Office of the Associate Dean Science
Office of the Associate Vice President of
Research
Biosafety Project Approval and Materials Registration
This protocol must be completed by each Principal Investigator holding a grant
administered by Trent University or supervising a research project where the use of
biohazardous infectious materials are described and used. This form must also be
completed if animal work is proposed involving the use of biohazardous agents or
animals carrying zoonotic agents infectious to humans or wildlife. Completed forms are
to be sent to the Office of Research for distribution to the Biosafety Committee. For
questions regarding the completion of this form please contact the Biosafety Officer at
ext 7061. Any changes to this form or to the projects described within must be completed
and forwarded on to the Biosafety Committee for reassessment.
Information on Biosafety at Trent can be accessed on the Web at
www.trentu.ca/sciencedean or www.trentu.ca/research
Please attach MSDS from Public Health Agency Canada (if available) or any other
information regarding the pathogenecity of the organism. Other sources of
information on Pathogens include U.S. CDC, UN Biosafety Program
Project # (for internal use only) _______________
Principal Investigator:
Department:
Office Number:
Phone Number:
Email Address:
Project(s) Title(s):
protocol.
Give all the Project(s) title(s) which will be covered by the
Lay Summary(s): Give a separate lay summary for each project included in this
Protocol. List each pathogen in each project.
Location where experimental work to be carried out:
Building
Room(s)
**For work being performed at affiliated institutions or away from Symons Campus
please indicate full address. If the affiliated institution has a safety officer, their signature
of approval will be required prior to review by the Biosafety Committee review**
Funding Agency/Agencies:
Names of all personnel working under the Principal Investigator in the location listed
above.
1.
3.
5.
2.
4.
6.
Note: All personnel (students and staff) who will be working with Biohazardous
material rated as risk group 2 or above are required to take the Biosafety course.
Contact the Biosafety Officer or Science Facilities Manager (ext. 7061) for course
information.
Methods: (Describe in detail the methods you will be using in the proposed project.
Attach additional pages if necessary).
1.0 Microorganisms
Does your work involve the use of microorganisms?
If not proceed to 2.
Yes
No
Is this for active work;
Yes
No
Or is this for a storage permit
Yes
No
(Note: All substances considered as biohazardous risk group 2 or greater must be
permitted and an inventory maintained, even if no experimental work is on-going).
Please complete the table below:
Name of
Is the
Microorganism
microorganism
(Family/genus/sp. known to be a
e.g., Pox
human
viridae/Vaccinia) pathogen?
Yes/No
(if yes give
name of
disease)
Is the
microrganism
known to be
an animal
pathogen?
Is the
microorganism
known to be a
zoonotic
agent?
Yes/No
(if yes give
name of
disease)
Yes/No
(if yes explain
the risk)
Risk
Group
(1,2,or
3)
Maximum
quantity
to be
cultured
or in
possession
at any one
time?
Yes/No
For each substance listed above what is the source of the microorganism?
1
2
3
4
5
6
2.0 Cell Culture
Does your work involve the use of cell cultures?
If no proceed to 3.
Please complete the table below:
Cell Type
Name of Cell
Line
Yes
Is this cell type used
in work? Yes/No
Human
Rodent
Other
* derived from fresh tissue
For each cell line list the supplier of primary cell culture tissue?
No
Established or
Primary*
(print one)
For each cell types give the HC or CFIA risk group (1 2 3).
3.0 Use of Human Source Materials
Does your work involve the use of human source materials?
If no proceed to 4.0
Indicate if the following will be used in the lab.
 Human blood (whole) or other bodily fluids?
If Yes please Specify:
Yes
No
Yes
No

Human blood (fraction) or other bodily fluids?
If Yes please specify:
Yes
No

Human Organs (unpreserved) ?
If Yes please specify:
Yes
No

Human tissues (unpreserved) ?
If yes please specify:
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
4.0 Genetically Modified Organisms and Cell lines
Will genetic modifications be made to the organism or cell line?
If no please proceed to 5.0
Will genetic sequences from the following be involved?
 Genes from any CDC class 1 pathogens
If yes pleas specify:

