- SAMPLE TTUHSC Institutional Biohazards Committee Registration Application to use Biohazardous Materials
Instructions for Registration
This registration must be submitted to and approved by the Institutional Biohazards Committee prior to the reporting of
protocol approval by the HSC to granting agencies for protocols which utilize hazardous materials and animals and prior
to commencement of any experimentation using these registered materials.
WHAT TO REGISTER:
IBC protocol approval is required before purchasing, storing, or using:
 Highly toxic chemicals or biotoxins (LD50 (oral/rat) < 50 mg/kg).
 Any Biosafety Level-2 or above agents.
 “Select agents” in any amount. ( infectious agents and biotoxins listed in 42 CFR Part 73).
 Tissues (fixed or unfixed), fluids or cell lines derived from humans or non-human primates (human
and non-human primate materials are considered at BSL-2).
NOTE: Any use of Biosafety level 2 microbiological/infectious agents, human or non-human primate fluids (i.e., blood, serum, etc.)
tissues or cells (i.e., cell lines, including established, immortalized cell lines like HeLa and Hep-2), and highly hazardous chemicals
must be reviewed and approved by the Institutional Biohazards Committee before the procedure is initiated. A non-comprehensive
listing of biohzards or highly hazardous chemicals/toxins which MUST be registered are available at:
http://www.ttuhsc.edu/Admin/safety/lab/CHEMICALS_TOXINS_REQUIRING_IBC_REGISTRATION.pdf
http://www.ttuhsc.edu/Admin/safety/lab/BIOLOGICALS REQUIRING_IBC_REGISTRATION.pdf
HOW TO REGISTER:
Determine which Biosafety Level (BSL) the protocol calls for, and determine if safety equipment, and facilities are
appropriate for procedures involving human or non-human primate fluids, tissues or cells. Biosafety Level 1 practices,
safety equipment and facilities may be exempt from IBC review; contact Safety Services for assessment or confirmation.
Again, see the following form for specific requirements. Contact Ericka Pearce or Rebekah Bonner in Safety Services
(743-2597) if you have any questions mailto: Lisa.Jacquez@ttuhsc.edu or Rebekah.Bonner@ttuhsc.edu.
This completed form must be submitted (through e-mail) to Lee Paradise (Lee.Paradise@ttuhsc.edu), Office of
Sponsored Programs. Upon approval by the Institutional Biohazards Committee, the completed IBC application, with
addendums, must be placed in the laboratory in the TTUHSC Laboratory Compliance Manual and be available to
employees in the laboratory.
NOTE: It is advisable to save a copy of the completed form on your computer for future updates.
NOTE: Certification of laboratory safety training for laboratory personnel will be established by successfully
completing appropriate exam(s) approved by the Institutional Biohazards Committee, and will be so
stated on the Biohazards License.
COMMITTEE MEETING DATE:
The Committee typically meets the first Tuesday of each month. Registration materials must be received no later than
9:00 a.m. the Tuesday Two (2) Weeks preceding the meeting in order to ensure consideration at that month’s meeting.
Revisions of information concerning changes to personnel, materials, procedures or practices from your previous
registration must be submitted (through e-mail) to Lee Paradise, Office of Sponsored Programs at least Two (2) Weeks
preceding the IBC meeting and prior to implementing the change. Protocols will be reviewed on an annual basis. Entire
protocols must be resubmitted every third year.
This form must be typed
http://www.ttuhsc.edu/admin/safety (SAMPLE)
Texas Tech University Health Sciences Center
Institutional Biohazards Committee
Registration Application to use Biohazardous Materials
(Submit to Lee Paradise@TTUHSC.edu no later than two (2) weeks prior to the first Tuesday of each month)
If assistance is needed in completing this form, please contact:
Ericka Pearce or Rebekah Bonner, Safety Services Department, BA-120 HSC
mailto: Lisa.Jacquez@ttuhsc.edu or Rebekah.Bonner@ttuhsc.edu
Tel.: (806) 743-2597; FAX: (806) 743-1299
All of the Following Questions Must Be Answered for this Form to be Complete
(If Not Applicable Please Type N/A)
Project and Researcher Information
1. Is this Registration:
New or
Renewal? If renewal, Protocol Number
2. Materials being registered on this application: Blood, Acrylamide
3. Title or Brief Description of Projects registered on this application (Please number projects if more than one): Presence of
Hepatitis B Virus antibodies in immunocompromised pediatric patients. Blood is being used to test for the presence of
antibodies to Hepatitis B Virus. Acrylamide is being used in electrophoresis gels.
