Biosafety Research Protocol – Notice of Intent
The UNCC Institutional Biosafety Committee (IBC) is responsible for oversight of all research and teaching
activities involved with potentially hazardous biological agents including but not limited to infectious agents,
human and non human primate materials (including established cell lines and whole blood), Select Agents,
biological toxins, commercial viral vector kits, recombinant DNA (rDNA thereafter referring to both
recombinant and synthetic DNA) and studies involving human gene transfer.
ALL RESEARCHERS who work with one or more of the materials listed in Section III “Materials Used
or Produced” MUST complete and submit this form to the IBC for approval via email to unccibc@uncc.edu. If you have any questions, contact the Office of Research Compliance (704) 687-1872.
SECTION I: GENERAL INFORMATION
1. Application Status:
New Application
Three Year Renewal
Amendment
2. Title of Project:
3. Principal Investigator:
Degree:
4. Department:
Academic Title:
5. Mailing Address:
6. Telephone:
Fax:
Email:
7. Co-Investigator/s:
Tel:
Email:
8. Lab Supervisor/Manager:
Tel:
Email:
9. Project Funded?
Y
N
If “yes”, provide: NORM Proposal # (i.e. 12-XXXX):
Funding Agency:
10. List Research Location/s:
a) On Campus – building & room/s:
b) Other UNCC site/s including leased space:
c) Non-UNCC Facility/ies being used for biohazard use? Y
1) If yes, building & room/s:
2) Did this facility grant approval for this study?
Required
N
Y
N
Pending
Not
(NOTE: if yes, attach a copy of IBC approval letter or equivalent to this protocol)
11. Using Select Agent/s?
Y
N
(CDC Select Agent List: http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html )
Biosafety Level and Risk Group
Go to BMBL: http://www.cdc.gov/biosafety/publications/bmbl5/BMBL.pdf or the CDC Select Agents list:
http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html# or the NIH Guidelines:
http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines_prn.pdf to identify agents and potential biosafety and/or
risk group levels. NOTE: Although certain agents may not be listed in these documents, a biosafety and/or risk group
level should be assigned. Assign the highest level (i.e. BSL-2/RG-2) if declaring multiple agents.
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BSL
BSL-1
BSL-2
BSL-3*
Risk Group
RG-1
RG-2
RG-3*
RG-4*
* University policy prohibits use of agents categorized in Risk Group and/or Biosafety Level 4. BSL-3 work is
currently not approved to be conducted at UNCC. Contact Environmental Health and Safety immediately at (704)
687-1111 if you plan to work with agents in NIH Risk Group 3 or Select Agents.
Special Containment Considerations – Animal and Plant Use
Go to the NIH Guidelines: http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines_prn.pdf OR the
USDA/APHIS website: http://www.aphis.usda.gov/biotechnology/index.shtml if working with animals or plants
involving rDNA or for plant use, require permitting for transport of USDA regulated articles (genetically modified plants,
soil containing plant pests, noxious weeds or pests, etc). Indicate below the appropriate containment level for the intended
use of such categories of animals or plants.
Animal Containment:
ABSL-1
ABSL-2
ABSL-3*
Plant/Pest Containment:
BL1-P
BL2-P
BL3-P*
Classification Determination
Indicate the relevant section/s of the BMBL (e.g. Section IV - RG classification; Section VIII – Agent Summary Statements)
and/or NIH Guidelines (e.g. Appendix B - BSL classification) in making your determinations above. If the agent/s you are
using are not referenced in these documents, provide scientific rationale for your classification determinations.
SECTION II: PROJECT DESCRIPTION
1.
Please give a non-technical description of the project (appropriate for lay public), focusing on the
use of biohazardous agents. (250 words or less)
2.
Summarize procedures and list associated occupational hazards for each procedure involving use
of biohazardous material, including a description of any risk-reducing devices (e.g. wear safety
glasses, gloves, labcoat, etc.).
Cross reference each procedure with personnel identified in Section B, “Personnel/Training
(e.x., John Doe will inoculate animals with HeLa cell lines, contains cervical cancer cells.)
3.
