.
Welcome to what is essentially a tutorial that describes the function of the UTHSC Institutional Biosafety Committee (IBC) as well as a summary of the various compliance documents that must be submitted/approved prior to initiation of different types of studies as well as any annual training that is required of all investigators that are involved in the research.
My name is Mark Miller, and I am the chair of the UTHSC IBC, and I will be your tour guide.

2. Purpose of the IBC
NIH Office of Biotechnology Activities (OBA) requires all research Institutions to have an IBC
the IBC reviews research protocols to ensure:
that the a proper risk assessment has been performed
that appropriate safety measures are being taken to mitigate the risks
The purpose of the UTHSC IBC is to ensure that all research done on the UTHSC campus is performed as safely as possible. We perform a risk assessment of proposed research, and we ensure that the investigators know the risks and are aware of and trained to perform these studies using procedures that appropriately mitigate the risks associated with their studies.
The National Institutes of Health (NIH) Office of Biotechnology Activities requires all institutions that receive extramural funds from NIH to have an IBC; so this is a requirement that must be met by the institution.

3. Institutional Compliance: IBC
The IBC coordinates with both the Institutional Review Board (IRB) and the Institutional Animal Use and Care Committee (IACUC)
IRB protects the rights of human subjects
IACUC ensures that all in vivo work is performed in accordance with the Animal Welfare Act and the Guide for the Care and Use of Laboratory Animals
IBC ensures that all investigators understand the risks associated with their work
These three committees collaborate to ensure that PIs have appropriate compliance documentation in place
The UTHSC has several units that work together to ensure that the research being performed at UTHSC is compliance with the various regulations/guidelines that govern research activities at NIH funded institutions. The compliance units are as follows:
(1) The Institutional Review Board (IRB) works to protect the rights of human subjects
(2) The IACUC ensures that all in vivo studies are performed in accordance with the Animal Welfare Act and the Guide for the Care and Use of Laboratory Animals.
(3) The IBC ensures that all investigators know and understand the risks associated with their work and know how to best mitigate these risks

4. UTHSC IBC Research Oversight
IBC compliance/training requirements depends on the type of work that will be performed
Work that requires full IBC Protocol approval
Any work involving rDNA
Any in vivo work involving agents that require BSL-2 containment
In vivo studies with Risk Group 2 (RG2) or Risk Group 3 (RG3) infectious agents
In vivo studies involving introduction of cells/materials derived from humans or non- human primates into research animals
Any work (in vitro or in vivo) involving RG3 agents that require BSL-3 containment
Work that requires notification of the IBC
In vitro work with RG1/RG2 agents, toxins, human/non-human-primate-derived materials
The IBC reviews all work on campus that involves occupational biohazards. Depending on the potential hazards of the work, some studies require simple notification to the IBC by the PI before initiating the studies, while other work cannot be initiated until the PI has submitted and gained full approval of a full IBC protocol.
The investigators performing the proposed/approved studies are also required to complete a variety of annual training, depending on the types of materials that they will be working with.
The remainder of this slideshow will go through the compliance/training checklist that details the various forms that must be submitted and approved and the training that must be received annually by all investigators that are involved in the studies.

5. Compliance Checklist
Do you work with rDNA (either naturally-derived or synthetic)?
Includes: plasmid DNA, recombinant viral vectors, recombinant infectious agents (any microbe that has been genetically manipulated), synthetic nucleic acids, etc.
If “Yes”:
Required annual training : (1) general laboratory/biosafety training and (2) IBC training
Required IBC documentation: full IBC Protocol (submitted and approved before initiating work)
If you are performing studies that involve any type of recombinant DNA or synthetic nucleic acids, or infectious agents that have been genetically altered, there are several things that must be done before initiating the studies.
All investigators working in labs at UTHSC are required to receive annual general laboratory/biosafety training. Details about training are provided near the end of this presentation.
In addition, the PI must submit and receive approval of an IBC protocol that completely describes the work that will be performed, identifies the hazards associated with the studies, and provides a description of the practices that will be used to mitigate the experimental risks.
A link to the IBC protocol form can be found on the UTHSC IBC website by clicking on the iMedRIS login link under the “Researchers” tab.