4. Principal Investigator: Dr. John Doe
5. Title: Professor
6. Department: Pediatrics
7. Address (office): BA120
8. Laboratory Room Number(s) where materials will be used: (Indicate use areas with a “U” and shared locations “C” (i.e., inner
lab, culture room, etc.)BA099U
9. Phone (Office): -7432597
(Laboratory): -7432599
10. FAX: 743-1299
11. E-Mail: john.doe@ttuhsc.edu
12. Co-Investigator: none
13. Title:
14. Department:
15. Staff Members included on this application (list all with titles):Jane Doe, Research Assistant; Jim Bob Doe, Student Assistant
16. Describe safety training received by above mentioned staff members:Completed New Employee Safety Orientation,
Laboratory Safety Training and received site specific training on hazardous materials used.
17. Administrative Controls – Processes or procedures established by the Principal Investigator for the purpose of reducing personnel
exposure to highly hazardous chemicals and/or biological materials (aerosols, contamination, dusts, etc.). Indicate those that apply
to this project.
Ergonomic Design Layout
Access Restriction
Site Specific Training
Special Personal Hygiene Measures
Signs and Labels
Special Housekeeping Issues
Project Risk Assessment
Special Prohibited Activities
Other Appropriate Means to Promote Safe Operation.
Describe as necessary any of the above in the following text box: Site specific training as mentioned above. Biohazard signs
are located outside of lab, on blood handling areas and refrigerators. Risk assessment performed prior to usage of any
hazardous material. Access restriction described on door sign. All personnel must wash hands and remove PPE prior to
exiting lab.
18. Engineering Controls – While performing this procedure, the following safety equipment must be accessible and used: (e.g.,
chemical fume hood, biological safety cabinet, etc.): Chemical fume hood used during initial dilution of Acrylamide.
http://www.ttuhsc.edu/admin/safety (SAMPLE)
19. Protective Equipment – Prior to performing this procedure, the following personal protective equipment must be obtained and
used: (e.g., gloves, eye protection, lab coats, etc.) Be specific. Lab coats, nitrile gloves approved as “Medical Device” and safety
glasses.
20. Waste Disposal – This procedure will result in the following regulated waste that must be disposed of in compliance with federal
and state environmental regulations. Proper waste procedures consist of (e.g., decontamination of etiological wastes must occur
prior to removal from the laboratory): All blood is decontaminated with a 10% bleach solution. Acrylamide is disposed of by
contacting safety services for pick up.
21. Emergency Procedures – In the event of a highly hazardous chemicals and/or biological material spill during this procedure, loss
of utilities, or other emergency, be prepared to execute the following emergency shutdown or containment procedures: List
decontamination materials or spill kits and any other necessary supplies to be used. Include signs and symptoms of release, contact
and exposures (e.g., appearance, odor, irritation, etc.) Address realistic worst case occurrences. Blood spill – cover with paper
towels and use 10% bleach solution (allow 10 minute contact time then clean up). Acrylamide spill – let dust settle then clean
up using proper PPE. Power failure – close fume hood and do not use.
Biohazardous Material(s) Relevant to this Application
22. Categories of Biohazardous Materials: (Check all that apply)
Toxins Complete Addendum B (download extra copies if necessary)
Biological Materials (Check all that apply below)
Bacteria (including Rickettsiae), viruses, fungi, parasites, and prions that are pathogenic to humans;
Human or non-Human Primate Fluids, Tissues, or Primary Cells;
Established Cell Lines requiring registration. NOTE: Registration is required for all human cell lines and any animal cell
lines that express human genes or substances pathogenic to humans. In general, other animal cell lines are exempt from registration.
