Download Recombinant or Synthetic Nucleic Acid

Recombinant or Synthetic Nucleic Acid Research Registration
1) All projects involving recombinant nucleic acids must be registered. Projects involving synthetic nucleic acids or
organisms or cells that contain synthetic nucleic acids must be registered provided that the synthetic nucleic acid is either
a) designed to integrate into DNA b) replication competent or able to replicate in a living cell or c) codes for a vertebrate
toxin with an LD50 of <100 nanograms/kilogram.
2) Registration & oversight of these projects is in accordance with the NIH GUIDELINES FOR RESEARCH INVOLVING
RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES. In the context of the Guidelines, these molecules
are defined as either: (i) molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a
living cell, i.e., recombinant nucleic acids; (ii) nucleic acid molecules that are chemically or by other means synthesized or
amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid
molecules, i.e., synthetic nucleic acids, or (iii) molecules that result from the replication of those described in (i) or (ii)
above. The Guidelines classify these experiments based on their potential hazard(s) to research staff, environment, and/or
public health.
3) Projects must be approved BEFORE any research is initiated.
Important sections of the NIH Guidelines include:
Section III - Experiments covered by the NIH Guidelines (page 15)
Section IV B-7- Responsibilities of the PI (page 29)
Appendix B - Classification of Human Etiologic Agents on the Basis of Hazard (page 39)
Appendix G - Physical Containment; Biosafety Levels 1 –4 (page 71)
Appendix P - Containment for Recombinant or Synthetic Nucleic Acid Research Involving Plants (page 113)
Appendix Q - Containment for Recombinant or Synthetic Nucleic Acid Research Involving Animals (page 124)
Project submissions are reviewed by the Biosafety Office; non-exempt projects are then forwarded to the full Institutional Biosafety
Committee (IBC) for review, comment, and approval. The IBC is composed of scientists that may not be experts in your particular
field of research. Please tailor your responses on the registration form accordingly. We must obtain sufficient information to
determine required containment level, facilities, procedures, practices, and expertise/training necessary for the safe conduct of the
project, therefore please be thorough. Insufficient information/incomplete forms will delay the approval process and the form will
be returned to you for revision. Please utilize the fillable document and type the form; hand written forms are not accepted.
If you have any questions, please contact the Biosafety Office at 392-1591 or [email protected]
The Biosafety in Microbiological and Biomedical Laboratories (5th Edition) is a valuable resource for details on containment, risk
assessment, agent summary statements, etc. and can be found at:
http://www.cdc.gov/biosafety/publications/bmbl5/index.htm
University of Florida
Environmental Health & Safety
Biological Safety Office
[email protected]
phone: (352)-392-1591
fax: (352)-392-3647
Section 1 – Basic Information
PI Name:
Department:
Office Phone:
Project Title:
Recombinant or Synthetic Nucleic Acid Registration
#RD -
Lab Phone:
Project Location: All Building(s):
Sponsor:
Title:
Address/Box:
Email:
All Room(s):
Section 2 – General Project Information
2.1 Recombinant /Synthetic nucleic acid use:
a.
b.
YES
NO
YES
NO
Will proteins or regulatory RNAs be expressed?
Is the source of the DNA/nucleic acids to be used associated with alterations of normal mammalian cell cycle or
cell growth (i.e. a potentially oncogenic or tumorigenic gene?)
If yes, explain:
c.
What is the maximum total volume of cultured recombinant/synthetic material being used at any one time?
d.
Will your experiments be conducted outside of containment (e.g. outside the facility, field trial)?
If yes, explain:
e.
Will you use any nucleic acid that codes for a vertebrate toxin with an LD50 of <100 nanograms/kilogram ?
If yes, describe:
f.
g.
Will you use any nucleic acid designed to integrate into DNA?
Will you use any nucleic acid that is replication competent or able to replicate in a living cell?
2.2 Do your experiments have any of the following dual-use research of concern issues:
a.
b.
c.
d.
e.
f.
g.
h.
i.
Transfer drug, antibiotic, vaccine, or chemical resistance genes?
Alter genes associated with an agent’s pathogenicity (ability to cause disease)?