Other human or animal pathogen and/or their toxins
If yes please specify:
Will intact genetic sequences be used from:
 SV 40 Large T antigen
If Yes please specify:

Known oncogenes
If Yes please specify:
Will a live vector(s) (viral or bacterial) be used for gene
transduction
If Yes name vector:
Will virus be replication defective
Will virus be infectious to humans or animals
Will this be expected to increase the Containment level required
Yes
Yes
Yes
No
No
No
5.0 Animal Experiments
Will any of the agents listed be used in live animals
Yes
No
Name of animal species to be used
ACC protocol number (All experiments with vertebrate animals requires approval f the
Animal Care Committee).
If using murine cell lines, was the cell line tested for murine or mammalian pathogens.
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
6.0 Biological Toxins
Will toxins of biological origin be used
If no please proceed to 7.0
If yes, please name the toxin:
What is the LD 50 of the toxin:
7.0 Import Requirements
Will the agent(s) be imported (or were they imported originally
prior to your acquisition)?
If no proceed to 8.0
Has an Import permit been obtained from HC for human
pathogens?
Has an Import permit been obtained from CFIA and has a
letter from HC indicating that an HC permit is not required,
been obtained
Has a copy of the permit been sent to the BSO
Yes
No
Note: Importation requirements for human, animal and plant pathogens vary
considerably contact the BSO for assistance in obtaining these permits. Persons receiving
hazardous substances will require Transport Dangerous Goods training. Contact the
Science Facilities Manager for details.
All imports require the approval and signature of the BSO prior to acquisition.
8.0 Radioactive Material.
Will Radioactive material be used.
If yes please give the Radiation Permit #.
Yes
No
If no proceed to 9.0.
Note: Work with Radioactive substances at Trent University requires a Radiation Work
Permit and that all personnel handling Radioactive Material have taken the Radiation
Safety Course.
Contact the RSO or the Science Facilities Manager at ext. 7061.
9.0 Training Requirements for Personnel named on Form
All personnel named on the above form who will be using any of the above named agents
are required to attend the following training course given by the Health and Safety cocoordinator and the BSO as a minimum. The use of animals or radioactive substances
will require additional training. Contact the Environmental Health and Safety Officer or
the Science Facilities Manager for additional information.


Biosafety
WHMIS
As the principal investigator, I have ensured that all of the personnel named on the form
who will be using any of the biohazardous agents in Sections 1-8 have been trained.
Signature:
Date:
9. Containment levels
For the work described above please and based on your Hazard Risk Assesment circle the
highest containment level required
1
2
3
Has the facility (Building and room number) been certified by the Biosafety Committee
for this level of containment?
Yes
No
10. Methodology
Attach the specific methodology you will use for your work. Include descriptions of
techniques such as any method which may produce aerosols (i.e., vortexing, centrifuging,
mixing of solutions). Include the specifics of your decontamination of instruments,
equipment, waste products and sample destruction.
11. Principal Investigator Commitment
I
agree to conduct my research in accordance with all of the
regulations and guidelines (Federal, Provincial and Institutional) which this project may
fall under. I agree that all of the information above is accurate to the best of my
knowledge and I agree not to change the project, with the exception of improving safety,
without notifying and getting the approval of the Biosafety Committee first.
Signature of Principal Researcher:
Approvals
Date:
Trent Bio-safety Committee
Chair, Bio-Safety Committee
Signature:____________________________
Date:________________
V.P. Research and International
Bio-Safety Officer
Signature:_____________________________
Date:________________
Chris Williams
Health & Safety Officer
Signature:_____________________________
Date:________________
Bill Gibson
External Safety Officer (if applicable
Signature:
Date:________________