The Franklin and Marshall College Institutional Biosafety Committee
BSL2 Biosafety Review: Research Registration Form
1. Instructions
PRIOR TO BEGINNING, MAKE CERTAIN YOU ARE USING THE CORRECT VERSION OF THIS FORM BY
DOWNLOADING THE LATEST VERSION FROM THE BIOSAFETY WEB SITE.
Information must be provided in all boxes shaded yellow as well as in all other appropriate tables. If you reply
‘Yes’ to a question, you need to provide additional details in the table associated with that question. Incomplete forms will
be returned without being processed. Examples of information to supply in a table are given in cells shaded grey in the
table. Use unshaded cells for your information. You must also electronically sign (that is, type your signature) this BSL2
Biosafety Review form, which includes the Acknowledgement of Your Responsibilities, prior to submission.
Since the IBC includes Institutional and community members from a variety of backgrounds, it is essential to provide
information in a manner that is understandable to readers who are scientifically educated but not specialists.
Table 1 PI Information
PI name
e-mail address
Department
Previous IBC protocol no.
(PI name and date of last
submission)
Guidance for assigning biosafety levels (BL) can be found at http://www.cdc.gov/biosafety/publications/index.htm (BMBL,
5th ed.) and http://oba.od.nih.gov/rdna/nih_guidelines_oba.html (NIH Guidelines).
Standard Operating Protocols (SOPs) for working with the materials registered in this Form must be submitted with this
form and maintained in your laboratory. Additional SOPs for your lab may need to be developed depending on the
materials registered in this BSL2 Biosafety Review Form. See template documents (available on the Biosafety web site)
for suggestions of what to include in SOPs and examples of SOPs. These template SOPs can be modified as appropriate
for working with the specific agents you are registering and for your lab.
2. Project Title and Description of Work
Provide a brief title describing the work encompassed by the biohazards being registered and a short (usually less than
150 words) summary in lay terminology of 1) the overall goal of the research and 2) the planned research activities to
assist Committee members to understand how the registered materials will be manipulated. This description must be
written in lay scientific terms.
Table 2. Project Title and Description of Work
2A: Project Title
2B: Summary including overall goal(s) and description of research activities (in lay scientific terminology)
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3. Unfixed Materials from Humans or Non-Human Primates
3-i. Does this work involve any unfixed materials derived from humans or non-human primates? These
materials include established cell lines, blood, other fluids, tissues, and primary cells.
Yes
No
If no, go to item 4.
If yes,
3a. Specify unfixed human or non-human primate material(s) employed including specific name(s) or
description(s) and Institutional Review Board (IRB) approval number as appropriate in Table 3. (Note that work with any
unfixed human-derived material is at least BSL2.)
3b. Forward the SOP(s) for work with these materials in your lab to the Biosafety Officer with the completed BSL2
Biosafety Review form for IBC review. Provide an identification number (SOP ID #) that permits matching the SOP to the
material.
Table 3. Unfixed Human or Non-Human Primate Materials
Human or primate materials
Human cell lines
E Example
Example
Human body fluids
Comments (e.g. primary tissue, established cell line,
known pathogens)
HEK293 cell line and BxPC-3 pancreatic adenocarcinoma
cell line
Including, but not limited to, blood and saliva collected from
volunteers
BL
IRB #
SOP ID#
BL2
NA
RLK #1
BL2
78901EP
Infection Control
Policy V-1;
Standard Body
Substance
Precautions (SBSP)
(Add additional rows as necessary to the table above.)
3-ii. Will any federally funded work with human embryonic stem cells (hESC) and/or human induced
pluripotent stem cells (hiPSC) be conducted?
Yes
No
If no, go to item 4.
If yes, contact the Biosafety Officer; additional information will be required.
4. Biological Toxins or Carcinogens
4-i. Does this work involve toxins of biological origin?
Yes
No
If no, go to item 4-ii.
If yes,
4a. Specify these toxin(s) in Table 4 below.