Alter genes associated with an agent’s virulence (extent or severity of disease)?
Alter genes associated with an agent’s transmissibility?
Enable evasion of diagnostic/detection modalities?
Alter the host range or tropism of a pathogen?
Change an organism’s normal ability to survive or be disseminated?
Enhances the susceptibility of a host/host population to a pathogen or toxin?
Reconstitutes an eradicated/extinct pathogen?
If you checked yes to any of the above, please explain each in more detail:
2.3 Proposed Biosafety / Biocontainment Level for the project (as a whole or by parts):
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Section 3 - Human Use
3.1 Will human subjects and/or human clinical specimens be used in this research?
If yes, have you received IRB approval?
Yes
No
No Date of intended submission:
Yes IRB#:
Approval pending – date submitted to IRB:
3.2 Human gene transfer projects involving Recombinant DNA, or DNA or RNA Derived from Recombinant DNA, into One or
More Human Research Participants will also require the following be submitted with this registration:
a. A description of the product:
1. Describe the derivation of the delivery vector system including the source (e.g., viral, bacterial, or plasmid vector); and
modifications (e.g., deletions to attenuate or self-inactivate, encapsulation in any synthetic complex, changes to tropisms,
etc.). Please reference any previous clinical experience with this vector or similar vectors.
2. Describe the genetic content of the transgene or nucleic acid delivered including the species source of the sequence and
whether any modifications have been made (e.g. mutations, deletions, and truncations). What are the regulatory elements
contained in the construct?
3. Describe any other material to be used in preparation of the agent (vector and transgene) that will be administered to the
human research subject (e.g., helper virus, packaging cell line, carrier particles).
4. Describe the methods for replication-competent virus testing, if applicable.
5. Describe the intended ex vivo or in vivo target cells and transduction efficiency.
6. Describe the gene transfer agent delivery method.
b. Investigator Study Brochure
c. Investigator Study Protocol
d. Informed Consent document
e. Status of IRB review (IRB approval is not needed prior to IBC review – after is OK)
f. Confirmation that the NIH protocol registration process is complete
g. If the human gene transfer project was initiated and reviewed by the NIH prior to April 27, 2016, please submit the RAC
approval letter, answers to Appendix M and items 3.2 b-e.
Please note that if UF is serving as the initial clinical trial site, all documentation described in Appendix M-I-A must be submitted to
the NIH OSP before the IBC can approve the project. Required documentation includes a letter from the IBC detailing their
assessment of whether public Recombinant DNA Advisory Committee (RAC) review is warranted. The IBC cannot approve any
protocols until the NIH registration process is complete so please plan accordingly. For additional information regarding the
registration and review process for human gene transfer protocols initiated on or after April 27, 2016, please see the following:
http://osp.od.nih.gov/sites/default/files/HGT_FAQ%20sheet_508%20complaint.pdf.
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Section 4 - Animal Use
4.1 Will your experiments involve the use of/introducing nucleic acid into animals?
Yes
No
4.2 Please list the animals you will be using:
4.3 How will the nucleic acid be transferred into the animal (e.g. viral vector, plasmid injection, transduced cells)?
4.4 Route of administration? Check all that apply.
Intravenous
Intranasal
Intraperitoneal
Other:
Subcutaneous
Intracerebroventricular
Intramuscular
4.5 Will you create transgenics/knockouts?
If yes,
a. Where will you create your transgenic animals?
With the help of the UF Mouse Models Core
Within your own laboratory
b.
Yes
No
What method will be used to create your transgenic animals?
Microinjection of gene construct into pronuclear fertilized oocytes
Insertion of gene construct into embryonic stem cells that are microinjected into oocytes
Vector-mediated transfer of construct to embryonic stem cells for microinjection into oocytes
Other:
4.6 Has this project received approval from the UF IACUC?
No
Date of intended submission:
Yes
IACUC #:
Approval pending – date submitted to IACUC:
4.7 Where do you plan to house your animals? Building:
Room:
Other:
4.8 Where do you plan to perform animal procedures? Building:
Room:
Other:
Section 5 – Plant Use
5.1 Will you isolate nucleic acids from plants?
Yes
No
Yes
No
Yes
No
If yes, which plants? (list)
5.2 Will you transfer nucleic acid into plants?
5.3 What type of plant(s) host?
5.4 How will you introduce nucleic acid into the plant?
5.5 Where will genetically modified plants be kept?
Laboratory
Growth chamber
Greenhouse
Field Trial
Location:
Location:
Location:
Location:
5.6 Are the plants regulated by the state or federal government as a noxious weed, invasive,
or exotic plant?
