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I B C R e g i s t r a ti o n F o r m P a g e | 1

ContentsSection 1: Purpose..............................................................................................................................3

Section 2: General Information.......................................................................................................4

Section 3: Hazard Declaration........................................................................................................5

Section 4: Project Abstract...............................................................................................................6

Section 5: Biological Hazards..........................................................................................................7

Section 6: Biological Hazards Cont...............................................................................................8Section 7: Toxin Hazards..................................................................................................................9

Section 8: Chemical Hazards.........................................................................................................10

Section 9: Drug Hazards.................................................................................................................11

Section 10: Cells & Tissue..............................................................................................................12

Section 11: Whole Animal Research...........................................................................................13

Section 12: Personnel Training.....................................................................................................14

Section 13: Recombinant DNA & Synthetic DNA (Part 1)....................................................15

NIH Guidelines (Section III-A-1)....................................................................................15

NIH Guidelines (Section III-B-1)....................................................................................15

NIH Guidelines (Section III-B-2)....................................................................................15

NIH Guidelines (Section III-C-1)....................................................................................15

NIH Guidelines (Section III-D-1-a)................................................................................16

NIH Guidelines (Section III-D-1-b)................................................................................16

NIH Guidelines (Section III-D-1-c)................................................................................16

NIH Guidelines (Section III-D-1-d)................................................................................16





NIH Guidelines (Section III-D-3-c)................................................................................17

NIH Guidelines (Section III-D-3-d)................................................................................17

NIH Guidelines (Section III-D-3-e)................................................................................17

NIH Guidelines (Section III-D-4)....................................................................................17

2017-11-29The University of Kansas Medical Center, Environment, Health & Safety (EHS)3901 Rainbow Blvd., MS 3032, Kansas City, KS 66160, (913) 588-1081, [email protected]





NIH Guidelines (Section III-E-1)....................................................................................18



Section 14: Recombinant DNA & Synthetic DNA (Part 2)....................................................19

Section 15: Human Gene Therapy (Part 1)...............................................................................20




Section 19: Final Comments..........................................................................................................24

Section 20: PI Project Responsibility Acknowledgement.....................................................25



Section 1: PurposeThis form is a Risk Assessment of hazards associated with your research project and is intended to assist in eliminating occupational exposures that may lead to illness, injury, or death. The Institutional Biosafety (IBC) will not consider any submissions unless ALL portions are successfully completed. This document will be reviewed as it pertains to industry standards, guidelines, and/or regulations.

This document must be completed and sent electronically to [email protected] in MICROSOFT WORD FORMAT ONLY. DO NOT SUBMIT THIS FORM HAND WRITTEN, SCANNED OR CONVERTED TO PDF.

IBC Program ContactsPrimary Contact Alternate Contact 1 Alternate

Contact 2Alternate Contact

3Amanda Knudson Charles “Sonny”

Cherrito Ryan Lickteig Dr. Partha Kasturi

IBC Coordinator Biological Safety Officer

Director, EHS Office Chair, IBC

913-588-1825 913-588-5206 913-588-5163 [email protected] [email protected] rlickteig@kumc.

[email protected]

u

Resources UtilizedNIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid MoleculesKUMC Procedure for Research Involving Recombinant or Synthetic Nucleic Acid Moleculeshttp://www.selectagents.gov/ http://www.cdc.gov/biosafety/publications/bmbl5/bmbl.pdf http://www.kumc.edu/environment-health-and-safety-office.html


http://www.kumc.edu/environment-health-and-safety-office.html

http://www.cdc.gov/biosafety/publications/bmbl5/bmbl.pdf

http://www.selectagents.gov/

https://policy.ku.edu/sites/policy.ku.edu/files/KUMC%20Procedure%20for%20Research%20Involving%20Recombinant%20or%20Synthetic%20Nucleic%20Acid%20Molecules%202016%2007%2020.pdf

https://policy.ku.edu/sites/policy.ku.edu/files/KUMC%20Procedure%20for%20Research%20Involving%20Recombinant%20or%20Synthetic%20Nucleic%20Acid%20Molecules%202016%2007%2020.pdf

http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines

http://osp.od.nih.gov/office-biotechnology-activities/biosafety/nih-guidelines

mailto:[email protected]