4b. Forward the SOP(s) for work with these materials to the Biosafety Officer with the completed BSL2 Biosafety
Review form for IBC review. Provide an identification number (SOP ID #) that permits matching the SOP to the material
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Table 4. Toxins of Biological Origin
Toxin
Example
Comments (include dose, LD50, route of administration,
safety precautions, etc.)
25 ng/kg mouse body weight (human LD50 = 100 ng/kg); IP injection; All
personnel handling the toxin have received booster vaccinations. Rooms
will be posted while DT is administered and animal cages will be marked
accordingly.
Diphtheria toxin
SOP ID#
RLK #2
(Add additional rows as necessary to the table above.)
Yes
4-ii. Will toxins, carcinogens, or hazardous chemicals be used in animals?
No
IACUC protocol
number(s)
(if available)
If no, go to item 5.
If yes, contact the Biosafety Officer and IACUC; additional forms will be required. If you have not yet submitted an
IACUC protocol, write ‘to be submitted’ in this column.
5. Infectious Agents that do not contain recombinant DNA (recombinant infectious agents should be listed in
Item 6)
5. Does your work involve any non-recombinant agents that are potentially infectious, including viruses,
bacteria, or parasites? Note: recombinant infectious agents (that is, containing recombinant DNA) belong in Item 6 and
Table 6 rather than in Item 5.
Yes
No
If no, go to item 6.
If yes,
5a. Specify agent(s) employed and indicate the BSL and/or Risk Group (RG) of each if applicable in Table 5 (a
useful web link for help in determining BSL and/or RG is http://www.absa.org/riskgroups/index.html).
5b. Forward the SOP(s) for work with agent(s) in your lab to the to the Biosafety Officer with the completed BSL2
Review form for IBC review. Provide an identification number (SOP ID #) that permits matching the SOP to the agent.
Table 5. Infectious Agents
Infectious agent
Example
Vaccinia virus
Comments (e.g. strain, modifications)
BL
BL2+
Western Reserve strain
RG
2
(Add additional rows as necessary to the table above.)
6. Recombinant Infectious Agents
6. Does this work involve recombinant infectious agents including viruses, bacteria, or parasites?
Yes
No
If no, go to item 7.
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SOP ID #
EXAMPLE
RLK #3
If yes,
6a. In Table 6a list recombinant pathogens including bacteria, parasites, and viruses (including recombinant
retroviruses). Include the type, specific strain, or name as applicable, and nature of the pathogen.
6b. In Table 6b list information about recombinant retroviral vectors (including lentiviral vectors).
6c. In Table 6c list recombinant inserts (including genes, cDNAs, microRNA or shRNA cassettes, etc.) expressed
in the pathogens described in Tables 6a and 6b. Provide any additional comments that will assist Committee members in
assessing biosafety concerns.
6d. Forward the SOP(s) for work with these materials in your lab to the to the Biosafety Officer with the completed
BSL2 Biosafety Review form for IBC review. Provide an identification number (SOP ID #) that permits matching the SOP
to the agent.
Table 6a. Recombinant Infectious Agents
Pathogen type,
strain, or name
Is this a
retroviru
s?
Is this
replication
competent
?
If this is
replication
defective,
is helper
virus(es)
used?
Yes/No
No
Yes/No
No
Yes
No
If YES,
fill out
Table 6B
Example
Adenovirus
Cre
recombinase
(Ad-CMVCre)
pLenti6-myc
lentiviral
vector
Yes/No
No
If this is
replication
defective, is a
packaging cell
line or
replicationdefective
packaging
plasmids used?
Yes/No
Yes
Does this encode
a product that
increases
expression of an
oncogene or
decrease
expression of a
tumor
suppressor?
Yes/No
No
No
Yes
Yes
Comments (e. g.,
oncogene name,
tumor suppressor
targeted by insert,
means used to make
virus replication
defective, helper
virus ID)
SOP
ID #
BL
Deleted for the
essential E1 gene as
well as the E3 gene;
thus, this agent is
non-replicative
Human c-myc
oncogene; lentiviral
particles produced are
replication defective &
only contain the c-myc
gene
RLK#
1
BL2
RLK#
3
BL2+
(Add additional rows as necessary to the table above.)