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Section 6 – Insect or Arthropod Use
6.1 Will you isolate nucleic acids from insects or arthropods?
Yes
No
Yes
No
If yes, which nucleic acids? (list)
From which insect/arthropod(s)?
6.2 Will you transfer nucleic acid into insects/arthropods?
If yes, which nucleic acids (list)?
Into which insect/arthropod(s)?
6.3 Is this insect regulated as a plant pest, exotic, or invasive species by the state or federal government?
Yes
No
6.4 How will you introduce nucleic acid into the insect/arthropod?
6.5 Where will the insects/arthropods be kept?
Laboratory
Growth chamber
Insectary
Field Trial
Location:
Location:
Location:
Location:
Section 7 – Use of human or non-human primate tissue, fluids, or cell lines
7.1 Will you use human or non-human primate tissues or fluids on this project?
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
If yes, where will you obtain these?
7.2 Will primary human/non-human primate cells (collected directly from the human/primate) be used?
If yes, where will you obtain these?
Are these oncogenic/tumorigenic?
7.3 Will human or non-human primate cell lines be used?
Which cell lines?
Where obtained (source or manufacturer, list)?
Are these oncogenic/tumorigenic?
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Section 8 – Pathogen Use
8.1 Will you transfer genes/ nucleic acid from a pathogen into another organism/host?
Yes
To register more than 3 pathogens, complete an additional section 8.1 and attach to this form
Question
Pathogen 1
Pathogen 2
No
Pathogen 3
Name of pathogen
What pathogen genes/nucleic
acids?
Gene/nucleic acid function?
Transferred into which host(s)?
8.2 Will you add genes /nucleic acids to a pathogenic organism?
To register more than 3 genes, complete an additional section 8.2 and attach to this form
Yes
Question
Nucleic acid/gene 3
Nucleic acid/gene 1
Nucleic acid/gene 2
No
Gene name?
Gene/nucleic acid function?
Gene/nucleic acid is from what
organism?
Transferred into which
pathogen(s)?
Is host range, pathogenicity,
virulence, or antibiotic resistance
of pathogen changed?
If yes, describe?
8.3 Will you delete genes /nucleic acids from a pathogenic organism?
To register more than 3 genes, complete an additional section 8.3 and attach to this form
Yes
Question
Nucleic acid/gene 3
Nucleic acid/gene 1
Nucleic acid/gene 2
No
Gene name?
Gene/nucleic acid function?
Deleted from what pathogen(s)?
Is host range, pathogenicity,
virulence, or antibiotic resistance
of pathogen changed?
If yes, describe?
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Section 9 – Details about the recombinant or synthetic nucleic acids:
Detail recombinant/synthetic nucleic acids used in this project below.
9.1 Viral vectors:
To register more than 4 constructs/vectors, complete an additional section 9.1 and attach to this form
QUESTION
Vector 1
Vector 2
Vector 3
Vector 4
Type of virus that makes
up the vector system?
Name of vector
construct?
Source of nucleic acid to
be inserted?
Name of inserted nucleic
acid?
Function of inserted
nucleic acid?
Discuss risks associated
with this inserted nucleic
acid if it were
accidentally transferred to
an unintended host
(e.g. is it oncogenic,
immunogenic, toxic,
immune suppressive,
angiogenic, an allergen,
etc)
Is insertional mutagenesis
a concern?
Why or why not?
List any key expression
control elements
(amphotropic
envelope gene, human
promoter, etc.)
List ALL host(s) the
vector will be transferred
into. Include
genus/species where
applicable (e.g.
packaging cell line, cell
lines, prokaryotes, plants,
animals, insects, etc)
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How will it be transferred
to each host (transfection,
viral transduction,
transformation, infection,
particle bombardment,
injection, etc)?
