Institutional Biosafety Committee (IBC) Protocol Application:

Use of Recombinant DNA & Infectious Agents Requiring Biosafety Level 2

PART I.

SECTION A: General Information

1. Investigator name:

2. Contact Information: Office Lab Email

3. Department :

4. Protocol Title:

5. Funding Agency/ Grant / Contract Number:

6. Proposed start date: Proposed end date:

7. Location of work: Building Room

8. Additional Collaborators (include all faculty students, and staff who will work on this protocol. Please include which personnel have undergone a background check and if so, by whom? (Text box will expand)

SECTION B: Protocol Information

9. Please include a brief overview of the project in layman’s terms and its goals into the box below. Please avoid technical terms and jargon, or provide definitions when necessary.

10. What is the highest Biosafety Level (BSL) applicable to conduct this project?

Consult CDC’s Biosafety in Microbiological and Biomedical Laboratories, 5th Edition to determine the Biosafety Level of the agent(s) used in your experiment. Please note: the CDC classifies work with human blood, body fluids, or tissue (e.g. human cell culture) as BSL-2. If the agent(s) to be used is classified as BSL-1 and you will NOT be using recombinant DNA, it is not necessary to complete this form or obtain IBC approval before initiation of work. If you will be working with rDNA, proceed to Section C. If you will be working with agents classified as BSL-2 or higher, you must also complete Part II of this Protocol Application.

SECTION C: The Use of Recombinant DNA (Including Exempt Experiments)

11. Please provide a brief description of the recombinant DNA (rDNA) work to be conducted for this project, including a description of any significant risks if appropriate. Enter “N/A” if this is not applicable, and skip to the PI Signature and Part II of the protocol application.

12. Exempt Experiments: The NIH Guidelines provide a description of rDNA molecules that are considered exempt. UTA’s IBC Policy requires registration of exempt rDNA, via submission of Part I of this Application, to properly document the exemption. If any category below applies to your research, please check the appropriate box and proceed to “Principal Investigator Certification & Signature.”

Exemption 1: Recombinant DNA molecules that are not in organisms or viruses.
Exemption 2: Recombinant DNA molecules that consist entirely of DNA segments from a single nonchromosomal or viral DNA source, though one or more of the segments may be a synthetic equivalent.
Exemption 3: Recombinant DNA molecules that consist entirely of DNA from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host (or a closely related strain of the same species), or when transferred to another host by well established physiological means.
Exemption 4: Recombinant DNA molecules that consist entirely of DNA from a eukaryotic host including its chloroplasts, mitochondria, or plasmids (but excluding viruses) when propagated only in that host (or a closely related strain of the same species).
Exemption 5: Recombinant DNA molecules that consist entirely of DNA segments from different species that exchange DNA by known physiological processes, though one or more of the segments may be a synthetic equivalent. A list of such exchangers will be prepared and periodically revised by the NIH Director. See NIH Guidelines Appendices A-I through A-VI, Exemptions Under Section III-F-5--Sublists of Natural Exchangers, for a list of natural exchangers that are exempt.
Exemption 6: Recombinant DNA molecules that do not present a significant risk to health or the environment. See NIH Guidelines Appendix C, Exemptions under Section III-F-6 for other classes of experiments which are exempt.

13. Non-exempt experiments: If your project involves experiments with rDNA that are not clearly exempt as described above, please supply the following information, then proceed to the Signature Page and Part II of the Application.

Original source of DNA and nature of inserted sequences
Vector(s) to be used, and source
Host(s) for propagation
For experiments involving a deliberate attempt to obtain expression of a foreign gene, identify what proteins will be produced (enter “none” if not applicable)
Is the expressed protein toxic to vertebrates? / YES / NO / N/A
Please describe containment conditions as specified in the NIH Guidelines
Which of the following will serve as hosts for the recombinant DNA?
Cultured Cells / Describe:
Animals / Species:
Whole Plants / Species:
Humans / Population:
Other / Describe:
Please list all laboratory personnel that will be working with recombinant DNA:
Please list the location of rDNA work (all labs):

Principal Investigator Certification & Signature:

I have reviewed and understand the recommendations in CDC’s Biosafety in Microbiological and Biomedical Laboratories, 5th Edition, the NIH Guidelines for Research Involving Recombinant DNA Molecules, and UTA’s Biohazard Recognition and Control Manual: Guidelines for Handling Pathogenic Microorganisms and Disposing Biohazardous Waste.