Table 6b. Recombinant Retroviruses
Name of vector or system
Example
ViraPower System
Source (e.g.,
company, or
scientist)
Invitrogen
‘Generation’
or number
of plasmids
in system
3rd
generation;
4 plasmids
(Add additional rows as necessary to the table above.)
4
Envelope
gene(s)
encoded
VSV-G
Tropism
Pantropic
Can the expression vector
infect human cells?
Yes/No
SOP ID#
Yes
EXAMPLE
RLK #3
Table 6c. Recombinant DNA in Infectious Agent(s) that are Listed in Tables 6a and 6b
Examples
Nature of insert (e.g.,
gene, cDNA, microRNA,
shRNA cassette)
Gene or product name (or
class of product)
Source/species
Biological role of rDNA
Biologically active
protein(s) or product(s)
Does product potentially
initiate or promote
oncogenesis?
Yes/No
Recombinant pathogen
(from Tables 6a and 6b) in
which this will be present
Cells to receive rDNA
during experiment (e.g.
HeLa, human, mouse)
NIH category (III-A to III-F)
BL
SOP ID #
Insert
Insert
Gene
Gene
c-Myc
Cre
Human
Phage P1
Encodes
transcription
factor
c-myc
protein
Yes
Site-specific
recombination
ViraPower
lentivirus
vector
Human
HEK293
Ad-CMV-Cre
III-D
BL2+
RLK #3
III-D
BL2
RLK #2
Insert 1
Insert 2
Insert 3
Insert 4
Cre
No
Human
HEK293
(If more genes need to be listed, duplicate this table and paste it below this original table.)
7. Recombinant DNA (not including recombinant viruses and other infectious agents, which were listed in Tables
6a and 6b)
7. Does this work involve recombinant DNA other than recombinant infectious agents (which were addressed
in Tables 6a and 6b)?
Yes
No
If no, go to item 8.
If yes,
7a. List recombinant inserts (including genes, cDNAs, microRNA or shRNA cassettes, etc.) used in Table 7. For
assistance, the NIH guidelines are available at http://oba.od.nih.gov/rdna/nih_guidelines_oba.html.
7b. Forward the SOP(s) for work with these materials in your lab to the Biosafety Officer with the completed BSL2
Biosafety Review form for IBC review. Provide an identification number (SOP ID #) that permits matching the SOP to the
material.
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Table 7. Recombinant DNA
Examples
Insert
Nature of insert (e.g.,
gene, cDNA, microRNA,
shRNA cassette)
Gene or product name (or
class of product)
Source/species
Biological role of rDNA
Biologically active
protein(s) or product(s)
Does product potentially
initiate or promote
oncogenesis?
Yes/No
Original host/vector
(e.g. E.coli/pUC; insect
cells/baculovirus)
Cells to receive rDNA
during experiment (e.g. E.
coli, yeast, HeLa)
NIH category (III-A to III-F)
BL
SOP ID #
Insert 1
Insert 2
Insert 3
Insert 4
Gene
Various amino acid
transporter genes
Yeast S. cerevisiae
Encodes amino
acid transporters
Amino acid
transporters
No
E. coli pBR
derivatives that also
replicate in yeast
E. coli and yeast
(S. cerevisiae)
III-F
BL1
EXAMPLE
RLK #4
(If more genes need to be listed, duplicate the table above and paste it below this original table.)
8. Biohazards in Animals
8-i. Will any of the biohazards or recombinant DNAs described above (items 3-7; including unfixed humanderived materials) be used in animals?
Yes
No
If no, go to item 8-ii.
If yes, specify biohazard(s)/recombinant DNAs, animal specie(s) and Institutional Animal Care and Use Committee
(IACUC) protocol number(s) in Table 8a. If you have not yet submitted an IACUC protocol, write ‘to be submitted’ in this
column.