How much will be
transferred to each host
(concentration/titer and
volume)?
What percentage of the
viral genome will be
transferred to the host(s)?
< 1/2
½ - 2/3
> 2/3
Other:
< 1/2
½ - 2/3
> 2/3
Other:
< 1/2
½ - 2/3
> 2/3
Other:
< 1/2
½ - 2/3
> 2/3
Other:
Is the virus capable of
integrating into the host
genome?
Is the virus replication
defective?
If yes, describe
If no, provide
justification for the use of
a replication
competent virus
Will you use defective
viral vector in the
presence of helper virus?
If yes, specify which:
List all helper plasmids
used to produce
recombinant virus
Has the vector
preparation been tested
(e.g. by commercial
vendor, another PI) or
will it be tested in your
lab for the presence of
replication competent
virus (RCV)?
If yes, describe the
method used for testing
and attach data as a
separate sheet if
available:
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Discuss safety features
of the viral vectors you
will be using (e.g. gene
deletions, expression of
packaging genes on
multiple plasmids, selfinactivating long terminal
repeats, limited tissue
tropism).
How did you obtain the
viral vector?
a.
Bought a commercial
kit Yes
No
a.
Which:
Bought a commercial
kit Yes
No
a.
Which:
Bought a commercial
kit Yes
No
a.
Which:
Bought a commercial
kit Yes
No
Which:
b.
Made all components
in my lab
Yes
No
b.
Made all components
in my lab
Yes
No
b.
Made all components
in my lab
Yes
No
b.
Made all components
in my lab
Yes
No
c.
Assembled in my lab
from components
made/obtained
elsewhere
Yes
No
c.
Assembled in my lab
from components
made/obtained
elsewhere
Yes
No
c.
Assembled in my lab
from components
made/obtained
elsewhere
Yes
No
c.
Assembled in my lab
from components
made/obtained
elsewhere
Yes
No
Obtained from:
d.
Received packaged
virus
Yes
No
Obtained from:
d.
Obtained from:
e.
Received transduced
cells
Yes
No
Obtained from:
Received packaged
virus
Yes
No
Obtained from:
d.
Obtained from:
e.
Received transduced
cells
Yes
No
Obtained from:
Received packaged
virus
Yes
No
Obtained from:
d.
Obtained from:
e.
Received transduced
cells
Yes
No
Obtained from:
Received packaged
virus
Yes
No
Obtained from:
e.
Received transduced
cells
Yes
No
Obtained from:
Attach a map of all viral constructs at the end of the document
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9.2 Plasmid vectors (transferable genetic elements, capable of autonomous replication within a suitable host)
To register more than 4 constructs/vectors, complete an additional section 9.2 and attach to this form.
QUESTION
Vector 1
Vector 2
Vector 3
Vector 4
Name of plasmid
construct?
Name of inserted nucleic
acid?
Source of nucleic acid
inserted?
Function of inserted
nucleic acid?
Discuss risks associated
with this inserted nucleic
acid if it were
accidentally transferred to
an unintended host
(e.g. oncogenic,
immunogenic, toxic,
immune suppressive,
angiogenic, an allergen,
etc)
List any key expression
control elements (human
promoter, enhancer, etc.)
List ALL host(s) the
plasmid will be
transferred into-list
genus/species where
applicable (e.g. cell
lines, prokaryotes ,
plants, animals, insects)
How will it be transferred
to each host?
(e.g. transformation,
conjugation,
electroporation, injection,
particle bombardment,
etc)
How much will be
transferred to each host
(concentration and
volume)?
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How did you obtain the
plasmid vector:
a.
Bought a commercial
kit Yes
No
a.
Bought a commercial
kit Yes
No
a.
Bought a commercial
kit Yes
No
a.
Bought a commercial
kit Yes
No
Which:
Which:
Which:
Which:
b.
Made all components
in my lab
Yes
No
b.
Made all components
in my lab
Yes
No
b.
Made all components
in my lab
Yes
No
b.
Made all components
in my lab
Yes
No
c.