I understand that I am responsible for the accuracy of the statements made in this protocol and for the conduct of research.

______

Principal Investigator Date

PART II.

The following information in Part II is required only for experiments utilizing agents categorized as Biosafety Level 2 and/or Non-Exempt rDNA Experiments. If your experiment involves only Exempt rDNA without the use of agents in BSL-2 and above, please complete and submit only

Part I of the Protocol Application.

SECTION D: The Use of Hazardous Materials

14. Biological Agent Information – Complete the table below for each agent classified as BSL-II or higher. Attach additional copies of this page as necessary.

Agent: / Agent: / Agent: / Agent:
Strain(s)
CDC BSL Classification
NIH Human Risk Group
Source/
Vendor
Max. Quantity in Possession at One Time
Used in Vitro?
Used in Vivo? (enter species)
Diseases & Symptoms Caused by Agent
Possible Routes of Human Exposure
Vaccine Available?
Vaccine Used by Personnel?
Pathogenic to Animals?
Pathogenic to Plants?
Antibiotic Resistant?
Classified as a USDA or CDC Select Agent or Toxin?
Location of Use

15. If your project will utilize human blood, body fluids, or tissue, please describe the source of these materials and any information relevant to determining its infectious potential. Please address if the materials will be tested for infectious agents prior to use in your laboratory. If so, what specific infectious agents will the materials be tested for? If the project includes use of needles, please describe how the UTA Needle Stick Policy will be communicated and/or distributed to lab personnel. If this does not apply to your project, please enter “N/A.”

16. Hazardous Materials – list all labs where work will take place, and check the appropriate box(es) if the lab contains any of the materials listed on the left.

Lab Room #
Hazardous Chemicals
Radioactive Materials
X-ray Equipment
Lasers
Biological Hazards
Animals
Recombinant DNA
Human Blood, Fluids, Tissue

Reminder: If your project involves the use of animals, you must obtain Institutional Animal Care and Use Committee (IACUC) approval prior to commencement of the research. For more information, consult the Animal Subjects page of the Office of Research Administration website: http://www.uta.edu/ra/RC/AnimalSubjects.php. If your project involves the use of human subjects (human blood, body fluids, or tissue), you may require approval from the Institutional Review Board for the Protection of Human Subjects (IRB) prior to commencement of the research. For more information, consult the Human Subjects page of the Office of Research Administration website: http://www.uta.edu/ra/RC/HumanSubjects.php.

INFORMATIONAL: Personnel Training – the following training is required for each of the hazardous materials listed. Please note that completion of all required training will be verified for each individual before the IBC will grant final approval of the research.

Hazardous Material / Training Requirement / How to Obtain Training
Chemical & Biological Hazards / Hazard Communication (HazCom) Training / Environmental Health & Safety Office
817-272-2185 or http://www.uta.edu/policy/documents/ehs/hazcom_update_memo.pdf
Radioactive Material &
X-Rays / Radiation Safety Training / Environmental Health & Safety Office
817-272-2185
Lasers / Laser Safety Training / Environmental Health & Safety Office
817-272-2185
Animals / Animal Care & Use Training / Office of Research Administration
http://www.uta.edu/ra/oric/animal/training.htm
Human Blood, Body Fluids, or Tissue / Bloodborne Pathogen Training / Environmental Health & Safety Office
817-272-2185
Shipping & Receiving Hazardous Materials / Shipping & Receiving Hazardous Materials Training / Environmental Health & Safety Office
817-272-2185

17. Laboratory Personnel – list all lab workers that use hazardous materials under your jurisdiction (please note training requirements listed above).