Complete Addendum A (download extra copies if necessary)
Proposed Biosafety Level: 1, or 2
Highly Hazardous Chemicals (Check all that apply below)
Carcinogens
Mutagens or Tumorigens
Teratogens
Poisons (LD50<50mg/kg)
Other Organ System Toxins
Complete Addendum B (download extra copies if necessary)
Recombinant DNA Molecules
Complete Addendum A (download extra copies if necessary) for infectious organisms, expression of hazardous genes
or drug resistance trait(s). Also, complete and submit a registration application with the Recombinant DNA
Committee.
Radioactive Materials or Radiation Producing Devices
Complete and submit a registration application with the Radiation Safety Committee.
Register only with the Institutional Biohazards Committee if the chemical is also characterized as Highly Hazardous.
Human Gene Therapy
Complete and submit registration applications with both the Institutional Review Board and the Recombinant DNA
Committee.
Register only with the Institutional Biohazards Committee if transfer of human fluids, tissues or cells are involved.
Animals
Complete and submit a registration application with the Animal Care and Use Committee after IBC approval.
Also, complete the following when the project involves hazardous chemicals, toxins or infectious agents.
Species:
Location(s):
http://www.ttuhsc.edu/admin/safety (SAMPLE)
ACUC Protocol No (If known):
Risks to Personnel from Animal: Urine Feces Saliva Blood Bedding
Contact with lesions on Animals Penetrating Injury from Contaminated Cages
Mucus Membrane Contact with Secretions or Excretions Other (specify):
Aerosols
Animal Bites or Scratches
Check all that apply. If any are marked, explain risk and precautions necessary to prevent or reduce the
risks to personnel:
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TTUHSC IBC Registration Application to use Biohazardous Materials
Complete this addendum for EACH biological agent
You will need a Material Safety Data Sheet to complete this form. If you do not have one, it can be obtained at:
http://ttu.chemwatchna.com. You need to retain a MSDS in your laboratory for all registered materials. A sample listing of
required biohazardous materials which must be registered with the IBC may be found at:
http://www.ttuhsc.edu/Admin/safety/lab/BIOLOGICALS REQUIRING_IBC_REGISTRATION.pdf
NOTE: Biosafety Level 2 (BSL 2) practices, facilities and equipment described in Biosafety in Microbiological and Biomedical
Laboratories (TTUHSC Laboratory Safety Manual, Appendix A under Tab 7) are applicable for the broad spectrum of moderate risk
agents encountered when using human fluids (i.e., blood, serum, etc.), tissues or cells (including cell lines). Biosafety Level 2
assumes the use of good microbiological techniques and a low probability of aerosol generation. Appropriate personal protective
measures are necessary for aerosol generating procedures. Biosafety Level 2 is also appropriate for non-human primate fluids, tissues
or cells.
All of the following questions must be answered for this form to be complete
(if not applicable please type n/a)
1. Principal InvestigatorDr. John Doe
2.a Is this an addition to an established IBC protocol:
YES or
NO
2.b If yes, Protocol Number
3. Human or non-Human Primate (fluid, tissue, cells, etc.), specify type and source: Blood from Immunocompromised Pediatric Patients.
or
Name of Microorganism:
(NOTE: Obtain [www.hc-sc.gc.ca/main/lcdc/web/biosafty/msds/index.html or through Safety Services) and maintain in the laboratory an
MSDS for this agent.)
4. If Microorganism, taxonomical Group:
Bacterium
Fungus
Virus
Parasite
Prion
5. Describe the source and use of materials applicable to this addendum:
(NOTE: When registering human-derived cells, tissues, or fluids, always answer “yes” to question 7 owing to the possibility of blood-borne
pathogens. Also note, if working with human materials, the Hepatitis B Vaccine is recommended and must be offered [can be declined].
Remember, many Bloodborne Pathogens including HIV do not have a vaccine. It is necessary that Universal Precautions are utilized
whenever human materials are used.)
6. Risk Group:
BSL1 or
BSL2
7. Possibly Pathogenic to Humans:
YES or
NO
8. If “YES” to question 7, identify Disease and/or Symptoms and/or Effects: Blood may contain Hepatitis Virus, HIV or other
Bloodborne Pathogens.
