IBC Use Only
R-DNA & Synthetic Nucleic
Registration # _________
Acids Registration Form
* The agent Risk Group (RG) can be found in the NIH Guidelines for Research Involving Recombinant
DNA Molecules, Appendix B.
** Recombinant and synthetic nucleic acid molecules are defined as:
(i) Molecules that a) are constructed by joining nucleic acid molecules and b) 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.
*** Whole animal means any and all multicellular organisms, in any life stage, of the kingdom Animalia (i.e.
insects, nematodes, fish, mammals, etc.).
THIS APPLICATION MUST BE TYPEWRITTEN
1.
2.
3.
4.
Principal Investigator:
Department/Division:
Office Address:
Lab Address:
M.D. [ ] Ph.D. [ ] Other:
Email:
Phone:
Phone:
5. List all professional personnel, employees and students involved in the project who will be working
with these materials. Attach an additional sheet if needed.
Name
Job Title
Lab Address
Phone Number
6. Do you request vaccination or medical surveillance?
University of Utah R-DNA Registration
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Yes [ ]
No [ ]
7. Project Title:
8. Grant # (if applicable):
Is this an NIH grant or contract number?
Yes [ ] No [ ]
If yes, NIH funding institute or center:
NIH program officer contact information (name, email, phone):
9. Are you using Recombinant DNA?
Yes [ ] No [ ]
Are you using Synthetic Nucleic ACID
Molecules?
10. Will known or potential human, animal, or
plant pathogens be used in this research (e.g.,
adenovirus, adeno-associated virus, lentivirus,
vaccinia virus)?
Yes [ ]
No [ ]
Yes [ ] No [ ]
If yes, please specify the genus, species, and strain:
Proposed Containment Level: BSL1 [ ] BSL2 [ ] BSL2
enhanced [ ] BSL3 [ ]
Vector?
Acquired from:
11. Cloning vector to be used (plasmid, viral
vector, etc.)?
Check here if not applicable [ ]
12. Will the vector contain more than twothirds of any eukaryotic viral genome?
13. Is a helper virus used?
14. Specify the gene(s) of interest to be
inserted, synthesized or amplified into the
recombinant.
Proposed Containment Level: BSL1 [ ] BSL2 [ ] BSL3 [ ]
A construct map must be attached for
Yes [ ] No [ ]
all vectors used in this experiment.
Yes [ ] No [ ]
If yes, a retrovirus? Yes [ ] No [ ]
Name of gene sequence(s)?
Acquired from:
Source (human/animal/microbial)?
15. Will experiments involve the cloning of
Yes [ ] No [ ]
toxin molecules with an LD50 of less than 100
nanograms per kilogram body weight?
16. Will experiments involve the deliberate
Yes [ ] No [ ]
transfer of a drug resistance trait to
microorganisms, other than antibiotic
resistance genes used for cloning in bacteria?
17. Will you have more than 10 liters of recombinant DNA culture
or synthetic nucleic acid molecules (all sources) in your lab at any
given time?
If yes, please explain:
18. Do laboratory personnel work with
human cell cultures, blood, tissues, organs,
or body fluids?
If yes, please specify:
Yes [ ]
No [ ]
If yes, please explain:
Yes [ ]
No [ ]
19. Please check all situation(s) that apply to your project:
Host-Vector Systems
Escherichia coli
Yes [ ]
No [ ]
Strain:
Risk Group*:
Other Bacteria
Yes [ ]
No [ ]
Strain:
Risk Group*:
Yeast
Yeast Artificial
Chromosome (YAC)
Yes [ ]
Yes [ ]
No [ ]
No [ ]
Strain:
Specify:
Cell and Tissue Culture
Will recombinant or synthetic DNA molecules be
propagated and/or maintained in cells in
tissue/cell culture?
Yes [ ]
Whole Animals**
Will whole animals be
used in this project?
Yes [ ] No [ ]
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Species:
No [ ]
Cell Line:
Will whole animals be
exposed to recombinant or
synthetic DNA molecules/
modified microorganisms?
Does this research involve
generating transgenic
animals?
Will transgenic animals be
purchased or transferred
as part of this research?
Has the Institutional
Animal Care and Use
Committee been notified?
Yes [ ] No [ ]
If yes, where will the animal work be conducted (bldg & room #)?
Proposed containment level? ABSL1 [ ] ABSL2 [ ] ABSL3 [ ]
Yes [ ] No [ ]
If yes, where will the transgenic animal work be conducted (bldg &
room #)?