Section 2: General Information Application DateProject TitleNIH Funded?IRB/HSC NumberIACUC Protocol Number

Principal InvestigatorPhoneEmailDepartmentOffice AddressLaboratory Address

Alternate ContactPhoneEmail

Collaborating EntityPhoneEmailEntity Address

List ALL individuals conducting research on your proposed project:

Last, FirstLast, First



Section 3: Hazard Declaration

CHECK ALL THAT APPLY TO YOUR PROJECT:Yes No

Select Pathogenic AgentsSelect ToxinsOther Biological ToxinsEtiological AgentsBloodborne PathogensHazardous ChemicalsHazardous / Chemotherapeutic DrugsInvestigational DrugsHuman Cells / TissueStem CellsNon-Human Primate Cells / TissuesNon-Human Primate ResearchAnimal ResearchTransgenic / Knockout Animal ModelsRadioactive IsotopesHuman Research (Clinical Trials)

Yes No RECOMBINANT DNA / SYNTHETIC DNA / HUMAN GENE THERAPY

Does your project involve Recombinant DNA or Synthetic DNA?Does your project involve Human Gene Therapy?

Yes No If yes, is your project exempt from the NIH Guidelines, per Section III-F?NOTE: if your answer is YES, you must thoroughly explain why below.


https://osp.od.nih.gov/wp-content/uploads/NIH_Guidelines.html#_Toc446948332

http://www.selectagents.gov/SelectAgentsandToxinsList.html

http://www.selectagents.gov/SelectAgentsandToxinsList.html


Section 4: Project Abstract Provide a BRIEF ABSTRACT (IN LAYMAN’S TERMS) of your project as it pertains specifically to recombinant/synthetic DNA, etiological agents (biological or toxin hazards) or gene therapy. Describe the types of manipulations to be conducted (e.g. cell culture, administration to animals/humans)? Additionally, please denote any viruses or bacteria that may be involved (lentiviruses, retroviruses, adenoviruses, adeno-associated viruses, etc.) making certain to describe their role in the project.



Section 5: Biological Hazards Does your project involve bacteria, viruses, pathogens, human blood, etc.)? Yes No

Denote all bacterial and viral agents involved in your research project: Biological

AgentAcquisition

Source How Hazard Will Be Utilized

Storage procedures for each agent:

Disposal procedures for each agent:

How will personnel be informed of the hazards involved and how to mitigate occupational exposure?

Primary containment used when manipulating each agent (e.g. BSC):

Personal protective equipment (PPE) used when manipulating each agent:

What are the agent characteristics (e.g. virulence, pathogenicity, environmental stability, attenuation)?

Are there any special containment conditions to be implemented?

Denote any hazard communication (LD50 data, special precautions, metabolite and excretion data, etc.):



Section 6: Biological Hazards Cont. Are you propagating cultures of pathogens?

Yes No If yes, explain below:

Does your project involve the use of prions? Yes No If yes, explain below:

Does your project involve any agents from the Select Agents and Toxins Exclusion List? Yes No If yes, explain below:

Does your project involve any agents that fall under the CDC Restricted Experiments? Yes No If yes, explain below:

Is your project considered Dual Use Research? Yes No If yes, explain below:


https://www.cdc.gov/flu/avianflu/avian-durc-qa.htm

https://www.selectagents.gov/re-changes.html

http://www.selectagents.gov/SelectAgentsandToxinsExclusions.html


Section 7: Toxin Hazards

Does your project involve purified Toxin Hazards? Yes NoDoes your project involve cloned Toxin Hazards?