9. If working with Human Materials, has HepB Vaccine been offered?
YES or
NO
10. Are there any other relevant vaccines to declare?
11. If “YES” on # 10, Possible Adverse Health Effects of Vaccine: Contracting Bloodborne Pathogens (from blood).
12. If Microorganism, Maximum Concentration of Microorganism Used:
13. Frequency of use: (Daily, Weekly, etc.) Twice a week
14. Aerosol Generating Procedures:
YES or
15. If “YES”, Identify Procedures:
NO
16. Use of Sharps (needles, scalpel blades, glass, etc.)
YES or
17. If “YES”, describe use:
http://www.ttuhsc.edu/admin/safety (SAMPLE)
NO
18. Use of live animals:
YES or
NO
19. Do you plan on shipping this material out to other users? YES or NO If “YES”, contact Safety Services before this submission to
obtain required shipping/receiving training materials 743-2597. NOTE: Under HSC OP 75.13 ( http://www.ttuhsc.edu/hsc/op/op7513.pdf)
this is required training, which must be completed and verified prior to the commencement of any packing and shipping of hazardous
materials. Your request for these training materials is required for approval of this IBC protocol.
http://www.ttuhsc.edu/admin/safety (SAMPLE)
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TTUHSC IBC Registration Application to use Hazardous Chemical Materials
Complete this page for EACH chemical agent
You will need a Material Safety Data Sheet to complete this form. If you do not have one, it can be obtained at:
http://ttu.chemwatchna.com. You need to retain a MSDS in your laboratory for all registered materials. A sample listing of
required chemicals and biotoxins which must be registered with the IBC may be found at:
http://www.ttuhsc.edu/Admin/safety/lab/CHEMICALS_TOXINS_REQUIRING_IBC_REGISTRATION.pdf
All of the following questions must be answered for this form to be complete
(if not applicable please type n/a)
1. Principal Investigator Dr. John Doe
3. Is this(check one):
2.a Is this an addition to an established IBC protocol:
2.b If yes, Protocol Number
Hazardous Chemical or
Toxin from a Biological Source
4. If Chemical,
Name of agent: Acrylamide
and Chemical Abstract Services (CAS) registry number: 79061
5. If Toxin, source:
6. Describe use of materials applicable to this addendum:
7. Grade or Percent Concentration:
in
8. Check all that apply:
“DANGER”
“MUTAGEN” OR “TUMORIGEN”
“WARNING”
“NEUROTOXIN”
“POISON”
“ORGAN SYSTEM TOXINS” (specify):
“CARCINOGEN”
”OTHER” (specify):
“TERATOGEN” OR “REPRODUCTIVE HAZARD”
9. Frequency of Use (Daily, Weekly, etc.):
10. Max. Quantity used at any time (mg., ml., etc.):
11. Max. Quantity Expected in Laboratory at any time:
12. Physical and Chemical Properties (Check all that apply):
Solid
Peroxide Formation
Fine Powder
Stable
Gel or Paste
Explosive
Liquid
Combustible
Aerosol
Will Polymerize
Compressed Gas
Flammable
Reactive Conditions
Shock Sensitive
Temperature Sensitive
Air Reactive
Water Reactive
Light Reactive
13. Toxicity Routes (Check all that apply):
Contact (skin or eyes)
Ingestion
Injection
Inhalation
Volatile
Non-volatile
Other (specify):
14. LD50 (oral) or LC50 for rats:
15. Target Organs and Possible Adverse Health Effects to Personnel (Check all that apply):
Liver
Reproductive System
Kidneys
Skin Damage
Central Nervous System
Eye Damage
Blood or Hematopoietic System
Sensitizer
Lungs or Respiratory System
Other (specify):
16. Containment:
17. Procedure will:
Open Bench
Fume hood
Generate Dust or Aerosol(s)
http://www.ttuhsc.edu/admin/safety (SAMPLE)
Other (specify):
Involve Sharps
Involve Live Animals
YES or
NO