Protection equipment and processes to be used while handling agents (check all that apply based
on your determination of the biosafety and/or risk-group level of biohazardous agent/s use):
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Shoe covers
Lab Coat/ Overalls
Disposable gloves
Eye protection
Fitted respirator (fit testing required: call EH&S)
Head cover
Full face shield
Disinfectant (NOTE:if using bleach,
requires at least 1:10 dilution of household
bleach prepared fresh on the day of use and
contact time of 10-15 minutes on surfaces)
Other:
SECTION III: MATERIALS USED or PRODUCED
To ‘check’ a box (), double click on the box and select “Checked” in the Default Value section!
NOTE: Complete and submit only the Addendum(s) applicable to your research. Addenda are available
as separate documents – contact the Office of Research Compliance at 687-1872 or unccibc@uncc.edu for more information or to obtain any applicable Addenda for completion and
submission along with this main form.
Check and complete all that apply:
The use of non-exempt Recombinant or Synthetic DNA
(ref: Addendum I and NIH Guidelines (Section III - A—F; includes creation of
transgenic or other genetically Modified Plants or Animals)
Addendum I
Animals Inoculated with or Exposed to Hazardous Materials
Addendum II
Human Subjects
Addendum III
Infectious Agents (Bacteria, Virus, Yeast, Fungus, Parasitic Agents) and
CDC/USDA Select Agents (go to:
Addendum IV
http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html )
Human/Non-Human Primate Material including Established Human Cell
Lines
Protocol-Related Carcinogens or Mutagens and Toxins (Biological or
Chemical)
Addendum V
Addendum VI
SECTION IV: PERSONNEL / TRAINING
1.
Describe the Principal Investigator(s)’s previous experience using the biohazardous agents described
in this form or using similar procedures. If the Principal Investigator does not have relevant experience,
explain how the required expertise will be provided/acquired.
2. List ALL personnel working under this protocol .
All such employees, including the Principal Investigator, should be trained in the safe use and handling
of potentially hazardous materials prior to commencement of this project. The IBC may require that
training be provided by someone other than the Principal Investigator.
List additional personnel together in last row; when personnel change, submit the updated information as an
amendment.
Name
Last Name,
First Name
9-digit
UNCC
ID #
Degree
Job title
Years
experience
Procedures performed
(from page 2)
Online CITI
training
completed?
(Provide date of
last training
module completed
below for each
person listed)
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a.
b.
c.
d.
e.
f.
SECTION V: OCCUPATIONAL HEALTH
To ‘check’ a box (), double click on the box and select “Checked” in the Default Value section!
All employees who have occupational exposure to potentially hazardous materials must be aware of their risk
of exposure to these materials as well as control measures that reduce or eliminate the exposure risk.
1.
2.
Have all employees working with human material been offered the
Hepatitis B vaccine per the OSHA Bloodborne Pathogens
Standard?
Y
N
Are serological tests or other immunizations required for this
protocol?
Y
N
N/A
If yes, identify each:
3. Will any personnel working with the proposed biohazard(s) be
requesting use of a respirator?
Y
N
If yes, contact the Environmental Health & Safety Office at 687-1111 to request respirator fit testing.
SECTION VI: SAFETY EQUIPMENT
To ‘check’ a box (), double click on the box and select “Checked” in the Default Value section!
1.
Date of last laboratory inspection:
2.
A. Biosafety cabinet type/s:
3.
A. Fume hood used?
Y
N
N/A
2B. Location/s:
2C.Certification date/s:
3B. Location/s:
3C. Certification date/s:
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SECTION VII: TRANSPORTATION / SHIPPING
Containers used to transport materials between off-site locations and UNCC must meet applicable Department of
Transportation (DOT) requirements and be properly labeled, sealed, leak-proof, and puncture resistant.
Go to the following for the links to:
DOT regulations [49 CFR]: http://ecfr.gpoaccess.gov/cgi/t/text/textidx?c=ecfr&tpl=/ecfrbrowse/Title49/49cfrv2_02.tpl
Air Transport Authority [IATA] Guidance on Shipping Infectious Substances:
http://www.iata.org/whatwedo/cargo/dangerous_goods/Pages/infectious_substances.aspx
US Department of Agriculture [USDA], Animal and Plant Health Inspection Service [APHIS] Guidance on
importation/interstate transport of regulated biological organisms, plants and plant pests:
http://www.aphis.usda.gov/plant_health/permits/organism/index.shtml)
1.