Name & Status (Faculty, Staff, or Student?) / Hazardous Chemicals / Radioactive Material &
X-Rays / Lasers / Biological Hazards / Animals / rDNA / Human Blood, Fluids, Tissues / Shipping or Receiving Hazardous Material

18. Reference Materials: Please note the location of laboratory safety information below. The location of this information should be communicated to employees. Enter “N/A” if the item is not necessary for the specific type of work conducted in your laboratory.

LOCATION

/ INFORMATION
Location and availability of the chemical hygiene plan (UTA Lab Safety Manual and Lab Safety Plan).
Location and availability of known reference material, including MSDS, on the hazards, safe handling, storage, and disposal of hazardous chemicals.
Permissible Exposures and recommended exposure limits to non-regulated substances. Permissible Exposure Limits (PEL)* of OSHA regulated substances.
Physical hazards and health hazards of chemicals in the workplace.
Signs and symptoms associated with exposures to hazardous chemical used.*
Documented annual review of the Laboratory Safety Plan for each person.
Biohazard risk, containment, and disposal procedures (UTA Biohazard Recognition and Control Manual)
UTA Needle Stick Policy and emergency contact information in the event of accident/needle stick

* Permissible exposure information and signs and symptoms of exposure can usually be found in the MSDS.

19. Personal Protective Equipment (PPE):

Instructions -

·  Conduct a walk through survey of work area to identify hazards for which eye, face and hand personal protective equipment is required. Identify items listed under “Laboratory Operation.” If a “Laboratory Operation does not apply to your lab, write “N/A” in the “Hazard” column.

·  In the “Hazard” column, describe the potential hazards for which PPE is required.

·  In the “PPE Required” column, describe specific PPE that is required when performing that work activity.

·  In the “Additional Lab Safety Precautions” column, identify additional safety equipment or procedures such as fume hoods, biological safety cabinets, autoclaves, etc.

Laboratory Operation

/ Hazard / PPE Required / Additional Lab Safety Precautions
Highly toxic or carcinogenic chemicals (list chemicals under Hazards)
Animals treated with highly toxic or carcinogenic materials
Radioactive materials (Please attach copy of radioactive material protocol approved by Radiation Safety Committee)
Infectious Biological Agents
Handling broken glass; inserting glass tubes into glass stoppers and handling other sharp edged objects
Explosion hazards
UV light or lasers
Animal handling
Human Blood, Body Fluids, or Tissue

20.  Emergency Procedures: Please describe emergency procedures to be followed in the event of a chemical spill, contamination of biological material, or personnel exposure.

21.  Lab Security: Describe the procedures for site security. How will lab access be limited (i.e. key, card reader)? How will lab entries be kept secure? Will anyone have access besides personnel listed in this protocol?

22.  Waste Disposal: Describe laboratory procedures for disposal and decontamination of biological waste, hazardous chemical waste, or sharps.

23.  Transport of Hazardous Materials: If biological material or hazardous chemicals will be transported between one or more laboratories, please describe the transport procedures and appropriate safety precautions.

24.  Floor Plan: please attach to this application a floor plan of each laboratory, showing the location and class of hazardous materials stored. Include locations of laboratory benches, desks, laboratory hoods, fire extinguishers, spill control supplies, and any other items to assist emergency response personnel.

Environmental Health and Safety Office Signature:

The EH&S Office must certify all BSL 2 laboratories before research can begin. Please contact the EH&S office at 817-272-2185 to make an appointment to certify your lab and /or biosafety cabinets used in this research protocol. (This process can occur simultaneously with submission and IBC review of your protocol, but EH&S must provide final sign-off below before research can commence.)

I hereby certify that the facilities are in accordance with UTA Policy, NIH Guidelines, and CDC recommendations.

______

EH&S Safety Specialist Date

The University of Texas at Arlington

IBC Protocol Application

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