Denote all toxins involved in your research project:

Toxin Name Acquisition Source How Hazard Will Be Utilized

Storage procedures for each toxin:

Disposal procedures for each toxin:


Primary containment used when manipulating each toxin (e.g. BSC, fume hood):

Personal protective equipment (PPE) used when manipulating each toxin:

Does your project involve any of these specific Toxins (cloned or recombinant)? Yes No If yes, explain below:

Are you propagating cultures that result in the production of toxins? Yes No If yes, explain below:

Does the project involve cloning of toxins with a LD50 of less than 100ng/kg body weight?Yes No If yes, explain below:

Denote how much of each toxin will be stored (stock-piled) at any given time (volume/weight):



http://www.selectagents.gov/PermissibleToxinAmounts.html


Section 8: Chemical Hazards

Does your project involve Hazardous Chemicals? Yes No

Denote all hazardous chemicals involved in your project:

Chemical Name Acquisition Source How Hazard Will Be Utilized

Storage procedures for each chemical:

Disposal procedures for each chemical:


Primary containment used when manipulating each chemical (e.g. BSC, fume hood):

Personal protective equipment (PPE) used when manipulating each chemical:




Section 9: Drug Hazards

Does your project involve Hazardous Drugs? Yes No

Denote all drugs involved in your project and other names the drugs are known by (e.g. Generic):

Drug Name Acquisition Source How Hazard Will Be Utilized

Storage procedures for each drug:

Disposal procedures for each drug:


Primary containment used when manipulating each drug (e.g. BSC, fume hood):

Personal protective equipment (PPE) used when manipulating each drug:


Does your project involve Investigational New Drugs?Yes No If yes, explain below:

Is there an Investigation New Drug (IND) number?Yes No N/A If yes, denote the IND# below:

Is the drug FDA approved?Yes No



Section 10: Cells & Tissue

Does your project involve Cells and/or Tissue? Yes No

List all human and animal cell lines/tissues involved in your project.Cell Line or

TissueHuman or

AnimalAcquisition

Source How Hazard Will Be Utilized

Storage procedures for each cell line/tissue type:

Disposal procedures for each cell line/tissue type:


Primary containment used when manipulating each cell line/tissue type: (e.g. BSC, fume hood):

Personal protective equipment (PPE) used when manipulating each cell line/tissue type:

Do you know what Biosafety Containment Level (e.g. BSL-1, BSL-2, BSL-3 or BSL-4) your research requires?

Yes No If yes, denote the BSL below:

Are you conducting research using stem cells?

Yes No If yes, explain below (make certain to denote the type of stem cells):

Are you propagating cultures? Yes No If yes, explain below:

Does the material contain known hazardous agents or pathogens? Yes No If yes, explain below:

Has the material been screened for pathogens? If yes, denote the method and the results:Yes No If yes, explain below:

Denote any safety information that personnel should be made aware (e.g. special precautions):



Section 11: Whole Animal Research

Does your project involve Whole Animals? Yes No

What is the ACUP number associated with this research?

Will animals be injected with anything (e.g. drugs, cells, pathogens, DNA, etc.) other than analgesics or anesthesia?

Yes NoIf yes, describe the agent, dose volume and frequency of administration for each agent, route of administration for each agent, and duration of treatment for each agent:

Will you be creating a novel animal line?Yes No If yes, describe the novel strain below:

What is the method of animal carcass disposal?

What is the duration of animal survival between exposure to each agent and euthanasia?

What is the length of time each agent remains a threat to humans working with the animals?

