IBC Registration: Clinical Trials
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2015-08-26
SECTION I
Instructions
This document’s purpose is to identify hazards related to Recombinant DNA or Etiologic Agents
associated with your research project, and is intended to assist the KUMC’s Institutional
Biosafety Committee (IBC) in the review process. The IBC will review your application and
related material as it pertains to the NIH Guidelines for Research Involving Recombinant or
Synthetic Nucleic Acid Molecules, November 6, 2013.
Principal Investigators (PI) are required to fully complete the below items for IBC review
consideration. Any supporting documents must be submitted along with this application.
NOTE: This document is to be both fully completed and sent electronically (not hand written) in
Microsoft Word format (not PDF).
1. The PI submits a completed IBC Application to ibc@kumc.edu.
2. The facilities may be subject to an onsite laboratory assessment.
3. Environment, Health & Safety (EHS) will present the documents to the IBC for review.
4. The PI is informed of the IBC meeting information as they may choose to be present.
5. The PI must respond to any questions or concerns the IBC may have during review.
6. The PI will be notified of the IBC decision.
7. Facilities related to the storage, preparation, transport, and waste disposal are subject
to continued audits and review.
If you have questions or comments, please contact:
Primary Contact
Secondary Contact
Alternate Contact
Charles “Sonny” Cherrito
Ryan Lickteig
Dr. Thomas Yankee
Biological Safety Officer
Director – EHS Office
Chair, IBC
913-588-5206
913-588-5163
913-235-5517
ccherrito@kumc.edu
rlickteig@kumc.edu
tyankee@kumc.edu
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The University of Kansas Medical Center, Institutional Biosafety Committee (IBC)
3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, ibc@kumc.edu, Website
IBC Registration: Clinical Trials
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2015-08-26
SECTION II
General Information
Application Date
Project Title
NIH Funded?
IRB Number
Principal Investigator
Phone
Email
Department
Office Address
Lab Building Location
Lab Room Location
Secondary Contact
Phone
Email
Collaborating Entity
Phone
Contact Phone
Contact Email
Department
Entity Address
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The University of Kansas Medical Center, Institutional Biosafety Committee (IBC)
3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, ibc@kumc.edu, Website
IBC Registration: Clinical Trials
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2015-08-26
SECTION III
Research Declaration
SPECIAL NOTE:
This section refers to the use of recombinant DNA techniques. In regards to Donor/Vector/Host systems,
two examples would be the below:
1. You are using a plasmid (vector) from E. coli (donor) to transfect a bacteria (host).
2. You are using DNA from one cell line (donor) to transfer into tumor cells (host) by means of a
lentivirus or adeno-associated virus (vector).
Are you using any of the below systems?
Donor
Yes
No
If Yes, explain:
Vector
Yes
No
If Yes, explain:
Host
Yes
No
If Yes, explain:
Is the material replication competent?
Yes
No
If yes, explain below:
Are you using inserted sequences?
Yes
No
If yes, describe the source and function below:
Will there be an attempt to obtain expression of a foreign gene (e.g. expression of GFP inside a cell)?
Yes
No
If yes, describe the protein will be produced below:
What are the agent characteristics (e.g. virulence, pathogenicity, environmental stability, attenuation)?
What are the containment conditions to be implemented (e.g. biosafety level or other special provisions)?
What types of manipulations are planned (e.g. cell culture, administration to animals)?
NIH Guidelines (Section III-F)
Do you feel your research is exempt from the NIH Guidelines?
Yes
No
If Yes, explain:
{L0036211.1 }
The University of Kansas Medical Center, Institutional Biosafety Committee (IBC)
3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, ibc@kumc.edu, Website
IBC Registration: Clinical Trials
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2015-08-26
PART I:
Section IV-B-2-b-(1)(i): Independent assessment of the containment levels required by the NIH Guidelines for
the proposed research.
Section IV-B-7-c-(1): Make an initial determination of the required levels of physical and biological containment
in accordance with the NIH Guidelines.
