PLEASE TYPE
Hand-written forms will be returned
R-DNA
Northern Arizona University
Institutional Biosafety Committee
Biological Safety Office
Document of Registration
RD -
Principal Investigator:
PI’s Title:
Department:
Address/Box:
Phone:
Email:
(Added by BSO)
Project Title:
1.
Location of project
2.
Animal Use:
Yes
No
Project bldg:
IACUC#:
Project room:
Animal housing and procedure rooms:
________________________________________
3.
Biological Agent Use:
Yes
No
4.
Bio-Safety Office approval date:
Isotope Use:
Yes
No
RCC Approval date:
5.
Will you attempt deliberate expression of a gene?
6.
Will you use or produce any toxins?
7.
Is your project purpose to introduce any drug / immunological resistance gene(s)?
8.
Will you be working with 10 or more liters of recombinant material?
9.
Purpose of the Project (one sentence):
Yes
Yes
No
No
Yes
Yes
No
No
10. Project goals/intent:
11. Expected outcome:
12. What will be analyzed or measured?
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R-DNA
Document of Registration
RD -
13. Use the table below to detail recombinants used in this project, one column per construct (attach sheets as
necessary).
Construct 1
Construct 2
Construct 3
Construct 4
Construct 5
Example
DNA/Gene
Source
Example: Green
fluorescent protein,
GFP
Gene function
Example: marker
Vector Name
Example. pTR-UF12
provide map(s)
Vector Type /
Origin
Example: Viral /
Adeno-associated
virus (AAV)
Expression
control elements
(promoter,
Example: CMV
enhancer,
enhancer, Chicken
regulatory
B-actin promoter
elements, etc)
Conc/titer of
rDNA (i.p./ml)
Example: 1 X 108 to
1 X1012 infectious
particles/ml
Example: E. coli,
Host and Strain
SureTM, Mouse heart
cells, in vivo
Host Range
(including any
genetic
alterations to
Example: Human,
other mammalian
cells
host range)
Is recombinant
made in your
lab? If not,
where?
Example: UF Powell
Gene Therapy
Center
What (approx.)
% of original
vector genome
has been
deleted or
substituted?
Example: two thirds
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R-DNA
Document of Registration
RD 14. Full Project Description in Lay Terminology with Methods and procedures (add additional pages as needed):
15. What effect would transgene expression have in an accidental host?
16. Other possible safety hazards associated with this project and how you will address them:
17. Biosafety level and NIH guideline citation (IBC use) ________________________________________________
18. Health surveillance (IBC use) ____________________________________________________________________
Please Attach Vector/Construct Maps. Electronic versions preferred (i.e. .bmp,
.tif, .jpg, .pdf), but hard copies acceptable.
The next page can be signed then faxed, mailed, or scanned and e-mailed.
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R-DNA
Document of Registration
RD -
This page can be signed then faxed, mailed, or scanned and e-mailed separately if needed.
19.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 (Please Type or Print)
Signatures
Date
13. I attest to the fact that these individuals are properly trained in the area of recombinant DNA
experimentation. Furthermore, I agree to comply with the NIH requirements pertaining to shipment and
transfer of recombinant DNA 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. The
information above is accurate and complete.
Principal Investigator
Date
14. The indicated sites have been inspected and are in compliance with the NIH Guidelines.
Biological Safety Officer
Date
Please return this completed form to:
Shelley Jones
Biological Safety Office
Bldg. 56
P.O. Box 4073
Fax – 928-523-0050
Shelley.Jones@nau.edu
Phone – 928-523-7268
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