Provide a brief abstract regarding your research project as it pertains specifically to recombinant DNA, synthetic DNA, etiological agents (biological or toxin hazards) or the hazards being inoculated:

Please Note: The IACUC Chemical and Drug Hazards Policy outlines the requirements for all drugs being inoculated into animals. Please be aware that your animals may require special housing to help reduce the risk of occupational exposure to animal workers. For clarification or any additional assistance, please contact the KUMC's Environment, Health & Safety Office.




https://kumed.sharepoint.com/sites/mykumc/oaw/policies


Section 12: Personnel Training

Have all personnel completed the REQUIRED ANNUAL online trainings found at https://tlc.netdimensions.com? Yes No

University Environment, Health & Safety General SafetyUniversity Hazard Communication & RCRA Chemical SafetyUniversity Biosafety TrainingUniversity Bloodborne PathogenUniversity Personal Protective Equipment (PPE)

SPECIAL CONSIDERATION The above five trainings are REQUIRED ANNUALLY from all laboratory personnel (regardless if using rDNA techniques or not). By denoting “YES” you are assuring KUMC leadership that you and your personnel have indeed taken the required trainings BEFORE INITIATION OF THIS PROJECT and if found to be untrue, your project may be suspended until all trainings have been completed by all personnel. Describe any additional training completed you feel is relevant:

Do you have a laboratory specific safety plan associated with the research described I this document and have all personnel been trained as to its contents?

Yes No If your answer is no, explain why below (REQUIRED):

Please Note: The EHS Office can provide a general safety plan 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.

NOTE: If you are not working with recombinant DNA, synthetic DNA, or human gene therapy, you may skip Sections 13-18; however, Sections 19-20 must be completed by all researchers.


https://kumed.sharepoint.com/sites/mykumc/ehs/plan

https://tlc.netdimensions.com/


Section 13: Recombinant DNA & Synthetic DNA (Part 1)

HAVE ALL PERSONNEL COMPLETED RECOMBINANT DNA TRAINING – INCLUDING THE PI?

Yes NoIt is an NIH requirement for all personnel involved in rDNA research to be trained on the hazards and reporting requirements when conducting rDNA research. Completion of the online University Biosafety Training complies with this mandate. Therefore, if you or your researchers have not taken this training, you must specify below what method of training has been completed that satisfies the NIH Guidelines and provide documentation.

NIH Guidelines Section IV-B-7-c: Required submissions by the Principal Investigator to the IBC.

NIH Guidelines (Section III-A-1) Does the project involve the deliberate transfer of a drug resistance trait?


NIH Guidelines (Section III-B-1)Does the project involve cloning a toxin with an LD50 of less than 100ng/kg body weight?


NIH Guidelines (Section III-B-2)Has the project been approved (under Section III-A-1-a) as Major Actions under the NIH Guidelines?


NIH Guidelines (Section III-C-1) Does the project involve the deliberate transfer of recombinant or synthetic DNA, or DNA/RNA derived from recombinant or synthetic DNA, into one or more human research participants?









NIH Guidelines (Section III-D-1-a) Does the project involve experiments using material at Risk Group 2?


NIH Guidelines (Section III-D-1-b) Does the project involve experiments using material at Risk Group 3?


NIH Guidelines (Section III-D-1-c) Does the project involve experiments using material at Risk Group 4?


NIH Guidelines (Section III-D-1-d) Does the project involve experiments using material at Restricted Agents as Host-Vector Systems?


NIH Guidelines (Section III-D-2-a) Does the project involve experiments in which DNA from Risk Group 2, Risk Group 3 or Risk Group 4 are cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems?


NIH Guidelines (Section III-D-2-b) Does the project involve experiments in which DNA from Restricted Agents are cloned into nonpathogenic prokaryotic or lower eukaryotic host-vector systems?


NIH Guidelines (Section III-D-3-a) Does the project involve experiments using infectious DNA or RNA viruses or defective Risk Group 2 DNA or RNA viruses in the presence of helper virus in tissue culture systems?




http://www.absa.org/riskgroups/















NIH Guidelines (Section III-D-3-b) Does the project involve experiments using infectious DNA or RNA viruses or defective Risk Group 3 DNA or RNA viruses in the presence of helper virus in tissue culture systems?


NIH Guidelines (Section III-D-3-c) Does the project involve experiments using infectious DNA or RNA viruses or defective Risk Group 4 DNA or RNA viruses in the presence of helper virus in tissue culture systems?