Briefly describe (in lay terms) your research project, emphasizing the use of recombinant DNA
and the target cells.
Describe the vector type (adenovirus, retrovirus, associated-adenovirus, etc.) and name:
Describe the insert to be delivered by the vector:
Denote the source of the vector (purchased, in-house, etc.):
Is the vector replication competent or incompetent?
Yes
No
If Yes, explain:
Describe the mutations to the vector to ensure that it is replication incompetent:
Has the sequence of the vector and the insert been confirmed?
Yes
No
If Yes, explain:
Does the project involve the transfer of a drug resistance trait drug resistance trait?
Yes
No
If Yes, explain:
Does the project involve cloning of toxins with a LD50 of less than 100ng/kg body weight?
Yes
No
If Yes, explain:
{L0036211.1 }
The University of Kansas Medical Center, Institutional Biosafety Committee (IBC)
3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, ibc@kumc.edu, Website
IBC Registration: Clinical Trials
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2015-08-26
PART II:
Section IV-B-2-b-(1)(ii): Assessment of the facilities, procedures, practices, and training and expertise of
personnel involved in recombinant or synthetic nucleic acid molecule research.
Section IV-B-7-d-(2): Instruct and train laboratory staff in: (i) the practices and techniques required to ensure
safety, and (ii) the procedures for dealing with accidents.
Section IV-B-7-d-(3): Inform the laboratory staff of the reasons and provisions for any precautionary medical
practices advised or requested (e.g., vaccinations or serum collection).
Have all personnel completed the REQUIRED ANNUAL below online trainings
found at https://tlc.netdimensions.com or via my.kumc.edu by accessing the TLC
link under the “Training” tab?
Yes
No
University Environment, Health & Safety General Safety, Online
University Hazard Communication & RCRA Chemical Safety Training, Online
University Biosafety Safety Training, Online
University Bloodborne Pathogen Training, Online
University Personal Protective Equipment (PPE), Online
Describe any additional training completed you feel is relevant:
Do you have a laboratory specific safety plan and have all personnel been trained as to its contents?
Yes
No
If not, explain:
Please Note: The EHS Office can provide a general template (also found here) that can assist you in
creating this safety manual/plan. Creation of a lab safety plan is HIGHLY recommended for BSL-1
environments, but is a REQUIREMENT, per the NIH and the BMBL, for anyone operating within a BSL-2 or
higher laboratory containment level.
{L0036211.1 }
The University of Kansas Medical Center, Institutional Biosafety Committee (IBC)
3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, ibc@kumc.edu, Website
IBC Registration: Clinical Trials
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2015-08-26
From where will the DNA or etiologic agent be obtained?
What location, building and room will the material be received and stored (be specific)?
In what format will the material arrive (e.g. Lyophilized, solution, suspension)?
Describe any modifications to the material that will be required before administration to the
patient (e.g. dissolve in solution, dilute to lower concentrations, etc.):
Where will the material be prepared for administration to the patient?
Yes
No
If Yes, explain:
Where will the material be administered to the patient (physical location, not dosing route)?
How will the material be delivered from the site of preparation to the site of the patient?
What kind of hazardous waste will your research generate and how will it be discarded?
Describe what containment equipment will be used (e.g. BSC’s, centrifuge safety caps, etc.):
Describe procedures that will be implemented for hazard communication:
Describe what personal protective equipment (PPE) will be used when conducting research:
{L0036211.1 }
The University of Kansas Medical Center, Institutional Biosafety Committee (IBC)
3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, ibc@kumc.edu, Website
IBC Registration: Clinical Trials
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2015-08-26
PART III:
Section IV-B-2-b-(1)(iii): Ensuring that all aspects of Appendix M have been appropriately addressed by the
Principal Investigator.
Has Appendix M of the NIH Guidelines been satisfied?