6. Compliance Checklist
Do you work with any infectious agents (any bacterial, viral, fungal, or parasitic agents)?
If “Yes”:
Required annual training : general laboratory/biosafety training
Required IBC documentation: Infectious Agents Usage form (submitted before initiating work)
If your research involves only in vitro studies with infectious agents, and has no rDNA component, the only compliance document that is needed is an approved “Infectious Agents Usage” form.
To complete this form, go to the UTHSC IBC webpage and log into iMedRIS (link is under the “Researchers” tab) and then follow the instructions.
As for all investigators that work in labs at UTHSC, you will be required to receive annual general laboratory/biosafety training.

7. Compliance Checklist
Do you plan to perform studies in research animals that involve infectious agents?
If “Yes”:
Required annual training : (1) general laboratory/biosafety training and (2) AALAS Learning Library online module on request by IACUC (not annual)
Required IBC documentation: Infectious Agents Usage form (submitted before initiating work)
Required IACUC documentation: IACUC protocol (submitted and approved before initiating work)
required that you enroll in the Occupational Health Surveillance Program (contact University Health at for information).
Is one or more of the infectious agents classified as Risk Group 2 or higher?
Required IBC documentation: full IBC Protocol (submitted and approved before initiating the studies)
If you plan to perform studies in research animals that involves the use of infectious agents, you will need to have several approvals in place prior to initiating the studies:
You will need to have submitted and received approval of an IACUC protocol as well as an approved Infectious Agents Usage Form. The IACUC protocol form is accessed from the IACUC webpage (click on the “Protocol Submission” tab and select “ACAP”)
Importantly, if any infectious agent that is classified as a Risk Group 2 or 3 agent, it will not be necessary to complete an Infectious Agent usage form, but instead you will need to submit and receive approval of an IBC protocol describing the studies. It should be noted that in vivo work that requires IBC approval will not be approved by IACUC until the IBC protocol has been approved.
With respect to training, you are required to receive annual general laboratory/biosafety training as well as any training modules required by IACUC (the IACUC office will notify you of any required AALAS Learning Library online training modules that might be required).
Finally, all individuals working with research animals are required to enroll in the Occupational Health Surveillance Program (University Health can be reached at for information).

8. Compliance Checklist
Do you work with human cell lines, primary cells from humans, or human tissues or other materials (serum, nasal washes, etc.)?
If “Yes”:
Required annual training : (1) general laboratory/biosafety training and (2) Blood borne pathogen training
Required IBC documentation: Human/ Non-Human Primate Materials Usage Form (submitted and approved before initiating work)
IRB Documentation: if the materials are not de-identified AND were not obtained from ATCC, you may need IRB approval (see IRB Getting Started Webpage)
If you plan to perform research that involves materials (cells/cell lines, tissues, secretions, etc.) derived from humans, you are required to notify the IBC by completing a Human/Non-human Primate Materials Usage form (via iMedRIS) and receive approval before initiating the work.
In addition to annual general laboratory/biosafety training, you will also be required to receive bloodborne pathogen training annually.
It is important to note that you may also need to seek and receive IRB approval prior to initiation of the studies. If you plan to work with materials that will be purchased directly from ATCC, you will not need to seek IRB approval. If you plan to work with materials obtained from any other source, you will be required to have IRB approval before initiating the work.

9. Compliance Checklist
Do you work with non-human primate cell lines, primary cells from non-human primates, or non- human primate tissues or other materials?
If “Yes”:
Required annual training : (1) general laboratory/biosafety training and (2) Blood borne pathogen training
Required IBC documentation: Human/ Non-Human Primate Materials Usage Form (submitted and approved prior to initiating studies)
Are any materials derived from the macaque genus?
Required annual training : Herpes B awareness training (contact lab animal care at for details)
The requirements are very similar if your work will involve materials derived from non-human primates. The one key difference is that if any materials that will be used were derived from the macaque genus, you will be required to required to receive an additional training annually: Herpes B awareness training.
Another difference: no IRB approval is needed for work involving materials derived from non-human primates.