Table 8a. Biohazards in Animals
Biohazard/recombinant DNA
Example
BxPC-3 human cells
Animal Specie(s)
and description
Nude mice
(Add additional rows as necessary to the table above.)
6
Comments
BL
Prior to injection in mice, BxPC-3 cells will be
transfected with plasmid pLWW, which expresses
GFP.
BL2
IACUC
protocol #
20YY-ZZZ
8-ii. Will any experiments, with or without biohazards, be conducted in genetically manipulated animals (e.g.,
transgenic or knockout animals)?
Yes
No
If no, go to item 9.
If yes,
8b. Provide appropriate information in Table 8b.
8c. Forward the SOP(s) for work with these materials in your lab to the Biosafety Officer with the completed BSL2
Biosafety Review form for IBC review. Provide an identification number (SOP ID #) that permits matching the SOP to the
material.
Table 8b. Genetically Manipulated Animals
Gene altered;
Transgene (TG) or knockout (KO)
and Source
Example
Simian diptheria toxin receptor (TG)
Species of
gene/marker
Monkey
Species and
type of
genetically
altered animal
Mouse
Biohazard (if used)
Does change
initiate or
promote
oncogenesis
?
Yes/No
BL
IACUC
protocol #
No
2+
20YY-ZZZ
Vaccinia virus
(Add additional rows as necessary to the table above.)
9. Biohazards in Humans
9. Will any of the biohazards or recombinant DNAs described above (items 2-6) be used in humans?
Yes
No
If no, go to item 10-i.
If yes, specify biohazard(s) and IRB protocol number(s) in Table 9. If recombinant DNA is used, the documents
pertaining to the review by the NIH RAC must also be sent to michael.billig@fandm.edu.
Table 9. Biohazards or Recombinant DNA in Humans
Biohazard or
recombinant DNA
Example
Recombinant
adenovirus
Comments
Trial
Phase
1 x 106 adenovirus with tumor suppressor gene p53 will be injected
into hepatic artery feeding hepatoma lesion, as per protocol xx-xxx
(attached)
I
(Add additional rows as necessary to the table above.)
7
IRB
protocol
#
FDA
New
drug
appro
val #
(IND)
78902
pending
WWW
For protocols
with
recombinant
DNA or
derived
materials, list
NIH category
and NIH RAC
protocol # and
status
NIH category
III-C; NIH RAC
#0311-WWW;
public review
done; summary
attached
Informed
consent
attached;
required
Yes
10. Facilities
10-i. Will experiments with any of the above biohazards be conducted in your laboratories?
Yes
No
If no, go to item 10-ii.
If yes, list your laboratory rooms in which experiments with any of the above materials will be conducted in Table 10a,
including the assigned BSL rating for the room and the appropriate equipment available for work with these materials
[e.g., BSL2 work generally requires certified biosafety cabinets (include the date of the most recent certification, which
must be within the last 12 months), appropriate safeguards for aerosol-generating procedures such as centrifugation,
vortexing, sonication, pipetting, etc., facilities for appropriate decontamination].
Table 10a. Your Laboratories and Facilities
Room #
Example
C57WW
Assigned
BL
Equipment for safe conduct of work with biohazards
BL2+
EXAMPLE Two biosafety cabinets, centrifuge with closed buckets, sharps containers in lab,
biohazard warning sign on door, SOPs available in lab notebook, personal protective equipment
including lab coats, gloves, & face protection utilized, autoclave available on the same hallway,
both red and orange trash bags available for use with the different levels of biohazards as
appropriate
Biosafety
Cabinet
Yes/No
Yes
two
If Yes,
date
certified
Both
certified
on
3/21/YY
(Add additional rows as necessary to the table above.)
10-ii. Will other facilities, labs, or equipment in other labs be used for work with any biohazard(s) listed
above?
Yes
No
If no, go to item 11.