Yes
No
If Yes, explain:
{L0036211.1 }
The University of Kansas Medical Center, Institutional Biosafety Committee (IBC)
3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, ibc@kumc.edu, Website
IBC Registration: Clinical Trials
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2015-08-26
PART IV:
Section IV-B-2-b-(1)(iv): Ensuring that no research participant is enrolled (see definition of enrollment in Section
I-E-7) in a human gene transfer experiment until the RAC review process has been completed (see Appendix M-IB, RAC Review Requirements), Institutional Biosafety Committee approval (from the clinical trial site) has been
obtained, Institutional Review Board approval has been obtained, and all applicable regulatory authorizations
have been obtained.
Has the collaborating entity’s IBC approved the research? If so, please provide the letter.
Yes
No
Has RAC review been conducted AND COMPLETED (note: this does not mean that a review has
been performed, but rather the review is completed)? If so, please provide the review letter.
Yes
No
Has the NIH Director approved this research (required for Major Actions as mentioned under
the NIH Guidelines)? If so, please provide the approval letter.
Yes
No
Has any other entity approved the research? If so, please explain and provide any letters.
Yes
No
If Yes, explain:
Does your project involve Investigational New Drugs?
Yes
No
If Yes, explain:
FDA Approved?
IND Number?
{L0036211.1 }
The University of Kansas Medical Center, Institutional Biosafety Committee (IBC)
3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, ibc@kumc.edu, Website
IBC Registration: Clinical Trials
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2015-08-26
PART V:
Section IV-B-2-b-(1)(v): For human gene transfer protocols selected for public RAC review and discussion,
consideration of the issues raised and recommendations made as a result of this review and consideration of the
Principal Investigator’s response to the RAC recommendations.
Have you responded to questions, concerns or recommendations the RAC review has generated through
either RAC themselves or public review? If there were questions or recommendations made, have they
been addressed?
Yes
No
If Yes, explain:
PART VI:
Section IV-B-2-b-(1)(vi): Ensuring that final IBC approval is granted only after the RAC review process has been
completed (see Appendix M-I-B, RAC Review Requirements).
Do you fully understand that your research project cannot be approved by the IBC until the RAC review
is complete and all relevant information has been obtained in order to effectively evaluate your project
being proposed?
Yes
No
If not, explain:
PART VII:
Section IV-B-2-b-(1)(vii): Ensuring compliance with all surveillance, data reporting, and adverse event reporting
requirements set forth in the NIH Guidelines.
Describe the medical surveillance procedures that will be implemented for both all personnel handling
the material and the patient as precautionary and upon occupational exposure or illness. Additionally,
describe any medical surveillance procedures you would recommend to assist in the safety of research
personnel and patients.
Describe the procedure that will be implemented for data and adverse event reporting.
{L0036211.1 }
The University of Kansas Medical Center, Institutional Biosafety Committee (IBC)
3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, ibc@kumc.edu, Website
IBC Registration: Clinical Trials
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2015-08-26
SECTION IV
Emergency Spill Response
Below is the appropriate contacts and response that should be implemented in the event of an
emergency spill of biological hazards. PI’s are encouraged to add any additional contacts or procedures
that deem necessary to mitigate occupational exposure. For further information on emergency spills
please refer to the KUMC Biosafety Plan.
Contact Name
Position
Phone
Alt. Phone
Email
Principle Investigator
(PI)
Charles “Sonny” Cherrito
Biological Safety Officer
913-588-5206
816-590-0730
ccherrito@kumc.edu
Ryan Lickteig
Director - EHS
913-588-5163
913-235-5517
rlickteig@kumc.edu
EHS Office
EHS Office
913-588-1081
N/A
ehs@kumc.edu
Research Field
Specific Hazards
Spill Response
Recombinant DNA
Gene Therapy
Infectious Substances
Vectors
Viruses
Bacteria
Treat with appropriate disinfectant for a minimum of 30
minutes contact time. Repeat the process completely.
Notify the above contacts in order until one is reached.
