BIOSAFETY OFFICER USE ONLY
Registration #:
Initiation Date:
IBC Approval Date:
Expiration Date:
UNH Institutional Biosafety Committee
Recombinant DNA Registration Form
This form is for registration of recombinant DNA experiments and work with transgenic animals and plants. A
registration for infectious work that is not recombinant is submitted on the Infectious Agents Registration Form
found on the OEHS Biosafety website.
For any questions about this form, or for help completing the form, please contact the Biological Safety Officer at 862-0197.
Section 1: Principal Investigator Information
Name:
Department:
Office (Building and room #):
Laboratory Contact Person:
Source of Funding:
Phone:
Position:
Phone:
Requested Start Date:
End Date:
Note: the IBC approves projects for up to a maximum of 3 years. After 3 years, a new registration will need to be filed.
Section 2: Project Description
Project Title:
Project Description:
(provide a brief summary of
project goals stated in nontechnical terminology)
Experimental Design:
(provide a technical
description of experiments;
information provided must
be sufficient to eliminate
the need to reference to
other documents or
scientific papers)
Requested Biosafety
Level (BSL):
☐BSL-1
☐BSL-2
☐BSL-3
Choose an item.
NIH Guidelines
Section:
If choosing Section III-E or III-F, a subsection must be determined and listed here:
Note: Details about each section can be found in the NIH guidelines at http://oba.od.nih.gov/oba/rac/Guidelines/NIH_Guidelines.htm.
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Section 3: Recombinant Material Specifics
Source of the
DNA/RNA (name of
gene and source
organism):
If viral, does the insert represent >2/3 of the viral genome?
What is the
biological activity of
the gene product or
sequence inserted?
Does it code for a toxic product?
☐Yes
☐Yes
☐No
☐No
Will a drug resistant trait be transferred to an organism that does not acquire it
normally?
☐Yes
☐No
Will there be an attempt to express a foreign gene? If yes, what protein is produced?
☐Yes - Protein produced:
☐No
Host organism(s)
for propagation
(Genus, species,
parent strain, cell
line):
☐Prokaryotic:
☐Eukaryotic:
Vector(s) used:
If a viral vector is used, please complete the following:
Virus Type (retrovirus, adenovirus, etc.):
Virus Name:
Explain the packaging system. Include whether or not a helper virus is used:
Is the tropism altered? How (narrowed/expanded)?
Is the viral vector defective or replication incompetent?
Is testing for replication competent virus (RCV) done?
Will the rDNA protocol ☐Yes - Explanation:
involve animals, whole
☐No
plants (including
transgenics) or
humans?
Explain and list
approval numbers as
necessary.
Scale of work
(bench scale is <9.9
liters):
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Section 4: Laboratory
Laboratory Building and Room Numbers
(where work will be performed)
Current Biosafety Level of Room
(e.g. None, BSL-1, BSL-2, BSL-3)
Personal Protective Equipment
(currently in use)
Section 5: Personnel
List all personnel working on the project and briefly note their experience and/or proficiency in
working with the proposed agents.
Name
Experience/Proficiency
Safety Training Completed (date/type)
Section 6: Work Practices
Disinfection
Surface Disinfectant Used:
Liquid Waste Disinfection:
Solid Waste Disinfection:
Hazardous Procedures
List all procedures that may
cause splash, aerosol or sharps
hazards (e.g. sonication,
centrifugation, vortexing,
needles, razors, scalpels):
Control equipment available to
reduce aerosol, splash or sharps
injury exposure risk (BSC,
centrifuge cups, bench shield):
Will there be a deliberate or possible release of recombinant materials to the environment?
Section 7: Materials Transport
Will biological materials be transferred from one lab to another?
Will materials be shipped offsite or received from a collaborator?
Has a Materials Transfer Agreement been approved?
Do you know if permits are required (APHIS, CDC, USDA Select
Agents)? If yes, which permit is required?
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☐Yes
☐Yes
☐Yes
☐Yes
☐No
☐No
☐No
☐No
☐ Not Sure
☐Yes
☐No
Section 8: Risk Assessment
A risk assessment must be performed by the Principal Investigator and Biological Safety Officer prior to submittal
to the IBC. Contact OEHS, 862-4041, ehs@unh.edu to schedule.
Section 9: Additional Information
Please add any additional information relevant to this rDNA registration in this section. Examples are: additional
personnel, training information, pathogens that are relevant to the work but are not recombinant, etc.
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Section 10: Principal Investigator’s Statement
As Principal Investigator I certify that this application is accurate and complete.
I understand that a risk assessment must be performed by me in conjunction with the Biological Safety Officer prior
to review by the Institutional Biosafety Committee (IBC).
I agree to comply with all requirements pertaining to the use, handling, storage, and disposal of recombinant and
biohazardous materials. I also agree to follow the recommendations from the current edition of the CDC/NIH
handbook, Biosafety in Microbiological and Biomedical Laboratories.
I agree to update this Project Registration Document whenever personnel or materials change, or annually at a
minimum. I understand that the IBC grants approval for up to 3 years and a new application will need to be
submitted following expiration of this protocol.
I also understand that I am responsible for the safe, responsible conduct of my program and design and implications
of the projects under my direction. Appropriate engineering controls and personal protective equipment will be
provided to all laboratory workers as necessary for the procedures required in the experiment. Any vaccinations or
medical surveillance requirements, as determined by the IBC, will also be met prior to the initiation of experimental
work.
I will comply with shipping and permitting requirements for infectious agents and biohazardous materials.
I understand that I must report any personnel exposure or biohazardous material release to the Biological Safety
Officer immediately.
I acknowledge that IBC registration and approval represents only institutional approval of the protocol as it relates
to biosafety issues. Approval is not transferrable to any other UNH faculty or staff member. I understand that I am
responsible to assure that work under this protocol complies fully with the NIH Guidelines for Research Involving
Recombinant DNA Molecules and all applicable UNH policies and procedures.
All other necessary institutional approvals are not covered by this registration.
X
Signature
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