If yes, list additional facilities, common equipment rooms or labs of other faculty, within the institution that will be
used for any biohazard(s) in this registration in Table 10b. If this work includes animals, you must indicate the rooms
in the animal facilities that will be used. The status of this protocol will be copied to the supervisor of the facility/room.
Table 10b. Other Facilities and Labs Used for Work
Facility &
Room #
Example
Examples
CAQ WWW
GCRG
Facility/room
supervisor
& e-mail address
Assigned
BL
Penny Devlin
pdevlin@hmc.psu.edu
Rebecca Jenkins
rjenkins@hes.hmc.psu.
edu
2
JCAHO
certified
Biohazard
Human cells in
nude mice
Human blood;
recombinant
adenovirus
Equipment utilized and safety
measures including
cleaning/decontamination methods
Cells in double, sealed, shatterproof
containers when transported to CAQ
Standard precautions as per routine;
contact isolation for work with
recombinant virus
(Add additional rows as necessary to the table above.)
11. Internal Transfers
11. Will any biohazard(s) listed above be transported between rooms within the Institution?
Yes
No
If no, go to item 12.
8
Approval for use of
this facility?
Yes/No
Approval ID
Yes
20YY-ZZZ
Yes
WW-YY
If yes, in Table 11 list each biohazard that will be transported and detail means and precautions utilized including
packaging of materials during transport. At a minimum, these materials need to be in two sealed, shatterproof containers.
While gloves should be worn when working with these materials in the lab, it is not appropriate to wear gloves when
transporting them through public areas.
Table 11. Transport
Example
Biohazard
Human cells
Transportation safeguards
Cells in double, sealed, shatterproof containers (e.g., a tube and a Tupperware container) when taken to CAQ;
however, gloves are not worn in public areas during transport
(Add additional rows as necessary to the table above.)
12. External Transfers
12. Will any biohazard(s) listed above be shipped or transported off campus?
Yes
No
If no, go to item 13.
If yes, in Table 12 detail 1) how each biohazard will be shipped or transported and 2) training or certification for this.
Table 12. Shipping
Example
Biohazard
Human cells
Shipping safeguards
Appropriate classification, packaging and labeling as per e.g. DOT,
IATA, etc. regulations
Training/certification
Online training completed by Dr. I. Ship who
is responsible for shipping these items
(Add additional rows as necessary to the table above.)
13. Training
BSL2 and Bloodborne Pathogen Training is required of everyone working in a designated BSL2 laboratory, even if the
individual’s work only involves BSL1 agents and manipulations. BSL2 and Bloodborne Pathogen Training is available as a
seminar offered at least 3 times a year – usually at the beginning of the semester (Contact the Biosafety Officer (Debra
Frielle, X4600, dfriellefandm.edu) for information). Training is also available as a Blackboard course (requires enrollment
and an exam, contact the Biosafety Officer) and as one-on-one training, by request. BSL2 training must be completed
once; annual renewal of Bloodborne Pathogen training is required by OSHA. Biosafety and Bloodborne Pathogen training
must be documented in writing; documentation will be maintained by the Biosafety Officer. If you wish, copies of the
training documentation may be requested from the Biosafety Officer and maintained in your lab as well.
In addition, you must have completed all appropriate institutional Chemical Safety Training within the last year. EHS
provides the annual Chemical Lab Safety training (contact Denise Freeman, X4153, denise.freeman@fandm.edu) and
maintains documentation of training.
13. Have you been appropriately trained to work with each of the above biohazards?
Yes
No
If yes, provide details of your training such as years of experience working with each biohazard, specific training or
courses, publications using the biohazards listed, or other relevant preparation in Table 13.
If no, detail how you will acquire appropriate training such as mentoring (provide e-mail address for mentor) or other
training in Table 13.
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Table 13. Your Training
TABLE 13A: Training for working with the biohazards listed in this form
TABLE 13B: If training was not completed at F&M, where is written documentation of your training maintained?
TABLE 13C: Date of completion of your most recent:
Chemical Safety (must be within last year):
Bloodborne Pathogens Training (must be within last year, if appropriate)
Biosafety Level 2 Training
14. Supervision of Others
14-i.