{L0036211.1 }
The University of Kansas Medical Center, Institutional Biosafety Committee (IBC)
3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, ibc@kumc.edu, Website
IBC Registration: Clinical Trials
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2015-08-26
SECTION V
Additional Comments
As we are a publicly funded organization, the University, at times, may receive requests to provide
information on certain material (e.g. committee meeting minutes) that may be subject to public
distribution per federal, state or local laws. Is there anything contained within in this document that
should not be disclosed to the public upon a records request (e.g. propriety material, etc.)?
Yes
No
If Yes, explain:
Please provide any additional comments in which you feel necessary for personnel to be informed in
regards to safety precautions (cage changing procedures, animal handling, special training, vaccines,
precautions for pregnant women and immunocompromised individuals, etc.). This information will
greatly assist in mitigating an occupational exposure, injury or even death. Feel free to be as specific,
detailed and descriptive as possible as this Risk Assessments integrity relies on the information you
provide (this is clearly stated within the BMBL and NIH Guidelines ).
{L0036211.1 }
The University of Kansas Medical Center, Institutional Biosafety Committee (IBC)
3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, ibc@kumc.edu, Website
IBC Registration: Clinical Trials
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2015-08-26
SECTION VI
PI Responsibilities
Institutional Biosafety Committee (IBC) Registration
This portion is to be completed by all researchers that conduct research involving recombinant DNA,
synthetic DNA and/or Gene Therapy. The signed portion acts as a registration with the KUMC IBC. This
page is to be signed and submitted (email, hard copy, etc.) to the Environment, Health & Safety Office.
The PI must ensure that the information contained in this registration is accurate and complete. The PI
accepts the responsibility for the safe conduct of work with this study at the Biological Safety Level
practices and procedures assigned by the IBC. The PI will inform all personnel, who may be at risk of
potential exposure regarding the work being conducted. The PI will assure that all personnel will receive
adequate training to perform all activities safely and proficiently.
Where applicable, the PI agrees to comply with the NIH requirements pertaining to shipment and
transfer of recombinant DNA materials. Additionally, as a condition of research approval and
continuation, the PI acknowledges the responsibility for the conduct of this research in accordance with
Section IV-B-7 of the NIH Guidelines. It is the PI’s responsibility to notify the IBC of any changes in their
protocol that involve the hazards mentioned in this application (change in vehicle, dosing route, adverse
events, etc.) and the PI must remain in communication with the IBC throughout the conduct of the
project.
If the IBC chooses to inspect the facilities in which the material is handled, stored, prepared,
transported, administered or disposed, it is the PI’s responsibility to arrange for the IBC or its members
to gain access to the facilities. Lastly, the PI has the right to attend the portion of the IBC meeting in
which their protocol is discussed.
The PI shall comply with the reporting requirements for all incidents (adverse events, illnesses, injury,
death, misconduct, protocol addendums, etc.) within 30 days to the NIH as outlined in the NIH
Guidelines, Section IV-B-7. The PI understands that the entities that are to receive the report include,
at a minimum, the NIH/OBA and the IBC. Additionally, the PI may be required to notify other
appropriate authorities that are associated with this research.
Signature - Principle Investigator (PI)
Date
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The University of Kansas Medical Center, Institutional Biosafety Committee (IBC)
3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, ibc@kumc.edu, Website
IBC Registration: Clinical Trials
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2015-08-26
IBC USE ONLY
Reviewing
Entity’s
Approval
Required
Yes
No
Approval
Date
Environment, Health & Safety (EHS)
Institutional Biosafety Committee (IBC)
Institutional Review Board (IRB)
Recombinant DNA Advisory Committee (RAC)
National Institutes of Health (NIH) Director
Office of Biotechnology Activities (NIH)
Center for Disease Control & Prevention (CDC)
Radiation Safety Committee (RSC)
Biosafety Level
Click Here
Risk Group
Click Here
Chemical & Drug Hazard Level
Click Here
Shipment Category
Click Here
Protocol Submitted?
Investigator Brochure Submitted?
Consent Form Completed?
Additional Notes:
{L0036211.1 }
The University of Kansas Medical Center, Institutional Biosafety Committee (IBC)
3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, ibc@kumc.edu, Website