NIH Guidelines (Section III-D-3-d) Does the project involve experiments using infectious DNA or RNA viruses or defective restricted poxviruses in the presence of helper virus in tissue culture systems?


NIH Guidelines (Section III-D-3-e) Does the project involve experiments using infectious DNA or RNA viruses or defective DNA or RNA viruses in the presence of helper virus which are not covered in Sections III-D-3-a through III-D-3-d may be conducted at BL1?


NIH Guidelines (Section III-D-4) Does the project involve whole animals?


NIH Guidelines (Section III-D-5) Does the project involve whole plants?


NIH Guidelines (Section III-D-6) Does the project involve more than 10 liters of culture?


NIH Guidelines (Section III-D-7) Does the project involve experiments using influenza viruses?












NIH Guidelines (Section III-E-1) Does the project involve the formation of recombinant or synthetic DNA containing MORE than two-thirds of the genome of any eukaryotic virus?


NIH Guidelines (Section III-E-2) Does the project involve whole plants?


NIH Guidelines (Section III-E-3) Does the project involve transgenic rodents?







Section 14: Recombinant DNA & Synthetic DNA (Part 2)

Additional information required for IBC review.

For recombinant DNA, list the plasmids being used?

Does your project involve E.coli?

Yes No If yes, explain which strain is being used below and how it will be used:

Are you using retroviral transduction? Yes No

Are you using lentiviral vectors?Yes No If yes, describe what generation of lentivirus is being used:

Are the viruses replication competent?Yes No

Describe the nature of the inserted sequences and which genes are being used:

Are the inserted genes wild-type?Yes No

Are the inserted genes mutant?Yes No

Are the inserted genes chimeric gene?Yes No

Does the research involve a collaborating institution? Yes No

If yes, has the collaborating institute’s IBC approved the research?Yes No



Section 15: Human Gene Therapy (Part 1)

Does your project involve Human Gene Therapy? Yes No

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.

Is KUMC the initiation site or add-on site for the clinical trial?

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.):

Describe the mutations to the vector to ensure that it is replication incompetent:

Is the vector replication competent or incompetent?Yes No If yes, explain below:

Has the sequence of the vector and the insert been confirmed?Yes No If yes, explain below:

Does the project involve the transfer of a drug resistance trait? Yes No If yes, explain below:





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.):

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:

Where will the material be prepared before administration to the patient?

What location (address) will the material be administration to the patient?




Section IV-B-2-b-(1)(iii): Ensuring that all aspects of Appendix M have been appropriately addressed by the Principal Investigator. 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 Appendix M of the NIH Guidelines been satisfied?Yes No If yes, explain below:

Has Recombinant DNA Advisory Committee (RAC) review been completed? If so, please provide the review letter.

Yes NoHas the collaborating entity’s IBC approved the research? If so, please provide the letter.

Yes No N/AHas any other entity approved the research? If so, please explain and provide any letters.


Does your project involve Investigational New Drugs?Yes No If yes, explain below:

Is there an Investigation New Drug (IND) number?

Is the drug FDA approved?





PART IV:Section IV-B-2-b-(1): 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?



PART V: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.





Section 19: Final CommentsAs 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.)?


Please provide any additional comments in which you feel necessary for personnel to be informed in regards to safety precautions (e.g. cage changing procedures, animal handling, special training, vaccines, precautions for pregnant women and/or 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 documents integrity relies on the accurate information you provide (this requirement is clearly stated within both the BMBL and NIH Guidelines).



http://www.cdc.gov/biosafety/publications/bmbl5/BMBL5_sect_II.pdf


Section 20: PI Project Responsibility Acknowledgement

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 the 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.) to the NIH as outlined in the NIH Guidelines, Section IV-B-7. The PI understands the entities that are to receive the report include, at a minimum, the NIH and the IBC. Additionally, the PI may be required to notify other appropriate authorities that are associated with this research.



Signature - Principal Investigator (PI) Date


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