Check ALL that apply:
To ‘check’ a box (), double click on the box and select “Checked” in the Default Value section!
Materials will not be transported outside of the laboratory where used.
Materials carried within the building to separate research areas
Materials carried outside between buildings: from:
to:
Materials will be transported to campus from the following off site location/s:
List all individuals who will transport materials from off-site:
Materials will be shipped off campus (using Fed-Ex, etc.).
Attach copies of current Shipper Training Certifications for persons who initiate shipments.
If no one in the laboratory has a Shipper Training Certification (DOT/ IATA) –
Please contact Airpack, Inc @ 704-329-7293 for assistance.
Contact the UNCC Office of Technology Transfer 704-687-8013 for Material Transfer Agreement Forms.
2.
Briefly describe how you will package biohazardous materials for transport to ensure appropriate
containment and protection of handlers based on the guidance resources noted above (NOTE: Intra- and
inter-building movement of biohazardous materials on campus may use the minimal packaging standard
required to contain the material and protect handlers):
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SECTION VIII: SECURITY
Describe below how you will secure and limit access to laboratories where hazardous materials
are used or stored. NOTE: To ‘check’ a box (), double click on the box and select “Checked” in the Default Value section!
Physical
Security:
Card key access
Lock doors when unoccupied
Keys issued by PI
Use Equipment Locks
Other:
No unauthorized personnel allowed
Internal
Security
Procedures:
Escort all Guests and Visitors
Escort Housekeeping and Maintenance personnel
Other:
SECTION IX: WASTE DISPOSAL
My lab will produce (check appropriate boxes):
Biological Waste consisting of:
Sharps waste
Solid waste
Liquid waste
Pathological waste
Infected animal carcasses
Carcinogenic/Toxic Waste consisting of:
Solid waste
Excess and expired carcinogenic chemicals or toxins
Carcinogenic animal carcasses
Chemical remains and contaminated bedding
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SECTION X : INVESTIGATOR’S ASSURANCE
1. I confirm that all persons involved with this project (including my collaborators) have been adequately trained in
good microbiological techniques, have received instruction on any specific hazards associated with the project
and worksite, and are aware of any specific safety equipment, practices and behaviors required while conducting
project procedures and using these facilities. The IBC may review my records documenting this instruction.
2. I will immediately report to the Environmental Health and Safety Office any accident, injury, spill of
biohazardous material, equipment or facility failure (i.e., ventilation failure), and /or any breakdown in
procedure that could result in potential exposure of laboratory personnel, staff or the public to biohazardous or
toxic material.
3. I confirm that any proposed changes to my work that would result in an increased level of biohazard will be
reported to the IBC before the change is implemented.
4. I confirm that no work that requires IBC approval will be initiated or modified until approval is received.
5. I will notify the IBC of all personnel changes or additions through the submission of an amendment.
6. I have read and understand my responsibilities as Principal Investigator outlined in Section IV-B-4 of the NIH
Guidelines, and agree to comply with these responsibilities.
7. I certify that the information provided within this application is accurate to the best of my knowledge. I also
understand that, should I use the project described in this application as a basis for a funding proposal (either
intramural or extramural), I am responsible for ensuring that the description of procedures in the funding
proposal is identical in principle to that contained in this application.
8. I confirm that all persons involved with this protocol will comply with all environmental laws and regulations
and that this project does not significantly impact the environment.
Investigator Name: ________________________________________________
Investigator Signature: ________________________________________________
Date: ________________________________________________
Included with this application:
The use of non-exempt Recombinant or Synthetic DNA (includes creation of transgenic or
other genetically modified plants or animals)
Animals Inoculated with or Exposed to Hazardous Materials
Human Subjects
Infectious agents (Bacteria, Virus, Yeast, Fungus, Parasitic Agents) and CDC/USDA
Select Agents (go to:
http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html)
Human/Non-Human Primate Material including Established Human Cell Lines
Protocol-Related Carcinogens or Mutagens and Toxins (Biological or Chemical)
Addendum I
Addendum II
Addendum III
Addendum IV
Addendum V
Addendum VI
Please send a hard copy/scan of the signed page to:
Office of Research Compliance ATTN: Cindy Stone, 320B Cameron or via email at
uncc-ibc@uncc.edu OR
Fax this page with signature to 704-687-0980.
Electronic signatures are not acceptable.
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