Assembled in my lab
from components
made/obtained
elsewhere
Yes
No
c.
Assembled in my lab
from components
made/obtained
elsewhere
Yes
No
c.
Assembled in my lab
from components
made/obtained
elsewhere
Yes
No
c.
Assembled in my lab
from components
made/obtained
elsewhere
Yes
No
Obtained from:
Obtained from:
Obtained from:
Obtained from:
d.
d.
d.
d.
Received cells
already containing
the plasmid
Yes
No
Obtained from:
Received cells
already containing
the plasmid
Yes
No
Obtained from:
Received cells
already containing
the plasmid
Yes
No
Obtained from:
Received cells
already containing
the plasmid
Yes
No
Obtained from:
Attach a map of all vector constructs at the end of the document
9.3 siRNA/shRNA/miRNA/dsRNA
To register more than 4 siRNA/shRNA/miRNA/dsRNA, complete an additional section 9.3 and attach to this form
QUESTION
siRNA 1
siRNA 2
siRNA 3
siRNA 4
siRNA
Description
Used with a plasmid or
viral vector?
Yes
No
Yes
No
Yes
No
Yes
No
Transferred into what
(cell or animal)?
Target gene?
Where will siRNA be
obtained from?
Expected length of time
of gene suppression
Is this able to suppress a
beneficial gene?
Why or why not?
Could this have any
detrimental off-target
effects?
Why or why not?
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QUESTION
shRNA
shRNA 1
shRNA 2
shRNA 3
shRNA 4
Description
Used with a plasmid or
viral vector?
Yes
No
Yes
No
Yes
No
Yes
No
Transferred into what
(cell or animal)?
Target gene?
Where will shRNA be
obtained?
Expected length of time
of gene suppression?
Is this able to suppress a
beneficial gene?
Why or why not?
Could this have any
detrimental off-target
effects?
Why or why not?
QUESTION
miRNA
miRNA 1
miRNA 2
miRNA 3
miRNA 4
Description
Used with what plasmid
or viral vector?
Yes
No
Yes
No
Yes
No
Yes
No
Transferred into what
(cell or animal)?
Target gene?
Where will miRNA be
obtained?
Expected length of time
of gene suppression
Is this able to suppress a
beneficial gene?
Why or why not?
Could this have any
detrimental off-target
effects?
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Why or why not?
QUESTION
dsRNA 1
dsRNA 2
dsRNA 3
dsRNA 4
dsRNA
Description
Used with what plasmid
or viral vector?
Yes
No
Yes
No
Yes
No
Yes
No
Transferred into what
(cell or animal)?
Target gene?
Where will dsRNA be
obtained?
Expected length of time
of gene suppression
Is this able to suppress a
beneficial gene?
Why or why not?
Could this have any
detrimental off-target
effects?
Why or why not?
9.4 Other recombinant/synthetic nucleic acids used not described above:
Please provide a narrative or detail.
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Section 10 – Research Description
10.1 Briefly describe the proposed work in lay terms. Your narrative must include:
a. brief introduction,
b. specific goal(s) of your experiment(s),
c. experimental approaches to be used with a focus on WHAT, WHY, and HOW recombinant or synthetic nucleic acids will be
used,
d. the endpoints to be measured
The Biosafety Office/IBC does not review the scientific merit of the work but rather evaluates projects to ensure that they incorporate steps to minimize potential
biohazard exposures and that biohazardous materials are disposed of in an appropriate manner. Provide sufficient information to ensure that the hazards and
potential risks are easily identified. Avoid using excess technical jargon and do not simply attach grant proposals, abstracts, manuscripts, or IACUC/lab protocols as a
substitute.