Proposed containment level? ABSL1 [ ] ABSL2 [ ] ABSL3 [ ]
If yes, please indicate the provider or recipient:
Yes [ ] No [ ]
Yes [ ] No [ ]
If yes, IACUC Protocol # and IACUC Project Title:
Yes [ ] No [ ]
Species:
Yes [ ] No [ ]
If yes, please explain:
Yes [ ] No [ ]
If yes, IRB Protocol # and IRB Project Title:
Whole Plants
Will experiments be
conducted with whole
plants?
Will plants, seeds, or plant
parts be released into the
environment or used in
field tests?
Human Subjects
Human Subject Recipient?
20. Give specific reference for your experiment from the NIH Guidelines for Research Involving
Recombinant DNA Molecules (e.g. Section III-D-1). The NIH Guidelines can be accessed at
http://oba.od.nih.gov/rdna/nih_guidelines_oba.html
This project falls under the following Section from the NIH Guidelines:
21. Please mark the box for all pieces of equipment that apply to this project:
Centrifuge
Vortex Mixer
Specimen Transport Containers
Blender
Fermentor
Vacuum Traps
Sonicator
Shaker
Cell Sorter
Homogenizer
Ventilated or Filtered Animal Caging
Hemocytometer
22. Attach a short, clear summary of your proposed recombinant DNA or synthetic nucleic acid experiments, in
lay terms that will explain their essential features. Avoid jargon and excess technical detail. Address each of the
following items and include any other data that you feel has important bearing upon the safety and the proposed
containment level for this project.
a. Provide a brief summary of your proposed experiments, and explain exactly why you are performing
operations that make the experiments non-exempt from the NIH Guidelines.
b. Briefly explain and justify the use of pathogenic organisms, synthetic nucleic acids or viral vectors
listed in box 10 or 11.
c. Identify and describe the risk(s) to humans associated with pathogenic organisms, synthetic nucleic
acid molecules or viral vectors used in the experiment.
d. Specifically identify the gene(s) of interest, including a description of any associated hazards (i.e.
genes that are chemically synthesized or amplified or genes that code for toxic, oncogenic, or
otherwise hazardous peptides).
e. Describe any special precautions required for containment and personal safety. Include procedures
for transport or shipment of biological materials or animals associated with this project.
f. If research involves the use of animals, identify and describe animal biosafety risks (i.e. excretion of
virus from the animal, what will happen to the animal after the experiment, and any ecological
University of Utah R-DNA Registration
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advantages or environmental risks that experimental animals might acquire through the
experiment).
g. Please attach written lab-specific safety procedures that will be followed for all work BSL-2 and
above (see NIH Guidelines Appendix G for Biosafety Level criteria). Procedures must address both
safety to laboratory personnel and containment of laboratory animals.
h. For experiments that will be conducted at BSL-2 or above, please describe the experience and
training of all individuals listed on this registration form that qualify them to work at the proposed
containment level. For individuals who lack training and experience, please describe your plan to
train them to a level of proficiency that will allow them to work safely under these conditions.
23. I hereby apply for approval of my plans for experiments involving recombinant DNA and/or
synthetic nucleic acid molecules. I am familiar with, and agree to abide by, the provisions of the current
NIH Guidelines (April 2002 Federal Register (or later) and appendices), and any other specific NIH or
University of Utah instructions pertaining to the proposed project. I agree to provide the IBC prompt
written notification of any significant changes in these protocols or of any major accidents involving
recombinant DNA and/or synthetic nucleic acid molecules. I agree to comply with NIH requirements
pertaining to shipment and transfer of recombinant DNA and/or synthetic DNA materials.
I accept responsibility for the safe conduct of work with this material as indicated on any page of this
form, and in any additional information submitted in connection with this application, or updating or
revising this application. I will ensure that all personnel receive appropriate training in regard to proper
safety practices and personal protective equipment needed for this work and that all building occupants
are educated when warranted.
I certify that all herein provided information, and any subsequent information submitted in connection
with this application, is accurate and complete.
Principal Investigator (signature/date):_____________________________________________________
Send a copy of completed forms to the following individual:
Biosafety Specialist
Environmental Health & Safety University of Utah
125 S. Fort Douglas Blvd., Building 605
Salt Lake City, Utah 84113
Office (801) 581-6590 Fax (801 585-7240
e-mail biosafety@ehs.utah.edu
10/31/2010
University of Utah R-DNA Registration
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