10. Compliance Checklist
Do you plan to perform studies in research animals that involve human- or non-human primate- derived materials (cell lines, primary cells/tissues, serum, nasal washes, etc.)?
If “Yes”:
Required annual training : (1) general laboratory/biosafety training and (2) Blood borne pathogen training, and (3) AALAS Learning Library online module on request by IACUC (not annual)
Required IBC documentation: full IBC Protocol (submitted and approved before initiating work)
Required IACUC documentation: IACUC protocol (submitted and approved before initiating work)
All studies in animals that involve introduction of materials that require BSL-2 containment require that the investigator submit and gain approval of an IBC protocol that fully describes the proposed studies. Because work with both human-derived and non-human primate derived materials requires BSL-2 containment, introduction of those materials into animals cannot be performed without approval of an IBC protocol.
Of course, this type of work will also require an approved IACUC protocol, will potentially require IRB approval, and will require annual general laboratory/biosafety training, bloodborne pathogen training, and any AALAS Learning Library online training modules that are required by the IACUC.

11. Compliance Checklist
Do you work with infectious agents that require BSL-3 containment?
If “Yes”:
Required annual training : (1) general laboratory/biosafety training and (2) BSL-3 safety training
Required IBC documentation: (1) full IBC Protocol (submitted and approved before initiating work) and (2) RBL Project Request (see IBC or RBL website)
Does the planned work involve use of infectious select agents?
If “Yes”: Additional requirements must be met (contact Jennifer Stabenow at or
If your studies involve the use of risk group 3 agents that require BSL-3 containment, you will be required to receive both general laboratory/biosafety training and BSL-3 safety training, and you will be required to submit and gain approval of both an IBC protocol and an RBL Project request.
All BSL-3 work on the UTHSC campus must per performed within the Regional Biocontainment Laboratory (RBL). The RBL project request is reviewed by the UTREC, the RBL advisory committee to ensure that the RBL is appropriate for the proposed work and to ensure that the RBL can accommodate the proposed work.
If the work involves select agent pathogens, there are a number of additional steps that must be taken before the work can begin. To initiate the process, the PI should contact Ms. Jennifer Stabenow using the indicated contact information.

12. Compliance Checklist
Do you work with toxins and/or select agent toxins?
If “Yes”:
Required annual training : (1) general laboratory/biosafety training and (2) IBC training
Required IBC documentation: Toxins Usage Form (submitted and approved before initiating work)
Notifications prior to initiating work involving select toxins: (1) Director of Research Safety Affairs [at ] and (2) UTHSC RO [at ]
If your work involves toxins and/or select toxins, you are required to submit receive approval of a Toxins Usage Form documenting the agents that will be used prior to initiating the studies. A link for this form can be found on either the IBC or RBL webpages.
You will also be required to receive general laboratory/biosafety training and IBC training annually.
If the proposed work involves select toxins, you are required to notify the UTHSC Institutional Biosafety Officer (IBO) and the UTHSC Responsible Official (RO) prior to initiating the studies.
At this time, Jennifer Stabenow is both the IBO and the RO, and she can be reached at or

13. Annual Safety Training
General Laboratory/Biosafety Training (two options)
In person classroom training module: provided by Safety Affairs staff members ( Available monthly
On-line training module: Skillsoft learning platform (accessible via Safety Affairs webpage)
Annual Blood Borne Pathogen Training
Skillsoft learning platform (accessible via Safety Affairs webpage)
It needs to be reiterated that safety training is required annually.
General laboratory/biosafety training is available either in a classroom setting or using an on-line training module.
Classroom training is provided monthly: to check the schedule of upcoming training sessions
An on-line learning program is accessible on the internet through the Skillsoft learning platform, and this can be accessed via the UTHSC Safety Affairs webpage
Blood borne pathogen training is also required annually and is available through the Skillsoft learning platform (via the Safety Affairs webpage).

14. Contacting the IBC
If you have any questions relating to IBC approval/notification relating to your research activities, feel free to contact the IBC office for guidance:
Via
Via phone:
Please do not hesitate to contact the IBC coordinator if you have any questions or need assistance relating to any IBC compliance issues.
We are happy to assist you in any way that we can.