‘Electronic’
(typed) initials
As PI, I understand it is my responsibility to ensure that ALL new individuals who enter my lab
to work with the materials registered on this Form 1) complete and document all appropriate
trainings (e.g., Biosafety Training, BBP training, lab-specific training) and 2) complete
documentation of any available safeguards (e.g., vaccinations, serum banking) required for the
biohazards they will work with.
14-ii. Will others work with any of the above biohazards in your lab or under your direction?
Yes
No
If yes, provide appropriate information in the Table 14a. Biosafety and Bloodborne Pathogen training of all individuals
listed in Table 14a related to the biohazards specific to this protocol must be documented and signed. In addition, labspecific technique training must be completed under the supervision of the PI. Documentation of this “hands-on” training
must be forwarded to the Biosafety Officer. All training documentation will be maintained by the Biosafety Officer.
In addition, each person listed must complete all required annual renewals, such as Chemical Safety Training and
Bloodborne Pathogens Training, that is appropriate for their activities (see list under Item 13 above).
NOTE: All information for each person MUST be provided.
Table 14a. Training of Personnel
Name
Position
Biohazard(s)
trained for
Example
Examples
Dr. J. Doe, MD
HMC resident also working in COM lab
Human materials
F. E. Smith
COM grad student
Recombinant DNA; vaccinia, diptheria toxin
Various medical professionals (e.g., RNs,
MDs) in GCRC
Human materials
10
Date(s) Institutional training completed
(must be within last year) REQUIRED
COM Safety: 3/21/WW
COM BBP*: 3/21/WW
HMC Safety: 3/21/WW
HMC BBP**: 3/21/WW
COM Safety: 3/21/WW
COM BBP*: NA
HMC Safety: NA
HMC BBP**: NA
COM Safety: NA
COM BBP*: NA
HMC Safety: various dates
HMC BBP**: various dates
Chem Safety:
BBP:
BSL2:
Chem Safety:
BBP:
BSL2:
Chem Safety:
BBP:
BSL2:
If any specific safeguards (e.g., vaccinations, serum banking) are recommended by the ‘Biosafety in Microbiological
and Biomedical Laboratories’ (can be downloaded from http://www.cdc.gov/biosafety/publications/index.htm or the
Advisory Committee for Immunization Practices (http://www.cdc.gov/vaccines/pubs/ACIP-list.htm#comp) for individuals
working with any of the biohazards registered on this form, provide appropriate information in Table 14b. One example of
a Specific Safeguard is that anyone working with unfixed human-derived materials must have documentation of
vaccination or declination of vaccination for hepatitis B. Vaccinations can be obtained through Appel Health
Services (X4082) at no cost to the employee, student or lab. Take the ‘Vaccine Administration Consent Form’ (available
through a link at http://www.fandm.edu/ehs/bloodborne-pathogens) to your appointment. Documentation of declination of
vaccination can be obtained by filling out the ‘Hepatitis B Vaccine Declination Form’ (available through a link at
http://www.fandm.edu/ehs/bloodborne-pathogens). The completed form should be sent to Human Resources.
DO NOT reveal personal health information in Table 14b. You only need to indicate that the decision about the
safeguard(s) is appropriately documented.
Table 14b. Specific Safeguards
Name
Position
Biohazard(s)
Specific safeguard(s)
(e.g., vaccinaitions)
TO ADHERE TO HIPAA, ONLY STATE THAT
“VACCINATION FOR… OR DECLINATION OF THIS
VACCINATION IS DOCUMENTED”
Example
Examples
Dr. J. Doe, MD
HMC resident also working
in COM lab
Human materials
Vaccination for hepatitis B or declination of this
vaccination is documented
F. E. Smith;
COM grad student
Vaccinia &
diptheria toxin
Various medical
professionals (e.g., RNs,
MDs) in GCRC
Human materials
Vaccination for vaccinia virus within last 10 years &
diptheria booster within last 10 years or declinations are
documented
Vaccination for hepatitis B or declination of this
vaccination is documented
Documentation of appropriate
vaccination(s) or declination(s)
REQUIRED
Where documented?