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Section 11 – Risk Assessment
11.1 Discuss any risks associated with accidental exposure to or accidental environmental release of the recombinant or synthetic
material or genetically modified organisms:
11.2 What section of the NIH Guidelines do these experiments fall under and what biosafety level would be appropriate for
conducting these experiments ? (see The NIH Guidelines or the EH&S Biosafety Office NIH Guidelines Summary for
assistance)
11.3 Describe how the following will be implemented to protect personnel from accidental exposure and/or prevent accidental
environmental release:
a. work practices:
b. personal protective equipment (PPE):
c. safety or containment equipment:
11.4 Describe your procedures for an accidental spill, exposure, or environmental release:
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Section 12 - Decontamination and Disposal
12.1 Which types of biological waste will be generated in your lab? Check all that apply.
Sharps
Recombinant /synthetic nucleic acid
Human pathogens
Animal pathogens
Plant pathogens
Human/primate blood, blood products, tissues, cultures, cells, or OPIM
Animal carcasses/tissues
Human remains/tissues
Mixed biological/chemical waste
Mixed biological/radioactive waste
12.2 Do you have access to an autoclave?
Yes
No
Building/room:
Proper function & testing monitored by (name):
Test method:
Test frequency:
12.3 Do you have a copy of the biological waste disposal guidelines posted in the lab (see http://www.ehs.ufl.edu/Bio/biowaste.htm#Policy and
http://webfiles.ehs.ufl.edu/biomed_waste_disposal_guide.pdf )?
Yes
No
12.4 Have all personnel been trained regarding proper biological waste disposal?
Yes
No
12.5 How will work surfaces be decontaminated?
12.6 How will solid waste be decontaminated and disposed of?
12.7 How will liquid waste be decontaminated and disposed of?
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Section 13 - Occupational Health and Training Information
Name and Title
Human/Non-human
primate samples used
Vaccinations/Tests
received
Training Courses
Taken
Years experience working
at:
BSL-1
Blood
Tissues
Primary cell cultures
OPIM:
None
Blood
Tissues
Primary cell cultures
OPIM:
None
Blood
Tissues
Primary cell cultures
OPIM:
None
Blood
Tissues
Primary cell cultures
OPIM:
None
Blood
Tissues
Primary cell cultures
OPIM:
None
Blood
Tissues
Primary cell cultures
OPIM:
None
Hepatitis B
Vaccinia
TB screening
Serum banking
Respirator fit testing
Other:
Hepatitis B
Vaccinia
TB screening
Serum Banking
Respirator fit testing
Other:
Hepatitis B
Vaccinia
TB screening
Serum Banking
Respirator fit testing
Other:
Hepatitis B
Vaccinia
TB screening
Serum Banking
Respirator fit testing
Other:
Hepatitis B
Vaccinia
TB screening
Serum Banking
Respirator fit testing
Other:
Hepatitis B
Vaccinia
TB screening
Serum Banking
Respirator fit testing
Other:
BSL-2
BSL-3
BBP
BMW
Shipping &
Transport
Biosafety
BBP
BMW
Shipping &
Transport
Biosafety
BBP
BMW
Shipping &
Transport
Biosafety
BBP
BMW
Shipping &
Transport
Biosafety
BBP
BMW
Shipping &
Transport
Biosafety
BBP
BMW
Shipping &
Transport
Biosafety
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Section 14 – Project Personnel and PI Assurance
The undersigned individual(s) will be involved in the experimentation described above. They are familiar with and agree to abide
by the current NIH Guidelines. ALL PARTICIPANT SIGNATURES REQUIRED.
Name (type or print)
Title
UF ID
Signature
Date
I attest to the fact that these individuals are properly trained in the area of recombinant /synthetic nucleic acid experimentation.
Furthermore, I agree to comply with the NIH requirements pertaining to handling, shipment, transfer, and disposal of
recombinant/synthetic nucleic acid materials.
I am familiar with and agree to abide by the provisions of the current NIH Guidelines and other specific NIH instructions pertaining to
the proposed project.
I understand that I must have EH&S or IBC approval before beginning this work.
I understand that changes to the project described above must be reported to EH&S Biosafety in advance.
I understand that associated IACUC or IRB approvals may be held pending EH&S or IBC approval of this work.
The information above is accurate and complete to the best of my knowledge.
Principal Investigator
Date
E-mail ([email protected]), fax (352-392-3647), or mail (PO Box 112190) the completed form to the Biosafety office. Please see the
calendar for IBC meeting dates and submission deadlines. Projects received after the 5pm deadline will be reviewed the following
month.
Please include any construct/vector/plasmid maps as attachments.
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