(Appel Health/Human
Resources)
Employee Health
Student Health
Employee Health
(Add additional rows as necessary to the table above.)
15. Adverse Outcomes
15. Have there been any accidental spills, accidental exposures, or adverse outcomes with any of the above
biohazards in your lab?
Yes
No
If yes, provide details in Table 15.
Table 15. Adverse Outcomes
16. Assignment of Biosafety Level
Highest BSL you assigned for above biohazards
Guidance for assigning biosafety levels (BL) can be found at http://www.cdc.gov/biosafety/publications/index.htm (BMBL,
5th ed.) and http://oba.od.nih.gov/rdna/nih_guidelines_oba.html (NIH Guidelines).
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17. Acknowledgement of Your Responsibilities
I the undersigned Principal Investigator recognize that I am responsible for
A) developing and making accessible SOPs describing appropriate means for working with each biohazard in my lab;
B) ensuring that everyone entering my lab
i) is appropriately instructed and trained to work with all biohazards they handle or encounter in the lab,
ii) performs all experiments with biohazards with appropriate biosafety precautions, and
iii) has received any required vaccinations or other specific safeguards necessary for any biohazard they handle or
encounter in the lab;
C) maintaining appropriate documentation of training and safeguards for everyone in my lab who works with or
encounters biohazards;
D) making available to the IBC all SOPs and documentation (e.g., of training) as requested and permitting inspection
of my lab by members of this Committee and other appropriate personnel;
E) maintaining certification of biosafety cabinets as necessary and ensuring appropriate operation of all equipment;
F) appropriately describing the biosafety concerns related to my experiments to individuals in charge of other labs or
facilities in which work with these biohazards is conducted;
G) immediately reporting to the Biosafety Officer (Debra Frielle, X4600; dfrielle@fandm.edu) and to EHS (Denise
Freeman, X 4153, denise.freeman@fandm.edu)
i) any spill of biohazardous materials or any equipment failure that could potentially result in exposure of anyone to
biohazardous materials;
ii) any signs, symptoms, or illnesses consistent with exposure to any biohazardous materials in my lab;
H) updating this application when changes are made including adding new biohazards or new people working with
biohazardous materials and reviewing this application as requested;
I) ensuring that initiation of work with the biohazards being registered occurs in accordance with the appropriate
sequence of submission and/or approval of this protocol as described in the ‘NIH Guidelines for Research Involving
Recombinant DNA Molecules’; and
J) adherence to the ‘NIH Guidelines for Research Involving Recombinant DNA Molecules’, guidelines in the current
edition of the ‘Biosafety in Microbiological and Biomedical Laboratories’, and the Institutional policy by everyone working
with these biohazards in my lab or under my direction.
‘Electronic’ (typed) signature of PI
PI e-mail address
Phone
Date
Table 17 PI Information
Office/room number
PI status
(e.g., faculty, post-doc, student)
18. Willingness to Mentor (optional)
Table 18. Willingness to Mentor
Based on my experience and training, I am able and willing to be contacted for advice or mentorship for work
with the following biosafety materials:
12
19. Notification of Others (optional)
In the following table, list other individuals you want informed regarding the status of this application (e.g., lab manager,
administrative assistant, etc.). Note that if the PI is not a faculty member, the faculty advisor must be listed in the table.
Name
Status/title
e-mail address
phone
Office/room
number
(Add additional rows as necessary to the table above.)
20. Additional Comments (optional)
Table 20. Additional information or comments
SUBMIT THIS FORM AS A WORD DOCUMENT ALONG WITH ALL OTHER NECESSARY DOCUMENTS, SUCH AS
SOPs, TO THE BIOSAETY OFFICER FOR IBC REVIEW.
For F&M IBC use only
Investigator & Protocol no:
Date rec’d:
Date approved:
Version 5/2014
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